Universal information structure as a tool of long-term follow-up monitoring in allergology

The article is dedicated to the issues of organization of long-term follow-up monitoring of the patient population in real clinical practice. Every medical intervention is analyzed from the position of positive evidence of its effectiveness, safety and clinical-economic benefits. Although randomized clinical trials (RCTs) are the gold standard of evidence-based medicine, they feature a range of drawbacks; in some cases, such trials are infeasible are extremely complicated to perform due to certain aspects. Along with that, results of RCTs may not completely correlate with clinical practice. Thus, a register – a system of long-term clinical monitoring of a patient population – is a significant source of information on effectiveness and safety of medical interventions. This tool of follow-up observation of a patient’s condition is irreplaceable in medicine, particularly, in allergology both for epidemiological purposes and to assess effectiveness and safety of therapeutic interventions: e.g., use of IgE antibodies – biopharmaceutical omalizumab.

Keywords: register, long-term follow-up monitoring system, effectiveness, safety, uncontrolled severe persisting bronchial asthma, omalizumab, children.

1. Glants S. Mediko-biologicheskaya statistika. Per. s angl. [Biomedical Statistics. Trans. from English]. Moscow, Praktika, 1998.

2. Martsevich S.Yu., Drozdova L.Yu., Kutishenko N.P., Ginzburg M.L. Registers as a way to study the efficacy and safety of drugs. Klinitsist = Clinician. 2012; 3−4: 4−9.

3. Fletcher R., Fletcher S., Vagner E. Klinicheskaya epidemiologiya: Osnovy dokazatel'noi meditsiny [Clinical Epidemiology: Evidence-based Medicine]. Moscow, Media Sfera, 1998.

4. Stanley K. Evaluation of randomized controlled trials. Circulation. 2007; 115 (13): 1819–22.

5. Topolyanskaya S.V. Ethical aspects of clinical trials in children. Pediatricheskaya farmakologiya = Pediatric pharmacology. 2010; 7 (3): 6−11.

6. Strom B.L., Kimmel S.E., Hennessy S. Pharmacoepidemiology. 5th Edition. New York: John Wiley & Sons Ltd. 2012.

7. Avorn J. In defense of pharmacoepidemiology ― embracing the yin and yang of drug research. N Engl J Med. 2007; 357 (22): 2219–21.

8. Rawlins M. De testimonio: on the evidence for decisions about the use of therapeutic interventions. Lancet. 2008; 372 (9656): 2152–61.

9. Norris S., Atkins D., Bruening W. et al. Selecting Observational Studies for Comparing Medical Interventions. Available at: http://www.effectivehealthcare.ahrq.gov/ehc/products/196/454/MethodsGuideNorris_06042010.pdf.

10. Gliklich R.E. Registries for Evaluating Patient Outcomes: A User’s Guide. Available at: http://effectivehealthcare.ahrq.gov/ehc/products/74/531/Registries%202nd%20ed% 20final%20to%20Eisenberg%209-15-10.pdf

11. Tricoci P., Allen J.M., Kramer J.M. et al. Scientific evidence underlying the ACC/AHA clinical practice guidelines. JAMA. 2009; 301 (8): 831–41.

12. Kennedy L., Craig A.M. Global registries for measuring pharmacoeconomic and quality-oflife outcomes: focus on design and data collection, analysis and interpretation. Pharmacoeconomics. 2004; 22 (9): 551–68.

13. Guidelines for good pharmacoepidemiology practices (GPP). Pharmacoepidemiology and Drug Safety. 2008; 17: 200–8.

14. Kobrinskii B.A. Federal'nye registry v sisteme elektronnogo zdravookhraneniya. Federal'nyi spravochnik. Zdravookhranenie Rossii. Tom 13 [Federal Register in e-health System. Federal Guide. Health Care of Russia. Volume 13]. P. 170−174. Available at: http://federalbook.ru/files/FSZ/soderghanie/Tom%2013/II/Kobrinskiy.pdf

15. Papadopoulos N., Flohr C. et al. Allergy Registry Task Force (A-reg). Available at: www.eaaci.org

16. Global Atlas of Allergy. Editors: Cezmi A. Akdis, Ioana Agache. Published by the European Academy of Allergy and Clinical Immunology. 2014. 388 p.

17. Namazova-Baranova L.S., Ogorodova L.M., Tomilova A.Yu., Deev I.A., Alekseeva A.A., Vishneva E.A., Gromov I.A., Evdokimova T.A., Kamaltynova E.M., Kolomeets I.L., Torshkhoeva R.M. Motion of astmapodobnyh symptoms and diagnosed asthma in the adolescent population. Pediatricheskaya farmakologiya = Pediatric pharmacology. 2009; 6 (3): 59−65.

18. Allergiya u detei: ot teorii — k praktike. Pod red. L.S. Namazovoi-Baranovoi [Allergies in Children: from Theory to Practice. Edited by L.S. Namazova-Baranova]. Moscow, Soyuz pediatrov Rossii, 2010. 668 p.

19. Vishneva E.A., Namazova-Baranova L.S. Bronchial asthma in children younger than 8 years: how to reduce the frequency of exacerbations and hospitalizations? Pediatricheskaya farmakologiya = Pediatric pharmacology. 2009; 6 (1): 51−54.

20. Kulichenko T.V. Vozrastnaya dinamika i sovremennye metody lecheniya bronkhial'noi astmy u detei i podrostkov. Avtoref. dis. ...dokt. med. nauk [Age Dynamics and Modern Methods of Treatment of Bronchial Asthma in Children and Adolescents. Author’s abstract]. Moscow, 2013. 50 p.

21. Vishneva E.A., Namazova-Baranova L.S., Alekseeva A.A., Efendieva K.E., Levina Yu.G., Voznesenskaya N.I., Tomilova A.Yu., Selimzyanova L.R., Promyslova E.A. Asthma in children: key principles for achieving control at the present stage e. Pediatricheskaya farmakologiya = Pediatric pharmacology. 2013; 10 (4): 60−72.

22. Papadopoulos N.G., Arakawa H., Carlsen K.-H., Custovic A., Gern J. et al. International consensus on (ICON) pediatric asthma. Allergy. 2012; 67: 976–997.

23. Agache I., Akdis C., Jutel M., Virchow J.C. Untangling asthma phenotypes and endotypes. Allergy. 2012; 67: 835−846.

24. Braunstahl G.J., Chen C.W., Maykut R., Georgiou P., Peachey G., Bruce J. The eXpeRience registry: the «real-world» effectiveness of omalizumab in allergic asthma. Respir Med. 2013 Aug; 107 (8): 1141−51. Doi: 10.1016/j.rmed.2013.04.017. Epub 2013 May 28.

25. Kulichenko T.V., Namazova-Baranova L.S., Torshkhoeva R.M., Lukina O.F., Vishneva E.A. Anti-IgE-therapy of severe asthma in children: a two-year experience. Pediatricheskaya farmakologiya = Pediatric pharmacology. 2010; 7 (3): 57−65.

26. Kulichenko T.V., Baranov A.A., Abelevich M.M., Balashova E.V., Vishneva E.A., Galustyan A.N., Elizarova S.Yu., Koroleva I.V., Manvelyan A.G., Namazova-Baranova L.S., Peshekhonova Yu.V., Timofeeva E.V., Torshkhoeva R.M., Tursina N.V., Chashina T.E. Generalized analysis using monoclonal antibodies to IgE in the treatment of asthma in children in the Russian Federation. Pediatricheskaya farmakologiya = Pediatric pharmacology. 2011; 8 (2): 50−56.

27. Brusselle G., Michils A., Louis R., Dupont L., Van de Maele B., Delobbe A. et al. Real-life effectiveness of omalizumab in patients with severe persistent allergic asthma: the PERSIST study. Respir Med. 2009; 103 (11): 1633−42. Epub 2009 Jul 19.

28. Rottem M. Omalizumab reduces corticosteroid use in patients with severe allergic asthma: real-life experience in Israel. J Asthma. 2012 Feb; 49 (1): 78−82. Doi: 10.3109/02770903.2011.637598. Epub 2011 Dec 7.

29. Tzortzaki E.G., Georgiou A., Kampas D., Lemessios M., Markatos M., Adamidi T., Samara K., Skoula G., Damianaki A., Schiza S., Tzanakis N., Siafakas N.M. Long-term omalizumab treatment in severe allergic asthma: the South-Eastern Mediterranean real-life experience. Pulm Pharmacol Ther. 2012 Feb; 25 (1): 77−82. Doi: 10.1016/j.pupt.2011.11.004. Epub 2011 Dec 3.

30. Schumann C., Kropf C., Wibmer T., Rüdiger S., Stoiber K.M., Thielen A., Rottbauer W., Kroegel C. Omalizumab in patients with severe asthma: the XCLUSIVE study. Clin Respir J. 2012; 6: 215–227.

31. López Tiro J.J., Contreras E.A., Del Pozo M.E., Gómez Vera J., Larenas Linnemann D. Real life study of three years omalizumab in patients with difficult-to-control asthma. Allergol Immunopathol (Madr). 2014 Apr 26. pii: S0301-0546 (14) 00030-5. Doi: 10.1016/j.aller.2013.11.008. Epub ahead of print.

32. Cazzola M., Camiciottoli G., Bonavia M., Gulotta C., Ravazzi A., Alessandrini A., Caiaffa M.F., Berra A., Schino P., Di Napoli P.L., Maselli R., Pelaia G., Bucchioni E., Paggiaro P.L., Macchia L. Italian real-life experience of omalizumab. Respir Med. 2010 Oct; 104 (10): 1410−6. Doi: 10.1016/j.rmed.2010.04.013. Epub 2010 May 18.

33. Vieira T., de Oliveira J.F., da Graça Castel-Branco M. Short and long-term quality of life and asthma control with omalizumab therapy in a real life setting in Portugal. Allergol Immunopathol (Madr). 2014 Jan-Feb; 42 (1): 3−10. Doi: 10.1016/j.aller.2012.07.006. Epub 2012 Dec 17.

34. Bavbek S.L., Aydın O., Kepil Özdemir S., Yılmaz I., Celik G.E., Demirel Y.S., Mungan D., Sin B., Kurşun N., Mısırlıgil Z. Therapy with omalizumab in patients with severe persistent allergic asthma: a real life data in Turkey. Article in Turkish. Tuberk Toraks. 2010; 58 (4): 425−34. PMID: 21341120 [PubMed, indexed for MEDLINE].

35. de Llano L.P., Vennera Mdel C., Álvarez F.J., Medina J.F., Borderías L., Pellicer C., González H., Gullón J.A., Martínez-Moragón E., Sabadell C., Zamarro S., Picado C. Spanish Registry. Effects of omalizumab in non-atopic asthma: results from a Spanish multicenter registry. J Asthma. 2013 Apr; 50 (3): 296−301. Doi: 10.3109/02770903.2012.757780. Epub 2013 Jan 28.

36. Deschildre A., Marguet C., Salleron J., Pin I., Rittié J.L., Derelle J., Taam R.A., Fayon M., Brouard J., Dubus J.C., Siret D., Weiss L., Pouessel G., Beghin L., Just J. Add-on omalizumab in children with severe allergic asthma: a 1-year real life survey. Eur Respir J. 2013 Nov; 42 (5): 1224−33. Doi: 10.1183/09031936.00149812. Epub 2013 Mar 21.

37. Braunstahl G..J, Chen C.W., Maykut R., Georgiou P., Peachey G., Bruce J. The eXpeRience registry: the real-world effectiveness of omalizumab in allergic asthma. Respir Med. 2013 Aug; 107 (8): 1141−51. Doi: 10.1016/j.rmed.2013.04.017. Epub 2013 May 28.

38. O'Neill S., Sweeney J., Patterson C.C., Menzies-Gow A., Niven R., Mansur A.H., Bucknall C., Chaudhuri R., Thomson N.C., Brightling C.E., O'Neill C., Heaney L.G. On behalf of the British Thoracic Society Difficult Asthma Network. The cost of treating severe refractory asthma in the UK: an economic analysis from the British Thoracic Society Difficult Asthma Registry. Thorax. 2014 Jun 10. pii: thoraxjnl-2013-204114. Doi: 10.1136/thoraxjnl-2013-204114. Epub ahead of print.