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.

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.

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.

This Phase 4, prospective, open-label study provides additional support for the utility of vedolizumab, adalimumab, and methotrexate combination therapy in biologic-naïve patients with newly diagnosed, moderate to high-risk Crohn's disease. Investigators examined the efficacy of this triple therapy for achieving endoscopic and clinical remission at Week 26.

Subcutaneous risankizumab maintenance therapy results in durable improvement in clinical and endoscopic outcomes over one year in patients with moderately to severely active Crohn’s disease. Endpoint achievement tended to be achieved in a higher proportion of patients treated with 360mg risankizumab than 160mg risankizumab, and both doses were higher when compared to placebo.

Etrasimod demonstrated significant efficacy in achieving clinical remission, and was well tolerated compared to placebo in an induction and maintenance therapy.

Treatment of patients with UC with filgotinib 200 mg was associated with an increase in clinical remission at Week 10 and Week 58. The proportion of patients with clinical remission at Week 58 was significantly greater in patients who continued FIL 200 mg therapy throughout the trial. The incidence of TEAEs was similar across all treatment groups.

Maintenance treatment with risankizumab was associated with an improvement in coprimary endpoints of clinical remission and endoscopic response in patients with Crohn’s disease compared with placebo.