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

2023; Elsevier BV; Volume: 11; Issue: 6 Linguagem: Inglês

10.1016/j.jaip.2023.03.009

2213-2201

Renaud Louis, Tim Harrison, Pascal Chanez, Francesco Menzella, George Philteos, Borja G. Cosío, Njira Lugogo, Gustavo de Luiz, Annie Burden, Timothy Adlington, N. Keeling, Justin Kwiatek, Esther Garcia Gil, Wolfgang Pohl, Daniel Doberer, Jean Benoît Martinot, Maud Deschampheleire, Ulrike Himpe, Kenneth R. Chapman, Amarjit Cheema, Delbert R. Dorscheid, Clare D. Ramsey, Jeffrey Rolf, Brandie Walker, Ronald Olivenstein, Claude Poirier, Pierre Larivée, Anne Sofie Bjerrum, Ingrid Louise Titlestad, Ole Hilberg, Maritta Kilpeläinen, Philippe Bonniaud, Camille Taillé, Iuliana-Angelica Tiotiu, Pierre‐Olivier Girodet, F.–X. Blanc, J. Pradelli, A. Didier, Cecilia Nocent Ejnaini, Gaëtan Deslée, Christophe Pison, Y. Douadi, Guillaume Mahay, Gilles Devouassoux, B. Melloni, Pauline-Marie Roux, Arnaud Bourdin, Stéphanie Fry, Thomas Schaum, Christof Schulz, Dirk Skowasch, Christian Taube, Tobias Welte, Wolfgang Gleiber, Randolf Brehler, Jens Schreiber, Wolfgang Schuette, Juliane Kronsbein, R. 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 A. J. Smit, Lennart Conemans, Helena van Veen, Gerald Staaks, Sverre Lehmann, José Maria Echave-Sustaeta, Christian Domingo, Gustavo de Luíz Martinez, Ruperto González‐Pérez, Juan Luis García‐Rivero, Xavier Muñoz, José Gregorio Soto Campos, Paloma Campo Mozo, Carmen Vidal Pan, A. Gómez-Bastero Fernández, Sergio Campos Tellez, Carlos Martínez‐Rivera, Irina Bobolea, Raquel Morillo Guerrero, Ismael Ali García, Juan Luis Rodríguez Hermosa, Nikolai Stenfors, Alf Tunsäter, Dan Curiac, Christophe von Garnier, Jörg D. Leuppi, Peter Schmid‐Grendelmeier, Shuaib Nasser, Rekha Chaudhuri, Monica Nordstrom, Dinesh Saralaya, Paul Pfeffer, Adel Mansur, Philip Short, Sally E. Wenzel, W. Brett Cherry, Heidi Zafra, E. González González, Weily Soong, Benjamin G. Davis, Neil L. Kao, Iftikhar Hussain, Diego Jose Maselli Caceres, James B. Harris, William J. Calhoun, Ileana Rodicio, David Kaufman, Mark B. Moss, Eric Sztejman, Samuel DeLeon, Kaharu Sumino, Ravindra Kashyap, Jeffrey Leflein, Rizan Hajal, Faisal Fakih, David Hill, Robert P. Lin, Mikell Jarratt, Vijay Subramaniam, Robert W. Sussman, N. Mumneh, Joan Reibman, Jared I. Darveaux, Ricardo Tan, Tonny Tanus, Vinay Sikand, Gailen D. Marshall, Hemalini Mehta, Jeremy Cole, Brad Goodman, Deborah Goss, Jose Bardelas, Aaron M. Milstone, Vinay Mehta, Lee Clore, Mark Millard, Michael Palumbo, Dileep Puppala, Mila A. Leong, Bruce M. Prenner, Emory Robinette, Hengameh Heidarian Raissy, David A. Fost, W PLESKOW, Michael B. Marcus, Jonathan Ilowite, Wendy C. Moore, G. Steven, Luis de la Cruz‐Merino, Geoffrey Chupp, William Berger, Christopher Randolph, Fernando Holguín, Shahrukh Kureishy, Edward M. Campbell, Rudi Peché, Laura Pini, Alberto Papi, Bianca Beghè, Silvia Peveri, Aythamy Henríquez Santa, Jacinto Ramos González, Ines Vinge, Roy St. John,

Inhalation and Respiratory Drug Delivery

The phase IIIb, randomized, parallel-group, placebo-controlled ANDHI double-blind (DB) study extended understanding of the efficacy of benralizumab for patients with severe eosinophilic asthma. Patients from ANDHI DB could join the 56-week ANDHI in Practice (IP) single-arm, open-label extension substudy.Assess potential for standard-of-care background medication reductions while maintaining asthma control with benralizumab.Following ANDHI DB completion, eligible adults were enrolled in ANDHI IP. After an 8-week run-in with benralizumab, there were 5 visits to potentially reduce background asthma medications for patients achieving and maintaining protocol-defined asthma control with benralizumab. Main outcome measures for non-oral corticosteroid (OCS)-dependent patients were the proportions with at least 1 background medication reduction (ie, lower inhaled corticosteroid dose, background medication discontinuation) and the number of adapted Global Initiative for Asthma (GINA) step reductions at end of treatment (EOT). Main outcomes for OCS-dependent patients were reductions in daily OCS dosage and proportion achieving OCS dosage of 5 mg or lower at EOT.For non-OCS-dependent patients, 53.3% (n = 208 of 390) achieved at least 1 background medication reduction, increasing to 72.6% (n = 130 of 179) for patients who maintained protocol-defined asthma control at EOT. A total of 41.9% (n = 163 of 389) achieved at least 1 adapted GINA step reduction, increasing to 61.8% (n = 110 of 178) for patients with protocol-defined EOT asthma control. At ANDHI IP baseline, OCS dosages were 5 mg or lower for 40.4% (n = 40 of 99) of OCS-dependent patients. Of OCS-dependent patients, 50.5% (n = 50 of 99) eliminated OCS and 74.7% (n = 74 of 99) achieved dosages of 5 mg or lower at EOT.These findings demonstrate benralizumab's ability to improve asthma control, thereby allowing background medication reduction.