Safety and Tolerability of Immune Globulin Intravenous in Chronic Inflammatory Demyelinating Polyradiculoneuropathy

Abstract

Background: Chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) is a common inflammatory neuropathy that can be progressive, stepwise progressive, or relapsing and remitting.Objectives: To further evaluate the long-term safety and tolerability of immune globulin intravenous, 10% caprylate-chromatography purified immune globulin intravenous in CIDP.Design: Randomized multicenter trial.Setting: Hospitals and outpatient clinics.Patients: Adults with CIDP (n = 113).Interventions: Immune globulin intravenous, 10% caprylate-chromatography purified (2 g/kg of body weight) or placebo was infused as a baseline loading dose, followed by a maintenance dose (1 g/kg) every 3 weeks for up to 24 weeks. Patients who responded were rerandomized into a double-blind extension phase of immune globulin intravenous, 10% caprylate-chromatography purified (1 g/kg) or placebo every 3 weeks for up to 24 weeks. Patients who relapsed during the extension phase were withdrawn from the study. Main Outcome Measures: Additional analyses of safety and tolerability. Results: Overall, 113 patients and 95 patients were exposed to immune globulin intravenous, 10% caprylate-Author Affiliations are listed at the end of this article. Group Information: The IGIV-C CIDP Efficacy (ICE) Study Group Members are listed on page 1087.

Thromboembolic complications of intravenous immunoglobulin therapy in patients with neuropathy: A two-year study

“…No analysis into potential determinants of TEC was reported in either. A similar very low TEC rate was reported from a recent therapeutic study of IVIg for CIDP [3]. The precise reasons for the difference in our rate of TEC in comparison with those of these other analyses are uncertain but may lie in the populations treated, which in our case could have consisted of a greater proportion of high-risk patients.…”

“…Of note, we found no correlation between the occurrence of TEC and the dose of IVIg infused. The significance of this result is however uncertain as there is some indication from existing literature that TEC due to IVIg may be at least in part, dose-related [3,11]. Furthermore and in keeping with this hypothesis, in our study, administration of IVIg doses ≥35 g/day correlated with occurrence of TEC.…”

“…Side-effects of IVIg therapy are described as rare and usually of mild severity and gravity [2,3]. However, thromboembolic complications (TEC) of IVIg therapy are well-documented [4].…”

Intravenous high-dose immunotherapy: practical recommendations for use in the treatment of neurological disimmune diseases

“…Раз-личий между лиофилизатом и раствором для инфузий, а также между препаратами разной концентрации и различных производителей, не выявлено [8][9][10][11][12]. Тем не менее имеются некоторые преимущества 10 % растворов по сравнению с 5 %, что позволяет делать выбор в их пользу.…”

Advances in the treatment of chronic inflammatory demyelinating neuropathies in 2010

“…Donofrio and colleagues [16] reviewed the long-term safety and tolerability of IVIg during the ICE study. Most loading dose courses (2 g/kg weight) and most maintenance dose courses (1 g/kg weight) were administered over 2 days and 1 day, respectively.…”