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
| Autor: | Kwaku Marfo, V Jehl, Denis Poddubnyy, M A Menter, Abhijit Shete, Mark Lebwohl, V Trivedi, Weibin Bao, P Primatesta, Cem Griffiths, P. J. Mease, A. Deodhar |
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| Rok vydání: | 2021 |
| Předmět: |
medicine.medical_specialty
business.industry Incidence (epidemiology) Arthritis Psoriatic Postmarketing surveillance Dermatology medicine.disease Malignancy Antibodies Monoclonal Humanized Clinical trial 030207 dermatology & venereal diseases 03 medical and health sciences Psoriatic arthritis 0302 clinical medicine Internal medicine Neoplasms Epidemiology medicine Humans Psoriasis Cumulative incidence Secukinumab Spondylitis Ankylosing business Follow-Up Studies |
| Zdroj: | The British journal of dermatologyReferences. 185(5) |
| ISSN: | 1365-2133 |
| Popis: | 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. |
| Databáze: | OpenAIRE |
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