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

Bernardo Sousa-Pinto; Luís Filipe Azevedo; Ana Sá-Sousa; Rafael José Vieira; Rita Amaral; Ludger Klimek; Wienczyslawa Czarlewski; Josep M. Anto; Anna Bedbrook; Violeta Kvedariene; Maria Teresa Ventura; Ignacio J. Ansotegui; Karl-Christian Bergmann; Luisa Brussino; G. Walter Canonica; Victoria Cardona; Pedro Carreiro-Martins; Thomas Casale; Lorenzo Cecchi; Tomás Chivato; Derek K. Chu; Cemal Cingi; Elisio M. Costa; Alvaro A. Cruz; Giulia De Feo; Philippe Devillier; Wytske J. Fokkens; Mina Gaga; Bilun Gemicioğlu; Tari Haahtela; Juan Carlos Ivancevich; Zhanat Ispayeva; Marek Jutel; Piotr Kuna; Igor Kaidashev; Helga Kraxner; Désirée E Larenas-Linnemann; Daniel Laune; Brian Lipworth; Renaud Louis; Michaël Makris; Riccardo Monti; Mario Morais-Almeida; Ralph Mösges; Joaquim Mullol; Mikaëla Odemyr; Yoshitaka Okamoto; Nikolaos G. Papadopoulos; Vincenzo Patella; Nhân Pham-Thi; Frederico S Regateiro; Sietze Reitsma; Philip W. Rouadi; Boleslaw Samolinski; Milan Sova; Ana Todo-Bom; Luis Taborda-Barata; Peter Valentin Tomazic; Sanna Toppila-Salmi; Joaquin Sastre; Ioanna Tsiligianni; Arunas Valiulis; Dana Wallace; Susan Waserman; Arzu Yorgancioglu; Mihaela Zidarn; Torsten Zuberbier; João Almeida Fonseca; Jean Bousquet; Oliver Pfaar

doi:10.1002/clt2.12128

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

Bernardo Sousa-Pinto, Luís Filipe Azevedo, Ana Sá-Sousa, Rafael José Vieira, Rita Amaral, Ludger Klimek, Wienczyslawa Czarlewski, Josep M. Anto, Anna Bedbrook, Violeta Kvedariene, Maria Teresa Ventura, Ignacio J. Ansotegui, Karl-Christian Bergmann, Luisa Brussino, G. Walter Canonica, Victoria Cardona, Pedro Carreiro-Martins, Thomas Casale, Lorenzo Cecchi, Tomás ChivatoDerek K. Chu, Cemal Cingi, Elisio M. Costa, Alvaro A. Cruz, Giulia De Feo, Philippe Devillier, Wytske J. Fokkens, Mina Gaga, Bilun Gemicioğlu, Tari Haahtela, Juan Carlos Ivancevich, Zhanat Ispayeva, Marek Jutel, Piotr Kuna, Igor Kaidashev, Helga Kraxner, Désirée E Larenas-Linnemann, Daniel Laune, Brian Lipworth, Renaud Louis, Michaël Makris, Riccardo Monti, Mario Morais-Almeida, Ralph Mösges, Joaquim Mullol, Mikaëla Odemyr, Yoshitaka Okamoto, Nikolaos G. Papadopoulos, Vincenzo Patella, Nhân Pham-Thi, Frederico S Regateiro, Sietze Reitsma, Philip W. Rouadi, Boleslaw Samolinski, Milan Sova, Ana Todo-Bom, Luis Taborda-Barata, Peter Valentin Tomazic, Sanna Toppila-Salmi, Joaquin Sastre, Ioanna Tsiligianni, Arunas Valiulis, Dana Wallace, Susan Waserman, Arzu Yorgancioglu, Mihaela Zidarn, Torsten Zuberbier, João Almeida Fonseca, Jean Bousquet (Lead / Corresponding author), Oliver Pfaar

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Abstract

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.

Original language	English
Article number	e12128
Number of pages	12
Journal	Clinical and Translational Allergy
Volume	12
Issue number	3
Early online date	28 Mar 2022
DOIs	https://doi.org/10.1002/clt2.12128
Publication status	Published - Mar 2022

Keywords

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

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10.1002/clt2.12128Licence: CC BY

Final Published VersionFinal published version, 379 KBLicence: CC BY

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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., ... Pfaar, O. (2022). Allergen immunotherapy in MASK-air users in real-life: Results of a Bayesian mixed-effects model. Clinical and Translational Allergy, 12(3), Article e12128. https://doi.org/10.1002/clt2.12128

@article{b74e321ea8884cd98858edc2c39c2dbc,

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

abstract = "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{\textregistered} app: those receiving sublingual AIT (SLIT), those receiving subcutaneous AIT (SCIT), and those receiving no AIT.Methods: We assessed the MASK-air{\textregistered} 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.",

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

author = "Bernardo Sousa-Pinto and Azevedo, {Lu{\'i}s Filipe} and Ana S{\'a}-Sousa and Vieira, {Rafael Jos{\'e}} and Rita Amaral and Ludger Klimek and Wienczyslawa Czarlewski and Anto, {Josep M.} and Anna Bedbrook and Violeta Kvedariene and Ventura, {Maria Teresa} and Ansotegui, {Ignacio J.} and Karl-Christian Bergmann and Luisa Brussino and Canonica, {G. Walter} and Victoria Cardona and Pedro Carreiro-Martins and Thomas Casale and Lorenzo Cecchi and Tom{\'a}s Chivato and Chu, {Derek K.} and Cemal Cingi and Costa, {Elisio M.} and Cruz, {Alvaro A.} and {De Feo}, Giulia and Philippe Devillier and Fokkens, {Wytske J.} and Mina Gaga and Bilun Gemicioğlu and Tari Haahtela and Ivancevich, {Juan Carlos} and Zhanat Ispayeva and Marek Jutel and Piotr Kuna and Igor Kaidashev and Helga Kraxner and Larenas-Linnemann, {D{\'e}sir{\'e}e E} and Daniel Laune and Brian Lipworth and Renaud Louis and Micha{\"e}l Makris and Riccardo Monti and Mario Morais-Almeida and Ralph M{\"o}sges and Joaquim Mullol and Mika{\"e}la Odemyr and Yoshitaka Okamoto and Papadopoulos, {Nikolaos G.} and Vincenzo Patella and Nh{\^a}n Pham-Thi and Regateiro, {Frederico S} and Sietze Reitsma and Rouadi, {Philip W.} and Boleslaw Samolinski and Milan Sova and Ana Todo-Bom and Luis Taborda-Barata and Tomazic, {Peter Valentin} and Sanna Toppila-Salmi and Joaquin Sastre and Ioanna Tsiligianni and Arunas Valiulis and Dana Wallace and Susan Waserman and Arzu Yorgancioglu and Mihaela Zidarn and Torsten Zuberbier and Fonseca, {Jo{\~a}o Almeida} and Jean Bousquet and Oliver Pfaar",

note = "Funding Information: MASK-air has been supported by Charit? Universit?tsmedizin Berlin, EU Grants (EU Structural and Development Funds, POLLAR: EIT Health POLLAR, EIT Health Twinning) and educational grants from Mylan-Viatris, ALK, GSK, Novartis and Uriach. Open access funding enabled and organized by Projekt DEAL. Publisher Copyright: {\textcopyright} 2022 The Authors. Clinical and Translational Allergy published by John Wiley & Sons Ltd on behalf of European Academy of Allergy and Clinical Immunology.",

year = "2022",

month = mar,

doi = "10.1002/clt2.12128",

language = "English",

volume = "12",

journal = "Clinical and Translational Allergy",

issn = "2045-7022",

publisher = "Springer Verlag",

number = "3",

}

Sousa-Pinto, B, Azevedo, LF, Sá-Sousa, A, Vieira, RJ, Amaral, R, Klimek, L, Czarlewski, W, Anto, JM, Bedbrook, A, Kvedariene, V, Ventura, MT, Ansotegui, IJ, Bergmann, K-C, Brussino, L, Canonica, GW, Cardona, V, Carreiro-Martins, P, Casale, T, Cecchi, L, Chivato, T, Chu, DK, Cingi, C, Costa, EM, Cruz, AA, De Feo, G, Devillier, P, Fokkens, WJ, Gaga, M, Gemicioğlu, B, Haahtela, T, Ivancevich, JC, Ispayeva, Z, Jutel, M, Kuna, P, Kaidashev, I, Kraxner, H, Larenas-Linnemann, DE, Laune, D, Lipworth, B, Louis, R, Makris, M, Monti, R, Morais-Almeida, M, Mösges, R, Mullol, J, Odemyr, M, Okamoto, Y, Papadopoulos, NG, Patella, V, Pham-Thi, N, Regateiro, FS, Reitsma, S, Rouadi, PW, Samolinski, B, Sova, M, Todo-Bom, A, Taborda-Barata, L, Tomazic, PV, Toppila-Salmi, S, Sastre, J, Tsiligianni, I, Valiulis, A, Wallace, D, Waserman, S, Yorgancioglu, A, Zidarn, M, Zuberbier, T, Fonseca, JA, Bousquet, J & Pfaar, O 2022, 'Allergen immunotherapy in MASK-air users in real-life: Results of a Bayesian mixed-effects model', Clinical and Translational Allergy, vol. 12, no. 3, e12128. https://doi.org/10.1002/clt2.12128

TY - JOUR

T1 - Allergen immunotherapy in MASK-air users in real-life

T2 - Results of a Bayesian mixed-effects model

AU - Sousa-Pinto, Bernardo

AU - Azevedo, Luís Filipe

AU - Sá-Sousa, Ana

AU - Vieira, Rafael José

AU - Amaral, Rita

AU - Klimek, Ludger

AU - Czarlewski, Wienczyslawa

AU - Anto, Josep M.

AU - Bedbrook, Anna

AU - Kvedariene, Violeta

AU - Ventura, Maria Teresa

AU - Ansotegui, Ignacio J.

AU - Bergmann, Karl-Christian

AU - Brussino, Luisa

AU - Canonica, G. Walter

AU - Cardona, Victoria

AU - Carreiro-Martins, Pedro

AU - Casale, Thomas

AU - Cecchi, Lorenzo

AU - Chivato, Tomás

AU - Chu, Derek K.

AU - Cingi, Cemal

AU - Costa, Elisio M.

AU - Cruz, Alvaro A.

AU - De Feo, Giulia

AU - Devillier, Philippe

AU - Fokkens, Wytske J.

AU - Gaga, Mina

AU - Gemicioğlu, Bilun

AU - Haahtela, Tari

AU - Ivancevich, Juan Carlos

AU - Ispayeva, Zhanat

AU - Jutel, Marek

AU - Kuna, Piotr

AU - Kaidashev, Igor

AU - Kraxner, Helga

AU - Larenas-Linnemann, Désirée E

AU - Laune, Daniel

AU - Lipworth, Brian

AU - Louis, Renaud

AU - Makris, Michaël

AU - Monti, Riccardo

AU - Morais-Almeida, Mario

AU - Mösges, Ralph

AU - Mullol, Joaquim

AU - Odemyr, Mikaëla

AU - Okamoto, Yoshitaka

AU - Papadopoulos, Nikolaos G.

AU - Patella, Vincenzo

AU - Pham-Thi, Nhân

AU - Regateiro, Frederico S

AU - Reitsma, Sietze

AU - Rouadi, Philip W.

AU - Samolinski, Boleslaw

AU - Sova, Milan

AU - Todo-Bom, Ana

AU - Taborda-Barata, Luis

AU - Tomazic, Peter Valentin

AU - Toppila-Salmi, Sanna

AU - Sastre, Joaquin

AU - Tsiligianni, Ioanna

AU - Valiulis, Arunas

AU - Wallace, Dana

AU - Waserman, Susan

AU - Yorgancioglu, Arzu

AU - Zidarn, Mihaela

AU - Zuberbier, Torsten

AU - Fonseca, João Almeida

AU - Bousquet, Jean

AU - Pfaar, Oliver

N1 - Funding Information: MASK-air has been supported by Charit? Universit?tsmedizin Berlin, EU Grants (EU Structural and Development Funds, POLLAR: EIT Health POLLAR, EIT Health Twinning) and educational grants from Mylan-Viatris, ALK, GSK, Novartis and Uriach. Open access funding enabled and organized by Projekt DEAL. Publisher Copyright: © 2022 The Authors. Clinical and Translational Allergy published by John Wiley & Sons Ltd on behalf of European Academy of Allergy and Clinical Immunology.

PY - 2022/3

Y1 - 2022/3

N2 - 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.

AB - 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.

KW - allergic rhinitis

KW - immunotherapy

KW - mobile health

KW - patient-reported outcomes

KW - real-life data analysis

UR - http://www.scopus.com/inward/record.url?scp=85127220768&partnerID=8YFLogxK

U2 - 10.1002/clt2.12128

DO - 10.1002/clt2.12128

M3 - Article

C2 - 35344295

SN - 2045-7022

VL - 12

JO - Clinical and Translational Allergy

JF - Clinical and Translational Allergy

IS - 3

M1 - e12128

ER -

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

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