MODIFIED TOTAL LYMPHOID IRRADIATION AND LOW-DOSE CORTICOSTEROIDS IN PROGRESSIVE MULTIPLE-SCLEROSIS

In a double-blind prospective randomized trial, we assessed the effica cy and safety of modified total lymphoid irradiation (TLI) plus low do se prednisone (TLI-LDP) as compared to sham TLI plus identical prednis one therapy (sham TLI-LDP) in 46 patients with progressive forms of mu ltiple sclerosis (MS). No significant difference existed between group s at study entry in patient age, sex, duration of MS, or disability st atus. However, following treatment, significantly fewer TLI patients s howed a sustained one point decline in the Expanded Disability Status Scale, the primary study endpoint, as compared to the sham TLI group u sing the Kaplan-Meier Product-limit survival analysis, (P<0.005). Risk for relapse requiring treatment with intravenous methylprednisolone w as reduced by 54% in the TLI-treated group (P<0.05). Significantly few er TLI-LDP patients had gadolinium enhancing plus new T2-weighted lesi ons (P=0.018) when compared to the sham group post-treatment. There wa s also a substantial and significant decrease in blood lymphocytes in the TLI-LDP group when compared to either pretreatment values or to sh am TLI-LDP through at least 12 months post-therapy. Side effects secon dary to TLI were generally mild and well-tolerated. These results furt her support the hypothesis that TLI and systemic immunosuppression hav e a beneficial effect in progressive forms of MS. (C) 1997 Elsevier Sc ience B.V.