Long-term efficacy and safety of biosimilar infliximab (CT-P13) after switching from originator infliximab: open-label extension of the NOR-SWITCH trial.
biosimilar
chronic inflammatory disease
drug costs
health economics
infliximab
switching
Journal
Journal of internal medicine
ISSN: 1365-2796
Titre abrégé: J Intern Med
Pays: England
ID NLM: 8904841
Informations de publication
Date de publication:
06 2019
06 2019
Historique:
pubmed:
15
2
2019
medline:
8
5
2020
entrez:
15
2
2019
Statut:
ppublish
Résumé
The 52-week, randomized, double-blind, noninferiority, government-funded NOR-SWITCH trial demonstrated that switching from infliximab originator to less expensive biosimilar CT-P13 was not inferior to continued treatment with infliximab originator. The NOR-SWITCH extension trial aimed to assess efficacy, safety and immunogenicity in patients on CT-P13 throughout the 78-week study period (maintenance group) versus patients switched to CT-P13 at week 52 (switch group). The primary outcome was disease worsening during follow-up based on disease-specific composite measures. Patients were recruited from 24 Norwegian hospitals, 380 of 438 patients who completed the main study: 197 in the maintenance group and 183 in the switch group. In the full analysis set, 127 (33%) had Crohn's disease, 80 (21%) ulcerative colitis, 67 (18%) spondyloarthritis, 55 (15%) rheumatoid arthritis, 20 (5%) psoriatic arthritis and 31 (8%) chronic plaque psoriasis. Baseline characteristics were similar in the two groups at the time of switching (week 52). Disease worsening occurred in 32 (16.8%) patients in the maintenance group vs. 20 (11.6%) in the switch group (per-protocol set). Adjusted risk difference was 5.9% (95% CI -1.1 to 12.9). Frequency of adverse events, anti-drug antibodies, changes in generic disease variables and disease-specific composite measures were comparable between arms. The study was inadequately powered to detect noninferiority within individual diseases. The NOR-SWITCH extension showed no difference in safety and efficacy between patients who maintained CT-P13 and patients who switched from originator infliximab to CT-P13, supporting that switching from originator infliximab to CT-P13 is safe and efficacious.
Sections du résumé
BACKGROUND AND OBJECTIVES
The 52-week, randomized, double-blind, noninferiority, government-funded NOR-SWITCH trial demonstrated that switching from infliximab originator to less expensive biosimilar CT-P13 was not inferior to continued treatment with infliximab originator. The NOR-SWITCH extension trial aimed to assess efficacy, safety and immunogenicity in patients on CT-P13 throughout the 78-week study period (maintenance group) versus patients switched to CT-P13 at week 52 (switch group). The primary outcome was disease worsening during follow-up based on disease-specific composite measures.
METHODS
Patients were recruited from 24 Norwegian hospitals, 380 of 438 patients who completed the main study: 197 in the maintenance group and 183 in the switch group. In the full analysis set, 127 (33%) had Crohn's disease, 80 (21%) ulcerative colitis, 67 (18%) spondyloarthritis, 55 (15%) rheumatoid arthritis, 20 (5%) psoriatic arthritis and 31 (8%) chronic plaque psoriasis.
RESULTS
Baseline characteristics were similar in the two groups at the time of switching (week 52). Disease worsening occurred in 32 (16.8%) patients in the maintenance group vs. 20 (11.6%) in the switch group (per-protocol set). Adjusted risk difference was 5.9% (95% CI -1.1 to 12.9). Frequency of adverse events, anti-drug antibodies, changes in generic disease variables and disease-specific composite measures were comparable between arms. The study was inadequately powered to detect noninferiority within individual diseases.
CONCLUSION
The NOR-SWITCH extension showed no difference in safety and efficacy between patients who maintained CT-P13 and patients who switched from originator infliximab to CT-P13, supporting that switching from originator infliximab to CT-P13 is safe and efficacious.
Identifiants
pubmed: 30762274
doi: 10.1111/joim.12880
pmc: PMC6850326
doi:
Substances chimiques
Antibodies, Monoclonal
0
CT-P13
0
Infliximab
B72HH48FLU
Banques de données
ClinicalTrials.gov
['NCT02148640']
EudraCT
['2014‐002056‐40']
Types de publication
Comparative Study
Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
653-669Commentaires et corrections
Type : CommentIn
Informations de copyright
© 2019 The Authors. Journal of Internal Medicine published by John Wiley & Sons Ltd on behalf of Association for Publication of The Journal of Internal Medicine.
Références
Ann Rheum Dis. 2017 Aug;76(8):1426-1431
pubmed: 28473425
Rheumatology (Oxford). 2017 Aug 1;56(suppl_4):iv49-iv62
pubmed: 28903542
Ann Rheum Dis. 2014 Nov;73(11):2010-21
pubmed: 23940213
Ann Rheum Dis. 2013 Oct;72(10):1605-12
pubmed: 23687259
Arthritis Rheumatol. 2018 Jan;70(1):60-68
pubmed: 29045077
Rheumatology (Oxford). 2017 Oct 1;56(10):1771-1779
pubmed: 28957563
Aliment Pharmacol Ther. 2017 Apr;45(8):1043-1057
pubmed: 28239873
Scand J Rheumatol. 2018 Sep;47(5):418-421
pubmed: 29310493
Ann Rheum Dis. 2017 Jan;76(1):51-57
pubmed: 26150601
Ann Rheum Dis. 2017 Feb;76(2):355-363
pubmed: 27130908
Postgrad Med J. 2007 Apr;83(978):251-60
pubmed: 17403952
J Crohns Colitis. 2017 Jun 1;11(6):690-696
pubmed: 28130330
Eur J Clin Pharmacol. 2018 May;74(5):655-661
pubmed: 29368188
Joint Bone Spine. 2018 Oct;85(5):507-509
pubmed: 29631065
Ann Rheum Dis. 2017 Feb;76(2):346-354
pubmed: 27117698
Rheumatology (Oxford). 2016 Feb;55(2):210-20
pubmed: 26268816
Ann Rheum Dis. 2017 Aug 9;:
pubmed: 28794078
Lancet. 2017 Jun 10;389(10086):2304-2316
pubmed: 28502609
Expert Opin Biol Ther. 2015;15(12):1677-83
pubmed: 26549204
Ann Rheum Dis. 2015 Jan;74(1):311-4
pubmed: 25342759
J Intern Med. 2019 Jun;285(6):653-669
pubmed: 30762274
Ann Rheum Dis. 2013 Oct;72(10):1613-20
pubmed: 23687260