Results from a Phase 3 study evaluating guselkumab (Tremfya) for active psoriatic arthritis (PsA) were posted on ClinicalTrials.gov on 2024-12-30. The study showed that guselkumab 100 mg q8w achieved an ACR20 response of 68.3% at Week 24, compared to 47.0% for placebo.
Background
The study investigated guselkumab, an intervention for participants with active psoriatic arthritis (PsA). The primary objective was to evaluate the efficacy of guselkumab treatment by assessing the reduction in signs and symptoms of PsA.
Trial design
The Phase 3 study (NCT04882098) enrolled 1054 participants with active psoriatic arthritis. The study's purpose was to evaluate the efficacy of guselkumab treatment, specifically by assessing the reduction in signs and symptoms of PsA. Interventions included guselkumab at doses of 100 mg every 8 weeks (q8w) and 100 mg every 4 weeks (q4w), compared against a placebo arm which later received guselkumab.
Key results
The trial reported key measurements at Week 24:
- For the Percentage of Participants Who Achieved an American College of Rheumatology (ACR) 20 Response at Week 24:
- Guselkumab 100 mg q8w group: 68.3%
- Guselkumab 100 mg q4w group: 66.6%
- Placebo Followed by Guselkumab group: 47.0%
- For the Change From Baseline in Psoriatic Arthritis (PsA) Modified Van Der Heijde-Sharp (vdH-S) Total Score at Week 24 (Least Squares Mean):
- Guselkumab 100 mg q8w group: 0.54
- Guselkumab 100 mg q4w group: 0.55
- Placebo Followed by Guselkumab group: 1.35
Key analyses demonstrated statistically significant differences:
- The difference in ACR20 response percentage between Guselkumab 100 mg q8w and placebo was 21.3% (95% CI: 14.4, 28.2), with a p-value of 0.001 (Cochran-Mantel-Haenszel method).
- The difference in ACR20 response percentage between Guselkumab 100 mg q4w and placebo was 19.7% (95% CI: 12.1, 27.2), with a p-value of 0.001 (Cochran-Mantel-Haenszel method).
- The Least Square Mean Difference in vdH-S Total Score between Guselkumab 100 mg q8w and placebo was -0.8 (95% CI: -1.28, -0.33), with a p-value of 0.001 (ANCOVA method).
- The Least Square Mean Difference in vdH-S Total Score between Guselkumab 100 mg q4w and placebo was -0.8 (95% CI: -1.31, -0.28), with a p-value of 0.002 (ANCOVA method).
What this means
The results indicate that guselkumab significantly improved signs and symptoms of psoriatic arthritis compared to placebo. Both the 100 mg q8w and 100 mg q4w dosing regimens demonstrated a higher proportion of participants achieving an ACR20 response at Week 24, with differences of 21.3% and 19.7% respectively, compared to placebo. Furthermore, guselkumab treatment led to a significantly smaller change from baseline in the Psoriatic Arthritis Modified Van Der Heijde-Sharp (vdH-S) Total Score, suggesting a beneficial effect on radiographic progression. These findings support the potential of guselkumab as an effective treatment option for patients with active psoriatic arthritis.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for the study NCT04882098, titled "A Study of Guselkumab in Participants With Active Psoriatic Arthritis", were posted on 2024-12-30 on clinicaltrials.gov.