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Double-blind, randomized controlled trial of therapeutic plasma exchanges vs sham exchanges in moderate-to-severe
Bruno Brochet1,2, Mathilde Deloire1, Christine Germain3
1CHU de Bordeaux, Service de Neurologie, Bordeaux, 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 < .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.
Insights
Therapeutic plasma exchange (TPE) showed no significant difference compared to sham-TPE for overall moderate-to-severe multiple sclerosis (MS) relapses. However, TPE improved neurological function and optic neuritis recovery significantly.
Area of Science:
- Neurology
- Immunology
- Clinical Trials
Background:
- No prior randomized controlled trials (RCTs) evaluated therapeutic plasma exchange (TPE) for moderate-to-severe multiple sclerosis (MS) relapses.
- Steroid-resistant MS relapses require effective treatment options.
Purpose of the Study:
- To compare the efficacy of TPE versus sham-TPE in patients experiencing recent, steroid-resistant, moderate-to-severe MS relapses.
- To assess recovery and functional improvement following TPE treatment.
Main Methods:
- A randomized controlled trial comparing TPE to sham-TPE was conducted.
- Patients with recent MS relapses ( < 2 months) resistant to steroids were enrolled.
- The primary endpoint was moderate improvement in objective and functional evaluations at 1 month.
Main Results:
- The overall proportion of patients achieving moderate improvement at 1 month did not differ significantly between TPE and sham-TPE groups.
- However, the TPE group showed significantly greater improvement in Kurtzke's functional systems scores at 1, 3, and 6 months.
- A significant benefit of TPE was observed in patients with optic neuritis (ON) relapses.
Conclusions:
- TPE demonstrated a significant benefit for patients with optic neuritis (ON) MS relapses.
- Overall neurological function improved more significantly in the TPE group compared to the sham-TPE group, despite not meeting the primary endpoint.
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