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Region Hovedstaden - en del af Københavns Universitetshospital
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Comparing the effects of tofacitinib, methotrexate and the combination, on bone marrow oedema, synovitis and bone erosion in methotrexate-naive, early active rheumatoid arthritis: results of an exploratory randomised MRI study incorporating semiquantitative and quantitative techniques

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

  • Philip G Conaghan
  • Mikkel Østergaard
  • Michael A Bowes
  • Chunying Wu
  • Thomas Fuerst
  • Désirée van der Heijde
  • Fedra Irazoque-Palazuelos
  • Oscar Soto-Raices
  • Pawel Hrycaj
  • Zhiyong Xie
  • Richard Zhang
  • Bradley T Wyman
  • John D Bradley
  • Koshika Soma
  • Bethanie Wilkinson
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OBJECTIVES: To explore the effects of tofacitinib-an oral Janus kinase inhibitor for the treatment of rheumatoid arthritis (RA)-with or without methotrexate (MTX), on MRI endpoints in MTX-naive adult patients with early active RA and synovitis in an index wrist or hand.

METHODS: In this exploratory, phase 2, randomised, double-blind, parallel-group study, patients received tofacitinib 10 mg twice daily + MTX, tofacitinib 10 mg twice daily + placebo (tofacitinib monotherapy), or MTX + placebo (MTX monotherapy), for 1 year. MRI endpoints (Outcome Measures in Rheumatology Clinical Trials RA MRI score (RAMRIS), quantitative RAMRIS (RAMRIQ) and dynamic contrast-enhanced (DCE) MRI) were assessed using a mixed-effect model for repeated measures. Treatment differences with p<0.05 (vs MTX monotherapy) were considered significant.

RESULTS: In total, 109 patients were randomised and treated. Treatment differences in RAMRIS bone marrow oedema (BME) at month 6 were -1.55 (90% CI -2.52 to -0.58) for tofacitinib + MTX and -1.74 (-2.72 to -0.76) for tofacitinib monotherapy (both p<0.01 vs MTX monotherapy). Numerical improvements in RAMRIS synovitis at month 3 were -0.63 (-1.58 to 0.31) for tofacitinib + MTX and -0.52 (-1.46 to 0.41) for tofacitinib monotherapy (both p>0.05 vs MTX monotherapy). Treatment differences in RAMRIQ synovitis were statistically significant at month 3, consistent with DCE MRI findings. Less deterioration of RAMRIS and RAMRIQ erosive damage was seen at months 6 and 12 in both tofacitinib groups versus MTX monotherapy.

CONCLUSIONS: These results provide consistent evidence using three different MRI technologies that tofacitinib treatment leads to early reduction of inflammation and inhibits progression of structural damage.

TRIAL REGISTRATION NUMBER: NCT01164579.

OriginalsprogEngelsk
TidsskriftAnnals of the Rheumatic Diseases
Vol/bind75
Udgave nummer6
Sider (fra-til)1024-33
Antal sider10
ISSN0003-4967
DOI
StatusUdgivet - jun. 2016

ID: 49686117