Antihistamine premedication in specific cluster immunotherapy: A double-blind, placebo-controlled study,☆☆,

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Abstract

BACKGROUND: Specific immunotherapy treatment in allergic diseases involves a risk of systemic side effects. A double-blind, placebo-controlled study was performed in 45 patients allergic to pollen to determine whether pretreatment with loratadine could reduce the number and severity of systemic reactions during the dose-increase phase of cluster immunotherapy. METHODS: The patients received cluster immunotherapy with a standardized birch (Betula verrucosa) or grass (Phleum pratense) pollen extract adsorbed to aluminum hydroxide. The immunotherapy schedule involved seven visits and 14 injections to reach a maintenance dose of 100,000 standardized quality units. Loratadine, 10 mg, or placebo tablets were administered 2 hours before the first injection at each visit. RESULTS: A total of 720 injections were given (309 injections in 21 patients receiving loratadine and 411 injections in 24 patients receiving placebo). The median numbers of injections to reach maintenance dose were 15 (range, 14 to 18) in the loratadine group and 16 (range, 14 to 23) in the placebo group (p = 0.037). The numbers of patients with systemic reactions were seven (33%) and 19 (79%) in the loratadine and placebo groups, respectively (p = 0.002). Twenty-five reductions caused by systemic reactions were observed in the placebo group in contrast to nine in the loratadine group (p = 0.047). No life-threatening systemic reactions were observed in either group. Systemic reactions were, however, more severe in the placebo group, mainly because of a significantly higher incidence of urticaria (10 vs 1, p = 0.022). CONCLUSION: Pretreatment with loratadine seems to reduce both the number and severity of systemic reactions in specific cluster immunotherapy. (J Allergy Clin Immunol 1996;97:1207-13.)

Section snippets

Patients

Forty-five patients, aged 21 to 59 years, who had had seasonal allergic rhinitis for a median duration of 15 years (range, 4 to 49 years), participated in the study. All patients fulfilled the criteria for immunotherapy according to the Position Paper from the European Academy of Allergology and Clinical Immunology (EAACI).1 They had severe allergy symptoms in either April and May or May through July, corresponding to the birch and grass pollen seasons, respectively. All patients had a positive

RESULTS

Twenty patients (95%) in the loratadine group reached the scheduled maintenance dose and completed the study in contrast to 17 (71%) in the placebo group. The one patient in the loratadine group, who did not complete the study, stopped immunotherapy after five injections with no SR because of lack of time. The seven patients in the placebo group, who did not reach the maintenance dose, stopped immunotherapy after six to 24 injections. All seven patients experienced SRs (1 to 9 SRs, Fig. 1), but

DISCUSSION

In this study, the number of patients experiencing SRs was high compared with other studies in which the same top dose of allergen was used. In this study 79% of the patients in the placebo group had SRs compared with 5% and 30% in another grass pollen and house dust mite study, respectively.5, 7 These studies used a conventional (1 injection per visit) schedule in contrast to our cluster (2 to 3 injections per visit) schedule. An editorial on SRs reported a higher frequency of SRs in studies

Acknowledgements

We thank Schering-Plough A/S, the staff at the Allergy Unit, and the participants for making the study possible.

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From the Allergy Unit, Medical Department, National University Hospital, Copenhagen.

☆☆

Reprint requests: Lone Nielsen, MD, Allergy Unit, Medical Department TTA 7511, National University Hospital, Tagensvej 20, DK-2200 Copenhagen N, Denmark.

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