Table 11.
Plasmapheresis versus placebo
| Study/N/Age/Location | Intervention and treatment duration | Summary of efficacy results |
|---|---|---|
| Schmitt et al (1990)33 N=17 Age: NR Germany |
Intervention IVMP vs IVMP and PMP vs IVMP and IA (IVMP in each arm followed by OPT); all n= NR Treatment duration IVMP: 1 week OPT: 4 weeks PMP: 1 week IA: 1 week Assessments Prior to study entry as well as 2 weeks, 3 months, and 1 year after baseline |
EDSS scoresa IVMP (followed by OPT) and PMP: Baseline: 5 2 weeks: 4.2 3 months: 3.8 1 year: 4.5 IVMP (followed by OPT): Baseline: 4.9 2 weeks: 4.4 3 months: 5 1 year: 6.2 IVMP (followed by OPT) and IA: Baseline: 5.4 2 weeks: 3.8 2 months: 3.3 1 year: 5.3 |
| Cooperative Study of PMP (1989, 1990)43,44 N=116 Mean (SD) age at treatment, years: RRMS PMP: 32.7 (SD, 6.1) RRMS placebo: 32.1 (SD, 7.5) US |
Intervention PMP with RCI plus oral CFX within 24 hrs of PMP (n=5,959) vs placebob with RCI plus oral CFX within 24 hrs of placebo (n=5,757) Treatment duration PMP: 5 times in first 14 days, then weekly for 6 weeks ACTH: twice daily for 11 days, then once daily for 3 days CFX: Daily for 12 weeks Assessments Prior to treatment and 2 weeks as well as 1, 2, 3, 6, 18, and 24 months after treatment onset |
Improvement in DSS scores vs pre-attack: PMP (with RCI/CFX): 2 weeks: 1.00 1 month: 0.50 2 months: 0.37 3 months: 0.03 6 months: 0.03 Placebo (with RCI/CFX): 2 weeks: 1.80 1 month: 1.60 2 months: 0.97 3 months: 0.79 6 months: 0.44 Patients who improved in DSS scores, %c: PMP (with RCI/CFX): 2 weeks: ~50% 1 month: ~64% 2 months: ~68% 3 months: ~70% 6 months: ~70% 12 months: ~64% 18 months: ~48% 24 months: ~38% Placebo (with RCI/CFX): 2 weeks: ~35% 1 month: ~47% 2 months: ~59% 3 months: ~59% 6 months: ~65% 12 months: ~55% 18 months: ~40% 24 months: ~38% |
Notes: PMP: 60 mL/kg body weight of patient plasma was exchanged for 3.5% albumin in normal saline containing 6.9 mEq Ca2+/L, 2 mEq mg2+/L, and 4 mEq K+/L. aPatients in one arm presenting successive relapse were treated with the other arm protocol. bControl subjects received an identical regimen of a timed placebo procedure during which their plasma was continuously separated, recombined with their blood cells, and returned to them. cEstimated from figure; actual values not reported.
Abbreviations: CFX, cyclophosphamide; DSS, Disability Status Scale; PMP, plasmapheresis; RCI, repository corticotropin injection; RCT, randomized controlled trial; RRMS, relapse-remitting multiple sclerosis; SD, standard deviation; US, United States.