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Tofacitinib CP-690,550 in patients with rheumatoid arthritis on methotrexate 12-Month data from a 24-month Phase 3 randomized radiographic study



Tofacitinib CP-690,550 in patients with rheumatoid arthritis on methotrexate 12-Month data from a 24-month Phase 3 randomized radiographic study







The purpose of this 24-month Phase 3 study is to examine structural preservation with tofacitinib in patients with RA with an inadequate response to methotrexate (MTX). Data from a planned 12-month interim analysis are reported. In this double-blind, parallel-group, placebo-controlled study (NCT00847613), patients on background MTX were randomized 4:4:1:1 to: tofacitinib 5 mg twice daily (BID); tofacitinib 10 mg BID; placebo?tofacitinib 5 mg BID; placebo?tofacitinib 10 mg BID. At Month 3, non-responder placebo patients were blindly advanced to tofacitinib as indicated above; remaining placebo patients were advanced at six months. Primary efficacy endpoints were all analyzed in a step-down procedure. Primary efficacy endpoints: ACR20 response rates (Month 6) for tofacitinib 5 and 10 mg BID were higher than placebo (51.5% and 61.8%, respectively, versus 25.3%; both p<0.0001); least squares (LS) mean changes in mTSS (Month 6) for 5 and 10 mg BID were 0.12 (p=0.0792) and 0.06 (p?0.05), respectively, versus placebo, 0.47; LS mean changes in HAQ-DI (Month 3) for 5 and 10 mg BID were -0.40 (significance not declared due to step-down procedure) and -0.54 (p<0.0001), respectively, versus placebo, -0.15; DAS28-4(ESR)<2.6 rates (Month 6) for 5 and 10 mg BID were 7.2% (significance not declared due to step-down procedure) and 16.0% (p<0.0001), respectively, versus placebo, 1.6%. The safety profile was consistent with previous studies. Data from this 12-month interim analysis demonstrate that tofacitinib inhibits progression of structural damage and improves RA disease activity in patients with RA on MTX.

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Accession: 036739032

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DOI: 10.1002/art.37816


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