VIVID-1: Mirikizumab meets expectations in Crohn’s disease

Mirikizumab met its primary endpoints in the phase 3 VIVID-1 trial, testing this agent among patients with moderate-to-severe Crohn’s disease (CD). The response rates were comparable between participants, regardless whether a prior biologic therapy had failed them or not.

Mirikizumab is a novel IL-23p19 inhibitor that has been approved for the treatment of patients with moderate-to-severe ulcerative colitis and has shown promising efficacy data among patients with CD [1].

To further assess the value of mirikizumab in CD, the multicentre, double-blind, placebo- and active-controlled, phase 3 VIVID-1 study (NCT03926130) randomised 1,150 adult patients with moderate-to-severe CD 6:3:2 to mirikizumab, ustekinumab, or a placebo [2]. In the mirikizumab arm, participants received 900 mg i.v. every 4 weeks during the induction phase, and 300 mg s.c. every 4 weeks during the maintenance phase. Furthermore, in the placebo arm, non-responders were re-randomised to mirikizumab or placebo after 12 weeks of therapy.

Prof. Marc Ferrante (University Hospitals Leuven, Belgium) presented the first results of the co-primary endpoints, being:

• clinical response (defined as ≥30% decrease in stool frequency and/or abdominal pain, and neither score worse than baseline) at week 12 plus endoscopic response (defined as ≥50% reduction from baseline in Simple Endoscopic Score for Crohn's Disease [SES-CD] Total Score) at week 52, and
• clinical response (defined as ≥30% decrease in stool frequency and/or abdominal pain, and neither score worse than baseline) at week 12 plus clinical remission (defined as Crohn's Disease Activity Index [CDAI] Total Score <150) at week 52.

The first co-primary endpoint was met by 38.0% of the participants in the mirikizumab arm and by 9.0% of the participants in the placebo arm (Δ28.7; 95% CI 20.6–36.8; P<0.0001), with consistent results among bio-naïve and bio-experienced participants. Next, 45.4% of the mirikizumab receivers and 19.6% of the placebo receivers achieved the second co-primary endpoint (Δ25.8; 95% CI 15.9–35.6; P<0.0001). These results were sustained in the more stringent secondary efficacy endpoints, such as a combined clinical response at week 12 and endoscopic remission at week 52 (23.5% vs 4.0%; 95% CI 13.1–25.7; P<0.0001). Finally, the safety profile of mirikizumab was consistent with the known favourable safety profile of this agent among patients with ulcerative colitis.

“Mirikizumab demonstrated significant and clinically meaningful improvements in primary and secondary efficacy endpoints compared with placebo in this population of patients with CD, with an acceptable safety profile,” decided Prof. Ferrante.

1. Sands BE, et al. Gastroenterology. 2022;162:495-508.
2. Ferrante M, et al. Primary efficacy and safety of mirikizumab in moderate to severe Crohn’s disease: results of the treat-through VIVID 1 study. OP05, 19^th Congress of ECCO, 21–24 February 2024, Stockholm, Sweden.

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Posted on 18 April 2024