AbbVie reported that its Phase 3 AFFIRM study of risankizumab (SKYRIZI®) in adults with moderately to severely active Crohn’s disease met both co‑primary endpoints. In the 289‑patient trial, 55 % of patients receiving risankizumab achieved clinical remission (CDAI < 150) at week 12 compared with 30 % of those given placebo, while 44 % achieved endoscopic response versus 14 % with placebo.
The durability of the response was highlighted by the fact that 67 % of patients who entered remission at week 12 remained in remission at week 24, and 57 % maintained endoscopic response, underscoring the potential for sustained disease control in a heavily treatment‑refractory population in which 65 % had failed two or more advanced therapies, including ustekinumab and Janus kinase inhibitors.
These results support AbbVie’s strategy to broaden SKYRIZI’s indications beyond psoriasis and psoriatic arthritis into inflammatory bowel disease, a market that could become a significant contributor to the company’s immunology platform as it seeks to offset the loss of Humira’s exclusivity. The data suggest that SKYRIZI could capture a meaningful share of the Crohn’s disease market, which is highly competitive and dominated by IL‑23 and IL‑12/23 inhibitors such as Stelara and the recently approved Tremfya.
In the broader competitive landscape, SKYRIZI’s performance in a refractory cohort positions it favorably against existing biologics. AbbVie has previously demonstrated superiority over Stelara in head‑to‑head trials, and the AFFIRM data reinforce the drug’s efficacy profile against other IL‑23 inhibitors that are now approved for Crohn’s disease.
Kori Wallace, M.D., Ph.D., vice president and global head of immunology clinical development at AbbVie, said, "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 announcement aligns with AbbVie’s broader immunology growth strategy, and while immediate market reaction data are not available, the positive topline results are expected to reinforce investor confidence in the company’s pipeline expansion into inflammatory bowel disease.
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