A double-blind, randomized trial of IV immunoglobulin treatment in acute optic neuritis

Roed, Hanne; Langkilde, Annika Reynberg; Sellebjerg, Finn; Lauritzen, M.; Bang, Peter Fibiger; Mørup, Anne Mette; Frederiksen, Jette Lautrup

doi:10.1212/01.wnl.0000152873.82631.b3

Cited by 125 publications

(52 citation statements)

References 31 publications

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“…One study in clinically isolated syndrome (CIS) patients showed significant postponement of conversion to definite MS [9]. One study in acute optic neuritis, with both arms receiving IFB, did not show an IVIG effect [17]. The remaining single cross-over study in stable motor deficit received placebo for 5 days, followed by 6 weeks observation, then IVIG for 5 days and 6 weeks observation.…”

mentioning

confidence: 99%

IVIG trials in MS. Is albumin a placebo?

Hommes¹,

Haas

Soelberg-Sorenson

et al. 2009

J Neurol

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mentioning

confidence: 99%

IVIG trials in MS. Is albumin a placebo?

Hommes¹,

Haas

Soelberg-Sorenson

et al. 2009

J Neurol

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“…In a phase III clinical trial, 68 patients with acute ON were randomised to IVIG liquid SSI or placebo [50]. There was no difference in the primary outcome (contrast sensitivity) after 6 months.…”

Section: Resultsmentioning

confidence: 99%

“…There was no significant difference in the total number of adverse events or in the number or frequency of specified adverse events between treatment groups. The adverse events were mainly mild, however, 1 patient experienced aseptic meningitis [50]. No serocoversions were reported.…”

Section: Resultsmentioning

confidence: 99%

Development, Manufacturing and Characterization of a Highly Purified, Liquid Immunoglobulin G Preparation from Human Plasma

Laursen

Blou

Sullivan

et al. 2014

Transfus Med Hemother

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Background: The use of plasma-derived immunoglobulin G (IgG) is increasing, and the number of diseases, including immunodeficiencies, neurological diseases and autoimmune conditions, treated with intravenous IgG (IVIG) is expanding. Consequently, there is a great need for high-yield production processes for plasma-derived IgG. The aim of this work was to develop a high-yield process leading to a highly purified, liquid, ready-to-use IgG for intravenous use. Methods: Plasma from healthy, voluntary, non-remunerated donors was fractionated by ethanol precipitation. IgG was extracted from fraction II + III using a phosphate/acetate buffer, pH 4, and purified by chromatography. Results: Precipitation with 6% polyethylene glycol at pH 7 removed high molecular-weight contaminating proteins, aggregates and contaminating viruses. Ion exchange chromatography at pH 5.7 on serially connected anion and cation exchange columns allowed for elution of IgG from the cation exchange column in good yield and high purity. Further safety was achieved by solvent/detergent treatment and repeated ion exchange chromatography. The product consisted of essentially only IgG monomers and dimers, and had a high purity with very low levels of IgM and IgA. Conclusion: A process providing highly purified IVIG in good yield was developed.

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“…In a third study [34], 64 patients with acute optic neuritis were randomized within 4 weeks from onset of symptom to treatment with IVIG 0.4 g/kg or placebo on day 0, 1, 2, 30 and 60. Contrast sensitivity, visual acuity, and color vision were measured at baseline, after 1 week, 1 month, and 6 months.…”

Section: Intravenous Immunoglobulin In Acute Relapsesmentioning

confidence: 99%

Intravenous immunoglobulins as therapeutic option in the treatment of multiple sclerosis

Dudešek

Zettl

2006

J Neurol

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Treatment of neurological disorders with intravenous immunoglobulin (IVIG) is an increasing feature of practice for an expanding range of indications. This article reviews the current literature regarding the role of IVIG treatment in multiple sclerosis (MS) and summarizes recommendations for the use of IVIG in different courses and clinical subsets of the disease. Principally based on the results of four randomized, double-blind, placebo-controlled trials (RCTs) and a corresponding meta-analysis, the amount of evidence for the efficacy of IVIG treatment is currently most convincing for the relapsing-remitting course of MS (RRMS); nevertheless, it lags clearly behind that for beta interferon due to smaller study sizes, partial deficits in study design and not established optimal dosage. This prompted the basis for a consensus statement in some countries to recommend IVIG as second-line treatment in RRMS, when other licensed therapies (i. e., beta interferon, glatiramer acetate) are individually not tolerated due to side effects or concomitant disease. Recent evidence indicates that IVIG is also effective in clinically isolated syndrome (CIS) and should be considered as a therapeutic option, particularly when licensed immunotherapy can not be offered. During an acute relapse additional IVIG administration to established steroid treatment showed no benefit. Despite promising experimental data on promotion of remyelination, fixed chronic deficits were not reversed or improved by long-term IVIG treatment either. Currently there is no indication for IVIG treatment in the chronic progressive disease stages, since a large and well-designed RCT failed to show any beneficial effect in patients with secondary progressive MS (SPMS) and data derived from primary progressive MS (PPMS) are still pending. However, preliminary results of a so far unpublished RCT including patients with PPMS and SPMS suggest a strong trend towards a beneficial effect in PPMS. So far, IVIG is the only therapy investigated for reducing postpartum relapses, whereas immunomodulatory drugs are contraindicated during pregnancy and lactation period. Data evaluating the peripartal use of IVIG along with the positive results of the trials in RRMS justify postpartal IVIG treatment particularly for mothers, who choose to breastfeed, under consideration of the recommendations specified for the relapsing-remitting disease course. As recently shown IVIG administration right from the early weeks of pregnancy appears to be a promising strategy, but cannot be recommended from the viewpoint of evidence-based medicine.

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A double-blind, randomized trial of IV immunoglobulin treatment in acute optic neuritis

Abstract: There was no effect of IV immunoglobulin (IVIG) on long-term visual function following acute optic neuritis, nor was there an effect of IVIG treatment in reducing latency on visual evoked potentials and thus preserving function of axons of the optic nerve.

Cited by 125 publications

References 31 publications

IVIG trials in MS. Is albumin a placebo?

IVIG trials in MS. Is albumin a placebo?

Development, Manufacturing and Characterization of a Highly Purified, Liquid Immunoglobulin G Preparation from Human Plasma

Intravenous immunoglobulins as therapeutic option in the treatment of multiple sclerosis

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