Risankizumab for Ulcerative Colitis Two Randomized Clinical Trials

JAMA. 2024;332:881-897 doi: 10.1001/jama.2024.12414

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.

August 2024

Risankizumab versus ustekinumab for moderate-to-severe Crohn’s disease

N Engl J Med. 2024 Jul 18;391(3):213-223. DOI 10.1056/NEJMoa2314585

Risankizumab was noninferior to ustekinumab with respect to clinical remission at Week 24, and superior with respect to endoscopic remission at Week 48. This study aimed to present data from SEQUENCE, a direct head-to-head trial assessing the efficacy and safety of risankizumab vs ustekinumab in patients with moderate-to-severe CD, in whom at least one anti-TNF treatment had failed.

July 2024

Vedolizumab, Adalimumab, and Methotrexate Combination Therapy in Crohn's Disease (EXPLORER)

Clin Gastroenterol Hepatol 2024;22:1487–96 doi: 10.1016/j.cgh.2023.09.010

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.

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.

This post hoc analysis provides additional support for the utility of risankizumab therapy in patients with moderately to severely active CD. Investigators examined the efficacy of risankizumab for providing early symptom relief, along with the prognostic value of early symptom relief for achieving future clinical and endoscopic endpoints.

May 2024

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.

Risankizumab was effective and well tolerated as induction therapy in patients with moderately to severely active Crohn’s disease, though there were no significant differences in efficacy between 600mg and 1200mg doses.

Ozanimod as induction therapy and maintenance therapy for ulcerative colitis

N Engl J Med 2021;385:1280–91 doi: 10.1056/NEJMoa2033617

Patients receiving ozanimod displayed a significant improvement in clinical response and all secondary endpoints during both the 10-week induction and 52-week maintenance study periods. Percentage of patients achieving clinical remission at Weeks 10 and 52 was the primary endpoint.