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

Author

Ann Rheum Dis. 2021 Jan;80(1):71-87.doi: 10.1136/annrheumdis-2020-218398. Epub 2020 Nov 6.

Peter Nash 1Andreas Kerschbaumer 2Thomas Dörner 3Maxime Dougados 4Roy M Fleischmann 5Klaus Geissler 6Iain McInnes 7Janet E Pope 8Désirée van der Heijde 9Michaela Stoffer-Marx 10Tsutomu Takeuchi 11Michael Trauner 12Kevin L Winthrop 13Maarten de Wit 14Daniel Aletaha 2Xenofon Baraliakos 15Wolf-Henning Boehncke 16Paul Emery 17John D Isaacs 18Joel Kremer 19Eun Bong Lee 20Walter P Maksymowych 21Marieke Voshaar 14Lai-Shan Tam 22Yoshiya Tanaka 23Filip van den Bosch 24René Westhovens 25Ricardo Xavier 26Josef S Smolen 27

Author Information

School of Medicine, Griffith University, Brisbane, Queensland, Australia josef.smolen@meduniwien.ac.at drpnash@tpg.com.au.

Division of Rheumatology, Department of Medicine 3, Medical University of Vienna, 1090 Vienna, Austria.

Dept. Med./Rheumatology and Clinical Immunology, Charite Univ. Hospital, Berlin, Germany.

Hopital Cochin, Rheumatology, Université Paris Descartes, Paris, France.

Department of Medicine, Southwestern University of Texas, Dallas, Texas, USA.

Hietzing Hospital, Wien, Austria.

Institute of Infection, Immunity and Inflammation, University of Glasgow, Glasgow, UK.

Medicine, Division of Rheumatology, The University of Western Ontario, London, Ontario, Canada.

Rheumatology, Leiden University Medical Center, Leiden, The Netherlands.

10 Section for Outcomes Research, Center for Medical Statistics, Informatics, and Intelligent Systems, Medical University of Vienna, Vienna, Austria.

11 Rheumatology, Keio Univ, School of Medicine, Tokyo, Japan.

12 Division of Gastroenterology and Hepatology, Department of Medicine 3, Medical University of Vienna, Vienna, Austria.

13 Oregon Health Sciences University, Portland, Oregon, USA.

14 Medical Humanities, Amsterdam University Medical Centre, Amsterdam, Netherlands.

15 Rheumazentrum Ruhrgebiet, Herne, Germany.

16 Dermatology, University Hospitals of Geneva, Geneva, Switzerland.

17 Leeds Institute of Rheumatic and Musculoskeletal Medicine, Leeds, UK.

18 Musculoskeletal Research Group, Newcastle University, Newcastle upon Tyne, UK.

19 Rheumatology, Albany Medical College, Albany, New York, USA.

20 Internal Medicine, Seoul National University College of Medicine, Seoul, Korea (the Republic of).

21 Medicine, University of Alberta Faculty of Medicine and Dentistry, Edmonton, Alberta, Canada.

22 Department of Medicine & Therapeutics, Chinese University of Hong Kong Shaw College, New Territories, Hong Kong.

23 First Department of Internal Medicine, University of Occupational and Environmental Health, Japan, Kitakyushu, Japan.

24 Rheumatology, University Hospital Gent, Gent, Belgium.

25 KU Leuven University Hospitals Leuven, Leuven, Belgium.

26 Division of Rheumatology, Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil.

27 Division of Rheumatology, Department of Medicine 3, Medical University of Vienna, 1090 Vienna, Austria josef.smolen@meduniwien.ac.at drpnash@tpg.com.au.

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.