Long-term safety and efficacy of low-dose cyclosporin A in severe psoriatic arthritis

Abstract.

Objective. The aim of this study was to evaluate the efficacy and tolerability of long-term treatment with cyclosporin A (CsA) in patients with psoriatic arthritis (PsA). Methods. Sixty patients with PsA were enrolled in a prospective, nonrandomised study of CsA. Patients with hypertension or hypercreatinemia were excluded. Disease activity was evaluated according to clinical activity measures and the Psoriasis Area Severity Index (PASI). Assessments were made at baseline and after 3, 6, 12, 18, and 24 months. Measurements. The primary endpoints were 20% and 50% improvement in disease activity according to American College of Rheumatology (ACR) responses at 6, 12, 18, and 24 months. Other endpoints were 70% ACR responses at 6, 12, 18, and 24 months and other measures of disease activity at 3, 6, 12, 18, and 24 months. Results. Forty-nine patients completed the 24-month of treatment with CsA. When all the clinical variables throughout the study were compared with baseline results, they all showed significant improvement after 6 months of treatment. Erythrocyte sedimentation rates (ESR) reached a significant improvement after 12 months of treatment (P<0.05). The PASI scores decreased from 15.1±4.3 to 5.2±2.7 after 24 months of treatment (P<0.001). Side effects included hypertrichosis (24% of patients), gum hyperplasia (12%), gastrointestinal intolerance (9%), hypertension (21%), neurological disturbance (7%), and nephrotoxicity (17%). Three patients withdrew due to treatment failure. One patient was lost to follow-up, and seven patients withdrew due to side effects. Conclusions. Cyclosporin A represents a helpful second-choice treatment for patients with active psoriatic arthritis. Administration of CsA necessitates expert and careful follow-up of patients.