Integrated safety analysis of tofacitinib from Phase 2 and 3 trials of patients with ankylosing spondylitis

Journal Reference: Adv Rheumatol. 2024 Dec 18;64:87 doi: 10.1186/s42358-024-00402-x

Deodhar et al. conducted a pooled analysis of Phase 2 and 3 RCT data to assess the safety of tofacitinib in AS. The results showed that tofacitinib 5 mg BID had a tolerable safety profile over 48 weeks, consistent with its use in other inflammatory conditions such as RA and PsA.

December 2024

Kavanaugh et al. conducted a post hoc analysis of a phase 2 trial examining deucravacitinib in patients with active psoriatic arthritis, focusing on the achievement of MDA components.

The analysis demonstrated that treatment with deucravacitinib led to a higher proportion of patients meeting each MDA component compared with placebo at 16 weeks.

October 2024

Phase 2 Trial of Anti-TL1A Monoclonal Antibody Tulisokibart for Ulcerative Colitis

N Engl J Med. 2024;391:1119-1129 doi: 10.1056/NEJMoa23140

Sands et al. demonstrated that 12-week treatment of tulisokibart, a monoclonal antibody targeting TL1A, significantly improved clinical remission rates compared to placebo in patients with moderate-to-severe ulcerative colitis.

Keywords:

September 2024

Magro et al. evaluated histologic outcomes for mirikizumab in Crohn's disease and found that early combined histologic-endoscopic response was associated with endoscopic remission after 1 year of treatment.

August 2024

In a large pool of Phase 2b/3 trial data, the incidence rate of uveitis with bimekizumab over 2034.4 patient years (PYs) remained low at 1.2/100 PYs, suggesting bimekizumab may be an appropriate treatment option for patients with axSpA and uveitis. Compared with placebo, bimekizumab had a lower incidence rate of uveitis in patients with and without a history of uveitis.

July 2024

Results of this analysis by Blauvelt, et al. showed a low adjudicated suicidal ideation and behaviour (SIB) rate of 0.13/100 patient-years for bimekizumab, consistent with general psoriasis population ranges. Bimekizumab did not increase the risk of SIB compared to other anti-IL-17A/anti-IL-23 therapies.

Worth, et al. found that namilumab did not show efficacy compared with placebo in patients with active axSpA, but the treatment was generally well tolerated. An unusually high proportion of ASAS20 responders at Week 12 were observed in the placebo group, which had a small sample size compared to the namilumab arm.

Filgotinib (FIL) 200mg was associated with numerical reductions in the number of draining perianal fistulas based on combined clinical and MRI findings compared with placebo. Reinisch et al. reported a numerically higher proportion of patients achieving the primary endpoint of a combined fistula response and/or remission at Week 24 with FIL 200mg compared with placebo.

June 2024

FitzGerald, et al. found that Deucravacitinib significantly impacted biomarkers associated with TYK2 signalling pathways of key inflammatory cytokines, including IL-23 and Type I IFN, and those related to collagen matrix turnover.

April 2024

Deucravacitinib improved physical and social functioning, mental health, fatigue, and pain in a
Phase 2 trial in patients with active PsA. Here, investigators aimed to report the impact of deucravacitinib in a Phase 2 study in patients with active PsA from a patient perspective.