TNF-α inhibitor-induced alopecia in psoriatic disease patients: a pharmacovigilance study

Abstract

The objective of this study was to investigate the association between TNF-alpha inhibitors and alopecia cases in psoriasis patients reported in the Food and Drug Administration Adverse Event Reporting System (FAERS) database. We performed a disproportionality analysis (case/non-case method) to examine the relationship between the development of alopecia by the use of TNF-alpha inhibitors from January 2016 to September 2022. Cases were all alopecia reports, whereas non-cases were all the other reports reported throughout the research period. We calculated the reported odds ratio (ROR) and corresponding 95% confidence interval (CI) to assess disproportionality signals and determine the relationship between alopecia and TNF-alpha inhibitors. As a positive control, docetaxel was used. Our study found that only infliximab and certolizumab pegol showed signal for alopecia. Additional study into alopecia connected with TNF-alpha inhibitors usage in psoriasis patients is required as disproportionality signals may have been altered by stimulated reporting or nocebo effect.