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A multicenter, randomized, double-blind, placebo-controlled trial of high-dose intravenous immunoglobulin for oral corticosteroid-dependent asthma.
Clin Immunol. 1999 May; 91(2):126-33.CI

Abstract

To determine the efficacy of high doses of intravenous gammaglobulin (IVIG) for the treatment of severe, steroid-dependent asthma in patients between 6 and 68 years of age, a randomized, double-blind, placebo-controlled multicenter clinical trial was conducted in private and university hospitals in the United States. Patients were randomized to one of three treatment arms: 2 g IVIG/kg/month (16 patients); 1 g IVIG/kg/month (9 patients); or 2 g iv albumin (placebo)/kg/month (15 patients). The treatment consisted of seven monthly infusions followed by a posttreatment observation period. The primary outcome measurement was mean daily prednisone-equivalent dose requirements, determined during the observation month preceding initiation of treatment and compared to the month preceding the seventh infusion. Secondary clinical endpoints measured were pulmonary function, frequency of emergency room visits or hospitalizations, and number of days absent from school or work. When adjusted for body weight, the mean dose requirements fell by 33, 39, and 33% in the placebo, IVIG (1 g/kg), and IVIG (2 g/kg) treatment arms, respectively. The differences between therapies were not statistically different (P = 0.9728). The mean percentage-of-predicted FEV1 fell in all three treatment groups during the treatment period but there was no significant difference between treatment groups (P = 0.8291). There was also no significant difference in the percentage of subjects requiring emergency room visits or hospitalizations or missing days of work/school, among the three treatment groups. The trial was terminated prematurely after interim analysis determined the adverse experience rate was different between the three groups. Three patients, all randomized to the 2-g/kg IVIG dose group, were hospitalized with symptoms consistent with aseptic meningitis. In summary, in this randomized, double-blind, placebo-controlled multicenter study, high doses of IVIG did not demonstrate a clinically or statistically significant advantage over placebo (albumin) infusions for the treatment of corticosteroid-dependent asthma. Subgroup analysis failed to identify markers predicting responsiveness. High-dose IVIG can also be associated with a significant incidence of serious adverse events.

Authors+Show Affiliations

The Alpha Therapeutic Corporation Asthma Study Group, San Francisco, California, USA.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

10227804

Citation

Kishiyama, J L., et al. "A Multicenter, Randomized, Double-blind, Placebo-controlled Trial of High-dose Intravenous Immunoglobulin for Oral Corticosteroid-dependent Asthma." Clinical Immunology (Orlando, Fla.), vol. 91, no. 2, 1999, pp. 126-33.
Kishiyama JL, Valacer D, Cunningham-Rundles C, et al. A multicenter, randomized, double-blind, placebo-controlled trial of high-dose intravenous immunoglobulin for oral corticosteroid-dependent asthma. Clin Immunol. 1999;91(2):126-33.
Kishiyama, J. L., Valacer, D., Cunningham-Rundles, C., Sperber, K., Richmond, G. W., Abramson, S., Glovsky, M., Stiehm, R., Stocks, J., Rosenberg, L., Shames, R. S., Corn, B., Shearer, W. T., Bacot, B., DiMaio, M., Tonetta, S., & Adelman, D. C. (1999). A multicenter, randomized, double-blind, placebo-controlled trial of high-dose intravenous immunoglobulin for oral corticosteroid-dependent asthma. Clinical Immunology (Orlando, Fla.), 91(2), 126-33.
Kishiyama JL, et al. A Multicenter, Randomized, Double-blind, Placebo-controlled Trial of High-dose Intravenous Immunoglobulin for Oral Corticosteroid-dependent Asthma. Clin Immunol. 1999;91(2):126-33. PubMed PMID: 10227804.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - A multicenter, randomized, double-blind, placebo-controlled trial of high-dose intravenous immunoglobulin for oral corticosteroid-dependent asthma. AU - Kishiyama,J L, AU - Valacer,D, AU - Cunningham-Rundles,C, AU - Sperber,K, AU - Richmond,G W, AU - Abramson,S, AU - Glovsky,M, AU - Stiehm,R, AU - Stocks,J, AU - Rosenberg,L, AU - Shames,R S, AU - Corn,B, AU - Shearer,W T, AU - Bacot,B, AU - DiMaio,M, AU - Tonetta,S, AU - Adelman,D C, PY - 1999/5/5/pubmed PY - 1999/5/5/medline PY - 1999/5/5/entrez SP - 126 EP - 33 JF - Clinical immunology (Orlando, Fla.) JO - Clin. Immunol. VL - 91 IS - 2 N2 - To determine the efficacy of high doses of intravenous gammaglobulin (IVIG) for the treatment of severe, steroid-dependent asthma in patients between 6 and 68 years of age, a randomized, double-blind, placebo-controlled multicenter clinical trial was conducted in private and university hospitals in the United States. Patients were randomized to one of three treatment arms: 2 g IVIG/kg/month (16 patients); 1 g IVIG/kg/month (9 patients); or 2 g iv albumin (placebo)/kg/month (15 patients). The treatment consisted of seven monthly infusions followed by a posttreatment observation period. The primary outcome measurement was mean daily prednisone-equivalent dose requirements, determined during the observation month preceding initiation of treatment and compared to the month preceding the seventh infusion. Secondary clinical endpoints measured were pulmonary function, frequency of emergency room visits or hospitalizations, and number of days absent from school or work. When adjusted for body weight, the mean dose requirements fell by 33, 39, and 33% in the placebo, IVIG (1 g/kg), and IVIG (2 g/kg) treatment arms, respectively. The differences between therapies were not statistically different (P = 0.9728). The mean percentage-of-predicted FEV1 fell in all three treatment groups during the treatment period but there was no significant difference between treatment groups (P = 0.8291). There was also no significant difference in the percentage of subjects requiring emergency room visits or hospitalizations or missing days of work/school, among the three treatment groups. The trial was terminated prematurely after interim analysis determined the adverse experience rate was different between the three groups. Three patients, all randomized to the 2-g/kg IVIG dose group, were hospitalized with symptoms consistent with aseptic meningitis. In summary, in this randomized, double-blind, placebo-controlled multicenter study, high doses of IVIG did not demonstrate a clinically or statistically significant advantage over placebo (albumin) infusions for the treatment of corticosteroid-dependent asthma. Subgroup analysis failed to identify markers predicting responsiveness. High-dose IVIG can also be associated with a significant incidence of serious adverse events. SN - 1521-6616 UR - https://www.unboundmedicine.com/medline/citation/10227804/A_multicenter_randomized_double_blind_placebo_controlled_trial_of_high_dose_intravenous_immunoglobulin_for_oral_corticosteroid_dependent_asthma_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S1521-6616(99)94714-9 DB - PRIME DP - Unbound Medicine ER -