Adherence to Omalizumab: A Multicenter "real-world" Study

Overview

Journal World Allergy Organ J

Specialty Allergy & Immunology

Date 2020 Feb 22

PMID 32082464

Citations 15

Authors

Raffaele Campisi

Claudia Crimi

Rossella Intravaia

Simona Strano

Alberto Noto

Maria Pia Foschino

Giuseppe Valenti

Vittorio Viviano

Corrado Pelaia

Luisa Ricciardi

Nicola Scichilone

Nunzio Crimi

Affiliations

Soon will be listed here.

Abstract

Background: Adherence to medications is crucial in patients with severe asthma in light of the negative clinical impact and costs of non-adherence. Adherence to omalizumab has not been well studied in real-world settings. The aim of this study was to assess adherence to omalizumab and evaluate treatment effectiveness in relation to adherence.

Methods: This was a retrospective, observational, and multicenter real-world study. Omalizumab dose, timing of administration, and duration of treatment (<2 years; 2-4 years; > 4 years) were analyzed. Adherence was evaluated by examining rates of expected and missing doses. Good adherence (<10% of doses missed) and poor adherence (>10% doses missed) were determined. For effectiveness in relation to adherence of omalizumab we considered asthma exacerbations, hospitalizations, asthma control test (ACT), and Forced Expiratory Volume in 1 s (FEV).

Results: A total of 196 patients were evaluated, and 161 were suitable for data analyses. Good adherence was shown in 90.7% of patients and poor adherence in 9.3%. Considering adherence in relation to treatment duration: <2 years, 87.8% of patients were adherent (expected doses, 1186; missed doses, 53); 2-4 years, 85.9% were adherent (expected doses, 2985; missed doses, 127); >4 years, 100% were adherent (expected doses, 6120; missed doses, none). Indices of efficacy between pre- and post-treatment showed significant improvement (p < 0.001). The effectiveness indices between pre- and post-treatment, among adherent and non-adherent patients, ACT, and asthma exacerbations both showed significant differences (p = 0.043 and p = 0.049, respectively). Binomial logistic regression analysis showed that increasing age, better ACT score, and 14-day timing were significantly associated with increased adherence to therapy.

Conclusions: High adherence to omalizumab was demonstrated in a real-world setting, which was associated with better outcomes and control of asthma.

Citing Articles

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An Overview of Adherence-What It Is and Why It Is Important.

Conroy E, Banzon T, Simoneau T, Phipatanakul W, van Boven J, Larenas-Linnemann D J Allergy Clin Immunol Pract. 2024; 12(12):3180-3188.

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Pelaia C, Giacalone A, Ippolito G, Pastore D, Maglio A, Piazzetta G Pragmat Obs Res. 2024; 15:45-51.

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PMID: 37965229 PMC: 10641582. DOI: 10.1183/23120541.00560-2023.

References

Broder M, Chang E, Ory C, Kamath T, Sapra S . Adherence and persistence with omalizumab and fluticasone/salmeterol within a managed care population. Allergy Asthma Proc. 2009; 30(2):148-57. DOI: 10.2500/aap.2009.30.3190. View

Karpel J, Massanari M, Geba G, Kianifard F, Inhaber N, Zeldin R . Effectiveness of omalizumab in reducing corticosteroid burden in patients with moderate to severe persistent allergic asthma. Ann Allergy Asthma Immunol. 2010; 105(6):465-70. DOI: 10.1016/j.anai.2010.09.011. View

Bender B, Bender S . Patient-identified barriers to asthma treatment adherence: responses to interviews, focus groups, and questionnaires. Immunol Allergy Clin North Am. 2004; 25(1):107-30. DOI: 10.1016/j.iac.2004.09.005. View

Rodrigo G, Neffen H, Castro-Rodriguez J . Efficacy and safety of subcutaneous omalizumab vs placebo as add-on therapy to corticosteroids for children and adults with asthma: a systematic review. Chest. 2010; 139(1):28-35. DOI: 10.1378/chest.10-1194. View

Lafeuille M, Gravel J, Zhang J, Gorsh B, Figliomeni M, Lefebvre P . Association between consistent omalizumab treatment and asthma control. J Allergy Clin Immunol Pract. 2013; 1(1):51-7. DOI: 10.1016/j.jaip.2012.08.006. View

Abraham I, Alhossan A, Lee C, Kutbi H, MacDonald K . 'Real-life' effectiveness studies of omalizumab in adult patients with severe allergic asthma: systematic review. Allergy. 2015; 71(5):593-610. DOI: 10.1111/all.12815. View

Braunstahl G, Chen C, Maykut R, Georgiou P, Peachey G, BRUCE J . The eXpeRience registry: the 'real-world' effectiveness of omalizumab in allergic asthma. Respir Med. 2013; 107(8):1141-51. DOI: 10.1016/j.rmed.2013.04.017. View

Caminati M, Senna G, Stefanizzi G, Bellamoli R, Longhi S, Chieco-Bianchi F . Drop-out rate among patients treated with omalizumab for severe asthma: Literature review and real-life experience. BMC Pulm Med. 2016; 16(1):128. PMC: 5000547. DOI: 10.1186/s12890-016-0290-5. View

Wu A, Butler M, Li L, Fung V, Kharbanda E, Larkin E . Primary adherence to controller medications for asthma is poor. Ann Am Thorac Soc. 2015; 12(2):161-6. PMC: 4342835. DOI: 10.1513/AnnalsATS.201410-459OC. View

10.

Osterberg L, Blaschke T . Adherence to medication. N Engl J Med. 2005; 353(5):487-97. DOI: 10.1056/NEJMra050100. View

11.

Green R, Shaw D . Strict adherence rules to obtain monoclonal therapy might cost lives. Lancet Respir Med. 2017; 5(9):678-679. DOI: 10.1016/S2213-2600(17)30238-2. View

12.

Gamble J, Stevenson M, Heaney L . A study of a multi-level intervention to improve non-adherence in difficult to control asthma. Respir Med. 2011; 105(9):1308-15. DOI: 10.1016/j.rmed.2011.03.019. View

13.

Hanania N, Alpan O, Hamilos D, Condemi J, Reyes-Rivera I, Zhu J . Omalizumab in severe allergic asthma inadequately controlled with standard therapy: a randomized trial. Ann Intern Med. 2011; 154(9):573-82. DOI: 10.7326/0003-4819-154-9-201105030-00002. View

14.

Bardelas J, Figliomeni M, Kianifard F, Meng X . A 26-week, randomized, double-blind, placebo-controlled, multicenter study to evaluate the effect of omalizumab on asthma control in patients with persistent allergic asthma. J Asthma. 2012; 49(2):144-52. DOI: 10.3109/02770903.2011.648296. View

15.

Schatz M, Kosinski M, Yarlas A, Hanlon J, Watson M, Jhingran P . The minimally important difference of the Asthma Control Test. J Allergy Clin Immunol. 2009; 124(4):719-23.e1. DOI: 10.1016/j.jaci.2009.06.053. View

16.

Casale T, Luskin A, Busse W, Zeiger R, Trzaskoma B, Yang M . Omalizumab Effectiveness by Biomarker Status in Patients with Asthma: Evidence From PROSPERO, A Prospective Real-World Study. J Allergy Clin Immunol Pract. 2018; 7(1):156-164.e1. DOI: 10.1016/j.jaip.2018.04.043. View

17.

Janson S, Solari P, Trzaskoma B, Chen H, Haselkorn T, Zazzali J . Omalizumab adherence in an observational study of patients with moderate to severe allergic asthma. Ann Allergy Asthma Immunol. 2015; 114(6):516-21. DOI: 10.1016/j.anai.2015.04.010. View

18.

Cazzola M, Camiciottoli G, Bonavia M, Gulotta C, Ravazzi A, Alessandrini A . Italian real-life experience of omalizumab. Respir Med. 2010; 104(10):1410-6. DOI: 10.1016/j.rmed.2010.04.013. View

19.

Al-Ahmad M, Arifhodzic N, Nurkic J, Maher A, Rodriguez-Bouza T, Al-Ahmed N . "Real-life" Efficacy and Safety Aspects of 4-Year Omalizumab Treatment for Asthma. Med Princ Pract. 2018; 27(3):260-266. PMC: 6062694. DOI: 10.1159/000487482. View

20.

Lai T, Wang S, Xu Z, Zhang C, Zhao Y, Hu Y . Long-term efficacy and safety of omalizumab in patients with persistent uncontrolled allergic asthma: a systematic review and meta-analysis. Sci Rep. 2015; 5:8191. PMC: 4314644. DOI: 10.1038/srep08191. View