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