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1. Severe Asthma Standard-of-Care Background Medication Reduction With Benralizumab: ANDHI in Practice Substudy

Author

Renaud Louis, Tim W. Harrison, Pascal Chanez, Francesco Menzella, George Philteos, Borja G. Cosio, Njira L. Lugogo, Gustavo de Luiz, Annie Burden, Timothy Adlington, Nanna Keeling, Justin Kwiatek, Esther Garcia Gil, Wolfgang Pohl, Daniel Doberer, Jean Benoit Martinot, Maud Deschampheleire, Ulrike Himpe, Kenneth Chapman, Amarjit Cheema, Delbert Dorscheid, Clare Ramsey, Jeffrey Rolf, Brandie Walker, Ronald Olivenstein, Claude Poirier, Pierre Larivee, Anne Sofie Bjerrum, Ingrid Titlestad, Ole Hilberg, Maritta Kilpeläinen, Philippe Bonniaud, Camille Taillé, Iuliana-Angelica Tiotiu, Pierre-Olivier Girodet, François-Xavier Blanc, Johana Pradelli, Alain Didier, Cecilia Nocent Ejnaini, Gaetan Deslee, Christophe Pison, Youcef Douadi, Guillaume Mahay, Gilles Devouassoux, Boris Melloni, Pauline-Marie Roux, Arnaud Bourdin, Stephanie Fry, Thomas Schaum, Christian Schulz, Dirk Skowasch, Christian Taube, Tobias Welte, Wolfgang Gleiber, Randolf Brehler, Jens Schreiber, Wolfgang Schuette, Juliane Kronsbein, Reiner Bonnet, Ekkehard Beck, Donato Lacedonia, Gianenrico Senna, Cristiano Caruso, Nunzio Crimi, Francesco Blasi, Pierachille Santus, Giorgio Walter Canonica, Gabriella Guarnieri, Girolamo Pelaia, Manlio Milanese, Claudio Micheletto, Angelo Guido Corsico, Nicola Scichilone, Giuseppe Spadaro, Bas Langeveld, Jurgen Holters, Jan Willem van den Berg, Arthur Smit, Lennart Conemans, Helena van Veen, Gerald Staaks, Sverre Lehmann, Jose Maria Echave-Sustaeta, Christian Domingo Ribas, Gustavo de Luiz Martinez, Ruperto Gonzalez Perez, Juan Luis Garcia Rivero, Xavier Muñoz Gall, Jose Gregorio Soto Campos, Paloma Campo Mozo, Carmen Vidal Pan, Ana Gomez-Bastero Fernandez, Sergio Campos Tellez, Carlos Martinez Rivera, Irina Diana Bobolea, Raquel Morillo Guerrero, Ismael Ali Garcia, Juan Luis Rodriguez Hermosa, Nikolai Stenfors, Alf Tunsäter, Dan Curiac, Christophe von Garnier, Joerg Leuppi, Peter Schmid-Grendelmeier, Shuaib Nasser, Rekha Chaudhuri, Monica Nordstrom, Dinesh Saralaya, Paul Pfeffer, Adel Mansur, Philip Short, Sally Wenzel, William Brett Cherry, Heidi Zafra, Erika Gonzalez, Weily Soong, Benjamin Davis, Neil Kao, Iftikhar Hussain, Diego Jose Maselli Caceres, James Harris, William Calhoun, Ileana Rodicio, David Kaufman, Mark Moss, Eric Sztejman, Samuel DeLeon, Kaharu Sumino, Ravindra Kashyap, Jeffrey Leflein, Rizan Hajal, Faisal Fakih, David Hill, Robert Lin, Mikell Jarratt, Vijay Subramaniam, Robert Sussman, Nayla Mumneh, Joan Reibman, Jared Darveaux, Ricardo Tan, Tonny Tanus, Vinay Sikand, Gailen Marshall, Hemalini Mehta, Jeremy Cole, Brad Goodman, Deborah Goss, Jose Bardelas, Aaron Milstone, Vinay Mehta, Lee Clore, Mark Millard, Michael Palumbo, Dileep Puppala, Mila Leong, Bruce Prenner, Emory Robinette, Hengameh Heidarian Raissy, David Fost, Warren Pleskow, Michael Marcus, Jonathan Ilowite, Wendy Moore, Gary Steven, Luis De la Cruz, Geoffrey Chupp, William Berger, Christopher Randolph, Fernando Holguin, Shahrukh Kureishy, and Edward Campbell

Subjects
Eosinophils, Severe asthma, Benralizumab, Eosinophilic asthma, Open-label extension, Oral corticosteroids, Immunology and Allergy
Published
2023

2. Efficacy and safety of intramuscular administration of tixagevimab-cilgavimab for early outpatient treatment of COVID-19 (TACKLE): a phase 3, randomised, double-blind, placebo-controlled trial

Author

Hugh Montgomery, F D Richard Hobbs, Francisco Padilla, Douglas Arbetter, Alison Templeton, Seth Seegobin, Kenneth Kim, Jesus Abraham Simón Campos, Rosalinda H Arends, Bryan H Brodek, Dennis Brooks, Pedro Garbes, Julieta Jimenez, Gavin C K W Koh, Kelly W Padilla, Katie Streicher, Rolando M Viani, Vijay Alagappan, Menelas N Pangalos, Mark T Esser, Wakana Abe, Tania Adan De Varona, Daria Adiatullina, Daniel Aguilar Zapata, Kevin Ahlers, Carolina Aimo, Ayoade Akere, Elena Akimova, Jorge Alatorre Alexander, Logan Aldrich, Ismael Ali Garcia, Karim Ali García, Lee Allison, Rosa Alonso Zuñiga, Ivan Aloysius, Javier Altclas, Andres Alvarisqueta, Martti Antila, Camila Anton, Elisabet Árboix Alamo, Samir Arora, Ramón Alejandro Avilés Felix, Natalya Bakhtina, Varenka Barbero-Becerra, Armando Barragan-Reyes, Alejandro Barreira, Mitchell Barrett, Jiri Beran, Nikolett Berki, Viktoria Berki, Richard Betten, Claudia Binelli, Lenka Brunzová, Cecilia Bussolari, Karianna Byargeon, Justyna Bytnar, Carlos Camberos, Pedro Campos Corzo, Grazia Cannon, Valentina Canovi, Simone Carla da Rosa, Ana Caroline Moser, Luis Carrera Rivas, Marcelo Martin Casas, Paulo Castañeda-Méndez, Ana Cavalcante, Eugenia Cherepova, Alexei Chermenskii, Lauren Clark, Mauro Codeluppi, Flavia Coelho, Belinda Contreras, Alex Cran, Taylor Dao, Chrisette Dharma, Cosimo Di Castri, Victoria Diaz Balocchi, Omar Durán, Kara Earl, Adam Ellery, Tomoko Endo, Andrea Everding, Rainald Fischer, Benedito Fonseca, Chelsea C. Franklin, Susan-Beatrice Franz, Anna Fumagalli, Mauricio Galindo-Amaya, Mariagiulia Galli, Laura Gerna, Karolly Gil Ureña, Henrikki Gomes Antila, Laura Ines Gomes Maricato, Gabriela Goncalvez, Martin Gonzalez, Jesús González-Lama, Stephen Granier, Jacob Granier, Stephan Grunwald, David Guardeño-Ropero, Monica Guberti, Sridhar Guduri, Carolina Guerrero García, Jehad Haggiagi, Kacie Hale, Toshimasa Hayashi, Maiara Hermes, Dante Hernandez Colin, Yuji Hirai, Masayuki Hojo, Tetsuya Homma, Billy Hour, Andreas Huber, Diego Iacovelli, Noriomi Ishibashi, Yutaro Iwabe, Shinyu Izumi, Arne Jessen, Heiko Jessen, Wilner Jeudy, Marta Jiménez Marcos, Rebecca Johnson, Eva Juárez-Hernández, Kiyomi Kabasawa, Katarzyna Kamińska, Megumi Kawabe, Angela Kemp, Oleg Khmelnitskiy, Carina Klassen, Olena Kobrynska, Pavel Koleckar, Stephanie Korn, Marc Kornmann, Viktor Kostenko, Evgenii Kovalchuk, Yana Kovalchuk, Tim Kümmerle, Ulrike Lachmund, Kerstin Lammersmann, Flávio Lastebasse, Ivana Lattuada, Felicitas Lauer, Kyrylo Lebed, Olga Lebed, Diego Lecona-Garcia, Maria Christina Leoni, Marina Lima, Raymond Little, Holly Little, Andrea Lizardi-Díaz, Michele Lobo-Becker, Francesco Luppi, Veronica Macias, Shigefumi Maesaki, Cristiano Magnaghi, Annalisa Mancini, Stanisław Mazur, Tatiana Melnikova, Sergio Menchaca, Ibrahim Menendez-Perez, Ewa Międlar, Shuuichi Mizunuma, Anastasiya Mochalova, Mihad Mohamed, Theresa Moll, Camila Montalvo, Amber Mottola, Birgit Mück, Rebeca Mussi Brugnolli, Akanksha Nanda, Dörthe Neuner, Agatha Ngwueke, Sebastian Noe, Martin Novacek, Laura Nuzzolo-Shihadeh, Emeka Obiekwe, Isaias G. Ocampo Gaytán, Norio Ohmagari, Shin Ohta, Ptuonye Onyewuchi, Iurii Pankov, Maurício Pedrosa, Yael Peré, Alejandro Pereyra, Eliana Perez, Eduardo Perez-Alba, Paloma Perpiña Lozano, Tanya Perrei, Dena Peterson, Ligia Pierroti, Felipe Pineda-Cárdenas, Teresa Plascencia Sanchez, Camila Poletti, Chiara Pomaranzi, Lisette Portes, Nils Postel, Monica Ramirez, Isabel Ramírez, Miguel Ramirez-Baena, Mahadev Ramjee, Giovanna Ratti, Jackie Reeve, Petr Reichert, Petra Reichertová, Edgar Alejandro Reyes Garcia, Celso Ricardo, Nicomedes Rodríguez Rodríguez, Jaun Roldán Sánchez, Matilde Romero-Lopez, Tyrone Rosales, Harvey Rosales, Mohamed Roshan, Simran Roshan, Patrizia Rovere Querini, Heather Rutter, Sadaf Sachwani, Hironori Sagara, Jun Sakai, Nina Samson, José Héctor Sánchez Mijangos, Liliana Sánchez, Ana Sánchez-González, Micko Sandford, Laura Santana, Felipe Santos de Carvalho, Reiko Sasao, Lubna Sato, Elizabeth Scheuermann, Olaf Schmidt, Masafumi Seki, Safia Shaikh, Daishi Shimada, Masaharu Shinkai, Masahiro Shinoda, Jackie Smith, Fernando Solorzano, Silvia Soncini, Katalin Soregine, Erica Sosa, Olalekan Sowade, Veronika Špinková, Ruth Staniford, Iska Steigemann, Vivien Steiner, Vladimir Strelkov, Cintya R. Suárez Pineda, Hiroki Suenaga, Shintaro Suzaki, Hannah Swayze, Yuji Tada, Yuichiro Takeshita, Yasuo Takiguchi, Akihiko Tanaka, Norihito Tarumoto, Albina Tatarintseva, Michelle Taubert, Elizaveta Terenya, César Tinoco, Tomohiro Tomiyasu, Gladys Torres-Vidal, Gabriela Trejo-Aguiar, Kenji Tsushima, Emma Tunstall, Caterina Turrà, Yoandy Valdes, Nelly Valencia Castro, Guilherme Visconti, Giordano Vitali, Apinya Vutikullird, Jezdancher Watti, Doreen Werth, Cheyanne Wilson, Philippe Wilson, Amy Workman, Pamela Wörle, Christoph Wyen, Yoshiko Yamaguchi, and Kei Yamamoto

Subjects
Adult, Pulmonary and Respiratory Medicine, Treatment Outcome, Double-Blind Method, SARS-CoV-2, Outpatients, Antibodies, Monoclonal, Humans, Middle Aged, COVID-19 Drug Treatment
Abstract

Background: Early intramuscular administration of SARS-CoV-2-neutralising monoclonal antibody combination, tixagevimab–cilgavimab, to non-hospitalised adults with mild to moderate COVID-19 has potential to prevent disease progression. We aimed to evaluate the safety and efficacy of tixagevimab–cilgavimab in preventing progression to severe COVID-19 or death. Methods: TACKLE is an ongoing, phase 3, randomised, double-blind, placebo-controlled study conducted at 95 sites in the USA, Latin America, Europe, and Japan. Eligible participants were non-hospitalised adults aged 18 years or older with a laboratory-confirmed SARS-CoV-2 infection (determined by RT-PCR or an antigen test) from any respiratory tract specimen collected 3 days or less before enrolment and who had not received a COVID-19 vaccination. A WHO Clinical Progression Scale score from more than 1 to less than 4 was required for inclusion and participants had to receive the study drug 7 days or less from self-reported onset of mild to moderate COVID-19 symptoms or measured fever. Participants were randomly assigned (1:1) to receive either a single tixagevimab–cilgavimab 600 mg dose (two consecutive 3 mL intramuscular injections, one each of 300 mg tixagevimab and 300 mg cilgavimab) or placebo. Randomisation was stratified (using central blocked randomisation with randomly varying block sizes) by time from symptom onset, and high-risk versus low-risk of progression to severe COVID-19. Participants, investigators, and sponsor staff involved in the treatment or clinical evaluation and monitoring of the participants were masked to treatment-group assignments. The primary endpoints were severe COVID-19 or death from any cause through to day 29, and safety. This study is registered with ClinicalTrials.gov, NCT04723394. Findings: Between Jan 28, 2021, and July 22, 2021, 1014 participants were enrolled, of whom 910 were randomly assigned to a treatment group (456 to receive tixagevimab–cilgavimab and 454 to receive placebo). The mean age of participants was 46·1 years (SD 15·2). Severe COVID-19 or death occurred in 18 (4%) of 407 participants in the tixagevimab–cilgavimab group versus 37 (9%) of 415 participants in the placebo group (relative risk reduction 50·5% [95% CI 14·6–71·3]; p=0·0096). The absolute risk reduction was 4·5% (95% CI 1·1–8·0; p Interpretation: A single intramuscular tixagevimab–cilgavimab dose provided statistically and clinically significant protection against progression to severe COVID-19 or death versus placebo in unvaccinated individuals and safety was favourable. Treating mild to moderate COVID-19 earlier in the disease course with tixagevimab–cilgavimab might lead to more favourable outcomes.

Published
2022

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