Noninterventional Study on Tolerability and Safety of One Strength Updosing With Novo-Helisen Depot House Dust Mites

The Standard dose escalation scheme with the unmodified (native) SCIT house dust mite preparation Novo-Helisen Depot consists of 14 injections.

The newly approved One Strength dose escalation scheme, recently approved for children (≥5 years), adolescents (12-17 years) and adults (≥18 years), offers a simplified dose escalation scheme with only 6 injections. To date, the safety and tolerability of this One Strength escalation scheme has been demonstrated in 2 clinical trials involving 243 patients (aged 5-65 years). The objective of the present non-interventional study is to compare the safety and tolerability of the One Strength dose escalation scheme (6 injections) in different age groups (children, adolescents, adults) and to supplement available clinical trial data on safety and tolerability with clinical study data in daily practice.

Data collection during the first 8 visits of treatment with NHD (D.p./D.f.) using the One Strength dose escalation scheme:

Visit 1: Informed consent, In-/Exclusion-criteria, demographics, medical history, first injection (dose escalation)

Visits 2-6: 2nd to 6th injection (dose escalation)

Visits 7-8: 7th and 8th injection (maintenance doses)

In line with the SmPC recommendations, all patients must be monitored for at least 30 minutes after each injection and then be examined by the physician. Individually, this observation time may be prolonged.

Inclusion criteria

• Written informed consent from the patient. For patients under the age of 18, the consent of both parents/legal guardians is also required.
• Patients who are eligible for treatment with the One Strength dose escalation scheme of NHD (D.p./D.f.) according to the specifications in the SmPC. These include children (5 to <12 years), adolescents (≥12 to <18 years) and adults (≥18 years) with allergic (IgE-mediated) diseases, such as allergic rhinitis, allergic conjunctivitis, allergic bronchial asthma (see section 4 of the current SmPC)
• The treatment decision must precede the decision to participate in the study and must be independent.

Exclusion criteria

• Any contraindication according to section 4.3 of the current SmPC for NHD (D.p./D.f.) for the One Strength dose escalation scheme.