Early endoscopic response to Skyrizi induction linked to fewer hospitalizations in Crohn’s
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Key takeaways:
- Patients who achieved endoscopic response or remission after induction had significantly fewer hospitalizations and surgeries through week 52.
- Similar outcomes were reported for those who were ulcer-free.
Early endoscopic improvement after Skyrizi induction was associated with fewer Crohn’s disease-related hospitalizations and surgeries through 52 weeks of maintenance in patients with moderately to severely active disease, research showed.
“Risankizumab, an interleukin-23 inhibitor, was effective and well-tolerated as induction therapy and maintenance of remission in patients with moderately to severely active CD,” Brian G. Feagan, MD, scientific director at Alimentiv, and colleagues wrote in Gastro Hep Advances. “The extensive endoscopic data from the [phase 3 FORTIFY] trial provided an opportunity to assess the potential value of endoscopy as a treatment target.”
In a post-hoc analysis of the FORTIFY trial, Feagan and colleagues investigated the association between endoscopic outcomes after Skyrizi (risankizumab, AbbVie) induction and rates of hospitalization and surgery through 52 weeks of maintenance treatment.
They included data from 298 patients who demonstrated a clinical response at the end of induction — defined as at least a 30% reduction in average daily stool frequency and/or at least a 30% drop in average daily abdominal pain score at week 12 — and continued risankizumab for 52 weeks. A secondary analysis included an additional 164 patients who received withdrawal placebo during maintenance.
At baseline, 121 patients had achieved endoscopic response, 83 patients had achieved endoscopic remission and 70 patients had no ulcers on endoscopy.
Patients who achieved endoscopic response after induction had significantly lower rates of CD-related hospitalizations through week 52 compared with non-responders (1.7 vs. 7.9 per 100 person-years), as did those who achieved endoscopic remission (1.2 vs. 6.9 per 100 person-years). Similar outcomes were reported for those who were ulcer-free on endoscopy (1.5 vs. 6.4 per 100 person-years).
Patients who achieved endoscopic outcomes at induction also did not undergo any CD-related surgeries through week 52 (response: 0 vs. 3.2; remission: 0 vs. 2.6; ulcer-free endoscopy: 0 vs. 2.4).
However, similar rates of hospitalizations and surgeries were reported among patients who received placebo during maintenance, regardless of positive outcomes after induction.
“Early improvement of endoscopic outcomes after 12-week induction therapy with risankizumab was associated with significant reductions in CD-related hospitalizations and surgeries through 52 weeks for patients receiving risankizumab maintenance therapy,” Feagan and colleagues wrote. “The observed association between early endoscopic response after induction and long-lasting disease modification with active maintenance therapy underscores the importance of continued maintenance therapy even in patients who have a symptomatic response to induction treatment.”
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