A prospective and multicenter safety-monitoring study of a short up-dosing schedule of immunotherapy with a mass-units-standardized extract of mites

Abstract

A prospective, multicenter pharmacovigilance study was carried out to evaluate the safety of a new 7-dose treatment schedule of subcutaneous immunotherapy as opposed to the conventional 13 doses normally recommended. The study was carried out in 14 centers and included 261 patients (children and adults) with respiratory allergic disease due to sensitization to mites (Dermatophagoides pteronyssinus and/or farinae). A total of 2290 doses were administered under the direct supervision of the participating specialists. One hundred and ten reactions in 63 patients (24.1%) were recorded, representing 4.8% of the total doses administered. Most of the reactions (98) were local. Only 12 were systemic (0.5% of the administered doses) and occurred in 10 patients (3.8% of the sample). Ten reactions reverted quickly with rescue medication. The maintenance dose had to be lowered in one patient and another patient was withdrawn from the study after suffering two asthmatic crises after two consecutive doses. In view of the results obtained, we can conclude that the new schedule shows an acceptable tolerance profile and does not present a greater risk of reactions than the conventional scheme of 13 doses using an identical extract. Moreover, the new schedule represents substantial savings in the number of doses and visits required to reach the maintenance dose.

Systemic Reactions to Dust Mite Subcutaneous Immunotherapy: A 3-Year Follow-up Study

“…There are a few studies showing a higher incidence of SR in children. 11 26 A possible explanation is that our study included more young children who might be greatly sensitized and vulnerable to allergies with less capacity of tolerance to allergen extracts. This difference may also reflect a higher proportion of children in subjects undergoing allergen-specific SCIT in Central China.…”

Seguridad de la inmunoterapia subcutánea con extractos tirosinados de ácaros de polvo doméstico en pacientes con enfermedad alérgica

“…39 En un estudio prospectivo y multicéntrico que evaluó la seguridad de la inmunoterapia subcutánea con extractos de ácaros de polvo doméstico (Dermatophagoides pteronyssinus o farinae) en 261 pacientes con enfermedad alérgica, 40 con las que se registraron 110 reacciones de las 2290 dosis administradas, de ellas solo 12 fueron sistémicas (0.5 %). 40 En otro análisis, retrospectivo observacional, efectuado en el mismo centro de referencia donde se llevó a cabo la investigación que se informa, se evaluó la presencia de reacciones adversas en pacientes que recibían inmunoterapia ultra rash con extractos polimerizados despigmentados para ácaros de polvo doméstico. Solo 8 pacientes presentaron reacciones sistémicas, que equivalieron a 0.1 % reacciones por inyección y a 1.3 % de los pacientes, 41 proporciones inferiores a las del actual estudio (5,8 %).…”