Consensus statement: Use of jakinib therapy in immune mediated inflammatory diseases

Abstract

Background: Janus kinase inhibitor therapy is approved for use in a variety of Immune mediated inflammatory diseases. Objectives: With 4 agents approved & 1 in development, it is timely to undertake a systematic literature review (SLR) of evidence across indications for efficacy, safety & management issues. Methods: Existing data was evaluated by a steering committee & subsequently by a 25 person expert committee leading to a consensus statement to assist the clinician once the decision had been made to commence a Jakinib. The Committee included patients, rheumatologists, gastroenterologist, haematologist, dermatologist & infectious disease specialists. SLR of Medline, Embase, Cochrane, abstracts from 2018 EULAR & ACR congresses & Epistemonikos identified 1,178 RA & PsA, 128 SLE, & 1339 “other indications” unique references meeting criteria that included randomized & open label clinical trials, registries, phase 4 trials, & meta-analyses. Warnings from regulators issued after the end of the SLR search date were taken into consideration. Cochrane risk of bias tool was used. Results: General principles included (1) shared decision making, (2) adherence to T2T principles, (3) reference to disease specific product information & (4) reference to country/region specific treatment algorithms. Mode of action & indications are discussed & consensus was reached on pre-treatment screening, contra-indications, monitoring, treatment dose, co-medications & adverse effects (see Table 1.), with 80-100% agreement. A research agenda was formulated to update the review as new information becomes available. Conclusion: The consensus provides an assessment of evidence for efficacy & safety of an important therapeutic class with guidance on practical management issues.