PMID- 20837852 OWN - NLM STAT- MEDLINE DCOM- 20101001 LR - 20140730 IS - 1538-3687 (Electronic) IS - 0003-9942 (Linking) VI - 67 IP - 9 DP - 2010 Sep TI - Safety and tolerability of immune globulin intravenous in chronic inflammatory demyelinating polyradiculoneuropathy. PG - 1082-8 LID - 10.1001/archneurol.2010.223 [doi] AB - 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 PATIENTS who relapsed during the extension phase were withdrawn from the study.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. FAU - Donofrio, Peter D AU - Donofrio PD AD - Department ofNeurology, Vanderbilt University, Nashville, TN 37232, USA. FAU - Bril, Vera AU - Bril V FAU - Dalakas, Marinos C AU - Dalakas MC FAU - Deng, Chunqin AU - Deng C FAU - Hanna, Kim AU - Hanna K FAU - Hartung, Hans-Peter AU - Hartung HP FAU - Hughes, Richard AU - Hughes R FAU - Latov, Norman AU - Latov N FAU - Merkies, Ingemar AU - Merkies I FAU - van Doorn, Pieter AU - van Doorn P CN - IGIV-C CIDP Efficacy (ICE) Study Group LA - eng SI - ClinicalTrials.gov/NCT00220740 PT - Clinical Trial, Phase III PT - Journal Article PT - Multicenter Study PT - Randomized Controlled Trial PL - United States TA - Arch Neurol JT - Archives of neurology JID - 0372436 RN - 0 (Immunoglobulins, Intravenous) SB - IM EIN - Arch Neurol. 2010 Dec; 67(12):1515 MH - Adult MH - Double-Blind Method MH - Humans MH - Immunoglobulins, Intravenous/*adverse effects/therapeutic use MH - Polyradiculoneuropathy, Chronic Inflammatory Demyelinating/*therapy MH - Treatment Outcome FIR - Apostolski, Slobodan IR - Apostolski S FIR - Banach, Marta IR - Banach M FIR - Barroso, Fabio IR - Barroso F FIR - Bartosik-Psujek, Halina IR - Bartosik-Psujek H FIR - Basta, Ivana IR - Basta I FIR - Bednarik, Josef IR - Bednarik J FIR - Belniak, Ewa IR - Belniak E FIR - Benedetti, Luana IR - Benedetti L FIR - Buchman, Aron IR - Buchman A FIR - Caress, James IR - Caress J FIR - Chapman, Kristine IR - Chapman K FIR - Chyrchel, Urszula IR - Chyrchel U FIR - Comi, Giancarlo IR - Comi G FIR - Dacci, Patrizia IR - Dacci P FIR - Del Carro, Ubaldo IR - Del Carro U FIR - Drory, Vivian IR - Drory V FIR - Dubrovsky, Alberto IR - Dubrovsky A FIR - Ehler, Eduard IR - Ehler E FIR - Fazio, Raffaella IR - Fazio R FIR - Fryze, Waldemar IR - Fryze W FIR - Fulgenzi, Ernesto IR - Fulgenzi E FIR - Gibson, Gillian IR - Gibson G FIR - Gonzalez-Cornejo, Salvador IR - Gonzalez-Cornejo S FIR - Gonzalez-Jaime, Jose de Jesus IR - Gonzalez-Jaime Jde J FIR - Grandis, Marina IR - Grandis M FIR - Haas, Judith IR - Haas J FIR - Kaminski, Marek IR - Kaminski M FIR - Kwiecinski, Hubert IR - Kwiecinski H FIR - Marchesoni, Cintia IR - Marchesoni C FIR - Munch, Christoph IR - Munch C FIR - Narciso, Eleonora IR - Narciso E FIR - Nogues, Martin IR - Nogues M FIR - Patwa, Huned IR - Patwa H FIR - Pardal, Ana Maria IR - Pardal AM FIR - Pavlovic, Sanja IR - Pavlovic S FIR - Pizzorno, Matteo IR - Pizzorno M FIR - Reisin, Ricardo IR - Reisin R FIR - Romero-Vargas, Samuel IR - Romero-Vargas S FIR - Ruiz-Sandoval, Jose Luis IR - Ruiz-Sandoval JL FIR - Schenone, A IR - Schenone A FIR - Selmaj, Krzysztof IR - Selmaj K FIR - Stelmasiak, Zbigniew IR - Stelmasiak Z FIR - Szczudlik, Andrzej IR - Szczudlik A FIR - Thomas, Florian P IR - Thomas FP FIR - Trivedi, Jaya IR - Trivedi J FIR - Tsao, Bryan IR - Tsao B FIR - Uncini, Antonio IR - Uncini A FIR - Villa, Andres IR - Villa A FIR - Vohanka, Stanislav IR - Vohanka S FIR - Wolfe, Gil IR - Wolfe G FIR - Zapletalova, Olga IR - Zapletalova O EDAT- 2010/09/15 06:00 MHDA- 2010/10/05 06:00 CRDT- 2010/09/15 06:00 PHST- 2010/09/15 06:00 [entrez] PHST- 2010/09/15 06:00 [pubmed] PHST- 2010/10/05 06:00 [medline] AID - 67/9/1082 [pii] AID - 10.1001/archneurol.2010.223 [doi] PST - ppublish SO - Arch Neurol. 2010 Sep;67(9):1082-8. doi: 10.1001/archneurol.2010.223.