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 Patients who relapsed during the extension phase were withdrawn from the study.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 - chromatography purified and placebo, respectively. Exposure to immune globulin intravenous, 10% caprylate - chromatography purified was approximately twice that of placebo (1096 vs 575 infusions). Most maintenance dose courses were administered over 1 day in the immune globulin intravenous, 10% caprylate - chromatography purified (89.1% of 783 dose courses) and placebo (91.1% of 359 dose courses) groups. The most common drug-related adverse events (AEs) with immune globulin intravenous, 10% caprylate - chromatography purified were headache (4.0 per 100 infusions) and pyrexia (2.4 per 100 infusions). Five drug-related serious AEs (pulmonary embolism, pyrexia, vomiting, and 2 headache events) were reported in 3 patients (2.7%) exposed to immune globulin intravenous, 10% caprylate - chromatography purified. The incidence of drug-related serious AEs was higher after loading dose infusions than after maintenance dose infusions (4 AEs vs 1 AE). Age, weight, CIDP severity, and previous immune globulin intravenous exposure had no substantial effect on the percentage of patients with AEs, including serious AEs. Conclusion: Data support a favorable safety and tolerability profile for administration of immune globulin intravenous, 10% caprylate - chromatography purified as CIDP maintenance therapy. Trial Registration: clinicaltrials.gov Identifier NCT00220740.

Additional Metadata
Persistent URL dx.doi.org/10.1001/archneurol.2010.223, hdl.handle.net/1765/33002
Citation
Donofrio, P., Bril, V., Dalakas, M.C., Deng, C., Hanna, K., Hartung, H.P., … van Doorn, P.A.. (2010). Safety and tolerability of immune globulin intravenous in chronic inflammatory demyelinating polyradiculoneuropathy. Archives of Neurology, 67(9), 1082–1088. doi:10.1001/archneurol.2010.223