Pilot Project «All-Russian Registry of Patients with Severe Bronchial Asthma.» The First Results in a Children’s Group of Patients (Moscow’s Observation Program)

The article presents the first results of the pilot observation program «The All-Russian Severe Asthma Patient Registry» which was started in Moscow. Objectives. The objective of this initiative is the accumulation of clinical data on patients with severe bronchial asthma in the Russian Federation. Methods. The chosen method was a registry, the rights holders of which were 3 professional associations — Interregional Public Organization «Russian Respiratory Society», Public Organization «Union of Pediatricians of Russia», All-Russian Public Organization «Association of Allergologists and Clinical Immunologists». Results. The results of the pilot project are presented by the data analysis of electronic case report forms of 36 children (totally, the project included 100 patients, 64 adults and 36 children) enrolled in the program from June to December 2016. Using the registry, a detailed analysis of the clinical characteristics of a group of children with severe atopic bronchial asthma was carried out, the results of a pharmacoepidemiological evaluation of therapy were given. Obtained by the researchers, a high frequency of the assignment of a genetically engineered biologic drug of omalizumab meets the international recommendations but does not reflect the all-Russian reality and can be explained by inclusion in the registry of pediatric patients observed only in the Federal State Autonomous Institution «National Scientific and Practical Center of Children’s Health» of the Ministry of Health of the Russian Federation. Conclusion. To determine true indicators that characterize bronchial asthma in children in the Russian Federation it is necessary, undoubtedly, to expand the geography of project participants.

children, patient registry, observation program, severe bronchial asthma, genetically engineered biological drug, omalizumab

1. ginasthma.org [Internet]. Global Initiative for Asthma. Global Strategy for Asthma Management and Prevention. 2016. Global Initiative for Asthma (GINA) [cited 2017 May 9]. Available from: http://www.ginasthma.org.

2. Masoli M, Fabian D, Holt S, et al. The global burden of asthma: executive summary of the GINA Dissemination Committee report. Allergy. 2004;59(5):469–478. doi: 10.1111/j.1398-9995.2004.00526.

3. Gibeon D, Batuwita K, Osmond M, et al. Obesity-associated severe asthma represents a distinct clinical phenotype: analysis of the British Thoracic Society Difficult Asthma Registry Patient cohort according to BMI. Chest. 2013;143(2):406–414. doi: 10.1378/ chest.12-0872.

4. Newby C, Heaney LG, Menzies-Gow A, et al. Statistical cluster analysis of the British Thoracic Society Severe refractory Asthma Registry: clinical outcomes and phenotype stability. PLoS One. 2014;9(7):e102987. doi: 10.1371/journal.pone.0102987.

5. Ciprandi G, Marseglia GL, Castagnoli R, et al. From IgE to clinical trials of allergic rhinitis. Expert Rev Clin Immunol. 2015;11(12):1321– 1333. doi: 10.1586/1744666X.2015.1086645.

6. Nutten S. Atopic dermatitis: global epidemiology and risk factors. Ann Nutr Metab. 2015;66 Suppl 1:8–16. doi: 10.1159/000370220.

7. Болезни детского возраста от А до Я: Пищевая аллергия. / Под ред. Баранова А.А., Намазовой-Барановой Л.С., Боровик Т.Э., Макаровой С.Г. — М.: ПедиатрЪ; 2013. — 160 с. [Bolezni detskogo vozrasta ot A do Ya: Pishchevaya allergiya. Ed by Baranov A.A., Namazova-Baranova L.S., Borovik T.E., Makarova S.G. Moscow: Pediatr; 2013. 160 p. (In Russ).]

8. Макарова С.Г., Намазова-Баранова Л.С., Вишнёва Е.А., и др. Актуальные вопросы диагностики пищевой аллергии в педиатрической практике // Вестник Российской академии медицинских наук. — 2015. — Т.70. — №1 — С. 41–46. [Makarova SG, Namazova-Baranova LS, Vishneva EA, et al. Topical issues of food allergy diagnosis in pediatric practice. Annals of the Russian Academy of Medical Sciences. 2015;70(1):41–46. (In Russ).] doi: 10.15690/ vramn.v70i1.1230.

9. Antonicelli L, Bucca C, Neri M, et al. Asthma severity and medical resource utilization. Eur Respir J. 2004;23(5):723–729. doi: 10.1183/09031936.04.00004904.

10. Mansur AH, Srivastava S, Mitchell V, et al. Longterm clinical outcomes of omalizumab therapy in severe allergic asthma: Study of efficacy and safety. Respir Med. 2017;124:36–43. doi: 10.1016/j. rmed.2017.01.008.

11. Molimard M, Mala L, Bourdeix I, Le Gros V. Observational study in severe asthmatic patients after discontinuation of omalizumab for good asthma control. Respir Med. 2014;108(4):571–576. doi: 10.1016/j.rmed.2014.02.003.

12. Новик Г.А., Вишнёва Е.А., Намазова-Баранова Л.С. Приверженность: роль в достижении контроля над бронхиальной астмой у детей // Педиатрическая фармакология. — 2015. — Т.12. — №2 — С. 190–196. [Novik GA, Vishneva EA, Namazova-Baranova LS. Adherence: its role in achieving control over bronchial asthma in children. Pediatric pharmacology. 2015;12(2):190–196. (In Russ).] doi: 10.15690/pf.v12i2.1282.

13. Вишнёва Е.А., Намазова-Баранова Л.С., Антонова Е.В., и др. Универсальная информационная структура как инструмент длительного динамического мониторинга в аллергологии // Педиатрическая фармакология. — 2014. — Т.11. — №5 — С. 65–70. [Vishneva EA, Namazova-Baranova LS, Antonova EV, et al. Universal information structure as a tool of long-term follow-up monitoring in allergology. Pediatric pharmacology. 2014;11(5):65–70. (In Russ).] doi: 10.15690/pf.v11i5.1167.

14. Вишнёва Е.А., Намазова-Баранова Л.С., Антонова Е.В., Смирнов В.И. Первая отечественная информационная система — база данных клинических случаев пациентов детского возраста с персистирующей бронхиальной астмой // Педиатрическая фармакология. — 2015. — Т.12. — №1 — С. 18–21. [Vishneva EA, Namazova-Baranova LS, Antonova EV, Smirnov VI. The first Russian information system — database of clinical cases of persistent bronchial asthma in pediatric patients. Pediatric pharmacology. 2015;12(1):18–21. (In Russ).] doi: 10.15690/pf.v12i1.1242.

15. Novelli F, Latorre M, Vergura L, et al. Asthma control in severe asthmatics under treatment with omalizumab: a cross-sectional observational study in Italy. Pulm Pharmacol Ther. 2015;31:123– 129. doi: 10.1016/j.pupt.2014.09.007.

16. Chipps BE, Zeiger RS, Borish L, et al. Key findings and clinical implications from The Epidemiology and Natural History of Asthma: Outcomes and Treatment Regimens (TENOR) study. J Allergy Clin Immunol. 2012;130(2):332–342.e10. doi: 10.1016/j. jaci.2012.04.014.

17. Baur X, Bakehe P, Vellguth H. Bronchial asthma and COPD due to irritants in the workplace — an evidence-based approach. J Occup Med Toxicol. 2012;7(1):19. doi: 10.1186/1745-6673-7-19.

18. grls.rosminzdrav.ru [интернет]. Государственный реестр лекарственных средств. Безопасность лекарственных препаратов [Gosudarstvennyi reestr lekarstvennykh sredstv. Bezopasnost’ lekarstvennykh preparatov (In Russ).] [доступ от 21.04.2017]. Доступ по ссылке www.grls.rosminzdrav.ru