ORIGINAL PAPER
A 6-month trial assessing the safety and efficacy of cyclosporine treatment in patients with active rheumatoid arthritis

Objective: The objective of this study was to determine efficacy and safety of the new generic cyclosporin formulation, Equoral capsules administered in monoterapia or in combination with other disease-modifying anti-rheumatic drugs in patients with active rheumatoid arthritis (RA).
Methods: Thirty patients receiving CsA for RA were prospectively studied over a mean treatment period of 6 months. Initially CsA was given orally 2.5 mg/kg/day. In the course of the observation the dose ranged between 2.5 and 4 mg/kg/day. Clinical evaluation for RA disease activity tender and swollen joint, VASP, patient’s and physician’s global assessments, morning stiffness duration, HAQ, ESR, CRP and treatment side effects was performed prior and to each visit. We studied also the pharmacokinetics of Equoral
The occurence of adverse reactions was noted.
Results: 18 patients (60%) completed 6 months study. Treatment terminations were due to adverse events in 6 cases, inefficacy in 4 patients, poor compliance in 2 patients. In 18 patients who completed 6 months of therapy, a significant improvement was noted compared to baseline in 6 out of 9 clinical disease variables and acute phase reactants. In terms of efficacy at 6 months of follow-up 12 of patients had a ACR 20%, 7 a 50% ACR, 3 a 70% ACR response. The DAS28 index dropped significantly from 4.8±0.9 at baseline visit to 3.3±1.5 (p<0.001) and overall, 13 patients were EULAR responder. In the course of the follow-up period there was a significant decrease in the mean daily dosage of NSAIDs and corticosteroid. Altogether a total of 48 adverse events were reported in 24 patients. Adverse events occured frequently (80%), but only 20% of the patients discontinued CsA permamently.
Conclusion: RA patients treated for six months with CsA showed statistically significant clinical improvement and decrease of inflammation parameters.
In the group of patients treated with CsA side effects were observed often, but rarely caused cessation of therapy.