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

Nash, Peter; Kerschbaumer, Andreas; Dörner, Thomas; Dougados, Maxime; Fleischmann, Roy M; Geissler, Klaus; McInnes, Iain; Pope, Janet E; van der Heijde, Désirée; Stoffer-Marx, Michaela; Takeuchi, Tsutomu; Trauner, Michael; Winthrop, Kevin L; de Wit, Maarten; Aletaha, Daniel; Baraliakos, Xenofon; Boehncke, Wolf-Henning; Emery, Paul; Isaacs, John D; Kremer, Joel; Lee, Eun Bong; Maksymowych, Walter P; Voshaar, Marieke; Tam, Lai-Shan; Tanaka, Yoshiya; van den Bosch, Filip; Westhovens, René; Xavier, Ricardo; Smolen, Josef S

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.