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FRI0072 Methotrexate in rheumatoid arthritis: a 5 year prospective study
  1. AM Stankovic,
  2. BK Lovic,
  3. JM Nedovic,
  4. AN Dimic,
  5. SK Stojanovic,
  6. BN Stamenkovic,
  7. VR Skakic
  1. Rheumatology, Institute of Rheumatology and Cardiology, Nis, Yugoslavia


Objectives The aim was to evaluate the efficacy and tolerability of low dose of longterm Methotrexate (MTX) treatment of rheumatoid arthritis (RA).

Methods This study examines prospectively the response to oral MTX (5 ? 12,5 mg) over a 5 year period of 70 patients (pts) with active RA. 54 pts were female, mean age 53,61 ± 12,8 years range (27 ? 76) and mean diseases duration 9,76 ± 7,58 years (range 0,6 ? 35). Patients who were receiving Prednizone at entry to the trial, were maintained by the same dose, not exceeding 10 mg/day. Clinical evaluation were performed by the same physician ? investigator every 3 months for the first year of the study and every 6 months thereafter. Every 4 weeks complete blood cound and every 12 weeks thereafter complete erytrocyte sedimentation (ERS), blood count, serum creatinine and liver blood tests were obtained. Patients were assessed at 0 stage (beginning) with 70 pts, after 3 months (mts) (with 62), 6 mts (with 52), 12 mts (with 49), 24 mts (with 36), 36 mts (with 26), 48 mts (with 13), and after 60 mts (with 11) patients.

Results 11 (15,7%) pts completed the 5 year study, 14 (20%) dropped out because of an adverse event or due to inefficacy. After 3, 6, 12, 24, 36 mts of treatment a good clinical response was shown by signiffcant clinical improvement in the joint swelling (p < 0, 001), morning siffness (p < 0, 001), as well as in both physicians and patients assessment of the disease activity (p < 0, 001) compared to pretreatment values. The clinical improvement was also associated with a decrease of ESR after 3, 6, 12 mts (p < 0, 001), after 24 and 36 mts (p < 0, 05). Although a sustained clinical response was noted in the diseases variables during the 5 year study, there was no significant difference noted in the improvement in the joint swelling after 48 and 60 mts, in duration of morning stiffness and in decrease of ESR after 60 mts of treatment.

Conclusion Methotrexate therapy appears to be effective and safe in the treatment of RA in this 5 year prospective study


  1. Weinblatt ME, Maier AL, Fraser PA, Coblyn S. Longterm prospective study of methotrexate in rheumatoid arthritis. Conclusion after 132 months of therapy. J Rheum. 1998;25(2):239–42

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