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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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.

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

Differential Properties of Janus Kinase Inhibitors in the Treatment of Immune-mediated Inflammatory Diseases

Rheumatology (Oxford) 2023;63(2):298–308 doi 10.1093/rheumatology/kead448

JAKis differ in structure, which affects their inhibitory concentration for different JAKs.

This review by Taylor, et al. compares the pharmacological profiles of JAKis, including abrocitinib, baricitinib, filgotinib, peficitinib, tofacitinib, and upadacitinib.

The results of a Bayesian network meta-analysis by Lee and Song showed that JAK inhibitors were more likely to achieve remission and LDA in DMARD-naive RA patients than MTX. However, there were no significant differences in remission rates nor LDA rates between the JAK inhibitors investigated.

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This study by Bergman, et al. showed that RA patients are significantly more likely to adhere to upadacitinib within the first 12 months of prescription versus adalimumab, baricitinib, and tofacitinib. There was also a significantly lower risk of discontinuation for upadacitinib versus the other treatment prescriptions.

August 2023

Data from this open-label extension showed the efficacy of upadacitinib observed at 56 weeks was maintained through to 152 weeks in the treatment of patients with PsA. No cumulative adverse effects were observed, and no new safety signals were identified.

July 2023

Upadacitinib significantly improved patient-reported outcomes in AxSpA patients with bDMARD-IR after 14 Weeks of treatment. There were notable improvements in disease activity, pain, fatigue, function, HRQoL, and work productivity.

Pots hoc analysis of safety data in patients with RA at increased risk of CV events from the upadacitinib SELECT phase III RA clinical programme helps to contextualise the overall risk profile of upadacitinib.