Assessment of safety profile of secukinumab in real-world scenario using United States food and drug administration adverse event reporting system database

Abstract

Secukinumab is an anti-IL-17 monoclonal antibody approved for treating psoriasis and various arthritides. A comprehensive evaluation of its safety, especially in a real-world setting, is necessary. This study aimed to describe the adverse events (AE) associated with secukinumab use using the United States Food and Drug Administration Adverse Event Reporting System (FAERS) database. FAERS data files containing AE reports from 2015 to 2021 were downloaded for data mining. Primary or secondary suspect medications indicated for psoriasis were identified and analyzed. Medical dictionary for regulatory activities (MedDRA version 24.1) was used to analyze the AE terms. To detect potential safety signals of AE from secukinumab use, disproportionality analysis was used. A total of 365,590 adverse event reports were identified; of these, 44,761 reports involved the use of secukinumab. Safety signals were identified for ocular infections and gastrointestinal adverse events at the standardised MedDRA query level. Safety signals for oral candidiasis, oral herpes, conjunctivitis, eye infections, and ulcerative colitis were identified at the preferred term level. The findings of our study are consistent with those of earlier studies, such as the increased risk of infections and inflammatory bowel disease. However, our study also identified additional safety signals that need to be further evaluated.

Figure 1

Study workflow for conducting disproportionality analysis. FAERS United States Food and Drug Administration adverse event reporting system, ICSRs individual case safety reports, MedDRA medical dictionary for regulatory activities, SOC system organ class, SMQ standardised MedDRA query, PT preferred term.

Figure 2

Yearly reporting of individual case safety reports (ICSR) of secukinumab, other biologics, and non-biologics, expressed as percentage of total in each group.

Figure 3

Most common adverse events reported in patients with psoriasis or related disorders following secukinumab use categorized according to the (a) MedDRA system organ class (b) standardised MedDRA query. MedDRA medical dictionary for regulatory activities.

Figure 4

Most common MedDRA preferred terms reported in patients with psoriasis or related disorders following secukinumab use expressed as percentage of total number of ICSRs (N = 44,761; excludes the preferred terms psoriasis, psoriatic arthropathy, and drug ineffective which were reported in 36.50%, 16.72%, and 14.76% of ICSRs, respectively). MedDRA medical dictionary for regulatory activities, ICSR individual case safety report.

Figure 5

Reporting odds ratio of adverse events at the MedDRA system organ class level reported in patients with psoriasis or related disorders receiving secukinumab or non-biologics. MedDRA medical dictionary for regulatory activities, CI confidence interval.

Figure 6

Reporting odds ratio of adverse events at the standardised MedDRA query level reported in patients with psoriasis or related disorders receiving secukinumab or non-biologics. MedDRA medical dictionary for regulatory activities, CI confidence interval.