AbbVie Announces Positive Phase 3 INSPIRE Trial Results for Skyrizi (risankizumab) in Moderately to Severely Active Ulcerative Colitis

On March 24, AbbVie announced the positive key results of the Phase III INSPIRE study of risankizumab (Skyrizi) for the treatment of adult patients with moderate to severe active ulcerative colitis. The results showed that the study met the primary endpoint of clinical remission at week 12 as well as all secondary endpoints.

Skyrizi is an interleukin-23 (IL-23) inhibitor that selectively blocks IL-23 by binding to the IL-23 p19 subunit. IL-23 is a cytokine involved in inflammatory processes and is considered to be associated with many chronic immune-mediated diseases.

During the 12-week induction treatment period, 20.3% of patients receiving risankizumab achieved clinical remission, compared to 6.2% in the placebo group. The proportion of patients achieving endoscopic improvement at week 12 was significantly higher in the risankizumab group than in the placebo group (36.5% vs 12.1%; p<0.00001). Additionally, 24.5% of patients treated with risankizumab achieved histologic-endoscopic mucosal improvement at week 12, compared to 7.7% in the placebo group (p<0.00001).

During the 12-week double-blind, placebo-controlled period, the safety of risankizumab 1200mg IV was consistent with the safety observed in previous studies for other indications, with no new safety risks identified. The most common adverse events observed in the risankizumab group were COVID-19, anemia, and arthralgia, with 2.3% of patients experiencing serious adverse events (SAE), compared to an SAE rate of 10.2% in the placebo group.

Skyrizi has been approved by the U.S. FDA and the European Medicines Agency for the treatment of plaque psoriasis, psoriatic arthritis, and Crohn's disease.

In 2023, as the patent for Humira expires, Amgen's adalimumab biosimilar officially enters the U.S. market, marking the end of Humira's "reign." IL-23 antibody Skyrizi and oral JAK1 inhibitor Rinvoq (upadacitinib) have strongly filled the gap, delivering impressive results with over 50% growth rates in 2022, generating revenues of $5.165 billion and $2.522 billion, respectively. Based on the outstanding performance of these three products, there is no doubt that AbbVie’s leadership position in the global autoimmune field remains unshakable.

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