CRediT contribution statement
Abhishek Abhishek (https://orcid.org/0000-0003-0121-4919): Conceptualisation (lead), Funding acquisition (lead), Methodology (equal), Project administration (equal), Resources (equal), Supervision (lead), Validation (equal), Writing – original draft (lead), Writing – reviewing and editing (lead).
Christopher Carroll (https://orcid.org/0000-0002-6361-6182): Conceptualisation (equal), Data curation (equal), Formal analysis (equal), Funding acquisition (equal), Investigation (equal), Methodology (equal), Project administration (equal), Resources (equal), Software (equal), Supervision (lead), Validation (equal), Visualisation (equal), Writing – original draft (equal), Writing – reviewing and editing (lead).
Munira Essat (https://orcid.org/0000-0003-2397-402X): Data curation (equal), Formal analysis (equal), Investigation (equal), Writing – reviewing and editing (equal).
Jo Leaviss (https://orcid.org/0000-0002-5632-6021): Data curation (equal), Formal analysis (equal), Investigation (equal), Writing – reviewing and editing (equal).
Georgina Nakafero (https://orcid.org/0000-0002-3859-7354): Conceptualisation (equal), Data curation (equal), Formal analysis (equal), Funding acquisition (equal), Investigation (equal), Visualisation (equal), Writing – original draft (equal), Writing – reviewing and editing (equal).
Amy Fuller (https://orcid.org/0000-0002-9669-1816): Data curation (equal), Formal analysis (equal), Investigation (equal), Visualisation (equal), Writing – original draft (equal), Writing – reviewing and editing (equal).
Matthew J Grainge (https://orcid.org/0000-0001-7181-4042): Conceptualisation (equal), Funding acquisition (equal), Validation (equal), Writing – reviewing and editing (equal).
Jennie Hancox (https://orcid.org/0000-0001-5938-5265): Conceptualisation (equal), Funding acquisition (equal), Methodology (equal), Software (equal), Supervision (equal), Validation (equal), Writing – reviewing and editing (equal).
Hywel C Williams (https://orcid.org/0000-0002-5646-3093): Conceptualisation (equal), Funding acquisition (equal), Writing – reviewing and editing (equal).
Timothy Card (https://orcid.org/0000-0003-2555-2250): Conceptualisation (equal), Funding acquisition (equal), Writing – reviewing and editing (equal).
Maarten W Taal (https://orcid.org/0000-0002-9065-212X): Conceptualisation (equal), Funding acquisition (equal), Writing – reviewing and editing (equal).
Guruprasad P Aithal (https://orcid.org/0000-0003-3924-4830): Conceptualisation (equal), Funding acquisition (equal), Writing – reviewing and editing (equal).
Christopher P Fox (https://orcid.org/0000-0002-6322-9254): Conceptualisation (equal), Funding acquisition (equal), Writing – reviewing and editing (equal).
Christian D Mallen (https://orcid.org/0000-0002-2677-1028): Conceptualisation (equal), Funding acquisition (equal), Writing – reviewing and editing (equal).
Kavita Vedhara (https://orcid.org/0000-0002-9940-7534): Conceptualisation (equal), Funding acquisition (equal), Methodology (equal), Supervision (equal), Writing – reviewing and editing (equal).
Danielle A van der Windt (https://orcid.org/0000-0002-7248-6703): Conceptualisation (equal), Funding acquisition (equal), Writing – reviewing and editing (equal).
Matthew D Stevenson (https://orcid.org/0000-0002-3099-9877): Conceptualisation (equal), Data curation (equal), Formal analysis (equal), Funding acquisition (equal), Investigation (equal), Methodology (equal), Resources (equal), Software (equal), Supervision (equal), Validation (equal), Visualisation (equal), Writing – reviewing and editing (equal).
Richard Riley (https://orcid.org/0000-0001-8699-0735): Conceptualisation (equal), Funding acquisition (equal), Methodology (equal), Software (equal), Supervision (equal), Validation (equal), Writing – reviewing and editing (equal).
Patient data statement
This work uses data provided by patients and collected by the NHS as part of their care and support. Using patient data is vital to improve health and care for everyone. There is huge potential to make better use of information from people’s patient records, to understand more about disease, develop new treatments, monitor safety and plan NHS services. Patient data should be kept safe and secure, to protect everyone’s privacy, and it is important that there are safeguards to make sure that they are stored and used responsibly. Everyone should be able to find out about how patient data are used. #datasaveslives You can find out more about the background to this citation here: https://understandingpatientdata.org.uk/data-citation.
Data-sharing statement
Some data may not be available due to licensing agreements. All data requests should be submitted to the corresponding author for consideration and further information.
Ethics statement
Work package 1 did not require ethical approval. WP2 was approved by the Independent Scientific Advisory Committee of the CPRD, Reference: 19_275R, 20_000236R. Research Ethics Committee approval was obtained for WP3. This study received ethical approval from the West Midlands-Black Country Research Ethics Committee (21/WM/0285).
Information governance statement
The University of Nottingham is committed to handling all personal information in line with the UK Data Protection Act (2018) and the General Data Protection Regulation (EU GDPR) 2016/679. Under the Data Protection legislation, The University of Nottingham is the Data Controller, and you can find out more about how we handle personal data, including how to exercise your individual rights and the contact details for our Data Protection Officer here: www.nottingham.ac.uk/governance/records-and-information-management/contact.aspx
Disclosure of interests
Full disclosure of interests: Completed ICMJE forms for all authors, including all related interests, are available in the toolkit on the NIHR Journals Library report publication page at https://doi.org/10.3310/PLRF8845.
Primary conflicts of interest: Abhishek Abhishek has received Institutional research grants from AstraZeneca and Oxford Immunotech; and personal fees from UpToDate (royalty), Springer (royalty), Cadilla Pharmaceuticals (lecture fees), NGM Bio (consulting), Limbic (consulting) and personal fees from Inflazome (consulting) unrelated to the work. Abhishek Abhishek is a member of the NIHR HTA topic prioritisation committee and NIHR East Midlands Research for Patient Benefit funding committee. This research was prioritised and funded prior to his involvement with these committees. Gurupresad P Aithal has received consulting fees from Abbott Products, Albireo Pharma, Amryth, AstraZeneca, BenevolentAI Bio, Clinipace, DNDI, GlaxoSmithKline, Merck, NuCANA, Puretech, Pfizer, Roche Diagnostics, Servier Pharmaceuticals, W.L Gore & Associates paid to the University of Nottingham unrelated to the work. Christopher Fox has received Consultancy/Advisory board fees from Abbvie, GenMab, Incyte, Morphosys, Roche, Takeda, Ono, Kite/Gilead, BMS/Celgene, BTG/Veriton and departmental research funding from BeiGene unrelated to the work. The other authors have no conflict of interest to declare. Keele University has received research funding for Christian D Mallen from NIHR, MRC, versus Arthritis and BMS. Christian D Mallen is Director of the NIHR School for Primary Care Research. Hywel C Williams worked for the National Institute of Health Research 2015–21 as Director of HTA Programme. He had no part to play in the funding of this study. Richard D Riley is a member of the NIHR General Committee. Richard D Riley reports royalties from his books Prognosis Research in Healthcare and IPD Meta-Analysis. Kavita Vedhara is a Trustee of the Academy of Social Sciences. Other authors do not have any competing interests to declare.
Copyright and credit statement
Every effort has been made to obtain the necessary permissions for reproduction, to credit original sources appropriately and to respect copyright requirements. However, despite our diligence, we acknowledge the possibility of unintentional omissions or errors and we welcome notifications of any concerns regarding copyright or permissions.
Publications
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. https://doi.org/10.1093/rap/rkac046
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. https://doi.org/10.1136/bmj-2022-074678.
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. https://doi.org/10.1016/j.eclinm.2023.102213.
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. https://doi.org/10.1136/rmdopen-2023-003980
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.
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:keae175. https://doi.org/10.1093/rheumatology/keae175
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 AEs from glucocorticoid sparing immune-suppressing drugs in immune-mediated inflammatory diseases: a prognostic systematic review. RMD Open 2024;10:e003588.
Disclaimers
This article presents independent research funded by the National Institute for Health and Care Research (NIHR). The views and opinions expressed by authors in this publication are those of the authors and do not necessarily reflect those of the NHS, the NIHR, the HTA programme or the Department of Health and Social Care. If there are verbatim quotations included in this publication the views and opinions expressed by the interviewees are those of the interviewees and do not necessarily reflect those of the authors, those of the NHS, the NIHR, the HTA programme or the Department of Health and Social Care.