P163 Serious infection risk of certolizumab compared with other systemic therapies in women with psoriasis

Abstract

Certolizumab is often used to treat psoriasis in patients with childbearing potential given lack of active placental transfer. We examined the relative risk of serious infection associated with certolizumab compared with other systemic therapies in a cohort of women with psoriasis of childbearing potential. Eligible patients in the British Association of Dermatologists Biologic and Immunomodulators Register were included. Eligible patients were women up to 50 years of age with a diagnosis of psoriasis, who received systemic treatments, had ≥ 6 months of follow-up data and were followed from treatment initiation to end of follow-up. Infections occurring during or within 90 days of treatment discontinuation resulting in hospitalization, administration of intravenous antimicrobials or death were considered serious. Inverse probability of treatment weights was applied to account for differences in baseline characteristics. An Andersen–Gill recurrent Cox regression model was used to estimate hazard ratios (HRs) with adjustment for chronological time. A sensitivity analysis censoring patients at the time of pregnancy was also performed. In total, 11 034 treatment episodes were included from 4775 eligible patients receiving certolizumab, adalimumab, etanercept, secukinumab, ustekinumab or standard therapies. The mean age and body mass index were 36.1 (SD 9.1) years and 31.1 (SD 8.4) kg m−2, respectively. Overall, 1088 serious infection events were reported, yielding an unadjusted incidence rate of 38.8 [95% confidence interval (CI) 36.5–41.2] per 1000 person-years. Adalimumab (HR 0.49, 95% CI 0.29–0.82) and ustekinumab (HR 0.40, 95% CI 0.24–0.68) were associated with a significantly lower risk of serious infection compared with certolizumab. Sensitivity analyses also yielded similar results. There were no deaths associated with serious infection in the certolizumab group. Our findings suggest that certolizumab is associated with a higher relative risk of serious infection in women, which becomes evident with extended follow-up. Interpretation of the results may be limited by potential residual and unmeasured confounding.