Points to consider for the treatment of immune-mediated inflammatory diseases with Janus kinase inhibitors: a consensus statement.
- Nash P School of Medicine, Griffith University, Brisbane, Queensland, Australia josef.smolen@meduniwien.ac.at drpnash@tpg.com.au.
- Kerschbaumer A Division of Rheumatology, Department of Medicine 3, Medical University of Vienna, 1090 Vienna, Austria.
- Dörner T Dept. Med./Rheumatology and Clinical Immunology, Charite Univ. Hospital, Berlin, Germany.
- Dougados M Hopital Cochin, Rheumatology, Université Paris Descartes, Paris, France.
- Fleischmann RM Department of Medicine, Southwestern University of Texas, Dallas, Texas, USA.
- Geissler K Hietzing Hospital, Wien, Austria.
- McInnes I Institute of Infection, Immunity and Inflammation, University of Glasgow, Glasgow, UK.
- Pope JE Medicine, Division of Rheumatology, The University of Western Ontario, London, Ontario, Canada.
- van der Heijde D Rheumatology, Leiden University Medical Center, Leiden, The Netherlands.
- Stoffer-Marx M Section for Outcomes Research, Center for Medical Statistics, Informatics, and Intelligent Systems, Medical University of Vienna, Vienna, Austria.
- Takeuchi T Rheumatology, Keio Univ, School of Medicine, Tokyo, Japan.
- Trauner M Division of Gastroenterology and Hepatology, Department of Medicine 3, Medical University of Vienna, Vienna, Austria.
- Winthrop KL Oregon Health Sciences University, Portland, Oregon, USA.
- de Wit M Medical Humanities, Amsterdam University Medical Centre, Amsterdam, Netherlands.
- Aletaha D Division of Rheumatology, Department of Medicine 3, Medical University of Vienna, 1090 Vienna, Austria.
- Baraliakos X Rheumazentrum Ruhrgebiet, Herne, Germany.
- Boehncke WH Dermatology, University Hospitals of Geneva, Geneva, Switzerland.
- Emery P Leeds Institute of Rheumatic and Musculoskeletal Medicine, Leeds, UK.
- Isaacs JD Musculoskeletal Research Group, Newcastle University, Newcastle upon Tyne, UK.
- Kremer J Rheumatology, Albany Medical College, Albany, New York, USA.
- Lee EB Internal Medicine, Seoul National University College of Medicine, Seoul, Korea (the Republic of).
- Maksymowych WP Medicine, University of Alberta Faculty of Medicine and Dentistry, Edmonton, Alberta, Canada.
- Voshaar M Medical Humanities, Amsterdam University Medical Centre, Amsterdam, Netherlands.
- Tam LS Department of Medicine & Therapeutics, Chinese University of Hong Kong Shaw College, New Territories, Hong Kong.
- Tanaka Y First Department of Internal Medicine, University of Occupational and Environmental Health, Japan, Kitakyushu, Japan.
- van den Bosch F Rheumatology, University Hospital Gent, Gent, Belgium.
- Westhovens R KU Leuven University Hospitals Leuven, Leuven, Belgium.
- Xavier R Division of Rheumatology, Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil.
- Smolen JS Division of Rheumatology, Department of Medicine 3, Medical University of Vienna, 1090 Vienna, Austria josef.smolen@meduniwien.ac.at drpnash@tpg.com.au.
- 2020-11-07
Published in:
- Annals of the rheumatic diseases. - 2020
English
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.
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.
- Language
-
- English
- Open access status
- hybrid
- Identifiers
-
- DOI 10.1136/annrheumdis-2020-218398
- PMID 33158881
- Persistent URL
- https://sonar.ch/global/documents/229906
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