AbbVie Reports Positive Phase 3 Results for Risankizumab SC Induction in Crohn's Disease

AbbVie announced positive topline results from the Phase 3, randomized, placebo-controlled, double-blind 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. The AFFIRM study results show significantly greater proportions of patients treated with risankizumab SC induction achieved the co-primary endpoints of Crohn's Disease Activity Index (CDAI) clinical remission (55% vs. 30%; p<0.0001) and endoscopic response (44% vs. 14%; p<0.0001) at week 12 compared to placebo.

Among patients 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. These data support strong efficacy of risankizumab in Crohn's disease while providing potential for an induction choice for patients.

This Phase 3 study enrolled a predominantly treatment-refractory population (65%) with 50% of those patients having failed two or more advanced therapies and 23% having failed ustekinumab and 12% having failed a Janus kinase inhibitor (JAKi). In the advanced therapy naïve subgroup, 73.1% achieved CDAI clinical remission versus 27.3% placebo, and 61.2% achieved endoscopic response versus 15.2% placebo. Among patients with prior advanced therapy failure, 45.2% achieved CDAI clinical remission versus 30.8% placebo, and 34.7% achieved endoscopic response versus 13.8% placebo.

The vice president and global head of immunology clinical development at AbbVie stated that 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. The level of endoscopic response is a particularly meaningful achievement for Crohn's disease patients, and for AbbVie, these results underscore continued innovation and research to raise the standard of care.

The lead investigator of the AFFIRM study noted that 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.

During the 12-week, double-blind, placebo-controlled period, the safety profile of risankizumab SC was consistent with the safety profile observed in Crohn's disease with no new safety risks observed. 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. Full results will be published in an upcoming medical journal and shared at future medical congresses.

Separately, RBC Capital Markets has initiated coverage of AbbVie at outperform saying the company has underperformed based on unfounded concerns and will benefit from growing Skyrizi and Rinvoq sales. The bank has a $260 price target.