Safety profile and causes of withdrawal due to adverse events in systemic lupus erythematosus patients treated long-term with cyclosporine A

Several case reports and uncontrolled trials have established the use of cy closporine A (CsA) in systemic lupus erythematosus (SLE) but some concerns have been raised because of its kidney damaging effects. We here report the results of a retrospective follow-up study designed to assess the safety p rofile and causes of discontinuation due to adverse events in SLE patients treated with CsA. We treated 56 SLE patients with oral CsA at doses of 3-5 mg/kg for an avera ge of 26 months. Adverse events not leading to the discontinuation of thera py were observed in 62.5% of the patients, the most frequent being hypertri chosis. CsA was slopped because of the occurrence of side effects in 9/56 ( 16%) of the patients. The most common were nephrotoxicity (3/9) and the occ urrence of tremors (3/9). These effects were always reversible within three months of CsA withdrawal. The patients who were older than 40 y had a sign ificant slightly increased risk of stopping CsA therapy for any adverse eve nts (RR 1.08; CI 95% 1.03-1.14). In comparison with previous studies, this study involved a larger cohort of SLE patients who were evaluated for a longer period of follow-up, and conf irmed the good tolerability of CsA in these subjects.