Early clinical remission and response following risankizumab therapy in CD

Risankizumab was significantly more efficacious than placebo in inducing clinical remission and response 4 weeks after treatment initiation in patients with moderate-to-severe Crohn’s disease (CD). Clinical remission and response rates continued to improve up to week 12. Since agents that induce an early and effective disease response are limited in CD, risankizumab adds value to the spectrum of therapy options.

The 12-week efficacy and safety data of the randomised, double-blind placebo-controlled phase 3 trials ADVANCE (NCT03105128) and MOTIVATE (NCT03104413), assessing risankizumab as induction therapy in patients with moderate-to-severe CD, have been presented earlier this year [1]. Dr Stefan Schreiber (University Hospital Schleswig-Holstein, Germany) and his colleagues further analysed the efficacy data of these trials [2]. Clinical remission, defined as Crohn’s disease activity index (CDAI) scores <150, was the primary endpoint of both trials.

At week 4, CDAI scores revealed that clinical remission was achieved in a significantly greater proportion of patients receiving risankizumab compared with patients receiving placebo in both the ADVANCE trial (risankizumab 600 mg: 18.4% vs risankizumab 1,200 mg 18.9% vs placebo 10.3%) and the MOTIVATE trial (risankizumab 600 mg 20.9% vs risankizumab 1,200 mg 19.4% vs placebo 11.2%). Stool frequency/abdominal pain scores confirmed that early clinical remission could be achieved with risankizumab treatment in this population. In addition, clinical response rates showed significant benefits of risankizumab over placebo at week 4. Furthermore, ongoing improvement of risankizumab efficacy up to week 12 was observed.

1. D'Haens G, et al. DDW Virtual Conference 2021, May 21–23.
2. Schreiber S, et al. Risankizumab induces early clinical remission and response in patients with moderate-to-severe Crohn’s disease: Results from the phase 3 ADVANCE and MOTIVATE studies. OP26, ECCO 2021 Virtual Congress, 2-3 & 8-10 July.

 

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Posted on 2 July, 20218 April, 2024