Adalimumab Phase 3 Trial in Juvenile Arthritis Completes, ACR 30 at 95.0%

A Phase 3 clinical trial evaluating adalimumab as a comparator in children with juvenile idiopathic arthritis (JIA) categories of enthesitis-related arthritis (ERA) and juvenile psoriatic arthritis (JPsA) reached its primary completion on February 19, 2024. In the open-label treatment period, adalimumab achieved a 95.0% response rate for Juvenile Idiopathic Arthritis American College of Rheumatology (JIA ACR) 30.

Background

The study investigated ixekizumab for safety and efficacy in children with enthesitis-related arthritis and juvenile psoriatic arthritis. Adalimumab served as an active comparator in this trial. Both conditions are forms of juvenile idiopathic arthritis.

Trial design

The Phase 3 study, NCT04527380, enrolled 101 participants with juvenile psoriatic arthritis or enthesitis-related arthritis. The trial compared ixekizumab to adalimumab in an open-label treatment period to assess their effects on disease activity.

Key results

In the open-label treatment (OLT) period, participants receiving adalimumab demonstrated a 95.0% rate of achieving JIA ACR 30, compared to 88.9% for ixekizumab. For JIA ACR 50, 90.0% of adalimumab recipients achieved this response, versus 79% for ixekizumab. JIA ACR 70 was achieved by 65.0% of participants on adalimumab and 64.2% on ixekizumab. Higher response rates were also observed for adalimumab at JIA ACR 90 (40.0% vs. 29.6% for ixekizumab) and JIA ACR 100 (35.0% vs. 18.5% for ixekizumab).

For juvenile psoriatic arthritis participants with at least 3% body surface area at baseline, the mean change from baseline in Psoriasis Area and Severity Index (PASI) was -0.70 for adalimumab. For ixekizumab, the mean change was -3.80 with a standard deviation of 3.541, indicating a greater reduction in PASI score for ixekizumab in this subgroup.

What this means

The primary completion of this Phase 3 trial provides comparative data for adalimumab in pediatric populations with specific forms of juvenile idiopathic arthritis. Adalimumab demonstrated high rates of JIA ACR responses across multiple thresholds, including 95.0% for JIA ACR 30, when compared to ixekizumab. While adalimumab showed strong performance in JIA ACR measures, ixekizumab appeared to offer a more pronounced improvement in PASI scores for juvenile psoriatic arthritis patients with sufficient baseline body surface area involvement.

Source

This information is based on ClinicalTrials.gov results posted for NCT04527380, which reached primary completion on February 19, 2024. The record is available at clinicaltrials.gov.