Skyrizi effective, well tolerated during induction, maintenance in moderate to severe CD
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Skyrizi was effective and well tolerated during induction and maintenance therapy in patients with moderate to severe Crohn’s disease, according to two presentations at the Congress of the European Crohn’s and Colitis Organization.
“Shorter baseline disease duration was associated with significantly greater rates of achievement of clinical and endoscopic endpoints, showing that you probably need to consider early treatment for early disease control,” Laurent Peyrin-Biroulet, MD, PhD, professor of gastroenterology at the University Hospital of Nancy-Lorraine University in France, said during the presentation.
Induction, maintenance
In the ADVANCE and MOTIVATE trials, 527 patients with moderate to severe CD received either IV Skyrizi (risankizumab, AbbVie, Boehringer Ingelheim) 600 mg induction therapy or placebo for 12 weeks. Patients who responded to induction therapy (n = 141) were re-randomized in the 52-week FORTIFY maintenance study and received either subcutaneous risankizumab 360 mg or placebo.
Peyrin-Biroulet and colleagues analyzed patients by years of CD duration at baseline (< 2, 2–5, > 5–10 and > 10 years) and assessed clinical and endoscopic outcomes using nonresponder imputation. Safety was also evaluated.
According to Peyrin-Biroulet, at 12 weeks, patients with CD duration less than 2 years achieved higher rates of endoscopic outcomes with IV risankizumab compared with patients with longer disease duration. In addition, a greater proportion of patients treated with risankizumab achieved clinical remission, endoscopic response, endoscopic remission and ulcer-free endoscopy compared with placebo, despite baseline CD duration.
At 12 weeks, clinical remission rates were numerically higher in patients with CD duration of less than 5 years compared with patients with disease duration greater than 5 years. Similar clinical and endoscopic outcomes were noted at week 52 with maintenance therapy, which correlated with shorter disease duration.
During induction, researchers observed fewer serious adverse events and infections with risankizumab compared with placebo.
Disease location
Peter Bossuyt, MD, PhD, of the department of gastroenterology at Imelda General Hospital in Belgium, discussed the efficacy of risankizumab based on CD disease location. Using data from the ADVANCE, MOTIVATE and FORTIFY studies, Bossuyt and colleagues analyzed clinical and endoscopic outcomes by site, which included ileal only, colonic only ileal-colonic subgroups.
At 12 weeks, a greater proportion of patients treated with risankizumab achieved CD Activity Index (CDAI) clinical remission and endoscopic response compared with placebo in the colonic only (n = 190) and ileal-colonic (n = 252) subgroups (P < .001). In addition, at week 52, patients who received risankizumab in the colonic only (n = 59) and ileal-colonic (n = 67) subgroups achieved CDAI clinical remission and endoscopic response, composite CDAI clinical remission and endoscopic response, and endoscopic remission vs. those in the placebo group (P ≤ .05).
According to Bossyut, among patients with endoscopic remission at 12 weeks, a greater proportion of patients who received risankizumab in the colonic only and ileal-colonic subgroups achieved sustained endoscopic remission at 52 weeks compared with placebo (P ≤ .01). Researchers also observed lower efficacy rates at weeks 12 and 52 in the ileal only subgroup vs. the colonic only and ileal-colonic subgroups.
“We have also shown that risankizumab induction and maintenance therapy demonstrates a greater improvement in patients with colonic involvement, compared to patients with placebo and compared to the patients with only ileal involvements,” Bossyut said during the presentation. “However, this interpretation should be taken with caution because the small numbers in the subgroups.”
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Bossyut P, et al. Abstract OP40. Presented at: Congress of European Crohn’s and Colitis Organization; Feb. 16-19, 2022 (virtual meeting).
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