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

R Priori

C Alessandri

F R Spinelli

Dipartimento di Terapia Medica, Cattedra di Reumatologia, UniversitaÁ degli Studi di Roma `La Sapienza' Roma, Italy

E Medda

Istituto Superiore di SanitaÁ, Laboratorio di Epidemiologia e Biostatistica, Roma, Italy

G Valesini

Dipartimento di Terapia Medica, Cattedra di Reumatologia, Universita Á degli Studi di Roma `La Sapienza', Policlinico Umberto I, 00161 Rome, Italy valesini{at}uniroma1.it

Several case reports and uncontrolled trials have established the use of cyclosporine 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 profile 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 average of 26 months. Adverse events not leading to the discontinuation of therapy were observed in 62.5% of the patients, the most frequent being hypertrichosis. CsA was stopped because of the occurrence of side effects in 9=56 (16%) of the patients. The most common were nephrotoxicity (3=9) and the occurrence 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 significant slightly increased risk of stopping CsA therapy for any adverse events (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 confirmed the good tolerability of CsA in these subjects.

Key Words: cyclosporine A • systemic lupus erythematosus • safety profile • adverse events

Lupus, Vol. 9, No. 9, 676-680 (2000)
DOI: 10.1191/096120300676096627


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