Guidelines on the Use of Intravenous Immune Globulin for Neurologic Conditions

Feasby, Tom; Banwell, Brenda; Benstead, Timothy; Bril, Vera; Brouwers, Melissa; Freedman, Mark S.; Hahn, Angelika F.; Hume, Heather; Freedman, J.; Pi, David; Wadsworth, Louis D.

doi:10.1016/j.tmrv.2007.01.002

Cited by 116 publications

(111 citation statements)

References 109 publications

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“…IVIg | sialylation | antibody | inflammation | autoimmune disease I ntravenous immunoglobulin (IVIg) is a therapeutic blood product prepared from the pooled plasma of 3,000-60,000 healthy donors per batch (1)(2)(3). It is a complex heterogeneous mixture of IgG subclasses and low amounts of IgA, IgM, and other plasma proteins (4).…”

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confidence: 99%

“…IVIg has been used for more than 30 years for the treatment of a variety of acute and chronic autoimmune and systemic inflammatory diseases (2)(3)(4)(5). Although efficacious in these diseases, the precise mechanism of action of IVIg is not well-understood.…”

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confidence: 99%

“…Although beneficial in numerous indications, IVIg preparations have distinct limitations, such as variable efficacy, clinical risks, high costs, and finite supply (2,3,8). Different IVIg preparations are frequently treated as interchangeable products clinically, but it is well-known that significant differences in product preparations exist that may impact tolerability and activity in selected clinical applications (9).…”

mentioning

confidence: 99%

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Controlled tetra-Fc sialylation of IVIg results in a drug candidate with consistent enhanced anti-inflammatory activity

Washburn

Schwab

Ortiz

et al. 2015

Proc. Natl. Acad. Sci. U.S.A.

198

161

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Despite the beneficial therapeutic effects of intravenous immunoglobulin (IVIg) in inflammatory diseases, consistent therapeutic efficacy and potency remain major limitations for patients and physicians using IVIg. These limitations have stimulated a desire to generate therapeutic alternatives that could leverage the broad mechanisms of action of IVIg while improving therapeutic consistency and potency. The identification of the important anti-inflammatory role of fragment crystallizable domain (Fc) sialylation has presented an opportunity to develop more potent Ig therapies. However, translating this concept to potent anti-inflammatory therapeutics has been hampered by the difficulty of generating suitable sialylated products for clinical use. Therefore, we set out to develop the first, to our knowledge, robust and scalable process for generating a well-qualified sialylated IVIg drug candidate with maximum Fc sialylation devoid of unwanted alterations to the IVIg mixture. Here, we describe a controlled enzymatic, scalable process to produce a tetra-Fc-sialylated (s4-IVIg) IVIg drug candidate and its qualification across a wide panel of analytic assays, including physicochemical, pharmacokinetic, biodistribution, and in vivo animal models of inflammation. Our in vivo characterization of this drug candidate revealed consistent, enhanced anti-inflammatory activity up to 10-fold higher than IVIg across different animal models. To our knowledge, this candidate represents the first s4-IVIg suitable for clinical use; it is also a valuable therapeutic alternative with more consistent and potent anti-inflammatory activity.IVIg | sialylation | antibody | inflammation | autoimmune disease

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confidence: 99%

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confidence: 99%

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confidence: 99%

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Controlled tetra-Fc sialylation of IVIg results in a drug candidate with consistent enhanced anti-inflammatory activity

Washburn

Schwab

Ortiz

et al. 2015

Proc. Natl. Acad. Sci. U.S.A.

198

161

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“…123 IVIG can have serious adverse effects, and 3-15% of recipients experience a systemic reaction to infusion. 121 This expensive therapy should be limited to treating conditions with sufficient evidence of efficacy to support its use.…”

Section: Biologically Based Practicesmentioning

confidence: 99%

Complementary and Alternative Medicine in Autism: An Evidence-Based Approach to Negotiating Safe and Efficacious Interventions with Families

2010

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Summary: This review focuses on helping clinicians identify resources and develop strategies they may use to effectively negotiate safe and effective use of complementary and alternative medicine (CAM) treatments with families of children with autism spectrum disorders (ASD), as well as other neurodevelopmental disorders. Since new types of CAM continue to be introduced into the autism community, emphasis is placed on providing clinicians with tools to help families negotiate the myriad of available treatments and make decisions based on current safety and efficacy data, while remaining mindful of the reasons families may be considering these treatments.We familiarize readers with high-quality, evidence-based resources that providers and families may use to ascertain current information about specific types of CAM, verify the content of biologically-based treatments, identify ongoing CAM research and obtain toolkits designed to help healthcare providers raise the topic of CAM usage and facilitate disclosure and discussion of CAM use with patients and their families. Key Words: Complementary and alternative medicine, autism, integrative medicine, gluten-free casein-free diet, melatonin, chelation, hyperbaric oxygen treatment, evidence-based medicine.

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“…Given the presumed contribution of the immune system to the pathogenesis of RE, a number of immunomodulatory therapies, including plasmapheresis, IVIG, and corticosteroids have been used to treat the disorder; plasmapheresis or IVIG are usually recommended [275,276]. These treatments appear to reduce the frequency of seizures, but are seldom curative.…”

Section: Rasmussen's Encephalitismentioning

confidence: 99%

Immune Mediated Diseases and Immune Modulation in the Neurocritical Care Unit

Geldern¹,

McPharlin

Becker

2012

Neurotherapeutics

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This chapter will review the spectrum of immunemediated diseases that affect the nervous system and may result in an admission to the neurological intensive care unit. Immunomodulatory strategies to treat acute exacerbations of neurological diseases caused by aberrant immune responses are discussed, but strategies for long-term immunosuppression are not presented. The recommendations for therapeutic intervention are based on a synthesis of the literature, and include recommendations by the Cochrane Collaborative, the American Academy of Neurology, and other key organizations. References from recent publications are provided for the disorders and therapies in which randomized clinical trials and large evidenced-based reviews do not exist. The chapter concludes with a brief review of the mechanisms of action, dosing, and side effects of commonly used immunosuppressive strategies in the neurocritical care unit.

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Guidelines on the Use of Intravenous Immune Globulin for Neurologic Conditions

Cited by 116 publications

References 109 publications

Controlled tetra-Fc sialylation of IVIg results in a drug candidate with consistent enhanced anti-inflammatory activity

Controlled tetra-Fc sialylation of IVIg results in a drug candidate with consistent enhanced anti-inflammatory activity

Complementary and Alternative Medicine in Autism: An Evidence-Based Approach to Negotiating Safe and Efficacious Interventions with Families

Immune Mediated Diseases and Immune Modulation in the Neurocritical Care Unit

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