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THU0191 Effects of tofacitinib, an oral janus kinase inhibitor, on patient-reported outcomes in japanese patients with rheumatoid arthritis
  1. H Yamanaka1,
  2. Y Tanaka2,
  3. T Takeuchi3,
  4. N Sugiyama4,
  5. T Hirose4,
  6. N Yoshii4,
  7. Y Morishima4,
  8. S Toyoizumi4
  1. 1Tokyo Women's Medical University, Tokyo
  2. 2University of Occupational and Environmental Health, Kitakyushu
  3. 3Keio University
  4. 4Pfizer Japan Inc, Tokyo, Japan

Abstract

Background Tofacitinib is an oral JAK inhibitor for the treatment of rheumatoid arthritis (RA). Improvements in patient-reported outcomes (PROs) have been reported in the global population of the Phase (P)2, P3 and long-term extension (LTE) tofacitinib studies.

Objectives To explore the effect of tofacitinib on PROs in Japanese patients (pts) with RA.

Methods In this post hoc analysis, data from Japanese pts with RA were obtained from two 12-week randomised dose-finding P2 studies in methotrexate (MTX) inadequate responder (IR) and DMARD-IR pts (NCT00603512/A3921039 and NCT00687193/A3921040), one 24-month P3 study in MTX-IR pts (ORAL Scan; NCT00847613/A3921044) and an open-label, LTE study in pts who completed a qualifying P2 or P3 study (NCT00661661/A3921041; completed April 2014). Pts received tofacitinib 5 or 10 mg twice daily (BID) or placebo (PBO) (P2 and ORAL Scan; no PBO in LTE). In ORAL Scan, non-responder PBO pts advanced to tofacitinib at Month 3; all remaining pts were advanced at Month 6. PROs included: mean change from baseline in Pt's Global Assessment of Arthritis (PtGA; visual analogue scale [VAS]), Physician's Global Assessment of Arthritis (PGA; VAS), Health Assessment Questionnaire-Disability Index (HAQ-DI), Pain (VAS), Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F), Medical Outcomes Study (MOS) Sleep Scale and Short-Form Health Survey (SF-36) domain scores. Significance was declared for p≤0.05 for the P2 and P3 studies reported here.

Results The analysis included 238 pts from P2 studies, 118 pts from ORAL Scan and 486 pts from the LTE study. Demographics and baseline characteristics were similar between treatment groups for all studies. In P2 studies at Week 12, tofacitinib 5 and 10 mg BID demonstrated significantly greater improvements from baseline vs PBO in PtGA, PGA, HAQ-DI, Pain, FACIT-F, MOS Sleep Scale and in 4 (Physical Function [PF], Role-Physical [RP], Bodily Pain [BP] and General Health [GH]) of the 8 SF-36 domain scores (Table). Significant improvements in PtGA, PGA, HAQ-DI, Pain and FACIT-F vs PBO were seen as early as Week 2. In ORAL Scan at Month 3, statistically significant improvements from baseline in PtGA, PGA, HAQ-DI and Pain were seen for both tofacitinib 5 and 10 mg BID vs PBO (Table) and these were maintained to Month 24. Significant improvements vs PBO as early as Month 1 were seen for PGA (tofacitinib 10 mg BID) and Pain (both doses). In the LTE study, mean changes from LTE study baseline in PtGA, PGA, HAQ-DI and Pain were -32.5, -40.8, -0.5 and -32.9, respectively, for all tofacitinib doses at Week 2, and -40.7, -50.2, -0.7 and -42.4, respectively, at Week 168. Mean changes from baseline in SF-36 domain scores at Week 12 and Week 168, respectively, were: 7.5 and 8.6 (PF); 6.9 and 6.9 (RP); 10.4 and 11.6 (BP); 5.7 and 5.4 (GH); 7.2 and 6.1 (Vitality [VT]); 5.0 and 4.5 (Social Function [SF]); 6.3 and 5.5 (Role-Emotional [RE]); and 6.1 and 4.8 (Mental Health [MH]).

Conclusions Tofacitinib 5 and 10 mg BID significantly improved PROs in Japanese pts with RA enrolled in the P2, P3 and LTE studies.

Acknowledgements This study was sponsored by Pfizer Inc. Editorial support was provided by K Haines of CMC and was funded by Pfizer Inc.

Disclosure of Interest H. Yamanaka Grant/research support from: AbbVie, Astellas, Ayumi, Bayer, Bristol-Myers Squibb, Chugai, Daiichi-Sankyo, Eisai, Mitsubishi-Tanabe, MSD, Nippon Kayaku, Nippon Shinyaku, Ono, Pfizer Inc, Taisyo-Toyama, Takeda, Teijin Pharma, Torii, UCB, YL Biologics, Consultant for: AbbVie, Astellas, Ayumi, Bayer, Bristol-Myers Squibb, Chugai, Daiichi-Sankyo, Eisai, Mitsubishi-Tanabe, MSD, Nippon Kayaku, Nippon Shinyaku, Ono, Pfizer Inc, Taisyo-Toyama, Takeda, Teijin Pharma, Torii, UCB, YL Biologics, Speakers bureau: AbbVie, Astellas, Ayumi, Bayer, Bristol-Myers Squibb, Chugai, Daiichi-Sankyo, Eisai, Mitsubishi-Tanabe, MSD, Nippon Kayaku, Nippon Shinyaku, Ono, Pfizer Inc, Taisyo-Toyama, Takeda, Teijin Pharma, Torii, UCB, YL Biologics, Y. Tanaka Grant/research support from: AbbVie, Astellas, Bristol-Myers Squibb, Chugai, Daiichi-Sankyo, Eisai, Mitsubishi-Tanabe, MSD, Takeda, Consultant for: AbbVie, Asahi Kasei, Astellas, Bristol-Myers Squibb, Chugai, Daiichi-Sankyo, Eli Lilly, GSK, Janssen, Mitsubishi-Tanabe, Pfizer Inc, Sanofi, Takeda, Teijin, YL Biologics, Speakers bureau: AbbVie, Asahi Kasei, Astellas, Bristol-Myers Squibb, Chugai, Daiichi-Sankyo, Eli Lilly, GSK, Janssen, Mitsubishi-Tanabe, Pfizer Inc, Sanofi, Takeda, Teijin, YL Biologics, T. Takeuchi Grant/research support from: AbbVie, Asahi Kasei, Astellas, Ayumi, Bristol-Myers Squibb, Chugai, Daiichi-Sankyo, Eisai, Taisyo-Toyama, Takeda and Teijin Pharma, Consultant for: AbbVie, Astellas, Bristol-Myers Squibb, Celtrion, Chugai, Daiichi-Sankyo, Eisai, Janssen, Mitsubishi-Tanabe, Nippon Kayaku, Pfizer Japan Inc, Takeda, Speakers bureau: AbbVie, Asahi Kasei, Astellas, AstraZeneca, Bristol-Myers Squibb, Daiichi-Sankyo, Eli Lilly Japan, Janssen, Merck Serono, Mitsubishi-Tanabe, Nippon Kayaku, Novartis, Pfizer Japan Inc, Takeda, N. Sugiyama Shareholder of: Pfizer Inc, Employee of: Pfizer Japan Inc, T. Hirose Shareholder of: Pfizer Inc, Employee of: Pfizer Japan Inc, N. Yoshii Shareholder of: Pfizer Inc, Employee of: Pfizer Japan Inc, Y. Morishima Shareholder of: Pfizer Inc, Employee of: Pfizer Japan Inc, S. Toyoizumi Employee of: Pfizer Japan Inc

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