Effectiveness and Safety of Adalimumab Biosimilars in Pediatric Psoriasis: A Multi-Center International Experience.

Abstract

Background: Many adalimumab biosimilars have been approved for the same indications as their originator (Humira ^®). However, data on their efficacy and safety in children with psoriasis are scarce.

Objective: To assess the effectiveness and safety of adalimumab biosimilars in a group of adalimumab-naïve patients and another group of patients who switched from originator adalimumab to biosimilars. The co-primary endpoints were the PASI absolute mean, PASI 75, and PASI 90 at 16, 24 and 52 weeks.

Methods: In this 52-week, multi-center, non-interventional, observational, retrospective study, patients starting biosimilars in routine practice after January 2022 were enrolled at 10 sites across Italy, Portugal, and France. Disease activity scores such as the Psoriasis Area Severity Index (PASI) and safety data were captured during 12 months following adalimumab biosimilar initiation.

Results: A total of 102 pediatric patients with psoriasis receiving adalimumab biosimilar therapy either as naïve (n = 72) or switching from originator adalimumab (n = 30) were enrolled. Median absolute PASI remained low at weeks 16, 24, and 52 in both groups (naïve 5.4, 4.3, 2.8; switching 2.6; 2.0; 1.4 respectively). PASI 75 response at weeks 16, 24, and 52 was observed in 41.7, 55.0, and 77.8% of patients in the naive group and 82.8%, 86.2%, and 92.6% of patients in the switch group. PASI 90 response at weeks 16, 24, and 52 was achieved by 23.3%, 26.7%, and 46.3% of patients in the naïve group and 58.6%, 65.5%, and 55.6% of patients in the switch group. Three patients discontinued biosimilars after the switch due to loss of efficacy. No emergency room visits or hospitalizations were observed during the study period and none of the patients experienced serious adverse effects.

Conclusion: Adalimumab biosimilars showed a favorable effectiveness/safety profile in childhood psoriasis. Switching from reference adalimumab to biosimilars did not impact effectiveness and safety. A likelihood of discontinuation was noted in patients who switched from Humira to biosimilars.