[Updated statement by the German Society for Pediatric and Adolescent Rheumatology (GKJR) on the FDA's report regarding malignancies in anti-TNF-treated patients from Aug. 4, 2009].
TNF inhibitors and other biologicals have greatly expanded the therapeutic options for juvenile idiopathic arthritis (JIA). While the efficacy of etanercept and adalimumab has been proven in randomized controlled clinical trials, their long-term safety remains the subject of ongoing investigations. Reports of leukaemia and tumours in children and adolescents treated with etanercept, infliximab and adalimumab have raised questions about an increased risk for malignancies, with lymphoma accounting for the largest group at 50% of all 48 malignancies reported by the FDA.Consequently, TNF inhibitors should be indicated under careful consideration of individual risk factors, such as increased family occurrence of malignancies, or pre-treatment with carcinogenic substances such as cyclophosphamide. This is particularly true for non-approved substances, and non-approved indications, and for combination therapy of TNF inhibitors with immunosuppressive drugs. On the other hand, however, treatment should not be stopped or started in any patient in whom treatment is necessary due to the current knowledge. Adequate patient information, surveillance and documentation of treatment in the registry of the GKJR is strongly recommended.
Horneff
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Zentrum für Allgemeine Pädiatrie und Neonatologie, Asklepios Klinik St Augustin, Arnold-Janssen-Str 29, 53757 Sankt Augustin. g.horneff@asklepios.com
Hospach
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T
Dannecker
G
G
Föll
D
D
Haas
J P
JP
Girschick
H J
HJ
Huppertz
H I
HI
Keitzer
R
R
Laws
H J
HJ
Michels
H
H
Minden
K
K
Trauzeddel
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R
D000293:Adolescent; D000328:Adult; D016907:Adverse Drug Reaction Reporting Systems; D001171:Arthritis, Juvenile / Q000188:drug therapy*; D001688:Biological Products / Q000009:adverse effects* / Q000627:therapeutic use; D002648:Child; D006801:Humans; D007938:Leukemia / Q000139:chemically induced; D008223:Lymphoma / Q000139:chemically induced; D009369:Neoplasms / Q000139:chemically induced*; D056687:Off-Label Use; D012955:Societies, Medical; D016896:Treatment Outcome; D014409:Tumor Necrosis Factor-alpha / Q000037:antagonists & inhibitors*; D014481:United States; D014486:United States Food and Drug Administration; D055815:Young Adult
D001688:Biological Products; D014409:Tumor Necrosis Factor-alpha