Kristian Kruse1, Eva Gerwin1, Andrea Eichel1, Kija Shah-Hosseini1, Ralph Mösges2. 1. Institute of Medical Statistics, Informatics and Epidemiology, University Hospital of Cologne, Cologne, Germany. 2. Institute of Medical Statistics, Informatics and Epidemiology, University Hospital of Cologne, Cologne, Germany. Electronic address: ralph@moesges.de.
Abstract
BACKGROUND: No parameters currently exist that can reliably predict the impact of preseasonal immunotherapy on the symptoms occurring during the season. OBJECTIVE: The purpose of our studies was to prove a correlation between preseasonal conjunctival allergen challenge and coseasonal primary clinical endpoints using the total combined score, ie, a combination of symptoms and medication score, as the primary outcome parameter. METHODS: Twelve weeks before both the birch and the grass pollen seasons, 2 separate prospective, double-blind, randomized, controlled studies were conducted followed by posttrial observations for each study during the active season. In the studies, patients who reacted to conjunctival allergen challenge were treated with sublingual immunotherapy tablets that contain either birch and/or alder or grass pollen allergoids. RESULTS: In all, 158 patients were included in the grass and 160 in the tree pollen study; of these, 100 and 109 patients, respectively, took part in the posttrial observations. When comparing patients with and without a positive reaction in the final conjunctival allergen challenge, the results revealed a significant difference in the total combined score (grass: P < .001; birch: P = .025). The same applied to the rescue medication score (P = .005; P = .025). A significant difference regarding the rhinoconjunctivitis symptom score was shown in the grass pollen study (P = .002), and the difference of well days was significant in the tree pollen study (P = .049). CONCLUSION: When comparing patients based on their reaction to allergen challenge after immunotherapy, each study leads to similarly significant results. Therefore, conjunctival allergen challenge can be used effectively as a parameter to predict allergic rhinoconjunctivitis symptoms during the season in patients treated with preseasonal sublingual immunotherapy tablets. Whether this can be transferred to untreated patients needs to be determined.
RCT Entities:
BACKGROUND: No parameters currently exist that can reliably predict the impact of preseasonal immunotherapy on the symptoms occurring during the season. OBJECTIVE: The purpose of our studies was to prove a correlation between preseasonal conjunctival allergen challenge and coseasonal primary clinical endpoints using the total combined score, ie, a combination of symptoms and medication score, as the primary outcome parameter. METHODS: Twelve weeks before both the birch and the grass pollen seasons, 2 separate prospective, double-blind, randomized, controlled studies were conducted followed by posttrial observations for each study during the active season. In the studies, patients who reacted to conjunctival allergen challenge were treated with sublingual immunotherapy tablets that contain either birch and/or alder or grass pollen allergoids. RESULTS: In all, 158 patients were included in the grass and 160 in the tree pollen study; of these, 100 and 109 patients, respectively, took part in the posttrial observations. When comparing patients with and without a positive reaction in the final conjunctival allergen challenge, the results revealed a significant difference in the total combined score (grass: P < .001; birch: P = .025). The same applied to the rescue medication score (P = .005; P = .025). A significant difference regarding the rhinoconjunctivitis symptom score was shown in the grass pollen study (P = .002), and the difference of well days was significant in the tree pollen study (P = .049). CONCLUSION: When comparing patients based on their reaction to allergen challenge after immunotherapy, each study leads to similarly significant results. Therefore, conjunctival allergen challenge can be used effectively as a parameter to predict allergic rhinoconjunctivitis symptoms during the season in patients treated with preseasonal sublingual immunotherapy tablets. Whether this can be transferred to untreated patients needs to be determined.
Authors: R Mösges; A F Koch; E Raskopf; J Singh; K Shah-Hosseini; A Astvatsatourov; B Hauswald; Y Yarin; F Corazza; L Haazen; S Pirotton; S Allekotte; G Zadoyan; T Legon; S R Durham; M H Shamji Journal: Allergy Date: 2018-02-13 Impact factor: 13.146
Authors: R Mösges; E M Kasche; E Raskopf; J Singh; L Sohlich; A Astvatsatourov; K Shah-Hosseini; S Pirotton; L Haazen; S R Durham; T Legon; G Zadoyan; M H Shamji Journal: Allergy Date: 2017-12-22 Impact factor: 13.146
Authors: M Worm; T Higenbottam; O Pfaar; R Mösges; W Aberer; K Gunawardena; D Wessiepe; D Lee; M F Kramer; M Skinner; B Lees; S Zielen Journal: Allergy Date: 2018-06-19 Impact factor: 13.146