Safety of Intravenous Immunoglobulin in the Treatment of Juvenile Dermatomyositis: Adverse Reactions Are Associated With Immunoglobulin A Content

Manlhiot, Cedric; Tyrrell, Pascal N.; Liang, Lisa; Atkinson, Adelle; Lau, Wendy; Feldman, Brian M.

doi:10.1542/peds.2007-1218

Cited by 51 publications

(25 citation statements)

References 17 publications

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“…The safety of IVIG was confirmed in 38 JDM patients receiving 1,056 infusions, with the most common complaints being fever, malaise, nausea, and vomiting [12]. A distinct advantage of IVIG therapy is the ability to use it as addon therapy or in combination, even in the setting of infection.…”

Section: Intravenous Immunoglobulinmentioning

confidence: 92%

Therapeutic Approaches in Myositis

Aggarwal

Oddis

2011

Curr Rheumatol Rep

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The inflammatory myopathies are a heterogeneous group of diseases including dermatomyositis, polymyositis, and inclusion body myositis. Few clinical trials have been conducted in myositis, making it difficult to provide clear recommendations on the treatment of these rare disorders. Although corticosteroids have not been tested in randomized controlled trials, the general expert consensus confirms their first-line use. However, in many patients, corticosteroid toxicity leads to significant disability, or these agents are ineffective, which then requires additional immunosuppression. Intravenous immunoglobulin is a reasonable short-term treatment with proven benefit in a controlled trial, but its long-term effectiveness remains unknown. The evidence for other immunosuppressive therapies has been derived mainly from case reports and open studies. These agents include methotrexate and/or azathioprine, followed by cyclosporine or tacrolimus (particularly for antisynthetase antibody-positive patients) and mycophenolate mofetil (for refractory rash). Newer therapies (eg, rituximab) are encouraging, but results from the largest randomized controlled trial studying this agent are soon to follow. The balance of evidence suggests that immunosuppressive drugs are effective in dermatomyositis and polymyositis, although randomized controlled trials are lacking.

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Section: Intravenous Immunoglobulinmentioning

confidence: 92%

Therapeutic Approaches in Myositis

Aggarwal

Oddis

2011

Curr Rheumatol Rep

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“…39 A retrospective review of pediatric patients treated with different IGIV products found that significantly fewer adverse events were associated with IGIV products containing lower levels of IgA. 40 Hyperosmolar IGIV solutions may be associated with hemodynamic changes and an increased risk for infusion-related adverse events, especially thromboembolic stroke. 11,17,41 One study found a 0.6% rate of stroke among patients receiving IGIV at their medical center.…”

Section: Similarities and Differences In Igiv Productsmentioning

confidence: 99%

The New Generation of Liquid Intravenous Immunoglobulin Formulations in Patient Care: A Comparison of Intravenous Immunoglobulins

Stein

2010

Postgraduate Medicine

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Intravenous immunoglobulin (IGIV) replacement therapy is the standard of care for primary immunodeficiencies with impaired humoral immunity. It is also the immunomodulatory therapy of choice for some types of neuroimmunologic and autoimmune hematologic disorders and for immunomodulation in bone marrow and some solid organ transplants. Currently available IGIV products include older lyophilized formulations, 5% liquid products, and newer, liquid, ready-to-use, 10% formulations. Differences in the formulations, manufacturing processes, excipients, pH, and other physicochemical properties of IGIV products may affect their clinical efficacy and tolerability. Among at-risk patients, the possibility of serious complications such as renal insufficiency, heart failure, thrombotic events, and immunological reactions may be increased if an IGIV formulation has sugar as a stabilizer, has high sodium or immunoglobulin A (IgA) content, or is hyperosmolar. The 10% liquid formulations may offer advantages because of their lower IgA concentrations, optimal pH, glycine or proline stabilizers, low sodium content, and lower osmolality. Liquid formulations are more convenient for patients and health care providers due to shorter infusion times and easier preparation and administration.

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“…Manlhiot et al [26] compared the incidence of adverse events with juvenile dermatomyositis. Among the 38 patients at a median age of 10 years, Gammagard S/D was associated with the lowest frequency of adverse events compared with 3 other products.…”

Section: Specific Ivig Productsmentioning

confidence: 99%

“…The most common reactions included fever, headache, nausea/vomiting, and lethargy. No life-threatening reactions occurred [26]. …”

Section: Specific Ivig Productsmentioning

confidence: 99%

“…The 2008 observational study by Manlhiot et al [26] compared 4 different IVIG products (Iveegam, Gammagard S/D, Gamimune 5%, and Gamimune 10%) in juvenile dermatomyositis patients, assessing differences in tolerance. In the 38 patients with a median age of 10 years, Gammagard S/D was associated with the lowest frequency of adverse events likely due to having the lowest IgA concentration.…”

Section: Specific Ivig Productsmentioning

confidence: 99%

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Immunoglobulin Replacement Therapy: A Twenty-Year Review and Current Update

Saeedian

Randhawa

2014

Int Arch Allergy Immunol

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Objective: The expansion of immunoglobulin replacement to multiple disease entities marks a decade-long advancement in immune therapy. Parallel to its extension, the characteristics and composition of immunoglobulin products have diversified. The aim of this study was to summarize a 20-year comprehensive literature review of currently commercially available immunoglobulin products, particularly examining individual product properties in a comparative format. Data Sources/Study Selections: The literature review was performed using PubMed and Ovid, screening a time span of 2 decades. Both authors reviewed the obtained articles for acceptable quality, and the selection was narrowed down based on criteria for randomized clinical and therapeutic trials. Results: Product-specific characteristics in terms of purification strategy, stabilizers, composition, and viral inactivation were found among the immunoglobulin products investigated. Such differing characteristics manifest in their variable clinical safety and efficacy as assessed by the comparative product analysis. In subgroups of patients, subcutaneous immunoglobulin therapy may be an alternative to intravenous immunoglobulin (IVIG) therapy with an equal efficacy and a lower number of systemic adverse events. Conclusion: Only few comprehensive clinical synopses are available to clearly demonstrate the differences in IVIG products despite the widespread clinical use of the therapy. This review defines significant characteristics of individual immunoglobulin products, noting important differences in product development and application and allowing informed clinical decisions to match a product with patients' risk factors and comorbidity. This balanced approach to gammaglobulin replacement therapy is imperative to produce the highest clinical efficacy and lowest number of adverse events.

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Safety of Intravenous Immunoglobulin in the Treatment of Juvenile Dermatomyositis: Adverse Reactions Are Associated With Immunoglobulin A Content

Cited by 51 publications

References 17 publications

Therapeutic Approaches in Myositis

Therapeutic Approaches in Myositis

The New Generation of Liquid Intravenous Immunoglobulin Formulations in Patient Care: A Comparison of Intravenous Immunoglobulins

Immunoglobulin Replacement Therapy: A Twenty-Year Review and Current Update

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