Post‐polio syndrome patients treated with intravenous immunoglobulin: a double‐blinded randomized controlled pilot study

Abstract

Post-polio syndrome (PPS) is characterized by new muscle weakness, atrophy, fatigue and pain developing several years after the acute polio. Some studies suggest an ongoing inflammation in the spinal cord in these patients. From this perspective, intravenous immunoglobulin (IvIg) could be a therapeutic option. We performed a double-blinded randomized controlled pilot study with 20 patients to investigate the possible clinical effects of IvIg in PPS. Twenty patients were randomized to either IvIg 2 g/kg body weight or placebo. Primary endpoints were changes in pain, fatigue and muscle strength 3 months after treatment. Surrogate endpoints were changes in cerebrospinal fluid (CSF) cytokine levels. Secondary endpoints were pain, fatigue and isometric muscle strength after 6 months. Patients receiving IvIg reported a significant improvement in pain during the first 3 months, but no change was noted for subjective fatigue and muscle strength. CSF levels of tumour necrosis factor-alpha (TNF-alpha) were increased compared with patients with non-inflammatory neurological disorders. In conclusion, in this small pilot study no effect was seen with IvIg treatment on muscle strength and fatigue, however IvIg treated PPS patients reported significantly less pain 3 months after treatment. TNF-alpha was increased in the CSF from PPS patients. The results are promising, but not conclusive because of the low number of patients studied.

Evidence-based guideline: Intravenous immunoglobulin in the treatment of neuromuscular disorders [RETIRED]

“…Two Class I studies evaluated IVIg efficacy in patients with postpolio syndrome. 29,30 The first study, a double-blind RCT, evaluated 142 patients with postpolio syndrome, most with severe weakness (Class IV or V based on the National Rehabilitation Postpolio Limb Classification). 29 The 2 primary outcome measures were improved strength of a muscle believed to be significantly affected by postpolio (25%-75% of normal for age and sex) and improved quality of life as measured by the Short Form-36.…”

“…30 There were 3 concurrent primary outcome measures: muscle strength as measured by fixed dynamometer on selected muscles, Fatigue Severity Scale, and pain as measured by visual analog scale and pain drawing instrument change at 3 months. The study showed that patients receiving IVIg had significantly improved pain levels at 3 months as compared with baseline; however, there were no effects on muscle strength or fatigue.…”

Intravenous Immunoglobulins in Neurological Diseases: Established and Novel Clinical Applications

“…Electrophysiologic studies show marked, but not restricted, involvement of the sensory fibres (Dalmau & Rosenfeld, 2008 In the study with highest power, a significant increase of mean muscle strength of 8.3% was reported after two IVIg treatment cycles during 3 months. Physical activity and subjective vitality also differed significantly in favour of the IVIG group (Farbu et al, 2007). Post-polio syndrome is a chronic condition.…”

Intravenøs IgG-behandling av nevromuskulære sykdommer

“…I tillegg ses ofte økende atrofi, økt trettbarhet og smerter. En av to randomiserte studier viste effekt av intravenøs IgGbehandling (totalt 2 g/kg) på muskelstyrke, fysisk aktivitet og subjektiv opplevelse av bedring (30), mens den andre studien viste bedring av smerter og livskvalitet, men ikke av pareser (31). Det er ikke utført langtidsstudier.…”