Risk of cancer in psoriasis patients treated with biologic therapy: A BADBIR cohort study

BACKGROUND: There are concerns that biologic therapies for psoriasis may increase cancer risk. OBJECTIVES: To compare risks of (i) incident cancer excluding keratinocyte carcinomas (KC; hereafter referred to as cancer) and (ii) KC among patients with moderate-to-severe psoriasis treated with biologic versus non-biologic systemic therapies, and across biologic classes. METHODS: Data from the British Association of Dermatologists Biologics and Immunomodulators Register (BADBIR), a UK and Republic of Ireland register collected 2007-2025, were linked to NHS Digital for enhanced cancer ascertainment. Biologic-naïve patients aged ≥16 years with chronic plaque psoriasis and no prior cancer or KC were included. Cancer or KC events occurring within 12 months of treatment initiation were excluded. Crude incidence rates per 1000 person-years (py) with 95% confidence intervals (CI) were calculated. Adjusted hazard ratios (aHRs; 95% CI) were estimated using propensity score-weighted flexible parametric survival models with multiple imputation for missing data. RESULTS: The cancer and KC analyses included 18,894 and 19,144 patients, respectively (58% receiving biologics in both), reflecting differences in outcome-specific exclusion criteria. In 1-year lagged analyses, cancer incidence rates per 1000 person-years were 6.40 [95% CI 5.83-7.02] in biologic initiators and 6.83 [95% CI 6.01-7.76] in non-biologic systemic initiators, with an aHR of 0.91 [95% CI 0.77-1.07]. Corresponding KC incidence rates were 2.63 [95% CI 2.28-3.04] and 2.42 [95% CI 1.96-3.00], respectively, with an aHR of 1.05 [95% CI 0.81-1.35]. Follow-up was shorter for IL-12/23i and IL-17i than for TNFi. Cancer risk did not differ significantly for IL-12/23i or IL-17i versus TNFi, nor was KC risk elevated for IL-12/23i. CONCLUSIONS: This real-world study found no evidence of an increased risk of cancer or KC with biologic compared with non-biologic systemic therapies, or across the biologic classes. Larger studies with longer follow-up, particularly for newer biologics, are needed to clarify long-term risk.