Double‐blind , randomized controlled trial of therapeutic plasma exchanges vs sham exchanges in moderate‐to‐severe relapses of multiple sclerosis
J Clin Apher. 2020-05-05; 35(4): 281-289
DOI: 10.1002/jca.21788
Lire sur PubMed
Author information:
(1)CHU de Bordeaux, Service de Neurologie, Bordeaux, France.
(2)Universite de Bordeaux, Bordeaux, France.
(3)USMR, Pole de Sante Publique, CHU de Bordeaux, Bordeaux, France.
(4)Etablissement Français du Sang, Site de l’Hôpital Pellegrin, Bordeaux, France.
(5)Service de Neurologie, CHU de Strasbourg, Strasbourg, France.
(6)Univ.Lille, Inserm U1172, CHU Lille, FHU Imminent, Lille, France.
(7)Service de Neurologie, CHU de Nancy, Nancy, France.
(8)Service de Neurologie, CHU de Nantes, Nantes, France.
(9)Service de Neurologie, CHU de Clermont-Ferrand, Clermont-Ferrand, France.
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