Trial results from a Phase 3 study evaluating guselkumab for chronic plaque psoriasis in pediatric participants were posted on ClinicalTrials.gov on 2023-07-19. The study reported that 65.9% of participants treated with guselkumab achieved an Investigator's Global Assessment (IGA) score of cleared (0) or minimal (1) at Week 16, compared to 16.0% for placebo.
Background
The study investigated guselkumab for the treatment of chronic plaque psoriasis in pediatric participants aged 6 through less than 18 years. This condition is characterized by well-demarcated, erythematous plaques covered with silvery scales.
Trial design
The Phase 3 study (NCT03451851) enrolled 120 participants with psoriasis. Its purpose was to evaluate the efficacy, safety, and pharmacokinetics of subcutaneously administered guselkumab. The study compared guselkumab against placebo and etanercept in pediatric participants with chronic plaque psoriasis.
Key results
The trial reported several key outcome measurements at Week 16 (Part 1):
- For the percentage of participants who achieved an Investigator's Global Assessment (IGA) score of cleared (0) or minimal (1):
- Guselkumab arm: 65.9%
- Placebo arm: 16.0%
- Etanercept arm: 69.2%
- For the percentage of participants who achieved Psoriasis Area and Severity Index (PASI) 75 Response:
- Guselkumab arm: 75.6%
- Placebo arm: 20.0%
- Etanercept arm: 69.2%
- For the percentage of participants who achieved PASI 90 Response:
- Guselkumab arm: 56.1%
- Placebo arm: 16.0%
- Etanercept arm: 53.8%
- For the percentage of participants who achieved an IGA score of cleared (0):
- Guselkumab arm: 39.0%
- Placebo arm: 4.0%
- Etanercept arm: 26.9%
Key analyses comparing guselkumab versus placebo included:
- For IGA (0) or (1) at Week 16, the difference in percentage was 49.9% (95.0% CI: 25.9-69.4), with a p-value of 0.001 (Fisher Exact).
- For PASI 75 Response at Week 16, the difference in percentage was 55.6% (95.0% CI: 32.1-74.0), with a p-value of 0.001 (Fisher Exact).
- For PASI 90 Response at Week 16, the difference in percentage was 40.1% (95.0% CI: 15.6-61.3), with a p-value of 0.003 (Fisher Exact).
- For IGA (0) at Week 16, the difference in percentage was 35.0% (95.0% CI: 10.5-56.8), with a p-value of 0.004 (Fisher Exact).
What this means
The results from this Phase 3 study indicate that guselkumab demonstrated superior efficacy compared to placebo in pediatric participants with chronic plaque psoriasis. A significantly higher percentage of participants treated with guselkumab achieved clinically meaningful improvements in skin clearance, as measured by IGA (0/1), PASI 75, and PASI 90 responses at Week 16. These statistically significant findings suggest that guselkumab could offer a new treatment option for this patient population.
Source
The information for this article was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for the study NCT03451851, titled "A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Subcutaneously Administered Guselkumab for the Treatment of Chronic Plaque Psoriasis in Pediatric Participants", were posted on 2023-07-19 on clinicaltrials.gov.