Skyrizi effective, well tolerated during induction, maintenance in moderate to severe CD

February 19, 2022

2 minute read

Source/Disclosures

Source:

Peyrin-Biroulet L, et al. Summary OP39. Presented at: European Crohn’s and Colitis Organization Congress; February 16-19, 2022 (virtual meeting).

Bossyut P, ​​et al. Summary OP40. Presented at: European Crohn’s and Colitis Organization Congress; February 16-19, 2022 (virtual meeting).

Disclosures:
Healio could not confirm relevant financial information at the time of publication.


We have not been able to process your request. Please try again later. If you continue to have this problem, please contact [email protected]

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 European Crohn’s Disease and Colitis Organization Congress.

“Shorter baseline disease duration was associated with significantly higher rates of achieving clinical and endoscopic endpoints, showing that you should probably consider early treatment for early disease control,” Laurent Peyrin-BirouletMD, PhD, professor of gastroenterology at the Nancy-Lorraine University Hospital in France, said during the presentation.

Initiation, maintenance

In the ADVANCE and MOTIVATE trials, 527 patients with moderate to severe CD received either Skyrizi IV (risankizumab, AbbVie, Boehringer Ingelheim) 600 mg as induction therapy or placebo for 12 weeks. Patients who responded to induction therapy (n=141) were re-randomized into the 52-week FORTIFY maintenance study and received either risankizumab 360 mg subcutaneously or placebo.

Peyrin-Biroulet and colleagues analyzed patients by years of CD duration at baseline ( 5–10 and > 10 years) and assessed clinical and endoscopic outcomes using nonresponder imputation. Safety was also assessed.

According to Peyrin-Biroulet, at 12 weeks, patients with CD duration of less than 2 years had higher rates of endoscopic findings with IV risankizumab compared to 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 to placebo, despite the initial duration of CD.

At 12 weeks, clinical remission rates were numerically higher in patients with CD duration less than 5 years compared to patients with disease duration greater than 5 years. Similar clinical and endoscopic findings 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 than with placebo.

Location of the disease

Pto be Bossyyou, MD, PhD, from the gastroenterology department of the general hospital of Imelda in Belgium, discussed the efficacy of risankizumab depending on the location of CD. Using data from the ADVANCE, MOTIVATE, and FORTIFY studies, Bossuyt and colleagues analyzed clinical and endoscopic outcomes by site, which included ileal-only, colonic-ileal-colonic only subgroups.

At 12 weeks, a greater proportion of risankizumab-treated patients achieved clinical remission and endoscopic response by CD activity index (CDAI) compared to placebo in the colonic-only subgroups (n=190) and ileocecal (n = 252) (P P .05).

According to Bossyut, among patients in endoscopic remission at 12 weeks, a greater proportion of patients who received risankizumab in the colon alone and ileocecal subgroups achieved sustained endoscopic remission at 52 weeks compared to placebo (P .01). The researchers also observed lower efficacy rates at weeks 12 and 52 in the ileal-only subgroup compared to the colonic-only and ileal-colic subgroups.

“We also showed that induction and maintenance treatment with risankizumab demonstrate greater improvement in patients with colonic involvement, compared to patients on placebo and compared to patients with only ileal involvement,” said Bossyut during the presentation. “However, this interpretation should be taken with caution due to the small numbers in the subgroups.”

Jack L. Goldstein