PMID- 37554981 OWN - NLM STAT- PubMed-not-MEDLINE LR - 20230810 IS - 1663-9812 (Print) IS - 1663-9812 (Electronic) IS - 1663-9812 (Linking) VI - 14 DP - 2023 TI - Characteristic analysis of adverse reactions of five anti-TNFa agents: a descriptive analysis from WHO-VigiAccess. PG - 1169327 LID - 10.3389/fphar.2023.1169327 [doi] LID - 1169327 AB - Introduction: Tumor necrosis factor (TNF) inhibitors (adalimumab, infliximab, etanercept, golimumab, and certolizumab pegol) have revolutionized the treatment of severe immune-mediated inflammatory diseases, including rheumatoid arthritis, Crohn's disease, psoriatic arthritis, ankylosing spondylitis, and ulcerative colitis. This study assessed adverse drug reactions (ADRs) after the use of TNFalpha inhibitors in VigiAccess of the World Health Organization (WHO) and compared the adverse reaction characteristics of five inhibitors to select the drug with the least risk for individualized patient use. Methods: The study was a retrospective descriptive analysis method in design. We sorted out five marketed anti-TNFalpha drugs, and their ADR reports were obtained from WHO-VigiAccess. Data collection included data on the age groups, sex, and regions of patients worldwide covered by ADR reports, as well as data on disease systems and symptoms caused by ADRs recorded in annual ADR reports and reports received by the WHO. By calculating the proportion of adverse reactions reported for each drug, we compared the similarities and differences in adverse reactions for the five drugs. Results: Overall, 1,403,273 adverse events (AEs) related to the five anti-TNFalpha agents had been reported in VigiAccess at the time of the search. The results show that the 10 most commonly reported AE manifestations were rash, arthralgia, rheumatoid arthritis, headache, pneumonia, psoriasis, nausea, diarrhea, pruritus, and dyspnea. The top five commonly reported AE types of anti-TNFalpha drugs were as follows: infections and infestations (184,909, 23.0%), musculoskeletal and connective tissue disorders (704,657, 28.6%), gastrointestinal disorders (122,373, 15.3%), skin and subcutaneous tissue disorders (108,259, 13.5%), and nervous system disorders (88,498, 11.0%). The preferred terms of myelosuppression and acromegaly were obvious in golimumab. Infliximab showed a significantly higher ADR report ratio in the infusion-related reaction compared to the other four inhibitors. The rate of ADR reports for lower respiratory tract infection and other infections was the highest for golimumab. Conclusion: No causal associations could be established between the TNFalpha inhibitors and the ADRs. Current comparative observational studies of these inhibitors revealed common and specific adverse reactions in the ADR reports of the WHO received for these drugs. Clinicians should improve the rational use of these high-priced drugs according to the characteristics of ADRs. CI - Copyright (c) 2023 Li, You, Su, Zhou and Gong. FAU - Li, Mingming AU - Li M AD - Department of Pharmacy, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China. FAU - You, Ruxu AU - You R AD - Department of Pharmacy, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China. FAU - Su, Yuyong AU - Su Y AD - Department of Pharmacy, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China. FAU - Zhou, Hongbo AU - Zhou H AD - Department of Pharmacy, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China. FAU - Gong, Shiwei AU - Gong S AD - School of Pharmacy, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China. LA - eng PT - Journal Article DEP - 20230724 PL - Switzerland TA - Front Pharmacol JT - Frontiers in pharmacology JID - 101548923 PMC - PMC10404848 OTO - NOTNLM OT - TNFalpha inhibitors OT - VigiAccess of the WHO OT - adverse drug reaction OT - pharmacovigilance OT - spontaneous reporting COIS- The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest. EDAT- 2023/08/09 06:43 MHDA- 2023/08/09 06:44 PMCR- 2023/07/24 CRDT- 2023/08/09 04:08 PHST- 2023/02/19 00:00 [received] PHST- 2023/07/10 00:00 [accepted] PHST- 2023/08/09 06:44 [medline] PHST- 2023/08/09 06:43 [pubmed] PHST- 2023/08/09 04:08 [entrez] PHST- 2023/07/24 00:00 [pmc-release] AID - 1169327 [pii] AID - 10.3389/fphar.2023.1169327 [doi] PST - epublish SO - Front Pharmacol. 2023 Jul 24;14:1169327. doi: 10.3389/fphar.2023.1169327. eCollection 2023.