Moesges, R., Kasche, E. M., Raskopf, E., Singh, J., Sohlich, L., Astvatsatourov, A., Shah-Hosseini, K., Pirotton, S., Haazen, L., Durham, S. R., Legon, T., Zadoyan, G. and Shamji, M. H. (2018). A randomized, double-blind, placebo-controlled, dose-finding trial with Lolium perenne peptide immunotherapy. Allergy, 73 (4). S. 896 - 905. HOBOKEN: WILEY. ISSN 1398-9995
Full text not available from this repository.Abstract
BackgroundA novel subcutaneous allergen immunotherapy formulation (gpASIT+) containing Lolium perenne peptides (LPP) and having a short up-dosing phase has been developed to treat grass pollen-induced seasonal allergic rhinoconjunctivitis. We investigated peptide immunotherapy containing the hydrolysate from perennial ryegrass allergens for the optimum dose in terms of clinical efficacy, immunogenicity and safety. MethodsThis prospective, double-blind, placebo-controlled, phase IIb, parallel, four-arm, dose-finding study randomized 198 grass pollen-allergic adults to receive placebo or cumulative doses of 70, 170 or 370 g LPP. All patients received weekly subcutaneous injections, with the active treatment groups reaching assigned doses within 2, 3 and 4 weeks, respectively. Efficacy was assessed by comparing conjunctival provocation test (CPT) reactions at baseline, after 4 weeks and after completion. Grass pollen-specific immunoglobulins were analysed before and after treatment. ResultsConjunctival provocation test (CPT) response thresholds improved from baseline to V7 by at least one concentration step in 51.2% (170 g; P = .023), 46.3% (370 g), and 38.6% (70 g) of patients receiving LPP vs 25.6% of patients receiving placebo (modified per-protocol set). Also, 39% of patients in the 170-g group became nonreactive to CPT vs 18% in the placebo group. Facilitated allergen-binding assays revealed a highly significant (P < .001) dose-dependent reduction in IgE allergen binding across all treatment groups (70 g: 17.1%; 170 g: 18.8%; 370 g: 26.4%). Specific IgG(4) levels increased to 1.6-fold (70 g), 3.1-fold (170 g) and 3.9-fold (370 g) (mPP). ConclusionThree-week immunotherapy with 170 g LPP reduced CPT reactivity significantly and increased protective specific antibodies.
| Item Type: | Journal Article | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| URN: | urn:nbn:de:hbz:38-191017 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| DOI: | 10.1111/all.13358 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Journal or Publication Title: | Allergy | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Volume: | 73 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Number: | 4 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Page Range: | S. 896 - 905 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Date: | 2018 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Publisher: | WILEY | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Place of Publication: | HOBOKEN | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| ISSN: | 1398-9995 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Language: | English | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Faculty: | Unspecified | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Divisions: | Unspecified | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Subjects: | no entry | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Refereed: | Yes | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| URI: | http://kups.ub.uni-koeln.de/id/eprint/19101 |
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