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- Title
Dose-response relationship of a new Timothy grass pollen allergoid in comparison with a 6-grass pollen allergoid.
- Authors
Pfaar, O.; Hohlfeld, J. M.; Al‐Kadah, B.; Hauswald, B.; Homey, B.; Hunzelmann, N.; Schliemann, S.; Velling, P.; Worm, M.; Klimek, L.
- Abstract
Background Subcutaneous allergen immunotherapy with grass pollen allergoids has been proven to be effective and safe in the treatment of patients with allergic rhinoconjunctivitis. Based on the extensive cross-reactivity among Pooideae species, it has been suggested that grass pollen extracts could be prepared from a single species, rather than from a multiple species mixture. Objective To find the optimal dose of a Phleum pratense ( P. pratense) allergoid preparation and compare its efficacy and safety to a 6-grass pollen allergoid preparation. Methods In this double-blind, placebo-controlled study (Eudra CT: 2011-000674-58), three doses of P. pratense allergoid (1800 therapeutic units ( TU), standard-dose 6000 TU and 18 000 TU) were compared with placebo and the marketed 6-grass pollen allergoid (6000 TU). In a pre-seasonal dosing regimen, 102 patients were randomized to five treatment groups and received nine subcutaneous injections. The primary efficacy endpoint was the change in weal size (late-phase reaction [LPR]) in response to the intracutaneous testing ( ICT) before and after treatment, comparing the active allergoids to placebo. Secondary outcomes were the change in Total Nasal Symptom Score ( TNSS) assessed in the allergen exposure chamber ( AEC), the changes in P. pratense-serum-specific IgG4 and the incidence of adverse events ( AEs). Results All three doses of the P. pratense and the 6-grass pollen allergoid preparations were significantly superior to placebo for the primary outcome, whereas there were no significant differences in the change in TNSS. Compared to the standard-dose, the high-dose of P. pratense did not produce any additional significant benefit, but showed a slight increase in AEs. Yet this increase in AEs was lower than for the 6-grass pollen preparation. Conclusions & Clinical relevance The standard-dose of the new P. pratense allergoid was comparable to the marketed 6-grass pollen preparation at equal dose for the parameters measured.
- Subjects
GRASS pollen; ALLERGENS; IMMUNOTHERAPY; PHLEUM; ALLERGIC rhinitis
- Publication
Clinical & Experimental Allergy, 2017, Vol 47, Issue 11, p1445
- ISSN
0954-7894
- Publication type
Article
- DOI
10.1111/cea.12977