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

Bernardo Sousa-Pinto 1 2, Luís Filipe Azevedo 1 2, Ana Sá-Sousa 1 2, Rafael José Vieira 1 2, Rita Amaral 1 2, Ludger Klimek 3 4, Wienczyslawa Czarlewski 5 6, Josep M Anto 7 8 9 10, Anna Bedbrook 6, Violeta Kvedariene 11 12, Maria Teresa Ventura 13, Ignacio J Ansotegui 14, Karl-Christian Bergmann 15 16 17, Luisa Brussino 18, G Walter Canonica 19 20, Victoria Cardona 21, Pedro Carreiro-Martins 22 23, Thomas Casale 24, Lorenzo Cecchi 25, Tomás Chivato 26, Derek K Chu 27, Cemal Cingi 28, Elisio M Costa 29, Alvaro A Cruz 30 31, Giulia De Feo 32, Philippe Devillier 33, Wytske J Fokkens 34, Mina Gaga 35, Bilun Gemicioğlu 36, Tari Haahtela 37, Juan Carlos Ivancevich 38, Zhanat Ispayeva 39, Marek Jutel 40 41, Piotr Kuna 42, Igor Kaidashev 43, Helga Kraxner 44, Désirée E Larenas-Linnemann 45, Daniel Laune 46, Brian Lipworth 47, Renaud Louis 48 49, Michaël Makris 50, Riccardo Monti 51, Mario Morais-Almeida 52, Ralph Mösges 53 54, Joaquim Mullol 55 56, Mikaëla Odemyr 57, Yoshitaka Okamoto 58, Nikolaos G Papadopoulos 59, Vincenzo Patella 60, Nhân Pham-Thi 61, Frederico S Regateiro 1 2, Sietze Reitsma 34, Philip W Rouadi 62 63, Boleslaw Samolinski 64, Milan Sova 65, Ana Todo-Bom 1, Luis Taborda-Barata 66 67 68, Peter Valentin Tomazic 69, Sanna Toppila-Salmi 37, Joaquin Sastre 70, Ioanna Tsiligianni 71 72, Arunas Valiulis 73, Dana Wallace 74, Susan Waserman 75, Arzu Yorgancioglu 76, Mihaela Zidarn 77 78, Torsten Zuberbier 15 16 17 79, João Almeida Fonseca 1 2 80, Jean Bousquet 15 16 17 78 81, Oliver Pfaar 82

Affiliations

01 March 2022

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doi: 10.1002/clt2.12128

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.

Keywords: allergic rhinitis; immunotherapy; mobile health; patient-reported outcomes; real-life data analysis.

Conflict of interest statement

IA reports personal fees from Hikma, Roxall, Astra Zeneca, Menarini, UCB, Faes Farma, Sanofi, Mundipharma, Bial, Amgen, Stallergenes Greer, Bayer. JB reports personal fees from Chiesi, Cipla, Hikma, Menarini, Mundipharma, Mylan, Novartis, Sanofi‐Aventis, Takeda, Teva, Uriach, other from KYomed‐Innov, personal fees from Purina, TC reports grants from Stallergenes Greer. AC reports personal fees from GSK, AstraZeneca, Sanofi, Novartis, Boehringer Ingelheim, Mylan, Mantecorp, Eurofarma. PhD reports personal fees and non‐financial support from Alk Abello, Stallergenes Greer. TH reports personal fees from GSK, Mundipharma, Orion Pharma, and Sanofi. JCI reports personal fees from Laboratorios Casasco, Abbott Ecuador, Bago Bolivia, Sanofi, Eurofarma Argentina, VK reports other from BerlinCHemie Menarini, other from Norameda. DLL reports personal fees from Allakos, Amstrong, Astrazeneca, DBV Technologies, Grunenthal, GSK, Mylan/Viatris, Menarini, MSD, Novartis, Pfizer, Sanofi, Siegfried, UCB, Alakos, Gossamer, Carnot, grants from Sanofi, Astrazeneca, Novartis, Circassia, UCB, GSK, Purina institute. RL reports grants and personal fees from GSK, AZ, Chiesi, Novartis, personal fees from Sanofi. MM reports personal fees from Menarini, personal fees from Astra Zeneca, personal fees from GSK, personal fees from Mylan, personal fees from Sanofi, personal fees from Pfizer, personal fees from Chiesi, RM reports personal fees from ALK, allergopharma, Allergy Therapeutics, Friulchem, Hexal, Servier, Klosterfrau, Bayer, FAES, GSK, MSD, Johnson&Johnson, Meda, Stada, UCB, Nuvo, Menarini, Mundipharma, Pohl‐Boskamp,grants from ASIT biotech, Leti, Optima, BitopAG, Hulka, Ursapharm, Inmunotek, grants and personal fees from Bencard, Stallergenes, grants, personal fees and non‐financial support from Lofarma, non‐financial support from Roxall, Atmos, Bionorica, Otonomy, Ferrero, personal fees and non‐financial support from Novartis. JM reports personal fees and other from SANOFI‐GENZYME & REGENERON, NOVARTIS, ALLAKOS, grants and personal fees from MYLAN Pharma, URIACH Group, personal fees from Mitsubishi‐Tanabe, Menarini, UCB, AstraZeneca, GSK, MSD. NGP reports personal fees from Novartis, Nutricia, HAL, MENARINI/FAES FARMA, SANOFI, MYLAN/MEDA, BIOMAY, AstraZeneca, GSK, MSD, ASIT BIOTECH, Boehringer Ingelheim, grants from Gerolymatos International SA, Capricare. OP reports grants and personal fees from ALK‐Abelló, Allergopharma, g Stallergenes Greer, HAL Allergy Holding B.V./HAL Allergie GmbH, Bencard Allergie GmbH/Allergy Therapeutics, Lofarma, grants and personal fees from ASIT Biotech Tools S.A., Laboratorios LETI/LETI Pharma, Anergis S.A., GlaxoSmithKline, personal fees from Astellas Pharma Global, personal fees from EUFOREA, ROXALL Medizin, Novartis, Sanofi‐Aventis and Sanofi‐Genzyme, Med Update Europe GmbH, streamedup! GmbH, Mobile Chamber Experts (a GA2LEN Partner), Indoor Biotechnologies, MEDA Pharma/MYLAN, John Wiley and Sons, AS, Paul‐Martini‐Stiftung (PMS), Ingress‐Health HWM, Regeneron Pharmaceuticals Inc., grants from Pohl‐Boskamp, Inmunotek S.L., Biomay, Circassia. JS reports grants and personal fees from SANOFI, personal fees from GSK, NOVARTIS, ASTRA ZENECA, MUNDIPHARMA, FAES FARMA. AMTB reports grants and personal fees from Novartis, Mundipharma, Teva Pharma, GSK (GlaxoSmithKline), AstraZeneca, grants from Leti, personal fees from BIAL. Dr. Tsiligianni reports personal fees from Honoraria for educational activities, speaking engagements, advisory boards from Boehringer Ingelheim, Astra Zeneca, GSK, Novartis, MSD and grants from GSK Hellas Astra Zeneca, and Elpen. DW reports personal fees from ALK.

Figures

FIGURE 1 Probability distributions of the comparisons between grass subcutaneous immunotherapy (SCIT) versus no allergen immunotherapy (AIT), and grass sublingual immunotherapy (SLIT) by tablet versus no AIT

FIGURE 1 Probability distributions of the comparisons between grass subcutaneous immunotherapy (SCIT) versus no allergen immunotherapy (AIT), and grass sublingual immunotherapy (SLIT) by tablet versus no AIT

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