Archivos suplementarios
Palabras clave
Asma
Manejo por pasos
Consulta diaria
Datos de mundo real
Resumen
Antecedentes: el omalizumab es un anticuerpo monoclonal que se prescribe en esquema de adición por pasos para el tratamiento del asma severa.
Objetivos: informar la experiencia en pacientes con asma severa a quienes se aplicó omalizumab conforme a las guías internaciones, en un contexto de datos de mundo real.
Métodos: estudio retrospectivo, clínico, observacional, abierto, analítico y transversal a partir de datos de la vida real. Se utilizó el esquema de Control del Asma de GINA 2006 para evaluar a los pacientes y con un cuestionario se calificaron las características del paciente, efectividad, seguridad y tolerancia al omalizumab.
Resultados: se estudiaron 48 pacientes, 34 mujeres y 14 hombres, con edad promedio de 39 años. La duración promedio de la enfermedad fue de 26 años. La concentración sérica promedio de la IgE fue de 522 UI. Al inicio del tratamiento, todos los pacientes estaban sin control del asma; al final, en 69% se obtuvo control del asma, 19% estaba parcialmente controlado y 12% sin modificaciones. Los cambios se observaron en promedio a los siete meses.
Conclusión: el omalizumab es efectivo y seguro para tratar el asma severa cuando se aplica conforme las guías internacionales para el manejo del asma bronquialReferencias
Frankland AW. Carl Prausnitz: a personal memoir. J Allergy Clin Immunol. 2004;114(3):700-704.
Ishizaka K, Ishizaka T, Hornbrook M. Physicochemical properties of reaginic antibody. V. Correlation of reaginic activity wth gamma-E-globulin antibody. J Immunol. 1966;97(6):840-853.
Holgate ST. New strategies with anti-IgE in allergic diseases. World Allergy Organ J. 2014;7:17
Burrows B. Association of asthma with serum ige level and skin-test reactivity to allergens. N Engl J Med. 1989;320:271-277.
Chang TW. The pharmacological basis of anti-IgE therapy. Nat Biotechnol. 2000;18(2):157-162.
Jiu-Yao W. What Taiwan contributes to the world of allergy and clinical immunology? Asia Pac Allergy. 2013;3(4):209-214.
Chang TW, Davis FM, Sun NC, Sun CR, MacGlashan DW Jr, Hamilton RG. Monoclonal antibodies specific for human IgE producing B cells: a potential therapeutics for IgE-mediated allergic diseases. Biotechnology (NY). 1990:8(2):122-6.
Becerril-Ángeles M, Pérez Chavira R., Martínez Aguilar Nora. Tratamiento del asma persistente y de difícil control: actualización de la terapia anti IgE. Rev Alerg Mex. 2011;58(Supl 1):1-18.
Heusser C, Jardieu P: Therapeutic potential of anti-IgE antibodies. Curr Opin Immunol. 1997;9:805-813.
Corne J, Djukanovic R, Thomas L, Warner J, Botta L, Grandordy B. The effect of intravenous administration of a chimeric anti-IgE antibody on serum IgE levels in atopic subjects: efficacy, safety, and pharmacokinetics. J Clin Invest. 1997;99(5):879-887.
Campbell JD, McQueen RB, Briggs A. The “e” in cost-effectiveness analyses. A case study of omalizumab efficacy and effectiveness for cost-effectiveness analysis evidence. Ann Am Thorac Soc. 2014;11 Suppl 2:S105-S111. doi: 10.1513/AnnalsATS.201309-295RM.
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, pii: S00916749(14):00204-8
Global Initiative for Asthma [sitio web ].2016 GINA Report, Global Strategy for Asthma Management and Prevention. Disponible en: http://ginasthma.org/gina-reports/
Global Strategy for Asthma Management and Prevention. GINA 2010.
British Thoracic Society Scottish Intercollegiate Guidelines Network. British guideline on the management of asthma. Thorax On Line 2008;63;1-121. doi:10.1136/thx.2008.097741
Guía Española para el Manejo del Asma [sitio web, sección Documentos]. Gema 2009. Disponible en: http://www.gemasma.com
Lougheed MD, Lemière C, Dell SD, Ducharme FM, Fitzgerald JM, Leigh R, Licskai C, et al. Canadian Thoracic Society Asthma Management Continuum-2010 Consensus Summary for children six years of age and over and adults. Can Respir J. 2010;17(1):15-24.
Kupry-Lipinska I, Kuna P. Loss of asthma control after cessation of omalizumab treatment: real life data. Postepy Dermatol Alergol. 2014 Feb;31(1):1-5. doi: 10.5114/pdia.2014.40553.
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):309-316.
Peters SP, Ferguson G, Deniz Y, Reisner C. Uncontrolled asthma: a review of the prevalence, disease burden and options for treatment. Respir Med. 2006;100(7):1139-1151.
Rees J. Asthma control in adults. BMJ. 2006;332(7544):767-71. doi: 10.1136/bmj.332.7544.767
García López JI, Del Llano JE, Salas JD, Recalde MJM. Aportación de los “Real World Data (RWD)” a la mejora de la práctica clínica y del consumo de recursos de los pacientes. España; Fundación Gaspar Casal; 2014.
The Association of British Pharmaceutical Industry. The vision for real world data. Harnessing the opportunities in the UK. Demonstrating value with real world data. London: ABPI, White Paper; 2011.
The Association of British Pharmaceutical Industry. Demonstrating value with real world data: A practical guide. London: ABPI guidance; 2011.
Motheral BR, Fairman KA. The use of claims databases for outcomes research: rationale, challenges, and strategies. Clin Ther. 1997;19(2):346-366.
Murdoch T, Detsky A. The Inevitable Application of Big Data to Health Care. JAMA 2013;309(13):1351-1352.
Garrison LP, Neumann PJ, Erickson P, Marshal D, Mullins D, et al. Using real world data for coverage and payment decision: the ISPOR real world data task force report. Value in Health. 2007;10:326-335.
Chung KF, Wenzel SE, Brozek JL, Bush A, Castro M, Sterk PJ, et al. International ERS/ATS guidelines on definition, evaluation and treatment of severe asthma. Eur Respir J. 2014;43:343-373. doi: 10.1183/09031936.00202013.
Ben Hughes, Marla Kessler. RWE Market Impact on Medicines: A Lens for Pharma. An international comparison of the impact of Real World Evidence on creating value from medicines. US: IMSHEALTH; 2013.
D’Urzo AD, Wong J. Effectiveness of omalizumab in severe persistent asthma under real‐life conditions. Can Fam Phys. 2014;60:643-645.
Kupczyk M, Kuna P. Omalizumab in an allergology clinic: real life experience and future developments. Postepy Dermatol Alergol. 2014;3(1):32‐35.
Sandtröm T. Omalizumab in the management of patients with allergic (IgE-mediated) asthma. J Asthma Allergy. 2009;2:49-62.
Braunstahl GJ, Chen CW, Maykut R, Georgiou P, Peachey G, Bruce J. The eXpeRience registry: the ‘real‐world’ effectiveness of omalizumab in allergic asthma. Respir Med. 2013 Aug;107:1141‐1151.
Barnes N, Menzies‐Gow A, Mansur AH, Spencer D, Percival F, Radwan A, Niven R.Effectiveness of omalizumab in severe allergic asthma: a retrospective UK real‐world study. J Asthma. 2013 Jun;50:529‐536.
Molimard M, Buhl R, Niven R, Le Gros V, Thielen A, Thirlwell J, Maykut R,Peachey G. omalizumab reduces oral corticosteroid use in patients with severe allergic asthma: real‐life data. Respir Med. 2010 Sep;104:1381‐1385.
Cazzola M, Camiciottoli G, Bonavia M, Gulotta C, Ravazzi A, Alessandrini A. Italian real‐life experience of omalizumab. Respir Med. 2010;104:1410‐1416.
Brusselle G, Michils A, Louis R, Dupont L, Van de Maele B, Delobbe A. “Real‐life” effectiveness of omalizumab in patients with severe persistent allergic asthma: The PERSIST study. Respir Med. 2009;103:1633‐1642.
Korn S, Thielen A, Seyfried S, Taube C, Kornmann O, Buhl R. Omalizumab in patients with severe persistent allergic asthma in a real‐life setting in Germany. Respir Med. 2009;103:1725‐1731.
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;102:71‐76.
Molimard M, Mala L, Bourde I, Le Gros V. Observational study in severe asthmatic patients after discontinuation of omalizumab for good control of asthma. Respir Med. 2014;108(4):571-576. doi: 10.1016/j.rmed.2014.02.003.
Noop A, Johansson SGO, Adedoyin J. After 6 years with Xolair; a 3 year withdrawal follow-up. Allergy 2010;65:55-60.
Fajt ML, Wenzel SE. Asthma phenotypes and the use of biologic medications in asthma and allergic disease: The next steps toward personalized care. J Allergy Clin Immunol. 2015;135:299-310.
Esta obra está bajo una licencia internacional Creative Commons Atribución-NoComercial 4.0.
Derechos de autor 2016 Revista Alergia México