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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 = 117) [corrected]. 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 Patients who relapsed during the extension phase were withdrawn from the study.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.

Safety and tolerability of immune globulin intravenous in chronic inflammatory demyelinating polyradiculoneuropathy. / Donofrio, Pd; Bril, V; Dalakas, Mc; Deng, C; Hanna, K; Hartung, Hp; Hughes, R; Latov, N; Merkies, I; van Doorn, P; Ice, Sg; Apostolski, S; Banach, M; Barroso, F; Bartosik-Psujek, H; Basta, I; Bednarik, J; Belniak, E; Benedetti, L; Buchman, A; Caress, J; Chapman, K; Chyrchel, U; Comi, G; Dacci, P; Del Carro, U; Drory, V; Dubrovsky, A; Ehler, E; Fazio, R; Fryze, W; Fulgenzi, E; Gibson, G; Gonzalez-Cornejo, S; Gonzalez-Jaime Jde, J; Grandis, M; Haas, J; Kaminski, M; Kwiecinski, H; Marchesoni, C; Munch, C; Narciso, E; Nogues, M; Patwa, H; Pardal, Am; Pavlovic, S; Pizzorno, M; Reisin, R; Romero-Vargas, S; Ruiz-Sandoval, Jl; Schenone, A; Selmaj, K; Stelmasiak, Z; Szczudlik, A; Thomas, Fp; Trivedi, J; Tsao, B; Uncini, A; Villa, A; Vohanka, S; Wolfe, G; Zapletalova, O.. - STAMPA. - 67(2010), pp. 1082-1088.

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