The international immune tolerance study: a multicenter prospective randomized trial in progress

DiMichele, Donna; Hay, Colin W.

doi:10.1111/j.1538-7836.2006.02127.x

Cited by 63 publications

(73 citation statements)

References 8 publications

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“…However, the International Immune Tolerance Induction (I-ITI) study [32], aimed at evaluating the success rate and time to success in 150 patients with good prognostic profile (historical peak titer C5 and B200 BU; starting titer \10 BU) randomized to receive FVIII doses of 50 IU/kg three times weekly or 200 IU/kg daily, was interrupted prematurely because of safety concerns. A significantly greater cumulative number of bleeding episodes in joint and non-joint sites was indeed observed in the low-dose arm versus the high-dose arm, at all stages of ITI, but particularly in the first ITI phase, when inhibitors were still detectable [33].…”

Section: Immune Tolerance Registriesmentioning

confidence: 99%

Immune tolerance induction for patients with severe hemophilia A: a critical literature review

Franchini

Lippi²

2011

J Thromb Thrombolysis

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The development of inhibitors that neutralize the function of clotting factor VIII (FVIII) is currently the most challenging complication associated with the treatment of hemophilia A as it increases the disease-related morbidity and mortality. Immune tolerance induction (ITI) is the only documented strategy to eradicate persistent inhibitors in severe hemophilia A patients. Several studies have been conducted so far to identify patient- and treatment-related factors associated with greater ITI success. The currently available literature on ITI in hemophilia A will be critically reviewed in this article. In particular, we will focus on the role of the type of FVIII product on ITI outcome by analyzing the clinical and experimental data.

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Section: Immune Tolerance Registriesmentioning

confidence: 99%

Immune tolerance induction for patients with severe hemophilia A: a critical literature review

Franchini

Lippi²

2011

J Thromb Thrombolysis

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“…20 27 The study closed enrollment in 2010 because more bleeding was noticed in the low-dose ITI arm and because of concerns over the accrual needed to reach the statistical end points.…”

Section: Factor VIII Dosing and Regimenmentioning

confidence: 99%

Current Controversies in the Formation and Treatment of Alloantibodies to Factor VIII in Congenital Hemophilia A

Kruse‐Jarres

2011

Hematology

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A is a rare bleeding disorder treated with numerous factor VIII (FVIII)-containing replacement concentrates. This treatment approach has led to the formation of alloantibodies that neutralize the FVIII activity (inhibitors) conveyed by these commercially available concentrates in ϳ 25% of patients with severe hemophilia A (FVIII activity Ͻ 1% of normal). This phenomenon significantly complicates the treatment of these patients and compromises the effectiveness and efficiency of these products to reverse or prevent bleeding complications. Studying the population with alloantibody inhibitors is imperative but difficult due to the overall small number of individuals affected and the heterogeneity within this limited group. Furthermore, few randomized clinical trials have been conducted to answer pertinent questions so many controversies persist. This article focuses on the conflicting data on the variables associated with alloantibody FVIII inhibitor development with a particular emphasis on age and intensity of first treatment, the role of primary prophylaxis regimens in modulating this phenomenon, and the degree of purity of FVIII product as a potential contributing risk factor. The optimal dosing regimen and type of FVIII replacement product that should be used to achieve the highest success rate in immune tolerance induction (ITI) protocols are also discussed, as well as whether the addition of immunomodulatory agents, especially rituximab, to ITI regimens enhances the durability of ITI and the eradication of alloantibody FVIII inhibitors.

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“…Retrospective cohort studies have shown that similarly high success rates (60-80%) could be obtained with alternative approaches to ITI [11]. The optimal ITI regimen and the predictors of ITI outcome are still debated [10], because evidence from large-scale and methodologically rigorous trials is lacking and the ongoing randomized studies [12,13] are far from complete. Most available data come from three retrospective ITI registries: the International Immune Tolerance Registry (IITR) [14], the North American Immune Tolerance Registry (NAITR) [15], and the German Immune Tolerance Registry [16].…”

Section: Introductionmentioning

confidence: 99%

Factor VIII gene (F8) mutations as predictors of outcome in immune tolerance induction of hemophilia A patients with high‐responding inhibitors

Coppola

Margaglione

Santagostino

et al. 2009

Journal of Thrombosis and Haemostasis

104

152

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The international immune tolerance study: a multicenter prospective randomized trial in progress

Cited by 63 publications

References 8 publications

Immune tolerance induction for patients with severe hemophilia A: a critical literature review

Immune tolerance induction for patients with severe hemophilia A: a critical literature review

Current Controversies in the Formation and Treatment of Alloantibodies to Factor VIII in Congenital Hemophilia A

Factor VIII gene (F8) mutations as predictors of outcome in immune tolerance induction of hemophilia A patients with high‐responding inhibitors

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