Trial reportBioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy2020
Efficacy and Safety of CT-P13 in Inflammatory Bowel Disease after Switching from Originator Infliximab: Exploratory Analyses from the NOR-SWITCH Main and Extension Trials.
Trial report in BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02148640 (A RANDOMIZED, DOUBLE-BLIND, PARALLEL-GROUP STUDY TO EVALUATE THE SAFETY AND EFFICACY OF SWITCHING FROM INNOVATOR INFLIXIMAB TO BIOSIMILAR INFLIXIMAB COMPARED WITH CONTINUED TREATMENT WITH INNOVATOR INFLIXIMAB IN PATIENTS WITH RHEUMATOID ARTHRITIS, SPONDYLOARTHRITIS, PSORIATIC ARTHRITIS, ULCERATIVE COLITIS, CROHN'S DISEASE AND CHRONIC PLAQUE PSORIASIS THE NOR-SWITCH STUDY), which is not on this map. Cited by 13 papers, 3 of them syntheses that pooled 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.
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.
A randomized, double-blind, parallel-group study to evaluate the safety and efficacy of switching from innovator infliximab to biosimilar infliximab compared with continued treatment with innovator infliximab in patients with rheumatoid arthritis, spondyloarthritis, psoriatic arthritis, ulcerative colitis, crohn's disease and chronic plaque psoriasis the nor-switch study
Who cites it
13 citing papers in PubMed, 3 syntheses or guidelines pooled it, 23 citations in OpenAlex.
- SYSTEMATIC REVIEW AND BRAZILIAN EXPERT CONSENSUS ON THE USE OF BIOSIMILARS IN INFLAMMATORY BOWEL DISEASE: BRAZILIAN ORGANIZATION FOR CROHN'S AND COLITIS.Arquivos de gastroenterologia · 2026Pooled it
- Infliximab for maintenance of medically-induced remission in Crohn's disease.The Cochrane database of systematic reviews · 2024Pooled it
- Comparative efficacy and safety of infliximab and vedolizumab therapy in patients with inflammatory bowel disease: a systematic review and meta-analysis.BMC gastroenterology · 2022Pooled it
- Safety and Effectiveness of Multi-Switch Between Adalimumab Originator and Biosimilars: A Multicenter (SUSTAIN) Study.Journal of clinical medicine · 2025Article
- Real-World Effectiveness and Safety of Infliximab Biosimilar CT-P13 for Rheumatic Diseases: A National Observational Cohort Study (ReFLECT).Advances in therapy · 2025Observational
- Efficacy and Safety of Infliximab and Vedolizumab Maintenance Therapy in Patients with Crohn's Disease and Ulcerative Colitis: A Systematic Review and Meta-Analysis.Journal of clinical medicine · 2025Review
- Review
- Evaluating the Efficacy of Infliximab in Inflammatory Bowel Disease: A Systematic Review of the Literature.Cureus · 2024Review
- An Update on Anti-TNF Biosimilar Switching-Real-World Clinical Effectiveness and Safety.Journal of the Canadian Association of Gastroenterology · 2024Article
- Reverse switching from the biosimilar SB2 to the originator infliximab in previously switched patients with inflammatory bowel diseases: results of a prospective long-term cohort study.Therapeutic advances in gastroenterology · 2024Article
- Korean clinical practice guidelines on biologics for moderate to severe Crohn's disease.Intestinal research · 2023Review
- Korean clinical practice guidelines on biologics and small molecules for moderate-to-severe ulcerative colitis.Intestinal research · 2023Review
- The efficacy of immunomodulators in the prevention and suppression of anti-drug antibodies to anti-tumor necrosis factor therapy in inflammatory bowel disease.Annals of gastroenterologyReview
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
29 authors at 15 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundThe NOR-SWITCH main and extension trials demonstrated that switching from originator to biosimilar infliximab (CT-P13) is efficacious and safe across six diseases. However, a subgroup analysis of Crohn's disease (CD) in the main trial displayed a close to significant difference favouring originator infliximab, and more scientific data have therefore been requested.
objectiveThe aim was to assess treatment efficacy, safety, and immunogenicity in an explorative subgroup analysis in CD and ulcerative colitis (UC) in the NOR-SWITCH trials. PATIENTS AND
methodsThe 52-week, randomised, non-inferiority, double-blind, multicentre, phase 4 NOR-SWITCH study was followed by a 26-week open extension trial where all patients received treatment with CT-P13. Treatment efficacy, safety, and immunogenicity in CD and UC were assessed throughout the 78-week study period.
resultsThe main and extension trials included 155 and 93 patients with CD and 93 and 80 patients with UC, respectively. Demographic and baseline characteristics were comparable in both treatment arms within patient groups. There were no differences in the main and extension trials regarding changes in activity indices, C-reactive protein, faecal calprotectin, patient's and physician's global assessment of disease activity and patient-reported outcome measures in CD and UC. Moreover, comparable results were also demonstrated for trough serum levels, presence of anti-drug antibodies, and reported adverse events.
conclusionEfficacy, safety, and immunogenicity of both the originator and biosimilar infliximab were comparable in CD and UC in the NOR-SWITCH main and extension trials. These explorative subgroup analyses confirm that there are no significant concerns related to switching from originator infliximab to CT-P13 in CD and UC.
trial registrationClinicalTrials.gov, number NCT02148640.
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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 Socratic graph.