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

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

The authors highlighted a significantly greater clinical remission rate at Week 52 for vedolizumab SC versus placebo in patients with moderately to severely active CD. This study aimed to report results from VISIBLE 2 which evaluated a new SC vedolizumab formulation as maintenance treatment in adults with moderately to severely active CD.

Guselkumab induced greater clinical and endoscopic improvements in patients with Crohn’s disease versus placebo, with a favourable safety profile in this Phase 2 trial by Sandborn, et al.

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.

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

Mirikizumab as induction and maintenance therapy for ulcerative colitis

N Engl J Med 2023;388(26):2444–2455 doi: 10.1056/NEJMoa2207940

Mirikizumab was more effective than placebo in inducing and maintaining clinical remission in patients with moderately to severely active ulcerative colitis. D’Haens, et al. also noted that opportunistic infections and cancer developed in a small number of mirikizumab-treated patients.

The results of two induction studies (UC1 and UC2) and a maintenance study (UC3) show upadacitinib superiority to placebo in treating ulcerative colitis (UC). Rates of clinical remission were significantly higher for all upadacitinib doses versus placebo in all three studies.