The Risk of Malignancy in Secukinumab-Treated Psoriasis, Psoriatic Arthritis, and Ankylosing Spondylitis Patients The British Journal of Dermatology

TAKE-HOME MESSAGE

• The authors report the 5-year safety data from the secukinumab clinical trial program and post-marketing surveillance data of patients with psoriasis, psoriatic arthritis, and ankylosing spondylitis. Malignancy was reported in 204 patients out of 23,908 patient treatment-years. The cumulative exposure–adjusted incidence rate of malignancy was 0.85 per 100 patient-years of treatment. The two most prevalent malignancies were basal cell carcinoma and squamous cell carcinoma. There were no cases of non-Hodgkin's lymphoma. The observed malignancy rate was similar to the expected rate in the general United States population.

• The long-term safety profile for up to 5 years of treatment with secukinumab for psoriasis, psoriatic arthritis, and ankylosing spondylitis is favorable and supports its use for these conditions.

–  Caroline K. Crabtree, MD

Abstract

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.

The British Journal of Dermatology

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

Br J Dermatol 2021 Apr 08;[EPub Ahead of Print], M Lebwohl, A Deodhar, CEM Griffiths, MA Menter, D Poddubnyy, W Bao, V Jehl, K Marfo, P Primatesta, A Shete, V Trivedi, PJ Mease