Asthma biologics: Comparing trial designs, patient cohorts and study results.
Journal
Annals of allergy, asthma & immunology : official publication of the American College of Allergy, Asthma, & Immunology
ISSN: 1534-4436
Titre abrégé: Ann Allergy Asthma Immunol
Pays: United States
ID NLM: 9503580
Informations de publication
Date de publication:
01 2020
01 2020
Historique:
received:
31
07
2019
revised:
25
09
2019
accepted:
15
10
2019
pubmed:
28
10
2019
medline:
22
4
2020
entrez:
27
10
2019
Statut:
ppublish
Résumé
Five biologic therapies have FDA-approved indications for difficult-to-control asthma. The clinical trials that proved the efficacy and safety of these biologics were often similar in their inclusion criteria, study designs, and endpoints. Many of these trials have been reanalyzed post hoc to identify subsets of subjects considered to be enhanced responders. As a result, keeping up with the literature and deciding on the most appropriate biologic for our patients has become increasingly difficult. This review summarizes and compares trial designs, patient cohorts, and study results of the major trials involving these therapies. Included are basic science articles, online Food and Drug Administration (FDA) applications, and all the published reports of phase II and phase III clinical trials for FDA-approved asthma biologics. Included are the major phase II and phase III clinical trials of 5 asthma biologics. Because of variations in inclusion criteria and natural variations in enrolled cohorts, the baseline clinical traits and severity of study populations in asthma biologic trials differed significantly, which is important because baseline annualized exacerbation rates and blood eosinophilia are both strong predictors of a biologic's success. Notwithstanding, the trial results, when considered together, can help guide care providers in choosing the most appropriate biologic for our patients. Understanding the details and differences in asthma biologic trial designs, patient cohorts, and in study results will help care providers make more informed decisions when choosing a biologic. We are hopeful this review will serve as a reference to care providers for this purpose.
Identifiants
pubmed: 31655122
pii: S1081-1206(19)31301-8
doi: 10.1016/j.anai.2019.10.016
pmc: PMC6911637
mid: NIHMS1542021
pii:
doi:
Substances chimiques
Anti-Asthmatic Agents
0
Antibodies, Monoclonal, Humanized
0
Biological Products
0
Omalizumab
2P471X1Z11
reslizumab
35A26E427H
dupilumab
420K487FSG
mepolizumab
90Z2UF0E52
Types de publication
Journal Article
Research Support, N.I.H., Extramural
Review
Langues
eng
Sous-ensembles de citation
IM
Pagination
44-56Subventions
Organisme : NHLBI NIH HHS
ID : K23 HL144418
Pays : United States
Informations de copyright
Copyright © 2019 American College of Allergy, Asthma & Immunology. Published by Elsevier Inc. All rights reserved.
Références
J Allergy Clin Immunol. 2019 Nov;144(5):1336-1342.e7
pubmed: 31425781
J Allergy Clin Immunol. 2019 May;143(5):1742-1751.e7
pubmed: 30359681
Nat Med. 2012 May 04;18(5):736-49
pubmed: 22561837
Curr Opin Allergy Clin Immunol. 2015 Feb;15(1):98-103
pubmed: 25479313
N Engl J Med. 1998 May 28;338(22):1592-600
pubmed: 9603798
J Allergy Clin Immunol Pract. 2017 Nov - Dec;5(6):1572-1581.e3
pubmed: 29122156
N Engl J Med. 2017 Jun 22;376(25):2448-2458
pubmed: 28530840
Ann Intern Med. 2011 May 3;154(9):573-82
pubmed: 21536936
Lancet Respir Med. 2014 Nov;2(11):879-890
pubmed: 25306557
Transl Res. 2016 Aug;174:98-121
pubmed: 26976119
Cochrane Database Syst Rev. 2015 Jul 27;(7):CD010834
pubmed: 26214266
Allergy. 2007 Feb;62(2):126-33
pubmed: 17298420
Int Forum Allergy Rhinol. 2015 Sep;5 Suppl 1:S7-10
pubmed: 26010063
J Asthma Allergy. 2016 Apr 04;9:71-81
pubmed: 27110133
J Allergy Clin Immunol. 2008 Jan;121(1):5-10; quiz 11-2
pubmed: 18036647
Ann Am Thorac Soc. 2018 Mar;15(3):348-356
pubmed: 29323930
J Allergy Clin Immunol Pract. 2019 Jan;7(1):156-164.e1
pubmed: 29800752
J Allergy Clin Immunol. 2011 Nov;128(5):989-95.e1-8
pubmed: 21958585
Proc Natl Acad Sci U S A. 2007 Oct 2;104(40):15858-63
pubmed: 17898169
N Engl J Med. 2018 Jun 28;378(26):2486-2496
pubmed: 29782217
J Allergy Clin Immunol. 2012 Aug;130(2):489-95
pubmed: 22766097
J Allergy Clin Immunol. 2010 Jun;125(6):1344-1353.e2
pubmed: 20513525
J Allergy Clin Immunol. 2017 Oct;140(4):1024-1031.e14
pubmed: 28687232
Int Arch Allergy Immunol. 2016;170(2):122-31
pubmed: 27637004
Clin Respir J. 2019 Mar;13(3):189-191
pubmed: 30666793
N Engl J Med. 2013 Jun 27;368(26):2455-66
pubmed: 23688323
N Engl J Med. 2014 Sep 25;371(13):1198-207
pubmed: 25199059
Mem Inst Oswaldo Cruz. 1997;92 Suppl 2:75-91
pubmed: 9698919
Nat Med. 2012 May 04;18(5):716-25
pubmed: 22561835
J Allergy Clin Immunol. 2010 Mar;125(3):752-4
pubmed: 20153038
Cell Mol Gastroenterol Hepatol. 2017 Jan 17;3(2):174-182
pubmed: 28275684
Annu Rev Immunol. 2006;24:147-74
pubmed: 16551246
Nat Rev Drug Discov. 2016 Jan;15(1):35-50
pubmed: 26471366
J Exp Med. 2007 Feb 19;204(2):253-8
pubmed: 17242164
Cochrane Database Syst Rev. 2017 Sep 21;9:CD010834
pubmed: 28933516
Curr Opin Allergy Clin Immunol. 2014 Dec;14(6):570-5
pubmed: 25159182
J Allergy Clin Immunol. 2001 Aug;108(2):184-90
pubmed: 11496232
Am J Respir Crit Care Med. 2009 Sep 1;180(5):388-95
pubmed: 19483109
Lancet. 2019 Nov 2;394(10209):1638-1650
pubmed: 31543428
MAbs. 2012 Jan-Feb;4(1):110-9
pubmed: 22327434
N Engl J Med. 2014 Sep 25;371(13):1189-97
pubmed: 25199060
Chest. 2016 Oct;150(4):799-810
pubmed: 27018175
J Allergy Clin Immunol. 2015 Dec;136(6):1476-1485
pubmed: 26518090
Curr Opin Otolaryngol Head Neck Surg. 2016 Jun;24(3):245-9
pubmed: 26977741
Lancet Respir Med. 2019 Jan;7(1):46-59
pubmed: 30416083
N Engl J Med. 2018 Jun 28;378(26):2475-2485
pubmed: 29782224
Cochrane Database Syst Rev. 2003;(3):CD003559
pubmed: 12917972
Am J Respir Crit Care Med. 2005 Jul 15;172(2):149-60
pubmed: 15849323
Am J Respir Crit Care Med. 2013 Apr 15;187(8):804-11
pubmed: 23471469
Allergy. 2005 Mar;60(3):309-16
pubmed: 15679715
Lancet. 2012 Aug 18;380(9842):651-9
pubmed: 22901886
Lancet Respir Med. 2015 May;3(5):355-66
pubmed: 25736990
Allergy. 2018 Feb;73(2):490-497
pubmed: 28859263
Int Forum Allergy Rhinol. 2013 Nov;3(11):877-84
pubmed: 24039208
Eur Respir J. 2014 Feb;43(2):343-73
pubmed: 24337046
J Exp Med. 2005 Nov 7;202(9):1213-23
pubmed: 16275760
Allergy. 2004 Aug;59(8):793-805
pubmed: 15230810
J Allergy Clin Immunol. 2009 Nov;124(5):895-902.e1-4
pubmed: 19811812
Curr Opin Pharmacol. 2007 Jun;7(3):279-82
pubmed: 17475560
Am J Respir Cell Mol Biol. 2013 Nov;49(5):741-50
pubmed: 23590308
Laryngoscope. 2015 Aug;125(8):1779-84
pubmed: 25891944
J Allergy Clin Immunol. 2015 Oct;136(4):904-13
pubmed: 25936567
Lancet. 2016 Oct 29;388(10056):2115-2127
pubmed: 27609408
Am J Respir Crit Care Med. 2014 Dec 15;190(12):1363-72
pubmed: 25338189
Nat Med. 2012 May 04;18(5):693-704
pubmed: 22561833
Eur Respir J. 2018 May 10;51(5):
pubmed: 29545284
Eur Respir J. 2001 Aug;18(2):254-61
pubmed: 11529281
Am J Respir Crit Care Med. 2004 Mar 1;169(5):573-7
pubmed: 14630618
J Allergy Clin Immunol. 2014 Mar;133(3):921-3
pubmed: 24418480
Lancet. 2016 Oct 29;388(10056):2128-2141
pubmed: 27609406
Cell Tissue Res. 2017 Mar;367(3):551-569
pubmed: 28190087
Front Immunol. 2019 Mar 04;10:364
pubmed: 30886621
Pediatr Pulmonol. 2019 Dec;54(12):1957-1967
pubmed: 31502421
J Investig Allergol Clin Immunol. 2015;25(1):1-11; quiz 2p following 11
pubmed: 25898689
BioDrugs. 2016 Dec;30(6):489-523
pubmed: 27807766
Lancet Respir Med. 2018 Jan;6(1):51-64
pubmed: 28919200
J Allergy Clin Immunol. 1997 Jul;100(1):110-21
pubmed: 9257795
J Asthma Allergy. 2011;4:49-59
pubmed: 21792319
Curr Med Res Opin. 2003;19(6):491-8
pubmed: 14594521