Comparative efficacy of subcutaneous (CT-P13) and intravenous infliximab in adult patients with rheumatoid arthritis: a network meta-regression of individual patient data from two randomised trials.
CT-P13
Disease activity
Indirect treatment comparison
Individual patient data
Infliximab
Intravenous
Network meta-regression
Rheumatoid arthritis
Subcutaneous
Tumour necrosis factor inhibitor
Journal
Arthritis research & therapy
ISSN: 1478-6362
Titre abrégé: Arthritis Res Ther
Pays: England
ID NLM: 101154438
Informations de publication
Date de publication:
16 04 2021
16 04 2021
Historique:
received:
29
10
2020
accepted:
22
03
2021
entrez:
17
4
2021
pubmed:
18
4
2021
medline:
22
6
2021
Statut:
epublish
Résumé
A subcutaneous (SC) formulation of infliximab biosimilar CT-P13 is approved in Europe for the treatment of adult patients with rheumatoid arthritis (RA). It may offer improved efficacy versus intravenous (IV) infliximab formulations. A network meta-regression was conducted using individual patient data from two randomised trials in patients with RA, which compared CT-P13 SC with CT-P13 IV, and CT-P13 IV with reference infliximab IV. In this analysis, CT-P13 SC was compared with CT-P13 IV, reference infliximab IV and pooled data for both reference infliximab IV and CT-P13 IV. Outcomes included changes from baseline in 28-joint Disease Activity Score based on C-reactive protein (DAS28-CRP), Simplified Disease Activity Index (SDAI) and Clinical Disease Activity Index (CDAI), and rates of remission, low disease activity or clinically meaningful improvement in functional disability per Health Assessment Questionnaire-Disability Index (HAQ-DI). The two studies enrolled 949 patients with RA; pooled data for 840 and 751 patients were evaluable at weeks 30 and 54, respectively. For the CT-P13 SC versus pooled IV treatment arm comparison, differences in changes from baseline in DAS28-CRP (- 0.578; 95% confidence interval [CI] - 0.831, - 0.325; p < 0.0001), CDAI (- 3.502; 95% CI - 5.715, - 1.289; p = 0.002) and SDAI (- 4.031; 95% CI - 6.385, - 1.677; p = 0.0008) scores at 30 weeks were statistically significant in favour of CT-P13 SC. From weeks 30 to 54, the magnitude of the differences increased and remained statistically significant in favour of CT-P13 SC. Similar results were observed for the comparison of CT-P13 SC with CT-P13 IV and with reference infliximab IV. Statistically significant differences at week 30 favoured CT-P13 SC over the pooled IV treatment arms for the proportions of patients achieving EULAR-CRP good response, American College of Rheumatology (ACR) 50 and ACR70 responses, DAS28-CRP-defined remission, low disease activity (DAS28-CRP, CDAI and SDAI criteria) and clinically meaningful HAQ-DI improvement. CT-P13 SC was associated with greater improvements in DAS28-CRP, CDAI and SDAI scores and higher rates of clinical response, low disease activity and clinically meaningful improvement in functional disability, compared with CT-P13 IV and reference infliximab IV. EudraCT, 2016-002125-11 , registered 1 July 2016; EudraCT 2010-018646-31 , registered 23 June 2010.
Sections du résumé
BACKGROUND
A subcutaneous (SC) formulation of infliximab biosimilar CT-P13 is approved in Europe for the treatment of adult patients with rheumatoid arthritis (RA). It may offer improved efficacy versus intravenous (IV) infliximab formulations.
METHODS
A network meta-regression was conducted using individual patient data from two randomised trials in patients with RA, which compared CT-P13 SC with CT-P13 IV, and CT-P13 IV with reference infliximab IV. In this analysis, CT-P13 SC was compared with CT-P13 IV, reference infliximab IV and pooled data for both reference infliximab IV and CT-P13 IV. Outcomes included changes from baseline in 28-joint Disease Activity Score based on C-reactive protein (DAS28-CRP), Simplified Disease Activity Index (SDAI) and Clinical Disease Activity Index (CDAI), and rates of remission, low disease activity or clinically meaningful improvement in functional disability per Health Assessment Questionnaire-Disability Index (HAQ-DI).
RESULTS
The two studies enrolled 949 patients with RA; pooled data for 840 and 751 patients were evaluable at weeks 30 and 54, respectively. For the CT-P13 SC versus pooled IV treatment arm comparison, differences in changes from baseline in DAS28-CRP (- 0.578; 95% confidence interval [CI] - 0.831, - 0.325; p < 0.0001), CDAI (- 3.502; 95% CI - 5.715, - 1.289; p = 0.002) and SDAI (- 4.031; 95% CI - 6.385, - 1.677; p = 0.0008) scores at 30 weeks were statistically significant in favour of CT-P13 SC. From weeks 30 to 54, the magnitude of the differences increased and remained statistically significant in favour of CT-P13 SC. Similar results were observed for the comparison of CT-P13 SC with CT-P13 IV and with reference infliximab IV. Statistically significant differences at week 30 favoured CT-P13 SC over the pooled IV treatment arms for the proportions of patients achieving EULAR-CRP good response, American College of Rheumatology (ACR) 50 and ACR70 responses, DAS28-CRP-defined remission, low disease activity (DAS28-CRP, CDAI and SDAI criteria) and clinically meaningful HAQ-DI improvement.
CONCLUSIONS
CT-P13 SC was associated with greater improvements in DAS28-CRP, CDAI and SDAI scores and higher rates of clinical response, low disease activity and clinically meaningful improvement in functional disability, compared with CT-P13 IV and reference infliximab IV.
TRIAL REGISTRATION
EudraCT, 2016-002125-11 , registered 1 July 2016; EudraCT 2010-018646-31 , registered 23 June 2010.
Identifiants
pubmed: 33863352
doi: 10.1186/s13075-021-02487-x
pii: 10.1186/s13075-021-02487-x
pmc: PMC8051052
doi:
Substances chimiques
Antibodies, Monoclonal
0
Antirheumatic Agents
0
CT-P13
0
Infliximab
B72HH48FLU
Types de publication
Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
119Références
Ann Rheum Dis. 2005 May;64(5):704-7
pubmed: 15485995
Value Health. 2011 Jun;14(4):429-37
pubmed: 21669367
Arthritis Rheum. 2002 Jun;46(6):1451-9
pubmed: 12115174
Rheum Dis Clin North Am. 2009 Nov;35(4):745-57, vii-viii
pubmed: 19962619
Stat Med. 2007 Jul 20;26(16):3057-77
pubmed: 17256804
Nat Rev Dis Primers. 2018 Feb 08;4:18001
pubmed: 29417936
J Rheumatol. 2006 May;33(5):847-53
pubmed: 16583466
Ann Rheum Dis. 2005 Jan;64(1):130-3
pubmed: 15608311
Arthritis Rheum. 1998 Sep;41(9):1564-70
pubmed: 9751088
Ann Rheum Dis. 2016 Jan;75(1):3-15
pubmed: 25969430
Arthritis Rheum. 2011 Mar;63(3):573-86
pubmed: 21294106
Rheumatology (Oxford). 2020 Nov 23;:
pubmed: 33230526
Ann Rheum Dis. 2006 Feb;65(2):227-33
pubmed: 15975967
Ann Rheum Dis. 2019 Nov;78(11):1463-1471
pubmed: 31511227
Clin Exp Rheumatol. 2005 Sep-Oct;23(5 Suppl 39):S93-9
pubmed: 16273792
Lancet. 2016 Oct 22;388(10055):2023-2038
pubmed: 27156434
Ann Rheum Dis. 2007 Sep;66(9):1233-8
pubmed: 17392352
Clin Exp Rheumatol. 2005 Sep-Oct;23(5 Suppl 39):S100-8
pubmed: 16273793
Arthritis Rheum. 2003 Jan;48(1):59-63
pubmed: 12528104
Arthritis Rheum. 1993 Jun;36(6):729-40
pubmed: 8507213
Arthritis Care Res (Hoboken). 2012 May;64(5):640-7
pubmed: 22473918
Ann Intern Med. 2019 Jan 1;170(1):ITC1-ITC16
pubmed: 30596879
Arthritis Rheum. 2000 Jul;43(7):1478-87
pubmed: 10902749
J R Stat Soc Ser A Stat Soc. 2020 Jun;183(3):1189-1210
pubmed: 32684669
Clin Rheumatol. 2005 Apr;24(2):117-22
pubmed: 15340864
Lancet. 1999 Dec 4;354(9194):1932-9
pubmed: 10622295
Ann Rheum Dis. 2013 Oct;72(10):1613-20
pubmed: 23687260
BMC Rheumatol. 2019 Dec 10;3:51
pubmed: 31867564
Arthritis Rheum. 1995 Jan;38(1):44-8
pubmed: 7818570
Ann Rheum Dis. 2020 Jun;79(6):685-699
pubmed: 31969328
Arthritis Res Ther. 2016 Apr 02;18:82
pubmed: 27038608
Arthritis Rheum. 2005 Jan;52(1):27-35
pubmed: 15641102
N Engl J Med. 2000 Nov 30;343(22):1594-602
pubmed: 11096166
Mod Rheumatol. 2009;19(5):478-87
pubmed: 19626391