Immunological effects and tolerability of a new fast updosed immunologically enhanced subcutaneous immunotherapy formulation with optimized allergen/adjuvant ratio
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 form...
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| Main Authors: | , |
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| Format: | Article (Journal) |
| Language: | English |
| Published: |
2012
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| In: |
Allergy
Year: 2012, Volume: 67, Issue: 5, Pages: 630-637 |
| ISSN: | 1398-9995 |
| DOI: | 10.1111/j.1398-9995.2012.02801.x |
| Online Access: | Verlag, Volltext: http://dx.doi.org/10.1111/j.1398-9995.2012.02801.x Verlag, Volltext: https://onlinelibrary.wiley.com/doi/abs/10.1111/j.1398-9995.2012.02801.x 
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| Author Notes: | O. Pfaar, K. Jung, H. Wolf, E. Decot, J. Kleine‐Tebbe, L. Klimek & E. Wüstenberg |
| Summary: | 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, Denmark). 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 IgE-blocking factor, IgG4 and IgE (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. |
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| Item Description: | Issue online: 11 April 2012 Gesehen am 25.06.2018 |
| Physical Description: | Online Resource |
| ISSN: | 1398-9995 |
| DOI: | 10.1111/j.1398-9995.2012.02801.x |