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Vol. 131, No. 2, 2003
Issue release date: June 2003
Int Arch Allergy Immunol 2003;131:111–118

A Double-Blind Placebo-Controlled Evaluation of Sublingual Immunotherapy with a Standardized Ragweed Extract in Patients with Seasonal Rhinitis

Evidence for a Dose-Response Relationship

André C. · Perrin-Fayolle M. · Grosclaude M. · Couturier P. · Basset D. · Cornillon J. · Piperno D. · Girodet B. · Sanchez R. · Vallon C. · Bellier P. · Nasr M.
aDépartement Scientifique et Médical, Stallergènes S.A., Antony; bDépartement de Pneumologie et d’Immunologie Clinique, Centre Hospitalier Lyon Sud; cGroupement d’Allergologie et d’Immunologie, Clinique du Rhône Moyen, Lyon; dGroupe Lyonnais d’Allergologie, Lyon, and eCentre Médical PAROT, Lyon, France

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Background: There is a growing consensus on the benefits of sublingual-swallow immunotherapy in the treatment of allergic diseases. Methods: This randomized, double-blind placebo-controlled study was undertaken to assess the efficacy and safety of sublingual immunotherapy with standardized ragweed pollen extract tablets, in patients with an allergic rhinitis. A total of 110 outpatients were randomized (immunotherapy [I]: 55; placebo [P]: 55), of whom 99 were analyzable for efficacy (I: 48; P: 51) and 106 analyzable for safety (I: 53; P: 53). After a 28-day progression phase, the patients received a maintenance treatment during 6.5 months. Efficacy variables included a global assessment of efficacy (patient/ investigator), symptoms and medication scores as well as the frequency of asthma attacks. Results: In the active treatment group, 43 patients completed the study, versus 49 on placebo. During the whole period of pollination, the difference favoring immunotherapy was highly significant for the global assessment by the patient (p = 0.004) and by the investigator (p = 0.005). Adverse reactions were reported more often in the active treatment but mild or moderate, and they abated after dose adjustment. A subgroup analysis of those patients receiving the highest dose of immunotherapy (3 tablets 3 times a week) showed a highly significant response for rhinitis and conjunctivitis total scores by comparison to lower dosages. Conclusion: This study confirms the efficacy and safety of sublingual immunotherapy and strongly suggests a dose-response relationship.

Copyright / Drug Dosage

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Drug Dosage: The authors and the publisher have exerted every effort to ensure that drug selection and dosage set forth in this text are in accord with current recommendations and practice at the time of publication. However, in view of ongoing research, changes in goverment regulations, and the constant flow of information relating to drug therapy and drug reactions, the reader is urged to check the package insert for each drug for any changes in indications and dosage and for added warnings and precautions. This is particularly important when the recommended agent is a new and/or infrequently employed drug.
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