Safety and tolerability of immune globulin intravenous in chronic inflammatory
demyelinating polyradiculoneuropathy.
Author(s): Donofrio PD, Bril V, Dalakas MC, Deng C, Hanna K, Hartung HP, Hughes R, Latov N,
Merkies I, van Doorn P; IGIV-C CIDP Efficacy (ICE) Study Group.
Collaborators: 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.
Affiliation(s): Department ofNeurology, Vanderbilt University, Nashville, TN 37232, USA.
Publication date & source: 2010, Arch Neurol. , 67(9):1082-8
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extension phase were withdrawn from the study.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.
Erratum in
Arch Neurol. 2010 Dec; 67(12):1515.
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