Abstract
Objective. To perform a comparative assessment of methotrexate and sulfasalazine efficacy when administered as monotherapy and in combination with low doses of GC in early RA considering disease activity and erosions development in joints of hands and feet. Material and methods. 124 pts with RA fulfilled ACR criteria were included. This group consisted of 29 males and 95 females with mean age 43,2+12,8 years and disease duration less than 2 years (mean 7,7+4,3 months). 79 from them (63,7%) had rheumatoid factor. Pts were randomized to receive methotrexate 10-20 mg/week (63 pts of group 1 — 50,8%) or sulfasalazine 1500-2000 mg/day (61 pts of group 2 — 49,2%). Prednisolone (PS) 10 mg/day was added to the treatment in pts with high activity of the disease. 27 (42,9%) pts of group 1 and 27 (44,3%) pts of group 2 received PS. DAS 28 was calculated at baseline, after 6 and 12 months of treatment. X-ray of hands and feet was performed at baseline and after 12 months. Results. 53 pts of group 1 (84,1%) and 52 pts of group 2 (85,2%) completed the study. In group 1 DAS 28 decreased from 5,25±1,18 to 3,45±1,23 (p<0,001) after6 months and to 3,17+1,13 (p<0,001) after 12 months. In group 2 DAS 28 decreased from 4,82+0,99 to 4,27±1,07 (p<0,001) after 6 months but after 12 months it increased to 4,60±1,37 and did not significantly differ from baseline level (p=0,295). DAS 28 ingroup 1 after 6 (3,45+1,23) and 12 months (3,17± 1,13) was significantly lower than in group 2 (respectively 4,27± 1,07 and 4,60+1,37, p<0,001). DAS 28 in pts receiving methotrexate and PS after6 (3,46±1,39) and 12 months (3,09+1,10) was also significantly lower than in pts receiving sulfasalasine and PS (4,81 + 1,0 and 5,02+: 1,39 respectively, p<0,001). New erosions appeared in 7,4% of pts receiving methotrexate with PS and in 36% of pts receiving sulfasalazine with GC. Conclusion. Methotrexate administered in combination with GC low doses is an optimal method for treatment of early RA providing decrease of activity and delay of joint erosions development.