Tofacitinib (CP‐690, 550) in patients with rheumatoid arthritis receiving methotrexate: Twelve‐month data from a twenty‐four–month phase III randomized radiographic study12. Issue 3 (25th February 2013)

• Record Type: Journal Article
• Authors: van der Heijde, Désirée; Tanaka, Yoshiya; Fleischmann, Roy; Keystone, Edward; Kremer, Joel; Zerbini, Cristiano; Cardiel, Mario H.; Cohen, Stanley; Nash, Peter; Song, Yeong‐Wook; Tegzová, Dana; Wyman, Bradley T.; Gruben, David; Benda, Birgitta; Wallenstein, Gene; Krishnaswami, Sriram; Zwillich, Samuel H.; Bradley, John D.; Connell, Carol A.; and the ORAL Scan Investigators
• Is Part Of: Arthritis and rheumatism. Volume 65:Issue 3(2013:Mar.)
• Page Start: 559
• Page End: 570
• Publication Date: 2013-02-25
• Subjects: Arthritis -- Periodicals; Rheumatism -- Periodicals; Arthritis -- Periodicals; Rheumatic Diseases -- Periodicals; Rhumatisme -- Périodiques; Arthrite -- Périodiques; 616.72
• DOI: 10.1002/art.37816
• Languages: English
• ISSNs: 0004-3591

Abstract

<abstract abstract-type="main" xml:lang="en"> <title>Abstract</title> <sec id="abs1-1" sec-type="section"> <title>Objective</title> <p>The purpose of this 24‐month phase III study was to examine structural preservation with tofacitinib in patients with rheumatoid arthritis (RA) with an inadequate response to methotrexate (MTX). Data from a planned 12‐month interim analysis are reported.</p> </sec> <sec id="abs1-2" sec-type="section"> <title>Methods</title> <p>In this double‐blind, parallel‐group, placebo‐controlled study, patients receiving background MTX were randomized 4:4:1:1 to tofacitinib at 5 mg twice daily, tofacitinib at 10 mg twice daily, placebo to tofacitinib at 5 mg twice daily, and placebo to tofacitinib at 10 mg twice daily. At month 3, nonresponder placebo‐treated patients were advanced in a blinded manner to receive tofacitinib as indicated above; remaining placebo‐treated patients were advanced at 6 months. Four primary efficacy end points were all analyzed in a step‐down procedure.</p> </sec> <sec id="abs1-3" sec-type="section"> <title>Results</title> <p>At month 6, response rates according to the American College of Rheumatology 20% improvement criteria for tofacitinib at 5 mg and 10 mg twice daily were higher than those for placebo (51.5% and 61.8%, respectively, versus 25.3%; both <italic>P</italic> < 0.0001). At month 6, least squares mean (LSM) changes in total modified Sharp/van der Heijde score for tofacitinib at 5 mg and 10 mg twice daily were 0.12 and 0.06, respectively, versus 0.47 for placebo (<italic>P</italic> = 0.0792 and <italic>P</italic> ≤ 0.05, respectively). At month 3, LSM changes in the Health Assessment Questionnaire disability index score for tofacitinib at 5 mg and 10 mg twice daily were –0.40 (significance not declared due to step‐down procedure) and –0.54 (<italic>P</italic> < 0.0001), respectively, versus –0.15 for placebo. At month 6, rates of remission (defined as a value <2.6 for the 4‐variable Disease Activity Score in 28 joints using the erythrocyte sedimentation rate) for tofacitinib at 5 mg and 10 mg twice daily were 7.2% (significance not declared due to step‐down procedure) and 16.0% (<italic>P</italic> < 0.0001), respectively, versus 1.6% for placebo. The safety profile was consistent with findings in previous studies.</p> </sec> <sec id="abs1-4" sec-type="section"> <title>Conclusion</title> <p>Data from this 12‐month interim analysis demonstrate that tofacitinib inhibits progression of structural damage and improves disease activity in patients with RA who are receiving MTX.</p> </sec> </abstract>