Cluster-Immuntherapie bei saisonaler allergischer Rhinitis: Erfahrungen zur Sicherheit einer Initialtherapie mit Depot-Allergoiden (Purethal®)

 

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Zusammenfassung

Hintergrund: Neben der Allergenkarenz ist die Hyposensibilisierungstherapie oder spezifische Immuntherapie (SIT) die einzige kausale Behandlungsmöglichkeit von Patienten mit allergischer Rhinokonjunktivitis. Die Effektivität der SIT ist abhängig vom spezifischen Allergen, der Qualität und Gesamtdosis der verabreichten Allergenextrakte und dem Applikationsschema. Bei der klassischen SIT wird ein Allergenextrakt repetitiv in ansteigenden Dosen subkutan injiziert. Es existieren unterschiedliche Therapie-Schemata für die subkutane SIT. Bei der Cluster-Therapie werden hierzu 2 - 3 Injektionen je Behandlungstag in wöchentlichen Abständen verabreicht.

Patienten: Wir untersuchten in dieser Studie 64 Patienten (33 Frauen, 31 Männer) im Alter von 18 bis 54 Jahren (Altersdurchschnitt: 26,9 ± 5,1 Jahre) hinsichtlich auftretender Nebenwirkungen des Cluster-Therapieschemas in der Dosissteigerungsphase.

Ergebnisse: Die Gesamtzahl der übersteigerten Lokalreaktionen (> Grad 1) betrug n = 77 entsprechend 15,2 % aller Injektionen. Hiervon waren 68 (88 %) Sofortphasenreaktionen, 8 (11 %) Spätphasenreaktionen und 1 (1 %) sowohl Sofort- als auch Spätphasenreaktionen. Von allen übersteigerten Lokalreaktionen waren 48 (62 %) Grad-1-Reaktionen, 15 (20 %) Grad-2-Reaktionen, 13 (17 %) Grad-3-Reaktionen und eine (1 %) Grad-4-Reaktion. Die Gesamtzahl der systemischen Reaktionen betrug n = 22 entsprechend 4,3 % aller Injektionen. Hiervon waren 19 (86 %) Sofortphasenreaktionen, 3 (14 %) Spätphasenreaktionen. Von allen systemischen Reaktionen wurden 18 (82 %) dem Stadium 1 zugeordnet und 4 (18 %) dem Stadium 2. Reaktionen entsprechend Stadium 3 und 4 wurden nicht beobachtet.

Es bestanden keine Alters- oder Geschlechtsabhängigkeiten hinsichtlich des Auftretens übersteigerter Lokalreaktionen und/oder systemischer Reaktionen (alle p > 0,05).

Schlussfolgerungen: Art und Anzahl der unerwünschten Reaktionen bei dem verwendeten Cluster-SIT-Schema entsprechen somit dem bei anderen Schemata üblichen Rahmen. Die Verwendung von Allergoiden erlaubt zudem eine Durchführung der Dosissteigerungsphase in lediglich 2 Behandlungstagen. Unter Sicherheitsaspekten könnte daher die Cluster-SIT zu einer interessanten Alternative herkömmlicher Therapieschemata für die Dosissteigerungsphase werden.

Abstract

Background: Specific immunotherapy (SIT) represents the only specific treatment that can be offered to allergic patients apart from allergen avoidance. SIT has been widely used in pollen allergic rhinitis. Clinical efficacy has been demonstrated in several controlled clinical trials and depends on the specific allergen the individual patient is sensitive to, the quality and total amount of allergen applied, and the SIT schedule. In classic SIT, gradually increasing dosages of the allergen extract are injected subcutaneously. Several dosage schedules for subcutaneous SIT can be applied. In Cluster-SIT, 2 - 3 injections per day of treatment are given once a week during induction treatment.

Patients: In this study, we investigated 64 patients (33 female, 31 male) from 18 to 54 years (26.9 ± 5.1 years) in terms of side-effects of Cluster-SIT during induction treatment.

Results: The total amount of enlarged local reactions (> grade 1) was n = 77 or 15.2 % of all injections. Of these, 68 (88 %) were classified as immediate reactions, 8 (11 %) were late phase reactions and 1 (1 %) was immediate as well as late phase reaction. Of all enlarged local reactions, 48 (62 %) were grade 1 reactions, 13 (17 %) were grade 2 reactions, 13 (17 %) were grade 3 reactions and 1 (1 %) was a grade 4 reaction. The total amount of systemic reactions was n = 22 or 4.3 % of all injections. Of these, 19 (86 %) were classified as immediate reactions, 3 (14 %) were delayed reactions. Of all systemic reactions, 18 (82 %) were grade 1 reactions and 4 (18 %) grade 2 reactions. Grade 3 or grade 4 reactions did not occur. There were no differences in gender or age regarding the occurrence of side effects (all p > 0.05).

Conclusions: Frequency and severity of adverse side effects in Cluster-SIT correspond to those in other dosage schedules. On behalf of security aspects, Cluster-SIT could become an interesting alternative dosage schedule for dose increase during SIT. Furthermore, in Cluster-SIT with allergoids, induction treatment can be carried out in two treatment days of approximately 2.5 hours each.

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Prof. Dr. med. Ludger Klimek

HNO-Heilkunde, Allergologie, Umweltmedizin · An den Quellen 10 · 65183 Wiesbaden

Email: Ludger.Klimek@t-online.de