Home 📚BioDBS Bibliography database[Title] Toxicity signals associated with secukinumab: A pharmacovigilance study based on the United States Food and Drug Administration Adverse Event Reporting System database

Toxicity signals associated with secukinumab: A pharmacovigilance study based on the United States Food and Drug Administration Adverse Event Reporting System database

database[Title] 2022-09-26

Br J Clin Pharmacol. 2022 Sep 15. doi: 10.1111/bcp.15535. Online ahead of print.

ABSTRACT

BACKGROUND: Secukinumab, the first IL-17A inhibitor, is widely used to treat immune diseases, including plaque psoriasis, psoriatic arthritis, and ankylosing spondylitis. Recently, many studies have reported adverse events associated with secukinumab, including gastrointestinal disorders, infection and infestations, and hypersensitive and nervous system disorders.

OBJECTIVE: Here, we aimed to explore the clinical characteristics, outcomes, and time to onset of the four main toxicities of secukinumab, using post-marketing data.

METHODS: Our study utilized data from the United States Food and Drug Administration Adverse Event Reporting System (FAERS) database from 2015-2021, using disproportionality analysis. Toxicities were defined based on the standardized Medical Dictionary for Regulatory Activities queries. Two disproportionality methods were used to detect potential signals: information component (IC) and reporting odds ratio (ROR). The signals were defined as ROR025 >1 and IC025 >0.

RESULTS: A total of 73,945,398 records were included in this study, in which 300,665 records were related to secukinumab. Diarrhea (N=3538), nasopharyngitis (N=3458), pruritus (N=4277), and rash (N=3270) were the most common adverse events. Inflammatory bowel disease (IC025 /ROR025 =3.25/9.69), genital candidiasis (IC025 /ROR025 =3.46/11.54), dermatitis psoriasiform (IC025 /ROR025 =1.94/4.04), and anosmia (IC025 /ROR025 =1.62/3.17) had the highest IC025 values of all toxicities. The time to onset of the four toxicities was mainly concentrated in the first month. Some patients simultaneously presented with two or more toxicities.

CONCLUSIONS: This pharmacovigilance study systematically explored the 4 main toxicities of secukinumab, and provided new safety signals based on past safety information. Some high-risk signals need to be paid attention.

PMID:36106653 | DOI:10.1111/bcp.15535