A double-blind, placebo-controlled, crossover therapy study with natural human IL-2 (nhuIL-2) in combination with regular intravenous gammaglobulin (IVIG) infusions in 10 patients with common variable immunodeficiency (CVID)

Clin Exp Immunol. 1997 Nov;110(2):167-73. doi: 10.1111/j.1365-2249.1997.tb08313.x.


Ten CVID patients with defective IL-2 synthesis in vitro were treated with nhuIL-2 in a placebo-controlled, double blind, crossover therapy study during a period of 12 months. No severe side-effects of nhuIL-2 were recorded. Marginal serum nhuIL-2 levels were measurable in individual patients only during the therapy phase. Serum levels of soluble IL-2 receptors were unaffected by the therapy. nhuIL-2 and placebo groups did not differ significantly with respect to requirement of IVIG substitutions which were performed whenever serum IgG levels dropped below 5 g/l: a total of 53 IVIG infusions (corresponding to 17.6 g IgG/month per patient) was necessary during the placebo phase, and 48 infusions (16.4 g IgG/month per patient) during the nhuIL-2 treatment phase. Thus, nhuIL-2 therapy was ineffective in improving spontaneous IgG synthesis in vivo. Nevertheless, the group of patients receiving nhuIL-2 during the first 6 months of the study exhibited a significant reduction of severe infections (n = 25) during the following 6 months of placebo treatment (n = 7) (P<0.045). The infection score dropped in this group from 181 to 23 (P<0.015). Patients of the second group receiving first placebo and then nhuIL-2 did not experience a significant difference in number and score of infectious episodes: 25 infections were recorded during the first 6 months and 24 during the following 6 months. We suppose that nhuIL-2 therapy of CVID patients reduces susceptibility to severe infections, possibly via the induction of a specific antibody response, which is effective at the earliest 6 months after initiating nhuIL-2 therapy.

Publication types

  • Clinical Trial
  • Randomized Controlled Trial

MeSH terms

  • Adult
  • Aged
  • Common Variable Immunodeficiency / blood
  • Common Variable Immunodeficiency / drug therapy*
  • Common Variable Immunodeficiency / immunology
  • Double-Blind Method
  • Drug Therapy, Combination
  • Female
  • Humans
  • Immunoglobulins / blood
  • Immunoglobulins, Intravenous / administration & dosage*
  • Interleukin-2 / administration & dosage*
  • Male
  • Middle Aged
  • Receptors, Interleukin-2 / blood


  • Immunoglobulins
  • Immunoglobulins, Intravenous
  • Interleukin-2
  • Receptors, Interleukin-2