Real-World Effectiveness and Safety of SDZ-ADL (Adalimumab Biosimilar) in Patients with Psoriasis from the British Association of Dermatologists Biologic and Immunomodulators Register (BADBIR)

Abstract

SDZ-ADL is a biosimilar of reference adalimumab. Here, the safety and effectiveness data of SDZ-ADL from the British Association of Dermatologists Biologic and Immuno-modulators Register (BADBIR) are reported. In the safety set, data of SDZ-ADL were compared with conventional systemics data. In the effectiveness set, the effectiveness and quality-of-life of patients treated with SDZ-ADL as a first-time biologic, or who switched from a previous biologic to SDZ-ADL, were assessed using the Psoriasis Activity Severity Index (PASI) and Dermatology Life Quality Index (DLQI), respectively. A total of 565 (incidence rate (IR) per 1000 person-years 29.1, 95% CI 26.8–31.6) serious infections and 48 (IR 2.5, 95% CI 1.8–3.3) myocardial infarction events were reported in the conventional systemics cohort compared with four (IR 31.5, 95% CI 8.6–80.7) and one (IR 7.9, 95% CI 0.2–43.9) in the biologic cohort, respectively. One patient (0.7% (1/136)) reported injection-site pain in the biologic cohort. At 12 months, PASI ≤ 2 was achieved in 84.6% (11/13) and 76.9% (10/13) and DLQI 0/1 was achieved in 70% (7/10) and 75% (3/4) of patients in the biologic-naïve and biologic-switch cohorts, respectively. After one year of therapy, 82.7% (110/133) patients remained on SDZ-ADL. SDZ-ADL was well-tolerated and effective in patients with psoriasis.