TY - JOUR
T1 - Points to consider for the treatment of immune-mediated inflammatory diseases with Janus kinase inhibitors
T2 - A consensus statement
AU - Nash, Peter
AU - Kerschbaumer, Andreas
AU - Dörner, Thomas
AU - Dougados, Maxime
AU - Fleischmann, Roy M.
AU - Geissler, Klaus
AU - McInnes, Iain
AU - Pope, Janet E.
AU - Van Der Heijde, Désirée
AU - Stoffer-Marx, Michaela
AU - Takeuchi, Tsutomu
AU - Trauner, Michael
AU - Winthrop, Kevin L.
AU - De Wit, Maarten
AU - Aletaha, Daniel
AU - Baraliakos, Xenofon
AU - Boehncke, Wolf Henning
AU - Emery, Paul
AU - Isaacs, John D.
AU - Kremer, Joel
AU - Lee, Eun Bong
AU - Maksymowych, Walter P.
AU - Voshaar, Marieke
AU - Tam, Lai Shan
AU - Tanaka, Yoshiya
AU - Van Den Bosch, Filip
AU - Westhovens, René
AU - Xavier, Ricardo
AU - Smolen, Josef S.
N1 - Publisher Copyright:
© Author(s) (or their.
PY - 2021/1/1
Y1 - 2021/1/1
N2 - 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.
AB - 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.
KW - Autoimmune Diseases
KW - Inflammation
KW - Therapeutics
UR - http://www.scopus.com/inward/record.url?scp=85096140803&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85096140803&partnerID=8YFLogxK
U2 - 10.1136/annrheumdis-2020-218398
DO - 10.1136/annrheumdis-2020-218398
M3 - Review article
C2 - 33158881
AN - SCOPUS:85096140803
SN - 0003-4967
VL - 80
SP - 71
EP - 87
JO - Annals of the rheumatic diseases
JF - Annals of the rheumatic diseases
IS - 1
ER -