Post-Marketing Safety Concerns With Secukinumab: A Disproportionality Analysis of the FDA Adverse Event Reporting System

Yamin Shu; Yufeng Ding; Yanxin Liu; Pan Wu; Xucheng He; Qilin Zhang

doi:10.3389/fphar.2022.862508

Post-Marketing Safety Concerns With Secukinumab: A Disproportionality Analysis of the FDA Adverse Event Reporting System

Front Pharmacol. 2022 Jun 8:13:862508. doi: 10.3389/fphar.2022.862508. eCollection 2022.

Authors

Yamin Shu¹, Yufeng Ding¹, Yanxin Liu², Pan Wu³, Xucheng He⁴, Qilin Zhang⁵

Affiliations

¹ Department of Pharmacy, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.
² Department of Pharmacy, Pengzhou People's Hospital, Pengzhou, China.
³ Department of Pharmacy, Qionglai Maternal and Child Health and Family Planning Service Center, Qionglai, China.
⁴ Department of Pharmacy, Pengzhou Second People's Hospital, Pengzhou, China.
⁵ Department of Pharmacy, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.

Abstract

Purpose: Secukinumab was approved for the treatment of psoriasis, psoriatic arthritis, and ankylosing spondylitis. However, the long-term safety of secukinumab in large sample population was unknown. The current study was to evaluate the secukinumab-assocaited adverse events (AEs) through data mining of the US Food and Drug Administration Adverse Event Reporting System (FAERS). Methods: Reports in the FAERS from the first quarter of 2015 (FDA approval of secukinumab) to the third quarter of 2021 were collected and analyzed. Disproportionality analyses, including the reporting odds ratio (ROR), the proportional reporting ratio (PRR), the Bayesian confidence propagation neural network (BCPNN), and the multi-item gamma Poisson shrinker (MGPS) algorithms, were employed in data mining to quantify the signals of secukinumab-related AEs. Results: A total of 89,228 reports of secukinumab as the "primary suspected (PS)" and 254,886 AEs induced by secukinumab were identified. Secukinumab-induced AE occurrence targeted 27 system organ classes (SOCs). A total of 257 signals of secukinumab-induced AEs in 19 SOCs were detected after conforming to the four algorithms simultaneously. Common significant signals of infections, respiratory disorders, skin and subcutaneous tissue disorders, immune system disorders, and ear and labyrinth disorders have emerged. Unexpected significant AEs such as injection site pain, vessel puncture site haemorrhage, arthralgia, hypokinesia, Bell's palsy, parotid gland enlargement, and stress might also occur. The median onset time of secukinumab-associated AEs was 56 days (interquartile range [IQR] 5-214 days), and most of the onsets occurred within the first 1, 2, 3, and 4 months after initiation of secukinumab. Conclusion: Our study found potential new AE signals and provided a broader understanding of secukinumab's safety profiles, supporting its rational use in chronic systemic inflammatory diseases.

Keywords: FAERS; adverse event; data mining; pharmacovigilance; secukinumab.