Risankizumab improves clinical remission rates of moderate to high active ulcerative colitis, finds research
A recent research published in the Journal of American Medical Association found that risankizumab improved clinical remission rates in an induction and maintenance study for individuals with moderate to high active ulcerative colitis.
Risankizumab is a monoclonal antibody that targets the p19 component of IL-23 specifically and its therapeutic benefits in treating ulcerative colitis are uncertain. Thus, this study by Edouard Louis and colleagues assessed the safety and effectiveness of risankizumab when used as an induction and maintenance treatment for individuals with ulcerative colitis.
There were two phase 3 randomized clinical studies with a total of 977 patients enrolled in the induction study between November 5, 2020, and August 4, 2022 (with a final follow-up scheduled for May 16, 2023). 754 individuals were enrolled in the maintenance study between August 28, 2018, and March 30, 2022 (with a final follow-up scheduled for April 11, 2023). The patients who had moderate to severe active ulcerative colitis with no previous exposure to risankizumab and had a history of intolerance or poor response to one or more conventional medicines, advanced therapies, or both types of therapy met the eligibility requirements.
In the induction experiment, the participants were randomized 2:1 to intravenously receive either 1200 mg of risankizumab or a placebo at weeks 0, 4, and 8. The patients who experienced a clinical response (as measured by the modified Mayo score) following intravenous risankizumab treatment were randomized 1:1:1 to receive either 360 mg of risankizumab or subcutaneous treatment with 180 mg or or placebo every eight weeks for 52 weeks as part of the maintenance trial. In the induction phase, the primary endpoint was clinical remission at week 12, and in the maintenance study, it was at week 52.
Among the 975 patients examined in the induction study, the clinical remission rates at week 12 were 20/325 (6.2%) for placebo and 132/650 (20.3%) for 1200 mg of risankizumab. The maintenance study included 548 patients. At week 52, the clinical remission rates were 46/183 (25.1%) for placebo, 70/186 (37.6%) for 360 mg of risankizumab and 72/179 (40.2%) for 180 mg of risankizumab. In the therapy groups, no undesirable indicators were seen. Risankizumab increased the rates of clinical remission in individuals with moderate to high active ulcerative colitis in both an induction study and a maintenance trial.
Reference:
Louis, E., Schreiber, S., Panaccione, R., Bossuyt, P., Biedermann, L., Colombel, J.-F., Parkes, G., Peyrin-Biroulet, L., D’Haens, G., Hisamatsu, T., Siegmund, B., Wu, K., Boland, B. S., Melmed, G. Y., Armuzzi, A., Levine, P., Kalabic, J., Chen, S., … Cheng, L. (2024). Risankizumab for Ulcerative Colitis. In JAMA. American Medical Association (AMA). https://doi.org/10.1001/jama.2024.12414
