AbbVie Reports Positive Phase 3 Results for Subcutaneous SKYRIZI

The study revealed that 35.8% of participants achieved endoscopic remission, defined as the healing of intestinal linings with minimal inflammation. Among those who entered the trial with existing ulcers, 36.6% reached a state of ulcer-free endoscopy following the induction and maintenance phases. Efficacy was notably higher in patients who had not previously received advanced therapies, with 45.1% achieving endoscopic remission and 49.0% reaching ulcer-free status.

Dr. Millie D. Long, lead investigator and chief of gastroenterology and hepatology at the University of North Carolina at Chapel Hill, noted that the results provide clinicians with critical evidence for managing patients at various stages of the disease. The AFFIRM trial population was characterized by long-standing illness, with 65% of participants having previously failed other advanced treatments. AbbVie expects these data to support ongoing regulatory reviews by the U.S. Food and Drug Administration and the European Medicines Agency as it seeks to expand access to the self-administered treatment.