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Risankizumab is superior to ustekinumab for endoscopic remission of Crohn’s disease
1. In this randomized controlled trial, risankizumab was non-inferior to ustekinumab in terms of clinical remission at 24 weeks in treating patients with moderate-to-severe Crohn’s disease.
2. Risankizumab was superior to ustekinumab in attaining endoscopic remission at 48 weeks.
Evidence Rating Level: 1 (Excellent)
Study Rundown: Crohn’s disease is a type of inflammatory bowel disease that may affect any segment of the gastrointestinal tract and is characterized by abdominal pain and diarrhea. Corticosteroids and other immunosuppressants comprise the mainstay treatment options for Crohn’s disease, with more severe presentations often requiring biologic agents to attain disease remission. Currently, tumor necrosis factor inhibitors (anti-TNF) are preferred for the first-line treatment of moderate-to-severe Crohn’s disease. Still, there is a lack of guidance on the selection of an alternative biologic drug when treatment with anti-TNFs fails or is poorly tolerated. Ustekinumab and risankizumab are human monoclonal IgG1 antibodies that target different subunits of cytokines involved in skin, joint, and gastrointestinal inflammation. In recent head-to-head trials, risankizumab was more effective than ustekinumab in treating plaque psoriasis. SEQUENCE aimed to investigate the efficacy and safety of risankizumab and ustekinumab in patients with moderate-to-severe Crohn’s disease in whom treatment with at least one anti-TNF agent had failed. Overall, this phase 3b trial demonstrated that risankizumab was non-inferior to ustekinumab concerning clinical remission at 24 weeks in the treatment of patients with moderate-to-severe Crohn’s disease. Risankizumab was superior to ustekinumab in attaining endoscopic remission at 48 weeks in these patients. The incidence of adverse events associated with the two biologic agents was similar. The results of the study may have been affected by bias introduced through its open-label design.
Click to read the study in NEJM
In-Depth [randomized controlled trial]: SEQUENCE is a randomized controlled trial investigating the efficacy and safety of risankizumab and ustekinumab in treating patients with moderate-to-severe Crohn’s disease. Patients between 18 and 80 years of age with Crohn’s disease who had an inadequate response to or unacceptable side effects with at least one anti-TNF agent were eligible for the trial. A baseline score of 220 to 450 on the Crohn’s Disease Activity Index (CDAI), with higher scores indicative of more severe disease activity, constituted the definition of moderate-to-severe disease. Enrolled patients were randomly assigned in a 1:1 ratio to receive either risankizumab or ustekinumab for up to 48 weeks at a pre-specified induction and dosing schedule. The primary outcome was clinical remission at week 24, as defined by a CDAI score of less than 150. The co-primary outcome was a superior endpoint, including endoscopic remission at week 48. Among 527 patients who underwent randomization, 520 were included in the efficacy analysis, with 255 receiving risankizumab and 265 receiving ustekinumab. In total, 90.2% and 72.8% of patients in the respective groups completed their assigned treatment. Risankizumab was noninferior to ustekinumab at week 24 with respect to clinical remission (58.6% vs. 39.5%; adjusted difference, 18.4 percentage points; 95% confidence interval [CI], 6.6 to 30.3). Risankizumab was superior to ustekinumab at week 48 for endoscopic remission (31.8% vs. 16.2%; adjusted difference, 15.6 percentage points; 95% CI, 8.4 to 22.9; p<0.001). In summary, this trial demonstrated that risankizumab was noninferior to ustekinumab for clinical and endoscopic remission in patients with Crohn’s disease.
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