The risk of malignancy in secukinumab-treated psoriasis, psoriatic arthritis and ankylosing spondylitis patients: analysis of up to five-year clinical trial and post-marketing surveillance data.

BACKGROUND Data on the use of biologic therapy and malignancy risk are inconsistent due to limited long-term robust studies. OBJECTIVE To assess the malignancy risk in secukinumab-treated psoriasis, psoriatic arthritis (PsA) and ankylosing spondylitis (AS) patients. METHODS This integrated safety analysis from both the secukinumab clinical trial program and post-marketing safety surveillance data included any patient receiving at least one approved dose of secukinumab with a maximum of five years follow-up. Safety analyses evaluated the rate of malignancy using exposure-adjusted incidence rates (EAIR; incidence rates/100-patient treatment-years [PTY]). Standardised incidence ratios (SIR) were reported using the Surveillance, Epidemiology, and End Results Program (SEER) database as a reference population. The crude incidence of malignancy was also reported using post-marketing surveillance data. RESULTS Safety data from 10,685 psoriasis, 2,523 PsA and 1,311 AS secukinumab-treated patients from 49 clinical trials were included. Across indications over a five-year period, the EAIR of malignancy was 0.85/100 PTY (95% confidence intervals [CI]: 0.74, 0.98) in secukinumab-treated patients, corresponding to 204 patients/23,908 PTY. Overall, the observed vs. expected number of malignancies from secukinumab clinical trial data were comparable, as indicated by a SIR of 0.99 (95% CI: 0.82, 1.19) across indications. The estimated crude cumulative incidence reporting rate/100 PTY for malignancy was 0.27 in the post-marketing surveillance data across indications with a cumulative exposure of 285,811 PTY. CONCLUSIONS In this large safety analysis, the risk of malignancy was low for up to five years of secukinumab treatment. These data support the long-term us of secukinumab in these indications.