VIDEO: Patients with UC achieve symptomatic remission ‘as early as week 4’ with Tremfya
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CHICAGO — In a Healio video exclusive, Jessica R. Allegretti, MD, MPH, explains that nearly 23% of patients with moderate to severe ulcerative colitis achieved clinical remission with Tremfya, compared with less than 10% on placebo.
In a late-breaker presentation at Digestive Disease Week, Allegretti shared results from the QUASAR phase 3 induction study, which evaluated the efficacy and safety of Tremfya (guselkumab, Janssen Biotech) induction therapy in patients with moderately to severely active UC, who had an inadequate response or were intolerant to previous therapy.
“Guselkumab is a human-selective, interleukin-23 p19 subunit antagonist that has been approved for the treatment of moderate to severe plaque psoriasis and psoriatic arthritis,” Allegretti, medical director of the Crohn’s and Colitis Center at Brigham and Women’s Hospital and associate professor of medicine at Harvard Medical School, said.
Allegretti and colleagues enrolled 701 patients (mean age, 40.5 years; 43.1% women), who were randomly assigned to guselkumab 200 mg IV (n = 421) or placebo (n = 280) every 4 weeks, for a total of three doses over a 12-week period. Patients were evaluated at baseline and at week 12, with a primary outcome of clinical remission.
According to results, 22.6% of patients treated with guselkumab achieved clinical remission at week 12 compared with 7.9% treated with placebo. Additionally, 61.5% of patients treated with guselkumab achieved clinical response vs. 27.9% with placebo. Researchers also reported endoscopic improvement and normalization and histo-endoscopic mucosal improvement with guselkumab, all of which were statistically significant compared with placebo.
Further, no significant adverse events were reported in the treatment arm that were not reported in the placebo group, Allegretti noted, and most were mild or moderate.
“Patients responded to this therapy relatively quickly,” she said. “When looking at symptomatic remission, we see that there is a significant difference from treatment compared to placebo as early as week 4.”
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Allegretti JR, et al. Abstract 913b: The efficacy and safety of guselkumab induction therapy in patients with moderately to severely active ulcerative colitis: Results from the phase 3 QUASAR induction study. Presented at: Digestive Disease Week; May 5-9, 2023; Chicago (hybrid meeting).
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