Janus Kinase Inhibitor—Tofacitinib Associated with Pemphigus: An Analysis of the FDA Adverse Event Reporting System Data

ExpExpert Opin Drug Saf. 2023;22(12):1317–1320 doi: 10.1080/14740338.2023.2248872

This study presents initial data suggesting an association between the use of JAK inhibitors and pemphigus. This research used the FAERS database to investigate connections between JAK inhibitor usage and the occurrence of pemphigus as an adverse event.

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The ContRAst 3 study investigated otilimab, in RA patients with inadequate responses to multiple treatments. Otilimab did not significantly improve ACR20 versus placebo at Weeks 12 or 24. In addition, there we no significant improvements in secondary endpoints, including disease activity, disability, and pain.

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Findings from post hoc analyses extend the knowledge base for radiographic benefits of filgotinib in patients with RA.

This study by Harrold, et al. showed that RA patients initiating upadacitinib reported improvements in RAPID3, pain, stiffness, and fatigue as early as Week 1, with 37.5% achieving RAPID3 LDA at Week 12. TNFi-experienced patients had similar outcomes.

Fleischmann, et al investigated the safety and efficacy of otilimab versus tofacitinib and placebo in RA patients treated with MTX (contRAst 1) or csDMARDs (contRAst 2). They found that while otilimab achieved the primary endpoint of ACR20 versus placebo in Week 12, it did not demonstrate non-inferiority to tofacitinib.

Incidence rates for autoimmune diseases increased between 2000 and 2019 in the UK, notably in coeliac disease, Sjogren's syndrome, and Graves' disease. Pernicious anaemia and Hashimoto's thyroiditis had the greatest decrease in incidence. These disorders affected about 10% of the population, with socioeconomic, seasonal, and regional variations observed.

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As part of the GBD 2021, the authors provide updated estimates for the global burden of RA. In 2020, approximately 17.6 million people worldwide had RA, with a 14.1% increase in prevalence since 1990. Mortality decreased by 23.8% from 1990 to 2020. The study forecasts an increase in cases to 31.7 million by 2050.

In the UPJOINT open label study, the proportion of patients with PsA, and an inadequate response to csDMARDs or bDMARDs, who achieved minimal disease activity with upadacitinib was in line with the results of previous studies at 24 weeks. No new safety signals were identified.

The efficacy and safety of updacitinib in bDMARD-IR patients with AS were sustained through to one year in an open-label extension of the SELECT-AXIS 2 study.

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September 2023

This meta-analysis by Wei, et al. found that JAKi therapy was not associated with a higher risk of MACE than treatment with adalimumab, abatacept, or placebo. However, a higher incidence of all-cause mortality was observed with tofacitinib treatment than with adalimumab treatment.