Safety of sublingual immunotherapy started during the pollen season

ABSTRACT

Background: Sublingual immunotherapy (SLIT) is safer than subcutaneous immunotherapy (SCIT) and this has lead to the reconsideration of the use of ultra-rush schedules for SLIT. The aim of this study was to assess the safety of ultra-rush SLIT in pollen-allergic children according to different timing of administration in relation to the pollen season.

Methods: In total, 34 children with pollen-induced rhinitis and 36 with pollen-induced asthma and rhinitis, were enrolled and assigned to three study groups: group 1 (n = 17 patients): conventional pre-seasonal-SLIT treatment; group 2 (n = 23 patients), seasonal SLIT ended before the pollen seasonal peak; group 3 (n = 30 patients), SLIT began after the pollen seasonal peak and ended after the pollen season. SLIT was performed using extracts from Stallergenes (Antony, France) and following an ultra-rush schedule, consisting in four doses at a 30-min intervals, and maintenance treatment by administering the top dose three times a week.

Results: In all, 54 adverse events (AEs) were reported: 12 in nine patients in group 1 (9/17, 52.9%), 22 in 14 patients in group 2 (14/23, 60.9%), and 20 in 13 patients in group 3 (13/30, 43.3%). No statistically significant differences were found between the three groups. Local AEs (oral itching and burning) were short lasting and self-resolving. Systemic AEs were also mild, except for a case of asthma, which lasted 5 days, in a patient from group 1. There were no severe reactions, and none of the patients dropped out.

Conclusions: This study suggests that SLIT with pollen extracts may be safely started at the beginning and also during the pollen season, with a tolerability profile comparable to the conventional pre-seasonal SLIT.

Key words: :

• Children
• Pollen allergy
• Safety
• Sublingual immunotherapy
• Ultrarush

Acknowledgements

Declaration of interest: This study was sponsored by Stallergenes, Italia, which had a role in planning the study and in preparing and reviewing the article. R. A., S. L. G., F. M., G. P., L. S., G. D. C. and M.-R. Y. have no relevant conflicts of interest with regards to the contents of this article.

C. I. is a scientific consultant for Stallergenes, Milan, Italy. J. S. is Medical Director, Stallergenes, Kamp-Lintfort, Germany. F. F. is Medical and Scientific Director, Stallergenes, Milan, Italy.