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Twice-Yearly Depemokimab in Severe Asthma with an Eosinophilic Phenotype

Title:	Twice-Yearly Depemokimab in Severe Asthma with an Eosinophilic Phenotype
Authors:	David J Jackson; Michael E Wechsler; Daniel J Jackson; David Bernstein; Stephanie Korn; Paul E Pfeffer; Ruchong Chen; Junpei Saito; Gustavo de Luíz Martinez; Lucyna Dymek; Loretta Jacques; Nicholas Bird; Stein Schalkwijk; Douglas Smith; Peter Howarth; Ian D Pavord; SWIFT-1 and SWIFT-2 Investigators; SWIFT-1 Investigators; SWIFT-2 Investigators; Syed Anees; Guy Chouinard; George Philteos; William Yang; Xingjun Cai; Bi Chen; Yuanrong Dai; Liang Dong; Wei Duan; Xiuhua Fu; Yingyun Fu; Huaqiong Huang; Bin Jia; Dongming Li; Jing Li; Xinglin Gao; Huiguo Liu; Zhuang Ma; Xiaodong Mei; Liping Peng; Zhongmin Qiu; Shenghua Sun; Dejun Sun; Liping Wei; Fuqiang Wen; Li Zhao; Ziwen Zhao; Cuixia Zheng; Huili Zhu; Kristian Brat; Petr Kopecky Jr; Daniela Kopecka; Irena Krcmova; Jaroslav Mares; Eva Volakova; Pauline-Marie Roux; Arnaud Bourdin; Joelle Courdeau-Labourie; Philippe Masson; Hervé Pegliasco; Sabine Ballenberger; Falk Brunner; Christian Gessner; Andreas Deimling; Martin Ehlers; Karin Foerster; Gerhard Hoheisel; Gabriele Illies; Claus Keller; Olaf Schmidt; Breda Cushen; Desmond Murphy; Bianca Beghè; Cristiano Caruso; Angelo Guido Di Corsico; Fabiano Marco; Giuseppe Idotta; Maria F Patria; Malgorzata Czuprynska-Borkowska; Marek Jutel; Izabella Krupa-Borek; Anna Latos; Bernadetta Majorek-Olechowska; Grazyna Pulka; Krzysztof Wytrychowski; Evgeny Bazdyrev; Anna Nikolaevna Galustyan; Svetlana Goncharova; Veronika Kadochnikova; Sergey Mikhaylov; Natalia Nenasheva; Irina Ryzhova; Natalia Shaporova; Ismael Ali García; Gustavo De Luiz Martinez; Maria Luz Garcia Garcia; Francisco de Borja García-Cosío Piqueras; Teresa Garriga Baraut; Concepción Morales García; Josep Morera Prat; Juan Roldán Sánchez; Fernando José Sánchez-Toril López; Nita Sehgal; Timothy Harrison; Adel Mansur; Monica Nordstrom; Paul Pfeffer; Dinesh Saralaya; Michael Anderson; Anup Banerjee; Jorge Beato; Subodh Bhuchar; Vasundhara Cheekati; Lee Clore; John De Beixedon; Chrisette Dharma; David Fuentes; Alan Goldsobel; Brad Goodman; James Edward Greenwald; William Greisner; Tatiana Hernandez; Yekaterina Khronusova; Kenneth Kim; Sara Llerena; Maxcie Sikora; Maria Mascolo; Dale Mohar; Dileep Puppala; Orlando Rivero; David Scarpino; Javier Chang; Dareen Siri; John Trimble; Neal Warshoff; Hubertus Jersmann; Ajay Kevat; Andrew Tai; Olga Voloshyna; Remi Gagnon; William Killorn; Justin Ling; Marcel Mallet; Lyle Melenka; Nathan Strauss; Robert Williams; Connie Yang; Brian Zidel; Lucie Heribanova; Stanislav Holub; Milan Kasl; Michal Svarc; Frederiqu Aubourg; Pascal Chanez; Pierrick Cros; Frederic De Blay; Toufik Didi; Alice Dupouy; Helen Fouquet; Sylvain Marchand-Adam; Fabien Rolland; Ferenc Gonczi; János Mucsi; Veronika Müller; Zoltan Novak; Gabor Papp; Erika Unger; Elena Bargagli; Alida Benfante; Marco Confalonieri; Stefano Del Giacco; Luigi Macchia; Sebastiano Gangemi; Enrico Marco Heffler; Manlio Milanese; Laura Pini; Giulia Scioscia; Alessandro Vatrella; Dina Visca; Nobukazu Fujimoto; Nobuhisa Ishikawa; Sumito Isogai; Ken Iesato; Tadashi Kamei; Tomoki Kimura; Yasutaka Kawai; Tetsuya Kawano; Arihiro Kiyosue; Makoto Kudo; Tohru Kojima; Toshiyuki Koya; Shigeru Komatsu; Motohiko Miura; Yoichi Nakamura; Hiroyuki Nakamura; Toshikazu Nagakura; Osamu Narumoto; Hiroyuki Tashimo; Norihiko Nakanishi; Hironori Sagara; Toshihiro Shirai; Eisuke Sasaki; Hisaho Takahashi; Hiromi Tomioka; Kenichi Takahashi; Kunihiko Terada; Naohiko Taba; Hiroshi Tanaka; Junichiro Tezuka; Koichi Takagi; Kazuhiro Usui; Taihei Yanagida; Shigemi Yoshihara; Malgorzata Bederska; Marta Chelminska; Anna Olech-Cudzik; Malgorzata Pawlukiewicz; Ignacio Antépara Ercoreca; Irina Diana Bobolea; Jaime Lozano Blasco; Rocio Diaz Campos; Ismael García Moguel; María Teresa Dordal Culla; Jose Maria Echave-Sustaeta; Maria Del Mar Fernández Nieto; Francisco Javier González Barcala; Luis Valdés Cuadrado; Juan Luis García Rivero; Ruperto González Pérez; José María Marín Trigo; Carlos Martínez Rivera; Celia Pinedo Sierra; Jacinta Ramos González; Ana Rañó Pérez; Juan Roldan Sanchez; Jaime Signes-Costa Miñana; Agustín Sojo González; Jose Soto Campos; María José Torres Jaén; José Luis Velasco Garrido; Ming-Cheng Chan; Shih-Lung Cheng; Ping-Hung Kuo; Kang- Yun Lee; Xin-Min Liao; Shu-Min Lin; Chau-Chyun Sheu; Shih-Ming Tsao; Haider Afzal; Sandeep Bansal; Barbara Baxter; Richard Beasley; Eric Caplan; Jose Carpio; Francisco Chevres; Timothy Craig; Kevin Deboer; Bruce Decotiis; Bruce Decotiis Jr; Michael Denenberg; David Elkayam; Roohi Faiyaz; Hiram Garcia; Jose Gomez-Cortes; Aurelio Torres Consuegra; Theresa Guilbert; Sheharyar Durrani; Marvin Heuer; Golda Hudes; Michael Hull; Thomas Hyers; Richard Kelly; Talal Khader; Shahrukh Kureishy; Jaime Landman; William Lavery; Mark Neustrom; Jeffrey Leflein; Mila Leong; Brian Lipson; Sashi Makam; David Marks; Gailen Marshall; Thomas Minor; Giselle Mosnaim; David Nyanjom; Jorge Paoli-Bruno; Edel Abreu; Gilberto Perez; Vandely Perez; Robert Ramirez; Raghu Reddy; Marimer Rensoli Velazquez; Agustin Rivas; Yamirka Sanchezm; Michael Schechter; C Andrew Schroeder; Kartik Shenoy; Vinay Sikand; Lawrence Sindel; John Southard; Clyde Southwell; Thomas Stern; Ricardo Tan; Zoya Treyster; Bernard Silverman; Jason Thomason; Christine Vidouria; H James Wedner; Paul Weinberg; Heidi Zafra; Syed Zaidi; Tomasz Ziedalski; Michael Zlupko.
Contributors:	J Jackson, David; E Wechsler, Michael; J Jackson, Daniel; Bernstein, David; Korn, Stephanie; E Pfeffer, Paul; Chen, Ruchong; Saito, Junpei; De Luíz Martinez, Gustavo; Dymek, Lucyna; Jacques, Loretta; Bird, Nichola; Schalkwijk, Stein; Smith, Dougla; Howarth, Peter; D Pavord, Ian; and SWIFT-2 Investigators, SWIFT-1; Investigators, SWIFT-1; Investigators, SWIFT-2; Anees, Syed; Chouinard, Guy; Philteos, George; Yang, William; Cai, Xingjun; Chen, Bi; Dai, Yuanrong; Dong, Liang; Duan, Wei; Fu, Xiuhua; Fu, Yingyun; Huang, Huaqiong; Jia, Bin; Li, Dongming; Li, Jing; Gao, Xinglin; Liu, Huiguo; Ma, Zhuang; Mei, Xiaodong; Peng, Liping; Qiu, Zhongmin; Sun, Shenghua; Sun, Dejun; Wei, Liping; Wen, Fuqiang; Zhao, Li; Zhao, Ziwen; Zheng, Cuixia; Zhu, Huili; Brat, Kristian; Kopecky Jr, Petr; Kopecka, Daniela; Krcmova, Irena; Mares, Jaroslav; Volakova, Eva; Roux, Pauline-Marie; Bourdin, Arnaud; Courdeau-Labourie, Joelle; Masson, Philippe; Pegliasco, Hervé; Ballenberger, Sabine; Brunner, Falk; Gessner, Christian; Deimling, Andrea; Ehlers, Martin; Foerster, Karin; Hoheisel, Gerhard; Illies, Gabriele; Keller, Clau; Schmidt, Olaf; Cushen, Breda; Murphy, Desmond; Beghè, Bianca; Caruso, Cristiano; Guido Di Corsico, Angelo; Marco, Fabiano; Idotta, Giuseppe; F Patria, Maria; Czuprynska-Borkowska, Malgorzata; Jutel, Marek; Krupa-Borek, Izabella; Latos, Anna; Majorek-Olechowska, Bernadetta; Pulka, Grazyna; Wytrychowski, Krzysztof; Bazdyrev, Evgeny; Nikolaevna Galustyan, Anna; Goncharova, Svetlana; Kadochnikova, Veronika; Mikhaylov, Sergey; Nenasheva, Natalia; Ryzhova, Irina; Shaporova, Natalia; Ali García, Ismael; De Luiz Martinez, Gustavo; Luz Garcia Garcia, Maria; de Borja García-Cosío Piqueras, Francisco; Garriga Baraut, Teresa
Publication Year:	2024
Collection:	Università degli studi di Trieste: ArTS (Archivio della ricerca di Trieste)
Subject Terms:	asthma; severe asthma; eosinophilia; Asthma (Allergy/Immunology); Asthma (Pulmonary/Critical Care); Clinical Medicine General; Outpatient-Based Clinical Medicine; Pulmonary/Critical Care General
Description:	Background: Depemokimab is an ultra-long-acting biologic therapy with enhanced binding affinity for interleukin-5 that may enable effective 6-month dosing intervals. Methods: In these phase 3A, randomized, placebo-controlled replicate trials, we evaluated the efficacy and safety of depemokimab in patients with severe asthma and an eosinophilic phenotype characterized by a high eosinophil count (≥300 cells per microliter in the previous 12 months or ≥150 cells per microliter at screening) and a history of exacerbations despite the receipt of medium- or high-dose inhaled glucocorticoids. Patients were randomly assigned in a 2:1 ratio to receive either depemokimab (at a dose of 100 mg subcutaneously) or placebo at weeks 0 and 26, plus standard care. The primary end point was the annualized rate of exacerbations at 52 weeks. Secondary end points, which were analyzed in a hierarchical manner to adjust for multiplicity, included the change from baseline in the score on the St. George's Respiratory Questionnaire (SGRQ), the forced expiratory volume in 1 second, and asthma symptom reports at 52 weeks. Results: Across the two trials, 792 patients underwent randomization and 762 were included in the full analysis; 502 were assigned to receive depemokimab and 260 to receive placebo. The annualized rate of exacerbations was 0.46 (95% confidence interval [CI]), 0.36 to 0.58) with depemokimab and 1.11 (95% CI, 0.86 to 1.43) with placebo (rate ratio, 0.42; 95% CI, 0.30 to 0.59; P
Document Type:	article in journal/newspaper
File Description:	STAMPA
Language:	English
Relation:	info:eu-repo/semantics/altIdentifier/pmid/39248309; info:eu-repo/semantics/altIdentifier/wos/WOS:001413001600006; volume:391; issue:24; firstpage:2337; lastpage:2349; numberofpages:13; journal:THE NEW ENGLAND JOURNAL OF MEDICINE; https://hdl.handle.net/11368/3101978
DOI:	10.1056/NEJMoa2406673
Availability:	https://hdl.handle.net/11368/3101978; https://doi.org/10.1056/NEJMoa2406673; https://www.nejm.org/doi/10.1056/NEJMoa2406673
Rights:	info:eu-repo/semantics/closedAccess ; license:Digital Rights Management non definito ; license:Copyright Editore ; license uri:iris.PRI00 ; license uri:iris.PRI02
Accession Number:	edsbas.42F3C130
Database:	BASE