OBJECTIVES:: To determine the clinical efficacy (DAS-28) of spironolactone when added to continuing regimen of Disease-Modifying anitrheumatic durgs (DMARDs) therapy in 28 naive rheumatoid arthritis (RA) patients, who failed to respond adequately on monotherapy or combination of conventional disease modifying agents.

METHODS:: A distinct study on 28 patients of 24 weeks was designed to gain additional data concerning the use of spironolactone (2 mg/kg/day) in RA patients. Modified Disease Activity score (DAS-28) Score at zero week, 12 weeks and 24 weeks were calculated statistically. Differences in parameters before and after spironolactone treatment were examined by 2-tailed paired student t-test. Results were considered significant at 95% level (p≤0.05) and presented as mean ± SEM.

RESULTS:: The modified disease activity score (DAS-28) at the baseline (0 week) 10.7% (n=3) and 89.3% (n=25) of patient had DAS-28 score 3.2- 5.1 (Moderate disease activity) and DAS-28 score 5.1 (severe disease activity), respectively. None had low disease activity (DAS-28 score <3.2). 26 patients completed the study. After 12 weeks treatment, 10.7% (n=3) of patients had mild disease activity, 53.8% (n=15) moderate disease activity & 35.7% (n=15) of patients had severe disease activity. After 24 weeks of treatment, 30.7% (n=8) of patients had mild disease activity, 50% (n=13) of patients with moderate disease activity and only 19.3% (n=5) of patients had severe disease activity. The 70% of patients initially with severe disease activity were fallen into mild or moderate disease activity categories. Overall, a composite DAS-28 score improved significantly from 6.3 ± 0.12% to 4.0 ±0.16 after 24 weeks (p< 0.01vs baseline) treatment with spironolactone.

CONCLUSIONS:: The study suggests that when spironolactone added with DMARDs to the patients who respond incompletely to DMARDs alone or in combination therapy, provides valuable improvements both clinically and biologically in RA patients.