TY - JOUR
T1 - Severe Asthma Standard-of-Care Background Medication Reduction With Benralizumab
T2 - ANDHI in Practice Substudy
AU - ANDHI study investigators
AU - Louis, Renaud
AU - Harrison, Tim W.
AU - Chanez, Pascal
AU - Menzella, Francesco
AU - Philteos, George
AU - Cosio, Borja G.
AU - Lugogo, Njira L.
AU - de Luiz, Gustavo
AU - Burden, Annie
AU - Adlington, Timothy
AU - Keeling, Nanna
AU - Kwiatek, Justin
AU - Garcia Gil, Esther
AU - Pohl, Wolfgang
AU - Doberer, Daniel
AU - Martinot, Jean Benoit
AU - Deschampheleire, Maud
AU - Himpe, Ulrike
AU - Chapman, Kenneth
AU - Cheema, Amarjit
AU - Dorscheid, Delbert
AU - Ramsey, Clare
AU - Rolf, Jeffrey
AU - Walker, Brandie
AU - Olivenstein, Ronald
AU - Poirier, Claude
AU - Larivee, Pierre
AU - Bjerrum, Anne Sofie
AU - Titlestad, Ingrid
AU - Hilberg, Ole
AU - Kilpeläinen, Maritta
AU - Bonniaud, Philippe
AU - Taillé, Camille
AU - Tiotiu, Iuliana Angelica
AU - Girodet, Pierre Olivier
AU - Blanc, François Xavier
AU - Pradelli, Johana
AU - Didier, Alain
AU - Nocent Ejnaini, Cecilia
AU - Deslee, Gaetan
AU - Pison, Christophe
AU - Douadi, Youcef
AU - Mahay, Guillaume
AU - Devouassoux, Gilles
AU - Melloni, Boris
AU - Roux, Pauline Marie
AU - Bourdin, Arnaud
AU - Fry, Stephanie
AU - Schaum, Thomas
AU - Schulz, Christian
AU - Skowasch, Dirk
AU - Taube, Christian
AU - Welte, Tobias
AU - Gleiber, Wolfgang
AU - Brehler, Randolf
AU - Schreiber, Jens
AU - Schuette, Wolfgang
AU - Kronsbein, Juliane
AU - Bonnet, Reiner
AU - Beck, Ekkehard
AU - Lacedonia, Donato
AU - Senna, Gianenrico
AU - Caruso, Cristiano
AU - Crimi, Nunzio
AU - Blasi, Francesco
AU - Santus, Pierachille
AU - Canonica, Giorgio Walter
AU - Guarnieri, Gabriella
AU - Pelaia, Girolamo
AU - Milanese, Manlio
AU - Micheletto, Claudio
AU - Corsico, Angelo Guido
AU - Scichilone, Nicola
AU - Spadaro, Giuseppe
AU - Langeveld, Bas
AU - Holters, Jurgen
AU - Willem van den Berg, Jan
AU - Smit, Arthur
AU - Conemans, Lennart
AU - van Veen, Helena
AU - Staaks, Gerald
AU - Lehmann, Sverre
AU - Echave-Sustaeta, Jose Maria
AU - Ribas, Christian Domingo
AU - de Luiz Martinez, Gustavo
AU - Gonzalez Perez, Ruperto
AU - Garcia Rivero, Juan Luis
AU - Gall, Xavier Muñoz
AU - Soto Campos, Jose Gregorio
AU - Mozo, Paloma Campo
AU - Pan, Carmen Vidal
AU - Fernandez, Ana Gomez Bastero
AU - Tellez, Sergio Campos
AU - Rivera, Carlos Martinez
AU - Bobolea, Irina Diana
AU - Guerrero, Raquel Morillo
AU - Garcia, Ismael Ali
AU - Rodriguez Hermosa, Juan Luis
AU - Stenfors, Nikolai
AU - Tunsäter, Alf
AU - Curiac, Dan
AU - von Garnier, Christophe
AU - Leuppi, Joerg
AU - Schmid-Grendelmeier, Peter
AU - Nasser, Shuaib
AU - Chaudhuri, Rekha
AU - Nordstrom, Monica
AU - Saralaya, Dinesh
AU - Pfeffer, Paul
AU - Mansur, Adel
AU - Short, Philip
AU - Wenzel, Sally
AU - Cherry, William Brett
AU - Zafra, Heidi
AU - Gonzalez, Erika
AU - Soong, Weily
AU - Davis, Benjamin
AU - Kao, Neil
AU - Hussain, Iftikhar
AU - Maselli Caceres, Diego Jose
AU - Harris, James
AU - Calhoun, William
AU - Rodicio, Ileana
AU - Kaufman, David
AU - Moss, Mark
AU - Sztejman, Eric
AU - DeLeon, Samuel
AU - Sumino, Kaharu
AU - Kashyap, Ravindra
AU - Leflein, Jeffrey
AU - Hajal, Rizan
AU - Fakih, Faisal
AU - Hill, David
AU - Lin, Robert
AU - Jarratt, Mikell
AU - Subramaniam, Vijay
AU - Sussman, Robert
AU - Mumneh, Nayla
AU - Reibman, Joan
AU - Darveaux, Jared
AU - Tan, Ricardo
AU - Tanus, Tonny
AU - Sikand, Vinay
AU - Marshall, Gailen
AU - Mehta, Hemalini
AU - Cole, Jeremy
AU - Goodman, Brad
AU - Goss, Deborah
AU - Bardelas, Jose
AU - Milstone, Aaron
AU - Mehta, Vinay
AU - Clore, Lee
AU - Millard, Mark
AU - Palumbo, Michael
AU - Puppala, Dileep
AU - Leong, Mila
AU - Prenner, Bruce
AU - Robinette, Emory
AU - Heidarian Raissy, Hengameh
AU - Fost, David
AU - Pleskow, Warren
AU - Marcus, Michael
AU - Ilowite, Jonathan
AU - Moore, Wendy
AU - Steven, Gary
AU - De la Cruz, Luis
AU - Chupp, Geoffrey
AU - Berger, William
AU - Randolph, Christopher
AU - Holguin, Fernando
AU - Kureishy, Shahrukh
AU - Campbell, Edward
N1 - Funding Information:
This study was funded by AstraZeneca.
Publisher Copyright:
© 2023 The Authors
PY - 2023/6
Y1 - 2023/6
N2 - 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.
AB - 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.
KW - Benralizumab
KW - Eosinophilic asthma
KW - Eosinophils
KW - Open-label extension
KW - Oral corticosteroids
KW - Severe asthma
UR - http://www.scopus.com/inward/record.url?scp=85152514359&partnerID=8YFLogxK
U2 - 10.1016/j.jaip.2023.03.009
DO - 10.1016/j.jaip.2023.03.009
M3 - Article
C2 - 36948488
AN - SCOPUS:85152514359
SN - 2213-2198
VL - 11
SP - 1759-1770.e7
JO - Journal of Allergy and Clinical Immunology: In Practice
JF - Journal of Allergy and Clinical Immunology: In Practice
IS - 6
ER -