Double-blind placebo-controlled evaluation of sublingual-swallow immunotherapy with standardized Parietaria judaica extract in children with allergic rhinoconjunctivitis,☆☆,

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Abstract

Background: Sublingual-swallow immunotherapy was recently recognized in the World Health Organization Position Paper (Allergen immunotherapy: therapeutic vaccines for allergic diseases) “as a viable alternative to parenteral injection therapy to treat allergic diseases” in adults. More controlled studies were required to assess the efficacy and safety of this treatment in children. Objective: This study was carried out to assess the clinical efficacy and safety profile of sublingual-swallow immunotherapy with high-dose allergen in children with allergies. Methods: We used a double-blind placebo-controlled design. Forty-one children with Parietaria -induced rhinoconjunctivitis were randomized to receive sublingual standardized Parietaria judaica extract (n = 20) or placebo (n = 21) for 2 years. The cumulative dose of allergen was 375 times higher than that used in parenteral immunotherapy and the cumulative dose of Par j 1 major allergen was 52.5 mg over 2 years. The main efficacy assessment criteria were symptoms and rescue medication scores recorded on the patients’ diary cards. Secondary criteria were changes in skin and conjunctival specific reactivity as well as blood parameters, analyzed after 1 and 2 years of immunotherapy. The safety of the treatment was assessed by evaluating the frequency and severity of adverse effects. Results: A significant reduction in rhinitis symptoms was observed in the active treatment group during the second season (P = .02), with no difference in medication scores. A significant decrease in skin reactivity (P = .002 after 2 years of treatment) and an increase in the threshold dose for conjunctival allergen provocation test (P = .02) were observed in the active treatment group compared with the group receiving placebo. A significant increase in specific IgG4 levels (P = .02) was also observed in the active group. Immunotherapy was well tolerated. Conclusion: Sublingual-swallow immunotherapy in Parietaria -allergic children provided a clinical benefit and a decreased specific reactivity to the allergen. The safety profile of this treatment, which constitutes an important issue, indicated good tolerance and compliance. (J Allergy Clin Immunol 1999;104:425-32.)

Section snippets

Study design

This was a double-blind, placebo-controlled, parallel-group study.

Forty-one patients with a positive history of rhinoconjunctivitis, with or without mild intermittent asthma, caused by Parietaria pollen sensitization documented by positive skin tests (wheal diameter >4mm) and positive radioallergosorbent test results (class II and above) were enrolled between November 1995 and March/April 1996. Patients with uncontrolled asthma, symptomatic polysensitization or who were treated with β-blockers

Patients

The 2 groups did not differ in terms of demographic variables, history of rhinitis, conjunctival provocation tests, skin reactivity, and immunologic parameters.

Of the 41 randomized patients, 3 from the active group and 3 from the placebo group left the study before the first pollen season and another 2 patients (1 active and 1 placebo) dropped out of the trial during the second year. Thirty-three patients (16 in the active treatment group and 17 in the placebo group) were therefore evaluable at

DISCUSSION

This study compared the efficacy of sublingual immunotherapy with standardized P judaica extract versus placebo in children with Parietaria pollinosis. The major outcome, indicating efficacy of treatment, was reduction in rhinitis symptom scores. Because no baseline assessment was performed, the active group was more severely symptomatic at the start of the trial, and this difference persisted during the first pollen season. As classically reported, no effect of immunotherapy was observed

Acknowledgements

We thank Dr Enrique Fernandez-Caldas, LETI, Spain, for Par j 1 dosage assays and ARMIA (Associazione Ricerca Malattie Immunologiche ed Allergiche) for supporting the study. We also thank Dr Giovanni Passalacqua for critically reading the text and Dr Anthony Saul for revising the English.

References (25)

  • HS Nelson et al.

    A double-blind, placebo-controlled evaluation of sublingual immunotherapy with standardized cat extract

    J Allergy Clin Immunol

    (1993)
  • G Passalacqua et al.

    Randomised controlled trial of local allergoid immunotherapy on allergic inflammation in mite-induced rhinoconjunctivitis

    Lancet

    (1998)
  • G D’Amato et al.

    Pollen-related allergy in Europe

    Allergy

    (1998)
  • HS Kaufman

    Parietaria: an unrecognized cause of respiratory allergy in the United States

    Ann Allergy

    (1990)
  • D Bass et al.

    Parietaria as a cause of asthma

    Med J Aust

    (1984)
  • HJ Malling et al.

    WHO Position Paper, allergen immunotherapy: therapeutic vaccines for allergic diseases

    Allergy

    (1998)
  • F Purello d’Ambrosio et al.

    Rush sublingual immunotherapy in Parietaria allergic patients

    Allergol Immunopathol (Madr)

    (1996)
  • C Troise et al.

    Sublingual immunotherapy in Parietaria pollen induced rhinitis: a double-blind study

    J Invest Allergol Clin Immunol

    (1995)
  • R Ariano et al.

    Efficacy and safety of oral immunotherapy in respiratory allergy to Parietaria judaica pollen: a double blind study

    J Invest Allergol Clin Immunol

    (1998)
  • MB Abelson et al.

    Conjunctival allergen challenge

    Arch Ophthalmol

    (1990)
  • HJ Malling

    Immunotherapy as an effective tool in allergy treatment

    Allergy

    (1998)
  • J Brostoff et al.

    Low dose sublingual therapy in patients with allergen rhinitis due to house dust mite

    Clin Allergy

    (1986)
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