Points to consider for the treatment of immune-mediated inflammatory diseases with Janus kinase inhibitors: a consensus statement

Nash, P. et al. (2021) Points to consider for the treatment of immune-mediated inflammatory diseases with Janus kinase inhibitors: a consensus statement. Annals of the Rheumatic Diseases, 80(1), pp. 71-87. (doi: 10.1136/annrheumdis-2020-218398) (PMID:33158881) (PMCID:PMC7788060)

Abstract

Objectives: Janus kinase inhibitors (JAKi) have been approved for use in various immune-mediated inflammatory diseases. With five agents licensed, it was timely to summarise the current understanding of JAKi use based on a systematic literature review (SLR) on efficacy and safety. Methods: Existing data were evaluated by a steering committee and subsequently reviewed by a 29 person expert committee leading to the formulation of a consensus statement that may assist the clinicians, patients and other stakeholders once the decision is made to commence a JAKi. The committee included patients, rheumatologists, a gastroenterologist, a haematologist, a dermatologist, an infectious disease specialist and a health professional. The SLR informed the Task Force on controlled and open clinical trials, registry data, phase 4 trials and meta-analyses. In addition, approval of new compounds by, and warnings from regulators that were issued after the end of the SLR search date were taken into consideration. Results: The Task Force agreed on and developed four general principles and a total of 26 points for consideration which were grouped into six areas addressing indications, treatment dose and comedication, contraindications, pretreatment screening and risks, laboratory and clinical follow-up examinations, and adverse events. Levels of evidence and strengths of recommendations were determined based on the SLR and levels of agreement were voted on for every point, reaching a range between 8.8 and 9.9 on a 10-point scale. Conclusion: The consensus provides an assessment of evidence for efficacy and safety of an important therapeutic class with guidance on issues of practical management.

• Item Type: Articles
• Additional Information: This research was funded by AbbVie and Eli Lilly and Company.
• Status: Published
• Refereed: Yes
• Glasgow Author(s) Enlighten ID: McInnes, Professor Iain
• Authors: Nash, P., Kerschbaumer, A., Dörner, T., Dougados, M., Fleischmann, R. M., Geissler, K., McInnes, I., Pope, J. E., van der Heijde, D., Stoffer-Marx, M., Takeuchi, T., Trauner, M., Winthrop, K. L., de Wit, M., Aletaha, D., Baraliakos, X., Boehncke, W.-H., Emery, P., Isaacs, J. D., Kremer, J., Lee, E. B., Maksymowych, W. P., Voshaar, M., Tam, L.-S., Tanaka, Y., van den Bosch, F., Westhovens, R., Xavier, R., and Smolen, J. S.
• College/School: College of Medical Veterinary and Life Sciences > School of Infection & Immunity
• Research Centre: College of Medical Veterinary and Life Sciences > School of Infection & Immunity > Centre for Immunobiology
• Journal Name: Annals of the Rheumatic Diseases
• Publisher: BMJ Publishing Group
• ISSN: 0003-4967
• ISSN (Online): 1468-2060
• Published Online: 06 November 2020
• Copyright Holders: Copyright © 2021 The Authors
• First Published: First published in Annals of the Rheumatic Diseases 80(1): 71-87
• Publisher Policy: Reproduced under a Creative Commons License