Objective. To evaluate the efficacy of long-term treatment with cyclos
porin A (CSA) in systemic lupus erythematosus (SLE). Methods. Thirty p
atients with SLE whose condition was either poorly responsive or unres
ponsive to treatment with steroids and/or cytotoxic drugs were enrolle
d in a prospective, nonrandomized study of CSA, Patients with hyperten
sion or hypercreatinemia were excluded, Disease activity was evaluated
according to the systemic lupus activity measure, Assessments were ma
de prior to study entry and after 6, 12, 18, and 24 months. Results. T
wenty-seven patients completed at least 24 months of treatment with CS
A, The mean disease activity score significantly decreased after 6 mon
ths of therapy (P < 0.01); this result was maintained throughout the s
tudy, A conspicuous steroid-sparing effect was observed following admi
nistration of CSA (P < 0.01). Side effects included hypertrichosis (63
% of patients), paresthesias (23%), gastrointestinal symptoms (20%), g
ingival hyperplasia (17%), hypertension (10%), tremors (7%), and nephr
otoxicity (13%), No significant changes in serum creatinine Levels wer
e observed. Conclusion. CSA represents a helpful second-choice treatme
nt for patients with active SLE, Administration of CSA necessitates ex
pert and careful followup of patients.