A prospective Italian survey on the safety of subcutaneous immunotherapy for respiratory allergy
Article first published online: 26 MAY 2009
© 2009 Blackwell Publishing Ltd
Clinical & Experimental Allergy
Volume 39, Issue 10, pages 1569–1574, October 2009
How to Cite
Schiappoli, M., Ridolo, E., Senna, G., Alesina, R., Antonicelli, L., Asero, R., Costantino, M. T., Longo, R., Musarra, A., Nettis, E., Crivellaro, M., Savi, E., Massolo, A. and Passalacqua, G. (2009), A prospective Italian survey on the safety of subcutaneous immunotherapy for respiratory allergy. Clinical & Experimental Allergy, 39: 1569–1574. doi: 10.1111/j.1365-2222.2009.03286.x
- Issue published online: 10 SEP 2009
- Article first published online: 26 MAY 2009
- Submitted 18 November 2008; revised 3 April 2009; accepted 15 April 2009
- respiratory allergy;
- subcutaneous immunotherapy;
- systemic reaction
Background Subcutaneous immunotherapy is effective for the treatment of respiratory allergy, and it is largely used in Italy, but no systematic safety assessment has been carried out so far.
Objective To assess prospectively the safety of injection immunotherapy in a multicentre, real-life survey.
Methods Eleven Italian allergy departments recorded the clinical characteristics of systemic reactions (SRs) due to immunotherapy. Vaccines were prescribed according to guidelines; only standardized depot extracts were used. SRs were graded according to the EAACI recommendations, and were classified as immediate or delayed.
Results One thousand seven hundred and thirty-eight patients (847 males, age range 5–71) received immunotherapy from eight different manufacturers, for a total of 2038 courses (300 patients received two extracts). A total of 60 785 injections were given over a mean immunotherapy duration of 3 years. Overall, 95 reactions were observed in 57 patients (3.28%), corresponding to 4.7% of the courses and 1.56/1000 injections. Twenty-five patients experienced more than one adverse event. There were 34 grade 2, 60 grade 3 and one grade 4 reactions and no fatality. SRs occurred more frequently in patients with asthma than in patients with rhinitis alone (4.1% vs. 1.1%), and were equally distributed between the build-up and the maintenance phase. Ragweed and grass extracts caused significantly more side effects than other allergens.
Conclusion In this large prospective study, the rate of SRs was low, thus confirming that injection immunotherapy has an acceptable risk/benefit ratio when prescribed and carried out according to recommendations.