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J Intern Med. 2019 Feb 14. doi: 10.1111/joim.12880. [Epub ahead of print]

Long-term efficacy and safety of biosimilar infliximab (CT-P13) after switching from originator infliximab: open-label extension of the NOR-SWITCH trial.

Author information

1
Department of Rheumatology, Diakonhjemmet Hospital, Oslo, Norway.
2
Department of Gastroenterology, Akershus University Hospital, Lørenskog, Norway.
3
Research Support Services CTU, Oslo University Hospital, Oslo, Norway.
4
Department of Medical Biochemistry, Oslo University Hospital, Radiumhospitalet, Oslo, Norway.
5
Institute of Clinical Medicine, University of Oslo, Oslo, Norway.
6
Department of Gastroenterology, Oslo University Hospital, Rikshospitalet, Oslo, Norway.
7
K.G. Jebsen Coeliac Disease Research Centre, University of Oslo, Oslo, Norway.
8
Department of Dermatology, Haukeland University Hospital, Bergen, Norway.
9
Department of Dermatology, Oslo University Hospital, Rikshospitalet, Oslo, Norway.
10
Department of Gastroenterology, Ålesund Hospital, Ålesund, Norway.
11
Department of Rheumatology, Haukeland University Hospital, Bergen, Norway.
12
Department of Rheumatology, University Hospital of Northern Norway, Tromsø, Norway.
13
Department of Dermatology, Sankt Olav's Hospital, Trondheim, Norway.
14
Department of Gastroenterology, Gjøvik Hospital, Gjøvik, Norway.
15
Department of Dermatology, Haugesund Hospital, Haugesund, Norway.
16
Department of Gastroenterology, Haugesund Hospital, Haugesund, Norway.
17
Department of Gastroenterology, Sankt Olav's Hospital, Trondheim, Norway.
18
Department of Gastroenterology, Sørlandet Hospital, Kristiansand, Norway.
19
Department of Gastroenterology, Baerum Hospital, Baerum, Norway.
20
Department of Rheumatology, Helgelandssykehuset, Mo I Rana, Norway.
21
Department of Dermatology, Førde Hospital, Førde, Norway.
22
Department of Gastroenterology, Telemark Hospital, Skien, Norway.
23
Department of Gastroenterology, Østfold Hospital, Fredrikstad, Norway.
24
Department of Rheumatology, Sørlandet Hospital, Kristiansand, Norway.
25
Department of Rheumatology, Levanger Hospital, Levanger, Norway.
26
Department of Rheumatology, Bodø Hospital, Bodø, Norway.
27
Department of Rheumatology, Førde Hospital, Førde, Norway.
28
Department of Gastroenterology, Oslo University Hospital Ullevål, Oslo, Norway.
29
Department of Gastroenterology, Sørlandet Hospital, Arendal, Norway.
30
Department of Rheumatology, Kongsvinger Hospital, Kongsvinger, Norway.
31
Department of Gastroenterology, Lillehammer Hospital, Lillehammer, Norway.
32
Department of Rheumatology, Østfold Hospital, Moss, Norway.
33
Department of Rheumatology, Revmatismesykehuset, Lillehammer, Norway.
34
Department of Gastroenterology, Vestfold Hospital, Tønsberg, Norway.
35
Department of Gastroenterology, Hamar Hospital, Hamar, Norway.
36
Department of Gastroenterology, Elverum Hospital, Elverum, Norway.
37
Department of Gastroenterology, Bodø Hospital, Bodø, Norway.
38
Department of Rheumatology, Betanien Hospital, Skien, Norway.
39
Patient representative, Norges Psoriasis- og eksemforbund, Trondheim, Norway.
40
Patient representative, Landsforeningen for fordøyelsessykdommer, Oslo, Norway.
41
Patient representative, Norsk Revmatikerforbund, Oslo, Norway.
42
Institute of Cancer Research and Molecular Medicine, Faculty of Medicine, Norwegian University of Science and Technology, Trondheim, Norway.

Abstract

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.

KEYWORDS:

biosimilar; chronic inflammatory disease; drug costs; health economics; infliximab; switching

PMID:
30762274
DOI:
10.1111/joim.12880

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