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Immunological effects and tolerability of a new fast updosed immunologically enhanced subcutaneous immunotherapy formulation with optimized allergen/adjuvant ratio
Author(s) -
Pfaar O.,
Jung K.,
Wolf H.,
Decot E.,
KleineTebbe J.,
Klimek L.,
Wüstenberg E.
Publication year - 2012
Publication title -
allergy
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 3.363
H-Index - 173
eISSN - 1398-9995
pISSN - 0105-4538
DOI - 10.1111/j.1398-9995.2012.02801.x
Subject(s) - medicine , tolerability , adjuvant , adverse effect , allergen , asthma , clinical endpoint , chills , immunology , allergy , allergen immunotherapy , immunotherapy , gastroenterology , randomized controlled trial , immune system
Background Subcutaneous immunotherapy ( SCIT ) traditionally includes an updosing phase injecting increasing doses of allergen over a period of several weeks, followed by a maintenance phase. To establish shorter and more convenient updosing schedules, a fast updosed immunologically enhanced SCIT formulation has been developed by optimizing the allergen/adjuvant (aluminium hydroxide) ratio. Methods In a randomized, controlled, parallel‐group trial, patients with grass pollen induced rhinoconjunctivitis with/without asthma were treated with an immunologically enhanced SCIT formulation ( AVANZ , ALK , D enmark). The trial included updosing with five injections (300, 600, 3000, 6000 and 15 000 SQ +) injected either in weekly interval (Group 1) or in 3–4 days interval (Group 2) followed by two maintenance injections (15 000 SQ +), approximately 10 weeks treatment. The immunological effects (primary endpoint) and tolerability (secondary endpoint) of the updosing schedules were evaluated. Results Four hundred patients were treated (Group 1: 201, Group 2: 199). In both groups, an immunological response with statistically significant increases in levels of I g E ‐blocking factor, I g G 4 and I g E ( P < 0.001), was induced from baseline to end of trial. Most frequently reported adverse events were local injection site reactions such as injection site swellings (Group 1: 30% of patients, Group 2: 41% of patients). Other frequently reported adverse events included systemic reactions (Group 1: 21% of patients, Group 2: 33% of patients), primarily mild to moderate allergic rhinitis and urticaria. Conclusions Fast updosed immunologically enhanced SCIT with an optimized allergen/adjuvant ratio induced significant immunological effects and had an acceptable safety profile. Clinical efficacy will be investigated in future clinical trials.