Ludger Klimek1, David Price2, Gabriella Gálffy3, Melanie Emmeluth4, Arkady Koltun5, Ferdinand Kopietz4, Duc Tung Nguyen4, Ranny van Weissenbruch6, Wolfgang Pohl7, Hans-Christian Kuhl4, Glenis Scadding8, Joaquim Mullol9. 1. Zentrum für Rhinologie und Allergologie, Wiesbaden, Germany, ludger.klimek@allergiezentrum.org. 2. Primary Care Respiratory Medicine, University of Aberdeen, Aberdeen, United Kingdom. 3. Pulmonology Hospital, Törökbálint, Hungary. 4. MEDA Pharma GmbH & Co. KG (A Mylan Co.), Bad Homburg, Germany. 5. Mylan, Inc., Canonsburg, Pennsylvania, USA. 6. Wilhelmina Ziekenhuis Assen, Assen, The Netherlands. 7. Karl Landsteiner Gesellschaft, Institut für Klinische und Experimentelle Pneumologie, Vienna, Austria. 8. Royal National Throat, Nose and Ear Hospital, London, United Kingdom. 9. Rhinology Unit & Smell Clinic, ENT Department, Hospital Clínic Barcelona, IDIBAPS, Universitat de Barcelona, CIBERES, Barcelona, Spain.
Abstract
INTRODUCTION: Phenotyping allergic rhinitis (AR) by immunoglobulin E (IgE) sensitivity and comorbidities may help characterize AR and provide a framework for treatment decisions. METHODS: This prospective, noninterventional study evaluated the effectiveness of MP-AzeFlu (azelastine hydrochloride plus fluticasone propionate intranasal spray formulation) across AR phenotypes. Patients with moderate-to--severe seasonal or perennial AR for whom MP-AzeFlu was prescribed were enrolled. AR subpopulations (ARPs) were assigned based on the classification of IgE response and comorbidities. AR symptoms over the previous 24 h were documented using an AR visual analog scale (AR-VAS), with ratings from "not at all bothersome" (0 mm) to "extremely bothersome" (100 mm), at the inclusion visit and on days 1, 3, 7, and the last day of the study (approximately day 14). AR quality-of-life measures were recorded using a VAS. RESULTS: A total of 1,103 patients with AR were included. Mean baseline AR-VAS scores ranged from 70.3 to 75.1 mm (severe) across ARPs. In the overall population, 86.6% of patients responded to treatment (AR-VAS score <50 mm on ≥1 days). In the ARPs, response rates ranged from 79.3 to 89.6%. Mean reduction in AR-VAS scores ranged from 47.9 to 40.9 mm, a decrease from severe to mild across all ARPs. Quality-of-life VAS scores were similarly reduced in the total population and ARPs. DISCUSSION/ CONCLUSION: MP-AzeFlu treatment reduced VAS severity and quality-of-life scores from baseline in the total population and ARPs, supporting MP-AzeFlu as an effective treatment for all patients with moderate-to-severe AR, regardless of AR phenotype or comorbidities.
INTRODUCTION: Phenotyping allergic rhinitis (AR) by immunoglobulin E (IgE) sensitivity and comorbidities may help characterize AR and provide a framework for treatment decisions. METHODS: This prospective, noninterventional study evaluated the effectiveness of MP-AzeFlu (azelastine hydrochloride plus fluticasone propionate intranasal spray formulation) across AR phenotypes. Patients with moderate-to--severe seasonal or perennial AR for whom MP-AzeFlu was prescribed were enrolled. AR subpopulations (ARPs) were assigned based on the classification of IgE response and comorbidities. AR symptoms over the previous 24 h were documented using an AR visual analog scale (AR-VAS), with ratings from "not at all bothersome" (0 mm) to "extremely bothersome" (100 mm), at the inclusion visit and on days 1, 3, 7, and the last day of the study (approximately day 14). AR quality-of-life measures were recorded using a VAS. RESULTS: A total of 1,103 patients with AR were included. Mean baseline AR-VAS scores ranged from 70.3 to 75.1 mm (severe) across ARPs. In the overall population, 86.6% of patients responded to treatment (AR-VAS score <50 mm on ≥1 days). In the ARPs, response rates ranged from 79.3 to 89.6%. Mean reduction in AR-VAS scores ranged from 47.9 to 40.9 mm, a decrease from severe to mild across all ARPs. Quality-of-life VAS scores were similarly reduced in the total population and ARPs. DISCUSSION/ CONCLUSION:MP-AzeFlu treatment reduced VAS severity and quality-of-life scores from baseline in the total population and ARPs, supporting MP-AzeFlu as an effective treatment for all patients with moderate-to-severe AR, regardless of AR phenotype or comorbidities.
Authors: J Bousquet; N Khaltaev; A A Cruz; J Denburg; W J Fokkens; A Togias; T Zuberbier; C E Baena-Cagnani; G W Canonica; C van Weel; I Agache; N Aït-Khaled; C Bachert; M S Blaiss; S Bonini; L-P Boulet; P-J Bousquet; P Camargos; K-H Carlsen; Y Chen; A Custovic; R Dahl; P Demoly; H Douagui; S R Durham; R Gerth van Wijk; O Kalayci; M A Kaliner; Y-Y Kim; M L Kowalski; P Kuna; L T T Le; C Lemiere; J Li; R F Lockey; S Mavale-Manuel; E O Meltzer; Y Mohammad; J Mullol; R Naclerio; R E O'Hehir; K Ohta; S Ouedraogo; S Palkonen; N Papadopoulos; G Passalacqua; R Pawankar; T A Popov; K F Rabe; J Rosado-Pinto; G K Scadding; F E R Simons; E Toskala; E Valovirta; P van Cauwenberge; D-Y Wang; M Wickman; B P Yawn; A Yorgancioglu; O M Yusuf; H Zar; I Annesi-Maesano; E D Bateman; A Ben Kheder; D A Boakye; J Bouchard; P Burney; W W Busse; M Chan-Yeung; N H Chavannes; A Chuchalin; W K Dolen; R Emuzyte; L Grouse; M Humbert; C Jackson; S L Johnston; P K Keith; J P Kemp; J-M Klossek; D Larenas-Linnemann; B Lipworth; J-L Malo; G D Marshall; C Naspitz; K Nekam; B Niggemann; E Nizankowska-Mogilnicka; Y Okamoto; M P Orru; P Potter; D Price; S W Stoloff; O Vandenplas; G Viegi; D Williams Journal: Allergy Date: 2008-04 Impact factor: 13.146
Authors: A Del Cuvillo; V Santos; J Montoro; J Bartra; I Davila; M Ferrer; I Jauregui; J Sastre; J Mullol; A Valero Journal: Rhinology Date: 2017-03-01 Impact factor: 3.681
Authors: Soyoung Hong; Dong Koog Son; Wan Ryung Lim; Sun Hang Kim; Hyunjung Kim; Hye Yung Yum; Hojang Kwon Journal: Environ Health Toxicol Date: 2012-02-13
Authors: Jan L Brożek; Jean Bousquet; Ioana Agache; Arnav Agarwal; Claus Bachert; Sinthia Bosnic-Anticevich; Romina Brignardello-Petersen; G Walter Canonica; Thomas Casale; Niels H Chavannes; Jaime Correia de Sousa; Alvaro A Cruz; Carlos A Cuello-Garcia; Pascal Demoly; Mark Dykewicz; Itziar Etxeandia-Ikobaltzeta; Ivan D Florez; Wytske Fokkens; Joao Fonseca; Peter W Hellings; Ludger Klimek; Sergio Kowalski; Piotr Kuna; Kaja-Triin Laisaar; Désirée E Larenas-Linnemann; Karin C Lødrup Carlsen; Peter J Manning; Eli Meltzer; Joaquim Mullol; Antonella Muraro; Robyn O'Hehir; Ken Ohta; Petr Panzner; Nikolaos Papadopoulos; Hae-Sim Park; Gianni Passalacqua; Ruby Pawankar; David Price; John J Riva; Yetiani Roldán; Dermot Ryan; Behnam Sadeghirad; Boleslaw Samolinski; Peter Schmid-Grendelmeier; Aziz Sheikh; Alkis Togias; Antonio Valero; Arunas Valiulis; Erkka Valovirta; Matthew Ventresca; Dana Wallace; Susan Waserman; Magnus Wickman; Wojtek Wiercioch; Juan José Yepes-Nuñez; Luo Zhang; Yuan Zhang; Mihaela Zidarn; Torsten Zuberbier; Holger J Schünemann Journal: J Allergy Clin Immunol Date: 2017-06-08 Impact factor: 10.793
Authors: Jean Bousquet; Holger J Schünemann; Akdis Togias; Claus Bachert; Martina Erhola; Peter W Hellings; Ludger Klimek; Oliver Pfaar; Dana Wallace; Ignacio Ansotegui; Ioana Agache; Anna Bedbrook; Karl-Christian Bergmann; Mike Bewick; Philippe Bonniaud; Sinthia Bosnic-Anticevich; Isabelle Bossé; Jacques Bouchard; Louis-Philippe Boulet; Jan Brozek; Guy Brusselle; Moises A Calderon; Walter G Canonica; Luis Caraballo; Vicky Cardona; Thomas Casale; Lorenzo Cecchi; Derek K Chu; Elisio M Costa; Alvaro A Cruz; Wienczyslawa Czarlewski; Gennaro D'Amato; Philippe Devillier; Mark Dykewicz; Motohiro Ebisawa; Jean-Louis Fauquert; Wytske J Fokkens; Joao A Fonseca; Jean-François Fontaine; Bilun Gemicioglu; Roy Gerth van Wijk; Tari Haahtela; Susanne Halken; Despo Ierodiakonou; Tomohisa Iinuma; Juan-Carlos Ivancevich; Marek Jutel; Igor Kaidashev; Musa Khaitov; Omer Kalayci; Jorg Kleine Tebbe; Marek L Kowalski; Piotr Kuna; Violeta Kvedariene; Stefania La Grutta; Désirée Larenas-Linnemann; Susanne Lau; Daniel Laune; Lan Le; Philipp Lieberman; Karin C Lodrup Carlsen; Olga Lourenço; Gert Marien; Pedro Carreiro-Martins; Erik Melén; Enrica Menditto; Hugo Neffen; Gregoire Mercier; Ralph Mosgues; Joaquim Mullol; Antonella Muraro; Leyla Namazova; Ettore Novellino; Robyn O'Hehir; Yoshitaka Okamoto; Ken Ohta; Hae Sim Park; Petr Panzner; Giovanni Passalacqua; Nhan Pham-Thi; David Price; Graham Roberts; Nicolas Roche; Christine Rolland; Nelson Rosario; Dermot Ryan; Boleslaw Samolinski; Mario Sanchez-Borges; Glenis K Scadding; Mohamed H Shamji; Aziz Sheikh; Ana-Maria Todo Bom; Sanna Toppila-Salmi; Ioana Tsiligianni; Marylin Valentin-Rostan; Arunas Valiulis; Erkka Valovirta; Maria-Teresa Ventura; Samantha Walker; Susan Waserman; Arzu Yorgancioglu; Torsten Zuberbier Journal: J Allergy Clin Immunol Date: 2019-10-15 Impact factor: 10.793