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Specialized toxicology research shows no embryo-fetal developmental toxicity, no genetic mutagenicity in bacterial and mammalian cell assays, and no adverse reproductive effects in animal models

It has been approved for use in psoriatic arthritis (PsA) in the United States based on the Golimumab-Randomized Evaluation of Safety and Efficacy in Subjects With Psoriatic Arthritis Using a Human Anti-TNF Monoclonal Antibody (GO-REVEAL) trial

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DOI: 10.1007/s00415-004-0455-7 16