Skip to main content

WHO Safety Study of Five TNF Inhibitors

Jul 25, 2023 6:36 pm

Large scale analysis of adverse events (AEs) in World Health Organization (WHO) VigiAccess database showed no new safety signals associated with long-standing use of five TNFα inhibitors. 

The retrospective study analyzed AEs obtained from WHO-VigiAccess and ascribed to tumor necrosis factor (TNFi) inhibitors (adalimumab, infliximab, etanercept, golimumab, and certolizumab pegol)  when used to treat immune-mediated inflammatory diseases, including rheumatoid arthritis, Crohn’s disease, psoriatic arthritis, ankylosing spondylitis, and ulcerative colitis.

A total of  1,403,273 adverse events (AEs) related to the five TNFi were reported in VigiAccess. The 10 most commonly reported AE manifestations included: rash, arthralgia, rheumatoid arthritis, headache, pneumonia, psoriasis, nausea, diarrhea, pruritus, and dyspnea.

The top 5 commonly reported AE types were : infections and infestations (23%), musculoskeletal and connective tissue disorders (28.6%), gastrointestinal disorders (15.3%), skin and subcutaneous tissue disorders (13.5%), and nervous system disorders (11.0%).

Between the 5 TNFi, myelosuppression and acromegaly were unique to golimumab, and lower respiratory tract infection and other infections was the highest for golimumab. Infliximab showed a significantly more infusion-related reactions compared to the other TNFi. 

Analysis of this large data set revealed common and specific adverse reactions familiar to this class of drugs, with nominal differences between the 5 different TNFis.


If you are a health practitioner, you may to comment.

Due to the nature of these comment forums, only health practitioners are allowed to comment at this time.

The author has no conflicts of interest to disclose related to this subject