Abstract
BackgroundEfficacy of house dust mite (HDM) allergen immunotherapy (AIT) in allergic rhinitis and controlled allergic asthma has been documented in controlled trials with adults and children. However, tolerability comparing clinical development and post marketing data, particularly in different subgroups, is missing.MethodsWe performed an analysis of pooled safety data for subcutaneous AIT (SCIT) with a high-dose house dust mite allergoid from 6 randomized, controlled trials (RCT) in HDM allergic respiratory disease (ARD) and of post marketing safety data from more than 10 years including different subgroups (age, gender, asthma status).ResultsIn all, 500 patients with ARD were treated in RCTs: 279 received the marketed dose of 1800 protein nitrogen units (PNU) high-dose HDM allergoid AIT (214 double-blind placebo controlled [HDM-DBPC], 65 children/adolescents usual care controlled [HDM-RCT(UC)]), and 221 placebo (PL). 38.8% adverse events (AEs) were observed with 1800 PNU in HDM-DBPC (31.2% PL, 35.5% HDM-ALL [1800 PNU]); the difference was primarily because of local reactions; there was no difference in systemic reactions (10.9% PL, 11.2% HDM-DBPC, 11.2% HDM-ALL); one out of 279 high-dose HDM allergoid-treated patients had a serious adverse event (SAE).Children (n = 39)/adolescents (n = 26) had fewer related AEs and local reactions compared to adults; systemic reactions: children 12.8%, adults 11.2% adolescents 7.7%. Females had slightly more AEs. Treatment was well tolerated in asthmatic patients (n = 267; GINA I n = 32, II n = 104, III n = 17, 114 no classification).In more than 10 years more than 100,000 patients were treated with high-dose HDM allergoid (1800 PNU) under daily practice conditions. Adverse drug reactions (ADRs) were reported in 0.5% of patients. 94.6% of these ADRs were expected.ConclusionSCIT with the marketed dose of high-dose HDM allergoid was well tolerated in clinical development and in daily practice. There was no increased risk for the investigated patient subgroups. Tolerability was comparable to HDM sublingual immunotherapy (SLIT) tablets.
Highlights
Allergen immunotherapy (AIT) is a therapy with disease-modifying effects and the only available treatment to target the disease instead of the symptoms
KG, Reinbek bei Hamburg, Germany verse events (AEs) were observed with 1800 protein nitrogen units (PNU) in house dust mite (HDM)-double-blind placebo controlled (DBPC) (31.2% PL, 35.5% HDM-ALL [1800 PNU]); the difference was primarily because of local reactions; there was no difference in systemic reactions (10.9% PL, 11.2% HDM-DBPC, 11.2% HDM-ALL); one out of 279 high-dose HDM allergoid-treated patients had a serious adverse event (SAE)
We present safety information from patients treated with the marketed dose of 1800 PNU (n = 279) as maintenance dose (100% D. pteronyssinus or 50%/50% D. pteronyssinus/D. farinae allergens/ mixtures)
Summary
Allergen immunotherapy (AIT) is a therapy with disease-modifying effects and the only available treatment to target the disease instead of the symptoms. Specific blocking antibodies, tolerance-inducing cells, and mediators are activated. These prevent further exacerbation of the allergen-triggered immune response, block the specific immune response, and attenuate the inflammatory response in tissue [1, 2]. Efficacy of AIT in HDM allergy is documented by a number of controlled trials in adults and few controlled trials in children [1, 4]. Efficacy of house dust mite (HDM) allergen immunotherapy (AIT) in allergic rhinitis and controlled allergic asthma has been documented in controlled trials with adults and children. Tolerability comparing clinical development and post marketing data, in different subgroups, is missing
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