Double‐blind study of true vs. sham plasma exchange in patients treated with immunosuppression for acute attacks of multiple sclerosis

Abstract

We enrolled 116 patients in a multicenter, randomized, double-blind controlled trial of an 8-week course of 11 plasma exchange (PE) treatments in exacerbations of MS. The control group received sham PE, and both groups received identical treatment with IM ACTH and oral cyclophosphamide. Serum IgG decreased in the PE and sham treatment groups by 76% versus 22% by treatment 5, and by 64% versus 14% by treatment 11. PE also produced significant reductions in IgA, IgM, C3, and fibrinogen. PE patients had moderately enhanced improvement at 2 weeks relative to the sham group. PE patients with relapsing/remitting disease had significantly enhanced improvement at 4 weeks and there was also an increased improvement at 12 months, although this latter effect disappeared when we analyzed relapsing/remitting patients as a separate subgroup. Life table analysis showed the median time to recover preattack disability status was shorter in PE- than in sham-treated relapsing/remitting patients (4 vs. 13 weeks), a result confirmed by raw disability status scores in which there was recovery to their average preattack disability score by 3 months. PE given with ACTH plus cyclophosphamide enhances recovery from an exacerbation of disease in relapsing/remitting patients, although we observed no clear long-term benefits.

Treatment of Acute Relapses in Multiple Sclerosis

“…Several alternatives, including plasmapheresis [48][49][50][51], cyclophosphamide [48,52,53], intravenous immunoglobulin G (IV-IG) [54][55][56][57][58], and natalizumab [59] have been studied with plasmapheresis as the only option supported by strong clinical evidence. The recent American Academy of Neurology guideline published in January 2011 [60] recommends considering using plasma exchange as a secondary treatment for severe flares in remitting-relapsing MS.…”

The current therapy of multiple sclerosis

“…Benefits were observed, but they were minimal and did not justify the cost (18). A more recent trial involving intravenous gammaglobulin (500 mg/kg body weight) in conjunction with intravenous methylprednisolone in chronic progressive MS was not shown to have any stabilizing effect on the course of the disease (19).…”

Clinical Efficacy of Plasma-Exchange in Patients with Progressive forms of Multiple Sclerosis and NMO-Spectrum Disease

“…A subsequent double blind study including 116 patients, compared the clinical efficacy of PLEX (11 courses in a period of 11 weeks) with that of sham treatment for acute attacks of MS, in combination with cyclophosphamide and ACTH [5]. A moderately enhanced improvement (not statistically significant) was observed in the PLEXgroup after 2 weeks.…”