EL7.AI
StocksMedium•23 October 2026•
3 min read

AFFIRM Results: 35.8% Achieved Endoscopic Remission With Subcutaneous Skyrizi Induction

Key Facts

1Endoscopic remission at week 24 was 35.8% with subcutaneous Skyrizi, compared with 9.1% with placebo.
236.6% achieved ulcer-free endoscopy at week 24, compared with 9.1% with placebo.
3The AFFIRM study included 289 patients, assigned in a 2:1 ratio to treatment and placebo.
4AbbVie said on October 13 that the subcutaneous induction application remained under review by the FDA and European Medicines Agency.

Subcutaneous induction doses of Skyrizi for Crohn’s disease remain under regulatory review, AbbVie said on October 13, and the statement did not announce a new FDA approval. The update came with the presentation of results from the Phase 3 AFFIRM study, which evaluated subcutaneous risankizumab in patients with moderately to severely active Crohn’s disease. At week 24, 35.8% of all patients achieved endoscopic remission, compared with 9.1% of those who received placebo. The results put the focus of the news on clinical data and the regulatory application process, rather than a new approval. The company submitted its application to the FDA on April 27, 2026.

Week 24 results also showed that 36.6% of patients who received subcutaneous Skyrizi achieved ulcer-free endoscopy, compared with 9.1% on placebo. By this measure, the rate recorded with treatment was higher than the placebo comparison, as it was for endoscopic remission. Both results concern endoscopic outcomes at week 24, while AbbVie presented initial week 12 results in March. At that time, clinical remission according to the CDAI was 55% with subcutaneous risankizumab, compared with 30% with placebo. The endoscopic response rate at week 12 was also 44% with treatment, versus 14% with placebo.

AFFIRM was a randomized, double-blind, placebo-controlled study involving 289 patients, assigned in a 2-to-1 ratio to subcutaneous risankizumab or placebo. AbbVie said participants had long-standing, difficult-to-treat Crohn’s disease, and 65% had previously experienced an inadequate response to advanced therapies. In the initial week 12 results, outcomes differed according to treatment history: among those who had not previously failed an advanced therapy, clinical remission was 73.1% and endoscopic response was 61.2%. Among those who had previously failed an advanced therapy, the two measures were 45.2% and 34.7%, respectively. The company said half of the patients who had previously failed an advanced therapy had failed two or more advanced therapies.

On safety, AbbVie said results through week 24 were consistent with the known safety profile of risankizumab and showed no new safety signals. This assessment remains tied to the follow-up period reported by the company, through week 24. Regarding how the treatment is administered, AbbVie said in April that the new induction option, if approved, would allow treatment to begin with either subcutaneous injections or intravenous infusion. It added that maintenance doses would continue to be administered subcutaneously every eight weeks. The company thus linked the regulatory application to an additional option for starting treatment while retaining the maintenance schedule it described.

In its October 13 update, AbbVie said the subcutaneous induction application remained under review by the FDA and the European Medicines Agency. The update does not establish that a subsequent decision has been issued, nor does it include an announced timeline for a decision on the application. The FDA application was submitted on April 27 for adults with moderately to severely active Crohn’s disease. The anticipated regulatory decision therefore remains the next milestone the company identified in the development of this treatment option. In the market, AbbVie shares closed at 284.89 dollars on October 22, 2026.