Escalating therapy in steroid-refractory relapses of multiple sclerosis - comparison of methylprednisolone to immunoadsorption "EMMA"

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Neurological disability in multiple sclerosis results to a large extent from accumulating residual deficits after acute relapses. Current standard treatment for a relapse is a short course of high-dose intravenous methylprednisolone (IVMP), with repetition at even higher doses if necessary. In case of insufficient response, extracorporeal procedures (plasmapheresis, PE, or immunoadsorption, IA) are applied. Both employ different therapeutic mechanisms and seem to be most effective if used early in the course of the relapse. However, current practice delays their use. Advantages of IA over PE are a selective removal of autoantibodies/immune complexes, avoiding transfusions with their associated complications, and its common performance via peripheral venous cannula. In this multi-centre randomised, evaluator-blinded, 2-armed, parallel-group trial, the superiority of IA over a 2nd IVMP course is evaluated. The primary endpoint - neurological disability by EDSS at day 45 after the beginning of randomised treatment (BoT) (or before any rescue treatment) - will be analysed by ANCOVA. A sample of 140 patients will ensure a power >80% to show superiority of IA, regarding a group difference of greater-than-or-equal 0.5 EDSS points as clinically relevant and accommodating heterogeneity as reported or even somewhat larger. Secondary endpoints are evolution of EDSS, MSFC, pFS, visual acuity (in optic neuritis) until day 45 and 180, various QoL & fatigue measures at EoS, acceptance of treatment, and response rates. Clinical safety is monitored by (serious) adverse events and further clinically relevant safety findings, analysed by exact Fisher-Test resp. (repeated-measures) ANCOVA.