Comparing the Effectiveness of Risankizumab and Ustekinumab in Managing Crohn’s Disease
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Reviewed & Translated by Dat Tien Nguyen, B.A, ScM.
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Posted on August 30th, 2024
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Due to the toxic effects and only moderate effectiveness of tumor necrosis factor (TNF) therapy, alternative treatments like risankizumab and ustekinumab are often used for Crohn’s disease. Both of these monoclonal antibodies target interleukin 23 (IL-23), though in different ways: risankizumab specifically targets the p19 subunit of IL-23, while ustekinumab binds to the p40 subunit, which is shared by both interleukin 12 (IL-12) and IL-23, thereby reducing levels of both cytokines. To compare the efficacy of risankizumab and ustekinumab in managing Crohn’s disease, a study was conducted with funding by AbbVie.
The phase 3 clinical trial included 520 participants who had been diagnosed with moderate-to-severe Crohn’s disease for at least 3 months prior to enrollment. The baseline disease severity was assessed using the Crohn’s Disease Activity Index (CDAI), which yielded an average score of 306, with 600 being the most severe. Visual assessment of the colon, evaluated using the Simple Endoscopic Score for Crohn’s Disease (SES-CD), resulted in an average score of 12, with 56 being the most severe. Participants were randomly assigned to receive either risankizumab or ustekinumab. The risankizumab group received an induction dose of 600 mg intravenously at weeks 0, 4, and 8, followed by a maintenance dose of 350 mg subcutaneously every 8 weeks starting from week 12. The ustekinumab group received an induction dose based on body weight (260 mg for those ≤55 kg, 390 mg for those >55 to 85 kg, and 520 mg for those >85 kg), followed by a maintenance dose of 90 mg subcutaneously every 8 weeks. After 48 weeks of treatment, significantly more patients in the risankizumab group achieved clinical and endoscopic remission compared to those in the ustekinumab group, defined by a CDAI score below 150 and an SES-CD of 4 or less. The researchers noted that risankizumab’s superiority over ustekinumab was also observed in another study on plaque psoriasis. This difference in effectiveness can be attributed to risankizumab’s higher affinity for IL-23 or because IL-12, neutralized by ustekinumab, plays a crucial role in regulating the gut microenvironment.
The phase 3 clinical trial included 520 participants who had been diagnosed with moderate-to-severe Crohn’s disease for at least 3 months prior to enrollment. The baseline disease severity was assessed using the Crohn’s Disease Activity Index (CDAI), which yielded an average score of 306, with 600 being the most severe. Visual assessment of the colon, evaluated using the Simple Endoscopic Score for Crohn’s Disease (SES-CD), resulted in an average score of 12, with 56 being the most severe. Participants were randomly assigned to receive either risankizumab or ustekinumab. The risankizumab group received an induction dose of 600 mg intravenously at weeks 0, 4, and 8, followed by a maintenance dose of 350 mg subcutaneously every 8 weeks starting from week 12. The ustekinumab group received an induction dose based on body weight (260 mg for those ≤55 kg, 390 mg for those >55 to 85 kg, and 520 mg for those >85 kg), followed by a maintenance dose of 90 mg subcutaneously every 8 weeks. After 48 weeks of treatment, significantly more patients in the risankizumab group achieved clinical and endoscopic remission compared to those in the ustekinumab group, defined by a CDAI score below 150 and an SES-CD of 4 or less. The researchers noted that risankizumab’s superiority over ustekinumab was also observed in another study on plaque psoriasis. This difference in effectiveness can be attributed to risankizumab’s higher affinity for IL-23 or because IL-12, neutralized by ustekinumab, plays a crucial role in regulating the gut microenvironment.