BACKGROUND: The efficacy and safety of benralizumab, an interleukin-5 receptor alpha-directed cytolytic monoclonal antibody, for the prevention of exacerbations in patients with moderate to very severe chronic obstructive pulmonary disease (COPD) are not known. METHODS: In the GALATHEA and TERRANOVA trials, we enrolled patients with COPD (at a ratio of approximately 2:1 on the basis of eosinophil count [≥220 per cubic millimeter vs. <220 per cubic millimeter]) who had frequent exacerbations despite receiving guideline-based inhaled treatment. Patients were randomly assigned to receive benralizumab (30 or 100 mg in GALATHEA; 10, 30, or 100 mg in TERRANOVA) every 8 weeks (every 4 weeks for the first three doses) or placebo. The primary end point was the treatment effect of benralizumab, measured as the annualized COPD exacerbation rate ratio (benralizumab vs. placebo) at week 56 in patients with baseline blood eosinophil counts of 220 per cubic millimeter or greater. Safety was also assessed. RESULTS: In GALATHEA, the estimates of the annualized exacerbation rate were 1.19 per year (95% confidence interval [CI], 1.04 to 1.36) in the 30-mg benralizumab group, 1.03 per year (95% CI, 0.90 to 1.19) in the 100-mg benralizumab group, and 1.24 per year (95% CI, 1.08 to 1.42) in the placebo group; the rate ratio as compared with placebo was 0.96 for 30 mg of benralizumab (P=0.65) and 0.83 for 100 mg of benralizumab (P=0.05). In TERRANOVA, the estimates of the annualized exacerbation rate for 10 mg, 30 mg, and 100 mg of benralizumab and for placebo were 0.99 per year (95% CI, 0.87 to 1.13), 1.21 per year (95% CI, 1.08 to 1.37), 1.09 per year (95% CI, 0.96 to 1.23), and 1.17 per year (95% CI, 1.04 to 1.32), respectively; the corresponding rate ratios were 0.85 (P=0.06), 1.04 (P=0.66), and 0.93 (P=0.40). At 56 weeks, none of the annualized COPD exacerbation rate ratios for any dose of benralizumab as compared with placebo reached significance in either trial. Types and frequencies of adverse events were similar with benralizumab and placebo. CONCLUSIONS: Add-on benralizumab was not associated with a lower annualized rate of COPD exacerbations than placebo among patients with moderate to very severe COPD, a history of frequent moderate or severe exacerbations, and blood eosinophil counts of 220 per cubic millimeter or greater (Funded by AstraZeneca [GALATHEA and TERRANOVA] and Kyowa Hakko Kirin [GALATHEA]; GALATHEA and TERRANOVA ClinicalTrials.gov numbers, NCT02138916 and NCT02155660.).

Benralizumab for the prevention of COPD exacerbations

Fabio Luigi Massimo Ricciardolo;
2019

Abstract

BACKGROUND: The efficacy and safety of benralizumab, an interleukin-5 receptor alpha-directed cytolytic monoclonal antibody, for the prevention of exacerbations in patients with moderate to very severe chronic obstructive pulmonary disease (COPD) are not known. METHODS: In the GALATHEA and TERRANOVA trials, we enrolled patients with COPD (at a ratio of approximately 2:1 on the basis of eosinophil count [≥220 per cubic millimeter vs. <220 per cubic millimeter]) who had frequent exacerbations despite receiving guideline-based inhaled treatment. Patients were randomly assigned to receive benralizumab (30 or 100 mg in GALATHEA; 10, 30, or 100 mg in TERRANOVA) every 8 weeks (every 4 weeks for the first three doses) or placebo. The primary end point was the treatment effect of benralizumab, measured as the annualized COPD exacerbation rate ratio (benralizumab vs. placebo) at week 56 in patients with baseline blood eosinophil counts of 220 per cubic millimeter or greater. Safety was also assessed. RESULTS: In GALATHEA, the estimates of the annualized exacerbation rate were 1.19 per year (95% confidence interval [CI], 1.04 to 1.36) in the 30-mg benralizumab group, 1.03 per year (95% CI, 0.90 to 1.19) in the 100-mg benralizumab group, and 1.24 per year (95% CI, 1.08 to 1.42) in the placebo group; the rate ratio as compared with placebo was 0.96 for 30 mg of benralizumab (P=0.65) and 0.83 for 100 mg of benralizumab (P=0.05). In TERRANOVA, the estimates of the annualized exacerbation rate for 10 mg, 30 mg, and 100 mg of benralizumab and for placebo were 0.99 per year (95% CI, 0.87 to 1.13), 1.21 per year (95% CI, 1.08 to 1.37), 1.09 per year (95% CI, 0.96 to 1.23), and 1.17 per year (95% CI, 1.04 to 1.32), respectively; the corresponding rate ratios were 0.85 (P=0.06), 1.04 (P=0.66), and 0.93 (P=0.40). At 56 weeks, none of the annualized COPD exacerbation rate ratios for any dose of benralizumab as compared with placebo reached significance in either trial. Types and frequencies of adverse events were similar with benralizumab and placebo. CONCLUSIONS: Add-on benralizumab was not associated with a lower annualized rate of COPD exacerbations than placebo among patients with moderate to very severe COPD, a history of frequent moderate or severe exacerbations, and blood eosinophil counts of 220 per cubic millimeter or greater (Funded by AstraZeneca [GALATHEA and TERRANOVA] and Kyowa Hakko Kirin [GALATHEA]; GALATHEA and TERRANOVA ClinicalTrials.gov numbers, NCT02138916 and NCT02155660.).
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Aged; Anti-Asthmatic Agents; Antibodies, Monoclonal, Humanized; Double-Blind Method; Eosinophils; Female; Humans; Injections, Subcutaneous; Leukocyte Count; Male; Middle Aged; Patient Acuity; Pulmonary Disease, Chronic Obstructive; Receptors, Interleukin-5
Criner G.J.; Celli B.R.; Brightling C.E.; Agusti A.; Papi A.; Singh D.; Sin D.D.; Vogelmeier C.F.; Sciurba F.C.; Bafadhel M.; Backer V.; Kato M.; Ramirez-Venegas A.; Wei Y.-F.; Bjermer L.; Shih V.H.; Jison M.; O'Quinn S.; Makulova N.; Newbold P.; Goldman M.; Martin U.J.; GALATHEA Study Investigators; TERRANOVA Study Investigators; Otto Burghuber; Bernhard Forstner; Gerhard Köberl; Bernd Lamprecht; Judith Löffler-Ragg; Horst Olschewski; Michael Studnicka; Francois Beaucage; Guy Chouinard; Anthony Dechant; Anthony Dowell; Jacques Hebert; Sohail Khattak; Kieran Killian; William Killorn; Andy Lam; Francois Maltais; Darcy Marciniuk; Lyle Melenka; Bonavuth Pek; Jeremy Road; Donald Sin; Alain Vaugeois; Brandie Walker; Tomas Dvorak; Stanislav Holub; Otakar Hokynar; Vitezslav Kolek; Daniela Kopecka; Jan Krepelka; Jaroslav Mares; Josef Veverka; Vladimir Zindr; Sabine Ballenberger; Rolf Dichmann; Christian Geßner; Margret Jandl; Claus Keller; Joachim Kirschner; Marc Kornmann; Petra Mikloweit; Ingomar Naudts; Axel Overlack; Isabelle Schenkenberger; Volker Schlegel; Lutz Von Versen; Claus Franz Vogelmeier; Stefan Zielen; István Albert; Beatrix Bálint; Mária Csilla Hangonyi; Teréz Kecskés; Anikó Kurucz; Balázs Medgyasszay; Lajos Molnár; János Mucsi; Márta Papp; Magdolna Póczi; Éva Radeczky; Zsolt Pápai Székely; Csilla Szabó; Gyöngyi Szabó; Melinda Szabó; Alfredo Antonio Chetta; Giuseppe Di Maria; Giulio Donazzan; Federica Meloni; Elisabetta Pace; Pierluigi Paggiaro; Alberto Papi; Fabio Luigi Massimo Ricciardolo; Antonio Spanevello; Fumiaki Aoki; Ryosuke Eda; Takeo Endo; Yasushi Fukushima; Kenichi Gemba; Naoki Hagimoto; Hiromasa Harada; Yasuko Harada; Norihiko Hata; Osamu Hataji; Nobuo Hatakeyama; Takahiko Horiguchi; Gen Ideura; Motoyasu Iikura; Azusa Ikegami; Shirou Imokawa; Yoshikazu Inoue; Takeshi Isobe; Ryoji Ito; Susumu Iwata; Tadashi Kamei; Motokazu Kato; Hideki Katsura; Yuji Kawarada; Norio Kihara; Masaharu Kinoshita; Takashi Kinoshita; Tomoo Kishaba; Hideo Kita; Arihiro Kiyosue; Shigeru Komatsu; Kazuki Konishi; Sekiya Koyama; Makoto Kudo; Kazuhiko Machida; Hironi Makita; Hiroto Matsuse; Naoki Miyazawa; Hiroyuki Nakamura; Yuji Nakatani; Kazuyuki Nishimura; Takashi Nishimura; Junichi Ogawa; Hiroyuki Ohbayashi; Tetsuro Ohdaira; Tsukasa Ohnishi; Kazuhiko Oki; Masahiko Saito; Kenji Sakamoto; Osamu Sakamoto; Hisakuni Sekino; Noriharu Shijubo; Masaharu Shinkai; Hideo Soto; Yoshitaka Sugawara; Noriaki Suko; Hisaho Takahashi; Masamitsu Takahashi; Tsuneyuki Takahashi; Hiroshi Tanaka; Hiroyuki Taniguchi; Tadayuki Terada; Takao Tochigi; Kazuyo Tohyama; Hirokazu Tokuyasu; Keisuke Tomii; Tomomasa Tsuboi; Mitsuyoshi Utsugi; Katsumaru Yamamoto; Michiko Yamamoto; Shuichi Yano; Makoto Yoshida; Frank Custers; Richard Dekhuijzen; Remco Djamin; Jan Willem Van Dan Berg; Lowie Vanfleteren; Pascal Wielders; Bogusława Cimoszko; Anna Doboszyńska; Andrzej Dyczek; Andrzej Fal; Krystyna Folcik; Łukasz Goliński; Marek Jutel; Andrzej Kolczyński; Piotr Kuna; Ewa Łączyńska; Wojciech Machowiak; Maciej Marczak; Joanna Markiewicz; Janusz Milanowski; Grzegorz Mincewicz; Maria Nittner-Marszalska; Wojciech Papiewski; Małgorzata Pawlukiewicz; Witold Pomiećko; Barbara Rewerska; Cezary Rybacki; Wojciech Skucha; Ewa Trębas-Pietraś; Ewa Uhryn; Małgorzata Żurowska-Gębala; Laurentia Andrei; Traian Mihaescu; Stefan Mihaicuta; Eniko Vera Pall; Ioan Petrui; Angelica Savu; Claudia Toma; Ana Trailescu; Vladimir Abrosimov; Nataliya Astafyeva; Evgenyi Bazdyrev; Nadezhda Berdnikova; Laura Bolieva; Ekaterina Bukreeva; Valery Chistyakov; Anna Galustyan; Halida Gantseva; Svetlana Goncharova; Sergey Grigoriev; Galina Ignatova; Inna Ilyashevich; Nadezhda Izmozherova; Magomed Kamalov; Yaroslava Khovaeva; Natalia Kuzubova; Lyudmila Kvitkova; Liudmila Lenskaya; Igor Leshchenko; Olga Magnitskaya; Boris Molotilov; Artem Molotkov; Svetlana Myasoedova; Sergey Nedogoda; Vladimir Nosov; Marina Osipenko; Andrey Peskov; Veronika Popova; Oksana Ratushnay; Irina Ryzhova; Olga Shangina; Natalia Shaporova; Evgeny Shmelev; Lybov Shpagina; Alexander Shutkin; Yuri Shvarts; Mikhail Smirnov; Irina Stitsenko; Maksim Vasilev; Arkadiy Vertkin; Elena Vishneva; Alexander Vizel; Anna Zateyschikova; Mohamed Abdool-Gaffar; Ismail Abdullah; Axel Bruning; Nyda Fourie; Michael Greenblatt; Mohammed Tayob; K Venter; An Soo Jang; Kwan Ho Lee; Sang Haak Lee; Sook Young Lee; Suk Joong Yong; Kwang Ha Yoo; Soo Taek Uh; Ramón Agüero Balbín; David Ramos Barbón; Álvar Agustí García-Navarro; José Luis Velasco Garrido; Sergi Pascual Guardia; Eduard Monso Molas; Luis De Teresa Parreño; Borja García-Cosio Piqueras; German Peces-Barba Romero; Myriam Calle Rubio; Fernando Sánchez-Toril López; Alicia Marín Tapia; Heidi Martin Braschler; Martin Brutsche; Michael Grob; Jörg Leuppi; Daiana Stolz; Alexander Turk; Nawar Bakerley; Mona Bafadhel; Christopher Brightling; Rekha Chaudhuri; Gourab Choudhury; Graham Devereux; Imran Hussain; Kai Lee; William MacNee; Ravindran Mahadeva; Matthew Masoli; Monica Nordstrom; Manish Patel; Allan Reid; Dinesh Saralaya; Tariq Sethi; Sukh Dave Singh; Anthony G de Soyza; Tom Wilkinson; Alice Turner; Helen Ward; Chandar Abboy; Ivan Ackerman; Idalia Acosta; Arun Adlakha; Bassil Aish; Mohamed Ali; Charles Andrews; Robby Ayoub; Anil Badhwar; Dennis Bassetti; Sherif El Bayadi; Richard Beasley; Shashi Bellam; Jonathan Bernstein; Maria Blahey; Scott Bloom; Eugene Bleecker; Wesley Bray; Johnathan Brewer; Robert Buynak; William Calhoun; Edward Campbell; Anthony Captain; Birjis Chinoy; Kenneth Chinsky; Geoffrey Chupp; Arsenio Columbie; Clinton Corder; Gerard Criner; Humberto Cruz; Edward Cullen; Kevin Deboer; Michael Denenberg; Mark Dransfield; Leonard Dunn; Miles Elmore; David Erb; Faisal Fakih; Gary Ferguson; Charles Fogarty; Mark Freed; Stephen Fritz; David Fuentes; Shariar Cohen-Gadol; Robert Garver; John Given; Luis Ramos Gonez; Raul Ebran Gonzalez; Robert Gordon; Gregory Gottschlich; Donald Graham; David Grant; Gary Greenwald; James Greenwald; Kenneth Haft; Gregory Hammond; Nadia Hansel; Jeffrey Harris; Humberto Hernandez; Marvin Heuer; Albrecht Heyder; David Hill; Willis Holloway; Octavian Ioachimescu; Richard Jackson; Ajay Jain; Nan Jiang; Thomas Kaelin; Adolfo Kaplan; Mitchell Kaye; Akram Khan; Yekaterina Khronusova; Ryan Klein; Joel Kline; Firas Koura; Ritsu Kuno; Ware Kuschner; Jean Claude Labissiere; David Laman Jr; John Lee; Mitchell Lee; Lawrence Levinson; Njira Lugogo; M Mador; Nathaniel Marchetti; Rafael Martinez; Richard Martinez; Peter Mattar; David Maybee; Dennis McGraw; Michael McGuire; Curtis Mello; Aaron Milstone; John Mitchell; Wendy Moore; Timothy Moriarty; Cheta Nand; Brooke Nevins; Ikeadi Ndukwu; Rachel Nisbet; David Nyanjom; Maria Nualart; Thomas O'Brien; Mikhail Palatnik; Gnyandev Patel; Amit Patel; Guido Perez; Christopher Perry; Michael Pfeffer; Krishna Pudi; Marina Raikhel; Murali Ramaswamy; Joe Ramsdell; Donato Ricci; Gary Richmond; Eugene Ryan; Fadi Saba; Boris Sagalovich; C Andrew Schroeder; Timothy Scialla; Frank Sciurba; Amit Shah; Nirav Shah; Zeeshan Shaikh; Akhtar Siddiqui; Barry Sigal; Thomas Siler; Howard Silverboard; William Sims; Clyde Southwell; Selwyn Spangenthal; Peruvemba Sriram; James Stocks; Tony Su; John Suen; Robert Sussman; Horia Tatu; Antonio Terrelonge; Alan Thomas; Mario Torres; Rodolfo Trejo; Miguel Trevino; Banks Turner; Manuel Villareal; Janine Vintch; Neal Warshoff; Jan Westerman; Philip Wexler; Thomas Yunger; Amir Zeki; Mariano Fernandez Acquier; Norma Aramayo; German Arce; Juan Belloni; Víctor Cambursano; Carlos De La Vega; Fernando Rodriguez Chariarse; Pedro Elias; Marcelo Fernández; Ana Lopez; Andrea Medina; María Otaola; Maria Salazan Saez; Maria De Salvo; Fernando Scherbovsky; Ana Stok; Jorge Taborda; Alberto Tolcachier; Fernando Verra; Carlos Victorio; Rita Gisela Delgado Vizcarra; Philip Bardin; Peter Bremner; Martin Phillips; John Upham; Peter Wark; Antoine Bolly; Alain Delobbe; Peter Driesen; Eduard Janssens; Wim Janssens; Olivier Michel; Bernard Vandooren; Martti Antila; Jussara Fiterman; Carlos Fritscher; Jorge Hetzel; Jose Jardim; Waldo De Mattos; Rafael Martins; Maria Eunice De Oliveira; Andreia Pez; Maria Sales; Rafael Stelmach; Priscila Wolff; Svetla Andreeva; Reneta Antonova; Ana Dancheva; Yuliya Ivanova; Slavcho Ivanov; Hristo Metev; Iveta Naydenova; Tatyana Petkova; Galina Petrova; Kostadinka Sotirova; Mariyana Stoyanova; Rumen Tiholov; Iliyana Valkanova; Oleg Yakov; Rosa Feijoo; Juana Pavie; Patricia Schönffeldt; Absalon Silva; Victor Martinez; David Espinosa; Alejandro Londono; Dora Molina; Gonzalo Prada; Andrés Rico; Gregorio Sanchez Vallejo; Alvaro Urbina; Ana Vanegas; Maria Villegas; Josip Aralica; Gordana Stjepanovic; Vibeke Backer; Uffe Bødtger; Christian Meyer; Læge Sven Nielsen; Anders Loekke Ottesen; Ingrid Titlestad; Nathalie Bautin; Arnaud Bourdin; Pascal Chanez; Francis Couturaud; Antoine Cuvelier; Gilles Devouassoux; Pierre-Olivier Girodet; Jean-François Muir; Jean-Louis Pépin; Alain Proust; Azzedine Yaici; Yochai Adir; Gershon Fink; Zvi Fridlender; Gabriel Izbicki; Mordechai Kramer; Yehuda Schwartz; Juan Moreno Hoyos Abril; Ricardo Campos Cerda; Efraín Montaño Gonzalez; Ricardo Ramirez Terrones; Rodolfo Posadas Valay; Alejandra Ramirez-Venegas; Paul Dawkins; Syed Hussain; Benedict Brockway; John Richmond; Colin Helm; Catherina Chang; Jørn Ahlqvist; Terje Tollåli; Tadeusz Tomala; Socorro Castro; William Chavez; Octavio Cubas; Rolando Estrella; Efrain Felix; Ronal Gamarra; Alfredo Guerreros; Alberto Matsuno; Danilo Salazar; Miguel Tsukayama; Albert Albay Jr; Teresita Aquino; Tito Atienza; Joven Roque Gonong; Ronnie Samoro; Joel Santiaguel; Beata Asankowicz-Bargiel; Ewa Pisarczyk-Bogacka; Renata Bijata-Bronisz; Marta Chełmińska; Małgorzata Dobryniewska; Anna Olech-Cudzik; Tomasz Fijołek; Krzysztof Filipek; Agata Kot; Bożena Kucińska; Krzysztof Lis; Elżbieta Rybicka-Liszewska; Marzenna Tarnowska-Matusiak; Robert Mróz; Piotr Napora; Wojciech Naumnik; Artur Niemiec; Władysław Pierzchała; Grzegorz Przybylski; Katarzyna Styka; Danuta Wrońska; Branislava Milenkovic; Dobrivoje Novkovic; Matijaz Flezar; 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