AbbVie's IL-23 Inhibitor Risankizumab Demonstrates Superiority Over Ustekinumab in Phase III SEQUENCE Study for Moderate to Severe Crohn’s Disease

On September 12, AbbVie announced that the Phase III SEQUENCE study of risankizumab versus ustekinumab for the treatment of moderate to severe Crohn's disease met all primary and secondary endpoints.

SEQUENCE Study is a multicenter, randomized, head-to-head Phase III clinical trial that enrolled 527 patients with moderate to severe Crohn's disease who had previously received one or more anti-tumor necrosis factor (TNF) drug treatments. All patients had a baseline Crohn's Disease Activity Index (CDAI) score of 220-450. The primary endpoints of the study were the proportion of patients achieving clinical remission (defined as CDAI below 150) at week 24 and the proportion of patients achieving endoscopic remission (defined as a Simple Endoscopic Score for Crohn’s Disease (SES-CD) score ≤4 with at least a 2-point reduction from baseline, and no subscore exceeding 1 point) at week 48.

The results showed that the clinical remission rate of patients in the Risankizumab groupNon-inferior toUstekinumab group (59% vs. 40%); Endoscopic remission rateSuperior toUstekinumab group (32% vs. 16%, P<0.0001).

Moreover, the safety of Risankizumab is consistent with what was observed in previous studies, with no new safety risks identified. The most common adverse events were COVID-19 and headache.

Risankizumab is an IL-23 monoclonal antibody co-developed by AbbVie and Boehringer Ingelheim. It specifically targets and binds to the p19 subunit of IL-23, thereby blocking the interaction between IL-23 and its receptor. IL-23 is a cytokine involved in inflammatory processes and is considered to be associated with many chronic immune-mediated diseases.

In March 2019, the product was approved for the first time in Japan for the treatment of generalized pustular psoriasis, erythrodermic psoriasis, plaque psoriasis, and psoriatic arthritis. In June 2022, the indications for risankizumab were expanded to include Crohn's disease. In July this year, risankizumab was submitted for marketing approval in China (see: ).

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