Double‐blind, randomized controlled trial of therapeutic plasma exchanges vs sham exchanges in moderate‐to‐severe relapses of multiple sclerosis
- 5 May 2020
- journal article
- research article
- Published by Wiley in Journal of Clinical Apheresis
- Vol. 35 (4), 281-289
- https://doi.org/10.1002/jca.21788
Abstract
Introduction No randomized controlled clinical trial of therapeutic plasma exchanges (TPE) has yet been performed for moderate‐to‐severe relapses of multiple sclerosis (MS). Objective To compare TPE to sham‐TPE in patients with a recent steroid‐resistant moderate‐to‐severe MS relapse. Methods Patients presenting with an MS relapse of less than 2 months without improvement and 15 days after a course of steroids were randomized. Specific criteria were used for each relapse type to define moderate‐to‐severe disability. The primary endpoint was the proportion of patients with at least a moderate improvement based on objective and functional evaluation after 1 month. Results Thirty‐eight patients were randomized. The intention‐to‐treat analysis included 14 patients in the TPE group and 17 in the Sham‐TPE group. The proportion of patients with at least moderate improvement at 1 month did not differ between the groups (P = .72), although 57.1% of the TPE group had full recovery compared with 17.6% of the sham group. Considering optic neuritis (ON), a significant difference in the proportion of different levels of improvement was observed in favor of the TPE group (P = .04). The combined Kurtzke's functional systems scores were significantly more improved in the TPE group than in the sham‐TPE group at months 1 (P < .01), 3 (P < .05), and 6 (P < .05). No major side effects were observed. Conclusions A significant difference between TPE and Sham‐TPE at the primary endpoint was only observed in patients with ON. Neurological function improved significantly more often in the TPE group than in the sham‐TPE group.Keywords
Funding Information
- Biogen
- Teva Pharmaceutical Industries
- Biogen
- Novartis
- Biogen
- Biogen Idec
- Terumo
- Chung Hua University
This publication has 27 references indexed in Scilit:
- Multiple sclerosis: clinical aspectsCurrent Opinion in Neurology, 2018
- Multiple Sclerosis PathologyCold Spring Harbor Perspectives in Medicine, 2018
- Multiple SclerosisThe New England Journal of Medicine, 2018
- Oral versus intravenous high-dose methylprednisolone for treatment of relapses in patients with multiple sclerosis (COPOUSEP): a randomised, controlled, double-blind, non-inferiority trialThe Lancet, 2015
- Effect of relapses on development of residual deficit in multiple sclerosisNeurology, 2003
- Long-term follow up of patients with clinically isolated syndromes, relapsing-remitting and secondary progressive multiple sclerosisMultiple Sclerosis Journal, 2003
- Early clinical predictors and progression of irreversible disability in multiple sclerosis: an amnesic processBrain, 2003
- A prospective study on the natural history of multiple sclerosis: clues to the conduct and interpretation of clinical trialsJournal of the Neurological Sciences, 1999
- Axonal pathology in multiple sclerosis: relationship to neurologic disabilityCurrent Opinion in Neurology, 1999
- Prognostic factors in a multiple sclerosis incidence cohort with twenty-five years of follow-upBrain, 1993