AbbVie Reports Positive Phase 3 Results for SKYRIZI Subcutaneous Induction in Crohn’s Disease Patients

AbbVie Inc. (ABBV) has released positive topline results from the Phase 3 AFFIRM study evaluating subcutaneous risankizumab (SKYRIZI) as induction therapy in patients with moderate to severe Crohn’s disease. The trial met its primary endpoint, demonstrating that 51% of patients achieved clinical response at Week 6, compared to 29% in the placebo group. Secondary endpoints also showed robust outcomes, with 38% of patients achieving clinical remission at Week 6 versus 19% in the placebo arm. The results reflect a significant improvement over existing therapies in the treatment landscape for Crohn’s disease, a chronic inflammatory condition affecting over 780,000 individuals in the United States alone. The AFFIRM trial included 612 patients across multiple clinical sites, with participants randomized to receive either subcutaneous SKYRIZI 300 mg, 150 mg, or placebo. The high response rates observed in the 300 mg cohort underscore the drug’s potential as a first-line biologic option. Safety profiles remained consistent with prior studies, with no new safety signals identified. These findings strengthen AbbVie’s biologics portfolio, which already includes SKYRIZI’s established success in psoriasis and ulcerative colitis. With Crohn’s disease representing a growing therapeutic opportunity, the data may support future regulatory submissions for an expanded indication. The trial’s success also bolsters investor confidence in ABBV’s pipeline, particularly as the company prepares for the patent expiration of its flagship product, Humira, in 2023 (though Humira remains a major revenue contributor through biosimilar competition). The market reaction to the announcement was positive, with ABBV shares gaining 1.8% in pre-market trading. Analysts noted that the AFFIRM results could extend SKYRIZI’s commercial lifecycle into new indications, potentially contributing over $2 billion annually in peak sales within a decade. Insurance coverage and reimbursement pathways are expected to be key factors in adoption, particularly in outpatient settings where subcutaneous administration offers logistical advantages over intravenous infusions.