Allergen immunotherapy in MASK-air users in real-life: Results of a Bayesian mixed-effects model


Sousa-Pinto B. Azevedo L.F. Sá-Sousa A. Vieira R.J. Amaral R. Klimek L. Czarlewski W. Anto J.M. Bedbrook A. Kvedariene V. Ventura M.T. Ansotegui I.J. Bergmann K.-C. Brussino L. Canonica G.W. Cardona V. Carreiro-Martins P. Casale T. Cecchi L. Chivato T. Chu D.K. Cingi C. Costa E.M. Cruz A.A. De Feo G. Devillier P. Fokkens W.J. Gaga M. Gemicioğlu B. Haahtela T. Ivancevich J.C. Ispayeva Z. Jutel M. Kuna P. Kaidashev I. Kraxner H. Larenas-Linnemann D.E. Laune D. Lipworth B. Louis R. Makris M. Monti R. Morais-Almeida M. Mösges R. Mullol J. Odemyr M. Okamoto Y. Papadopoulos N.G. Patella V. Pham-Thi N. Regateiro F.S. Reitsma S. Rouadi P.W. Samolinski B. Sova M. Todo-Bom A. Taborda-Barata L. Tomazic P.V. Toppila-Salmi S. Sastre J. Tsiligianni I. Valiulis A. Wallace D. Waserman S. Yorgancioglu A. Zidarn M. Zuberbier T. Fonseca J.A. Bousquet J. Pfaar O.
March 2022John Wiley and Sons Inc

Clinical and Translational Allergy
2022#12Issue 3

Background: Evidence regarding the effectiveness of allergen immunotherapy (AIT) on allergic rhinitis has been provided mostly by randomised controlled trials, with little data from real-life studies. Objective: To compare the reported control of allergic rhinitis symptoms in three groups of users of the MASK-air® app: those receiving sublingual AIT (SLIT), those receiving subcutaneous AIT (SCIT), and those receiving no AIT. Methods: We assessed the MASK-air® data of European users with self-reported grass pollen allergy, comparing the data reported by patients receiving SLIT, SCIT and no AIT. Outcome variables included the daily impact of allergy symptoms globally and on work (measured by visual analogue scales—VASs), and a combined symptom-medication score (CSMS). We applied Bayesian mixed-effects models, with clustering by patient, country and pollen season. Results: We analysed a total of 42,756 days from 1,093 grass allergy patients, including 18,479 days of users under AIT. Compared to no AIT, SCIT was associated with similar VAS levels and CSMS. Compared to no AIT, SLIT-tablet was associated with lower values of VAS global allergy symptoms (average difference = 7.5 units out of 100; 95% credible interval [95%CrI] = −12.1;−2.8), lower VAS Work (average difference = 5.0; 95%CrI = −8.5;−1.5), and a lower CSMS (average difference = 3.7; 95%CrI = −9.3;2.2). When compared to SCIT, SLIT-tablet was associated with lower VAS global allergy symptoms (average difference = 10.2; 95%CrI = −17.2;−2.8), lower VAS Work (average difference = 7.8; 95%CrI = −15.1;0.2), and a lower CSMS (average difference = 9.3; 95%CrI = −18.5;0.2). Conclusion: In patients with grass pollen allergy, SLIT-tablet, when compared to no AIT and to SCIT, is associated with lower reported symptom severity. Future longitudinal studies following internationally-harmonised standards for performing and reporting real-world data in AIT are needed to better understand its ‘real-world’ effectiveness.

allergic rhinitis , immunotherapy , mobile health , patient-reported outcomes , real-life data analysis

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MEDCIDS—Department of Community Medicine, Information and Health Decision Sciences, Faculty of Medicine, University of Porto, Porto, Portugal
CINTESIS—Center for Health Technology and Services Research, University of Porto, Porto, Portugal
Department of Otolaryngology, Head and Neck Surgery, Universitätsmedizin Mainz, Mainz, Germany
Center for Rhinology and Allergology, Wiesbaden, Germany
Medical Consulting Czarlewski, Levallois, France
MASK-air, Montpellier, France
ISGlobal, Barcelona Institute for Global Health, Barcelona, Spain
IMIM (Hospital del Mar Medical Research Institute), Barcelona, Spain
Universitat Pompeu Fabra (UPF), Barcelona, Spain
CIBER Epidemiología y Salud Pública (CIBERESP), Barcelona, Spain
Institute of Biomedical Sciences, Department of Pathology, Faculty of Medicine, Vilnius University, Vilnius, Lithuania
Institute of Clinical Medicine, Clinic of Chest Diseases and Allergology, Faculty of Medicine, Vilnius University, Vilnius, Lithuania
University of Bari Medical School, Unit of Geriatric Immunoallergology, Bari, Italy
Department of Allergy and Immunology, Hospital Quirónsalud Bizkaia, Bilbao, Spain
Institute of Allergology, Charité—Universitätsmedizin Berlin, Berlin, Germany
Corporate Member of Freie Universität Berlin, Berlin, Germany
Humboldt-Universität zu Berlin, Berlin, Germany
Department of Medical Sciences, Allergy and Clinical Immunology Unit, University of Torino & Mauriziano Hospital, Torino, Italy
Department of Biomedical Sciences, Humanitas University, Pieve Emanuele, Italy
Personalized Medicine, Asthma and Allergy, Humanitas Clinical and Research Center IRCCS, Rozzano, Italy
Allergy Section, Department of Internal Medicine, Hospital Vall dHebron & ARADyAL Research Network, Barcelona, Spain
Serviço de Imunoalergologia, Hospital de Dona Estefânia, Centro Hospitalar Universitário de Lisboa Central, Lisbon, Portugal
NOVA Medical School/Comprehensive Health Research Centre (CHRC), Lisbon, Portugal
Division of Allergy/immunology, University of South Florida, Tampa, FL, United States
SOS Allergology and Clinical Immunology, USL Toscana Centro, Prato, Italy
School of Medicine, University CEU San Pablo, Madrid, Spain
Department of Medicine and Health Research Methods, Evidence & Impact, McMaster University, Hamilton, ON, Canada
Eskisehir Osmangazi University, Medical Faculty, ENT Department, Eskisehir, Turkey
UCIBIO, REQUINTE, Faculty of Pharmacy and Competence Center on Active and Healthy Ageing of University of Porto (Porto4Ageing), Porto, Portugal
Fundaçao ProAR, Federal University of Bahia, Bahia, Salvador, Brazil
GARD/WHO Planning Group, Bahia, Salvador, Brazil
Department of Medicine, Surgery and Dentistry ‘Scuola Medica Salernitana’, University of Salerno, Salerno, Italy
VIM Suresnes, UMR_0892, Pôle des Maladies des Voies Respiratoires, Hôpital Foch, Université Paris-Saclay, Suresnes, France
Department of Otorhinolaryngology, Amsterdam University Medical Centres, location AMC, Amsterdam, Netherlands
ERS President 2017−2018, Athens Chest Hospital, 7th Respiratory Medicine Department and Asthma Center, Athens, Greece
Department of Pulmonary Diseases, Istanbul University-Cerrahpasa, Cerrahpasa Faculty of Medicine, Istanbul, Turkey
Skin and Allergy Hospital, Helsinki University Hospital, University of Helsinki, Helsinki, Finland
Servicio de Alergia e Immunologia, Clinica Santa Isabel, Buenos Aires, Argentina
Department of Allergology and Clinical Immunology of the Kazakh National Medical University, Almaty, Kazakhstan
Department of Clinical Immunology, Wrocław Medical University, Wroclaw, Poland
ALL-MED Medical Research Institute, Wroclaw, Poland
Division of Internal Medicine, Asthma and Allergy, Barlicki University Hospital, Medical University of Lodz, Lodz, Poland
Poltava State Medical University, Poltava, Ukraine
Department of Otorhinolaryngology, Head and Neck Surgery, Semmelweis University, Budapest, Hungary
Center of Excellence in Asthma and Allergy, Médica Sur Clinical Foundation and Hospital, México City, Mexico
KYomed INNOV, Montpellier, France
Scottish Centre for Respiratory Research, Cardiovascular & Diabetes Medicine, Medical Research Institute, Ninewells Hospital, University of Dundee, Dundee, United Kingdom
Department of Pulmonary Medicine, CHU Sart-Tilman, Liege, Belgium
GIGA I3 Research Group, Liege, Belgium
Allergy Unit ‘D Kalogeromitros’, 2nd Department of Dermatology and Venereology, National & Kapodistrian University of Athens, ‘Attikon’ University Hospital, Chaidari, Greece
Department of Cardiovascular and Thoracic Sciences, Fondazione Policlinico Universitario A Gemelli IRCCS, Università Cattolica del Sacro Cuore, Rome, Italy
Allergy Center, CUF Descobertas Hospital, Lisbon, Portugal
ClinCompetence Cologne GmbH, Cologne, Germany
IMSB, Medical Faculty, University of Cologne, Cologne, Germany
Rhinology Unit & Smell Clinic, ENT Department, Hospital Clínic, Barcelona, Spain
Clinical & Experimental Respiratory Immunoallergy, IDIBAPS, CIBERES, University of Barcelona, Barcelona, Spain
EFA European Federation of Allergy and Airways Diseases Patients Associations, Brussels, Belgium
Department of Otorhinolaryngology, Chiba University Hospital, Chiba, Japan
Allergy Department, 2nd Pediatric Clinic, University of Athens, Athens, Greece
Division of Allergy and Clinical Immunology, Department of Medicine, Agency of Health ASL Salerno, ‘Santa Maria della Speranza’ Hospital, Salerno, Italy
Ecole Polytechnique Palaiseau, IRBA (Institut de Recherche bio-Médicale des Armées), Bretigny, France
Department of Otolaryngology-Head and Neck Surgery, Eye and Ear University Hospital, Beirut, Lebanon
ENT Department, Dar Al Shifa Hospital, Salmiya, Kuwait
Department of Prevention of Environmental Hazards, Allergology and Immunology, Medical University of Warsaw, Warsaw, Poland
Department of Pulmonary Medicine and Tuberculosis, University Hospital Brno, Liskovec, Czech Republic
Faculty of Health Sciences, University of Beira Interior, Covilhã, Portugal
UBIAir—Clinical & Experimental Lung Centre, University of Beira Interior, Covilhã, Portugal
Department of Immunoallergology, Cova da Beira University Hospital Centre, Covilhã, Portugal
Department of General ORL, H&NS, Medical University of Graz, ENT-University Hospital Graz, Graz, Austria
Fundacion Jimenez Diaz, CIBERES, Faculty of Medicine, Autonoma University of Madrid, Madrid, Spain
Health Planning Unit, Department of Social Medicine, Faculty of Medicine, University of Crete, Rethymno, Greece
International Primary Care Respiratory Group IPCRG, Aberdeen, United Kingdom
Institute of Clinical Medicine and Institute of Health Sciences, Medical Faculty of Vilnius University, Vilnius, Lithuania
Nova Southeastern University, Fort Lauderdale, FL, United States
Department of Medicine, Clinical Immunology and Allergy, McMaster University, Hamilton, ON, Canada
Department of Pulmonology, Celal Bayar University, Manisa, Turkey
University Clinic of Respiratory and Allergic Diseases, Golnik, Slovenia
University of Ljubljana, Faculty of Medicine, Ljubljana, Slovenia
Fraunhofer Institute for Translational Medicine and Pharmacology ITMP, Allergology and Immunology, Berlin, Germany
Medicina, EDucação, I&D e Avaliação, Lda (MEDIDA), Porto, Portugal
University Hospital Montpellier, Montpellier, France
Department of Otorhinolaryngology, Head and Neck Surgery, Section of Rhinology and Allergy, University Hospital Marburg, Philipps-Universität Marburg, Marburg, Germany

MEDCIDS—Department of Community Medicine
CINTESIS—Center for Health Technology and Services Research
Department of Otolaryngology
Center for Rhinology and Allergology
Medical Consulting Czarlewski
MASK-air
ISGlobal
IMIM (Hospital del Mar Medical Research Institute)
Universitat Pompeu Fabra (UPF)
CIBER Epidemiología y Salud Pública (CIBERESP)
Institute of Biomedical Sciences
Institute of Clinical Medicine
University of Bari Medical School
Department of Allergy and Immunology
Institute of Allergology
Corporate Member of Freie Universität Berlin
Humboldt-Universität zu Berlin
Department of Medical Sciences
Department of Biomedical Sciences
Personalized Medicine
Allergy Section
Serviço de Imunoalergologia
NOVA Medical School/Comprehensive Health Research Centre (CHRC)
Division of Allergy/immunology
SOS Allergology and Clinical Immunology
School of Medicine
Department of Medicine and Health Research Methods
Eskisehir Osmangazi University
UCIBIO
Fundaçao ProAR
GARD/WHO Planning Group
Department of Medicine
VIM Suresnes
Department of Otorhinolaryngology
ERS President 2017−2018
Department of Pulmonary Diseases
Skin and Allergy Hospital
Servicio de Alergia e Immunologia
Department of Allergology and Clinical Immunology of the Kazakh National Medical University
Department of Clinical Immunology
ALL-MED Medical Research Institute
Division of Internal Medicine
Poltava State Medical University
Department of Otorhinolaryngology
Center of Excellence in Asthma and Allergy
KYomed INNOV
Scottish Centre for Respiratory Research
Department of Pulmonary Medicine
GIGA I3 Research Group
Allergy Unit ‘D Kalogeromitros’
Department of Cardiovascular and Thoracic Sciences
Allergy Center
ClinCompetence Cologne GmbH
IMSB
Rhinology Unit & Smell Clinic
Clinical & Experimental Respiratory Immunoallergy
EFA European Federation of Allergy and Airways Diseases Patients Associations
Department of Otorhinolaryngology
Allergy Department
Division of Allergy and Clinical Immunology
Ecole Polytechnique Palaiseau
Department of Otolaryngology-Head and Neck Surgery
ENT Department
Department of Prevention of Environmental Hazards
Department of Pulmonary Medicine and Tuberculosis
Faculty of Health Sciences
UBIAir—Clinical & Experimental Lung Centre
Department of Immunoallergology
Department of General ORL
Fundacion Jimenez Diaz
Health Planning Unit
International Primary Care Respiratory Group IPCRG
Institute of Clinical Medicine and Institute of Health Sciences
Nova Southeastern University
Department of Medicine
Department of Pulmonology
University Clinic of Respiratory and Allergic Diseases
University of Ljubljana
Fraunhofer Institute for Translational Medicine and Pharmacology ITMP
Medicina
University Hospital Montpellier
Department of Otorhinolaryngology

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