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FRI0607 Effect of Methotrexate and Intra-Articular Betamethasone with or Without Additional Cyclosporine on Magnetic Resonance Imaging (MRI)-Determined Inflammatory and Destructive Changes in Very Early Rheumatoid Arthritis – Results from a 24-Months' Randomised Double Blind Placebo Controlled Trial
  1. S. Møller-Bisgaard1,2,
  2. B.J. Ejbjerg2,
  3. I. Eshed3,
  4. K. Hørslev-Petersen2,
  5. A.G. Jurik4,
  6. J. Vallø5,
  7. H. Thomsen6,
  8. T. Torfing7,
  9. K. Stengaard-Pedersen8,
  10. M.L. Hetland1,
  11. P. Junker2,
  12. N.S. Krogh9,
  13. T. Lottenburger2,
  14. T. Ellingsen2,
  15. L.S. Andersen1,
  16. I. Hansen8,
  17. H. Skjødt1,
  18. A.J. Svendsen5,
  19. U. Tarp8,
  20. J. Pødenphant1,
  21. J.K. Pedersen2,
  22. H. Lindegaard2,
  23. M. Østergaard1
  1. 1Dept of Rheum, Uni. Hosp., Cph
  2. 2Dept of Rheum, Uni. Hosp., South DK, Denmark
  3. 3Dept of Radiol, Sheba Medical Center, Ramat Gan, Israel
  4. 4Dept of Radiol, Uni. Hosp., Aarhus
  5. 5Uni. Hosp., South DK
  6. 6Dept of Radiol, Uni. Hosp., Cph
  7. 7Dept of Radiol, Uni. Hosp., South DK
  8. 8Dept of Rheum, Uni. Hosp., Aarhus
  9. 9ZiteLab ApS, Cph., Denmark

Abstract

Background MRI has been shown to be more sensitive than clinical examination and x-ray for detection of inflammatory and destructive joint changes in early rheumatoid arthritis (RA) and to discriminate between treatment arms in clinical trials using the semi-quantitative Outcome Measures in Rheumatology Clinical Trials (OMERACT) RA MRI scoring (RAMRIS) system.

Objectives To investigate whether MRI-determined measures of disease activity and joint destruction were suppressed in very early RA patients following a treat-to-target strategy with methotrexate (MTX) and intraarticular (i.a.) betamethasone and to investigate whether concomitant cyclosporine (CYA) had an additional effect on MRI determined inflammatory and destructive findings over 2 years.

Methods In the 2-year randomised, double-blind, multicentre, clinical, treat-to-target trial, CIMESTRA, 160 patients with early (<6 months) RA were treated with MTX, i.a. betamethasone and CYA/placebo CYA. 129 patients participated in the MRI substudy, and had contrast-enhanced MRIs at months 0, 6, 12 and 24 that covered the non-dominant wrist (wrist-only group) and if technically possible both wrist and metacarpophalangeal (MCP) joints (wrist+MCP group). MRIs were evaluated by an experienced radiologist blinded to patient identity, clinical and biochemical data but not to chronology, using the RAMRIS scoring system assessing inflammatory (osteitis, synovitis, tenosynovisits) and destructive (erosions, joint space narrowing) changes. Observed data, without any data imputations, are reported. Non-parametric statistics were used. A value of p<0.05 was considered statistically significant.

Results MRI-results from the wrist-only group are shown in table 1. The data in the wrist+MCP group were overall similar (data not shown). No statistically significant differences between the treatment groups were observed in any MRI characteristics at baseline or at any follow-up time point.

Both the wrist-only group and the wrist+MCP group showed significant reductions compared to baseline in osteitis, synovitis and tenosynovitis at 6 months (all parameters) and 12 and 24 months (synovitis and tenosynovitis). Statistically significant, but numerically low, increases in erosion and JSN scores from baseline to 6, 12 and 24 months were seen.

Conclusions A treat-to-target strategy with MTX and i.a. betamethasone reduced MRI inflammatory findings significantly, with no additional effect of CYA, but minor structural damage progression was still observed.

References

  1. Hetland ML, et al. 2006. Arthritis Rheum 54:1401-1409.

  2. Hetland ML, et al. 2009. Ann Rheum Dis 68:384-390.

Disclosure of Interest None declared

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