Efficacy and Safety of Plasma Exchange with Albumin Replacement as a Therapy for Amyotrophic Lateral Sclerosis

Abstract

Background: Neuroinflammation is being increasingly recognized as a key factor in the pathogenesis of amyotrophic lateral sclerosis (ALS). A therapeutic approach for ALS using plasma exchange with albumin replacement (PE-A) has been proposed to remove antibody complexes, inflammatory mediators, and toxins to decrease neuronal damage caused by inflammation. Methods: In this pilot study, 15 patients underwent 24 weeks of PE-A with 5% albumin and their revised ALS Functional Rating Scale (ALSFRS-R) scores and Forced Vital Capacity (FVC) were tracked for 48 weeks to evaluate the efficacy of PE-A as a therapy for ALS. Results: There was a statistically significant decline of ALSFRS-R scores as well as FVC (%) throughout the study. A post hoc comparison with clinically matched control patients showed no statistically significant difference. Likewise, no significant differences were found when the rate of ALSFRS-R decline in the PE-A-treated patients was compared to the European Medicines Agency (EMA) guideline estimate of a −1 point/month decrease in untreated patients. However, 50% of the PE-A-treated patients showed a slow rate of decline of