Risankizumab meets primary endpoints in maintenance study for Crohn’s disease patients

Clinical remission was sustained throughout the 52-week FORTIFY maintenance study for patients with Crohn’s Disease who responded well to risankizumab induction therapy.

Some 70% of participants had inadequate response to at least 1 prior biologic therapy

Risankizumab is a humanised monoclonal antibody inhibiting IL-23 that has demonstrated greater efficacy than placebo in two 12-week phase 3 induction studies (ADVANCE [NCT03105128] and MOTIVATE [NCT03104413]). Patients with moderate-to-severe CD who responded well to risankizumab (600 mg or 1,200 mg intravenous injection every 4 weeks) were eligible for the FORTIFY maintenance study (NCT03105102)1.

Participants were randomised 1:1:1 to 180 mg risankizumab (subcutaneous injection every 2 months; n=179), 360 mg risankizumab (n=184), or placebo (n=179). Approximately 70% of the participants had an inadequate response to at least 1 prior biologic therapy. Co-primary endpoints were clinical remission and endoscopic response. Prof. Marc Ferrante (University Hospital Leuven, Belgium) presented the findings of the trial.

A large proportion of placebo users achieved clinical remission as well

Crohn’s Disease Activity Index (CDAI) clinical remission scores showed that patients who continued risankizumab were significantly more likely to achieve clinical remission at week 52 than patients who switched to placebo in the maintenance study (risankizumab 180 mg, 55.4%; P=0.003; risankizumab 360 mg, 52.2%; P=0.005; placebo, 40.9%). However, a large proportion of placebo users achieved clinical remission as well. Prof. Ferrante argued that a carry-over effect of the risankizumab induction therapy is a possible explanation for this result.

The endoscopic response, defined as a reduction >50% in the simple endoscopic score (SES)-CD from induction baseline, showed clear benefits of risankizumab over placebo (risankizumab 180 mg, 47.1%; P<0.001; risankizumab 360 mg, 46.5%; P<0.001; placebo, 22.0%). Adverse events (AEs) were evenly distributed over the 3 study groups. Likewise, there was no apparent difference between the number of serious AEs between the study conditions (risankizumab 180 mg, 33; risankizumab 360 mg, 35; placebo, 31). Risankizumab receivers did not show an increased risk of serious infections.

References
  1. Ferrante M, et al. Efficacy and Safety of Risankizumab as Maintenance Therapy in Patients with Crohn’s Disease: 52 Week Results from the Phase 3 FORTIFY Study. LB13, UEG Week 2021 Virtual Congress, 3-5 October.