Evidence map›Paper›PMID 30762274›Full record

Trial reportJournal of internal medicine2019

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

G L Goll, K K Jørgensen, J Sexton, I C Olsen, N Bolstad, E A Haavardsholm, K E A Lundin, K S Tveit, M Lorentzen, I P Berset and 38 more

Abstract readComparative StudyRandomized Controlled TrialEquivalence Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Journal of internal medicine, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 56 papers, 5 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
56citing papers in PubMed, 5 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

56 citing papers in PubMed, 5 syntheses or guidelines pooled it.

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  20. Biosimilars in IBD: What Every Clinician Needs to Know.Current gastroenterology reports · 2024
    Review
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

48 authors.

G L GollDepartment of Rheumatology, Diakonhjemmet Hospital, Oslo, Norway.
K K JørgensenDepartment of Gastroenterology, Akershus University Hospital, Lørenskog, Norway.
J SextonDepartment of Rheumatology, Diakonhjemmet Hospital, Oslo, Norway.
I C OlsenDepartment of Rheumatology, Diakonhjemmet Hospital, Oslo, Norway.
N BolstadDepartment of Medical Biochemistry, Oslo University Hospital, Radiumhospitalet, Oslo, Norway.
E A HaavardsholmDepartment of Rheumatology, Diakonhjemmet Hospital, Oslo, Norway.
K E A LundinInstitute of Clinical Medicine, University of Oslo, Oslo, Norway.
K S TveitDepartment of Dermatology, Haukeland University Hospital, Bergen, Norway.
M LorentzenDepartment of Dermatology, Oslo University Hospital, Rikshospitalet, Oslo, Norway.
I P BersetDepartment of Gastroenterology, Ålesund Hospital, Ålesund, Norway.
B T S FevangDepartment of Rheumatology, Haukeland University Hospital, Bergen, Norway.
S KalstadDepartment of Rheumatology, University Hospital of Northern Norway, Tromsø, Norway.
K RyggenDepartment of Dermatology, Sankt Olav's Hospital, Trondheim, Norway.
D J WarrenDepartment of Medical Biochemistry, Oslo University Hospital, Radiumhospitalet, Oslo, Norway.
R A KlaasenDepartment of Medical Biochemistry, Oslo University Hospital, Radiumhospitalet, Oslo, Norway.
Ø AsakDepartment of Gastroenterology, Gjøvik Hospital, Gjøvik, Norway.
S BaighDepartment of Dermatology, Haugesund Hospital, Haugesund, Norway.
I M BlomgrenDepartment of Gastroenterology, Haugesund Hospital, Haugesund, Norway.
Ø BrennaDepartment of Gastroenterology, Sankt Olav's Hospital, Trondheim, Norway.
T J BruunDepartment of Rheumatology, University Hospital of Northern Norway, Tromsø, Norway.
K DvergsnesDepartment of Gastroenterology, Sørlandet Hospital, Kristiansand, Norway.
S O FrigstadDepartment of Gastroenterology, Baerum Hospital, Baerum, Norway.
I M HansenDepartment of Rheumatology, Helgelandssykehuset, Mo I Rana, Norway.
I S H HattenDepartment of Dermatology, Førde Hospital, Førde, Norway.
G Huppertz-HaussDepartment of Gastroenterology, Telemark Hospital, Skien, Norway.
M HenriksenDepartment of Gastroenterology, Østfold Hospital, Fredrikstad, Norway.
S S HoieDepartment of Rheumatology, Sørlandet Hospital, Kristiansand, Norway.
J KroghDepartment of Rheumatology, Levanger Hospital, Levanger, Norway.
I P MidtgardDepartment of Rheumatology, Bodø Hospital, Bodø, Norway.
P MielnikDepartment of Rheumatology, Førde Hospital, Førde, Norway.
B MoumInstitute of Clinical Medicine, University of Oslo, Oslo, Norway.
G NorabergDepartment of Gastroenterology, Sørlandet Hospital, Arendal, Norway.
A PoyanDepartment of Rheumatology, Kongsvinger Hospital, Kongsvinger, Norway.
U PrestegårdDepartment of Gastroenterology, Lillehammer Hospital, Lillehammer, Norway.
H U RashidDepartment of Rheumatology, Østfold Hospital, Moss, Norway.
E K StrandDepartment of Rheumatology, Revmatismesykehuset, Lillehammer, Norway.
K SkjetneDepartment of Dermatology, Sankt Olav's Hospital, Trondheim, Norway.
K A SeebergDepartment of Gastroenterology, Vestfold Hospital, Tønsberg, Norway.
R TorpDepartment of Gastroenterology, Hamar Hospital, Hamar, Norway.
C M YstrømDepartment of Gastroenterology, Elverum Hospital, Elverum, Norway.
C VoldDepartment of Gastroenterology, Bodø Hospital, Bodø, Norway.
C C ZettelDepartment of Rheumatology, Betanien Hospital, Skien, Norway.
K WaksvikPatient representative, Norges Psoriasis- og eksemforbund, Trondheim, Norway.
B GulbrandsenPatient representative, Landsforeningen for fordøyelsessykdommer, Oslo, Norway.
J HagforsPatient representative, Norsk Revmatikerforbund, Oslo, Norway.
C MørkInstitute of Cancer Research and Molecular Medicine, Faculty of Medicine, Norwegian University of Science and Technology, Trondheim, Norway.
J JahnsenDepartment of Gastroenterology, Akershus University Hospital, Lørenskog, Norway.
T K KvienDepartment of Rheumatology, Diakonhjemmet Hospital, Oslo, Norway.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

BACKGROUND AND

objectivesThe 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.

methodsPatients 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.

resultsBaseline 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.

conclusionThe 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.

Indexed as

AdultAntibodies, MonoclonalArthritisColitis, UlcerativeDouble-Blind MethodDrug SubstitutionFemaleHumansInfliximabMaleMiddle AgedNorwayPsoriasisTime FactorsTreatment OutcomeAntibodies, MonoclonalCT-P13Infliximabbiosimilarchronic inflammatory diseasedrug costshealth economicsinfliximabswitching

Identifiers

PMID30762274
PMCPMC6850326

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.