Severe Asthma Standard-of-Care Background Medication Reduction With Benralizumab: ANDHI in Practice Substudy.
Benralizumab
Eosinophilic asthma
Eosinophils
Open-label extension
Oral corticosteroids
Severe asthma
Journal
The journal of allergy and clinical immunology. In practice
ISSN: 2213-2201
Titre abrégé: J Allergy Clin Immunol Pract
Pays: United States
ID NLM: 101597220
Informations de publication
Date de publication:
06 2023
06 2023
Historique:
received:
17
08
2022
revised:
22
02
2023
accepted:
05
03
2023
medline:
12
6
2023
pubmed:
23
3
2023
entrez:
22
3
2023
Statut:
ppublish
Résumé
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.
Sections du résumé
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.
Identifiants
pubmed: 36948488
pii: S2213-2198(23)00293-3
doi: 10.1016/j.jaip.2023.03.009
pii:
doi:
Substances chimiques
Adrenal Cortex Hormones
0
Anti-Asthmatic Agents
0
Antibodies, Monoclonal, Humanized
0
benralizumab
71492GE1FX
Banques de données
ClinicalTrials.gov
['NCT03170271']
Types de publication
Journal Article
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
1759-1770.e7Investigateurs
Wolfgang Pohl
(W)
Daniel Doberer
(D)
Jean Benoit Martinot
(JB)
Maud Deschampheleire
(M)
Ulrike Himpe
(U)
Kenneth Chapman
(K)
Amarjit Cheema
(A)
Delbert Dorscheid
(D)
Clare Ramsey
(C)
Jeffrey Rolf
(J)
Brandie Walker
(B)
Ronald Olivenstein
(R)
Claude Poirier
(C)
Pierre Larivee
(P)
Anne Sofie Bjerrum
(AS)
Ingrid Titlestad
(I)
Ole Hilberg
(O)
Maritta Kilpeläinen
(M)
Philippe Bonniaud
(P)
Camille Taillé
(C)
Iuliana-Angelica Tiotiu
(IA)
Pierre-Olivier Girodet
(PO)
François-Xavier Blanc
(FX)
Johana Pradelli
(J)
Alain Didier
(A)
Cecilia Nocent Ejnaini
(C)
Gaetan Deslee
(G)
Christophe Pison
(C)
Youcef Douadi
(Y)
Guillaume Mahay
(G)
Gilles Devouassoux
(G)
Boris Melloni
(B)
Pauline-Marie Roux
(PM)
Arnaud Bourdin
(A)
Stephanie Fry
(S)
Thomas Schaum
(T)
Christian Schulz
(C)
Dirk Skowasch
(D)
Christian Taube
(C)
Tobias Welte
(T)
Wolfgang Gleiber
(W)
Randolf Brehler
(R)
Jens Schreiber
(J)
Wolfgang Schuette
(W)
Juliane Kronsbein
(J)
Reiner Bonnet
(R)
Ekkehard Beck
(E)
Donato Lacedonia
(D)
Gianenrico Senna
(G)
Cristiano Caruso
(C)
Nunzio Crimi
(N)
Francesco Blasi
(F)
Pierachille Santus
(P)
Giorgio Walter Canonica
(GW)
Gabriella Guarnieri
(G)
Girolamo Pelaia
(G)
Manlio Milanese
(M)
Claudio Micheletto
(C)
Angelo Guido Corsico
(AG)
Nicola Scichilone
(N)
Giuseppe Spadaro
(G)
Bas Langeveld
(B)
Jurgen Holters
(J)
Jan Willem van den Berg
(J)
Arthur Smit
(A)
Lennart Conemans
(L)
Helena van Veen
(H)
Gerald Staaks
(G)
Sverre Lehmann
(S)
Jose Maria Echave-Sustaeta
(JM)
Christian Domingo Ribas
(CD)
Gustavo de Luiz Martinez
(G)
Ruperto Gonzalez Perez
(R)
Juan Luis Garcia Rivero
(JL)
Xavier Muñoz Gall
(XM)
Jose Gregorio Soto Campos
(JG)
Paloma Campo Mozo
(PC)
Carmen Vidal Pan
(CV)
Ana Gomez-Bastero Fernandez
(AG)
Sergio Campos Tellez
(SC)
Carlos Martinez Rivera
(CM)
Irina Diana Bobolea
(ID)
Raquel Morillo Guerrero
(RM)
Ismael Ali Garcia
(IA)
Juan Luis Rodriguez Hermosa
(JL)
Nikolai Stenfors
(N)
Alf Tunsäter
(A)
Dan Curiac
(D)
Christophe von Garnier
(C)
Joerg Leuppi
(J)
Peter Schmid-Grendelmeier
(P)
Shuaib Nasser
(S)
Rekha Chaudhuri
(R)
Monica Nordstrom
(M)
Dinesh Saralaya
(D)
Paul Pfeffer
(P)
Adel Mansur
(A)
Philip Short
(P)
Sally Wenzel
(S)
William Brett Cherry
(WB)
Heidi Zafra
(H)
Erika Gonzalez
(E)
Weily Soong
(W)
Benjamin Davis
(B)
Neil Kao
(N)
Iftikhar Hussain
(I)
Diego Jose Maselli Caceres
(DJ)
James Harris
(J)
William Calhoun
(W)
Ileana Rodicio
(I)
David Kaufman
(D)
Mark Moss
(M)
Eric Sztejman
(E)
Samuel DeLeon
(S)
Kaharu Sumino
(K)
Ravindra Kashyap
(R)
Jeffrey Leflein
(J)
Rizan Hajal
(R)
Faisal Fakih
(F)
David Hill
(D)
Robert Lin
(R)
Mikell Jarratt
(M)
Vijay Subramaniam
(V)
Robert Sussman
(R)
Nayla Mumneh
(N)
Joan Reibman
(J)
Jared Darveaux
(J)
Ricardo Tan
(R)
Tonny Tanus
(T)
Vinay Sikand
(V)
Gailen Marshall
(G)
Hemalini Mehta
(H)
Jeremy Cole
(J)
Brad Goodman
(B)
Deborah Goss
(D)
Jose Bardelas
(J)
Aaron Milstone
(A)
Vinay Mehta
(V)
Lee Clore
(L)
Mark Millard
(M)
Michael Palumbo
(M)
Dileep Puppala
(D)
Mila Leong
(M)
Bruce Prenner
(B)
Emory Robinette
(E)
Hengameh Heidarian Raissy
(H)
David Fost
(D)
Warren Pleskow
(W)
Michael Marcus
(M)
Jonathan Ilowite
(J)
Wendy Moore
(W)
Gary Steven
(G)
Luis De la Cruz
(L)
Geoffrey Chupp
(G)
William Berger
(W)
Christopher Randolph
(C)
Fernando Holguin
(F)
Shahrukh Kureishy
(S)
Edward Campbell
(E)
Rudi Peche
(R)
Laura Pini
(L)
Alberto Papi
(A)
Bianca Beghé
(B)
Silvia Peveri
(S)
Aythamy Henriquez Santa
(AH)
Jacinto Ramos Gonzalez
(JR)
Ines Vinge
(I)
Roy John
(R)
Commentaires et corrections
Type : CommentIn
Informations de copyright
Copyright © 2023 The Authors. Published by Elsevier Inc. All rights reserved.