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OP0152 Effects of Tofacitinib Monotherapy versus Methotrexate on Patient-Reported Outcomes in the 2-Year Phase 3 Oral Start TRIAL in Methotrexate-NaÏVe Patients with Rheumatoid Arthritis
  1. R. Alten1,
  2. V. Strand2,
  3. R. Fleischmann3,
  4. T. Koncz4,
  5. S. Zwillich4,
  6. J. Bradley4,
  7. D. Gruben4,
  8. B. Wilkinson4,
  9. S. Krishnaswami4,
  10. G. Wallenstein4
  1. 1Schlosspark-Klinik, University Medicine, Berlin, Germany
  2. 2Biopharmaceutical Consultant, Portola Valley
  3. 3Metroplex Clinical Research Center, Dallas
  4. 4Pfizer Inc, Groton, United States


Background Tofacitinib is a novel, oral Janus kinase inhibitor for the treatment of rheumatoid arthritis (RA).

Objectives To compare the effects of twice daily (BID) tofacitinib 5 mg and 10 mg monotherapy versus methotrexate (MTX) on patient-reported outcomes (PROs) in the 24-month Phase 3, randomised, double-blind, parallel-group ORAL Start study (NCT01039688) in MTX-naïve patients. Results from a 12-month interim analysis have been presented previously [1,2] here we present the final analysis at 24 months.

Methods MTX-naïve patients with moderate-to-severe active RA were randomised 2:2:1 to receive tofacitinib 5 mg (n=373) or 10 mg BID (n=397), or MTX (n=186) titrated from 10 mg per week to 20 mg per week by Week 8. Secondary PRO endpoints included the mean change from baseline in: Patient Global Assessment of arthritis (PtGA; Visual Analogue Scale [VAS]), pain (VAS), physical function (Health Assessment Questionnaire-Disability Index; HAQ-DI), fatigue (Functional Assessment of Chronic Illness Therapy-Fatigue Scale; FACIT-F), and health-related quality of life (HR-QoL; Short Form 36 version 2, acute; SF-36). Analyses used a linear mixed-effect model with baseline values as covariates in the full analysis set (all randomised patients who received ≥1 dose of study drug and had ≥1 post-baseline measurement). Least squares (LS) mean changes from baseline (±standard error [SE]) and proportions of patients reporting improvements ≥minimum clinically important differences (MCID; no imputation for missing data) in PROs at Month 24 are presented. P-values presented here are with no correction for type I error inflation.

Results A total of 658 patients completed the 24-month study (266, 286, and 106 in the tofacitinib 10 mg and 5 mg and MTX groups, respectively). Over 24 months, significantly (p<0.05) greater improvements from baseline were observed with both tofacitinib 5 and 10 mg BID compared with MTX across the PROs analysed, with the exception of the SF-36 mental component summary score, which was significant at Month 3 but not later (Table 1). Compared with MTX, significantly greater proportions of patients receiving tofacitinib 10 mg BID reported changes ≥MCID in all PROs at Month 3, and all PROs, except HAQ-DI, at Months 12 and 24 and FACIT-F at Month 12. Numerically more patients administered tofacitinib 5 mg BID reported changes ≥MCID across PROs versus MTX.

Table 1.

PROs at Months 3, 12 and 24

Conclusions In this Phase 3 trial in MTX-naïve patients with RA, tofacitinib 5 and 10 mg BID monotherapy significantly improved multiple PROs over 24 months compared with MTX.


  1. Lee EB et al. Arthritis Rheum 2012; 64 (Suppl 10): S1049.

  2. Strand V et al. Ann Rheum Dis 2013; 72: 252-253.

Acknowledgements Writing support was provided by Erin Bekes PhD, of Complete Medical Communications and funded by Pfizer Inc.

Disclosure of Interest R. Alten Grant/research support: Pfizer Inc, Speakers bureau: Pfizer Inc, V. Strand Consultant for: Pfizer Inc, R. Fleischmann Grant/research support: Pfizer Inc, Consultant for: Pfizer Inc, T. Koncz Shareholder of: Pfizer Inc, Employee of: Pfizer Inc, S. Zwillich Shareholder of: Pfizer Inc, Employee of: Pfizer Inc, J. Bradley Shareholder of: Pfizer Inc, Employee of: Pfizer Inc, D. Gruben Shareholder of: Pfizer Inc, Employee of: Pfizer Inc, B. Wilkinson Shareholder of: Pfizer Inc, Employee of: Pfizer Inc, S. Krishnaswami Shareholder of: Pfizer Inc, Employee of: Pfizer Inc, G. Wallenstein Shareholder of: Pfizer Inc, Employee of: Pfizer Inc

DOI 10.1136/annrheumdis-2014-eular.3168

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