Tolerability of SLIT With LAIS® Mites Allergoid Tablets
Tolerability of SLIT With LAIS® Mites Allergoid Tablets
To expand knowledge on the application and tolerability of immunotherapy with LAIS® Mites
 allergoid tablets as well as knowledge on the alleviation of symptoms during sublingual
 therapy in special consideration of the chosen titration schedule in everyday practice.
Until now, results from controlled studies with their specific requirements (patient
 selection, defined inclusion and exclusion criteria, close patient management and monitoring,
 randomisation) are available for LAIS® Mites allergoid tablets only for a small patient
 population. In addition, an open-label, controlled study and an observational study have been
 carried out investigating the clinical efficacy and tolerability of the preparation. Owing to
 the differences in the study designs, the allergen dose administered and the frequency with
 which the preparation was applied varied among the individual studies, making it necessary to
 gather further data on the safety and tolerability of the preparation in a larger patient
 population.

 The observation schedule of this NIS (NIS in accordance with Article 67 Paragraph 6 of the
 German Medicinal Products Act (AMG)), which takes into account the recommendations made by
 the German Federal Institute for Drugs and Medical Devices (BfArM) and by the Paul Ehrlich
 Institute for planning, implementing and evaluating an NIS, is geared to the routine
 procedure carried out for patients with allergies to tree pollen.

 The aim of this observational study is to observe and document the tolerability and
 improvement of symptoms after treatment with LAIS® Mites allergoid tablets under normal
 application conditions and in consideration of the chosen titration schedule in therapeutic
 practice - in accordance with the patient information leaflet - in a large patient
 population:

 Retrospective survey of rhinitis/rhinoconjunctivitis symptoms induced by tree pollen Overall
 symptomatology Documentation of restrictions caused by allergy/asthma Tolerability of the
 treatment by means of AE documentation Patient compliance

 Additional requirements extending beyond the specifications listed in the patient information
 leaflet on product use, patient groups, dosage, contraindications, etc., will not be made.
Inclusion Criteria:

 -  Patients aged 18 years or older having allergies within the scope of specifications
 stated in the patient information leaflet

 Exclusion Criteria:

 -  Contraindications according to the patient information leaflet