COMMAND: Long-term efficacy benefits of risankizumab in ulcerative colitis

In patients with moderately to severely active ulcerative colitis (UC) who responded to risankizumab induction therapy, risankizumab maintenance therapy outperformed placebo withdrawal treatment regarding various clinical, endoscopic, and patient-reported outcomes.

INSPIRE (NCT03398148), a previous phase 3 induction trial, demonstrated the superiority of the IL-23 inhibitor risankizumab (1,200 mg i.v.) over placebo in terms of clinical and endoscopic endpoints in patients with UC [1]. The current phase 3 COMMAND trial (NCT03398135) enrolled 588 patients with UC who responded to the 12-week induction regimen of INSPIRE [2]. These participants were randomised 1:1:1 to risankizumab, either 180 mg or 360 mg s.c., every 8 weeks, or a placebo. Clinical remission (defined as modified Mayo score [MMS] stool frequency subscore ≤1 and not greater than baseline, rectal bleeding subscore =0, and endoscopic subscore ≤1) at week 52 was the primary endpoint, and Prof. Stefan Schreiber (University Hospital Schleswig-Holstein, Germany) presented the findings.

At week 52, 40.2% and 37.6% of the participants in the 180 mg and 360 mg groups achieved clinical remission, compared with 25.1% of the participants on placebo, significantly favouring the experimental arms over the control arm. This difference appeared to be more pronounced among adequate responders to prior advanced therapy (50.9% in the 180 mg group, 61.7% in the 360 mg group, vs 31.1% on placebo) but was still present among participants who did show an inadequate response to a previous advanced therapy (36.6% in the 180 mg group,  29.5% in the 360 mg group, vs 23.2% on placebo). Endoscopic, histologic, patient-reported, and more stringent clinical endpoints all favoured risankizumab over placebo in this population (see Figure). Lastly, the drug was well tolerated and the safety profile was consistent with previously published data.

Figure: Histologic and endoscopic endpoints at week 52 in the COMMAND trial [2]



HEMI, Histological-endoscopic mucosal improvement; SC, subcutaneous.

“Risankizumab maintenance therapy was superior to placebo withdrawal treatment in patients with UC who responded to risankizumab induction therapy, without substantial toxicity,” concluded Prof. Schreiber.

1. Louis et al. Abstract OP021, UEG Journal. 2023;11(S8).
2. Schreiber S, et al. Risankizumab maintenance therapy in patients with moderately to severely active ulcerative colitis: efficacy and safety in the randomized phase 3 COMMAND study. OP06, 19^th Congress of ECCO, 21–24 February 2024, Stockholm, Sweden.

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Posted on 18 April, 2024