A 6-month trial assessing the safety and efficacy of cyclosporine treatment in patients with active rheumatoid arthritis
Journal Title: Reumatologia - Year 2005, Vol 43, Issue 5
Abstract
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
Authors and Affiliations
Jerzy Świerkot, Katarzyna Gruszecka-Marczyńska, Jacek Szechiński
Keywords
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