Publications

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.

Results from the Phase 3 GRAVTI study by Hart et al. showed that SC induction followed by SC maintenance treatment with guselkumab resulted in superior clinical and endoscopic improvements in participants with moderately to severely active CD through 48 weeks compared with placebo. Hart et al. evaluated efficacy and safety of guselkumab SC induction followed by SC maintenance in participants with moderately to severely active CD in a    treat-through design.

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).

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.

This interim analysis by Panaccione et al. supports the positive long–term risk–benefit profile for UPA 15mg and 30mg among patients with moderately to severely active UC. U–ACTIVATE is a Phase 3 LTE study evaluating the long-term safety and efficacy of UPA in patients with moderately to severely active UC who enrolled in the preceding induction and maintenance studies. Panaccione et al. reported the interim results from the U-ACTIVATE study after approximately 3 years of total treatment, showing that the risk–benefit profile of UPA in patients with moderately to severely active UC is favourable.

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.

Ferrante et al. conducted a phase 3 trial evaluating the efficacy and safety of mirikizumab in patients with moderately-to-severely active Crohn’s disease. The study demonstrated that mirikizumab significantly improved clinical and endoscopic outcomes compared with placebo at week 52, with a favourable safety profile and tolerable adverse events.

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.