Publications

Danese et al. observed that efmarodocokin alfa did not demonstrate efficacy compared to the PBO, and this Phase II study ended early for futility; however, there was evidence of target engagement (skin AEs, regenerating islet derived protein 3-alpha).

Danese et al. report that in the TUSCANY-2 study, afimkibart showed a favourable
benefit–risk profile with clinically meaningful improvements and early onset of response during induction, sustained through maintenance, and an acceptable safety profile with no safety signals. Danese et al. describe results from the Phase 2b TUSCANY-2 trial that evaluated the safety and efficacy of 50mg, 150mg, and 450mg doses of afimkibart in adults with moderately-to-severely active UC.

Danese et al. showed that patients who achieved disease clearance 8 weeks after ustekinumab induction were more likely to be in long-term clinical, symptomatic and quality of life remission with ustekinumab maintenance treatment than patients who did not. Authors evaluated disease clearance in the Phase 3 UNIFI program and its association with long-term outcomes.

Vermeire et al. provides data that supports the long-term efficacy and safety of obefazimod 50mg QD, with a substantial proportion of patients achieving clinical remission at Weeks 48 and 96. Vermeire et al. evaluated the 2-year outcome data of an OLM study, which assessed the long-term safety and efficacy of obefazimod 50mg QD.

Sands et al. evaluated tamuzimod, a selective sphingosine 1-phosphate receptor 1 modulator, in patients with moderately-to-severely active UC. At Week 13, clinical remission (defined as an MMS stool frequency subscore of ≤1, rectal bleeding subscore of 0, and endoscopic subscore ≤1, excluding friability) was achieved by 28% and 24% of patients receiving tamuzimod 60 mg and 30 mg, respectively, compared with 11% in the placebo group. The treatment was well tolerated; most AEs were mild or moderate.

Louis et al. demonstrated risankizumab to significantly improve clinical remission rates compared to placebo in both an induction trial and in a maintenance trial for patients with moderately to severely active ulcerative colitis.

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.

Peyrin-Biroulet et al. evaluated the efficacy and safety of etrasimod in patients with moderately to severely active isolated proctitis, demonstrating significant improvement in clinical outcomes compared to placebo. The study reported a favourable safety profile, making etrasimod a viable treatment option for this population.

Long-term SC maintenance therapy of q8w and q12w ustekinumab in patients who responded to IV ustekinumab induction was safe and effective at maintaining symptomatic remission. Investigators aimed to present the final efficacy and safety results of the UNIFI LTE study through 4 years.