Trial results for guselkumab (Tremfya) in participants with moderately to severely active Crohn's disease were posted on ClinicalTrials.gov on 2025-02-21. The Phase 3 study demonstrated that 56.1% of participants receiving guselkumab 400 mg achieved clinical remission at Week 12, compared to 21.4% for placebo.
Background
Guselkumab (Tremfya) is an investigational therapy for moderately to severely active Crohn's disease. This chronic inflammatory condition affects the digestive tract, causing various debilitating symptoms.
Trial design
The Phase 3 study (NCT05197049) enrolled 350 participants with moderately to severely active Crohn's disease. The trial evaluated the efficacy and safety of various subcutaneous guselkumab doses compared to placebo.
Key results
Key results from the trial demonstrated significant improvements with guselkumab compared to placebo:
- At Week 12, 56.1% of participants receiving guselkumab 400 mg achieved clinical remission, compared to 21.4% in the placebo group.
- Endoscopic response at Week 12 was observed in 41.3% of participants on guselkumab 400 mg versus 21.4% for placebo.
- Patient-reported outcome (PRO)-2 remission at Week 12 was achieved by 49.1% of participants in the guselkumab 400 mg group, compared to 17.1% for placebo.
- Clinical response at Week 12 was seen in 73.5% of participants receiving guselkumab 400 mg, versus 33.3% for placebo.
- At Week 24, clinical remission was achieved by 60.9% of participants on guselkumab 400 mg + 100 mg and 58.3% on guselkumab 400 mg + 200 mg, compared to 21.4% for placebo.
Statistical analyses using the Mantel Haenszel method showed significant adjusted treatment differences:
- For clinical remission at Week 12, the adjusted treatment difference was 34.9% (95% CI: 25.1, 44.6; p=0.001).
- For endoscopic response at Week 12, the adjusted treatment difference was 19.9% (95% CI: 10.2, 29.6; p=0.001).
- For PRO-2 remission at Week 12, the adjusted treatment difference was 32.1% (95% CI: 22.9, 41.2; p=0.001).
- For clinical response at Week 12, the adjusted treatment difference was 40.3% (95% CI: 29.9, 50.7; p=0.001).
- For clinical remission at Week 24 (Guselkumab 400 mg + 100 mg vs placebo), the adjusted treatment difference was 39.3% (95% CI: 28.0, 50.7; p=0.001).
- For clinical remission at Week 24 (Guselkumab 400 mg + 200 mg vs placebo), the adjusted treatment difference was 37.0% (95% CI: 25.6, 48.4; p=0.001).
The data also noted that 65.8% of participants in the placebo group experienced treatment-emergent adverse events (TEAEs) through Week 48.
What this means
The trial results indicate that guselkumab significantly improves clinical remission, endoscopic response, and patient-reported outcomes in participants with moderately to severely active Crohn's disease compared to placebo. The consistent statistical significance (p=0.001 for all reported analyses) across multiple endpoints suggests a robust treatment effect. These findings support the potential of guselkumab as an effective subcutaneous therapy for this challenging condition.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for study NCT05197049, titled "A Study of Guselkumab Subcutaneous Therapy in Participants With Moderately to Severely Active Crohn's Disease," were posted on 2025-02-21 on clinicaltrials.gov.