Skyrizi induction, maintenance therapy improves patient-reported symptoms in CD
Click Here to Manage Email Alerts
CHARLOTTE, N.C. — Patient-reported outcomes of abdominal pain and stool frequency improved with risankizumab induction, while maintenance therapy was effective for symptomatic remission and resolution in patients with Crohn’s disease.
“Abdominal pain and increased stool frequency are two of the most burdensome symptoms of Crohn’s disease. For patients, fast resolution of symptoms is an important goal in therapy,” Ryan Ungaro, MD, MS, associate professor of medicine at the Icahn School of Medicine at Mount Sinai, said. “Risankizumab, an anti-IL-23 biologic, was shown to be well-tolerated and superior for inducing and maintaining clinical remission and endoscopic response in patients with moderate to severe CD.”
Using pooled data from the ADVANCE and MOTIVATE induction studies, which examined IV risankizumab (Skyrizi, AbbVie) 600 mg vs. placebo, as well as the FORTIFY maintenance study, which evaluated subcutaneous risankizumab 180 mg and 360 mg vs. placebo, Ungaro and colleagues examined the correlation between risankizumab therapy and patient reported outcomes (PROs) of abdominal pain score and stool frequency, as well as endoscopic endpoints, at weeks 12 and 52.
According to study results, a higher proportion of patients who received IV risankizumab 600 mg vs. placebo reported improvements from baseline at weeks 4, 8 and 12. Of those who reported an abdominal pain score of at least 1 at baseline, more patients achieved a score of zero at weeks 8 and 12. Similarly, a greater proportion of patients in the risankizumab group who reported stool frequency of greater than 2.8 at baseline achieved a frequency of less than or equal to 1 at weeks 4, 8 and 12.
During the maintenance period, more patients in the subcutaneous risankizumab (180 mg and 360 mg) group compared with the withdrawal/placebo group achieved remission in abdominal pain while stool frequency remission rates were greater among those in the subcutaneous risankizumab 360 mg group vs. withdrawal/placebo at week 52.
Researchers further reported a “significant difference” in the complete resolution of symptoms among patients in the subcutaneous risankizumab 360 mg group vs. withdrawal/placebo.
Abdominal pain remission at week 12 weakly correlated with endoscopic remission and ulcer-free endoscopy at that timepoint, and stool frequency remission also had a weak/moderate correlation at week 12 with endoscopic outcomes.
However, at week 52, researchers reported moderate correlations between endoscopic outcomes and symptom remission.
Further, risankizumab at induction and maintenance was “generally well-tolerated,” with no new safety concerns reported.
“Crohn’s-related symptomatic PROs improved with risankizumab induction therapy,” Ungaro concluded. “Both maintenance doses were effective in resolving abdominal pain; however, only the 360 mg subcutaneous risankizumab maintenance dose was significantly different than withdrawal for improving daily stool frequency, as well as combined symptomatic resolution characterized by abdominal pain score and stool frequency resolution.”
He added, “Symptom improvements and endoscopic outcomes were weakly correlated after induction and moderately correlated during maintenance, underscoring the importance of an objective measure to assess disease activity.”
Collapse
Ungaro R, et al. Abstract S713: Induction and maintenance treatment with risankizumab leads to symptomatic relief in patients with moderate to severe Crohn’s disease. Presented at: ACG Annual Scientific Meeting; Oct. 21-26, 2022; Charlotte, N.C. (hybrid meeting).
Read more about
Click Here to Manage Email Alerts