Effectiveness and Safety of IL-17A Inhibitors in Pediatric Psoriasis: A Real-World, Multicenter, International Study.

backgroundSecukinumab and ixekizumab are interleukin (IL)-17A inhibitors approved for the treatment of moderate-to-severe plaque psoriasis in children and adolescents. While their efficacy has been established in clinical trials, real-world data on long-term treatment persistence and the representativeness of trial populations are limited.

objectiveThe aims were to evaluate the 24-month drug survival, effectiveness, and safety of secukinumab and ixekizumab in a real-world pediatric cohort, and to assess the hypothetical eligibility of these patients for pivotal phase 3, randomized controlled trials (RCTs).

methodsThis multicenter, retrospective study analyzed pediatric patients (< 18 years) with moderate-to-severe plaque psoriasis treated with secukinumab or ixekizumab across 38 international referral centers. The primary endpoint was the 24-month treatment continuation rate. Secondary endpoints included clinical effectiveness (Physician Global Assessment [PGA] 0/1; Psoriasis Area and Severity Index [PASI] 75, 90, and 100 response rates at months 3, 6, and 12) and safety. Additionally, we assessed the eligibility of this real-world cohort for the pivotal phase 3 RCTs of these treatments.

resultsA total of 152 patients (mean age 12.9 years; 53.9% female) received 160 treatments (139 secukinumab, 21 ixekizumab). The 24-month continuation rate was significantly higher for secukinumab compared to ixekizumab (p = 0.036). No significant differences in drug survival were observed based on weight status (p = 0.65) or prior biologic exposure (p = 0.10). PASI 100 was achieved at month 12 by 61.5% of patients on secukinumab and 33.3% on ixekizumab. Higher response rates were observed in bio-naïve patients and those with normal weight. The most commonly reported adverse events (AEs) were eczema and candidiasis in the secukinumab group, and injection site pain in the ixekizumab group, with no serious AEs reported. Only a limited proportion of this real-life cohort would have met the inclusion criteria for pivotal RCTs, primarily due to lower baseline disease severity or specific clinical conditions.

conclusionOur study confirms the high effectiveness and favorable safety profile of IL-17A inhibitors in pediatric psoriasis. The low rate of hypothetical RCT eligibility highlights a gap between trial populations and clinical practice, underscoring the vital role of daily-practice data in guiding treatment.