Confirmative study of the effectiveness of thymopentin in active rheumatoid arthritis.

Forty-one patients with active rheumatoid arthritis entered a controlled double-blind randomized study. Of these patients, 21 received prolonged intravenous injections (10 min) of thymopentin 50 mg three times a week for 3 consecutive weeks, whereas 20 received placebo. Both groups were comparable with regard to clinical parameters. No immunological tests were performed. Analysis of the results after 3 weeks showed that the improvement in the thymopentin group was statistically significant (p less than 0.05 or p less than 0.01) for all clinical parameters, except for the left-hand grip strength. On the other hand, no significant improvement was observed for any parameter, except morning stiffness, in the patients on placebo. The intergroup comparison showed statistically significant differences, favoring thymopentin over placebo treatment, in the Ritchie index, the scores of swollen joints, the assessment of severity of pain, and the scores for changes in the activity of the disease. The present placebo-controlled double blind study thus confirms the positive results generated in a similar open study, i.e., the beneficial therapeutic effect of prolonged intravenous injections of thymopentin in patients with severe rheumatoid arthritis. The drug appears to be safe at the dose regimen used.