A comparison of cyclosporine, sulfasalazine, and symptomatic therapy in the treatment of psoriatic arthritis

Objective. To compare the efficacy and tolerability of cyclosporine (CSA) w ith that of symptomatic therapy (ST) alone and sulfasalazine (SSZ) in the t reatment of psoriatic arthritis (PsA). Methods. Twelve rheumatology centers recruited 99 patients with active PsA in a 24 week, prospective, randomized, open, controlled study. The patients were treated with CSA (3 mg/kg/day) or SSZ (2000 mg/day) plus ST, or ST al one (nonsteroidal antiinflammatory drugs, analgesics, and/or prednisone les s than or equal to 5 mg/day). The primary endpoint was the 6 month change i n pain. Analyses were on the basis of the intention-to-treat principle. Results. In comparison with both SSZ and ST, there was a statistically sign ificant difference in favor of CSA in terms of the mean changes in the pain score (p < 0.05), which was considered the primary response variable. A si gnificant decrease in favor of CSA versus ST alone was also observed for sw ollen joint count (p = 0.05), tender joint count (p = 0.01), joint/pain ten derness score (p = 0.002), patient and physician global assessment by at le ast one point (p = 0.04 and 0.01, respectively), total Arthritis Impact Mea surement Scale score (p = 0.002), and spondylitis functional index (p = 0.0 02). There was a statistically significant difference in the ACR 50% and AC R 70% response rates between the CSA and ST groups (p = 0.02, 0.05). Compar ing the SSZ and ST alone groups, only the spondylitis functional index decr eased significantly in the SSZ treated patients (p = 0.03). The Psoriasis A rea and Severity Index was significantly lower in the CSA than in the ST an d SSZ groups (p = 0.0001 and 0.01, respectively). Decrease in erythrocyte s edimentation rate was significant only in the SSZ versus the ST group (p = 0.02), whereas reduction in C-reactive protein was significant in the CSA t reated patients compared with the ST group (p = 0.006). The most common adv erse event in the CSA group was mild, reversible kidney dysfunction. Conclusion. The results of this open trial confirm that CSA is well tolerat ed by patients with PsA and suggest that it is more efficacious than ST or SSZ.