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Placebo-controlled trial of tofacitinib monotherapy in rheumatoid arthritis

Fleischmann R, Kremer J, Cush J, et al. - The New England Journal of Medicine 2012; 367(6):495-507

This is the first phase 3 study to be published for the oral Janus kinase (JAK) inhibitor tofacitinib. This study investigated tofacitinib as a monotherapy in adults with active rheumatoid arthritis who previously failed to respond to disease modifying anti-rheumatic drugs (DMARDs). The study demonstrated that tofacitinib, compared to placebo, was more likely to be associated with reductions in the signs and symptoms of rheumatoid arthritis and improvement in physical function. 59.8% of patients receiving 5 mg and 65.7% of patients receiving 10 mg tofacitinib met the criteria for an ACR 20 response compared to 26.7% on placebo. Common side effects were headache and upper respiratory tract infection. There was an increased rate of serious infections with tofacitinib compared with placebo. Tofacitinib also resulted in increases in LDL cholesterol levels. This study indicates that tofacitinib is efficacious as monotherapy.