Safety and efficacy of Juniperus ashei sublingual-swallow ultra-rush pollen immunotherapy in cypress rhinoconjunctivitis. A double-blind, placebo-controlled study

Int Arch Allergy Immunol. 2007;142(3):239-46. doi: 10.1159/000097026. Epub 2006 Nov 15.

Abstract

Background: The safety and efficacy of high-dose sublingual-swallow immunotherapy (SLIT) has been established in pollen rhinoconjunctivitis. This treatment has now been evaluated using an ultra-rush incremental dose regimen with a Juniperus ashei allergen extract in patients allergic to Cupressus sempervirens and Cupressus arizonica.

Methods: Patients received either placebo or SLIT. Evaluation of safety was based on the frequency of adverse events during the incremental dose period (half a day) and during maintenance therapy (4 months). Evaluation of efficacy was based on symptom and medication scores at the pollen peak.

Results: Seventy of the 76 patients included completed the study. There were no drop-outs during the rush procedure. One patient in the active group dropped out during the maintenance therapy due to adverse events: gastric pain and vomiting. There was also 1 drop-out in the placebo group due to pregnancy. Adverse events were infrequent, local and mild. Symptom scores for rhinitis and conjunctivitis were not statistically different between groups, but there was a marked and significant (p < 0.03) decrease of the medication score (about 50%) and nasal steroid consumption (about 75%) in the active treatment group. An increase from baseline of serum IgE and IgG4 J. ashei-specific antibodies was only observed in actively treated patients (p < 0.04 and p < 0.01, respectively).

Conclusions: The tolerability and safety of high-dose ultra-rush SLIT were comparable to those reported in previous SLIT studies. SLIT with J. ashei extract, due to its high Jun a 1 content, significantly reduced nasal steroid consumption in patients allergic to European cypress.

Publication types

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

MeSH terms

  • Administration, Sublingual
  • Adult
  • Antigens, Plant / administration & dosage*
  • Conjunctivitis, Allergic / prevention & control*
  • Cross Reactions
  • Cupressus / adverse effects
  • Cupressus / immunology*
  • Desensitization, Immunologic / methods*
  • Double-Blind Method
  • Female
  • Humans
  • Immunoglobulin E / blood
  • Immunoglobulin G / blood
  • Juniperus / adverse effects
  • Juniperus / immunology*
  • Male
  • Middle Aged
  • Plant Extracts / administration & dosage
  • Pollen / adverse effects
  • Pollen / immunology
  • Rhinitis, Allergic, Seasonal / prevention & control*

Substances

  • Antigens, Plant
  • Immunoglobulin G
  • Plant Extracts
  • Immunoglobulin E