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Efficacy and safety of tofacitinib and adalimumab with methotrexate in patients with rheumatoid arthritis

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The Oral Rheumatoid Arthritis trial (ORAL) Strategy assessed the comparative efficacy of tofacitinib monotherapy, tofacitinib plus methotrexate, and adalimumab plus methotrexate for the treatment of rheumatoid arthritis in patients with a previous inadequate response to methotrexate.

The Oral Rheumatoid Arthritis trial (ORAL) Strategy assessed the comparative efficacy of tofacitinib monotherapy, tofacitinib plus methotrexate, and adalimumab plus methotrexate for the treatment of rheumatoid arthritis in patients with a previous inadequate response to methotrexate. Patients were randomly assigned to receive oral tofacitinib (5 mg twice daily) monotherapy, oral tofacitinib (5 mg twice daily) plus methotrexate, or subcutaneous adalimumab (40 mg every other week) plus methotrexate. The primary endpoint was the proportion of patients who attained an American College of Rheumatology response of at least 50% (ACR50) at month 6 in the full analysis set. Exactly 1146 patients received treatment (384 had tofacitinib monotherapy; 376 had tofacitinib and methotrexate; and 386 had adalimumab and methotrexate). At 6 months, ACR50 response was attained in 147 of 384 patients with tofacitinib monotherapy, 173 of 376 patients with tofacitinib and methotrexate, and 169 of 386 patients with adalimumab and methotrexate. In total, 23 of 384 patients receiving tofacitinib monotherapy, 26 of 376 patients receiving tofacitinib plus methotrexate, and 36 of 386 patients receiving adalimumab plus methotrexate discontinued due to adverse events. No new or unexpected safety issues were reported for either treatment in this study for up to 1 year. Researchers concluded that tofacitinib and methotrexate combination therapy was non-inferior to adalimumab and methotrexate combination therapy in the treatment of rheumatoid arthritis in patients with an inadequate response to methotrexate in this trial. Tofacitinib monotherapy was not shown to be non-inferior to either combination.

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http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(17)31618-5/fulltext

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