Adverse events associated with Bimzelx

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This study analysed the U.S. Food and Drug Administration’s Adverse Event Reporting System (FAERS) adverse event reports to evaluate the safety profiles of Bimzelx (bimekizuma).

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Objective:
To evaluate adverse events (AEs) associated with Bimekizumab through data mining of the U.S. Food and Drug Administration’s Adverse Event Reporting System (FAERS), aiming to explore potential drug-related AEs and provide guidance for clinical medication safety.

Methods:
AE reports related to Bimekizumab from the fourth quarter of 2023 to the fourth quarter of 2024 were extracted from the FAERS database. The reports were classified and grouped according to risk signals based on Preferred Terms (PT) and System Organ Classes (SOC).

Results:
Among 7444 AE reports where Bimekizumab was identified as the primary suspected drug, 78 PTs of AEs were identified, spanning 23 different SOCs. Females accounted for a higher proportion of AE reports than males (54.35% vs. 37.86%), with the 45- to 59-year age group reporting the most cases (11.32%). The median time to AE onset was 32.00 days (interquartile range: 0.00–100.00 days), with the majority occurring more than 60 days after administration (n = 189, 10.09%). Among the significant positive risk signals, PTs such as Candida infection, streptococcal and staphylococcal infections, tonsillitis, otitis media, kidney and skin infections, oral herpes, acne, injection-site pain, positive Mycobacterium tuberculosis complex test, latent tuberculosis, inflammatory bowel disease, and suicidal depression demonstrated high signal intensity and substantial reporting frequency, aligning closely with the drug’s prescribing information. Additionally, the study identified several AEs not explicitly mentioned in the label, including Mycoplasma pneumonia, Lyme disease, cellulitis, erysipelas, lung abscess, pertussis, rectal abscess, staphylococcal sepsis, subcutaneous abscess, eye infection, diabetic foot, skin plaques, disorder and discoloration, injection-site induration, warmth and pruritus, angular cheilitis, coated tongue, chapped lips, hemorrhagic diarrhea, pharyngeal ulceration, genital pruritus, and blepharitis.

Conclusion:
Bimekizumab carries the risk of inducing multiple AEs during treatment. In clinical practice, close monitoring of infections and infestations, general disorders and administration-site conditions, gastrointestinal disorders, skin and subcutaneous tissue disorders, and psychiatric disorders is advised. Should any AEs or disease progression occur, timely intervention measures must be implemented to prevent severe systemic damage and clinical deterioration.

Source: onlinelibrary.wiley.com

*Funding: No funding was received

Bimzelx (bimekizumab)