Efficacy and safety of treatment with omalizumab for chronic spontaneous urticaria: A systematic review for the EAACI Biologicals Guidelines

被引:60
作者
Agache, Ioana [1 ]
Rocha, Claudio [2 ]
Pereira, Ana [2 ]
Song, Yang [2 ]
Alonso-Coello, Pablo [3 ,4 ]
Sola, Ivan [2 ]
Beltran, Jessica [2 ]
Posso, Margarita [3 ]
Akdis, Cezmi [5 ,6 ]
Akdis, Mubeccel [5 ,6 ]
Brockow, Knut [7 ]
Chivato, Tomas [8 ]
del Giacco, Stefano [9 ]
Eiwegger, Thomas [10 ,11 ,12 ,13 ]
Eyerich, Kilian [14 ]
Gimenez-Arnau, Ana [15 ]
Gutermuth, Jan [16 ]
Guttman-Yassky, Emma [17 ]
Maurer, Marcus [18 ]
Ogg, Graham [19 ]
Ong, Peck [20 ]
O'Mahony, Liam [21 ,22 ]
Schwarze, Jurgen [23 ]
Werfel, Thomas [24 ]
Canelo-Aybar, Carlos [3 ,4 ]
Palomares, Oscar [25 ]
Jutel, Marek [26 ,27 ]
机构
[1] Transylvania Univ, Fac Med, 2A Pictor Ion Andreescu, Brasov 500051, Romania
[2] Biomed Res Inst St Pau IIB St Pau, Dept Clin Epidemiol & Publ Hlth, Iberoamer Cochrane Ctr, Barcelona, Spain
[3] IMIM Hosp del Mar Med Res Inst, Dept Epidemiol & Evaluat, Barcelona, Spain
[4] CIBER Epidemiol & Salud Publ CIBERESP, Barcelona, Spain
[5] Univ Zurich, Swiss Inst Allergy & Asthma Res SIAF, Davos, Switzerland
[6] Christine Kuhne Ctr Allergy Res & Educ, Davos, Switzerland
[7] Tech Univ Munich, Dept Dermatol & Allergol Biederstein, Munich, Germany
[8] Univ CEU San Pablo, Med, Madrid, Spain
[9] Univ Cagliari, Dept Med Sci & Publ Hlth, Cagliari, Italy
[10] Hosp Sick Children, Res Inst, Translat Med Program, Toronto, ON, Canada
[11] Univ Toronto, Dept Immunol, Toronto, ON, Canada
[12] Univ Toronto, Hosp Sick Children, Food Allergy & Anaphylaxis Program, Div Immunol & Allergy,Dept Paediat, Toronto, ON, Canada
[13] Univ Toronto, Hosp Sick Children, Food Allergy & Anaphylaxis Program, Div Immunol & Allergy,Dept Immunol, Toronto, ON, Canada
[14] Tech Univ Munich, Dept Dermatol & Allergy Biederstein, Munich, Germany
[15] Univ Autonoma Barcelona, Hosp del Mar, Inst Mar Invest Med, Dept Dermatol, Barcelona, Spain
[16] Vrije Univ Brussel VUB, Univ Ziekenhuis Brussel, Dept Dermatol, Brussels, Belgium
[17] Icahn Sch Med Mt Sinai, Dept Dermatol, New York, NY 10029 USA
[18] Univ Med Berlin, Dept Dermatol & Allergy, Allergie Ctr Charite, Dermatol Allergol, Berlin, Germany
[19] Univ Oxford, Weatherall Inst Mol Med, Dept Med, MRC Human Immunol Unit, Oxford, England
[20] Univ Southern Calif, Keck Sch Med, Los Angeles, CA 90007 USA
[21] Univ Coll Cork, APC Microbiome Ireland, Dept Med, Cork, Ireland
[22] Univ Coll Cork, APC Microbiome Ireland, Dept Microbiol, Cork, Ireland
[23] Univ Edinburgh, Ctr Inflammat Res Child Life & Hlth, Edinburgh, Midlothian, Scotland
[24] Hannover Med Sch, Dept Dermatol & Allergy, Div Immunodermatol & Allergy Res, Hannover, Germany
[25] Univ Complutense Madrid, Chem Sch, Dept Biochem & Mol Biol, Madrid, Spain
[26] Wroclaw Med Univ, Dept Clin Immunol, Wroclaw, Poland
[27] ALL MED Med Res Inst, Wroclaw, Poland
基金
英国医学研究理事会;
关键词
chronic idiopathic urticaria; chronic spontaneous urticaria; itch severity score; omalizumab; urticaria activity score; CHRONIC IDIOPATHIC URTICARIA; DISEASE-ACTIVITY; IMPORTANT DIFFERENCE; QUALITY; GRADE; SERUM;
D O I
10.1111/all.14547
中图分类号
R392 [医学免疫学];
学科分类号
100102 ;
摘要
This systematic review evaluates the efficacy and safety of omalizumab for chronic spontaneous urticaria (CSU). PubMed, Embase, and Cochrane Library were searched for RCTs. Critical and important CSU-related outcomes were considered. The risk of bias and the certainty of the evidence were assessed using GRADE. Ten RCTs including 1620 subjects aged 12 to 75 years old treated with omalizumab for 16 to 40 weeks were evaluated. Omalizumab 150 mg does not result in clinically meaningful improvement (high certainty) of the urticaria activity score (UAS)7 (mean difference (MD) -5; 95%CI -7.75 to -2.25), and the itch severity score (ISS)7 (MD -2.15; 95% CI -3.2 to -1.1) does not increase (moderate certainty) quality of life (QoL) (Dermatology Life Quality Index (DLQI); MD -2.01; 95%CI -3.22 to -0.81) and decreases (moderate certainty) rescue medication use (MD -1.68; 95%CI -2.95 to -0.4). Omalizumab 300 mg results in clinically meaningful improvements (moderate certainty) of the UAS7 (MD -11.05; 95%CI -12.87 to -9.24), the ISS7 (MD -4.45; 95%CI -5.39 to -3.51), and QoL (high certainty) (DLQI; MD -4.03; 95% CI -5.56 to -2.5) and decreases (moderate certainty) rescue medication use (MD -2.04; 95%CI -3.19 to -0.88) and drug-related serious AEs (RR 0.77; 95%CI 0.20 to 2.91).
引用
收藏
页码:59 / 70
页数:12
相关论文
共 49 条
[1]   IgM and IgA in addition to IgG autoantibodies against FceRIα are frequent and associated with disease markers of chronic spontaneous urticaria [J].
Altrichter, Sabine ;
Zampeli, Vasiliki ;
Ellrich, Andre ;
Zhang, Ke ;
Church, Martin K. ;
Maurer, Marcus .
ALLERGY, 2020, 75 (12) :3208-3215
[2]   Quality of life and patients' satisfaction in chronic urticaria and respiratory allergy [J].
Baiardini, I ;
Giardini, A ;
Pasquali, M ;
Dignetti, P ;
Guerra, L ;
Specchia, C ;
Braido, F ;
Majani, G ;
Canonica, GW .
ALLERGY, 2003, 58 (07) :621-623
[3]   WHY THE COCHRANE RISK OF BIAS TOOL SHOULD INCLUDE FUNDING SOURCE AS A STANDARD ITEM [J].
Bero, Lisa A. .
COCHRANE DATABASE OF SYSTEMATIC REVIEWS, 2013, (12)
[4]   Omalizumab vs. placebo in the management of chronic idiopathic urticaria: a systematic review [J].
Carrillo, Diana C. ;
Sanchez Borges, Mario ;
Garcia, Elizabeth ;
Egea, Eduardo ;
Serrano, Carlos D. .
WORLD ALLERGY ORGANIZATION JOURNAL, 2014, 7
[5]   Impact of omalizumab on patient-reported outcomes in chronic idiopathic urticaria: Results from a randomized study (XTEND-CIU) [J].
Casale, Thomas B. ;
Murphy, Thomas R. ;
Holden, Michael ;
Rajput, Yamina ;
Yoo, Bongin ;
Bernstein, Jonathan A. .
JOURNAL OF ALLERGY AND CLINICAL IMMUNOLOGY-IN PRACTICE, 2019, 7 (07) :2487-+
[6]   The potential pharmacologic mechanisms of omalizumab in patients with chronic spontaneous urticaria [J].
Chang, Tse Wen ;
Chen, Christina ;
Lin, Chien-Jen ;
Metz, Martin ;
Church, Martin K. ;
Maurer, Marcus .
JOURNAL OF ALLERGY AND CLINICAL IMMUNOLOGY, 2015, 135 (02) :337-+
[7]   New biological treatments for asthma and skin allergies [J].
Eyerich, Stefanie ;
Metz, Martin ;
Bossios, Apostolos ;
Eyerich, Kilian .
ALLERGY, 2020, 75 (03) :546-560
[8]   Serum autoreactivity predicts time to response to omalizumab therapy in chronic spontaneous urticaria [J].
Gericke, Janine ;
Metz, Martin ;
Ohanyan, Tatevik ;
Weller, Karsten ;
Altrichter, Sabine ;
Skov, Per Stahl ;
Falkencrone, Sidsel ;
Brand, Janko ;
Kromminga, Arno ;
Hawro, Tomasz ;
Church, Martin K. ;
Maurer, Marcus .
JOURNAL OF ALLERGY AND CLINICAL IMMUNOLOGY, 2017, 139 (03) :1059-1061
[9]   GRADE:: an emerging consensus on rating quality of evidence and strength of recommendations [J].
Guyatt, Gordon H. ;
Oxman, Andrew D. ;
Vist, Gunn E. ;
Kunz, Regina ;
Falck-Ytter, Yngve ;
Alonso-Coello, Pablo ;
Schuenemann, Holger J. .
BRITISH MEDICAL JOURNAL, 2008, 336 (7650) :924-926
[10]  
Guyatt GH, 2011, J CLIN EPIDEMIOL, V64, P1311, DOI [10.1016/j.jclinepi.2011.03.017, 10.1016/j.jclinepi.2011.06.004]