The risk of malignancy in patients with secukinumab‐treated psoriasis, psoriatic arthritis and ankylosing spondylitis: analysis of clinical trial and postmarketing surveillance data with up to five years of follow‐up

• Published in: British journal of dermatology (1951) Vol. 185; no. 5; pp. 935 - 944
• Main Authors: Lebwohl, M., Deodhar, A., Griffiths, C.E.M., Menter, M.A., Poddubnyy, D., Bao, W., Jehl, V., Marfo, K., Primatesta, P., Shete, A., Trivedi, V., Mease, P.J.
• Format: Journal Article
• Language: English
• Published: England Oxford University Press 01.11.2021
• Subjects: Ankylosing spondylitis; Antibodies, Monoclonal, Humanized; Arthritis; Arthritis, Psoriatic - drug therapy; Arthritis, Psoriatic - epidemiology; Clinical trials; Epidemiology; Follow-Up Studies; Humans; Malignancy; Monoclonal antibodies; Neoplasms - chemically induced; Neoplasms - drug therapy; Neoplasms - epidemiology; Patients; Psoriasis; Psoriasis - drug therapy; Psoriasis - epidemiology; Psoriatic arthritis; Safety; Spondylitis, Ankylosing - drug therapy; Spondylitis, Ankylosing - epidemiology; Surveillance
• ISSN: 0007-0963; 1365-2133
• DOI: 10.1111/bjd.20136

Summary Background Data on the use of biologic therapy and malignancy risk are inconsistent due to limited long‐term robust studies. Objectives To assess the malignancy risk in patients with secukinumab‐treated psoriasis, psoriatic arthritis (PsA) and ankylosing spondylitis (AS). Methods This integrated safety analysis from both the secukinumab clinical trial programme and postmarketing safety surveillance data included any patient receiving at least one approved dose of secukinumab with a maximum of 5 years of follow‐up. Safety analyses evaluated the rate of malignancy using exposure‐adjusted incidence rates [EAIR; incidence rates per 100 patient treatment‐years (PTY)]. Standardized incidence ratios (SIRs) were reported using the Surveillance, Epidemiology, and End Results Program (SEER) database as a reference population. Crude incidence of malignancy was also reported using postmarketing surveillance data. Results Safety data from 49 clinical trials with secukinumab‐treated patients were included: 10 685 patients with psoriasis, 2523 with PsA and 1311 with AS. Across indications over a 5‐year period, the EAIR of malignancy was 0·85 per 100 PTY [95% confidence interval (CI) 0·74–0·98] in secukinumab‐treated patients, corresponding to 204 patients per 23 908 PTY. Overall, the observed vs. expected number of malignancies from secukinumab clinical trial data were comparable, as indicated by an SIR of 0·99 (95% CI 0·82–1·19) across indications. The estimated crude cumulative incidence reporting rate per 100 PTY for malignancy was 0·27 in the postmarketing 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 5 years of secukinumab treatment. These data support the long‐term use of secukinumab in these indications. What is already known about this topic? Secukinumab is approved for the treatment of moderate‐to‐severe psoriasis, psoriatic arthritis, ankylosing spondylitis and nonradiographic axial spondyloarthritis. Clinical studies in these indications have reported low exposure‐adjusted incidence rates (EAIR) of malignancies at one year, but there is currently a lack of longer‐term data on the incidence of malignancy in secukinumab‐treated patients. What does this study add? The cumulative EAIR of malignancy is 0·85 per 100 patient years [95% confidence interval (CI) 0·74–0·98] in secukinumab‐treated patients across indications. The observed vs. expected number of malignancies were comparable, as indicated by a standardized incidence rate of 0·99 (95% CI 0·82–1·19). This assessment provides a broader understanding of the safety of secukinumab, and supports its long‐term use in these chronic systemic immune‐mediated conditions. Linked Comment: P.C.M. van de Kerkhof. Br J Dermatol 2021; 185:879.