Omalizumab Therapy in Severe Asthma: Experience from the Spanish Registry-Some New Approaches

被引:64
作者
del Carmen Vennera, Maria [1 ,2 ,3 ]
Perez de Llano, Luis [4 ]
Bardagi, Santiago [5 ]
Ausin, Pilar [3 ,6 ]
Sanjuas, Carles [3 ,6 ]
Gonzalez, Hector [7 ]
Gullon, Jose A. [7 ]
Martinez-Moragon, Eva [8 ]
Carretero, Jose A. [9 ]
Vera, Elisabet [9 ]
Medina, Juan F. [10 ]
Alvarez, Francisco J. [10 ]
Entrenas, Luis M. [11 ]
Padilla, Alicia [12 ]
Irigaray, Rosa [13 ]
Picado, Cesar [1 ,2 ,3 ]
机构
[1] Univ Barcelona, Dept Pneumol & Resp Allergy, Hosp Clin, E-08036 Barcelona, Spain
[2] Inst Invest Biomed August Pi i Sunyer IDIBAPS, Barcelona, Spain
[3] Ctr Invest Biomed Red Enfermedades Resp CIBERES, Palma De Mallorca, Spain
[4] Hosp Xeral Calde, Dept Pneumol, Lugo, Spain
[5] Hosp Gen Mataro, Dept Pneumol, Mataro, Spain
[6] Hosp del Mar IMIM, Dept Pneumol, Barcelona, Spain
[7] Hosp Univ Canarias, Dept Pneumol, San Cristobal Laguna, Spain
[8] Hosp Sagunto, Dept Pneumol, Valencia, Spain
[9] Hosp Univ M Servet, Dept Pneumol, Zaragoza, Spain
[10] Hosp Univ V del Rocio, Dept Pneumol, Seville, Spain
[11] Hosp Univ Reina Sofia, Dept Pneumol, Cordoba, Spain
[12] Hosp Costa Sol, Dept Pneumol, Marbella, Spain
[13] Hosp Manacor, Dept Pneumol, Manacor, Spain
关键词
efficacy; IgE-mediated diseases; omalizumab; out-of-range IgE levels; uncontrolled severe asthma; SEVERE PERSISTENT ASTHMA; ANTI-IGE; ALLERGIC-ASTHMA; DISEASE;
D O I
10.3109/02770903.2012.668255
中图分类号
R392 [医学免疫学];
学科分类号
100102 ;
摘要
Objective. The efficacy of omalizumab in severe asthma has been widely demonstrated. The main objective of this study was to evaluate the efficacy and tolerability of omalizumab in a real-life setting in Spain, particularly in those patients with immunoglobulin E (IgE) levels out of range. Methods. Totally 266 uncontrolled severe asthma patients receiving high-dose inhaled corticosteroids (ICSs) plus long-acting beta 2-agonist (LABA) were recruited. Main efficacy outcomes were asthma exacerbation rate (AER), asthma control test (ACT), and global evaluation of treatment effectiveness (GETE). Results. AER was reduced from 3.6 (3.6) in previous year to 0.67 (1.2) at 4 months (p < .05) and to 1.04 (1.8) at 2 years (p < .05). ACT increased significantly from 14.3 (4.7) at baseline to 18.4 (4.4) at 4 months (p < .05) and to 20.3 (4.0) (p < .05) at 2 years. After 4 months, 74.6% of patients had reached a good or excellent rate on the GETE scale (p < .05). This rate continued increasing up to 81.6% at 2 years. These efficacy results were similar for patients with "off-label" IgE > 700 IU/ml. At follow-up, maintenance treatment with oral steroids was discontinued in a considerable number of patients: from 89 to 19 (p < .05). Omalizumab was discontinued because of lack of efficacy only in 28/266 (10.5%) patients. Overall, 30 patients (11.4%) reported adverse events. Severe adverse events were not observed. Conclusion. This real-life study confirms that omalizumab is very efficacious and very well tolerated in patients with uncontrolled severe asthma. Results did not vary in the subgroup of patients with IgE levels >700 IU/ ml.
引用
收藏
页码:416 / 422
页数:7
相关论文
共 21 条
[1]  
[Anonymous], EMEA XOL SMPC
[2]   Rhinosinusitis and Asthma: A Link for Asthma Severity [J].
Bachert, C. ;
Claeys, S. E. M. ;
Tomassen, P. ;
van Zele, T. ;
Zhang, N. .
CURRENT ALLERGY AND ASTHMA REPORTS, 2010, 10 (03) :194-201
[3]   Can guideline-defined asthma control be achieved? The gaining optimal asthma control study [J].
Bateman, ED ;
Boushey, HA ;
Bousquet, J ;
Busse, WW ;
Clark, TJH ;
Pauwels, RA ;
Pedersen, SE .
AMERICAN JOURNAL OF RESPIRATORY AND CRITICAL CARE MEDICINE, 2004, 170 (08) :836-844
[4]   Low-dose anti-IgE therapy in patients with atopic eczema with high serum IgE levels [J].
Belloni, Benedetta ;
Ziai, Mahzad ;
Lim, Annick ;
Lemercier, Brigitte ;
Sbornik, Martin ;
Weidinger, Stephan ;
Andres, Christian ;
Schnopp, Christina ;
Ring, Johannes ;
Hein, Ruediger ;
Ollert, Markus ;
Mempel, Martin .
JOURNAL OF ALLERGY AND CLINICAL IMMUNOLOGY, 2007, 120 (05) :1223-1225
[5]   The effect of treatment with omalizumab, an anti-IgE antibody, on asthma exacerbations and emergency medical visits in patients with severe persistent asthma [J].
Bousquet, J ;
Cabrera, P ;
Berkman, N ;
Buhl, R ;
Holgate, S ;
Wenzel, S ;
Fox, H ;
Hedgecock, S ;
Blogg, M ;
Della Cioppa, G .
ALLERGY, 2005, 60 (03) :302-308
[6]   "Real-life" effectiveness of omalizumab in patients with severe persistent allergic asthma: The PERSIST study [J].
Brusselle, G. ;
Michils, A. ;
Louis, R. ;
Dupont, L. ;
de Maele, B. Van ;
Delobbe, A. ;
Pilette, C. ;
Lee, C. S. ;
Gurdain, S. ;
Vancayzeele, S. ;
Lecomte, P. ;
Hermans, C. ;
MacDonald, K. ;
Song, M. ;
Abraham, I. .
RESPIRATORY MEDICINE, 2009, 103 (11) :1633-1642
[7]   Randomized Trial of Omalizumab (Anti-IgE) for Asthma in Inner-City Children [J].
Busse, William W. ;
Morgan, Wayne J. ;
Gergen, Peter J. ;
Mitchell, Herman E. ;
Gern, James E. ;
Liu, Andrew H. ;
Gruchalla, Rebecca S. ;
Kattan, Meyer ;
Teach, Stephen J. ;
Pongracic, Jacqueline A. ;
Chmiel, James F. ;
Steinbach, Suzanne F. ;
Calatroni, Agustin ;
Togias, Alkis ;
Thompson, Katherine M. ;
Szefler, Stanley J. ;
Sorkness, Christine A. .
NEW ENGLAND JOURNAL OF MEDICINE, 2011, 364 (11) :1005-1015
[8]   Italian real-life experience of omalizumab [J].
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. .
RESPIRATORY MEDICINE, 2010, 104 (10) :1410-1416
[9]   A 26-Week, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Effect of Omalizumab on Markers of Asthma Impairment in Patients With Persistent Allergic Asthma [J].
Figliomeni, M. ;
Kianifard, F. ;
Meng, X. .
JOURNAL OF ALLERGY AND CLINICAL IMMUNOLOGY, 2011, 127 (02) :AB84-AB84
[10]  
*GINA, NHLBI WHO WORKSH REP