Primary completion of a Phase 3 study for guselkumab (Tremfya) in participants with moderately to severely active ulcerative colitis was reported on 2024-04-02. The trial demonstrated that 27.6% of participants receiving combined guselkumab 400 mg achieved clinical remission at Week 12, compared to 6.5% in the placebo group. This represents an adjusted treatment difference of 21.1% (p=0.001).
Background
Guselkumab is being investigated for the treatment of moderately to severely active ulcerative colitis. The study aimed to evaluate its efficacy, including clinical remission of guselkumab subcutaneous induction compared to placebo.
Trial design
The Phase 3 study (NCT05528510) enrolled 418 participants with moderately to severely active ulcerative colitis. The trial's primary purpose was to evaluate the efficacy of guselkumab subcutaneous induction compared to placebo, focusing on clinical remission. The study included intervention arms for guselkumab dose 1, guselkumab dose 2, and guselkumab dose 3.
Key results
The trial reported the following key efficacy outcomes:
- At Week 12, the percentage of participants in clinical remission was 27.6% for the Combined Guselkumab 400 mg group compared to 6.5% for Placebo. The adjusted treatment difference was 21.1% (95% Confidence Interval: 14.5% to 27.6%, p=0.001).
- At Week 12, the percentage of participants in symptomatic remission was 51.3% for the Combined Guselkumab 400 mg group compared to 20.9% for Placebo. The adjusted treatment difference was 30.4% (95% Confidence Interval: 21.6% to 39.2%, p=0.001).
- At Week 12, the percentage of participants with endoscopic improvement was 37.3% for the Combined Guselkumab 400 mg group compared to 12.9% for Placebo. The adjusted treatment difference was 24.3% (95% Confidence Interval: 16.6% to 31.9%, p=0.001).
- At Week 12, the percentage of participants in clinical response was 65.6% for the Combined Guselkumab 400 mg group compared to 34.5% for Placebo. The adjusted treatment difference was 31.0% (95% Confidence Interval: 21.6% to 40.5%, p=0.001).
- At Week 12, the percentage of participants with histologic-endoscopic mucosal improvement was 30.5% for the Combined Guselkumab 400 mg group compared to 10.8% for Placebo. The adjusted treatment difference was 19.6% (95% Confidence Interval: 12.4% to 26.9%, p=0.001).
- At Week 24, the percentage of participants in clinical remission was 35.3% for the Guselkumab 400 mg q4w - Guselkumab 100 mg q8w group compared to 9.4% for Placebo. The adjusted treatment difference was 25.9% (95% Confidence Interval: 16.7% to 35.1%, p=0.001).
What this means
The results from this Phase 3 study indicate that guselkumab significantly improved clinical remission, symptomatic remission, endoscopic improvement, clinical response, and histologic-endoscopic mucosal improvement in participants with moderately to severely active ulcerative colitis compared to placebo. The consistent and highly statistically significant adjusted treatment differences across various endpoints suggest a robust positive effect. These findings support the potential of guselkumab as an effective treatment option for this patient population.
Source
The information for this article was sourced from ClinicalTrials.gov, a public database of clinical studies. The primary completion of study NCT05528510, titled "A Study of Guselkumab Therapy in Participants With Moderately to Severely Active Ulcerative Colitis", was reported on 2024-04-02 on clinicaltrials.gov.