Article Text

Download PDFPDF
THU0258 Oral Start: Effects of the Oral JAK Inhibitor Tofacitinib Monotherapy Versus Methotrexate on Patient-Reported Outcomes in the Phase 3 Oral Start Trial of Active Rheumatoid Arthritis
  1. V. Strand1,
  2. R. Fleischmann2,
  3. R. E. Alten3,
  4. T. Koncz4,
  5. S. H. Zwillich4,
  6. J. D. Bradley4,
  7. D. Gruben4,
  8. B. Wilkinson4,
  9. S. Krishaswami4,
  10. G. Wallenstein4
  1. 1Stanford University, Stanford
  2. 2Metroplex Clinical Research Center, Dallas, United States
  3. 3Schlosspark-Klinik, Berlin, Germany
  4. 4Pfizer Inc, Groton, United States


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

Objectives To compare the effects of tofacitinib 5 mg and 10 mg twice daily (BID) monotherapy versus methotrexate (MTX) on patient-reported outcomes in a 12-month interim analysis of a randomised, double-blind, parallel group Phase 3 study (NCT01039688).1

Methods MTX-naïve patients with RA (≥6 tender/swollen joints; erythrocyte sedimentation rate [ESR] >28 mm/hr and/or C-reactive protein [CRP) >7mg/L]) were randomised 2:2:1 to tofacitinib 5 mg BID, 10 mg BID, or MTX titrated from 10 mg/week to 20 mg/week. PROs were secondary endpoints, including mean changes from baseline in: patient-reported pain (Visual Analogue Scale; VAS), Patient Global Assessment (PtGA) of disease activity (VAS), physical function (Health Assessment Questionnaire-Disability Index; HAQ-DI), health-related quality of life (HR-QoL) (Short Form 36 version 2, acute; SF-36), and fatigue (Functional Assessment of Chronic Illness Therapy-Fatigue; FACIT-F). Analyses used a linear mixed-effect model, with baseline values as covariates, on all patients who received ≥1 study drug dose (full analysis set) and had both a baseline and ≥1 post-baseline value. Least squares mean changes from baseline at Month 12 are presented; non-responder imputation for minimum clinically important differences (MCID) of PROs.

Results At the 12-month cut-off (24 May 2012), 769 patients who received treatment were ongoing; 307 with tofacitinib 5 mg BID, 328 with tofacitinib 10 mg BID, 134 with MTX. Tofacitinib treatment resulted in statistically significant improvements versus MTX in all PROs except SF-36 mental component score for the 5 mg BID dose (Table 1). Changes in values for all PROs were numerically greater in patients receiving tofacitinib 10 mg BID than those receiving 5 mg BID. A significantly greater proportion of pts achieved at least MCID with tofacitinib 10 mg BID vs MTX for all PROs (FACIT-F data not available) (Table 1).

Conclusions In this Phase 3 study, MTX-naive patients receiving tofacitinib monotherapy generally reported significant improvements in PROs compared with MTX over 12 months’ treatment.


  • Lee EB, et al. Arthritis Rheum 2012; 64(S10): S1049

Disclosure of Interest V. Strand Consultant for: Pfizer Inc., R. Fleischmann Grant/research support from: Pfizer Inc., Consultant for: Pfizer Inc., R. Alten Grant/research support from: Pfizer Inc., Speakers bureau: 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. Krishaswami Shareholder of: Pfizer Inc., Employee of: Pfizer Inc., G. Wallenstein Shareholder of: Pfizer Inc., Employee of: Pfizer Inc.

Statistics from

Request Permissions

If you wish to reuse any or all of this article please use the link below which will take you to the Copyright Clearance Center’s RightsLink service. You will be able to get a quick price and instant permission to reuse the content in many different ways.