A prospective controlled crossover trial of a new presentation (10% vs. 5%) of a heat-treated intravenous immunoglobulin

Int Immunopharmacol. 2005 Mar;5(3):619-26. doi: 10.1016/j.intimp.2004.11.010.

Abstract

Thirty-five patients with primary or secondary immunoglobulin deficiency were included in a crossover study to test the tolerance, clinical efficacy, and safety of a liquid pasteurized 10% concentrated intravenous gammaglobulin versus a 5% concentrated presentation. No statistically significant differences were found between these parameters. Total serum immunoglobulin-(Ig)G and IgG subclass levels were similar in both groups. No modifications in serum alanine transferase (ALT) levels and viral status (HBsAg, HCV-RNA, p24 antigen or RNA for HIV) were observed throughout treatment. Adverse reactions were reported in 3 out of 70 infusions (4.3%), 2 in the experimental group and 1 in the control group. The maximum recommended rate of infusion for the 10% gammaglobulin is the same as for the 5% gammaglobulin product (0.04 ml/kg/min); generally speaking, this means that infusion time is halved. We conclude that a 10% gammaglobulin product is a well-tolerated, clinically efficacious and safe intravenous preparation, and that it could be a short infusion time alternative for primary and secondary antibody deficiencies.

Publication types

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

MeSH terms

  • Adolescent
  • Adult
  • Aged
  • Alanine Transaminase / blood
  • Aspartate Aminotransferases / blood
  • Cross-Over Studies
  • Female
  • HIV / genetics
  • Hepatitis B Surface Antigens / blood
  • Humans
  • Immunoglobulin Isotypes / blood
  • Immunoglobulins / blood
  • Immunoglobulins, Intravenous / administration & dosage*
  • Immunoglobulins, Intravenous / adverse effects
  • Immunoglobulins, Intravenous / therapeutic use
  • Immunologic Deficiency Syndromes / drug therapy*
  • Male
  • Middle Aged
  • Multivariate Analysis
  • Prospective Studies
  • RNA, Viral / blood
  • Treatment Outcome

Substances

  • Hepatitis B Surface Antigens
  • Immunoglobulin Isotypes
  • Immunoglobulins
  • Immunoglobulins, Intravenous
  • RNA, Viral
  • Aspartate Aminotransferases
  • Alanine Transaminase