[Preliminary results in a placebo-controlled, double-blind crossover clinical trial with human interleukin-2 (n-IL-2) in patients with variable immunodeficiency syndrome (CVID)].
Ten CVID patients with an in vitro defect for IL-2-synthesis were treated for 12 months in a placebo-controlled double-blind crossover therapy study with human natural IL-2 s.c. There were no severe side effects of n-IL-2 recorded. Serum levels of soluble IL-2 receptors were unaffected by the therapy. Serum IL-2 levels were only measurable in single patients during the therapy phase. Since verum and placebo groups did not differ with respect to requirement for intravenous gammaglobulin substitutions, n-IL-2 therapy was uneffective in switching on IgG synthesis in vivo. Nevertheless, there was an elevation in vitro of IgM synthesis in 5 patients and of IgG synthesis in 4 patients during n-IL-2 therapy after stimulation of patients' lymphocytes with staphylococcus aureus Cowan I (SAC) plus n-IL-2 or with Pokeweed Mitogen (PWM) without n-IL-2. Additionally, an elevated IL-2-synthesis in vitro was recorded after OKT3 stimulation for 3 CVID patients. There was a significant reduction of severe infections from 25 during the first 6 months of the study to 7 infections during the following 6 months, in the group of patients which received n-IL-2 first. In the second group, which received placebo first, there were no significant differences between placebo and n-IL-2 therapy phase detectable (25 infections during the first 6 months of the study and 24 severe infections in the second phase).(ABSTRACT TRUNCATED AT 250 WORDS)
Rump
J A
JA
Abteilung Rheumatologie, Medizinische Universitätsklinik Freiburg.
Jahreis
A
A
Schlesier
M
M
Stecher
S
S
Dräger
R
R
Struff
W G
WG
Peter
H H
HH
D017074:Common Variable Immunodeficiency / Q000628:therapy*; D004311:Double-Blind Method; D006801:Humans; D007376:Interleukin-2 / Q000627:therapeutic use*
D007376:Interleukin-2
Erste Ergebnisse einer plazebokontrollierten, doppelblinden Crossover-Therapiestudie mit humanem Interleukin-2 (n-IL-2) bei Patienten mit variablem Immundefektsyndrom (CVID).