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

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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.



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Authors: M Lebwohl, A Deodhar, C E M Griffiths, M A Menter, D Poddubnyy, W Bao, V Jehl, K Marfo, P Primatesta, A Shete, V Trivedi, P J Mease

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