Efficacy and Safety of the First Adalimumab Biosimilar in Chinese Children with Severe Plaque Psoriasis: The PISCES Study, a Multicenter Prospective Study

Abstract

Adalimumab, a monoclonal antibody targeting tumor necrosis factor-alpha, has been approved for the treatment of severe plaque psoriasis in children aged 4 years and older. Data on its use in the clinical management of pediatric psoriasis in China remains limited. This study is the first prospective analysis of the adalimumab biosimilar (GELELI®, the first biosimilar of adalimumab approved in China, and QLETLI® in the UK) safety and effectiveness for severe pediatric plaque psoriasis in China. Weight-based dosage was administered to 80 patients (ages 4–18 years) from multiple centers. Primary endpoints included the proportions of patients achieving PASI75 and PGA 0/1 at week 16. The mean psoriasis area and severity index (PASI) score decreased from 15.31 ± 8.375 at baseline to 6.29 ± 4.208 at week 4. PASI 50/90/100 response rates were 91.1%, 49.4%, and 21.5% at week 12. At week 16, 81.0% and 68.4% of patients attained PASI75 and PGA 0/1, respectively. The incidence of adverse events was 82.5%. Adverse drug reactions accounted for 62.5%. No serious adverse events were reported. The biosimilar demonstrates efficacy and safety in the treatment of Chinese children with severe plaque psoriasis, consistent with clinical trial data for the originator drug. Clinicaltrials.gov: NCT05803187.