PMID- 32829329 OWN - NLM STAT- MEDLINE DCOM- 20210126 LR - 20210126 IS - 1423-0097 (Electronic) IS - 1018-2438 (Print) IS - 1018-2438 (Linking) VI - 181 IP - 10 DP - 2020 TI - Effect of Specific Immunoglobulin E Response and Comorbidities on Effectiveness of MP-AzeFlu in a Real-Life Study. PG - 754-764 LID - 10.1159/000508749 [doi] AB - 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. CI - (c) 2020 The Author(s) Published by S. Karger AG, Basel. FAU - Klimek, Ludger AU - Klimek L AD - Zentrum fur Rhinologie und Allergologie, Wiesbaden, Germany, ludger.klimek@allergiezentrum.org. FAU - Price, David AU - Price D AD - Primary Care Respiratory Medicine, University of Aberdeen, Aberdeen, United Kingdom. FAU - Galffy, Gabriella AU - Galffy G AD - Pulmonology Hospital, Torokbalint, Hungary. FAU - Emmeluth, Melanie AU - Emmeluth M AD - MEDA Pharma GmbH & Co. KG (A Mylan Co.), Bad Homburg, Germany. FAU - Koltun, Arkady AU - Koltun A AD - Mylan, Inc., Canonsburg, Pennsylvania, USA. FAU - Kopietz, Ferdinand AU - Kopietz F AD - MEDA Pharma GmbH & Co. KG (A Mylan Co.), Bad Homburg, Germany. FAU - Nguyen, Duc Tung AU - Nguyen DT AD - MEDA Pharma GmbH & Co. KG (A Mylan Co.), Bad Homburg, Germany. FAU - van Weissenbruch, Ranny AU - van Weissenbruch R AD - Wilhelmina Ziekenhuis Assen, Assen, The Netherlands. FAU - Pohl, Wolfgang AU - Pohl W AD - Karl Landsteiner Gesellschaft, Institut fur Klinische und Experimentelle Pneumologie, Vienna, Austria. FAU - Kuhl, Hans-Christian AU - Kuhl HC AD - MEDA Pharma GmbH & Co. KG (A Mylan Co.), Bad Homburg, Germany. FAU - Scadding, Glenis AU - Scadding G AD - Royal National Throat, Nose and Ear Hospital, London, United Kingdom. FAU - Mullol, Joaquim AU - Mullol J AD - Rhinology Unit & Smell Clinic, ENT Department, Hospital Clinic Barcelona, IDIBAPS, Universitat de Barcelona, CIBERES, Barcelona, Spain. LA - eng PT - Journal Article PT - Multicenter Study DEP - 20200821 PL - Switzerland TA - Int Arch Allergy Immunol JT - International archives of allergy and immunology JID - 9211652 RN - 0 (Drug Combinations) RN - 0 (Nasal Sprays) RN - 0 (Phthalazines) RN - 37341-29-0 (Immunoglobulin E) RN - CUT2W21N7U (Fluticasone) RN - ZQI909440X (azelastine) SB - IM MH - Administration, Intranasal MH - Adult MH - Comorbidity MH - Drug Combinations MH - Female MH - Fluticasone/*therapeutic use MH - Humans MH - Immunoglobulin E/*metabolism MH - Male MH - Middle Aged MH - Nasal Sprays MH - Phenotype MH - Phthalazines/*therapeutic use MH - Prospective Studies MH - Quality of Life MH - Rhinitis, Allergic/diagnosis/*drug therapy MH - Severity of Illness Index MH - Treatment Outcome MH - Visual Analog Scale MH - Young Adult PMC - PMC7592928 OTO - NOTNLM OT - Allergic rhinitis OT - Allergic rhinitis phenotype OT - Comorbidities OT - Immunoglobulin E response OT - Visual analog scale COIS- L.K. worked as a paid consultant for Allergopharma, MEDA/Mylan, HAL Allergie, ALK Abello, and LET! Pharma and has received financial grants from Allergopharma, ALK Abello, Allergy Therapeutics, Stallergenes, Quintiles, HAL Allergie, LET! Pharma, Sanofi, AstraZeneca, GSK, ASIT Biotech, and Lofarma. D.P. has board membership with Amgen, AstraZeneca, Boehringer Ingelheim, Chiesi, Circassia, Mylan, Mundipharma, Napp, Novartis, Regeneron Pharmaceuticals, Sanofi Genzyme, and Teva Pharmaceuticals; consultancy agreements with Amgen, AstraZeneca, Boehringer Ingelheim, Chiesi, GlaxoSmithKline, Mylan, Mundipharma, Napp, Novartis, Pfizer, Teva Pharmaceuticals, and Theravance; grants and unrestricted funding for investigator-initiated studies (conducted through Observational & Pragmatic Research Institute Pte Ltd.) from AKL Research and Development Ltd., AstraZeneca, Boehrin-ger Ingelheim, British Lung Foundation, Chiesi, Circassia, Mylan, Mundipharma, Napp, Novartis, Pfizer, Regeneron Pharmaceuticals, Respiratory Effectiveness Group, Sanofi Genzyme, Teva Pharmaceuticals, Theravance, UK National Health Service, and Zentiva (Sanofi Generics); payment for lectures/speaking engagements from AstraZeneca, Boehringer Ingelheim, Chiesi, Cipla, GlaxoSmithKline, Kyorin, Mylan, Merck, Mundipharma, Novartis, Pfizer, Regeneron Pharmaceuticals, Sanofi Genzyme, and Teva Pharmaceuticals; payment for manuscript preparation from Mundipharma and Teva Pharmaceuticals; payment for the development of educational materials from Mundipharma and Novartis; payment for travel/accommodation/meeting expenses from AstraZeneca, Boehringer Ingelheim, Circassia, Mundipharma, Napp, Novartis, and Teva Pharmaceuticals; funding for patient enrollment or completion of research from Chiesi, Novartis, Teva Pharmaceuticals, and Zentiva (Sanofi Generics); stock/stock options from AKL Research and Development Ltd., which produces phytopharmaceuticals; owns 74% of the social enterprise Optimum Patient Care Ltd (Australia and UK) and 74% of Observational & Pragmatic Research Institute Pte. Ltd. (Singapore); and is peer reviewer for grant committees of the Efficacy and Mechanism Evaluation Programme and Health Technology Assessment. G.G. was a paid consultant and speaker for AstraZeneca, Chiesi, BMS, MSD, Berlin Chemi, Boehringer Ingelheim, Roche, Novartis, Pfizer, Orion, including Ipsen, and Mylan as speaker. M.E. is an employee of MEDA Pharma GmbH & Co. KG (a Mylan Company). A.K. is a Mylan, Inc. employee and shareholder. AK has also been employed at Novartis and Lundbeck pharmaceutical companies. F.K. is an employee of MEDA Pharma GmbH & Co. KG (a Mylan Company). D.T.N. is an employee of MEDA Pharma GmbH & Co. KG (a Mylan Company). R.V.W. has nothing to disclose. W.P. has been a paid speaker for and worked as a paid consultant for AstraZeneca, Boehringer lngelheim, Chiesi, GSK, Novartis, and TEVA. H.K. worked as a paid consultant for AstraZeneca, Boehringer lngelheim, Chiesi, GSK, and Novartis. G.S. has received financial grants from GSK for mepolizumab study and has worked as a paid consultant and speaker for Meda/Mylan and ALK-Abello. J.M. has conducted research/received research grant support from MYLAN-MEDA Pharma, URIACH Group, GSK, MSD, FAES, UCB; received consultancy fees from MYLAN-MEDA Pharma, URIACH Group, Allakos, ALK-Abello, Genentech - Roche, Novartis, Regeneron, Sanofi Genzyme, GSK, MSD, Harlington Pharmaceuticals, and UCB; and has worked as paid instructor for Novartis and as speaker for MYLAN-MEDA Pharma, URIACH Group, and Genentech - Roche. EDAT- 2020/08/24 06:00 MHDA- 2021/01/27 06:00 PMCR- 2020/08/21 CRDT- 2020/08/24 06:00 PHST- 2020/05/14 00:00 [received] PHST- 2020/05/19 00:00 [accepted] PHST- 2020/08/24 06:00 [pubmed] PHST- 2021/01/27 06:00 [medline] PHST- 2020/08/24 06:00 [entrez] PHST- 2020/08/21 00:00 [pmc-release] AID - 000508749 [pii] AID - iaa-0181-0754 [pii] AID - 10.1159/000508749 [doi] PST - ppublish SO - Int Arch Allergy Immunol. 2020;181(10):754-764. doi: 10.1159/000508749. Epub 2020 Aug 21.