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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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.

July 2023

Phase 3 trial of baricitinib demonstrates efficacy with acceptable safety profile in polyarticular and extended oligoarticular juvenile idiopathic arthritis, juvenile psoriatic arthritis and enthesitis-related arthritis.

Cicirello, et al. present results showing that baricitinib is comparable in treatment persistence with TNF inhibitors. However, treatment persistence up to 24 months was significantly longer for baricitinib, but the effect size of one month is not clinically meaningful.

June 2023

This single-centre study by Khan, et al. suggests that high-dose methotrexate (25 mg/week, subcutaneously) may be as efficacious as tofacitinib in patients with established RA who are DMARD naïve or have not received a therapeutic dose of DMARDs.

JAK Inhibitors and the Risk of Malignancy: A Meta-analysis Across Disease Indications

Ann Rheum Dis. 2023;82(8):1059–1067 doi: 10.1136/ard-2023-224049

The objective of this study was to estimate the association of JAKi with the incidence of malignancy, compared with placebo, TNFi and MTX.

The results from Simon, et al. show that baricitinib treatment correlates with improvements in bone stiffness. Further improvements were also observed at the end of Week 52, with an increase in estimated failure load and no measurable progression in bone erosion being reported.

Reinisch, et al. show that filgotinib treatment has no effect on semen parameters for men with active inflammatory diseases. This contrasts with pre-clinical studies that showed fertility issues in male animals.

Pots hoc analysis of peficitinib Phase 3 trials shows that continued treatment with peficitinib up to Week 52 is linked to improved remission rates in Asian patients with RA.