Real-World Safety of Ixekizumab: A Disproportionality Analysis Using the FDA Adverse Event Reporting System and the VigiAccess Databases

This study evaluated the safety profile of ixekizumab, a treatment for moderate-to-severe plaque psoriasis, using 72,847 adverse event (AE) reports from the FAERS and VigiAccess databases. Common AEs included injection site reactions and infections, with 41.1% occurring within the first month of treatment. Unexpected AEs such as cellulitis and herpes zoster were identified, and a potential link to inflammatory bowel disease was noted. The study underscores the need for ongoing safety monitoring and preventive measures, like vaccination, due to the immunomodulatory effects of ixekizumab. The findings are preliminary and may be limited by underreporting and variable reporting quality.