Phase IV PISCES study: Adalimumab biosimilar in children and adolescents with PsO

Results from the phase IV, prospective, multicenter, single-arm PISCES (NCT05803187) study, evaluating an adalimumab biosimilar in 80 Chinese children and adolescents (aged 4–18 years) with severe plaque psoriasis (PsO), were published in Dermatology and Therapy by Huang et al. The primary efficacy endpoints were the proportion of patients achieving a ≥75% reduction from baseline in Psoriasis Area and Severity Index (PASI75) and the proportion of patients achieving a physician’s global assessment (PGA) score of 0 or 1 at Week 16.  

Key data: At Week 16, 81.0% (95% confidence interval [CI], 70.6–89.0) of patients (n = 79) achieved PASI75 and 68.4% (95% CI, 56.9–78.4) achieved a PGA score of 0/1, with responses observed from Week 4. At Week 24, PASI75 and PGA 0/1 response rates were 86.1% and 79.7%, respectively. Children’s Dermatology Life Quality Index (CDLQI) scores improved from 14.6 ± 5.7 at baseline to 3.5 ± 4.1 at Week 16. Adverse events (AEs) were reported in 82.5% of patients (n = 80) and adverse drug reactions (ADRs) in 62.5%. The most common ADRs were infection disorders (26.3%), primarily upper respiratory tract infection (URTI; 10%), urinary tract infection (UTI; 6.3%), bronchitis (3.8%), and pharyngitis (2.5%); all were Grade 1/2. No serious AEs or serious ADRs were reported. 

Key learning: In the PISCES study, the adalimumab biosimilar was associated with clinically relevant PASI75 and PGA 0/1 responses with a manageable safety profile through Week 24 in Chinese children and adolescents with severe plaque PsO, supporting the adalimumab biosimilar as a treatment option in this patient population. Further evaluation in larger studies with longer follow-up is required.