Immunotherapy safety: a prospective multi-centric monitoring study of biologically standardized therapeutic vaccines for allergic diseases


  • The authors above publish this paper on behalf of the members of the Immunotherapy Committee of the Sociedad Española de Alergología e Inmunología Clínica (SEAIC), who participated in the development of this study: A. Beristain, M. Boquete, T. Chivato, C. Colas, P. Font (Biostatistic Department, University of Cordoba, Spain), P. Guardia, J. Luque (Biostatistic Department, University of Cordoba, Spain), A. Malet, D. Muñoz, E. Muñoz, A. Nieto, J.M. Olaguibel, F. Rodríguez, C. Vidal

Javier Cuesta-Herranz, Allergy Department, Fundación Jiménez Díaz, Avda. Reyes Católicos, 2, 28040 Madrid, Spain.


Background The fear of side-effects has led to strict regulations preventing a more widespread use of specific immunotherapy (SIT) in some countries, in spite of the low risk of systemic reactions (SRs) reported in well-controlled studies. The goal of the study was to carry out a prospective and multi-centric trial to evaluate the safety, risk factors and compliance degree of commercially available SIT.

Materials and methods The study was carried out in 14 allergy departments from Spain. Four-hundred and eighty-eight patients with rhinitis and/or asthma were submitted to treatment with biologically standardized allergen extracts commercially available. They were administered following the European Academy of Allergy and Clinical Immunology guidelines.

Results Four hundred and twenty-three patients (86.7%) completed the treatment and remained under control at the end of the trial. Out of 17 526 administered doses, 17 368 doses (99.1%) were not associated with a reaction. Eighteen patients (3.7%) experienced 53 (0.3% of the doses) SRs. All immediate SRs were mild or moderate and responded well to ordinary treatment measures. There were no fatal reactions, anaphylactic shock or life-threatening reactions. A higher ratio of SRs was found among asthmatic and dust mite allergic patients, although multi-variable logistic analysis did not demonstrate any risk factor associated with SRs. There was also a subgroup of patients at risk for recurrent reactions, and therefore 40% of SRs had been avoided if the maximal number of SRs had been previously limited to only three SRs.

Conclusions This multi-centric study showed that SIT was a safe treatment with a very good compliance. Future guidelines of SIT should limit the maximal number of SRs.