Real-World Effectiveness of Dupilumab for Patients with Severe Asthma: A Retrospective Study

被引:37
作者
Numata, Takanori [1 ]
Araya, Jun [1 ]
Miyagawa, Hanae [1 ]
Okuda, Keitaro [1 ]
Takekoshi, Daisuke [1 ]
Hashimoto, Mitsuo [1 ]
Minagawa, Shunsuke [1 ]
Ishikawa, Takeo [1 ]
Hara, Hiromichi [1 ]
Kuwano, Kazuyoshi [1 ]
机构
[1] Jikei Univ, Dept Resp Dis, Sch Med, Tokyo, Japan
关键词
dupilumab; severe asthma; exacerbation; transient eosinophilia; real-world; SUPER-RESPONDER; BENRALIZUMAB; MEPOLIZUMAB; PLACEBO; EOSINOPHILS; EFFICACY; ALLERGY; SAFETY;
D O I
10.2147/JAA.S357548
中图分类号
R392 [医学免疫学];
学科分类号
100102 ;
摘要
Background: Treatment with dupilumab, an anti-interleukin (IL)-4 receptor a monoclonal antibody that blocks both the IL-4 and IL-13 pathways, has demonstrated efficacy for the treatment of severe asthma (SA) with type 2 inflammation. However, few studies have focused on the efficacy of this biologic for the treatment of SA in a real-world setting. Methods: From April 2019 to December 2021, 26 Japanese patients with SA received dupilumab at Jikei University Hospital. We retrospectively evaluated the number of moderate-to-severe exacerbations, pulmonary function, maintenance dose of corticosteroids, biomarkers, and adverse events. Results: During a mean follow-up period of 12.6 months, 10 patients received dupilumab as the first biologic, and 16 switched to dupilumab from other biologics. Dupilumab treatment significantly reduced the number of annual exacerbations from 3.4 +/- 4.1 to 1.6 +/- 2.7 (/person-year, p < 0.01) at the last follow-up regardless of previous biologic use. The Asthma Control Test score significantly improved in all patients by six months after administration but tended to worsen by 24 months in patients with previous biologic use. On the other hand, blood eosinophil counts (BEC5) transiently increased and peaked three to six months after administration. The peak timing can be affected by previous biologic use. Adverse events included wheezing immediately after injection, hypereosinophilia, mild conjunctivitis, and relapse of chronic eosinophilic pneumonia in the patient switched from benralizumab. Conclusion: Dupilumab treatment was useful for patients with SA in a real-world setting. However, the BEC should be monitored carefully, especially in patients who previously received anti-IL-5/IL-5 receptor antibody.
引用
收藏
页码:395 / 405
页数:11
相关论文
共 43 条
[1]   Trends in hospitalizations for asthma during the COVID-19 outbreak in Japan [J].
Abe, Kazuhiro ;
Miyawaki, Atsushi ;
Nakamura, Masaki ;
Ninomiya, Hideki ;
Kobayashi, Yasuki .
JOURNAL OF ALLERGY AND CLINICAL IMMUNOLOGY-IN PRACTICE, 2021, 9 (01) :494-496.e1
[2]   Asthma control and quality of life in a real-life setting: a cross-sectional study of adult asthma patients in Japan (ACQUIRE-2) [J].
Adachi, Mitsuru ;
Hozawa, Soichiro ;
Nishikawa, Masanori ;
Yoshida, Atsushi ;
Jinnai, Tatsunori ;
Tamura, Gen .
JOURNAL OF ASTHMA, 2019, 56 (09) :1016-1025
[3]   Efficacy and safety of dupilumab in patients with severe chronic rhinosinusitis with nasal polyps (LIBERTY NP SINUS-24 and LIBERTY NP SINUS-52): results from two multicentre, randomised, double-blind, placebo-controlled, parallel-group phase 3 trials [J].
Bachert, Claus ;
Han, Joseph K. ;
Desrosiers, Martin ;
Hellings, Peter W. ;
Amin, Nikhil ;
Lee, Stella E. ;
Mullol, Joaquim ;
Greos, Leon S. ;
Bosso, John V. ;
Laidlaw, Tanya M. ;
Cervin, Anders U. ;
Maspero, Jorge F. ;
Hopkins, Claire ;
Olze, Heidi ;
Canonica, G. Walter ;
Paggiaro, Pierluigi ;
Cho, Seong H. ;
Fokkens, Wytske J. ;
Fujieda, Shigeharu ;
Zhang, Mei ;
Lu, Xin ;
Fan, Chunpeng ;
Draikiwicz, Steven ;
Kamat, Siddhesh A. ;
Khan, Asif ;
Pirozzi, Gianluca ;
Patel, Naimish ;
Graham, Neil M. H. ;
Ruddy, Marcella ;
Staudinger, Heribert ;
Weinreich, David ;
Stahl, Neil ;
Yancopoulos, George D. ;
Mannent, Leda P. .
LANCET, 2019, 394 (10209) :1638-1650
[4]   Oral Glucocorticoid-Sparing Effect of Mepolizumab in Eosinophilic Asthma [J].
Bel, Elisabeth H. ;
Wenzel, Sally E. ;
Thompson, Philip J. ;
Prazma, Charlene M. ;
Keene, Oliver N. ;
Yancey, Steven W. ;
Ortega, Hector G. ;
Pavord, Ian D. .
NEW ENGLAND JOURNAL OF MEDICINE, 2014, 371 (13) :1189-1197
[5]   Efficacy and safety of benralizumab for patients with severe asthma uncontrolled with high-dosage inhaled corticosteroids and long-acting β2-agonists (SIROCCO): a randomised, multicentre, placebo-controlled phase 3 trial [J].
Bleecker, Eugene R. ;
FitzGerald, J. Mark ;
Chanez, Pascal ;
Papi, Alberto ;
Weinstein, Steven F. ;
Barker, Peter ;
Sproule, Stephanie ;
Gilmartin, Geoffrey ;
Aurivillius, Magnus ;
Werkstrom, Viktoria ;
Goldman, Mitchell .
LANCET, 2016, 388 (10056) :2115-2127
[6]   Biologic Therapies for Severe Asthma [J].
Brusselle, Guy G. ;
Koppelman, Gerard H. .
NEW ENGLAND JOURNAL OF MEDICINE, 2022, 386 (02) :157-171
[7]   Real-World Experience with Dupilumab in Severe Asthma: One-Year Data from an Italian Named Patient Program [J].
Campisi, Raffaele ;
Crimi, Claudia ;
Nolasco, Santi ;
Beghe, Bianca ;
Antonicelli, Leonardo ;
Guarnieri, Gabriella ;
Scichilone, Nicola ;
Porto, Morena ;
Macchia, Luigi ;
Scioscia, Giulia ;
Barbaro, Maria Pia Foschino ;
Papi, Alberto ;
Crimi, Nunzio .
JOURNAL OF ASTHMA AND ALLERGY, 2021, 14 :575-583
[8]   Dupilumab Efficacy and Safety in Moderate-to-Severe Uncontrolled Asthma [J].
Castro, M. ;
Corren, J. ;
Pavord, I. D. ;
Maspero, J. ;
Wenzel, S. ;
Rabe, K. F. ;
Busse, W. W. ;
Ford, L. ;
Sher, L. ;
FitzGerald, J. M. ;
Katelaris, C. ;
Tohda, Y. ;
Zhang, B. ;
Staudinger, H. ;
Pirozzi, G. ;
Amin, N. ;
Ruddy, M. ;
Akinlade, B. ;
Khan, A. ;
Chao, J. ;
Martincova, R. ;
Graham, N. M. H. ;
Hamilton, J. D. ;
Swanson, B. N. ;
Stahl, N. ;
Yancopoulos, G. D. ;
Teper, A. .
NEW ENGLAND JOURNAL OF MEDICINE, 2018, 378 (26) :2486-2496
[9]  
Castro M, 2015, LANCET RESP MED, V3, P355, DOI [10.1016/S2213-2600(15)00042-9, 10.1016/S2213-2600(15)00119-8]
[10]   Inflammatory and Comorbid Features of Patients with Severe Asthma and Frequent Exacerbations [J].
Denlinger, Loren C. ;
Phillips, Brenda R. ;
Ramratnam, Sinna ;
Ross, Kristie ;
Bhakta, Nirav R. ;
Cardet, Juan Carlos ;
Castro, Mario ;
Peters, Stephen P. ;
Phipatanakul, Wanda ;
Aujle, Shean ;
Bacharier, Leonard B. ;
Bleecker, Eugene R. ;
Comhair, Suzy A. A. ;
Coverstone, Andrea ;
DeBoer, Mark ;
Erzurum, Serpil C. ;
Fain, Sean B. ;
Fajt, Merritt ;
Fitzpatrick, Anne M. ;
Gaffin, Jonathan ;
Gaston, Benjamin ;
Hastie, Annette T. ;
Hawkins, Gregory A. ;
Holguin, Fernando ;
Irani, Anne-Marie ;
Israel, Elliot ;
Levy, Bruce D. ;
Ngoc Ly ;
Meyers, Deborah A. ;
Moore, Wendy C. ;
Myers, Ross ;
Opina, Maria Theresa D. ;
Peters, Michael C. ;
Schiebler, Mark L. ;
Sorkness, Ronald L. ;
Teague, W. Gerald ;
Wenzel, Sally E. ;
Woodruff, Prescott G. ;
Mauger, David T. ;
Fahy, John V. ;
Jarjour, Nizar N. .
AMERICAN JOURNAL OF RESPIRATORY AND CRITICAL CARE MEDICINE, 2017, 195 (03) :302-313