The British Journal of Rheumatology, Vol 36, 345-352, Copyright © 1997 by British Society for Rheumatology
R Rau, G Herborn, H Menninger and J Blechschmidt
The objective was to compare the safety and efficacy of methotrexate (MTX)
and gold sodium thiomalate (GSTM) in patients with early erosive rheumatoid
arthritis (RA). A total of 174 patients with active early erosive RA
without deformities were enrolled in a 12 month, two-centre double-blind
randomized trial. They received a weekly i.m. dose of 15 mg MTX (n = 87) or
50 mg GSTM (n = 87), respectively. Clinical and laboratory evaluations were
carried out every 3 months in all patients, including the withdrawals. Ten
patients (11.5%) in the MTX group and 21 patients (24.1%) in the GSTM group
achieved a clinical remission of the disease [no swollen joints,
erythrocyte sedimentation rate (ESR) < 20 mm, no steroids] within the
study period (P < 0.05). An at least marked improvement (> 50%
reduction of the number of swollen and tender joints and the ESR) was
assessed in 59/87 (68%) and 66/87 (76%) patients treated with MTX or GSTM,
respectively (P > 0.05). Significantly more patients in the GSTM group
were withdrawn due to toxicity (six MTX/32 GSTM). A total of 126 patients
(73 on MTX and 53 on GSTM) completed 12 months on their original
medication. In the completers, a significant improvement of > 50%
compared to baseline was noted in all six clinical variables [morning
stiffness, joint count of swollen and tender joints, Lansbury index, grip
strength and activities of daily living (ADL) score], the ESR and the
C-reactive protein, without intergroup differences. The number of patients
taking prednisone was reduced from 21 to 7% in the MTX group and from 15 to
4% in the GSTM group. While significantly more patients achieved a clinical
remission with GSTM treatment, tolerability was significantly better with
MTX.
ORIGINAL PAPERS
Comparison of intramuscular methotrexate and gold sodium thiomalate in the treatment of early erosive rheumatoid arthritis: 12 month data of a double-blind parallel study of 174 patients
Department of Rheumatology, Evangelisehes Fachkrankenhaus, Ratingen, Germany.
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