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Melanoma associated with tumour necrosis factor‐α inhibitors: a R esearch on A dverse D rug events And R eports ( RADAR ) project
Author(s) -
Nardone B.,
Hammel J.A.,
Raisch D.W.,
Weaver L.L.,
Schneider D.,
West D.P.
Publication year - 2014
Publication title -
british journal of dermatology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 2.304
H-Index - 179
eISSN - 1365-2133
pISSN - 0007-0963
DOI - 10.1111/bjd.12779
Subject(s) - medicine , adalimumab , adverse event reporting system , etanercept , golimumab , infliximab , certolizumab pegol , database , adverse effect , melanoma , oncology , tumor necrosis factor alpha , cancer research , computer science
Summary Background Tumour necrosis factor‐α inhibitors ( TNF α I s) are used for treatment of inflammatory disorders. There is evidence linking these agents with occurrence of malignancies. For four out of five TNF α I s the F ood and D rug A dministration ( 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 TNF α I s and development of malignant melanoma. Methods We searched the FDA A dverse E vent R eporting S ystem ( FAERS ) database for terms related to melanoma and TNF α I s 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 TNF α I s vs. nonexposed subjects. Results There were 972 reports of melanoma associated with a TNF α I identified in the FAERS database, with 69 reports among individuals using more than one TNF α I . A safety signal was detected for infliximab, golimumab, etanercept and adalimumab, but not certolizumab pegol. For TNF α I s 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 TNF α I s 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 TNF α I s 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 TNF α I therapy.