Global pharma powerhouse AbbVie has announced today that its Phase 3 AFFIRM study of risankizumab (SKYRIZI) has delivered robust topline results in adults with moderately to severely active Crohn’s disease.
The randomized, placebo-controlled, double-blind trial found risankizumab significantly outperformed placebo in achieving key disease milestones.
Patients treated with risankizumab subcutaneous (SC) induction therapy saw 55% reach clinical remission versus 30% on placebo, and 44% achieved endoscopic response compared to 14% at week 12. Among those continuing on 12 weeks of maintenance after initial response, 67% achieved clinical remission and 57% showed endoscopic response at week 24.
The study enrolled a predominantly treatment-refractory population, with 65% of participants previously failing advanced therapies, including 23% who had failed ustekinumab and 12% who had failed a Janus kinase inhibitor.
“This study evaluated a difficult-to-treat Crohn's disease patient population, including a majority with a prior failure to advanced therapy, and these data reinforce risankizumab as a leading, effective treatment for patients,” said Kori Wallace, vice president, global head of immunology clinical development, AbbVie.
“The level of endoscopic response is a particularly meaningful achievement for Crohn's disease patients; and for AbbVie, these results underscore our continued innovation and research to raise the standard of care.”
Millie D Long, chief, Division of Gastroenterology and Hepatology, University of North Carolina, Chapel Hill, and lead investigator of the AFFIRM study, emphasized the real-world impact: “Crohn's disease is a complex, often debilitating condition that affects far more than a patient's digestive health, disrupting work, relationships and daily life.
"These high endoscopic response rates across populations, in particular among those who have not failed an advanced therapy, demonstrate the potential of subcutaneous induction risankizumab as an effective therapy for Crohn's disease.”
Risankizumab was well-tolerated during the 12-week double-blind period, with no new safety risks observed. The most common adverse events were upper respiratory tract infection, abdominal pain, and arthralgia, while serious adverse events occurred in 0.5% of risankizumab patients versus 3.1% of placebo recipients.
