- Nakafero G, Card T, Grainge MJ, Williams HC, Taal MW, Aithal GP, et al. Risk-stratified monitoring for thiopurine toxicity in immune-mediated inflammatory diseases: prognostic model development, validation, and, health economic evaluation. EClinicalMedicine 2023;64:102213.37745026
- Leaviss J, Carroll C, Essat M, van der Windt D, Grainge MJ, Card T, et al.; Monitoring Inflammatory Conditions Investigators. Prognostic factors for liver, blood and kidney adverse events from glucocorticoid sparing immune-suppressing drugs in immune-mediated inflammatory diseases: a prognostic systematic review. RMD Open 2024;10:e003588.38199851
- Abhishek A, Grainge M, Card T, Williams HC, Taal MW, Aithal GP, et al. Risk-stratified monitoring for sulfasalazine toxicity: prognostic model development and validation. RMD Open 2024;10:e003980.38453215
- Abhishek A, Stevenson MD, Nakafero G, Grainge MJ, Evans I, Alabas O, et al. Discontinuation of anti-tumour necrosis factor alpha treatment owing to blood test abnormalities, and cost-effectiveness of alternate blood monitoring strategies. Br J Dermatol 2024;190:559–64.37931161
- Fuller A, Hancox J, Williams HC, Card T, Taal MW, Aithal GP, et al. Patient and health professional views on risk-stratified monitoring of immune-suppressing treatment in adults with inflammatory diseases. Rheumatology 2024;64:969–75.
- Abhishek A, Doherty M, Kuo C, Mallen CD, Zhang W, Grainge MJ. Rheumatoid arthritis is getting less frequent-results of a nationwide population-based cohort study. Rheumatology 2017;56:736–44.28064207
- van Staa TP, Cooper C, Brusse LS, Leufkens H, Javaid MK, Arden NK. Inflammatory bowel disease and the risk of fracture. Gastroenterology 2003;125:1591–7.14724810
- Springate D, Parisi R, Kontopantelis E, Reeves D, Griffiths CEM, Ashcroft DM. Incidence, prevalence and mortality of patients with psoriasis: a U.K. population-based cohort study. Br J Dermatol 2017;176:650–8.27579733
- Nakafero G, Grainge M, Myles P, et al. Predictors and temporal trend of flu vaccination in auto-immune rheumatic diseases in the UK: a nationwide prospective cohort study. Rheumatology 2018;57:1726–34.29901743
- Dean LE, Jones GT, MacDonald AG, Downham C, Sturrock RD, Macfarlane GJ. Global prevalence of ankylosing spondylitis. Rheumatology 2014;53:650–7.24324212
- Rees F, Doherty M, Grainge M, Davenport G, Lanyon P, Zhang W. The incidence and prevalence of systemic lupus erythematosus in the UK, 1999–2012. Ann Rheum Dis 2016;75:136–41.25265938
- Lamb C, Kennedy N, Raine T, Hendy PA, Smith PJ, Limdi JK, et al. British Society of Gastroenterology consensus guidelines on the management of inflammatory bowel disease in adults. Gut 2019;68:s1–106.31562236
- Ledingham J, Gullick N, Irving K, Gorodkin R, Aris M, Burke J, et al.; BSR and BHPR Standards, Guidelines and Audit Working Group. BSR and BHPR guideline for the prescription and monitoring of non-biologic disease-modifying anti-rheumatic drugs. Rheumatology 2017;56:865–8.28339817
- American College of Rheumatology Ad Hoc Committee. American College of Rheumatology Ad Hoc Committee on Clinical Guidelines. Guidelines for monitoring drug therapy in rheumatoid arthritis. Arthritis Rheum 1996;39:723–31.8639168
- Menter A, Korman NJ, Elmets CA, Feldman SR, Gelfand JM, Gordon KB, et al. Guidelines of care for the management of psoriasis and psoriatic arthritis: section 4. Guidelines of care for the management and treatment of psoriasis with traditional systemic agents. J Am Acad Dermatol 2009;61:451–85.19493586
- Zorzela L, Loke YK, Ioannidis JP, Golder S, Santaguida P, Altman DG, et al. PRISMA harms checklist: improving harms reporting in systematic reviews. BMJ 2016;352:i157.26830668
- McMaster University. Unit HIR Hedges Project. 2022. URL: https://hiruweb.mcmaster.ca/hkr/hedges/ (accessed 1 April 2023).
- Sterne J, Savović J, Page M, Elbers RG, Blencowe NS, Boutron I, et al. RoB 2: a revised tool for assessing risk of bias in randomised trials. BMJ 2019;366:l4898.31462531
- Sterne J, Hernán M, Reeves B, Savović J, Berkman ND, Viswanathan M, et al. ROBINS-I: a tool for assessing risk of bias in non-randomised studies of interventions. BMJ 2016;355:i4919.27733354
- Shemilt I, Khan N, Park S, Thomas J. Use of cost-effectiveness analysis to compare the efficiency of study identification methods in systematic reviews. Syst Rev 2016;5:140.27535658
- Hemingway H, Croft P, Perel P, Hayden JA, Abrams K, Timmis A, et al.; PROGRESS Group. Prognosis research strategy (PROGRESS) 1: a framework for researching clinical outcomes. BMJ 2013;346:e5595.23386360
- Riley RD, Moons KGM, Snell KIE, Ensor J, Hooft L, Altman DG, et al. A guide to systematic review and meta-analysis of prognostic factor studies. BMJ 2019;364:k4597.30700442
- Page M, McKenzie J, Bossuyt P, et al. The PRISMA 2020 statement: an updated guideline for reporting systematic reviews. BMJ 2021;372:n71.33782057
- Chang S, Matchar D, Smetana G, Umscheid CA. Methods Guide for Medical Test Reviews. Rockville, MD: Agency for Healthcare Research and Quality; 2012.
- Wilson DB. Practical Meta-Analysis Effect Size Calculator [Online Calculator]. Campbell Collaboration. 2023. URL: https://www.campbellcollaboration.org/calculator/ (accessed 4 April 2023).
- Hayden J, van der Windt D, Cartwright J, Côté P, Bombardier C. Assessing bias in studies of prognostic factors. Ann Intern Med 2013;158:280–6.23420236
- Iorio A, Spencer F, Falavigna M, Alba C, Lang E, Burnand B, et al. Use of GRADE for assessment of evidence about prognosis: rating confidence in estimates of event rates in broad categories of patients. BMJ 2015;350:h870.25775931
- Burmester GR, Lin Y, Patel R, van Adelsberg J, Mangan EK, Graham NMH, et al. Efficacy and safety of sarilumab monotherapy versus adalimumab monotherapy for the treatment of patients with active rheumatoid arthritis (MONARCH): a randomised, double-blind, parallel-group phase III trial. Ann Rheum Dis 2017;76:840–7.27856432
- Deodhar A, Gensler LS, Kay J, Maksymowych WP, Haroon N, Landewé R, et al. A fifty-two-week, randomized, placebo-controlled trial of certolizumab pegol in nonradiographic axial spondyloarthritis. Arthritis Rheumatol 2019;71:1101–11.30848558
- Finckh A, Dehler S, Gabay C, SCQM doctors. The effectiveness of leflunomide as a co-therapy of tumour necrosis factor inhibitors in rheumatoid arthritis: a population-based study. Ann Rheum Dis 2009;68:33–9.18230627
- Fragoulis GE, Paterson C, Gilmour A, Derakhshan MH, McInnes IB, Porter D, Siebert S. Neutropaenia in early rheumatoid arthritis: frequency, predicting factors, natural history and outcome. RMD Open 2018;4:e000739.30402267
- Nikiphorou E, Negoescu A, Fitzpatrick JD, Goudie CT, Badcock A, Östör AJK, Malaviya AP. Indispensable or intolerable? Methotrexate in patients with rheumatoid and psoriatic arthritis: a retrospective review of discontinuation rates from a large UK cohort. Clin Rheumatol 2014;33:609–14.24609758
- Moran GW, Dubeau MF, Kaplan GG, Yang H, Eksteen B, Ghosh S, Panaccione R. Clinical predictors of thiopurine-related adverse events in Crohn’s disease. World J Gastroenterol 2015;21:7795–804.26167079
- Tesser J, Kafka S, Dehoratius RJ, Xu S, Hsia EC, Turkiewicz A. Efficacy and safety of intravenous golimumab plus methotrexate in patients with rheumatoid arthritis aged < 65 years and those ≥ 65 years of age. Arthritis Res Ther 2019;21:190.31429794
- van der Heijde D, Dijkmans B, Geusens P, Sieper J, DeWoody K, Williamson P, Braun J; Ankylosing Spondylitis Study for the Evaluation of Recombinant Infliximab Therapy Study Group. Efficacy and safety of infliximab in patients with ankylosing spondylitis: results of a randomized, placebo-controlled trial (ASSERT). Arthritis Rheum 2005;52:582–91.15692973
- Gelfand JM, Wan J, Zhang H, Shin DB, Ogdie A, Syed MN, Egeberg A. Risk of liver disease in patients with psoriasis, psoriatic arthritis, and rheumatoid arthritis receiving methotrexate: a population-based study. J Am Acad Dermatol 2021;84:1636–43.33607181
- Humphreys J, Warner A, Costello R, Lunt M, Verstappen S, Dixon W. Quantifying the hepatotoxic risk of alcohol consumption in patients with rheumatoid arthritis taking methotrexate. Ann Rheum Dis 2017;76:1509–14.28341765
- Broekman MMTJ, Coenen MJH, Wanten GJ, van Marrewijk CJ, Klungel OH, Verbeek ALM, et al. Risk factors for thiopurine-induced myelosuppression and infections in inflammatory bowel disease patients with a normal TPMT genotype. Aliment Pharmacol Ther 2017;46:953–63.28914446
- Chiu YM, Lai MS, Arnold Chan K. Commensurate incidence and outcomes of liver enzyme elevation between anti-tumor necrosis factor users with or without prior hepatitis B virus infections. PLOS ONE 2018;13:e0196210.29694398
- Curtis JR, Beukelman T, Onofrei A, Cassell S, Greenberg JD, Kavanaugh A, et al. Elevated liver enzyme tests among patients with rheumatoid arthritis or psoriatic arthritis treated with methotrexate and/or leflunomide. Ann Rheum Dis 2010;69:43–7.19147616
- Dirven L, Klarenbeek NB, van den Broek M, van Groenendael JHLM, de Sonnaville PBJ, Kerstens PJSM, et al. Risk of alanine transferase (ALT) elevation in patients with rheumatoid arthritis treated with methotrexate in a DAS-steered strategy. Clin Rheumatol 2013;32:585–90.23224330
- Fangbin Z, Xiang G, Minhu C, Liang D, Feng X, Min H, Pinjin H. Should thiopurine methyltransferase genotypes and phenotypes be measured before thiopurine therapy in patients with inflammatory bowel disease? Ther Drug Monit 2012;34:695–701.23149442
- Jiang M, Zha Q, He Y, Lu A. Risk factors of gastrointestinal and hepatic adverse drug reactions in the treatment of rheumatoid arthritis with biomedical combination therapy and Chinese medicine. J Ethnopharmacol 2012;141:615–21.21782923
- Karlsson Sundbaum J, Eriksson N, Hallberg P, Lehto N, Wadelius M, Baecklund E. Methotrexate treatment in rheumatoid arthritis and elevated liver enzymes: a long-term follow-up of predictors, surveillance, and outcome in clinical practice. Int J Rheumat Dis 2019;22:1226–32.
- Kent PD, Luthra HS, Michet C Jr. Risk factors for methotrexate-induced abnormal laboratory monitoring results in patients with rheumatoid arthritis. J Rheumatol 2004;31:1727–31.15338491
- Kim JH, Cheon JH, Hong SS, Eun CS, Byeon JS, Hong SY, et al. Influences of thiopurine methyltransferase genotype and activity on thiopurine-induced leukopenia in Korean patients with inflammatory bowel disease: a retrospective cohort study. J Clin Gastroenterol 2010;44:e242–8.20308917
- Labidi A, Hafi M, Ben Mustapha N, Serghini M, Fekih M, Boubaker J. Toxicity profile of thiopurines in inflammatory bowel disease: a retrospective cohort analysis. Tunis Med 2020;98:404–12.32548844
- Kreijne JE, de Vries AC, de Veer RC, Bouma G, Dijkstra G, Voskuil MD, et al.; Initiative on Crohn and Colitis (ICC). Limited added value of laboratory monitoring in thiopurine maintenance monotherapy in inflammatory bowel disease patients. Aliment Pharmacol Ther 2020;51:1353–64.32342997
- Parisi I, O’Beirne J, Rossi RE, Tsochatzis E, Manousou P, Theocharidou E, et al. Elevated liver enzymes in inflammatory bowel disease: the role and safety of infliximab. Eur J Gastroenterol Hepatol 2016;28:786–91.27015138
- Park SK, Hong M, Ye BD, Kim KJ, Park SH, Yang DH, et al. Influences of XDH genotype by gene–gene interactions with SUCLA2 for thiopurine-induced leukopenia in Korean patients with Crohn’s disease. Scand J Gastroenterol 2016;51:684–91.26863601
- Tilling L, Townsend S, David J. Methotrexate and hepatic toxicity in rheumatoid arthritis and psoriatic arthritis. Clin Drug Investig 2006;26:55–62.
- Verstappen SM, Bakker MF, Heurkens AH, van der Veen MJ, Kruize AA, Geurts MAW, et al.; Utrecht Rheumatoid Arthritis Cohort Study Group. Adverse events and factors associated with toxicity in patients with early rheumatoid arthritis treated with methotrexate tight control therapy: the CAMERA study. Ann Rheum Dis 2010;69:1044–8.19581281
- Wong DR, Coenen MJH, Derijks LJJ, Vermeulen SH, van Marrewijk CJ, Klungel OH, et al.; TOPIC Recruitment Team. Early prediction of thiopurine-induced hepatotoxicity in inflammatory bowel disease. Aliment Pharmacol Ther 2017;45:391–402.27943397
- Islam MN, Alam MN, Haq SA, Moyenuzzaman M, Patwary MI, Rahman MH. Efficacy of sulphasalazine plus methotrexate in rheumatoid arthritis. Bangladesh Med Res Counc Bull 2000;26:1–7.11192489
- Herrlinger KR, Cummings JR, Barnardo MC, Schwab M, Ahmad T, Jewell DP. The pharmacogenetics of methotrexate in inflammatory bowel disease. Pharmacogenet Genomics 2005;15:705–11.16141796
- Macaluso FS, Sapienza C, Ventimiglia M, Renna S, Rizzuto G, Orlando R, et al. The addition of an immunosuppressant after loss of response to anti-TNFalpha monotherapy in inflammatory bowel disease: a 2-year study. Inflamm Bowel Dis 2018;24:394–401.29361087
- Svensson B, Boonen A, Albertsson K, Van Der Heijde D, Keller C, Hafstrom I. Low-dose prednisolone in addition to the initial disease-modifying antirheumatic drug in patients with early active rheumatoid arthritis reduces joint destruction and increases the remission rate: a two-year randomized trial. Arthritis Rheum 2005;52:3360–70.16255010
- Mease PJ, Smolen JS, Behrens F, Nash P, Liu Leage S, Li L, et al.; SPIRIT H2H Study Group. A head-to-head comparison of the efficacy and safety of ixekizumab and adalimumab in biological-naive patients with active psoriatic arthritis: 24-week results of a randomised, open-label, blinded-assessor trial. Ann Rheum Dis 2020;79:123–31.31563894
- Mease P, Hall S, FitzGerald O, van der Heijde D, Merola JF, Avila-Zapata F, et al. Tofacitinib or adalimumab versus placebo for psoriatic arthritis. N Engl J Med 2017;377:1537–50.29045212
- Lofberg R, Louis EV, Reinisch W, Robinson AM, Kron M, Camez A, Pollack PF. Adalimumab produces clinical remission and reduces extraintestinal manifestations in Crohn’s disease: results from CARE. Inflamm Bowel Dis 2012;18:1–9.21351211
- Ricceri F, Bardazzi F, Chiricozzi A, Dapavo P, Ferrara F, Mugheddu C, et al. Elderly psoriatic patients under biological therapies: an Italian experience. J Eur Acad Dermatol Venereol 2019;33:143–6.29906311
- Burmester GR, Kivitz AJ, Kupper H, Arulmani U, Florentinus S, Goss SL, et al. Efficacy and safety of ascending methotrexate dose in combination with adalimumab: the randomised CONCERTO trial. Ann Rheum Dis 2015;74:1037–44.24550168
- Burmester GR, Landewe R, Genovese MC, Friedman AW, Pfeifer ND, Varothai NA, Lacerda AP. Adalimumab long-term safety: infections, vaccination response and pregnancy outcomes in patients with rheumatoid arthritis. Ann Rheumat Dis 2016;76:414–7.27338778
- Burmester GR, Kaeley GS, Kavanaugh AF, Gabay C, MacCarter DK, Nash P, et al. Treatment efficacy and methotrexate-related toxicity in patients with rheumatoid arthritis receiving methotrexate in combination with adalimumab. Rmd Open 2017;3:e000465.28955494
- Cohen S, Genovese MC, Choy E, Perez-Ruiz F, Matsumoto A, Pavelka K, et al. Efficacy and safety of the biosimilar ABP 501 compared with adalimumab in patients with moderate to severe rheumatoid arthritis: a randomised, double-blind, phase III equivalence study. Ann Rheumat Dis 2017;76:1679–87.28584187
- Cohen S, Pablos JL, Pavelka K, Müller GA, Matsumoto A, Kivitz A, et al. An open-label extension study to demonstrate long-term safety and efficacy of ABP 501 in patients with rheumatoid arthritis. Arthrit Res Therapy 2019;21:84.
- Fleischmann RM, Genovese MC, Enejosa JV, Mysler E, Bessette L, Peterfy C, et al. Safety and effectiveness of upadacitinib or adalimumab plus methotrexate in patients with rheumatoid arthritis over 48 weeks with switch to alternate therapy in patients with insufficient response. Ann Rheum Dis 2019;78:1454–62.31362993
- Fleischmann RM, Alten R, Pileckyte M, Lobello K, Hua SY, Cronenberger C, et al. A comparative clinical study of PF-06410293, a candidate adalimumab biosimilar, and adalimumab reference product (Humira®) in the treatment of active rheumatoid arthritis. Arthrit Res Therapy 2018;20:178.
- Fleischmann R, Mysler E, Hall S, Kivitz AJ, Moots RJ, Luo Z, et al.; ORAL Strategy Investigators. Efficacy and safety of tofacitinib monotherapy, tofacitinib with methotrexate, and adalimumab with methotrexate in patients with rheumatoid arthritis (ORAL strategy): a phase 3b/4, double-blind, head-to-head, randomised controlled trial. Lancet 2017;390:457–68.28629665
- Szekanecz Z, Koncz A, Dunkel J, Vencovsky J, collaborators C. Cigarette smoking and clinical response to certolizumab pegol treatment in Hungarian, Czech, and Slovak patients with rheumatoid arthritis: 104-week data from the CIMDORA prospective, non-interventional study. Clin Exp Rheumatol 2019;37:1010–8.30963993
- Yamamoto K, Takeuchi T, Yamanaka H, Ishiguro N, Tanaka Y, Eguchi K, et al. Efficacy and safety of certolizumab pegol plus methotrexate in Japanese rheumatoid arthritis patients with an inadequate response to methotrexate: the J-RAPID randomized, placebo-controlled trial. Mod Rheumatol 2014;24:715–24.24313916
- Smolen J, Landewé RB, Mease P, Brzezicki J, Mason D, Luijtens K, et al. Efficacy and safety of certolizumab pegol plus methotrexate in active rheumatoid arthritis: the RAPID 2 study. A randomised controlled trial. Ann Rheum Dis 2009;68:797–804.19015207
- Fleischmann R, Vencovsky J, van Vollenhoven RF, Borenstein D, Box J, Coteur G, et al. Efficacy and safety of certolizumab pegol monotherapy every 4 weeks in patients with rheumatoid arthritis failing previous disease-modifying antirheumatic therapy: the FAST4WARD study. Ann Rheum Dis 2009;68:805–11.19015206
- Bathon JM, Martin RW, Fleischmann RM, Tesser JR, Schiff MH, Keystone EC, et al. A comparison of etanercept and methotrexate in patients with early rheumatoid arthritis. N Engl J Med 2000;343:1586–93.11096165
- Moreland LW, Weinblatt ME, Keystone EC, Kremer JM, Martin RW, Schiff MH, et al. Etanercept treatment in adults with established rheumatoid arthritis: 7 years of clinical experience. J Rheumatol 2006;33:854–61.16541481
- Chen XX, Dai Q, Huang AB, Wu HX, Zhao DB, Li XF, et al. A multicenter, randomized, double-blind clinical trial of combination therapy with Anbainuo, a novel recombinant human TNFRII:Fc fusion protein, plus methotrexate versus methotrexate alone or Anbainuo alone in Chinese patients with moderate to severe rheumatoid arthritis. Clin Rheumatol 2013;32:99–108.23053688
- Gottlieb AB, Langley RG, Strober BE, Papp KA, Klekotka P, Creamer K, et al. A randomized, double-blind, placebo-controlled study to evaluate the addition of methotrexate to etanercept in patients with moderate to severe plaque psoriasis. Br J Dermatol 2012;167:649–57.22533447
- Liu LF, Chen JS, Gu J, Xu JH, Jin HZ, Pang XW, et al. Etanercept biosimilar (recombinant human tumor necrosis factor-alpha receptor II: IgG Fc fusion protein) and methotrexate combination therapy in Chinese patients with moderate-to-severe plaque psoriasis: a multicentre, randomized, double-blind, placebo-controlled trial. Arch Dermatol Res 2020;312:437–45.31873772
- Combe B, Codreanu C, Fiocco U, Gaubitz M, Geusens PP, Kvien TK, et al.; Etanercept European Investigators Network. Efficacy, safety and patient-reported outcomes of combination etanercept and sulfasalazine versus etanercept alone in patients with rheumatoid arthritis: a double-blind randomised 2-year study. Ann Rheum Dis 2009;68:1146–52.18794178
- Combe B, Codreanu C, Fiocco U, Gaubitz M, Geusens PP, Kvien TK, et al.; Etanercept European Investigators Network (Etanercept Study 309 Investigators). Etanercept and sulfasalazine, alone and combined, in patients with active rheumatoid arthritis despite receiving sulfasalazine: a double-blind comparison. Ann Rheum Dis 2006;65:1357–62.16606651
- Iannone F, Santo L, Anelli MG, Bucci R, Semeraro A, Quarta L, et al. Golimumab in real-life settings: 2 years drug survival and predictors of clinical outcomes in rheumatoid arthritis, spondyloarthritis, and psoriatic arthritis. Semin Arthritis Rheum 2017;47:108–14.28216195
- Braun J, Deodhar A, Inman RD, van der Heijde D, Mack M, Xu S, Hsu B. Golimumab administered subcutaneously every 4 weeks in ankylosing spondylitis: 104-week results of the GO-RAISE study. Ann Rheum Dis 2012;71:661–7.22012970
- Roberti R, Iannone LF, Palleria C, De Sarro C, Spagnuolo R, Barbieri MA, et al. Safety profiles of biologic agents for inflammatory bowel diseases: a prospective pharmacovigilance study in Southern Italy. Curr Med Res Opin 2020;36:1457–63.32573307
- Sepriano A, Ramiro S, van der Heijde D, Ávila-Ribeiro P, Fonseca R, Borges J, et al. Effect of comedication with conventional synthetic disease-modifying antirheumatic drugs on retention of tumor necrosis factor inhibitors in patients with spondyloarthritis: a prospective cohort study. Arthrit Rheumatol 2016;68:2671–9.
- Weinblatt ME, Bingham III CO, Mendelsohn AM, Noonan L, Sheng S, Kim L, et al. Intravenous golimumab inhibits radiographic progression and maintains clinical efficacy and safety in patients with active rheumatoid arthritis despite methotrexate therapy: 2-year results of a phase 3 trial of intravenous golimumab. Arthritis Rheum 2013;65:S1183–4.
- Akhlaghi S, Sahebari M, Mahmoodi M, Yaseri M, Mansournia MA, Rafatpanah H, Zeraati H. Additional effect of etanercept or infliximab on the liver function tests of patients with rheumatoid arthritis: a cohort study. Ther Clin Risk Manag 2018;14:1943–50.30349273
- Van Vollenhoven RF, Geborek P, Forslind K, Albertsson K, Ernestam S, Petersson IF, et al.; Swefot Study Group. Conventional combination treatment versus biological treatment in methotrexate-refractory early rheumatoid arthritis: 2 year follow-up of the randomised, non-blinded, parallel-group Swefot trial. Lancet 2012;379:1712–20.22464340
- van Vollenhoven RF, Ernestam S, Geborek P, Petersson IF, Cöster L, Waltbrand E, et al. Addition of infliximab compared with addition of sulfasalazine and hydroxychloroquine to methotrexate in patients with early rheumatoid arthritis (Swefot trial): 1-year results of a randomised trial. Lancet 2009;374:459–66.19665644
- Schultz M, Keeling SO, Katz SJ, Maksymowych WP, Eurich DT, Hall JJ. Clinical effectiveness and safety of leflunomide in inflammatory arthritis: a report from the RAPPORT database with supporting patient survey. Clin Rheumatol 2017;36:1471–8.28550389
- Sheytanov I, Petranova TS, Monov S, Stoilov N, Batalov A, Nestorova R. Leflunomide treatment in patients with early and refractory rheumatoid arthritis. J Balkan Tribol Assoc 2013;19:251–64.
- Tlustochowicz ME, Kisiel B, Tlustochowicz W. Quality of life and clinical outcomes in Polish patients with high activity rheumatoid arthritis treated with leflunomide (Arava (R)) in Therapeutic Program: a retrospective analysis of data from the PLUS study. Adv Clin Exp Med 2019;28:1545–53.31660707
- Chen Z, Li XP, Li ZJ, Xu L, Li XM. Reduced hepatotoxicity by total glucosides of paeony in combination treatment with leflunomide and methotrexate for patients with active rheumatoid arthritis. Int Immunopharmacol 2013;15:474–7.23415907
- Ren LM, Li R, Chen LN, Zhu P, Gu F, Sun LY, et al. Efficacy and safety of weekly leflunomide for the treatment of early rheumatoid arthritis: a randomized, multi-center study. Int J Rheumat Dis 2016;19:651–7.
- Verschueren P, De Cock D, Corluy L, Joos R, Langenaken C, Taelman V, et al. Effectiveness of methotrexate with step-down glucocorticoid remission induction (COBRA Slim) versus other intensive treatment strategies for early rheumatoid arthritis in a treat-to-target approach: 1-year results of CareRA, a randomised pragmatic open-label superiority trial. Ann Rheum Dis 2017;76:511–20.27432356
- Grove ML, Hassell AB, Hay EM, Shadforth MF. Adverse reactions to disease-modifying anti-rheumatic drugs in clinical practice. QJM 2001;94:309–19.11391029
- Ordi-Ros J, Saez-Comet L, Perez-Conesa M, Vidal X, Mitjavila F, Castro Salomó A, et al. Enteric-coated mycophenolate sodium versus azathioprine in patients with active systemic lupus erythematosus: a randomised clinical trial. Ann Rheum Dis 2017;76:1575–82.28450313
- Macaluso FS, Renna S, Maida M, Dimarco M, Sapienza C, Affronti M, et al. Tolerability profile of thiopurines in inflammatory bowel disease: a prospective experience. Scand J Gastroenterol 2017;52:981–7.28554266
- Dougados M, vam der Linden S, Leirisalo-Repo M, Huitfeldt B, Juhlin R, Veys E, et al. Sulfasalazine in the treatment of spondylarthropathy. A randomized, multicenter, double-blind, placebo-controlled study. Arthritis Rheum 1995;38:618–27.7748217
- Gordon MM, Porter DR, Capell HA. Does sulphasalazine cause drug induced systemic lupus erythematosus? No effect evident in a prospective randomised trial of 200 rheumatoid patients treated with sulphasalazine or auranofin over five years. Ann Rheum Dis 1999;58:288–90.10225813
- Capell HA, Maiden N, Madhok R, Hampson R, Thomson EA. Intention-to-treat analysis of 200 patients with rheumatoid arthritis 12 years after random allocation to either sulfasalazine or penicillamine. J Rheumatol 1998;25:1880–6.9779839
- Masuda H, Takahashi Y, Nishida Y, Asai S. Comparison of the effect of mesalazine and sulfasalazine on laboratory parameters: a retrospective observational study. Eur J Clin Pharmacol 2012;68:1549–55.22546896
- Dougados M, Emery P, Lemmel EM, de la Serna R, Zerbini CA, Brin S, van Riel P. Efficacy and safety of leflunomide and predisposing factors for treatment response in patients with active rheumatoid arthritis: RELIEF 6-month data. J Rheumatol 2003;30:2572–9.14719196
- Di Paolo MC, Paoluzi OA, Pica R, Iacopini F, Crispino P, Rivera M, et al. Sulphasalazine and 5-aminosalicylic acid in long-term treatment of ulcerative colitis: report on tolerance and side-effects. Dig Liver Dis 2001;33:563–9.11816545
- Miner P Jr, Hanauer S, Robinson M, Schwartz J, Arora S. Safety and efficacy of controlled-release mesalamine for maintenance of remission in ulcerative colitis. Dig Dis Sci 1995;40:296–304.7851193
- Sandborn WJ, Korzenik J, Lashner B, Leighton JA, Mahadevan U, Marion JF, et al. Once-daily dosing of delayed-release oral mesalamine (400-mg tablet) is as effective as twice-daily dosing for maintenance of remission of ulcerative colitis. Gastroenterology 2010;138:1286–96.e1.20064514
- Cohen SB, Radominski SC, Kameda H, Kivitz AJ, Tee M, Cronenberger C, et al. Long-term efficacy, safety, and immunogenicity of the infliximab (IFX) biosimilar, PF-06438179/GP1111, in patients with rheumatoid arthritis after switching from reference IFX or continuing biosimilar therapy: week 54–78 data from a randomized, double-blind, phase III trial. Biodrugs 2020;34:197–207.31939063
- Rau R, Schleusser B, Herborn G, Karger T. Long-term treatment of destructive rheumatoid arthritis with methotrexate. J Rheumatol 1997;24:1881–9.9330927
- Chiricozzi A, Zangrilli A, Bavetta M, Bianchi L, Chimenti S, Saraceno R. Real-life 9-year experience with adalimumab in psoriasis and psoriatic arthritis: results of a single-centre, retrospective study. J Eur Acad Dermatol Venereol 2017;31:304–11.27324646
- Burmester GR, Matucci-Cerinic M, Mariette X, Navarro-Blasco F, Kary S, Unnebrink K, Kupper H. Safety and effectiveness of adalimumab in patients with rheumatoid arthritis over 5 years of therapy in a phase 3b and subsequent postmarketing observational study. Arthritis Res Ther 2014;16:R24.24460746
- Macaluso FS, Fries W, Viola A, Centritto A, Cappello M, Giuffrida E, et al. The SPOSIB SB2 sicilian cohort: safety and effectiveness of infliximab biosimilar SB2 in inflammatory bowel diseases, including multiple switches. Inflamm Bowel Dis 2020;27:182–9.
- Delabaye I, De Keyser F; REMITRACT study group. 74-week follow-up of safety of infliximab in patients with refractory rheumatoid arthritis. Arthritis Res Ther 2010;12:R121.20569501
- Geborek P, Crnkic M, Petersson IF, Saxne T, South Swedish Arthritis Treatment Group. Etanercept, infliximab, and leflunomide in established rheumatoid arthritis: clinical experience using a structured follow up programme in southern Sweden. Ann Rheum Dis 2002;61:793–8.12176803
- Shear NH, Hartmann M, Toledo-Bahena M, Katsambas A, Connors L, Chang Q, et al.; REALITY Investigators. Long-term efficacy and safety of infliximab maintenance therapy in patients with plaque-type psoriasis in real-world practice. Br J Dermatol 2014;171:631–41.24673357
- Kinder AJ, Hassell AB, Brand J, Brownfield A, Grove M, Shadforth MF. The treatment of inflammatory arthritis with methotrexate in clinical practice: treatment duration and incidence of adverse drug reactions. Rheumatology 2005;44:61–6.15611303
- van Vollenhoven R, Takeuchi T, Pangan AL, Friedman A, Mohamed MEF, Chen S, et al. Efficacy and safety of upadacitinib monotherapy in methotrexate-naïve patients with moderately to severely active rheumatoid arthritis (SELECT-EARLY): a randomized, double-blind, active-comparator, multi-center, multi-country Trial. Arthritis Rheumatol 2020;72:1607–20.32638504
- Bakker MF, Jacobs JWG, Welsing PMJ, Verstappen SMM, Tekstra J, Ton E, et al.; Utrecht Rheumatoid Arthritis Cohort Study Group. Low-dose prednisone inclusion in a methotrexate-based, tight control strategy for early rheumatoid arthritis: a randomized trial. Ann Intern Med 2012;156:329–39.22393128
- Fleischmann R, Schiff M, van der Heijde D, Ramos-Remus C, Spindler A, Stanislav M, et al. Baricitinib, methotrexate, or combination in patients with rheumatoid arthritis and no or limited prior disease-modifying antirheumatic drug treatment. Arthritis Rheumatol 2017;69:506–17.27723271
- Lee EB, Fleischmann R, Hall S, Wilkinson B, Bradley JD, Gruben D, et al.; ORAL Start Investigators. Tofacitinib versus methotrexate in rheumatoid arthritis. N Engl J Med 2014;370:2377–86.24941177
- van Jaarsveld CH, Jacobs JW, van der Veen MJ, Blaauw AA, Kruize AA, Hofman DM, et al. Aggressive treatment in early rheumatoid arthritis: a randomised controlled trial. On behalf of the Rheumatic Research Foundation Utrecht, The Netherlands. Ann Rheum Dis 2000;59:468–77.10834865
- Kremer JM, Genovese MC, Cannon GW, Caldwell JR, Cush JJ, Furst DE, et al. Concomitant leflunomide therapy in patients with active rheumatoid arthritis despite stable doses of methotrexate. A randomized, double-blind, placebo-controlled trial. Ann Intern Med 2002;137:726–33.12416946
- Cohen S, Cannon GW, Schiff M, Weaver A, Fox R, Olsen N, et al. Two-year, blinded, randomized, controlled trial of treatment of active rheumatoid arthritis with leflunomide compared with methotrexate. Utilization of leflunomide in the treatment of Rheumatoid Arthritis Trial Investigator Group. Arthritis Rheum 2001;44:1984–92.11592358
- Lu LJ, Bao CD, Dai M, Teng JL, Fan W, Du F, et al. Multicenter, randomized, double-blind, controlled trial of treatment of active rheumatoid arthritis with T-614 compared with methotrexate. Arthritis Rheum 2009;61:979–87.19565542
- van Ede AE, Laan RF, Rood MJ, Huizinga TW, van de Laar MA, van Denderen CJ, et al. Effect of folic or folinic acid supplementation on the toxicity and efficacy of methotrexate in rheumatoid arthritis: a forty-eight week, multicenter, randomized, double-blind, placebo-controlled study. Arthritis Rheum 2001;44:1515–24.11465701
- Emery P, Breedveld FC, Lemmel EM, Kaltwasser JP, Dawes PT, Gömör B, et al. A comparison of the efficacy and safety of leflunomide and methotrexate for the treatment of rheumatoid arthritis. Rheumatology 2000;39:655–65.10888712
- Wei W, Zhang LL, Xu JH, Xiao F, Bao CD, Ni LQ, et al. A multicenter, double-blind, randomized, controlled phase III clinical trial of chicken type II collagen in rheumatoid arthritis. Arthritis Res Ther 2009;11:R180.19951408
- Zhao L, Jiang Z, Zhang Y, Ma H, Cai C. Analysis of efficacy and safety of treatment of active rheumatoid arthritis with iguratimod and methotrexate. Biomed Res 2017;28:2353–9.
- Yazici Y, Sokka T, Kautiainen H, Swearingen C, Kulman I, Pincus T. Long term safety of methotrexate in routine clinical care: discontinuation is unusual and rarely the result of laboratory abnormalities. Ann Rheum Dis 2005;64:207–11.15208176
- Zhang LL, Wei W, Xiao F, Xu JH, Bao CD, Ni LQ, Li XF. A randomized, double-blind, multicenter, controlled clinical trial of chicken type II collagen in patients with rheumatoid arthritis. Arthritis Rheum 2008;59:905–10.18576295
- Warren RB, Weatherhead SC, Smith CH, Exton LS, Mohd Mustapa MF, Kirby B, Yesudian PD. British Association of Dermatologists’ guidelines for the safe and effective prescribing of methotrexate for skin disease 2016. Br J Dermatol 2016;175:23–44.27484275
- Muralidharan N, Antony PT, Jain VK, Mariaselvam CM, Negi VS. Multidrug resistance 1 (MDR1) 3435C>T gene polymorphism influences the clinical phenotype and methotrexate-induced adverse events in South Indian Tamil rheumatoid arthritis. Eur J Clin Pharmacol 2015;71:959–65.26071279
- Bologna C, Viu P, Picot MC, Jorgensen C, Sany J. Long-term follow-up of 453 rheumatoid arthritis patients treated with methotrexate: an open, retrospective, observational study. Br J Rheumatol 1997;36:535–40.9189054
- Papadopoulos NG, Alamanos Y, Papadopoulos IA, Tsifetaki N, Voulgari PV, Drosos AA. Disease modifying antirheumatic drugs in early rheumatoid arthritis: a longterm observational study. J Rheumatol 2002;29:261–6.11838843
- Kremer J, Genovese M, Cannon GW, Caldwell J, Cush J, Furst DE, et al. Combination leflunomide and methotrexate (MTX) therapy for patients with active rheumatoid arthritis failing MTX monotherapy: open-label extension of a randomized, double-blind, placebo controlled trial. J Rheumatol 2004;31:1521–31.15290730
- Jiang M, Zha Q, Zhang C, Lu C, Yan X, Zhu W, et al. Predicting and verifying outcome of Tripterygium Wilfordii Hook F. based therapy in rheumatoid arthritis: from open to double-blinded randomized trial. Sci Rep 2015;5:9700.26814847
- Barker J, Hoffmann M, Wozel G, Ortonne JP, Zheng H, van Hoogstraten H, Reich K. Efficacy and safety of infliximab vs. methotrexate in patients with moderate-to-severe plaque psoriasis: results of an open-label, active-controlled, randomized trial (RESTORE1). Br J Dermatol 2011;165:1109–17.21910713
- Gisondi P, Cazzaniga S, Chimenti S, Giannetti A, Maccarone M, Picardo M, et al.; Psocare Study Group. Metabolic abnormalities associated with initiation of systemic treatment for psoriasis: evidence from the Italian Psocare Registry. J Eur Acad Dermatol Venereol 2013;27:e30–41.22313340
- Kingsley GH, Kowalczyk A, Taylor H, Ibrahim F, Packham JC, McHugh NJ, et al. A randomized placebo-controlled trial of methotrexate in psoriatic arthritis. Rheumatology 2012;51:1368–77.22344575
- Reich K, Langley RG, Papp KA, Ortonne JP, Unnebrink K, Kaul M, Valdes JM. A 52-week trial comparing briakinumab with methotrexate in patients with psoriasis. N Engl J Med 2011;365:1586–96.22029980
- Chen XX, Li ZG, Wu HX, Zhao DB, Li XF, Xu JH, et al. A randomized, controlled trial of efficacy and safety of Anbainuo, a bio-similar etanercept, for moderate to severe rheumatoid arthritis inadequately responding to methotrexate. Clin Rheumatol 2016;35:2175–83.27184046
- Braun J, Kastner P, Flaxenberg P, Währisch J, Hanke P, Demary W, et al.; MC-MTX.6/RH Study Group. Comparison of the clinical efficacy and safety of subcutaneous versus oral administration of methotrexate in patients with active rheumatoid arthritis: results of a six-month, multicenter, randomized, double-blind, controlled, phase IV trial. Arthritis Rheum 2008;58:73–81.18163521
- Klareskog L, van der Heijde D, de Jager JP, Gough A, Kalden J, Malaise M, et al.; TEMPO (Trial of Etanercept and Methotrexate with Radiographic Patient Outcomes) Study Investigators. Therapeutic effect of the combination of etanercept and methotrexate compared with each treatment alone in patients with rheumatoid arthritis: double-blind randomised controlled trial. Lancet 2004;363:675–81.15001324
- Ishaq M, Muhammad JS, Hameed K, Mirza AI. Leflunomide or methotrexate? Comparison of clinical efficacy and safety in low socio-economic rheumatoid arthritis patients. Mod Rheumatol 2011;21:375–80.21229373
- Kotyla P, Batko B, Zuber Z, Almgren-Rachtan A, Chudek J, Kucharz EJ. Effectiveness of subcutaneously administered methotrexate in patients with rheumatoid arthritis. Adv Clin Exp Med 2019;28:1229–35.31464109
- Takeuchi T, Miyasaka N, Zang C, Alvarez D, Fletcher T, Wajdula J, et al. A phase 3 randomized, double-blind, multicenter comparative study evaluating the effect of etanercept versus methotrexate on radiographic outcomes, disease activity, and safety in Japanese subjects with active rheumatoid arthritis. Mod Rheumatol 2013;23:623–33.23011358
- Lila AM, Mazurov VI, Denisov LN, Nesmeyanova OB, Ilivanova EP, Eremeeva AV, et al. A phase III study of BCD-055 compared with innovator infliximab in patients with active rheumatoid arthritis: 54-week results from the LIRA study. Rheumatol Int 2019;39:1537–46.31292709
- van der Heijde D, Burmester G, Melo-Gomes J, Codreanu C, Mola EM, Pedersen R, et al.; Etanercept Study 400 Investigators. The safety and efficacy of adding etanercept to methotrexate or methotrexate to etanercept in moderately active rheumatoid arthritis patients previously treated with monotherapy. Ann Rheum Dis 2008;67:182–8.17728331
- Bae SC, Kim J, Choe JY, Park W, Lee SH, Park YB, et al.; HERA Study Investigators. A phase III, multicentre, randomised, double-blind, active-controlled, parallel-group trial comparing safety and efficacy of HD203, with innovator etanercept, in combination with methotrexate, in patients with rheumatoid arthritis: the HERA study. Ann Rheum Dis 2017;76:65–71.26905864
- Cohen SB, Czeloth N, Lee E, Klimiuk PA, Peter N, Jayadeva G. Long-term safety, efficacy, and immunogenicity of adalimumab biosimilar BI 695501 and adalimumab reference product in patients with moderately-to-severely active rheumatoid arthritis: results from a phase 3b extension study (VOLTAIRE-RAext). Expert Opin Biol Ther 2019;19:1097–105.31387417
- Blauvelt A, Lacour JP, Fowler JF, Weinberg JM, Gospodinov D, Schuck E, et al. Phase III randomized study of the proposed adalimumab biosimilar GP2017 in psoriasis: impact of multiple switches. Br J Dermatol 2018;179:623–31.29917226
- Kennedy NA, Heap GA, Green HD, Hamilton B, Bewshea C, Walker GJ, et al.; UK Inflammatory Bowel Disease Pharmacogenetics Study Group. Predictors of anti-TNF treatment failure in anti-TNF-naive patients with active luminal Crohn’s disease: a prospective, multicentre, cohort study. Lancet Gastroenterol Hepatol 2019;4:341–53.30824404
- Van den Bosch F, Manger B, Goupille P, McHugh N, Rødevand E, Holck P, et al. Effectiveness of adalimumab in treating patients with active psoriatic arthritis and predictors of good clinical responses for arthritis, skin and nail lesions. Ann Rheum Dis 2010;69:394–9.19815494
- Papp K, Bachelez H, Costanzo A, Foley P, Gooderham M, Kaur P, et al. Clinical similarity of biosimilar ABP 501 to adalimumab in the treatment of patients with moderate to severe plaque psoriasis: a randomized, double-blind, multicenter, phase III study. J Am Acad Dermatol 2017;76:1093–102.28291552
- Mease PJ, van der Heijde D, Ritchlin CT, Okada M, Cuchacovich RS, Shuler CL, et al.; SPIRIT-P1 Study Group. Ixekizumab, an interleukin-17A specific monoclonal antibody, for the treatment of biologic-naive patients with active psoriatic arthritis: Results from the 24-week randomised, double-blind, placebo-controlled and active (adalimumab)-controlled period of the phase III trial SPIRIT-P1. Ann Rheum Dis 2017;76:79–87.27553214
- Menter A, Gordon KB, Leonardi CL, Gu Y, Goldblum OM. Efficacy and safety of adalimumab across subgroups of patients with moderate to severe psoriasis. J Am Acad Dermatol 2010;63:448–56.20605254
- Menter A, Tyring SK, Gordon K, Kimball AB, Leonardi CL, Langley RG, et al. Adalimumab therapy for moderate to severe psoriasis: a randomized, controlled phase III trial. J Am Acad Dermatol 2008;58:106–15.17936411
- Asahina A, Nakagawa H, Etoh T, Ohtsuki M, Adalimumab MSG. Adalimumab in Japanese patients with moderate to severe chronic plaque psoriasis: efficacy and safety results from a Phase II/III randomized controlled study. J Dermatol 2010;37:299–310.20507398
- Thaçi D, Ortonne JP, Chimenti S, Ghislain PD, Arenberger P, Kragballe K, et al. A phase IIIb, multicentre, randomized, double-blind, vehicle-controlled study of the efficacy and safety of adalimumab with and without calcipotriol/betamethasone topical treatment in patients with moderate to severe psoriasis: the BELIEVE study. Br J Dermatol 2010;163:402–11.20377585
- Mease PJ, Gladman DD, Ritchlin CT, Ruderman EM, Steinfeld SD, Choy EHS, et al.; Adalimumab Effectiveness in Psoriatic Arthritis Trial Study Group. Adalimumab for the treatment of patients with moderately to severely active psoriatic arthritis: results of a double-blind, randomized, placebo-controlled trial. Arthritis Rheum 2005;52:3279–89.16200601
- Gladman DD, Mease PJ, Ritchlin CT, Choy EHS, Sharp JT, Ory PA, et al. Adalimumab for long-term treatment of psoriatic arthritis: forty-eight week data from the adalimumab effectiveness in psoriatic arthritis trial. Arthritis Rheum 2007;56:476–88.17265483
- Kennedy WP, Simon JA, Offutt C, Horn P, Herman A, Townsend MJ, et al. Efficacy and safety of pateclizumab (anti-lymphotoxin-alpha) compared to adalimumab in rheumatoid arthritis: a head-to-head phase 2 randomized controlled study (The ALTARA Study). Arthritis Res Ther 2014;16:467.25359150
- Sandborn WJ, van Assche G, Reinisch W, Colombel JF, D’Haens G, Wolf DC, et al. Adalimumab induces and maintains clinical remission in patients with moderate-to-severe ulcerative colitis. Gastroenterology 2012;142:257–65.e1.22062358
- Suzuki Y, Motoya S, Hanai H, Hibi T, Nakamura S, Lazar A, et al. Four-year maintenance treatment with adalimumab in Japanese patients with moderately to severely active ulcerative colitis. J Gastroenterol 2017;52:1031–40.28321512
- Suzuki Y, Motoya S, Hanai H, Matsumoto T, Hibi T, Robinson AM, et al. Efficacy and safety of adalimumab in Japanese patients with moderately to severely active ulcerative colitis. J Gastroenterol 2014;49:283–94.24363029
- Xu H, Li Z, Wu J, Xing Q, Shi G, Li J, et al. IBI303, a biosimilar to adalimumab, for the treatment of patients with ankylosing spondylitis in China: a randomised, double-blind, phase 3 equivalence trial. Lancet Rheumatol 2019;1:e35–43.38229357
- Huang F, Gu J, Zhu P, Bao C, Xu J, Xu H, et al. Efficacy and safety of adalimumab in Chinese adults with active ankylosing spondylitis: results of a randomised, controlled trial. Ann Rheum Dis 2014;73:587–94.23475983
- Griffiths CEM, Thaçi D, Gerdes S, Arenberger P, Pulka G, Kingo K, et al.; EGALITY Study Group. The EGALITY study: a confirmatory, randomized, double-blind study comparing the efficacy, safety and immunogenicity of GP2015, a proposed etanercept biosimilar, vs. the originator product in patients with moderate-to-severe chronic plaque-type psoriasis. Br J Dermatol 2017;176:928–38.27787890
- Davis JC, Van Der Heijde D, Braun J, Dougados M, Cush J, Clegg DO, et al. Recombinant human tumor necrosis factor receptor (etanercept) for treating ankylosing spondylitis: A randomized, controlled trial. Arthritis & Rheumatism 2003; 48(11):3230–6.14613288
- Klareskog L, Gaubitz M, Rodriguez-Valverde V, Malaise M, Dougados M, Wajdula J; Etanercept Study 301 Investigators. A long-term, open-label trial of the safety and efficacy of etanercept (Enbrel) in patients with rheumatoid arthritis not treated with other disease-modifying antirheumatic drugs. Ann Rheum Dis 2006;65:1578–84.16540554
- Keystone EC, Genovese MC, Hall S, Bae SC, Han C, Gathany TA, et al. Safety and efficacy of subcutaneous golimumab in patients with active rheumatoid arthritis despite methotrexate therapy: final 5-year results of the GO-FORWARD trial. J Rheumatol 2016;43:298–306.26669912
- Papp KA, Tyring S, Lahfa M, Prinz J, Griffiths CEM, Nakanishi AM, et al.; Etanercept Psoriasis Study Group. A global phase III randomized controlled trial of etanercept in psoriasis: safety, efficacy, and effect of dose reduction. Br J Dermatol 2005;152:1304–12.15948997
- Tyring S, Gordon KB, Poulin Y, Langley RG, Gottlieb AB, Dunn M, Jahreis A. Long-term safety and efficacy of 50 mg of etanercept twice weekly in patients with psoriasis. Arch Dermatol 2007;143:719–26.17576937
- Gottlieb AB, Kircik L, Eisen D, Jackson JM, Boh EE, Strober BE, et al. Use of etanercept for psoriatic arthritis in the dermatology clinic: the Experience Diagnosing, Understanding Care, and Treatment with Etanercept (EDUCATE) study. J Dermatolog Treat 2006;17:343–52.17853307
- Puig L, Camacho Martinez FM, Gimeno Carpio E, Lopez-Avila A, Garcia-Calvo C. Efficacy and safety of clinical use of etanercept for the treatment of moderate-to-severe psoriasis in Spain: results of a multicentric prospective study at 12 months follow-up. Dermatology 2012;225:220–30.23235195
- Reich K, Nestle FO, Papp K, Ortonne JP, Evans R, Guzzo C, et al.; EXPRESS Study Investigators. Infliximab induction and maintenance therapy for moderate-to-severe psoriasis: a phase III, multicentre, double-blind trial. Lancet 2005;366:1367–74.16226614
- Park W, Hrycaj P, Jeka S, Kovalenko V, Lysenko G, Miranda P, et al. A randomised, double-blind, multicentre, parallel-group, prospective study comparing the pharmacokinetics, safety, and efficacy of CT-P13 and innovator infliximab in patients with ankylosing spondylitis: the PLANETAS study. Ann Rheum Dis 2013;72:1605–12.23687259
- Espinoza F, Le Blay P, Combe B. Biologic disease-modifying antirheumatic drug (bDMARD)-induced neutropenia: a registry from a retrospective cohort of patients with rheumatic diseases treated with 3 classes of intravenous bDMARD. J Rheumatol 2017;44:844–9.28412711
- Park W, Yoo D, Jaworski J, Brzezicki J, Gnylorybov A, Kadinov V, et al. Comparable long-term efficacy, as assessed by patient-reported outcomes, safety and pharmacokinetics, of CT-P13 and reference infliximab in patients with ankylosing spondylitis: 54-week results from the randomized, parallel-group PLANETAS study. Arthritis Res Ther 2016;18:25.26795209
- Choe JY, Prodanovic N, Niebrzydowski J, Staykov I, Dokoupilova E, Baranauskaite A, et al. A randomised, double-blind, phase III study comparing SB2, an infliximab biosimilar, to the infliximab reference product Remicade in patients with moderate to severe rheumatoid arthritis despite methotrexate therapy. Ann Rheum Dis 2017;76:58–64.26318384
- Gottlieb AB, Evans R, Li S, Dooley LT, Guzzo CA, Baker D, et al. Infliximab induction therapy for patients with severe plaque-type psoriasis: a randomized, double-blind, placebo-controlled trial. J Am Acad Dermatol 2004;51:534–42.15389187
- Smolen JS, Choe JY, Prodanovic N, Niebrzydowski J, Staykov I, Dokoupilova E, et al. Comparing biosimilar SB2 with reference infliximab after 54 weeks of a double-blind trial: clinical, structural and safety results. Rheumatology 2017;56:1771–9.28957563
- Smolen JS, Choe JY, Prodanovic N, Niebrzydowski J, Staykov I, Dokoupilova E, et al. Safety, immunogenicity and efficacy after switching from reference infliximab to biosimilar SB2 compared with continuing reference infliximab and SB2 in patients with rheumatoid arthritis: results of a randomised, double-blind, phase III transition study. Ann Rheum Dis 2018;77:234–40.29042358
- Braun J, Deodhar A, Dijkmans B, Geusens P, Sieper J, Williamson P, et al.; Ankylosing Spondylitis Study for the Evaluation of Recombinant Infliximab Therapy Study Group. Efficacy and safety of infliximab in patients with ankylosing spondylitis over a two-year period. Arthritis Rheum 2008;59:1270–8.18759257
- Konttinen L, Honkanen V, Uotila T, Pöllänen J, Waahtera M, Romu M, et al.; ROB-FIN Study Group. Biological treatment in rheumatic diseases: results from a longitudinal surveillance: adverse events. Rheumatol Int 2006;26:916–22.16402217
- Santos-Moreno P, Sanchez G, Gomez D, Bello-Gualtero J, Castro C. Direct comparative effectiveness among 3 anti-tumor necrosis factor biologics in a real-life cohort of patients with rheumatoid arthritis. J Clin Rheumatol 2016;22:57–62.26886438
- Komano Y, Tanaka M, Nanki T, Koike R, Sakai R, Kameda H, et al.; REAL Study Group. Incidence and risk factors for serious infection in patients with rheumatoid arthritis treated with tumor necrosis factor inhibitors: a report from the Registry of Japanese Rheumatoid Arthritis Patients for Longterm Safety. J Rheumatol 2011;38:1258–64.21498482
- Gonczi L, Gecse KB, Vegh Z, Kurti Z, Rutka M, Farkas K, et al. Long-term efficacy, safety, and immunogenicity of biosimilar infliximab after one year in a prospective nationwide cohort. Inflamm Bowel Dis 2017;23:1908–15.28922253
- Konttinen L, Tuompo R, Uusitalo T, Luosujärvi R, Laiho K, Lähteenmäki J, et al.; ROB-FIN Study Group. Anti-TNF therapy in the treatment of ankylosing spondylitis: the Finnish experience. Clin Rheumatol 2007;26:1693–700.17332979
- Scott DL, Ibrahim F, Farewell V, O’Keeffe AG, Ma M, Walker D, et al. Randomised controlled trial of tumour necrosis factor inhibitors against combination intensive therapy with conventional disease-modifying antirheumatic drugs in established rheumatoid arthritis: the TACIT trial and associated systematic reviews. Health Technol Assess 2014;18:i-1–164.
- Scott DL, Smolen JS, Kalden JR, van de Putte LB, Larsen A, Kvien TK, et al.; European Leflunomide Study Group. Treatment of active rheumatoid arthritis with leflunomide: two year follow up of a double blind, placebo controlled trial versus sulfasalazine. Ann Rheum Dis 2001;60:913–23.11557646
- Gisbert JP, Nino P, Rodrigo L, Cara C, Guijarro LG. Thiopurine methyltransferase (TPMT) activity and adverse effects of azathioprine in inflammatory bowel disease: long-term follow-up study of 394 patients. Am J Gastroenterol 2006;101:2769–76.17026564
- Avallone EV, Pica R, Cassieri C, Zippi M, Paoluzi P, Vernia P. Azathioprine treatment in inflammatory bowel disease patients: type and time of onset of side effects. Eur Rev Med Pharmacol Sci 2014;18:165–70.24488903
- Wong DR, Coenen MJ, Vermeulen SH, Derijks LJJ, van Marrewijk CJ, Klungel OH, et al.; TOPIC Recruitment Team. Early assessment of thiopurine metabolites identifies patients at risk of thiopurine-induced leukopenia in inflammatory bowel disease. J Crohns Colitis 2017;11:175–84.27402913
- Qian M, Song NJ. Serum calprotectin correlates with risk and disease severity in psoriasis patients and the decrease of calprotectin predicts better response to tumor necrosis factor inhibitors. Eur Rev Med Pharmacol Sci 2018;22:4299–309.30024620
- Coenen MJH, de Jong DJ, van Marrewijk CJ, Derijks LJJ, Vermeulen SH, Wong DR, et al.; TOPIC Recruitment Team. Identification of patients with variants in TPMT and dose reduction reduces hematologic events during thiopurine treatment of inflammatory bowel disease. Gastroenterology 2015;149:907–17.e7.26072396
- Nguyen M, Kabir M, Ravaud P. Short-term efficacy and safety of leflunomide in the treatment of active rheumatoid arthritis in everyday clinical use: open-label, prospective study. Clin Drug Investig 2004;24:103–12.
- Kalden J, Schattenkirchner M, Sorensen H, Emery P, Deighton C, Rozman B, et al. The efficacy and safety of leflunomide in patients with active rheumatoid arthritis: a five-year followup study. Arthritis Rheum 2003;48:1513–20.12794818
- Kellner H, Bornholdt K, Hein G. Leflunomide in the treatment of patients with early rheumatoid arthritis: results of a prospective non-interventional study. Clin Rheumatol 2010;29:913–20.20496042
- Lu F, Tu Y, Peng X, Wang L, Wang H, Sun Z, et al. A prospective multicentre study of mycophenolate mofetil combined with prednisolone as induction therapy in 213 patients with active lupus nephritis. Lupus 2008;17:622–9.18625634
- Conti F, Ceccarelli F, Perricone C, Massaro L, Cipriano E, Pacucci VA, et al. Mycophenolate mofetil in systemic lupus erythematosus: results from a retrospective study in a large monocentric cohort and review of the literature. Immunol Res 2014;60:270–6.25468307
- Schiff M, Beaulieu A, Scott DL, Rashford M. Mycophenolate mofetil in the treatment of adults with advanced rheumatoid arthritis: three 24-week, randomized, double-blind, placebo- or ciclosporin-controlled trials. Clin Drug Investig 2010;30:613–24.
- Nilsson A, Danielsson A, Lofberg R, Benno P, Bergman L, Fausa O, et al. Olsalazine versus sulphasalazine for relapse prevention in ulcerative colitis: a multicenter study. Am J Gastroenterol 1995;90:381–7.7872274
- Achit H, Peyrin-Biroulet L, Ayav C, Guillemin F, Frimat L. Lack of monitoring is associated with risk of acute kidney events among patients with inflammatory bowel disease. J Clin Med 2022;11:2954.35683343
- Banerjee R, Ravikanth VV, Pal P, Bale G, Avanthi US, Goren I, et al. NUDT15 C415T variant compared with TPMT genotyping in predicting azathioprine-induced leucopenia: prospective analysis of 1014 inflammatory bowel disease patients in India. Aliment Pharmacol Ther 2020;52:1683–94.33111378
- Calafat M, Manosa M, Canete F, Ricart E, Iglesias E, Calvo M, et al.; ENEIDA Registry of GETECCU. Increased risk of thiopurine-related adverse events in elderly patients with IBD. Aliment Pharmacol Ther 2019;50:780–8.31429097
- Chaparro M, Ordas I, Cabre E, Garcia-Sanchez V, Bastida G, Peñalva M, et al. Safety of thiopurine therapy in inflammatory bowel disease: long-term follow-up study of 3931 patients. Inflamm Bowel Dis 2013;19:1404–10.23665964
- Cheng YW, McLean R, Sewell JL, Huang CY, Khalili M. Inflammatory bowel disease type influences development of elevated liver enzymes. JGH Open 2022;6:846–53.36514498
- Dickson AL, Daniel LL, Zanussi J, Dale Plummer W, Wei WQ, Liu G, et al. TPMT and NUDT15 variants predict discontinuation of azathioprine for myelotoxicity in patients with inflammatory disease: real-world clinical results. Clin Pharmacol Ther 2022;111:263–71.34582038
- Houwen JPA, Egberts ACG, de Boer A, van Maarseveen EM, Houwen RHJ, Lalmohamed A. Influence of allopurinol on thiopurine associated toxicity: a retrospective population-based cohort study. Br J Clin Pharmacol 2021;87:2333–40.33118191
- Kakuta Y, Kawai Y, Okamoto D, Takagawa T, Ikeya K, Sakuraba H, et al.; MENDEL Study Group. NUDT15 codon 139 is the best pharmacogenetic marker for predicting thiopurine-induced severe adverse events in Japanese patients with inflammatory bowel disease: a multicenter study. J Gastroenterol 2018;53:1065–78.29923122
- Kim HS, Cheon JH, Jung ES, Park J, Aum S, Park SJ, et al. A coding variant in FTO confers susceptibility to thiopurine-induced leukopenia in East Asian patients with IBD. Gut 2017;66:1926–35.27558924
- Ribaldone DG, Adriani A, Caviglia GP, Nicolò AD, Agnesod D, Simiele M, et al. Correlation between thiopurine S-methyltransferase genotype and adverse events in inflammatory bowel disease patients. Medicina 2019;55:441.31387318
- AlAskar D, Alsardi M, Al Sulais E, Mosli M, Alameel T. Risk of neutropenia in inflammatory bowel disease patients treated with TNF inhibitors: a single-center, retrospective cohort study. Saudi J Gastroenterol 2020;26:210–5.32496224
- Chiu YM, Lai MS, Chan KA. Assessing risk of liver enzyme elevation in patients with immune-mediated diseases and different hepatitis B virus serostatus receiving anti-TNF agents: a nested case-control study. Arthritis Res Ther 2017;19:214.29089055
- Choi SJ, Oh JS, Hong S, Lee CK, Yoo B, Kim YG. Liver enzyme elevation in patients with ankylosing spondylitis treated with tumor necrosis factor inhibitors: a single-center historical cohort study. Korean J Intern Med 2020;35:723–31.31870134
- Hastings R, Ding T, Butt S, Gadsby K, Zhang W, Moots RJ, Deighton C. Neutropenia in patients receiving anti-tumor necrosis factor therapy. Arthritis Care Res 2010;62:764–9.
- Kavanaugh A, Krueger GG, Beutler A, Guzzo C, Zhou B, Dooley LT, et al.; IMPACT 2 Study Group. Infliximab maintains a high degree of clinical response in patients with active psoriatic arthritis through 1 year of treatment: Results from the IMPACT 2 trial. Ann Rheum Dis 2007;66:498–505.17114188
- Madani AN, Al-Saif FM, Alzamil LR, Almazroua AM, Alfurayh NA, Aldokhayel SD, et al. Monitoring the effect of TNF-alpha inhibitors on laboratory parameters and adverse effects in different diseases: a retrospective, single-center study. Ann Saudi Med 2022;42:309–18.36252145
- Shelton E, Chaudrey K, Sauk J, Khalili H, Masia R, Nguyen DD, et al. New onset idiosyncratic liver enzyme elevations with biological therapy in inflammatory bowel disease. Aliment Pharmacol Ther 2015;41:972–9.25756190
- Swart IAP, Visman IM, Heslinga M, van der Horst-Bruinsma IE, van Denderen JC, Nurmohamed MT. The effect of anti-TNF on renal function in patients with ankylosing spondylitis: a prospective cohort study. Clin Rheumatol 2022;41:3747–52.35962246
- Amital H, Arnson Y, Chodick G, Shalev V. Hepatotoxicity rates do not differ in patients with rheumatoid arthritis and psoriasis treated with methotrexate. Rheumatol 2009;48:1107–10.
- Bologna C, Viu P, Jorgensen C, Sany J. Effect of age on the efficacy and tolerance of methotrexate in rheumatoid arthritis. Br J Rheumatol 1996;35:453–7.8646436
- Cavalli M, Eriksson N, Sundbaum JK, Wallenberg M, Kohnke H, Baecklund E, et al. Genome-wide association study of liver enzyme elevation in an extended cohort of rheumatoid arthritis patients starting low-dose methotrexate. Pharmacogenomics 2022;23:813–20.36070248
- Hayashi K, Sada KE, Asano Y, Asano SH, Yamamura Y, Ohashi K, et al. Risk of higher dose methotrexate for renal impairment in patients with rheumatoid arthritis. Sci Rep 2020;10:18715.33127957
- Hoekstra M, van Ede AE, Haagsma CJ, van de Laar MAFJ, Huizinga TWJ, Kruijsen MWM, Laan RFJM. Factors associated with toxicity, final dose, and efficacy of methotrexate in patients with rheumatoid arthritis. Ann Rheum Dis 2003;62:423–6.12695153
- Kwon OC, Lee JS, Kim YG, Lee CK, Yoo B, Hong S. Safety of the concomitant use of methotrexate and a prophylactic dose of trimethoprim-sulfamethoxazole. Clin Rheumatol 2018;37:3215–20.29383453
- Mori S, Arima N, Ito M, Ueki Y, Abe Y, Aoyagi K, Fujiyama S. Incidence, predictive factors and severity of methotrexate-related liver injury in rheumatoid arthritis: a longitudinal cohort study. Rheumatol Adv Pract 2020;4:rkaa020.33134809
- Suzuki Y, Hirose T, Sugiyama N, Nomura K, Campos-Alberto E. Post-marketing surveillance of high-dose methotrexate (>8 mg/week) in Japanese patients with rheumatoid arthritis: a post hoc sub-analysis of patients according to duration of prior methotrexate use. Mod Rheumatol 2021;31:575–86.32933346
- Nakafero G, Grainge MJ, Card T, Taal MW, Aithal GP, Zhang W, et al. Development and validation of a prognostic model for leflunomide discontinuation with abnormal blood tests during long-term treatment: cohort study using data from the Clinical Practice Research Datalink Gold and Aurum. Rheumatology 2022;61:2783–91.34718430
- Nakafero G, Grainge MJ, Card T, Mallen CD, Riley R, van der Windt D, et al. Incidence and pattern of mycophenolate discontinuation associated with abnormal monitoring blood-test results: cohort study using data from the Clinical Practice Research Datalink Aurum. Rheumatol Adv Pract 2022;6:rkac046.35702565
- Sakthiswary R, Chan GYL, Koh ET, Leong KP, Thong BYH. Methotrexate-associated nonalcoholic fatty liver disease with transaminitis in rheumatoid arthritis. Sci World J 2014;2014:823763.
- Schmajuk G, Miao Y, Yazdany J, Boscardin WJ, Daikh DI, Steinman MA. Identification of risk factors for elevated transaminases in methotrexate users through an electronic health record. Arthritis Care Res 2014;66:1159–66.
- Sherbini AA, Gwinnutt JM, Hyrich KL, Verstappen SMM; RAMS Co-Investigators. Rates and predictors of methotrexate-related adverse events in patients with early rheumatoid arthritis: results from a nationwide UK study. Rheumatology 2022;61:3930–8.35078225
- Sundbaum JK, Baecklund E, Eriksson N, Kohnke H, Wallenberg M, Cavalli M, et al. Genome-wide association study of liver enzyme elevation in rheumatoid arthritis patients starting methotrexate. Pharmacogenomics 2021;22:973–82.34521259
- Svanstrom H, Lund M, Melbye M, Pasternak B. Concomitant use of low-dose methotrexate and NSAIDs and the risk of serious adverse events among patients with rheumatoid arthritis. Pharmacoepidemiol Drug Saf 2018;27:885–93.29797447
- Zhu J, Wang ZC, Tao L, Han L, Huang Q, Fang X, et al. MTHFR gene polymorphism association with psoriatic arthritis risk and the efficacy and hepatotoxicity of methotrexate in psoriasis. Front Med 2022;9:869912.
- Yang C, Williams RD, Swerdel JN, Almeida JR, Brouwer ES, Burn E, et al. Development and external validation of prediction models for adverse health outcomes in rheumatoid arthritis: a multinational real-world cohort analysis. Semin Arthritis Rheum 2022;56:152050.35728447
- Fraser SDS, Lin SX, Stammers M, Culliford D, Ibrahim K, Barrett R, et al. Persistently normal blood tests in patients taking methotrexate for RA or azathioprine for IBD: a retrospective cohort study. Br J Gen Pract 2022;72:e528–37.35256384
- Koller T, Galambosova M, Filakovska S, Kubincova M, Hlavaty T, Toth J, et al. Drug-induced liver injury in inflammatory bowel disease: 1-year prospective observational study. World J Gastroenterol 2017;23:4102–11.28652663
- Pakchotanon R, Ye JY, Cook RJ, Chandran V, Gladman DD. Liver abnormalities in patients with psoriatic arthritis. J Rheumatol 2020;47:847–53.31615918
- Gossec L, Baraliakos X, Kerschbaumer A, de Wit M, McInnes I, Dougados M, et al. EULAR recommendations for the management of psoriatic arthritis with pharmacological therapies: 2019 update. Ann Rheum Dis 2020;79:700–12.32434812
- Smolen JS, Landewé RBM, Bijlsma JWJ, Burmester GR, Dougados M, Kerschbaumer A, et al. EULAR recommendations for the management of rheumatoid arthritis with synthetic and biological disease-modifying antirheumatic drugs: 2019 update. Ann Rheum Dis 2020;79:685–99.31969328
- Dejaco C, Singh YP, Perel P, Hutchings A, Camellino D, Mackie S, et al.; European League Against Rheumatism. 2015 Recommendations for the management of polymyalgia rheumatica: a European League Against Rheumatism/American College of Rheumatology collaborative initiative. Ann Rheum Dis 2015;74:1799–807.26359488
- Fraenkel L, Bathon JM, England BR, St Clair EW, Arayssi T, Carandang K, et al. 2021 American College of Rheumatology guideline for the treatment of rheumatoid arthritis. Arthritis Rheumatol 2021;73:1108–23.34101376
- Menter A, Gelfand JM, Connor C, Armstrong AW, Cordoro KM, Davis DMR, et al. Joint American Academy of Dermatology-National Psoriasis Foundation guidelines of care for the management of psoriasis with systemic nonbiologic therapies. J Am Acad Dermatol 2020;82:1445–86.32119894
- Donahue KE, Schulman ER, Gartlehner G, Jonas BL, Coker-Schwimmer E, Patel SV, et al. Comparative effectiveness of combining MTX with biologic drug therapy versus either MTX or biologics alone for early rheumatoid arthritis in adults: a systematic review and network meta-analysis. J Gen Intern Med 2019;34:2232–45.31388915
- Xie Y, Liu Y, Liu Y. Are biologics combined with methotrexate better than biologics monotherapy in psoriasis and psoriatic arthritis: a meta-analysis of randomized controlled trials. Dermatol Ther 2021;34:e14926.33655646
- Edwards CJ, Campbell J, van Staa T, Arden NK. Regional and temporal variation in the treatment of rheumatoid arthritis across the UK: a descriptive register-based cohort study. BMJ Open 2012;2:e001603.
- Steffen A, Holstiege J, Klimke K, Akmatov MK, Bätzing J. Patterns of the initiation of disease-modifying antirheumatic drugs in incident rheumatoid arthritis: a German perspective based on nationwide ambulatory drug prescription data. Rheumatol Int 2018;38:2111–20.30306254
- Egeberg A, Skov L, Gislason GH, Thyssen JP, Mallbris L. Incidence and prevalence of psoriasis in Denmark. Acta Derm Venereol 2017;97:808–12.28417141
- Tugwell P, Bennett K, Gent M. Methotrexate in rheumatoid arthritis. Indications, contraindications, efficacy, and safety. Ann Intern Med 1987;107:358–66.3304050
- Weinblatt ME, Coblyn JS, Fox DA, Fraser PA, Holdsworth DE, Glass DN, Trentham DE. Efficacy of low-dose methotrexate in rheumatoid arthritis. N Engl J Med 1985;312:818–22.3883172
- Nakafero G, Grainge MJ, Card T, Mallen CD, Zhang W, Doherty M, et al. What is the incidence of methotrexate or leflunomide discontinuation related to cytopenia, liver enzyme elevation or kidney function decline? Rheumatology 2021;60:5785–94.33725120
- Nakafero G, Grainge MJ, Williams HC, Card T, Taal MW, Aithal GP, et al. Risk stratified monitoring for methotrexate toxicity in immune mediated inflammatory diseases: prognostic model development and validation using primary care data from the UK. BMJ 2023;381:e074678.37253479
- Herrett E, Gallagher AM, Bhaskaran K, Forbes H, Mathur R, van Staa T, Smeeth L. Data resource profile: clinical practice research datalink (CPRD). Int J Epidemiol 2015;44:827–36.26050254
- Wolf A, Dedman D, Campbell J, Booth H, Lunn D, Chapman J, Myles P. Data resource profile: clinical practice research datalink (CPRD) aurum. Int J Epidemiol 2019;48:1740.30859197
- Lewis JD, Bilker WB, Weinstein RB, Strom BL. The relationship between time since registration and measured incidence rates in the General Practice Research Database. Pharmacoepidemiol Drug Saf 2005;14:443–51.15898131
- Jones S. METHOTREXATE (Oral or Subcutaneous) for Psoriasis and Other Dermatological Conditions. 2018. URL: https://www.cheshireandmerseysideformulary.nhs.uk/docs/files/methotrexate_wirral_v2.pdf?UNLID=296190751202643095914 (accessed 1 September 2024).
- NHS England. National Shared Care Protocol: Methotrexate (Oral and Subcutaneous) for Patients in Adult Services (Excluding Cancer Care). 2022. URL: www.england.nhs.uk/wp-content/uploads/2022/07/B1621_xvii_methotrexate-oral-and-subcutaneous-for-patients-in-adult-services-excluding-cancer-care.docx (accessed 1 September 2024).
- Ledingham J, Gullick N, Irving K, Gorodkin R, Aris M, Burke J, et al. BSR and BHPR guideline for the prescription and monitoring of non-biologic disease-modifying anti-rheumatic drugs. Rheumatology 2017;56:2257.29029272
- Section 2: AKI definition. Kidney Int Suppl 2012;2:19–36.
- Chalasani N, Björnsson E. Risk factors for idiosyncratic drug-induced liver injury. Gastroenterology 2010;138:2246–59.20394749
- Safy-Khan M, de Hair MJH, Welsing PMJ, van Laar JM, Jacobs JWG; Society for Rheumatology Research Utrecht (SRU). Current smoking negatively affects the response to methotrexate in rheumatoid arthritis in a dose-responsive way, independently of concomitant prednisone use. J Rheumatol 2021;48:1504–7.33526623
- Bressolle F, Bologna C, Kinowski JM, Sany J, Combe B. Effects of moderate renal insufficiency on pharmacokinetics of methotrexate in rheumatoid arthritis patients. Ann Rheum Dis 1998;57:110–3.9613341
- Carmichael SJ, Beal J, Day RO, Tett SE. Combination therapy with methotrexate and hydroxychloroquine for rheumatoid arthritis increases exposure to methotrexate. J Rheumatol 2002;29:2077–83.12375315
- Meijer B, Wilhelm AJ, Mulder CJJ, Bouma G, van Bodegraven AA, de Boer NKH. Pharmacology of thiopurine therapy in inflammatory bowel disease and complete blood cell count outcomes: a 5-year database study. Ther Drug Monit 2017;39:399–405.28489727
- Riley RD, Ensor J, Snell KIE, Harrell FE, Martin GP, Reitsma JB, et al. Calculating the sample size required for developing a clinical prediction model. BMJ 2020;368:m441.32188600
- Schafer JL. Multiple imputation: a primer. Stat Methods Med Res 1999;8:3–15.10347857
- Steyerberg EW. Clinical Prediction Models: A Practical Approach to Development, Validation, and Updating. Cham: Springer International Publishing AG; 2019.
- Royston P, Altman DG. External validation of a Cox prognostic model: principles and methods. BMC Med Res Methodol 2013;13:33.23496923
- Cox DR. Note on grouping. J Am Stat Assoc 1957;52:543–7.
- Moons KG, Altman DG, Reitsma JB, Ioannidis JPA, Macaskill P, Steyerberg EW, et al. Transparent Reporting of a multivariable prediction model for individual prognosis or diagnosis (TRIPOD): explanation and elaboration. Ann Intern Med 2015;162:W1–73.25560730
- Raine T, Bonovas S, Burisch J, Kucharzik T, Adamina M, Annese V, et al. ECCO guidelines on therapeutics in ulcerative colitis: medical treatment. J Crohns Colitis 2022;16:2–17.34635919
- Feuerstein JD, Ho EY, Shmidt E, Singh H, Falck-Ytter Y, Sultan S, Terdiman JP; American Gastroenterological Association Institute Clinical Guidelines Committee. AGA clinical practice guidelines on the medical management of moderate to severe luminal and perianal fistulizing Crohn’s disease. Gastroenterology 2021;160:2496–508.34051983
- Feuerstein JD, Isaacs KL, Schneider Y, Siddique SM, Falck-Ytter Y, Singh S; AGA Institute Clinical Guidelines Committee. AGA clinical practice guidelines on the management of moderate to severe ulcerative colitis. Gastroenterology 2020;158:1450–61.31945371
- Fanouriakis A, Tziolos N, Bertsias G, Boumpas DT. Update οn the diagnosis and management of systemic lupus erythematosus. Ann Rheum Dis 2021;80:14–25.33051219
- Meggitt SJ, Anstey AV, Mohd Mustapa MF, Reynolds NJ, Wakelin S. British Association of Dermatologists’ guidelines for the safe and effective prescribing of azathioprine 2011. Br J Dermatol 2011;165:711–34.21950502
- Da Rosa GP, Marques S, Coelho F, Pereira E, Ferreira E, Rodrigues-Pereira P, et al. Azathioprine-induced interstitial nephritis in an anti-neutrophil cytoplasmic antibody (ANCA) myeloperoxidase (MPO) vasculitis patient. Eur J Rheumatol 2018;5:135–8.30185363
- McHenry PM, Allan JG, Rodger RS, Lever RS. Nephrotoxicity due to azathioprine. Br J Dermatol 1993;128:106.8427817
- Meys E, Devogelaer JP, Geubel A, Rahier J, Nagant de Deuxchaisnes C. Fever, hepatitis and acute interstitial nephritis in a patient with rheumatoid arthritis. Concurrent manifestations of azathioprine hypersensitivity. J Rheumatol 1992;19:807–9.1613715
- Parnham AP, Dittmer I, Mathieson PW, McIver A, Dudley C. Acute allergic reactions associated with azathioprine. Lancet 1996;348:542–3.
- Lewis JD, Abramson O, Pascua M, Liu L, Asakura LM, Velayos FS, et al. Timing of myelosuppression during thiopurine therapy for inflammatory bowel disease: implications for monitoring recommendations. Clin Gastroenterol Hepatol 2009;7:1195–201; quiz 1141.19631285
- Joint Formulary Committee. British National Formulary. London: BMJ Group and Pharmaceutical Press; 2023.
- Parkes GC, Whelan K, Lindsay JO. Smoking in inflammatory bowel disease: impact on disease course and insights into the aetiology of its effect. J Crohns Colitis 2014;8:717–25.24636140
- Parisis D, Bernier C, Chasset F, Arnaud L. Impact of tobacco smoking upon disease risk, activity and therapeutic response in systemic lupus erythematosus: a systematic review and meta-analysis. Autoimmun Rev 2019;18:102393.31520802
- Klotz U. Clinical pharmacokinetics of sulphasalazine, its metabolites and other prodrugs of 5-aminosalicylic acid. Clin Pharmacokinet 1985;10:285–302.2864155
- Broekman MMTJ, Coenen MJH, van Marrewijk CJ, Wanten GJA, Wong DR, Verbeek ALM, et al. More dose-dependent side effects with mercaptopurine over azathioprine in IBD treatment due to relatively higher dosing. Inflamm Bowel Dis 2017;23:1873–81.28644183
- Sandborn WJ. Rational dosing of azathioprine and 6-mercaptopurine. Gut 2001;48:591–2.11302950
- Ansari A, Elliott T, Baburajan B, Mayhead P, O'Donohue J, Chocair P, et al. Long-term outcome of using allopurinol co-therapy as a strategy for overcoming thiopurine hepatotoxicity in treating inflammatory bowel disease. Aliment Pharmacol Ther 2008;28:734–41.19145729
- Ansari A, Patel N, Sanderson J, O’Donohue J, Duley JA, Florin TH. Low-dose azathioprine or mercaptopurine in combination with allopurinol can bypass many adverse drug reactions in patients with inflammatory bowel disease. Aliment Pharmacol Ther 2010;31:640–7.20015102
- Smith MA, Blaker P, Marinaki AM, Anderson SH, Irving PM, Sanderson JD. Optimising outcome on thiopurines in inflammatory bowel disease by co-prescription of allopurinol. J Crohns Colitis 2012;6:905–12.22386736
- Kiszka-Kanowitz M, Theede K, Thomsen SB, Bjerrum JT, Brynskov J, Gottschalck IB, et al. Low-dose azathioprine and allopurinol versus azathioprine monotherapy in patients with ulcerative colitis (AAUC): an investigator-initiated, open, multicenter, parallel-arm, randomised controlled trial. EClinicalMedicine 2022;45:101332.35274092
- Warner B, Johnston E, Arenas-Hernandez M, Marinaki A, Irving P, Sanderson J. A practical guide to thiopurine prescribing and monitoring in IBD. Frontline Gastroenterol 2018;9:10–5.29484155
- Hande S, Wilson-Rich N, Bousvaros A, Zholudev A, Maurer R, Banks P, et al. 5-aminosalicylate therapy is associated with higher 6-thioguanine levels in adults and children with inflammatory bowel disease in remission on 6-mercaptopurine or azathioprine. Inflamm Bowel Dis 2006;12:251–7.16633046
- Gao X, Zhang FB, Ding L, Liu H, Wang XD, Chen BL, et al. The potential influence of 5-aminosalicylic acid on the induction of myelotoxicity during thiopurine therapy in inflammatory bowel disease patients. Eur J Gastroenterol Hepatol 2012;24:958–64.22664938
- Ogdie A, Coates LC, Gladman DD. Treatment guidelines in psoriatic arthritis. Rheumatology 2020;59:i37–46.32159790
- Singh JA. Treatment guidelines in rheumatoid arthritis. Rheum Dis Clin North Am 2022;48:679–89.35953230
- Ransford RA, Langman MJ. Sulphasalazine and mesalazine: serious adverse reactions re-evaluated on the basis of suspected adverse reaction reports to the Committee on Safety of Medicines. Gut 2002;51:536–9.12235076
- Farr M, Tunn EJ, Symmons DP, Scott DG, Bacon PA. Sulphasalazine in rheumatoid arthritis: haematological problems and changes in haematological indices associated with therapy. Br J Rheumatol 1989;28:134–8.2565128
- McConkey B. Ten years of sulphasalazine use in rheumatoid arthritis. Br J Rheumatol 1989;28:175–6.2565130
- van Riel PLCM, van Gestel AM, van de Putte LBA. Long-term usage and side-effect profile of sulphasalazine in rheumatoid arthritis. Rheumatology 1995;XXXIV:40–2.
- de Abajo FJ, Montero D, Madurga M, García Rodríguez LA. Acute and clinically relevant drug-induced liver injury: a population based case-control study. Br J Clin Pharmacol 2004;58:71–80.15206996
- McConkey B, Amos RS, Durham S, Forster PJ, Hubball S, Walsh L. Sulphasalazine in rheumatoid arthritis. BMJ 1980;280:442–4.6102877
- Farr M, Scott DGI, Bacon PA. Side effect profile of 200 patients with inflammatory arthritides treated with sulphasalazine. Drugs 1986;32:49–53.2877853
- Amos RS, Pullar T, Bax DE, Situnayake D, Capell HA, McConkey B. Sulphasalazine for rheumatoid arthritis: toxicity in 774 patients monitored for one to 11 years. BMJ (Clin Res Ed) 1986;293:420–3.
- MacGilchrist AJ, Hunter JA. Sulphasalazine hepatotoxicity: lack of a hypersensitivity response. Ann Rheum Dis 1986;45:967–8.2878646
- Marabani M, Madhok R, Capell HA, Hunter JA. Leucopenia during sulphasalazine treatment for rheumatoid arthritis. Ann Rheum Dis 1989;48:505–7.2568110
- Jobanputra P, Amarasena R, Maggs F, Homer D, Bowman S, Rankin E, et al. Hepatotoxicity associated with sulfasalazine in inflammatory arthritis: a case series from a local surveillance of serious adverse events. BMC Musculoskelet Disord 2008;9:48.18405372
- Keisu M, Ekman E. Sulfasalazine associated agranulocytosis in Sweden 1972–1989. Eur J Clin Pharmacol 1992;43:215–8.1358622
- Wiese MD, Alotaibi N, O’Doherty C, Sorich MJ, Suppiah V, Cleland LG, Proudman SM. Pharmacogenomics of NAT2 and ABCG2 influence the toxicity and efficacy of sulphasalazine containing DMARD regimens in early rheumatoid arthritis. Pharmacogenomics J 2014;14:350–5.24394199
- Singh JA, Saag KG, Bridges SL Jr, Akl EA, Bannuru RR, Sullivan MC, et al. 2015 American College of Rheumatology guideline for the treatment of rheumatoid arthritis. Arthritis Rheumatol 2016;68:1–26.
- Pfizer. Salazopyrin Tablets. Healthcare Professionals (SmPC). 2021. URL: www.medicines.org.uk/emc/product/3838/smpc#gref (accessed 23 July 2023).
- Riley RD, Debray TPA, Collins GS, Archer L, Ensor J, van Smeden M, Snell KIE. Minimum sample size for external validation of a clinical prediction model with a binary outcome. Stat Med 2021;40:4230–51.34031906
- Ko CW, Singh S, Feuerstein JD, Falck-Ytter C, Falck-Ytter Y, Cross RK; American Gastroenterological Association Institute Clinical Guidelines Committee. AGA clinical practice guidelines on the management of mild-to-moderate ulcerative colitis. Gastroenterology 2019;156:748–64.30576644
- Dignass A, Van Assche G, Lindsay JO, Lémann M, Söderholm J, Colombel JF, et al.; European Crohn's and Colitis Organisation (ECCO). The second European evidence-based consensus on the diagnosis and management of Crohn’s disease: current management. J Crohns Colitis 2010;4:28–62.21122489
- Van Staa TP, Travis S, Leufkens HG, Logan RF. 5-aminosalicylic acids and the risk of renal disease: a large British epidemiologic study. Gastroenterology 2004;126:1733–9.15188168
- Logan RF, van Staa TP. Sulphasalazine and mesalazine: serious adverse reactions re-evaluated on the basis of suspected adverse reaction reports to the Committee on Safety of Medicines. Gut 2003;52:1530–1; author reply 1530.12970150
- Muller AF, Stevens PE, McIntyre AS, Ellison H, Logan RF. Experience of 5-aminosalicylate nephrotoxicity in the United Kingdom. Aliment Pharmacol Ther 2005;21:1217–24.15882242
- Moss JG, Parry CM, Holt RCL, McWilliam SJ. 5-ASA induced interstitial nephritis in patients with inflammatory bowel disease: a systematic review. Eur J Med Res 2022;27:61.35488310
- Heap GA, So K, Weedon M, Edney N, Bewshea C, Singh A, et al. Clinical features and HLA association of 5-aminosalicylate (5-ASA)-induced nephrotoxicity in inflammatory bowel disease. J Crohns Colitis 2016;10:149–58.26619893
- Farrell RJ, Peppercorn MA, Fine SN, Michetti P. Mesalamine-associated thrombocytopenia. Am J Gastroenterol 1999;94:2304–6.10445572
- Frattini F, Crestani S, Vescovi PP, Franchini M. Pure white cell aplasia induced by mesalazine in a patient with ulcerative colitis. Hematology 2013;18:181–2.23321335
- Turunen U, Elomaa I, Anttila VJ, Seppälä K. Mesalazine tolerance in patients with inflammatory bowel disease and previous intolerance or allergy to sulphasalazine or sulphonamides. Scand J Gastroenterol 1987;22:798–802.2890198
- Deltenre P, Berson A, Marcellin P, Degott C, Biour M, Pessayre D. Mesalazine (5-aminosalicylic acid) induced chronic hepatitis. Gut 1999;44:886–8.10323894
- Braun M, Fraser GM, Kunin M, Salamon F, Kaspa RT. Mesalamine-induced granulomatous hepatitis. Am J Gastroenterol 1999;94:1973–4.10406274
- Corrigan G, Stevens PE. Review article: interstitial nephritis associated with the use of mesalazine in inflammatory bowel disease. Aliment Pharmacol Ther 2000;14:1–6.
- Gisbert JP, González-Lama Y, Maté J. 5-aminosalicylates and renal function in inflammatory bowel disease: a systematic review. Inflamm Bowel Dis 2007;13:629–38.17243140
- Tillotts Pharma UK Limited. Summary of product characteristics of mesalazine. 2023. URL: www.medicines.org.uk/emc/product/2827/smpc/print (accessed 18 June 2023).
- Ginzler EM, Dooley MA, Aranow C, Kim MY, Buyon J, Merrill JT, et al. Mycophenolate mofetil or intravenous cyclophosphamide for lupus nephritis. N Engl J Med 2005;353:2219–28.16306519
- Dooley MA, Jayne D, Ginzler EM, Isenberg D, Olsen NJ, Wofsy D, et al.; ALMS Group. Mycophenolate versus azathioprine as maintenance therapy for lupus nephritis. N Engl J Med 2011;365:1886–95.22087680
- van Gelder T, Hesselink DA. Mycophenolate revisited. Transp Int 2015;28:508–15.
- Orvis AK, Wesson SK, Breza TS Jr, Church AA, Mitchell CL, Watkins SW. Mycophenolate mofetil in dermatology. J Am Acad Dermatol 2009;60:183–99; quiz 200.19150270
- Rathinam SR, Gonzales JA, Thundikandy R, Kanakath A, Murugan SB, Vedhanayaki R, et al.; FAST Research Group. Effect of corticosteroid-sparing treatment with mycophenolate mofetil vs methotrexate on inflammation in patients with uveitis: a randomized clinical trial. JAMA 2019;322:936–45.31503307
- Bishnoi A, Vinay K, Kumaran MS, Parsad D. Oral mycophenolate mofetil as a stabilizing treatment for progressive non-segmental vitiligo: results from a prospective, randomized, investigator-blinded pilot study. Arch Dermatol Res 2021;313:357–65.32737577
- Hiemstra TF, Walsh M, Mahr A, Savage CO, de Groot K, Harper L, et al.; European Vasculitis Study Group (EUVAS). Mycophenolate mofetil vs azathioprine for remission maintenance in antineutrophil cytoplasmic antibody–associated vasculitis: a randomized controlled trial. JAMA 2010;304:2381–8.21060104
- British Association for Dermatology. Patient Information Leaflet. 2021. URL: https://www.bad.org.uk/pils/mycophenolate-mofetil (accessed 30 July 2026).
- Stevens PE, Levin A; Kidney Disease: Improving Global Outcomes Chronic Kidney Disease Guideline Development Work Group Members. Evaluation and management of chronic kidney disease: synopsis of the kidney disease: improving global outcomes 2012 clinical practice guideline. Ann Intern Med 2013;158:825–30.23732715
- Smith CH, Yiu ZZN, Bale T, Burden AD, Coates LC, Edwards W, et al.; British Association of Dermatologists’ Clinical Standards Unit. British Association of Dermatologists guidelines for biologic therapy for psoriasis 2020: a rapid update. Br J Dermatol 2020;183:628–37.32189327
- Menter A, Strober BE, Kaplan DH, Kivelevitch D, Prater EF, Stoff B, et al. Joint AAD-NPF guidelines of care for the management and treatment of psoriasis with biologics. J Am Acad Dermatol 2019;80:1029–72.30772098
- Bessissow T, Renard M, Hoffman I, Vermeire S, Rutgeerts P, Van Assche G. Review article: non-malignant haematological complications of anti-tumour necrosis factor alpha therapy. Aliment Pharmacol Ther 2012;36:312–23.22725726
- Hoffmann JHO, Knoop C, Schäkel K, Enk AH, Hadaschik EN. Long-term safety of combination treatment with methotrexate and tumor necrosis factor (TNF)-α antagonists versus TNF-α antagonists alone in psoriatic patients. J Dermatol 2021;48:835–43.33470023
- Burden AD, Warren RB, Kleyn CE, McElhone K, Smith CH, Reynolds NJ, et al.; BADBIR Study Group. The British Association of Dermatologists’ Biologic Interventions Register (BADBIR): design, methodology and objectives. Br J Dermatol 2012;166:545–54.22356636
- Diao JA, Inker LA, Levey AS, Tighiouart H, Powe NR, Manrai AK. In search of a better equation: performance and equity in estimates of kidney function. N Engl J Med 2021;384:396–9.33406354
- Mori S, Arima N, Ito M, Fujiyama S, Kamo Y, Ueki Y. Non-alcoholic steatohepatitis-like pattern in liver biopsy of rheumatoid arthritis patients with persistent transaminitis during low-dose methotrexate treatment. PLOS ONE 2018;13:e0203084.30142184
- Munnig-Schmidt E, Zhang M, Mulder CJ, Barclay ML. Late-onset rise of 6-MMP metabolites in IBD patients on azathioprine or mercaptopurine. Inflamm Bowel Dis 2018;24:892–6.29522107
- Winter J, Walker A, Shapiro D, Gaffney D, Spooner RJ, Mills PR. Cost-effectiveness of thiopurine methyltransferase genotype screening in patients about to commence azathioprine therapy for treatment of inflammatory bowel disease. Aliment Pharmacol Ther 2004;20:593–9.15352906
- van Moorsel SAW, Deben DS, Creemers RH, Winkens B, Bus P, Pierik MJ, et al. Predictive algorithm for thiopurine-induced hepatotoxicity in inflammatory bowel disease patients. Ther Drug Monit 2022;44:747–54.36070763
- González-Lama Y, Bermejo F, López-Sanromán A, García-Sánchez V, Esteve M, Cabriada JL, et al.; ‘Grupo Español de Trabajo en Enfermedad de Crohn y Colitis Ulcerosa (GETECCU)’. Thiopurine methyl-transferase activity and azathioprine metabolite concentrations do not predict clinical outcome in thiopurine-treated inflammatory bowel disease patients. Aliment Pharmacol Ther 2011;34:544–54.21722149
- Boekema M, Horjus-Talabur Horje CS, Roosenboom B, Roovers L, van Luin M. Therapeutic drug monitoring of thiopurines: effect of reduced 6-thioguanine nucleotide target levels in inflammatory bowel disease patients. Br J Clin Pharmacol 2022;88:3741–8.35293629
- Barnes A, Ooi SJ, Lynch KD, Parthasarathy N, Bishara M, Gounder M, et al. Proactive metabolite testing in patients on thiopurine may yield long-term clinical benefits in inflammatory bowel disease. Dig Dis Sci 2023;68:889–96.35687221
- Meijer B, Kreijne JE, van Moorsel SAW, Derijks LJJ, Bouma G, Mulder CJJ, et al. 6-methylmercaptopurine-induced leukocytopenia during thiopurine therapy in inflammatory bowel disease patients. J Gastroenterol Hepatol 2017;32:1183–90.27859568
- Desai D, Jena A, Sharma V, Hibi T. Time to incorporate preemptive NUDT15 testing before starting thiopurines in inflammatory bowel disease in Asia and beyond: a review. Expert Rev Clin Pharmacol 2023;16:643–53.37387532
- Vernier-Massouille G, Cosnes J, Lemann M, Marteau P, Reinisch W, Laharie D, et al. Nodular regenerative hyperplasia in patients with inflammatory bowel disease treated with azathioprine. Gut 2007;56:1404–9.17504943
- Simsek M, Meijer B, Ramsoekh D, Bouma G, van der Wouden EJ, den Hartog B, et al.; Dutch Initiative on Crohn and Colitis (ICC). Clinical course of nodular regenerative hyperplasia in thiopurine treated inflammatory bowel disease patients. Clin Gastroenterol Hepatol 2019;17:568–70.29775790
- Holroyd CR, Seth R, Bukhari M, Malaviya A, Holmes C, Curtis E, et al. The British Society for Rheumatology biologic DMARD safety guidelines in inflammatory arthritis. Rheumatology 2018;58:e3–42.
- Lennard L. TPMT in the treatment of Crohn’s disease with azathioprine. Gut 2002;51:143–6.12117866
- Qasim A, Seery J, Buckley M, Morain CO. TPMT in the treatment of inflammatory bowel disease with azathioprine. Gut 2003;52:767–7; author reply 767.12692068
- Ricart E, Taylor WR, Loftus EV, O'Kane D, Weinshilboum RM, Tremaine WJ, et al. N-acetyltransferase 1 and 2 genotypes do not predict response or toxicity to treatment with mesalamine and sulfasalazine in patients with ulcerative colitis. Am J Gastroenterol 2002;97:1763–8.12135032
- Mielnik P, Sexton J, Fagerli KM, Bakland G, Hu Y, Kristianslund EK, et al. Discontinuation rate of sulfasalazine, leflunomide and methotrexate due to adverse events in a real-life setting (NOR-DMARD). Rheumatol Adv Pract 2023;7:rkad053.37431434
- Lowry PW, Franklin CL, Weaver AL, Szumlanski CL, Mays DC, Loftus EV, et al. Leucopenia resulting from a drug interaction between azathioprine or 6-mercaptopurine and mesalamine, sulphasalazine, or balsalazide. Gut 2001;49:656–64.11600468
- Mayberry H, Moshkovska T, Mayberry JF. Co-prescribing azathiopurine or 6-mercaptopurine and 5-aminosalicylate compounds in ulcerative colitis. Inflamm Bowel Dis 2009;15:190–2.18839420
- Rennie TJW, Petrie M, Metcalfe W, Walbaum D, Joss N, Barton E, et al. The impact of age on patient tolerance of mycophenolate following kidney transplantation. Nephrology 2020;25:566–74.32323461
- Tang JT, de Winter BC, Hesselink DA, Sombogaard F, Wang LL, van Gelder T. The pharmacokinetics and pharmacodynamics of mycophenolate mofetil in younger and elderly renal transplant recipients. Br J Clin Pharmacol 2017;83:812–22.27753146
- Gourishankar S, Houde I, Keown PA, Landsberg D, Cardella CJ, Barama AA, et al. The CLEAR study: a 5-day, 3-g loading dose of mycophenolate mofetil standard 2-g dosing in renal transplantation. Clin J Am Soc Nephrol 2010;5:1282–9.20498245
- Ghabril M, Bonkovsky HL, Kum C, Davern T, Hayashi PH, Kleiner DE, et al.; US Drug-Induced Liver Injury Network. Liver injury from tumor necrosis factor-α antagonists: analysis of thirty-four cases. Clin Gastroenterol Hepatol 2013;11:558–64.e3.23333219
- Björnsson ES, Gunnarsson BI, Gröndal G, Jonasson JG, Einarsdottir R, Ludviksson BR, et al. Risk of drug-induced liver injury from tumor necrosis factor antagonists. Clin Gastroenterol Hepatol 2015;13:602–8.25131534
- Rajakulendran S, Gadsby K, Allen D, O’Reilly S, Deighton C. Neutropenia while receiving anti-tumour necrosis factor treatment for rheumatoid arthritis. Ann Rheum Dis 2006;65:1678–9.17105865
- French JB, Bonacini M, Ghabril M, Foureau D, Bonkovsky HL. Hepatotoxicity associated with the use of anti-TNF-α agents. Drug Saf 2016;39:199–208.26692395
- Sandys V, Moloney B, Lane L, Qazi J, Doyle B, Barry M, et al. Granulomatous interstitial nephritis secondary to adalimumab therapy. Clin Kidney J 2018;11:219–21.29644062
- Plant R, Rafi Ahmed A, McHale T, Giblin L. A Case of adalimumab-induced granulomatous interstitial nephritis. Cureus 2021;13:e15986.34336477
- National Institute for Health and Care Excellence. NICE Health Technology Evaluations: The Manual. 2022. URL: www.nice.org.uk/process/pmg36/resources/nice-health-technology-evaluations-the-manual-pdf-72286779244741 (accessed 1 September 2024).
- Jones KC, Wetherley HL, Birch S, Castelli A, Chalkley M, Dargan A, et al. Unit Costs of Health and Social Care 2024. Kent: Personal Social Services Research Unit; 2024.
- National Institute for Health and Care Excellence. Axicabtagene Ciloleucel for Treating Relapsed or Refractory Diffuse Large B-Cell Lymphoma after 1 Systemic Therapy [ID1684]. 2023. URL: www.nice.org.uk/guidance/indevelopment/gid-ta10580/documents (accessed 1 September 2024).
- NHS England. National Cost Collection for the NHS. URL: www.england.nhs.uk/costing-in-the-nhs/national-cost-collection/ (accessed 27 May 2026).
- National Institute for Health and Care Excellence. Single Technology Appraisal Dapagliflozin for Treating Chronic Kidney Disease [ID3866]. 2021. URL: www.nice.org.uk/guidance/ta775/documents/committee-papers (accessed 1 September 2024).
- Kerr M, Bedford M, Matthews B, O’Donoghue D. The economic impact of acute kidney injury in England. Nephrol Dial Transplant 2014;29:1362–8.24753459
- Sawhney S, Marks A, Fluck N, Levin A, Prescott G, Black C. Intermediate and long-term outcomes of survivors of acute kidney injury episodes: a large population-based cohort study. Am J Kidney Dis 2017;69:18–28.27555107
- Andrade RJ, Lucena MI, Fernández MC, Pelaez G, Pachkoria K, García-Ruiz E, et al.; Spanish Group for the Study of Drug-Induced Liver Disease. Drug-induced liver injury: an analysis of 461 incidences submitted to the Spanish registry over a 10-year period. Gastroenterology 2005;129:512–21.16083708
- National Institute for Health and Care Excellence. Single Technology Appraisal Sofosbuvir-Velpatasvir-Voxilaprevir for Treating Chronic Hepatitis C [ID1055]. 2017. URL: www.nice.org.uk/guidance/ta507/documents/committee-papers (accessed 1 September 2024).
- Stevenson M, Pandor A, James MS, et al. Sepsis: the LightCycler SeptiFast Test MGRADE®, SepsiTest™ and IRIDICA BAC BSI assay for rapidly identifying bloodstream bacteria and fungi-a systematic review and economic evaluation. Health Technol Assess 2016;20:1–246.
- National Institute for Health and Care Excellence. Sodium Zirconium Cyclosilicate for Treating Hyperkalaemia Technology Appraisal Guidance [TA599]. 2022. URL: www.nice.org.uk/guidance/ta599 (accessed 1 September 2024).
- National Institute for Health and Care Excellence. Non-alcoholic Fatty Liver Disease (NAFLD): Assessment and Management. 2016. URL: www.nice.org.uk/guidance/ng49 (accessed 1 September 2024).
- National Institute for Health and Care Excellence. MRI-Based Technologies for Assessing Non-alcoholic Fatty Liver Disease. 2022. URL: www.nice.org.uk/guidance/indevelopment/gid-dg10045/documents (accessed 1 September 2024).
- An R, Wang PP. Length of stay, hospitalization cost, and in-hospital mortality in US adult inpatients with immune thrombocytopenic purpura, 2006–2012. Vasc Health Risk Manag 2017;13:15–21.28176930
- Guest G, Bunce A, Johnson L. How many interviews are enough?: an experiment with data saturation and variability. Field Methods 2006;18:59–82.
- Braun V, Clarke V. Using thematic analysis in psychology. Qual Res Psychol 2006;3:77–101.
- Lesage A, Leclère B, Moret L, Le Glatin C. Decreasing patient-reported burden of treatment: a systematic review of quantitative interventional studies. PLOS ONE 2021;16:e0245112.33434200
Blood-test monitoring strategies for patients established on immune-suppressing drugs: a mixed-methods study · References
References
Attribution. Abhishek Abhishek; Christopher Carroll; Munira Essat; Jo Leaviss; Georgina Nakafero; Amy Fuller et al. (2026). Blood-test monitoring strategies for patients established on immune-suppressing drugs: a mixed-methods study. National Institute for Health and Care Research. Copyright © 2026 Abhishek et al. Licensed under CC BY 4.0. NCBI Bookshelf NBK624374. CC BY 4.0. Original source ↗. Text reproduced from the Bookshelf XML without changing wording; figures, images and supplements are not reproduced.