The data gathered in this post-marketing surveillance study aligned with the previously established safety profile of tofacitinib, and reports were found to have consistent safety profiles in the treatment of both patient with PsA and RA. However, the results of this study should be interpreted considering the limitations of post-marketing surveillance studies.

This review by Taylor, et al. reviews the long-term safety and efficacy data for baricitinib. Results from several studies showed that baricitinib has greater efficacy and survival compared to TNF inhibitors, and that the rate of CDAI <10 for baricitinib-treated RA patients increased over the course of seven years. Data also showed that remission rates were higher in real-world evidence than in RCTs.

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.

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.

June 2023

Mirikizumab as induction and maintenance therapy for ulcerative colitis

N Engl J Med 2023;388(26):2444–2455 doi: 10.1056/NEJMoa2207940

Mirikizumab was more effective than placebo in inducing and maintaining clinical remission in patients with moderately to severely active ulcerative colitis. D’Haens, et al. also noted that opportunistic infections and cancer developed in a small number of mirikizumab-treated patients.

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.

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.

This study confirms the safety of long-term apremilast use in patients with plaque PsO, active PsA, or oral ulcers associated with Behçet’s syndrome. In coming to this conclusion, investigators conducted a pooled analysis of apremilast data from 15 clinical studies with open-label extension phases, focusing on long-term safety.