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Review
. 2016 Dec;19(12):1216-1225.
doi: 10.1111/1756-185X.12901. Epub 2016 Jul 25.

Efficacy and safety of tofacitinib in patients with active rheumatoid arthritis: review of key Phase 2 studies

Roy Fleischmann  1 , Joel Kremer  2 , Yoshiya Tanaka  3 , David Gruben  4 , Keith Kanik  4 , Tamas Koncz  5 , Sriram Krishnaswami  4 , Gene Wallenstein  4 , Bethanie Wilkinson  4 , Samuel H Zwillich  4 , Edward Keystone  6
Affiliations
Review

Efficacy and safety of tofacitinib in patients with active rheumatoid arthritis: review of key Phase 2 studies

Roy Fleischmann et al. Int J Rheum Dis. 2016 Dec.

Abstract

Tofacitinib is an oral Janus kinase inhibitor for the treatment of rheumatoid arthritis (RA). Here, the safety and efficacy data from five Phase 2 studies of tofacitinib in patients with RA are summarized. Tofacitinib 1-30 mg twice daily was investigated, as monotherapy and in combination with methotrexate, in patients with RA. Tofacitinib 20 mg once daily was investigated in one study. Tofacitinib 5 and 10 mg twice daily were selected for investigation in Phase 3 studies; therefore, the efficacy and safety of tofacitinib 5 and 10 mg twice daily in Phase 2 studies are the focus of this review. Tofacitinib ≥ 5 mg twice daily was efficacious in a dose-dependent manner, with statistically significant and clinically meaningful reductions in the signs and symptoms of RA and patient-reported outcomes. The safety profile was consistent across studies. The efficacy and safety profile of tofacitinib in Phase 2 studies supported its further investigation and the selection of tofacitinib 5 mg twice daily and tofacitinib 10 mg twice daily for evaluation in Phase 3 studies.

Keywords: Phase 2; efficacy; rheumatoid arthritis; safety; tofacitinib.

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Figures

Figure 1
Figure 1
ACR20 response rates at Week 6 (A3921019) and Week 12 (A3921025, A3921035, A3921039, and A3921040). ACR, American College of Rheumatology; ADA, adalimumab; BID, twice daily; FAS, full analysis set; LOCF, last observation carried forward; QD, once daily; SE, standard error. *P ≤ 0.05; **P < 0.001; ***P < 0.0001 versus placebo.
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References

    1. Strand V, Khanna D (2010) The impact of rheumatoid arthritis and treatment on patients’ lives. Clin Exp Rheumatol 28, S32–40. - PubMed
    1. Smolen JS, Landewé R, Breedveld FC et al (2010) EULAR recommendations for the management of rheumatoid arthritis with synthetic and biological disease‐modifying antirheumatic drugs. Ann Rheum Dis 69, 964–75. - PMC - PubMed
    1. Rezaei H, Saevarsdottir S, Forslind K et al (2012) In early rheumatoid arthritis, patients with a good initial response to methotrexate have excellent 2‐year clinical outcomes, but radiological progression is not fully prevented: data from the methotrexate responders population in the SWEFOT trial. Ann Rheum Dis 71, 186–91. - PubMed
    1. Singh JA, Furst DE, Bharat A et al (2012) 2012 update of the 2008 American College of Rheumatology recommendations for the use of disease‐modifying antirheumatic drugs and biologic agents in the treatment of rheumatoid arthritis. Arthritis Care Res (Hoboken) 64, 625–39. - PMC - PubMed
    1. Barton JL (2009) Patient preferences and satisfaction in the treatment of rheumatoid arthritis with biologic therapy. Patient Prefer Adherence 3, 335–44. - PMC - PubMed

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