Tolerability of Omalizumab in Asthma as a Major Compliance Factor: 10-Year Follow Up

Authors

  • Mona Al-Ahmad Department of Microbiology, Faculty of Medicine, Kuwait University, Kuwait; Al-Rashed Allergy Center, Ministry of Health
  • Jasmina Nurkic Al-Rashed Allergy Center, Ministry of Health
  • Ahmed Maher Al-Rashed Allergy Center, Ministry of Health
  • Nermina Arifhodzic Al-Rashed Allergy Center, Ministry of Health
  • Edin Jusufovic Cathedra for Internal Medicine Department, Faculty of Medicine, University of Tuzla, Tuzla

DOI:

https://doi.org/10.3889/oamjms.2018.394

Keywords:

Omalizumab, Asthma, Tolerability, Compliance, Safety, Long-term

Abstract

BACKGROUND: There is a lack of data related to real life, long-term safety, tolerability and compliance of omalizumab treatment in asthma patients beyond 6 years.

AIM: Study aimed to assess safety, tolerability, compliance and all reasons for treatment discontinuation during 10 years on omalizumab.

SUBJECT AND METHODS: This is a retrospective, observational study of uncontrolled asthma patients receiving omalizumab for the last 10 years. All data were collected from patients’ files (demographics, adverse events, comorbidities, compliance index, reasons for discontinuation of omalizumab). Reactions to omalizumab were classified as local and systemic, and their severity as mild, moderate or severe. Reactions were either immediate (minutes to hours after drug administration) or delayed (after days). Compliance to omalizumab, defined as Compliance index (CI), was calculated by comparing milligrams of given to milligrams of prescribed dose/ per year.

RESULTS: Out of 35 patients receiving omalizumab, 15 drop out at different time points mostly due to treatment efficacy or appearance of new comorbidities. Patients who continue for the next ten years had mild to moderate adverse events related to omalizumab. There was no increased risk of severe adverse events during 10 years on omalizumab. Patient’s treatment tolerability, despite mild to moderate adverse events, is in favour of compliance.

CONCLUSION: Compliance with omalizumab mildly decreased over 10 years but was not affected by severe adverse events of treatment or new comorbidities. Although, omalizumab is safe medicine appearance of new comorbidities has to be closely followed up.

Downloads

Download data is not yet available.

Metrics

Metrics Loading ...

Plum Analytics Artifact Widget Block

References

Khadadah M. The cost of asthma in Kuwait. Med Princ Pract. 2013; 22(1):87-91. https://doi.org/10.1159/000341154 PMid:22889866 PMCid:PMC5586966

Peters SP, Ferguson G, Deniz Y, et al. Uncontrolled asthma: A review of the prevalence, disease burden and options for treatment. Respiratory Medicine. 2006; 100(7):1139-1151. https://doi.org/10.1016/j.rmed.2006.03.031 PMid:16713224

Global initiative for asthma. Global strategy for asthma management and prevention. Available from, www.ginasthma.com, 2017.

Fan Chung K. Anti-IgE monoclonal antibody, omalizumab: a new treatment for allergic asthma. Expert Opinion on Pharmacotherapy. 2004; 5 (2):439-446. https://doi.org/10.1517/14656566.5.2.439 PMid:14996639

Chipps BE, Lanier B, Milgrom H, Deschildre A, Hedlin G, Szefler SJ et al. Omalizumab in children with uncontrolled allergic asthma: Review of clinical trial and real-world experience. J Allergy Clin Immunol. 2017; 139(5):1431-1444. https://doi.org/10.1016/j.jaci.2017.03.002 PMid:28477722

Lai T, Wang S, Xu Z, Zhang C, Zhao Y, Hu Y et al. Long-term efficacy and safety of omalizumab in patients with persistent uncontrolled allergic asthma: a systematic review and meta-analysis. Scientific Reports. 2015; 5:8191. https://doi.org/10.1038/srep08191 PMid:25645133 PMCid:PMC4314644

Cerner Multum, Inc. "Australian Product Information."Cerner Multum, Inc. "UK Summary of Product Characteristics." "Product Information. Xolair (omalizumab) )." Genentech, South San Francisco, CA.

FDA Drug Safety Communication: FDA approves label changes for asthma drug Xolair (omalizumab), including describing slightly higher risk of heart and brain adverse events. 2016. [https://www.fda.gov/Drugs/DrugSafety/ucm414911.htm].

Corren J, Casale TB, Lanier B, Buhl R, Holgate S, Jimenez P. Safety and tolerability of omalizumab. Clin Exp Allergy. 2009; 39 (6):788-797. https://doi.org/10.1111/j.1365-2222.2009.03214.x PMid:19302249

Al Said A, Cushen B, Costello R. Targeting patients with asthma for omalizumab therapy: choosing the right patient to get the best value for money. Ther Adv Chronic Dis. 2017; 8(2-3):31–45. https://doi.org/10.1177/2040622317690494 PMid:28348726 PMCid:PMC5354131

European medicines agency. EMEA/493707/2009 Xolair. Available from: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Summary_for_the_public/human/000606/WC500057293.pdf.

Harjinder S, Peters J, Yogeet K, Diaz JD. Impact of Visit Compliance on Response to Omalizumab Therapy in a Real-Life Clinical Setting:Reality Study. J Allergy Clin Immunol. 2016; 137 (2). AB13. https://doi.org/10.1016/j.jaci.2015.12.041

Bateman ED, Hurd SS, Barnes PJ, Bousquet J, Drazen JM, FitzGerald JM et al. Global strategy for asthma management and prevention: GINA executive summary. Eur Respir J. 2008; 31(1):143-78. https://doi.org/10.1183/09031936.00138707 PMid:18166595

Novartis Pharmaceuticals Canada Inc. Xolair Prescribing Information. Date of Revision, 10, 2010.

Norman G, Faria R, Paton F, Llewellyn A, Fox D, Palmer S et al. Omalizumab for the treatment of severe persistent allergic asthma: a systematic review and economic evaluation. Health Technology Assessment. 2013; 17.52. Southampton (UK): NIHR Journals Library.

Di Bona D, Fiorino I, Taurino M, Frisenda F, Minenna E, Pasculli C et al. Long-term "real-life" safety of omalizumab in patients with severe uncontrolled asthma: A nine-year study. Respiratory Medicine. 2017; 130:55-60. https://doi.org/10.1016/j.rmed.2017.07.013 PMid:29206634

Cox L, Platts-Mills TA, Finegold I, Schwartz LB, Simons FE, Wallace DV. American academy of allergy, asthma & immunology.; American college of allergy, asthma and immunology. American academy of allergy, asthma & immunology/American college of allergy, asthma and immunology joint task force report on omalizumab-associated anaphylaxis. J Allergy Clin Immunol. 2007; 120(6):1373-1377. https://doi.org/10.1016/j.jaci.2007.09.032 PMid:17996286

Abraham I, Alhossan A, Lee CS, Kutbi H, MacDonald K. 'Real-life' effectiveness studies of omalizumab in adult patients with severe allergic asthma:systematic review. Allergy. 2016; 71(5):593-610. https://doi.org/10.1111/all.12815 PMid:26644231

Galvao VR, Castells MC. Hypersensitivity to biological agents-updated diagnosis, management and treatment. J Allergy Clin Immunol Pract. 2015; 3(2):175-185. https://doi.org/10.1016/j.jaip.2014.12.006 PMid:25754718

Ayres JG, Higgins B, Chilvers ER, Ayre G, Blogg M, Fox H. Efficacy and tolerability of anti-immunoglobulin E therapy with omalizumab in patients with poorly controlled (moderate-to-severe) allergic asthma. Allergy. 2004; 59(7):701–8. https://doi.org/10.1111/j.1398-9995.2004.00533.x PMid:15180756

Humbert M, Beasley R, Ayres J, Slavin R, Hébert J, Bousquet J et al. Benefits of omalizumab as add-on therapy in patients with severe persistent asthma who are inadequately controlled despite best available therapy (GINA 2002 step 4 treatment): INNOVATE. Allergy. 2005; 60(3):309–16. https://doi.org/10.1111/j.1398-9995.2004.00772.x PMid:15679715

Molimard M, de Blay F, Didier A, Le Gros V. Effectiveness of omalizumab (Xolair) in the first patients treated in real-life practice in France. Respir Med. 2008; 102(1):71–6. https://doi.org/10.1016/j.rmed.2007.08.006 PMid:17920257

Senna G, Caminati M, Canonica GW. Safety and tolerability of sublingual immunotherapy in clinical trials and real life. Curr Opin Allergy Clin Immunol. 2013; 13(6):656–62. https://doi.org/10.1097/ACI.0000000000000007 PMid:24126613

Cazzola M, Camiciottoli G, Bonavia M, Gulotta C, Ravazzi A, Alessandrini A et al. Italian real-life experience of omalizumab. Respir Med. 2010; 104:1410-1416. https://doi.org/10.1016/j.rmed.2010.04.013 PMid:20483574

Rottem M. Omalizumab reduces corticosteroid use in patients with severe allergic asthma: real-life experience in Israel. J Asthma. 2012; 49:78-82. https://doi.org/10.3109/02770903.2011.637598 PMid:22149205

Vennera MC, Perez De Llano L, Bardagí S, Ausin P, Sanjuas C, González H et al. Spanish Registry. Omalizumab therapy in severe asthma: experience from the Spanish registry - some new approaches. J Asthma. 2012; 49:416-422. https://doi.org/10.3109/02770903.2012.668255 PMid:22443408

Vieira T, Oliveira J, Castel-Branco M. Short and long-term quality of life and asthma control with omalizumab therapy in a real life setting in Portugal. Allergo Immunopathol. 2014; 42:3-10. https://doi.org/10.1016/j.aller.2012.07.006 PMid:23253691

Barnes N, Menzies-Gow A, Mansur A, Spencer D, Percival F, Radwan A et al. Effectiveness of omalizumab in severe allergic asthma: a retrospective UK real-world study. J Asthma. 2013; 50:529-536. https://doi.org/10.3109/02770903.2013.790419 PMid:23574000 PMCid:PMC3681088

Braunstahl G, Chlumsky J, Peachey G, Chen CW. Reduction in oral corticosteroid use in patients receiving omalizumab for allergic asthma in the real world setting. Allergy Asthma Clin Immunol. 2013; 9:47. https://doi.org/10.1186/1710-1492-9-47 PMid:24305549 PMCid:PMC3879326

Grimaldi-Bensouda L, Zureik M, Aubier M, Humbert M, Levy J, Benichou J et al. Does omalizumab make a difference to the real life treatment of asthma exacerbations? Results from a large cohort of patients with severe uncontrolled asthma. Chest. 2013; 143:398-405. https://doi.org/10.1378/chest.12-1372 PMid:23505637

Tzortzaki EG, Georgiou A, Kampas D, Lemessios M, Markatos M, Adamidi T, et al. Longterm omalizumab treatment in severe allergic asthma: the south-eastern Mediterranean "real-life" experience. Pulm Pharmacol Ther. 2012; 25: 77-82. https://doi.org/10.1016/j.pupt.2011.11.004 PMid:22155001

López Tiro JJ, Contreras EA, del Pozo ME, Gómez Vera J, Larenas Linnemann D. Real life study of three years omalizumab in patients with difficult-to-control asthma. Allergol Immunopathol. 2015; 43:120-126. https://doi.org/10.1016/j.aller.2013.11.008 PMid:24780091

Konstantinou GN, Chioti AG, Daniilidis M. Self-reported hair loss in patients with chronic spontaneous urticaria treated with omalizumab: an under-reported, transient side effect? Eur Ann Allergy Clin Immunol. 2016; 48(5):205-7. PMid:27608479

Kewalramani A, Bollinger ME, Postolache TT. Asthma and Mood Disorders. Int J Child Health Hum Dev. 2008; 1(2):115–123. PMid:19180246 PMCid:PMC2631932

Miller BD. Depression and asthma: a potentially lethal mixture. Journal of Allergy and Clinical Immunology. 1987; 80(3):481-6. https://doi.org/10.1016/0091-6749(87)90080-7

Soler M, Matz J, Townley R Buhl R, O'Brien J, Fox H et al. The anti IgE antibody omalizumab reduces exacerbations and steroids requirement in allergic asthmatics. Eur Respir J. 2001; 18:254-61. https://doi.org/10.1183/09031936.01.00092101 PMid:11529281

Caminati M, Senna G, Stefanizzi G, Bellamoli R, Longhi S, Chieco-Bianchi F et al. Drop-out rate among patients treated with omalizumab for severe asthma: Literature review and real-life experience. BMC Pulm Med. 2016; 16(1):128. https://doi.org/10.1186/s12890-016-0290-5 PMid:27562427 PMCid:PMC5000547

Stirling RG, Chung KF. Severe asthma: definition and mechanisms. Allergy. 2001; 56:825–40. https://doi.org/10.1034/j.1398-9995.2001.00143.x

Abyad A. Alzheimer's in the Middle East. Alzheimer's Dis Related Dementia. JSM. 2015; 2(1):1012.

Varghese B, Al-Hajoj S. Mapping the epidemiology and trends of extra-pulmonary tuberculosis in Saudi Arabia. International Journal of Mycobacteriology. 2015; 4(4):261-269. https://doi.org/10.1016/j.ijmyco.2015.06.002 PMid:26964806

Cruz AA, Lima F, Sarinho E, Ayre G, Martin C, Fox H, Cooper PJ. Safety of anti-immunoglobulin E therapy with omalizumab in allergic patients at risk of geohelminth infection, Clin Exp Allergy. 2007; 37(2):197-207. https://doi.org/10.1111/j.1365-2222.2007.02650.x PMid:17250692 PMCid:PMC1859973

Alâ€Mazeedi K, Elâ€Shazly M, Alâ€Ajmi HS. Impact of psoriasis on quality of life in Kuwait. International journal of dermatology. 2006; 45(4):418-24. https://doi.org/10.1111/j.1365-4632.2006.02502.x PMid:16650169

FDA: Early Communication about an Ongoing Safety Review of Omalizumab (marketed as Xolair). 2009. [http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/DrugSafetyInformationforHeathcareProfessionals/ucm172218.htm.

Iribarren C, Rahmaoui A, Long AA, Szefler SJ, Bradley MS, Carrigan G et al. Cardiovascular and cerebrovascular events among patients receiving omalizumab: Results from EXCELS, a prospective cohort study in moderate to severe asthma. J Allergy Clin Immunol. 2017; 139(5):1489-1495. https://doi.org/10.1016/j.jaci.2016.07.038 PMid:27639934

Long A, Rahmaoui A, Rothman KJ, Guinan E, Eisner M, Bradley MS et al. Incidence of malignancy in patients with moderate-to-severe asthma treated with or without omalizumab. J Allergy Clin Immunol. 2014; 134(3):560-567. https://doi.org/10.1016/j.jaci.2014.02.007 PMid:24679845

Braido F, Baiardini I, Blasi F, Pawankar R, Canonica GW. Adherence to asthma treatments: 'we know, we intend, we advocate'. Curr Opin Allergy Clin Immunol. 2015; 15(1):49–55. https://doi.org/10.1097/ACI.0000000000000132 PMid:25479318

Osterberg L, Blaschke T. Adherence to medication. N Engl J Med. 2005; 353(5):487–97. https://doi.org/10.1056/NEJMra050100 PMid:16079372

Busse W, Corren J, Lanier BQ, McAlary M, Fowler-Taylor A, Cioppa GD et al. Omalizumab, anti-IgE recombinant humanized monoclonal antibody, for the treatment of severe allergic asthma. J Allergy Clin Immunol. 2001; 108(2):184–90. https://doi.org/10.1067/mai.2001.117880 PMid:11496232

Published

2018-10-18

How to Cite

1.
Al-Ahmad M, Nurkic J, Maher A, Arifhodzic N, Jusufovic E. Tolerability of Omalizumab in Asthma as a Major Compliance Factor: 10-Year Follow Up. Open Access Maced J Med Sci [Internet]. 2018 Oct. 18 [cited 2024 Apr. 18];6(10):1839-44. Available from: https://oamjms.eu/index.php/mjms/article/view/oamjms.2018.394

Issue

Section

B - Clinical Sciences