Low Risk of Malignancy with Secukinumab Save
Analysis of ongoing safety from the secukinumab (SEC) drug development program shows a low risk for malignancy in SEC patients treated for up to five years for either psoriasis, psoriatic arthritis (PsA) or ankylosing spondylitis (AS).
Safety data from 10,685 psoriasis, 2,523 PsA and 1,311 AS secukinumab‐treated patients from 49 clinical trials were included.
Over a five‐year period, the SEC exposed malignancy incidence rate was 0.85/100 patient years (PY) exposure (95% confidence intervals [CI]: 0.74, 0.98). This equates to 204 cancers with 23,908 PY.
When compared to the population expected number of malignancies (based on the comparator group from the Surveillance, Epidemiology, and End Results Program or SEER database), the standardised incidence ratios (SIR) for secukinumab treated patients was 0.99 (95% CI: 0.82, 1.19) across indications; meaning it was not increased.
From the post‐marketing surveillance data across indications, the cumulative incidence rate was 0.27/PY with a cumulative exposure of 285,811 PYs.
The risk of malignancy with SEC was not increase and appears to be low for up to five years of treatment in psoriasis, PsA and AS patients.