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

INTRODUCTION: 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. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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. TRIAL REGISTRATION: Clinicaltrials.gov: NCT05803187.