| アブストラクト | BACKGROUND: Tumour necrosis factor-alpha inhibitors (TNFalphaIs) are used for treatment of inflammatory disorders. There is evidence linking these agents with occurrence of malignancies. For four out of five TNFalphaIs the Food and Drug Administration (FDA) label states, 'melanoma has been reported in patients treated with these agents'. OBJECTIVES: To determine whether a statistically significant association exists between administration of TNFalphaIs and development of malignant melanoma. METHODS: We searched the FDA Adverse Event Reporting System (FAERS) database for terms related to melanoma and TNFalphaIs for detection of safety signals. We also searched a large urban academic electronic medical record (EMR) database for which we calculated the relative risk (RR) of melanoma in subjects exposed to TNFalphaIs vs. nonexposed subjects. RESULTS: There were 972 reports of melanoma associated with a TNFalphaI identified in the FAERS database, with 69 reports among individuals using more than one TNFalphaI. A safety signal was detected for infliximab, golimumab, etanercept and adalimumab, but not certolizumab pegol. For TNFalphaIs as a class of drugs, a safety signal was detectable in the FAERS database, and RR was significant in the EMR database. For the EMR cohort, 6045 patients were exposed to TNFalphaIs and 35 cases of melanoma were detected. Significance for RR was detected for adalimumab (RR 1.8, P = 0.02) and etanercept (RR 2.35, P = 0.0004 < 0.001). CONCLUSIONS: We identified a significant association between exposure to TNFalphaIs and malignant melanoma in two different analyses. Our findings add to existing evidence linking these agents with the occurrence of malignant melanoma. Additional investigations are required to explore this association further along with the risk of melanoma with TNFalphaI therapy. |
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| ジャーナル名 | The British journal of dermatology |
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| 投稿日 | 2013/12/18 |
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| 投稿者 | Nardone, B; Hammel, J A; Raisch, D W; Weaver, L L; Schneider, D; West, D P |
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| 組織名 | Department of Dermatology, Northwestern University, 676 N. Saint Clair Street,;Suite 1600, Chicago, IL, 60611, U.S.A. |
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| Pubmed リンク | https://www.ncbi.nlm.nih.gov/pubmed/24328939/ |
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