Trial reportAnnals of the rheumatic diseases2013
A randomised, double-blind, multicentre, parallel-group, prospective study comparing the pharmacokinetics, safety, and efficacy of CT-P13 and innovator infliximab in patients with ankylosing spondylitis: the PLANETAS study.
Trial report in Annals of the rheumatic diseases, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 213 papers, 13 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.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
213 citing papers in PubMed, 13 syntheses or guidelines pooled it, 602 citations in OpenAlex.
- Blood-test monitoring strategies for patients established on immune-suppressing drugs: a mixed-methods study.Health technology assessment (Winchester, England) · 2026Pooled it
- Biosimilars in Pediatric Inflammatory Bowel Diseases: A Systematic Review and Real Life-Based Evidence.Frontiers in pharmacology · 2022Pooled it
- [Long version on the S3 guidelines for axial spondyloarthritis including Bechterew's disease and early forms, Update 2019 : Evidence-based guidelines of the German Society for Rheumatology (DGRh) and participating medical scientific specialist societies and other organizations].Zeitschrift fur Rheumatologie · 2019Guideline
- 2019 Update of the American College of Rheumatology/Spondylitis Association of America/Spondyloarthritis Research and Treatment Network Recommendations for the Treatment of Ankylosing Spondylitis and Nonradiographic Axial Spondyloarthritis.Arthritis & rheumatology (Hoboken, N.J.) · 2019Guideline
- Systematic review: efficacy and safety of switching patients between reference and biosimilar infliximab.Alimentary pharmacology & therapeutics · 2019Pooled it
- Non-medical Switching from Originator Tumor Necrosis Factor Inhibitors to Their Biosimilars: Systematic Review of Randomized Controlled Trials and Real-World Studies.Advances in therapy · 2018Pooled it
- Comparative Efficacy of Tumor Necrosis Factor-α Inhibitors in Ankylosing Spondylitis: A Systematic Review and Bayesian Network Metaanalysis.The Journal of rheumatology · 2018Pooled it
- Immunogenicity of Biologics in Chronic Inflammatory Diseases: A Systematic Review.BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy · 2017Pooled it
- Monoclonal Antibody and Fusion Protein Biosimilars Across Therapeutic Areas: A Systematic Review of Published Evidence.BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy · 2016Pooled it
- Biosimilars for the Treatment of Chronic Inflammatory Diseases: A Systematic Review of Published Evidence.BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy · 2016Pooled it
- Infliximab-Related Infusion Reactions: Systematic Review.Journal of Crohn's & colitis · 2015Pooled it
- Comparative efficacy and safety of biosimilar infliximab and other biological treatments in ankylosing spondylitis: systematic literature review and meta-analysis.The European journal of health economics : HEPAC : health economics in prevention and care · 2014Pooled it
- EULAR recommendations for the management of rheumatoid arthritis with synthetic and biological disease-modifying antirheumatic drugs: 2013 update.Annals of the rheumatic diseases · 2014Guideline
- Efficacy, pharmacokinetics and safety of subcutaneous versus intravenous CT-P13 in rheumatoid arthritis: a randomized phase I/III trial.Rheumatology (Oxford, England) · 2021Trial
- Increased Induction Infliximab Clearance Predicts Early Antidrug Antibody Detection.Journal of clinical pharmacology · 2021Trial
- 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.BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy · 2020Trial
- Comparison of the Efficacy and Safety of Adalimumab (Humira) and the Adalimumab Biosimilar Candidate (HS016) in Chinese Patients with Active Ankylosing Spondylitis: A Multicenter, Randomized, Double-Blind, Parallel, Phase III Clinical Trial.BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy · 2020Trial
- A phase III study of BCD-055 compared with innovator infliximab in patients with active rheumatoid arthritis: 54-week results from the LIRA study.Rheumatology international · 2019Trial
- Long-term efficacy and safety of biosimilar infliximab (CT-P13) after switching from originator infliximab: open-label extension of the NOR-SWITCH trial.Journal of internal medicine · 2019Trial
- A randomised, single-blind, single-dose, three-arm, parallel-group study in healthy subjects to demonstrate pharmacokinetic equivalence of ABP 501 and adalimumab.Annals of the rheumatic diseases · 2017Trial
153 more citing papers are in PubMed but not listed here.
Corrections and comments
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Authors and funding
14 authors at 10 institutions in 7 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectivesTo compare the pharmacokinetics (PK), safety and efficacy of innovator infliximab (INX) and CT-P13, a biosimilar to INX, in patients with active ankylosing spondylitis (AS).
methodsPhase 1 randomised, double-blind, multicentre, multinational, parallel-group study. Patients were randomised to receive 5 mg/kg of CT-P13 (n=125) or INX (n=125). Primary endpoints were area under the concentration-time curve (AUC) at steady state and observed maximum steady state serum concentration (Cmax,ss) between weeks 22 and 30. Additional PK, efficacy endpoints, including 20% and 40% improvement response according to Assessment in Ankylosing Spondylitis International Working Group criteria (ASAS20 and ASAS40), and safety outcomes were also assessed.
resultsGeometric mean AUC was 32 765.8 μgh/ml for CT-P13 and 31 359.3 μgh/ml for INX. Geometric mean Cmax,ss was 147.0 μg/ml for CT-P13 and 144.8 μg/ml for INX. The ratio of geometric means was 104.5% (90% CI 94% to 116%) for AUC and 101.5% (90% CI 95% to 109%) for Cmax,ss. ASAS20 and ASAS40 responses at week 30 were 70.5% and 51.8% for CT-P13 and 72.4% and 47.4% for INX, respectively. In the CT-P13 and INX groups more than one adverse event occurred in 64.8% and 63.9% of patients, infusion reactions occurred in 3.9% and 4.9%, active tuberculosis occurred in 1.6% and 0.8%, and 27.4% and 22.5% of patients tested positive for anti-drug antibodies, respectively.
conclusionsThe PK profiles of CT-P13 and INX were equivalent in patients with active AS. CT-P13 was well tolerated, with an efficacy and safety profile comparable to that of INX up to week 30.
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