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Title: Waiting for JAK inhibitor safety data.
Austin Authors: Kragstrup, Tue Wenzel;Glintborg, Bente;Svensson, Annemarie L;McMaster, Christopher ;Robinson, Philip C;Deleuran, Bent;Liew, David F L 
Affiliation: Department of Biomedicine, Aarhus University, Aarhus, Denmark..
Department of Clinical Medicine, University of Copenhagen, Kobenhavn, Denmark..
Department of Rheumatology, Center for Rheumatology and Spine Diseases, Centre of Head and Orthopedics, University Hospital of Copenhagen Rigshospitalet, Glostrup, Denmark..
Faculty of Medicine, University of Queensland School of Clinical Medicine, Brisbane, Queensland, Australia..
Department of Rheumatology, Aarhus University Hospital, Aarhus, Denmark..
Department of Medicine, University of Melbourne, Parkville, Victoria, Australia..
Diagnostic Center, Silkeborg Regional Hospital, Silkeborg, Denmark..
DANBIO and Copenhagen Center for Arthritis Research (COPECARE), Center for Rheumatology and Spine Diseases, Centre of Head and Orthopedics, University Hospital of Copenhagen Rigshospitalet, Glostrup, Denmark..
Clinical Pharmacology and Therapeutics
The Centre for Digital Transformation of Health, University of Melbourne, Parkville, Victoria, Australia..
Department of Rheumatology, Royal Brisbane and Women's Hospital, Herston, Queensland, Australia..
Issue Date: Feb-2022
Publication information: RMD open 2022-02; 8(1)
Abstract: The US Food and Drug Administration (FDA) has recently added a new 'black box warning' on all currently approved Janus kinase (JAK) inhibitors indicated for the treatment of arthritis and other inflammatory conditions based on results from the ORAL Surveillance study of tofacitinib versus tumour necrosis factor alpha inhibitors in rheumatoid arthritis. This is a warning difficult to ignore because the data, being from a randomised controlled trial, are of high fidelity and hard to reproach. It is especially problematic because safety data for all the other JAK inhibitors will be pending for several years. So how might we proceed, without being bound by our stasis? The lack of absolute certainty seems to require a pragmatic approach to the routine care use of JAK inhibitors. The patients who were at greatest risk were older and had other risk factors for the corresponding adverse events, in keeping with effect modification. This highlights the need to focus on risk stratification when tailoring therapy. In this viewpoint, we propose a simple illustration to guide clinical decision-making. First, identify general risk factors for venous thromboembolic event (VTE), major adverse cardiac event (MACE) and cancer (age>65 years and smoking) and whether there is a previous history of VTE, MACE or cancer. Then, evaluate risk based on the number of other risk factors for VTE and the number of other risk factors for MACE. Ultimately, 'treat-to-target' will in the end always be 'treat-to-agreement'. As we have done in the past, and will do in the future, the optimal treatment strategy will have to be tailored based on individual patient risk factors and preferences in a shared-decision process.
DOI: 10.1136/rmdopen-2022-002236
ORCID: 0000-0002-6439-397X
Journal: RMD open
PubMed URL: 35197363
PubMed URL:
Type: Journal Article
Subjects: antirheumatic agents
arthritis, psoriatic
arthritis, rheumatoid
spondylitis, ankylosing
Appears in Collections:Journal articles

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