AbbVie Reports Increased Proportion of Patients Achieving Clinical Remission with Skyrizi in Crohn's Disease Phase 3 Trials

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Recently, the latest analysis presented by AbbVie at the virtual Digestive Disease Week (DDW) 2021 conference showed that in two Phase 3 induction trials (ADVANCE and MOTIVATE), at Week 12 of treatment, a significantly higher proportion of patients with moderately to severely active Crohn's disease (CD) treated with two doses of Skyrizi (600 mg and 1200 mg) achieved the co-primary endpoints of clinical remission and endoscopic response compared with patients receiving placebo (both p < 0.001). This marks the first presentation of data from the two studies following the release of top-line results earlier this year.

The ADVANCE study enrolled patients who were previously intolerant to or had an inadequate response to conventional therapy (non-bio-IR) and/or biologic therapy (bio-IR); the MOTIVATE study enrolled only bio-IR patients. In the ADVANCE study, subgroup analyses demonstrated that Skyrizi was effective in patients with moderate-to-severe CD regardless of prior treatment status, with numerically higher efficacy observed in non-bio-IR patients compared to bio-IR patients.

Skyrizi is part of a collaboration between AbbVie and Boehringer Ingelheim, with AbbVie responsible for global development and commercialization. The drug is a monoclonal antibody targeting IL-23p19. IL-23 is a cytokine that plays a key role in various chronic immune-mediated diseases. In the United States and the European Union, Skyrizi has been approved for the treatment of plaque psoriasis. Currently, multiple Phase 3 clinical trials are ongoing to evaluate Skyrizi for the treatment of psoriasis, Crohn's disease, ulcerative colitis, and psoriatic arthritis.

CD is an unpredictable disease that imposes a significant physical, emotional, and economic burden on patients. However, despite currently available therapies, many patients with CD still fail to achieve disease control.

The latest data presented at the DDW conference indicate that, compared with placebo, Skyrizi helps more patients achieve clinical remission and endoscopic response. The detailed efficacy data from the two studies are as follows:

During the 12-week induction period, the safety profile of Skyrizi in the two studies was generally consistent with the known safety profile of Skyrizi from prior clinical trials. No new safety risks were observed.

In the ADVANCE study, serious adverse events (SAEs) occurred in 7.2%, 3.8%, and 15.1% of patients in the Skyrizi 600 mg, Skyrizi 1200 mg, and placebo groups, respectively. The most commonly observed adverse events (AEs) in the Skyrizi treatment groups were headache, nasopharyngitis, and fatigue. The rates of serious infections were 0.8%, 0.5%, and 3.8% in the Skyrizi 600 mg, Skyrizi 1200 mg, and placebo groups, respectively. The incidence of adverse events leading to discontinuation was 2.4%, 1.9%, and 7.5% in the Skyrizi 600 mg, Skyrizi 1200 mg, and placebo groups, respectively. Two deaths occurred in the placebo group. No adjudicated major adverse cardiovascular events (MACE) or adjudicated hypersensitivity reactions were reported.

In the MOTIVATE study, serious adverse events (SAEs) occurred in 4.9%, 4.4%, and 12.6% of patients in the Skyrizi 600 mg, Skyrizi 1200 mg, and placebo groups, respectively. In the Skyrizi treatment groups, the most commonly observed adverse events (AEs) were headache, arthralgia, and nasopharyngitis. The serious infection rates were 0.5%, 1.0%, and 2.4% in the Skyrizi 600 mg, Skyrizi 1200 mg, and placebo groups, respectively. The incidence of AEs leading to discontinuation was 1.0%, 2.4%, and 8.2% in the Skyrizi 600 mg, Skyrizi 1200 mg, and placebo groups, respectively. One patient in the Skyrizi 1200 mg group died from squamous cell lung carcinoma diagnosed on Day 8 of the study, which was considered unrelated to the study drug. No adjudicated MACE or adjudicated hypersensitivity events were reported.

Reference: AbbVie Presents New Late-Breaking Data Analyses Showing Risankizumab (SKYRIZI®) Achieves Clinical Remission and Endoscopic Response at Week 12 in Patients with Moderate to Severe Crohn's Disease