Agostinis F, Foglia C, Landi M, et al. Allergy. 2008;63(12):1637–1639
PURPOSE OF THE STUDY. To evaluate the rate and type of adverse events experienced by children receiving sublingual immunotherapy (SLIT) for pollen allergy with either single or multiple allergen extracts.
STUDY POPULATION. Prospective postmarketing survey of 433 children receiving SLIT for respiratory allergies attributable to pollen.
METHODS. Consecutive children with respiratory allergies attributable to pollens who were receiving SLIT with multiple or single allergens were enrolled. Parents recorded adverse events (eye symptoms, rhinitis/ear itching, asthma, oral itching/swelling, nausea, vomiting, abdominal pain, diarrhea, urticaria, angioedema, and anaphylaxis) on a diary card. The adverse events were graded as mild, moderate, or severe.
RESULTS. Four hundred thirty-three children (male: n = 285; age range: 3–18 years) receiving SLIT were surveyed. Of them, 179 received a single allergen extract and 254 received multiple allergens. The total number of doses given was 40 169 (17 143 with single allergen). Overall, 178 adverse events were reported. Of those, 76 occurred in children receiving a single allergen extract (42.46% of patients; 4.43 of 1000 doses) and 102 in children receiving multiple allergens (40.3% of patients; 4.42 of 1000 doses; not significant). A total of 165 episodes (92.5%) were mild and self-resolving, distributed equally in the 2 groups. In 13 cases, the events were judged to be of moderate severity and medical advice was required. Three patients discontinued SLIT, despite the local adverse effects being mild. No emergency treatment was required.
CONCLUSIONS. The use of multiple allergens, compared with single allergens, for SLIT does not increase the rate of adverse events in children.
REVIEWERS COMMENTS. Although it is not commercially available in the United States, SLIT for pollen allergy has gained widespread acceptance in Europe, and evidence supporting its safety and efficacy is accumulating. The promise of SLIT is that it might provide a safer and more-convenient alternative to subcutaneous immunotherapy while maintaining efficacy. Much of the literature supporting its use has involved single allergen extracts, and recent case reports described anaphylaxis with multiple-allergen SLIT. This study, which did not evaluate efficacy, addressed the question of whether the use of multiple allergen extracts for SLIT is safe in children. In this study, the authors did not find any serious adverse events in children using either single or multiple allergen extracts. Their survey involved a limited number of patients and, although SLIT seems to be safe for children, the possibility of anaphylaxis with pollen SLIT cannot be excluded on the basis of these results.
- Copyright © 2009 by the American Academy of Pediatrics