title: Efficacy of tofacitinib monotherapy in methotrexate-naive patients with early or established rheumatoid arthritis.
abstract: BACKGROUND
  Tofacitinib is an oral Janus kinase inhibitor for the treatment of rheumatoid arthritis (RA). Tofacitinib monotherapy was previously shown to inhibit structural damage, reduce clinical signs and symptoms of RA, and improve physical functioning over 24 months in methotrexate (MTX)-naive adult patients with RA. In this post hoc analysis, we compared efficacy and safety of tofacitinib in patients with early (disease duration <1 year) versus established (≥1 year) RA.
  
  
  METHODS
  MTX-naive patients ≥18 years with active RA received tofacitinib monotherapy (5 or 10 mg two times a day, or MTX monotherapy, in a 24-month Phase 3 trial.
  
  
  RESULTS
  Of 956 patients (tofacitinib 5 mg two times a day, n=373; tofacitinib 10 mg two times a day, n=397; MTX, n=186), 54% had early RA. Baseline disease activity and functional disability were similar in both groups; radiographic damage was greater in patients with established RA. At month 24, clinical response rates were significantly greater in patients with early versus established RA in the tofacitinib 5 mg two times a day group. Both tofacitinib doses had greater effects on clinical, functional and radiographic improvements at 1 and 2 years compared with MTX, independent of disease duration. No new safety signals were observed.
  
  
  CONCLUSIONS
  Treatment response was generally similar in early and established RA; significantly greater improvements were observed at month 24 with tofacitinib 5 mg two times a day in early versus established RA. Tofacitinib 5 and 10 mg two times a day demonstrated greater efficacy versus MTX irrespective of disease duration. No difference in safety profiles was observed between patients with early or established RA.
  
  
  BACKGROUND
  NCT01039688; Results.
authors: University of Texas Southwestern Medical Center, Metroplex Research Center , Dallas, Texas , USA.
authors: Roy M
authors: RM
authors: Fleischmann
authors: Leiden University Medical Center , Leiden , The Netherlands.
authors: Tom W J
authors: TW
authors: Huizinga
authors: University of California San Diego School of Medicine , San Diego, California , USA.
authors: Arthur F
authors: AF
authors: Kavanaugh
authors: Pfizer Inc , Groton, Connecticut , USA.
authors: Bethanie
authors: B
authors: Wilkinson
authors: Pfizer Inc , New York, New York , USA.
authors: Kenneth
authors: K
authors: Kwok
authors: Pfizer Inc , New York, New York , USA.
authors: Ryan
authors: R
authors: DeMasi
authors: Amsterdam Rheumatology and Immunology Center , Amsterdam , The Netherlands.
authors: Ronald F
authors: RF
authors: van Vollenhoven
keywords: DMARDs (synthetic); Early Rheumatoid Arthritis; Methotrexate; Rheumatoid Arthritis