AbbVie has announced positive topline results from the Phase III AFFIRM study evaluating the efficacy and safety of risankizumab (SKYRIZI) subcutaneous (SC) induction treatment versus placebo in adult patients with moderately to severely active Crohn's disease (CD).
The results showed significantly greater numbers of patients treated with risankizumab SC induction achieved the co-primary endpoints of Crohn's Disease Activity Index (CDAI) clinical remission and endoscopic response at week 12 compared to placebo.
Among those with clinical response after 12 weeks of risankizumab SC induction treatment followed by 12 weeks of maintenance, 67% achieved CDAI clinical remission at week 24 and 57% achieved endoscopic response at week 24.
The Phase III study enrolled a predominantly treatment-refractory population, with 50% of patients having failed two or more advanced therapies, 23% having failed ustekinumab and 12% having failed a Janus kinase inhibitor (JAKi).
"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 Dr 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.
"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," said Dr Millie D. Long, MPH, Chief, Division of Gastroenterology and Hepatology, University of North Carolina, Chapel Hill and lead investigator of the AFFIRM study.
These high endoscopic response rates across populations, particularly among those who have not failed an advanced therapy, demonstrate the potential of subcutaneous induction with risankizumab as an effective therapy for Crohn's disease.
During the 12-week, double-blind, placebo-controlled period, the safety profile of risankizumab SC was consistent with that observed in Crohn's disease, with no new safety risks identified.
The most common adverse events observed among patients receiving risankizumab were upper respiratory tract infection, abdominal pain and arthralgia.
Serious adverse events occurred in 0.5% of patients in the risankizumab SC group compared to 3.1% in the placebo group.
The company stated that full results will be published in an upcoming medical journal and also shared at future medical congresses.