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THU0225 Tofacitinib Monotherapy is Effective in Methotrexate-NaÏVe Patients with Disease Duration Less Than 6 Months: a Post-HOC Analysis of Early Rheumatoid Arthritis Subjects in a Phase 3 Trial
  1. T. W. J. Huizinga1,
  2. R. Fleischmann2,
  3. R. van Vollenhoven3,
  4. D. Gruben4,
  5. B. Wilkinson4,
  6. T. Koncz5,
  7. J. Bradley4,
  8. S. H. Zwillich4,
  9. B. Benda6
  1. 1Leiden University Medical Center, Leiden, Netherlands
  2. 2Metroplex Research Center, Dallas, United States
  3. 3Karolinska Institute, Stockholm, Sweden
  4. 4Pfizer Inc., Groton
  5. 5Pfizer Inc., New York
  6. 6Pfizer Inc., Collegeville, United States


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

Objectives To assess the efficacy of tofacitinib monotherapy in patients (pts) with early RA (eRA), as defined by disease duration (i.e., time since diagnosis) <6 months, in a Phase 3, 24-month (Mo) study (ORAL Start, NCT01039688) of tofacitinib vs methotrexate (MTX) in MTX-naïve pts with active RA. Primary analyses have been reported.1

Methods Pts were randomised 2:2:1 to tofacitinib 5 mg twice daily (BID), tofacitinib 10 mg BID, or MTX. Post-hoc subgroup analyses from the planned 12-Mo interim analyses of signs and symptoms (rates of ACR20, 50 and 70; DAS28-4[ESR] [DAS]-defined remission and low disease activity [LDA] [DAS <2.6 and ≤3.2, respectively]), physical function (mean change from baseline [BL] in HAQ-DI) and structure preservation (mean change from BL in modified Total Sharp Score [mTSS] and rates of no radiographic progression [mTSS change ≤0.5]) in pts with eRA are presented.

Results 409 of 952 pts receiving treatment had a disease duration <6 Mo. In this eRA subpopulation, ACR (20/50/70) response rates, rates of DAS-defined remission and LDA and mean HAQ-DI improvement were significantly better with tofacitinib vs MTX at Mo 3 and inhibition of structural damage at Mo 6 and 12. Results by disease duration <6 Mo or ≥6 Mo are summarised in Figure 1.

Conclusions Tofacitinib monotherapy significantly inhibited progression of structural damage and improved RA signs and symptoms and physical functioning vs MTX, in MTX-naïve pts with early as well as established disease.


  1. Lee EB et al Arthritis Rheum 20;64(10[supplement]):S1049.

Disclosure of Interest T. J. Huizinga Grant/research support from: Dutch Arthritis Foundation, The Dutch NIH en the EU, Consultant for: Merck, UCB, Bristol Myers Squibb, Biotest AG, Pfizer, Novartis, Roche, Sanofi-Aventis, Abbott, Crescendo Bioscience, Nycomed, Boeringher, Takeda, Eli Lilly, Employee of: LUMC, Paid instructor for: Roche, Pfizer, Speakers bureau: Roche, Pfizer, R. Fleischmann Grant/research support from: Pfizer Inc., Consultant for: Pfizer Inc., R. van Vollenhoven Grant/research support from: AbbVie, BMS, GSK, MSD, Pfizer, Roche, UCB, Consultant for: AbbVie, BMS, GSK, MSD, Pfizer, Roche, UCB, D. Gruben Shareholder of: Pfizer Inc., Employee of: Pfizer Inc., B. Wilkinson Shareholder of: Pfizer Inc., Employee of: Pfizer Inc., T. Koncz Shareholder of: Pfizer Inc., Employee of: Pfizer Inc., J. Bradley Shareholder of: Pfizer Inc., Employee of: Pfizer Inc., S. Zwillich Shareholder of: Pfizer Inc., Employee of: Pfizer Inc., B. Benda Shareholder of: Pfizer Inc., Employee of: Pfizer Inc.

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