Trial results for guselkumab (Tremfya) in pediatric participants with chronic plaque psoriasis were posted on ClinicalTrials.gov on 2025-03-28. The study showed that guselkumab achieved an Investigator's Global Assessment (IGA) score of cleared (0) or minimal (1) in 65.9% of participants at Week 16, compared to 16.0% for placebo. Additionally, 75.6% of guselkumab-treated participants achieved a Psoriasis Area and Severity Index (PASI) 75 response, versus 20.0% for placebo.
Background
The study evaluated guselkumab for the treatment of chronic plaque psoriasis in pediatric participants aged 6 through less than 18 years.
Trial design
The study (NCT03451851) was a Phase 3 trial that enrolled 120 participants. It investigated subcutaneously administered guselkumab for the treatment of chronic plaque psoriasis in pediatric participants. The study included comparator arms of placebo and etanercept.
Key results
The trial evaluated several key efficacy outcomes at Week 16. For the outcome "Percentage of Participants Who Achieved an Investigator's Global Assessment (IGA) Score of Cleared (0) or Minimal (1) at Week 16":
- In the guselkumab group, 65.9% of participants achieved an IGA score of cleared (0) or minimal (1).
- In the placebo group, 16.0% of participants achieved an IGA score of cleared (0) or minimal (1).
- In the etanercept group, 69.2% of participants achieved an IGA score of cleared (0) or minimal (1).
A Fisher Exact analysis comparing guselkumab to placebo showed a difference in percentage of 49.9% (95.0% CI: 25.9 to 69.4) with a p-value of 0.001.
For the outcome "Percentage of Participants Who Achieved Psoriasis Area and Severity Index (PASI) 75 Response at Week 16":
- In the guselkumab group, 75.6% of participants achieved a PASI 75 response.
- In the placebo group, 20.0% of participants achieved a PASI 75 response.
- In the etanercept group, 69.2% of participants achieved a PASI 75 response.
A Fisher Exact analysis comparing guselkumab to placebo showed a difference in percentage of 55.6% (95.0% CI: 32.1 to 74.0) with a p-value of 0.001.
For the outcome "Percentage of Participants Who Achieve PASI 90 Response at Week 16":
- In the guselkumab group, 56.1% of participants achieved a PASI 90 response.
- In the placebo group, 16.0% of participants achieved a PASI 90 response.
- In the etanercept group, 53.8% of participants achieved a PASI 90 response.
A Fisher Exact analysis comparing guselkumab to placebo showed a difference in percentage of 40.1% (95.0% CI: 15.6 to 61.3) with a p-value of 0.003.
For the outcome "Percentage of Participants Who Achieved an IGA Score of Cleared (0) at Week 16":
- In the guselkumab group, 39.0% of participants achieved an IGA score of cleared (0).
- In the placebo group, 4.0% of participants achieved an IGA score of cleared (0).
- In the etanercept group, 26.9% of participants achieved an IGA score of cleared (0).
A Fisher Exact analysis comparing guselkumab to placebo showed a difference in percentage of 35.0% (95.0% CI: 10.5 to 56.8) with a p-value of 0.004.
What this means
The results from this Phase 3 trial indicate that guselkumab significantly improved outcomes for pediatric participants with chronic plaque psoriasis compared to placebo. The substantial differences observed in IGA 0/1, PASI 75, PASI 90, and IGA 0 responses suggest that guselkumab could be an effective treatment option for this patient population. These findings provide important data for clinicians considering therapeutic strategies for pediatric chronic plaque psoriasis.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for 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 2025-03-28 on clinicaltrials.gov.