Ixekizumab was found to be safe and effective for the treatment of moderate to severe plaque psoriasis in pediatric patients in a multicenter, randomized clinical trial, the findings of which were published in JAMA Dermatology.
The Multicenter, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate Safety, Tolerability, and Efficacy of Ixekizumab in Patients From 6 to Less Than 18 Years of Age With Moderate-to-Severe Plaque Psoriasis (IXORA-PEDS) trial was conducted from 2017 to 2021 at 68 sites. Patients (N=171) were randomly assigned in a 2:1 ratio to receive subcutaneous, weight-based ixekizumab (n=115) or placebo (n=56) every 4 weeks for 12 weeks. At week 12, all patients entered a 48-week open-label maintenance therapy period followed by an extension period up to week 108. Safety and efficacy were evaluated.
Patients were mean age, 13.5 (standard deviation [SD], 3.04) years, 57.9% were girls, and 83.8% were White.
Of the 166 participants who entered the maintenance and extension periods, 83.7% completed the study.
At weeks 60 and 108, 95.7% and 94.5% had achieved Psoriasis Area and Severity Index (PASI) 50, 90.0% and 91.7% PASI 75, 80.3% and 79.9% PASI 90, and 53.2% and 55.1% PASI 100, respectively.
Compared with baseline, at week 108 significant effects were observed for PASI (least squares mean [LSM] change, -19.39; P <.001), itch numeric rating scale (NRS) score (LSM change, -3.21; P <.001), Nail Psoriasis Severity Index (NPSI; LSM change, -31.12; P <.001), Psoriasis Scalp Severity Index (PSSI; LSM change, -27.02; P <.001), and Palmoplantar Psoriasis Area and Severity Index (PPASI; LSM change, -3.21; P <.001) instruments.
Treatment-emergent adverse events (TEAEs) occurred in 87.7% of patients. TEAEs were mild (41.3%), moderate (40.3%), and severe (6.1%). A total of 5 participants discontinued treatment due to adverse events.
The most common adverse events of special interest included infections (n=145), injection site reactions (n=40), allergic reactions or hypersensitivity (n=20), and depression (n=8).
The major limitation of this study was the lack of comparator from week 12.
This study demonstrated to the investigators that there is evidence to support the safety and efficacy of ixekizumab for the treatment of moderate to severe plaque psoriasis among children.
Disclosure: Multiple authors declared affiliations with industry. Please refer to the original article for a full list of disclosures.
Paller AS, Seyger MMB, Magariños GA, et al. Long-term Efficacy and Safety of Up to 108Weeks of Ixekizumab in Pediatric Patients With Moderate to Severe Plaque Psoriasis The IXORA-PEDS Randomized Clinical Trial. JAMA Dermatol. 2022;158(5):533-541. doi:10.1001/jamadermatol.2022.0655