Environmental and Ooccupational Disorders
Specific immunotherapy with a standardized latex extract in allergic workers: A double-blind, placebo-controlled study

https://doi.org/10.1067/mai.2003.1390Get rights and content

Abstract

Background: Preventive measures have been proposed to reduce the risk of sensitization to natural rubber latex (NRL), but this is not always feasible. Objective: The aim of this study was to determine the efficacy and safety of specific immunotherapy with a standardized latex extract in sensitized workers. Methods: Twenty-four patients allergic to NRL with contact urticaria (n = 8) and rhinitis or asthma (n = 16) were included (16 in the active group and 8 in the placebo group). Treatment started in a cluster immunotherapy protocol, with injections every week for 3 months and then every other week for another 3 months. Results: Patients in the active group had significantly lower values than patients in the placebo group in skin terms of reactivity to NRL (P < .01), rubbing test results (P = .047), and latex glove use test results (P = .046) after 6 months of treatment. There were no significant differences between the active and placebo groups in symptom scores, use of medication, self-assessment, or methacholine test results either before or after treatment. Differences in nasal and bronchial symptoms during specific inhalation challenges (P = not significant and P = .05, respectively) were observed in favor of the active group. In the active group 32 systemic reactions were observed (8% of doses), mostly during the build-up period, being more frequent in patients with respiratory symptoms (P = .004). All reactions responded promptly to treatment. Conclusion: Clinical efficacy was shown mainly on cutaneous symptoms, although an improvement in rhinitis and asthma symptoms was also observed during specific inhalation challenges. Latex-specific immunotherapy might be a useful approach for the treatment of latex allergy in sensitized workers. (J Allergy Clin Immunol 2003;111:985-94.)

Section snippets

Study design

This clinical trial was conducted in accordance with good clinical practice after approval by the hospital ethics committee and the Spanish Medicine Agency. All patients provided written consent to participate in the trial. This was a randomized, double-blind, placebo-controlled trial conducted in parallel groups. Fifty patients were screened, and 24 were randomized into 2 treatment groups (ie, active or placebo groups). Treatment lasted 6 months, and tolerance to SIT was monitored throughout

Results

The baseline characteristics of subjects are shown in Table I. Both treatment groups were similar in their demographic and clinical characteristics at baseline.

Discussion

This study compares the results of latex SIT with placebo in sensitized workers in terms of safety and efficacy end points. To our knowledge, this is the second double-blind, placebo-controlled study published on latex SIT. The first was carried out by Leynadier et al9 at the end of 2000. In this trial a similar crude extract of latex was used for SIT. These authors used a maximum dose of 5 to 10 reactivity units, which corresponds to 1 to 2 μg of total protein, in contrast to the maximum dose

References (20)

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Reprint requests: Joaquín Sastre, MD, PhD, Fundación Jiménez Díaz, Servicio de Alergia, Av. Reyes Católicos 2, 28040 Madrid, Spain.

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