The safety of JAK-1 inhibitors. (5th May 2021)

• Record Type: Journal Article
• Authors: Clarke, Benjamin; Yates, Mark; Adas, Maryam; Bechman, Katie; Galloway, James
• Is Part Of: Rheumatology. Volume 60(2021)Supplement 2
• Page Start: ii24
• Page End: ii30
• Publication Date: 2021-05-05
• Subjects: rheumatoid arthritis -- JAK inhibitor -- safety -- zoster -- trials -- pharmacovigilance; Rheumatism -- Periodicals; Rheumatology -- Periodicals; 616.723005
• DOI: 10.1093/rheumatology/keaa895
• Languages: English
• ISSNs: 1462-0324

Abstract

Abstract: As efficacy and safety data emerge, differences between JAK inhibitor subclasses are appearing. JAK1 selective drugs, upadacitinib and filgotinib, have broadly come with the same overarching safety recommendations as other immunosuppressive drugs for RA: caution is needed regarding infection risk; monitoring for laboratory abnormalities, including lipids and muscle enzymes, is indicated. A distinguishing feature of JAK inhibitors is a risk for zoster reactivation. Numerically, overall rates of serious infection are similar among JAK inhibitor classes. There are currently no signals for diverticular perforation. VTE incidence rates were similar across comparator groups for the JAK1 selective agents. These observations are not yet conclusive evidence for different safety profiles between JAK1 selective agents and other JAK inhibitors. Differences in study population, design, and concomitant steroid use are examples of potential confounders. It is too early to draw conclusions on long-term outcomes such as malignancy and cardiovascular risk. Post-marketing pharmacovigilance studies will be essential. CME: This supplement is CME Accredited. To receive a CME certificate of participation, you should: Read all the papers in the supplement Register or log in at www.paradigmmc.com/962 to complete and submit the post activity assessment. You must answer 70% of the questions correctly to earn credit. You will have unlimited opportunities to successfully complete the assessment. You will receive a maximum of 7.0 AMA PRA Category 1 Credits TM upon successful completion of the assessment.