Long-term use of IgA-depleted intravenous immunoglobulin in immunodeficient subjects with anti-IgA antibodies

Cunningham‐Rundles, Charlotte; Zhou, Zhuo; Mankarious, Samia; Courter, S

doi:10.1007/bf00919386

Cited by 87 publications

(57 citation statements)

References 20 publications

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“…84 Anti-IgA antibodies are usually of the IgG1 subclass and are more common in IgA-de¢cient subjects who are also IgG2 de¢cient. 80,85 Anti-IgA antibodies may be of the IgE isotype leading to true anaphylactic reactions but the actual incidence of such antibodies is unknown. Anti-IgA antibodies are also possibly associated with certain HLA types in IgA-de¢cient healthy individuals.…”

Section: Anti-immunoglobulin a Antibodiesmentioning

confidence: 99%

The clinical significance of immunoglobulin A deficiency

2007

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Section: Anti-immunoglobulin a Antibodiesmentioning

confidence: 99%

The clinical significance of immunoglobulin A deficiency

2007

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“…6,38,39 Silk et al 40 reported that in children with IgG2 subclass and specific antibody deficiency who failed to improve after a 12-month period of prophylactic antibiotic therapy with trimethoprim-sulfamethoxazole, IVIG therapy significantly decreased the number of episodes of recurrent sinopulmonary infections. Similarly, Bernatowska-Matuszkiewicz et al 39 demonstrated the clinical efficacy of IVIG in pediatric patients with severe pulmonary inflammatory disease and IgG3 subclass deficiency by decreasing the duration of hospitalization and use of antibiotics and steroids.…”

Section: Discussionmentioning

confidence: 99%

“…Patients who have recurrent infections and are poorly responsive to medical management are candidates for IV immunoglobulin (IVIG) replacement therapy. [5][6][7] Patients with IgA and/or IgG subclass deficiency have frequent infections with pneumococci and Haemophilus influenzae. It is important to measure specific antibodies against these microorganisms before and after vaccination with the polysaccharide or conjugate vaccines now commercially available.…”

Section: Introductionmentioning

confidence: 99%

Prospective, randomized comparison of OM-85 BV and a prophylactic antibiotic in children with recurrent infections and immunoglobulin A and/or G subclass deficiency

Genel

Kütükçüler

2003

Current Therapeutic Research

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Background: Patients with immunoglobulin (Ig)A and/or IgG subclass deficiency may be asymptomatic or may have recurrent, mainly respiratory infections.Objective: This study compared the clinical efficacy and tolerability of prophylactic therapy with either the oral immunomodulator bacterial extract OM-85 BV or benzathine penicillin G (BPG) in the prevention of recurrent infections in symptomatic patients.Methods: In this 26-month, prospective, randomized study conducted at the Department of Pediatric Immunology, Ege University (Izmir, Turkey), children aged 1 to 12 years with recurrent infections and IgA and/or IgG subclass deficiency were enrolled. After an initial 12-month control period, patients were randomized to receive OM-85 BV or BPG. OM-85 BV (3.5-mg capsule) was given once daily for the first 10 days of each month for the first 3 months of the study. IM injections of BPG were given at a dose of 1.2 million units (for patients with body weight Ͼ27 kg) or at a half-dose (for patients with body weight Յ27 kg) every 3 weeks for 12 months. In nonresponders (ie, those who continued to have recurrent infections at 12-month follow-up), IV immunoglobulin (IVIG) replacement therapy at 400 mg/kg body weight was given every 4 weeks for an additional 12 months. The results of IVIG therapy were assessed by the authors using clinical observation. Adverse effects and adverse drug reactions were documented by the authors for each vaccine, prophylactic therapy, and IVIG.Results 52] months; P ϭ 0.036) and had lower serum IgG (P Ͻ 0.001), IgG1 (P ϭ 0.006), IgG2 (P ϭ 0.003), IgG3 (P ϭ 0.035), and IgM (P ϭ 0.008) levels and antibody responses to tetanus toxoid and Haemophilus influenzae type b (Hib) vaccines (P ϭ 0.036 and 0.013, respectively). At 12-month follow-up, a protective effect of the prophylactic IVIG therapy was seen, with a statistically significant reduction in the number of infections to 3.3 (2.4) and in the number of antibiotic courses to 2.7 (2.5) (both P ϭ 0.005). Conclusions:In this study population of children with recurrent infections and IgA and/or IgG subclass deficiency, prophylactic therapy with either OM-85 BV or an antibiotic significantly decreased the number of infections per year. In addition, nonresponders benefited from IVIG replacement therapy. (Curr Ther Res Clin Exp. 2003;64:600-615)

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“…The characteristics of the various products may result in differences in efficacy and safety, which may have a significant impact on the choice of product for some patients. High IgG purity and low immunoglobulin A (IgA) content are particularly important for patients with anti-IgA antibodies, who are at risk of developing an anaphylactic reaction to IgA, especially upon intravenous administration [3]. Other patient safety considerations include the origin of the immunoglobulin and donor selection, viral inactivation and removal steps in the production process, aggregate content of the formulation and tolerability to excipients.…”

Section: Introductionmentioning

confidence: 99%

A 10% ready-to-use intravenous human immunoglobulin offers potential economic advantages over a lyophilized product in the treatment of primary immunodeficiency

Kallenberg

2007

Clinical and Experimental Immunology

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SummaryIntravenous immunoglobulin (IVIg) replacement therapy is the standard of care for patients with primary humoral immunodeficiencies. This study evaluated differences in infusion time between a 10% IVIg ready-to-use solution and a 6% IVIg lyophilized product and addressed potential cost implications. After receiving in-hospital treatment with 6% IVIg lyophilized solution for at least 6 months, 14 patients with humoral immunodeficiency without anti-IgA antibodies received five successive infusions with 10% IVIg ready-to-use solution. Data on infusion times were collected during the last two infusions of each IVIg product when maximum infusion rates had been reached. The median infusion time was reduced from 104·4 min with the 6% IVIg lyophilized solution to 51·0 min with the 10% IVIg ready-to-use solution (51% reduction), with corresponding median maximum infusion rates of 4·1 ml/kg/h and 5·9 ml/kg/h, respectively. Median gammaglobulin (IgG) trough levels were 7·1 g/l for the 6% IVIg lyophilized solution and 7·9 g/l for the 10% IVIg ready-to-use solution. Fewer adverse events were observed after infusing with 10% IVIg ready-to-use solution compared with 6% IVIg lyophilized preparation. We conclude that the 10% IVIg ready-to-use solution was well tolerated by most patients and reduced the median infusion time by 51% compared with a 6% lyophilized preparation of IVIg. The reduced bed occupancy and nursing time associated with a reduced infusion time, together with the elimination of a reconstitution step, were estimated to provide a cost-saving of €59·42 per patient per infusion. Thus, this product has the potential to reduce overall costs of IVIg treatment. Reduced infusion time is also likely to improve patients' quality of life.

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Long-term use of IgA-depleted intravenous immunoglobulin in immunodeficient subjects with anti-IgA antibodies

Cited by 87 publications

References 20 publications

The clinical significance of immunoglobulin A deficiency

The clinical significance of immunoglobulin A deficiency

Prospective, randomized comparison of OM-85 BV and a prophylactic antibiotic in children with recurrent infections and immunoglobulin A and/or G subclass deficiency

A 10% ready-to-use intravenous human immunoglobulin offers potential economic advantages over a lyophilized product in the treatment of primary immunodeficiency

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