Points to consider for the treatment of immune-mediated inflammatory diseases with Janus kinase inhibitors: A consensus statement
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Kerschbaumer, A
Dörner, T
Dougados, M
Fleischmann, RM
Geissler, K
McInnes, I
Pope, JE
Van Der Heijde, D
Stoffer-Marx, M
Takeuchi, T
Trauner, M
Winthrop, KL
De Wit, M
et al.
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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.
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Annals of the Rheumatic Diseases
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© Author(s) (or their employer(s)) 2020. This is an Open Access article distributed under the terms of the Creative Commons Attribution-NonCommercial 4.0 International License, which permits unrestricted, non-commercial use, distribution and reproduction in any medium, providing that the work is properly cited.
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Clinical sciences
Immunology
Health services and systems
Public health
Autoimmune Diseases
Inflammation
Therapeutics
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Nash, P; Kerschbaumer, A; Dörner, T; Dougados, M; Fleischmann, RM; Geissler, K; McInnes, I; Pope, JE; Van Der Heijde, D; Stoffer-Marx, M; Takeuchi, T; Trauner, M; Winthrop, KL; De Wit, M; et al., Points to consider for the treatment of immune-mediated inflammatory diseases with Janus kinase inhibitors: A consensus statement, Annals of the Rheumatic Diseases, 2020