» Articles » PMID: 33950230

The Safety of JAK-1 Inhibitors

Overview
Specialty Rheumatology
Date 2021 May 5
PMID 33950230
Citations 41
Authors
Affiliations
Soon will be listed here.
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.

Citing Articles

Effective Second-Line b/tsDMARDs for Patients with Rheumatoid Arthritis Unresponsive to First-Line b/tsDMARDs from the FIRST Registry.

Kanda R, Miyazaki Y, Nakayamada S, Fukuyo S, Kubo S, Miyagawa I Rheumatol Ther. 2025; .

PMID: 40025347 DOI: 10.1007/s40744-025-00747-9.


Flavonoids as Natural Anti-Inflammatory Agents in the Atopic Dermatitis Treatment.

Zawawi N, Ahmad H, Madatheri R, Fadilah N, Maarof M, Fauzi M Pharmaceutics. 2025; 17(2).

PMID: 40006628 PMC: 11859288. DOI: 10.3390/pharmaceutics17020261.


JAK inhibitors: a new choice for diabetes mellitus?.

Zhou M, Shen Q, Li B Diabetol Metab Syndr. 2025; 17(1):33.

PMID: 39849637 PMC: 11755809. DOI: 10.1186/s13098-025-01582-2.


Continuous Treatment with Tofacitinib but Not Filgotinib Is Effective in Non-Responders with Active Ulcerative Colitis: A Propensity Score-Matching Analysis.

Yagi S, Fukui H, Ikenouchi M, Shiraishi T, Kaku K, Wakita M J Clin Med. 2025; 14(1.

PMID: 39797304 PMC: 11721360. DOI: 10.3390/jcm14010217.


Therapeutic potential of antibody-drug conjugates possessing bifunctional anti-inflammatory action in the pathogenies of rheumatoid arthritis.

Dixit T, Vaidya A, Ravindran S Arthritis Res Ther. 2024; 26(1):216.

PMID: 39695738 PMC: 11656801. DOI: 10.1186/s13075-024-03452-0.


References
1.
Cunningham A, Lal H, Kovac M, Chlibek R, Hwang S, Diez-Domingo J . Efficacy of the Herpes Zoster Subunit Vaccine in Adults 70 Years of Age or Older. N Engl J Med. 2016; 375(11):1019-32. DOI: 10.1056/NEJMoa1603800. View

2.
Burmester G, Kremer J, Van den Bosch F, Kivitz A, Bessette L, Li Y . Safety and efficacy of upadacitinib in patients with rheumatoid arthritis and inadequate response to conventional synthetic disease-modifying anti-rheumatic drugs (SELECT-NEXT): a randomised, double-blind, placebo-controlled phase 3 trial. Lancet. 2018; 391(10139):2503-2512. DOI: 10.1016/S0140-6736(18)31115-2. View

3.
Smolen J, Genovese M, Takeuchi T, Hyslop D, Macias W, Rooney T . Safety Profile of Baricitinib in Patients with Active Rheumatoid Arthritis with over 2 Years Median Time in Treatment. J Rheumatol. 2018; 46(1):7-18. DOI: 10.3899/jrheum.171361. View

4.
Westhovens R, Taylor P, Alten R, Pavlova D, Enriquez-Sosa F, Mazur M . Filgotinib (GLPG0634/GS-6034), an oral JAK1 selective inhibitor, is effective in combination with methotrexate (MTX) in patients with active rheumatoid arthritis and insufficient response to MTX: results from a randomised, dose-finding study (DARWIN.... Ann Rheum Dis. 2016; 76(6):998-1008. DOI: 10.1136/annrheumdis-2016-210104. View

5.
Mease P, Charles-Schoeman C, Cohen S, Fallon L, Woolcott J, Yun H . Incidence of venous and arterial thromboembolic events reported in the tofacitinib rheumatoid arthritis, psoriasis and psoriatic arthritis development programmes and from real-world data. Ann Rheum Dis. 2020; 79(11):1400-1413. PMC: 7569391. DOI: 10.1136/annrheumdis-2019-216761. View