abstract details

The summaries are free for public use. ARTHROS will continue to add and archive summaries of articles deemed relevant to ARTHROS by our Faculty.

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

Author

Br J Dermatol. 2021 Apr 8. doi: 10.1111/bjd.20136. Online ahead of print.

M Lebwohl 1A Deodhar 2C E M Griffiths 3M A Menter 4D Poddubnyy 5W Bao 6V Jehl 7K Marfo 7P Primatesta 7A Shete 7V Trivedi 6P J Mease 8

Author Information

1 Kimberly and Eric J Waldman, Department of Dermatology, Icahn School of Medicine at Mount Sinai, New York City, New York, USA.

2 Oregon Health & Science University, Portland, Oregon, USA.

3 The Dermatology Centre, Salford Royal NHS Foundation Trust, University of Manchester, Manchester Academic Health Science Centre, Manchester, UK.

4 Division of Dermatology, Baylor Scott and White, Dallas, Texas, USA.

5 Division of Gastroenterology, Infectious Diseases and Rheumatology, Charité, Universitätsmedizin Berlin, Germany and Epidemiology unit, German Rheumatism Research Centre, Berlin, Germany.

6 Novartis Pharmaceuticals Corporation, East Hanover, New Jersey, USA.

7 Novartis Pharma AG, Basel, Switzerland.

8 Department of Rheumatology, Swedish Medical Center/Providence St, Joseph Health and University of Washington, Seattle, Washington, USA.

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.