The British Journal of Rheumatology, Vol 37, 1060-1068, Copyright © 1998 by British Society for Rheumatology
H Menninger, G Herborn, O Sander, J Blechschmidt and R Rau
OBJECTIVE: To compare the safety and efficacy of methotrexate (MTX) and
gold sodium thiomalate (GSTM) in patients with active early erosive
rheumatoid arthritis (RA) during 3 yr. METHODS: A total of 174 patients
from two centres were randomly assigned to receive weekly i.m. injections
of either 15 mg MTX or 50 mg GSTM for 1 yr in a double-blind fashion.
Thereafter, the study was continued as an open prospective trial for an
additional 2 yr with the same dose of MTX and half of the GSTM dose.
Clinical and laboratory evaluations were carried out at baseline and at
months 6, 12, 18, 24 and 36 in all patients, including withdrawals.
RESULTS: An intention-to-treat analysis revealed inactivation ['clinical
remission': no swollen/tender joints, erythrocyte sedimentation rate (ESR)
of < 20 mm/h in males and < 30 mm in females, no corticosteroids
within the last 4 weeks] in 33.3% of MTX patients and 37.9% of GSTM
patients. The mean time to inactivation was insignificantly shorter with
GSTM (MTX: 12.1 months; GSTM: 9.1 months; P = 0.06). At least marked
improvement (> 50% reduction of the number of swollen/tender joints and
of the ESR) was found in 78.2% (MTX) and 87.4% (GSTM). Withdrawal from the
study due to toxicity was recorded in 16.1% of MTX and 52.9% of GSTM
patients after a mean time of 30.6 and 6.1 months, respectively (P =
0.0001). In MTX and GSTM non-completers, inactivation was recorded in 24.2
and 54.7% of all patients. Among completers (54 and 34 patients,
respectively), significant improvement compared to baseline was noted in
all seven clinical variables (morning stiffness, overall joint pain, count
of tender/swollen joints, Lansbury articular score, functional score and
grip strength), ESR and C- reactive protein without significant intergroup
differences. The steroid-sparing effect appeared more pronounced with GSTM.
CONCLUSION: Over 36 months, treatment with MTX or GSTM induces inactivation
('clinical remission') of early and erosive RA in about one-third and at
least marked improvement in four-fifths of patients (intention-to- treat
analysis). Patients withdrawn from MTX or GSTM due to toxicity develop a
clinical remission from the disease; this occurred more often with GSTM.
Tolerability is significantly better with MTX.
ORIGINAL PAPERS
A 36 month comparative trial of methotrexate and gold sodium thiomalate in the treatment of early active and erosive rheumatoid arthritis
Department of Medicine I, Bavarian Red Cross Hospital for Rheumatic Diseases, Bad Abbach, Germany.
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