Severe Asthma Standard-of-Care Background Medication Reduction With Benralizumab: ANDHI in Practice Substudy
Articolo
Data di Pubblicazione:
2023
Abstract:
Background: 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. Objective: Assess potential for standard-of-care background medication reductions while maintaining asthma control with benralizumab. Methods: 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. Results: 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. Conclusions: These findings demonstrate benralizumab's ability to improve asthma control, thereby allowing background medication reduction.
Tipologia CRIS:
1.1 Articolo in rivista
Keywords:
Benralizumab; Eosinophilic asthma; Eosinophils; Open-label extension; Oral corticosteroids; Severe asthma
Elenco autori:
Renaud, Louis; W Harrison, Tim; Chanez, Pascal; Menzella, Francesco; Philteos, George; G Cosio, Borja; L Lugogo, Njira; de Luiz, Gustavo; Burden, Annie; Adlington, Timothy; Keeling, Nanna; Kwiatek, Justin; Esther Garcia, Gil; Study Investigators, Andhi; Pohl, Wolfgang; Doberer, Daniel; Benoit Martinot, Jean; Deschampheleire, Maud; Chapman, Kenneth; Dorscheid, Delbert; Rolf, Jeffrey; Poirier, Claude; Sofie Bjerrum, Anne; Hilberg, Ole; Kilpeläinen, Maritta; Bonniaud, Philippe; Taillé, Camille; Tiotiu, Iuliana-Angelica; Girodet, Pierre-Olivier; Blanc, François-Xavier; Pradelli, Johana; Nocent Ejnaini, Cecilia; Deslee, Gaetan; Pison, Christophe; Mahay, Guillaume; Devouassoux, Gilles; Melloni, Boris; Roux, Pauline-Marie; Bourdin, Arnaud; Fry, Stephanie; Schaum, Thomas; Schulz, Christian; Skowasch, Dirk; Taube, Christian; Welte, Tobias; Gleiber, Wolfgang; Brehler, Randolf; Schreiber, Jens; Schuette, Wolfgang; Kronsbein, Juliane; Bonnet, Reiner; Beck, Ekkehard; Lacedonia, Donato; Pini, Laura; Senna, Gianenrico; Caruso, Cristiano; Papi, Alberto; Crimi, Nunzio; Blasi, Francesco; Santus, Pierachille; Walter Canonica, Giorgio; Beghé, Bianca; Guarnieri, Gabriella; Pelaia, Girolamo; Milanese, Manlio; Peveri, Silvia; Micheletto, Claudio; Guido Corsico, Angelo; Scichilone, Nicola; Spadaro, Giuseppe; Langeveld, Bas; Holters, Jurgen; Willem van den Berg, Jan; Smit, Arthur; Conemans, Lennart; van Veen, Helena; Staaks, Gerald; Lehmann, Sverre; Maria Echave-Sustaeta, Jose; Domingo Ribas, Christian; de Luiz Martinez, Gustavo; Gonzalez Perez, Ruperto; Luis Garcia Rivero, Juan; Muñoz Gall, Xavier; Gregorio Soto Campos, Jose; Campo Mozo, Paloma; Vidal Pan, Carmen; Gomez-Bastero Fernandez, Ana; Campos Tellez, Sergio; Martinez Rivera, Carlos; Diana Bobolea, Irina; Morillo Guerrero, Raquel; Henriquez Santa, Aythamy; Ramos Gonzalez, Jacinto; Ali Garcia, Ismael; Luis Rodriguez Hermosa, Juan; Stenfors, Nikolai; Tunsäter, Alf; Curiac, Dan; Vinge, Ines; von Garnier, Christophe; Leuppi, Joerg; Schmid-Grendelmeier, Peter; Nasser, Shuaib; Chaudhuri, Rekha; Nordstrom, Monica; Saralaya, Dinesh; Pfeffer, Paul; Mansur, Adel; Short, Philip; Wenzel, Sally; Brett Cherry, William; Zafra, Heidi; Gonzalez, Erika; Soong, Weily; Davis, Benjamin; Kao, Neil; Hussain, Iftikhar; Jose Maselli Caceres, Diego; Harris, James; Calhoun, William; Rodicio, Ileana; Kaufman, David; Moss, Mark; Sztejman, Eric; John, Roy St.; Deleon, Samuel; Sumino, Kaharu; Kashyap, Ravindra; Leflein, Jeffrey; Hajal, Rizan; Hill, David; Lin, Robert; Jarratt, Mikell; Subramaniam, Vijay; Sussman, Robert; Mumneh, Nayla; Reibman, Joan; Darveaux, Jared; Tan, Ricardo; Tanus, Tonny; Sikand, Vinay; Marshall, Gailen; Mehta, Hemalini; Cole, Jeremy; Goodman, Brad; Goss, Deborah; Bardelas, Jose; Milstone, Aaron; Mehta, Vinay; Clore, Lee; Millard, Mark; Palumbo, Michael; Puppala, Dileep; Leong, Mila; Prenner, Bruce; Robinette, Emory; Heidarian Raissy, Hengameh; Fost, David; Pleskow, Warren; Marcus, Michael; Ilowite, Jonathan; Moore, Wendy; Steven, Gary; De la Cruz, Luis; Chupp, Geoffrey; Berger, William; Randolph, Christopher; Holguin, Fernando; Kureishy, Shahrukh; Campbell, Edward
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