Serial immune evaluation of cyclosporine- and placebo-treated multiple sclerosis patients

During an ongoing clinical trial of cyclosporine (CsA) immunosuppression therapy for chronic progressive multiple sclerosis (MS), a comparison was made of the immune responses of 18 CsA‐ and 18 placebo (P)‐treated MS patients. Patients randomized to receive either CsA or P had identical entry immune profiles. However, these MS patients displayed significantly increased T‐helper:T‐suppressor (TH:TS) ratios (P less than 0.01), percentage (%) active‐T (P less than 0.01), % Ia+‐T (P less than 0.05) and % Ta1+‐T (P less than 0.01) cell phenotypes when compared to age‐matched normal controls. Further, the MS‐P‐treated patients displayed significant increases (all P less than 0.01) in % pan‐T, % helper‐T, % active‐T and % Ta1+‐T cell phenotypes as well as panel mixed lymphocyte culture (panel MLC) functional responsiveness from entry to cumulative 12‐month study data. In contrast, the MS‐CsA‐treated patients only displayed an increased % pan‐T cell phenotype. The cumulative 12‐month follow‐up data showed that the MS‐P‐treated patients displayed significantly higher immune parameters than the MS‐CsA‐treated patients for % pan‐T (P less than 0.05), % helper‐T (P less than 0.01), TH:TS ratio (P less than 0.05), % active‐T (P less than 0.01), % Ta1+‐T cells (P less than 0.01) and panel MLC stimulation index (P less than 0.01). Thus, MS‐CsA‐treated patients did not display the progressive immune activation seen on serial evaluation during the follow‐up time period that characterized the placebo‐treated MS group.