Cluster-Immuntherapie bei allergischer Rhinokonjunktivitis und Asthma bronchiale: Sicherheit der Initialtherapie mit Novo-Helisen Depot

Abstract

Background: Specific immunotherapy (SIT) represents the only causal treatment that can be offered to allergic patients apart from allergen avoidance. In classic SIT, gradually increasing dosages of the allergen extract are injected subcutaneously. Several dosage schedules for subcutaneous SIT can be applied. The classic approach involves single injections at each therapy visit. In Cluster-SIT, two to three injections per day of treatment are given once a week during initial treatment. Patients: In this trial, we investigated 46 patients (17 female, 29 male) from 11 - 71 years (40.7 ′ 13 years) with regard to side effects of a Cluster regime during induction treatment with Novo-Helisen Depot. Four patients were treated with two different extracts, so that a total of 50 initial therapies were observed; 19 patients (41%) suffered from bronchial asthma. Results: We performed 34 treatments with mite extracts, eight treatments with grass pollen extracts and eight treatments with tree pollen extracts with 744 injections in total. The total number of enlarged local reactions (≥ grade 1) was 23, or 3.1% of all injections. Of these, 22 (3.0%) were classified as immediate reactions and one (0.1%) was a late-phase reaction. Of all enlarged local reactions, 22 (3.0%) were grade 1 reactions (5 - 8 cm) and one (0.1%) was a grade 2 reaction (8 - 12 cm). Grades 3 and 4 reactions were not observed. Only one systemic reaction was observed (0.1% of all injections). This reaction was a delayed phase reaction grade 1 (urticaria). Grades 2, 3, or 4 reactions did not occur. There were no differences in gender or age regarding the occurence of side effects (all p > 0.05). Conclusions: Frequency and severity of adverse side effects in Cluster-SIT with Novo-Helisen Depot show an excellent tolerability corresponding to the occurrence of side-effects with other dosage schedules.