The real-life clinical effects of 52 weeks of omalizumab therapy for severe persistent allergic asthma

International Journal of Clinical Pharmacy

Volumn 37, Issue 1, 2015, Pages 36-43

  Gouder, Caroline ^a   West, Lorna Marie ^b   Montefort, Stephen ^c  

^a MATER DEI HOSPITAL   (Malta)

^b Sir Paul Boffa Hospital   (Malta)

^c UNIVERSITY OF MALTA   (Malta)

Author keywords

Allergic asthma; Anti IgE antibodies; Effectiveness; Health care utilizations; Omalizumab; Tolerability

Indexed keywords

IMMUNOGLOBULIN E; IPRATROPIUM BROMIDE; LEUKOTRIENE RECEPTOR BLOCKING AGENT; OMALIZUMAB; PREDNISOLONE; STEROID; ANTIASTHMATIC AGENT; ANTIIDIOTYPIC ANTIBODY; MONOCLONAL ANTIBODY;

ADULT; ADVERSE OUTCOME; AGED; ALLERGIC ASTHMA; ARTHRALGIA; ARTICLE; ASTHMA CONTROL TEST; CLINICAL ARTICLE; CLINICAL ASSESSMENT; CLINICAL EFFECTIVENESS; CLINICAL EVALUATION; COMPARATIVE STUDY; CONTROLLED STUDY; DISEASE EXACERBATION; DIZZINESS; DRUG EFFECT; DRUG EFFICACY; DRUG SAFETY; DRUG TOLERABILITY; DRUG TOLERANCE; DRUG WITHDRAWAL; ECONOMIC ASPECT; FEMALE; FORCED EXPIRATORY VOLUME; HEADACHE; HEALTH CARE COST; HEALTH CARE SYSTEM; HEALTH CARE UTILIZATION; HOSPITALIZATION; HUMAN; INJECTION SITE REACTION; LETHARGY; LUNG FUNCTION; MALE; MIDDLE AGED; MYALGIA; NAUSEA; OBSERVATIONAL STUDY; OUTCOME ASSESSMENT; PRIORITY JOURNAL; PROSPECTIVE STUDY; QUESTIONNAIRE; RESPIRATORY TRACT DISEASE ASSESSMENT; RESPIROMETRY; RHINOPHARYNGITIS; THERAPY EFFECT; TREATMENT DURATION; ASTHMA; COHORT ANALYSIS; HYPERSENSITIVITY; SEVERITY OF ILLNESS INDEX; TIME; TREATMENT OUTCOME;

ADULT; AGED; ANTI-ASTHMATIC AGENTS; ANTIBODIES, ANTI-IDIOTYPIC; ANTIBODIES, MONOCLONAL, HUMANIZED; ASTHMA; COHORT STUDIES; FEMALE; HUMANS; HYPERSENSITIVITY; MALE; MIDDLE AGED; PROSPECTIVE STUDIES; SEVERITY OF ILLNESS INDEX; TIME FACTORS; TREATMENT OUTCOME;

EID: 84925495840     PISSN: 22107703     EISSN: 22107711     Source Type: Journal    
DOI: 10.1007/s11096-014-0034-7     Document Type: Article

References (33)

1. Braunstahl G, 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;107(8):1141–51.
2. From the Global Strategy for Asthma Prevention, Global Initiative for Asthma (GINA). 2010. http://www.ginasthma.org. Accessed 15 Jan 2014.
3. 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.
4. Hanania NA, Alpan O, Hamilos DL, Condemi JJ, Reyes-Rivera I, Zhu J, et al. Omalizumab in severe allergic asthma inadequately controlled with standard therapy: a randomized trial. Ann Intern Med. 2011;154(9):573–82.
5. 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.
6. 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.
7. Bousquet J, Siergiejko Z, Swiebocka E, Humbert M, Rabe KF, Smith N, et al. Persistency of response to omalizumab therapy in severe allergic (IgE-mediated) asthma. Allergy. 2011;66(5):671–8.
8. Holgate ST, Chuchalin AG, Hebert J, Lötvall J, Persson GB, Chung KF, et al. Efficacy and safety of a recombinant anti-immunoglobulin E antibody (omalizumab) in severe allergic asthma. Clin Exp Allergy. 2004;34(4):632–8.
9. Lanier B, Bridges T, Kulus M, Taylor AF, Berhane I, Vidaurre CF. Omalizumab for the treatment of exacerbations in children with inadequately controlled allergic (IgE-mediated) asthma. J Allergy Clin Immunol. 2009;124(6):1210–6.
10. Barnes N, Menzies-Gow A, Mansur A, Spencer D, Percival F, Radwan R, et al. Effectiveness of omalizumab in severe allergic asthma: a retrospective UK real world study. J Asthma. 2013;50(5):529–36.
11. Schumann C, Kropf C, Wibmer T, Rüdiger S, Stoiber KM, Thielen A, et al. Omalizumab in patients with severe asthma: the XCLUSIVE study. Clin Respir J. 2012;6(4):215–27.
12. 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;103:1633–42.
13. 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;103:1725–31.
14. Cazzola M, Camiciottoli G, Bonavia M, Gulotta C, Ravazzi A, Alessandrini A, et al. Italian real-life experience of omalizumab. Respir Med. 2010;104:1410–6.
15. Korn S, Schumann C, Kropf C, Stoiber K, Thielen A, Taube C, et al. Effectiveness of omalizumab in patients 50 years and older with severe persistent allergic asthma. Ann Allergy Asthma Immunol. 2010;105(4):313–9.
16. 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(2):398–405.
17. ®) full prescribing information (EU). 2007. http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/000606/human_med_001162.jsp&mid=WC0b01ac058001d124. 6 Aug 2013.
18. Rottem M. Omalizumab reduces corticosteroid use in patients with severe allergic asthma: real-life experience in Israel. J Asthma. 2012;49:78–82.
19. ®). 2014. http://www.medicines.org.uk/emc/medicine/24912/SPC/Xolair+150mg+Solution+for+InjectIion.
20. Nathan RA, Sorkness CA, Kosinski M, Schatz M, Li JT, Marcus P, et al. Development of the asthma control test: a survey for assessing asthma control. J Allergy Clin Immunol. 2004;113:59–65.
21. Lloyd A, Turk F, Leighton T, Canonica GW. Psychometric evaluation of global evaluation of treatment effectiveness: a tool to assess patients with moderate-to-severe allergic asthma. J Med Econ. 2007;10(3):285–96.
22. Thomas M, Kay S, Pike J, Williams A, Rosenzweig JR, Hillyer EV, et al. The Asthma Control Test (ACT) as a predictor of GINA-guideline-defined asthma control: analysis of a multinational cross-sectional survey. Prim Care Respir J. 2009;18:41–9.
23. Malta Government Gazzette. Healthcare fees regulations. Legal Notice 201 of 2004.
24. British Medical Association and the Royal Pharmaceutical Society of Great Britain. British National Formulary. Great Britain: The Pharmaceutical Press; 2014.
25. Health care in Malta, hospitals, health centres and pharmacies. 2011. http://www.malta.com/en/local-information/health-care. 2 Mar 2014.
26. National Statistics office Labour force survey: Q2/2013. 2013. http://nso.gov.mt/statdoc/document_file.aspx?id=3722. 2 Mar 2014.
27. National Institute for Health and Clinical Excellence. Asthma (severe, persistent, patients aged 6 +, adults)—omalizumab (rev TA133, TA201): appraisal consultation document. 2012. http://guidance.nice.org.uk/TA/WaveR/110/Consultation/DraftGuidance. 26 Jan 2013.
28. National Institute for Health and Clinical Excellence. Omalizumab for treating severe persistent allergic asthma (review of technology appraisal guidance 133 and 201). 2013. http://www.nice.org.uk/nicemedia/live/13550/62987.pdf. 29 Jul 2013.
29. ®) in the first patients treated in real-life practice in France. Respir Med. 2008;102:71–6.
30. Herland K, Akselsen JP, Skjønsberg OH, Bjermer L. How representative are clinical study patients with asthma or COPD for a larger “real life” population of patients with obstructive lung disease? Respir Med. 2005;99(1):11–9.
31. Vieira T, de Oliveira JF, da Graca 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). 2012; doi:10.1016/j.aller.2012.07.006. 28 Nov 2013.
32. Tzortzaki EG, Georgiou A, Kampas D, Lemessios M, Markatos M, Adamidi T, et al. Long-term omalizumab treatment in severe allergic asthma: the South-Eastern Mediterranean “real-life” experience. Pulm Pharmacol Ther. 2012;25(1):77–82.
33. Menzella F, Facciolongo N, Piro R, Formisano D, Roggeri A, Simonazzi A, et al. Clinical and pharmacoeconomic aspects of omalizumab: a 4-year follow-up. Ther Adv Respir Dis. 2012;6(2):87–95.