[Data of two years of the comparative study methotrexate/aurothiomalate in 102 patients].

UNLABELLED: 102 patients (pat.) with active erosive rheumatoid arthritis (RA) with a median disease duration of only 14 months without malalignment or deformities entered a randomized study to compare the effects of 15 mg methotrexate (MTX) and 50 mg gold sodium thiomalate (GST) administered intramuscularly once a week. The study was double blind during the first year and open during the second year. Clinical and laboratory evaluations were made every three months. X-rays of hands, wrists and forefeet in standard a.p.-projection were taken at month 0, 6, 12 and 24. 32 joints were evaluated according to Larsen. 17/52 (MTX) and 21/50 (GST) patients were withdrawn for several reasons. Withdrawals for toxicity were significantly more frequent in the GST group. 35 patients in the MTX group and 26 patients in the GST group were evaluated for efficacy. All clinical parameters, ESR and CRP improved by more than 50% in both groups without significant intergroup difference. The greatest improvement was seen already after six months. An > 50% improvement occurred in 57% of pat. in both groups. The Larsen score (sum of the Larsen grades of 32 joints) deteriorated significantly in both groups during the first six months (MTX = 3.0, GST = +4.3), it remained stable thereafter in the MTX group and decreased in the gold group. The number of erosive joints increased significantly in both groups during the first six months. This increase was slowed down after six months in the MTX group, in the gold group a decrease was seen indicating a healing of erosions. All differences between the groups were not significant, however.
CONCLUSION: While tolerability was better with MTX, both drugs were similarly effective in the treatment of RA and slowed down radiologic progression.

RCT Entities:   Population Interventions Outcomes