P054 Safety outcomes with GP2015 (etanercept biosimilar) in psoriasis: real-world evidence from the British Association of Dermatologists Biologics and Immunomodulators Register (BADBIR)

Abstract GP2015 (Erelzi; Sandoz) is an etanercept biosimilar indicated for several inflammatory disorders, including moderate-to-severe plaque psoriasis. The British Association of Dermatologists Biologics and Immunomodulators Register (BADBIR) is a prospective observational cohort study designed to monitor the long-term safety of biologic therapies for psoriasis. The purpose of this study, funded by Sandoz, was to describe baseline characteristics and safety outcomes in patients enrolled in BADBIR and treated with GP2015 or conventional therapy. Adult (≥ 18 years) and paediatric (< 18 years) patients with plaque psoriasis were recruited between 5 October 2017 and 31 July 2022 from 165 sites across the UK and Ireland. The GP2015 cohort included patients who started GP2015 within ≤ 6 months. The conventional therapy cohort included biologic-naive patients who started conventional systemic therapy within ≤ 6 months. Adverse event (AE) rates per 1000 patient-years were calculated for each cohort. Time to first event was compared using Cox proportional hazard models, when at least one event was observed in each cohort, with ≥ 10 total events. Models were adjusted using deciles of a propensity score calculated using baseline variables. Missing data were replaced using multiple imputation. Overall, 42 and 6013 patients were included in the GP2015 and conventional therapy cohorts, respectively. At baseline, the mean disease duration was longer (25.3 vs. 18.2 years) and the Psoriasis Area and Severity Index score was lower (12.8 vs. 15.2) in the GP2015 vs. the conventional therapy cohort, respectively. In the GP2015 cohort, two AEs occurred (one cardiac serious AE and one malignant event). In the conventional therapy cohort, common AEs included serious infections (n = 635) and malignant events (n = 346). There were no cases of tuberculosis in either cohort. Among patients with psoriasis treated with GP2015, AE rates were low. However, patient numbers at this stage are limited and greater numbers are required to further assess safety outcomes.