Potential of the domestic biosimile omalizumab in achievement of control in patients with severe asthma: short communication

Cover Page

Cite item

Full Text

Open Access Open Access
Restricted Access Access granted
Restricted Access Subscription Access

Abstract

BACKGROUND: Severe atopic asthma is a medical and social problem due to its prevalence, the tendency to exacerbations, the impact on the quality of life and on the work ability, and high treatment costs. The appearance biosimilar omalizumab among biologicals makes such therapy more accessible to patients. This article presents the results of an open prospective clinical study of the biosimilar omalizumab in patients with the severe atopic asthma.

AIM: To evaluate the efficacy and tolerability of the domestically produced biosimilar omalizumab in the real clinical practice.

MATERIALS AND METHODS: The study involved 15 adult patients (19–66 years) with a reliable history consistent with moderate to severe atopic asthma who hadn`t have asthma control at the time of inclusion in the study. All patients received the Genolar (omalizumab, Generic JSC, Russia) for 52 weeks at the dose calculated according to the instructions. The efficacy was evaluated taking into account changes in symptom severity, improved asthma control using the Asthma Control Questionnaire (ACQ-5), pulmonary function tests, peak flow measurements, assessment the asthma exacerbations number and the healthcare resources use.

RESULTS: According to our study results, all patients demonstrated a decrease in the night and daytime attacks frequency and the shortness of breath severity due to omalizumab, which made it possible to reduce the basic therapy and refuse systemic glucocorticosteroids using in patients who previously received there. After 6 months we obtained an improvement in the asthma symptoms control: ΔACQ-5=-1.87 (p=0.0002) compared to baseline with a trend towards further improvement in indicators and reached ΔACQ-5=-2.18 (p=0.0001) to the 52nd week. We also obtained a statistically significant improvement in pulmonary function (after a year of treatment, the increase in forced expiratory volume in the first second was +19.85% compared to baseline, p=0.0001). No asthma exacerbation was registered during 12 months omalizumab treatment.

CONCLUSION: Our study showed that the biosimilar treatment in patients with severe atopic asthma allowed to achieve asthma control, decrease the exacerbations number and reduce the basic therapy volume, including oral-corticosteroid elimination.

About the authors

Darya S. Kulichenko

National Research Center--Institute of Immunology Federal Medical-Biological Agency of Russia

Author for correspondence.
Email: darya.mdinaradze@yandex.ru
ORCID iD: 0000-0002-7375-1759

MD

Russian Federation, Moscow

Ksenia S. Pavlova

National Research Center--Institute of Immunology Federal Medical-Biological Agency of Russia

Email: ksenimedical@gmail.com
ORCID iD: 0000-0002-4164-4094

MD, Cand. Sci. (Med.)

Russian Federation, Moscow

Oksana M. Kurbacheva

National Research Center--Institute of Immunology Federal Medical-Biological Agency of Russia; Russian University of Medicine

Email: kurbacheva@gmail.com
ORCID iD: 0000-0003-3250-0694

MD, Dr. Sci. (Med.), Professor

Russian Federation, Moscow; Moscow

Natalia I. Ilina

National Research Center--Institute of Immunology Federal Medical-Biological Agency of Russia; Russian University of Medicine; The Russian National Research Medical University named after N.I. Pirogov

Email: instimmun@yandex.ru
ORCID iD: 0000-0002-3556-969X

MD, Dr. Sci. (Med.), Professor

Russian Federation, Moscow; Moscow; Moscow

References

  1. Global Initiative for Asthma [Internet]. Global strategy for asthma management and prevention [2021 Nov 1]. Available from: https://ginasthma.org/gina-reports/. Accessed: 15.01.2024.
  2. Clinical guidelines. Bronchial asthma. Russian Respiratory Society, Russian Association of Allergists and Clinical Immunologists, Union of Paediatricians of Russia; 2021. (In Russ). Available from: https://cr.minzdrav.gov.ru/recomend/359. Accessed: 15.01.2024.
  3. Federal State Statistics Service [Internet]. Zdravookhranenie. (In Russ). Available from: https://rosstat.gov.ru/folder/13721. Accessed: 15.01.2024.
  4. Syrov VV. Ideas about the epidemiology and possibilities of preventing bronchial asthma at the present stage. Allergol Immunol Pediatr. 2016;46(3):20–33. doi: 10.24411/2500-11752016-00017
  5. Avdeev SN, Nenasheva NM, Zhudenkov KV et al. Prevalence, incidence, phenotypes and other characteristics of severe bronchial asthma in the Russian Federation. Pulmonology. 2018;28(3):341–358. doi: 10.18093/0869-0189-2018-28-3-341-358
  6. Kravchenko NYu, Bobkov AP, Frantuzevich LYa, et al. First results of an observational study (registry) in patients with severe bronchial asthma in 57 regions of the Russian Federation. In: Proceedings of the Scientific Research Institute of Healthcare Organization and Medical Management: Collection of scientific papers. Moscow: Research Institute of Healthcare Organization and Medical Management of the Moscow Health Department; 2021. P. 227–241.
  7. Pfaller B, José Yepes-Nuñez J, Agache I, et al. Biologicals in atopic disease in pregnancy: An EAACI position paper. Allergy. 2021;76(1):71–89. doi: 10.1111/all.14282
  8. Agache I, Beltran J, Akdis C, et al. Efficacy and safety of treatment with biologicals (benralizumab, dupilumab, mepolizumab, omalizumab and reslizumab) for severe eosinophilic asthma. A systematic review for the EAACI Guidelines: Recommendations on the use of biologicals in severe asthma. Allergy. 2020;75(5):1023–1042. doi: 10.1111/all.14221
  9. Emelyanov AV, Sergeeva GR, Leshenkova EV. Bronchial asthma. Alone with the doctor. Meditsinskii sovet. 2014;(16):18–23. EDN: SWKYBJ
  10. Holgate S, Casale T, Wenzel S, et al. The anti-inflammatory effects of omalizumab confirm the central role of Ige in allergic inflammation. J Allergy Clin Immunol. 2005;115(3):459–465. doi: 10.1016/j.jaci.2004.11.053
  11. Ishizaka K, Ishizaka T. Identification of gamma-E-antibodies as a carrier of reaginic activity. J Immunol. 1967;99(6):1187–1198.
  12. Beck LA, Marcotte GV, Macglashan D, et al. Omalizumab-induced reductions in mast cell Fc epsilon RI expression and function. J Allergy Clin Immunol. 2004;114(3):527–530. doi: 10.1016/j.jaci.2004.06.032
  13. Humbert M, Beasley R, Ayres 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):309–316. doi: 10.1111/j.1398-9995.2004.00772.x
  14. Alvares L, Kumar P, Muthukumar M, et al. Population health impact of omalizumab over 15 years of experience in moderate to severe allergic asthma. Value Health. 2017;20(9):A652–653. doi: 10.1016/j.jval.2017.08.1530
  15. MacDonald KM, Kavati A, Ortiz B, et al. Short- and long- term real-world effectiveness of omalizumab in severe allergic asthma: systematic review of 42 studies published 2008–2018. Expert Rev Clin Immunol. 2019;15(5):553–569. doi: 10.1080/1744666X.2019.1574571
  16. Chipps BE, Lanier B, Milgrom H, 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. doi: 10.1016/j.jaci.2017.03.002
  17. Nenasheva NM, Aver’yanov AV, Il’ina NI, et al. Comparative study оf biosimilar Genolar clinical efficacy оn the randomized phase III study results. Pul'monologiya. 2020;30(6):782–796. doi: 10.18093/0869-0189-2020-30-6-782-796
  18. Kulichenko DS, Pavlova KS, Kurbacheva OM, Ilyina NI. Personalized targeted therapy for moderate and severe atopic bronchial asthma. Meditsinskii sovet. 2022;16(4):15–23. doi: 10.21518/2079-701X-2022-16-4-15-23
  19. Bousquet J, Cabrera P, Berkman N, et al. The effect of treatment with omalizumab, an anti-IgE antibody, on asthma exacerbations and emergency medical visits in patients with severe persistent asthma. Allergy. 2005;60(3):302–308. doi: 10.1111/j.1398-9995.2004.00770.x

Supplementary files

Supplementary Files
Action
1. JATS XML
Download
2. Fig. 1. Dynamics of asthma control during omalizumab therapy at follow-up visits assessed using Asthma Control Questionnaire-5 (ACQ-5), score.

Download (50KB)
Indexing metadata
3. Fig. 2. Dynamics of asthma control during omalizumab therapy at follow-up visits assessed using forced expiratory volume in 1st second (FEV1), % of predicted normal value.

Download (57KB)
Indexing metadata

Copyright (c) 2024 Pharmarus Print Media

Creative Commons License
This work is licensed under a Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International License.

This website uses cookies

You consent to our cookies if you continue to use our website.

About Cookies