ADMIRE-CD-II: Darvadstrocel does not meet primary endpoint in complex peri-anal fistula

Darvadstrocel treatment did not lead to better outcomes than placebo in patients with complex peri-anal fistula (CPF) and Crohn’s disease (CD) in the phase 3 ADMIRE-CD II trial.

Darvadstrocel, a suspension of expanded adult, adipose-derived, allogeneic mesenchymal stem cells, was assessed as a potential therapy for patients with CPF and CD in a global phase 3 study, called ADMIRE-CD-II (NCT03279081). Participants (n=568) were randomised 1:1 to a single dose of darvadstrocel or a placebo. Clinical and MRI assessment at week 24 was the primary outcome measure, of which the results were shared by Dr Zuzana Serclova (Hořovice Hospital, Czech Republic) [1].

At week 24, the combined remission endpoint was met by 46.3% of the participants in the placebo arm and by 48.8% of the participants in the experimental arm (Δ2.4; 95% CI -5.8 to 10.6; P=0.57). At week 52, there was still no difference between the groups for this endpoint of combined remission (39.7% vs 41.0%; Δ1.3; 95% CI -6.8 to 9.3; P=0.76). Finally, darvadstrocel was well tolerated and the treatment arms were comparable regarding safety events.

“Treatment of CPF with a single dose of darvadstrocel showed numerically higher response rates for key efficacy endpoints compared with placebo, but these differences were not clinically meaningful or statistically significant,” concluded Dr Serclova.

1. Serclova Z, et al. Efficacy and safety of darvadstrocel treatment in patients with complex perianal fistulas and Crohn’s disease: results from the global ADMIRE-CD II phase 3 study. OP18, 19^th Congress of ECCO, 21–24 February 2024, Stockholm, Sweden.

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Posted on 18 April 202418 April 2024