INTRODUCTION
Allergic rhinitis (AR) affects 17% to 29% of the adult population in Europe, thereby constituting a serious public health problem. An incidence rate of AR of approximately 9 per 1000 patient-years has been reported for children as well as for adults in Dutch general practices. In addition, allergy to house dust mites (HDM), generally induced byDermatophagoides (D) pteronyssinus or D. farinae , is the most common inhalant allergy with sensitization in 49% of subjects with a clinical diagnosis of AR in Western Europe.
Next to symptomatic treatment (antihistamines, decongestants, and nasal corticosteroids), treatment with sublingual immunotherapy (SLIT) has increased in recent years. Several clinical trials have shown that treatment with HDM SLIT-tablet immunotherapy effectively reduced symptoms associated with HDM AR with or without asthma. Hence, treatment with HDM SLIT-tablet has become common practice. However, most data concerning tolerability, side effects and compliance have been obtained in clinical trials and not in a daily clinical practice setting. While RCTs have high internal validity and are needed to demonstrate a favorable risk/benefit profile, the controlled clinical trial setting with patient selection based on in- and exclusion criteria may impact the generalizability of the results to daily practice.
To assess the general applicability of the efficacy and safety data collected in randomized controlled trials (RCT’s), we set out to conduct a complementary multi-center, observational study in outpatient clinics. The study objectives were to assess the safety, tolerability, treatment satisfaction, compliance, and clinical effectiveness of HDM SLIT-tablet treatment, when prescribed as part of regular clinical practice.
METHODS