Trial reportBioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy2017
Efficacy and Safety of Switching from Innovator Rituximab to Biosimilar CT-P10 Compared with Continued Treatment with CT-P10: Results of a 56-Week Open-Label Study in Patients with Rheumatoid Arthritis.
Trial report in BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 3 registered trials, which are not on this map. Cited by 22 papers, 2 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.
Phase 1, Randomized, Controlled, Multicenter, 2-Arm, Parallel-Group, Double-Blind Study to Demonstrate the Equivalence of CT-P10 to MabThera With Respect to the Pharmacokinetic Profile in Patients With Rheumatoid Arthritis
An Open-Label, Single-Arm, Maintenance Study to Demonstrate Long-Term Efficacy and Safety of CT-P10 in Patients With Rheumatoid Arthritis Who Were Treated With Rituximab (MabThera or CT-P10) in Study CT-P10 1.1
Biosimilars of Rituximab in ANCA-associated Vasculitis Compared to the Originator (BRAVO): a CanVasc Multicentre Study
Who cites it
22 citing papers in PubMed, 2 syntheses or guidelines pooled it.
- The Efficacy, Safety, and Immunogenicity of Switching Between Reference Biopharmaceuticals and Biosimilars: A Systematic Review.Clinical pharmacology and therapeutics · 2020Pooled it
- Biosimilarity and Interchangeability: Principles and Evidence: A Systematic Review.BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy · 2018Pooled it
- Efficacy and safety of switching from rituximab to biosimilar CT-P10 in rheumatoid arthritis: 72-week data from a randomized Phase 3 trial.Rheumatology (Oxford, England) · 2019Trial
- Trial
- Safety and effectiveness of rituximab biosimilar (Rituximab-GP2013) versus originator in rheumatoid arthritis: real-world evidence from a single center.Clinics (Sao Paulo, Brazil) · 2026Article
- Article
- Comparison of treatment retention of originator vs biosimilar products in clinical rheumatology practice in Sweden.Rheumatology (Oxford, England) · 2022Observational
- The safety and clinical effectiveness of rapid infusion with CT-P10 in patients with non-Hodgkin's lymphoma or chronic lymphocytic leukemia: A retrospective non-interventional post-authorization safety study in Europe.Hematological oncology · 2022Article
- A Developer's Perspective on Clinical Evidence and Benefits for Rituximab Biosimilar Uptake, with a Focus on CT-P10.Clinical drug investigation · 2022Review
- Development of anti-rituximab antibodies in rituximab-treated patients: Related parameters & consequences.The Indian journal of medical research · 2022Review
- Adverse events of active and placebo groups in SARS-CoV-2 vaccine randomized trials: A systematic review.The Lancet regional health. Europe · 2022Article
- Switching from Biologic to Biosimilar Products: Insight from an Integrated Health Care System.BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy · 2022Article
- Clinical and Regulatory Concerns of Biosimilars: A Review of Literature.International journal of environmental research and public health · 2020Review
- Immunogenicity of Biosimilars for Rheumatic Diseases, Plaque Psoriasis, and Inflammatory Bowel Disease: A Review from Clinical Trials and Regulatory Documents.BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy · 2020Review
- Comparison of Rituximab Originator With CT-P10 Biosimilar in Patients With Primary Sjögren's Syndrome: A Retrospective Analysis in a Real-Life Setting.Frontiers in medicine · 2020Article
- Management of rheumatoid arthritis: 2019 updated consensus recommendations from the Hong Kong Society of Rheumatology.Clinical rheumatology · 2019Review
- The role of the Nocebo effect in the use of biosimilars in routine rheumatology clinical practice.Mediterranean journal of rheumatology · 2019Review
- Practical Guidance on Biosimilars, With a Focus on Latin America: What Do Rheumatologists Need to Know?Journal of clinical rheumatology : practical reports on rheumatic & musculoskeletal diseases · 2019Review
- Knowledge and use of biosimilars in oncology: a survey by the European Society for Medical Oncology.ESMO open · 2019Article
- Nocebos in rheumatology: emerging concepts and their implications for clinical practice.Nature reviews. Rheumatology · 2018Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
20 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundCT-P10 is a biosimilar candidate of innovator rituximab (RTX) that demonstrated a comparable clinical profile to RTX in a phase I randomized controlled trial (RCT) in rheumatoid arthritis (RA) (ClinicalTrials.gov identifier: NCT01534884).
objectiveThis open-label extension (OLE) study (NCT01873443) compared the efficacy and safety of CT-P10 in patients with RA who received CT-P10 from the outset (i.e., from the start of the RCT and also in the OLE; 'maintenance group') with those who received RTX during the RCT and switched to CT-P10 during the OLE ('switch group').
methodsPatients who completed the RCT were recruited. Based on the Disease Activity Score using 28 joints (DAS28) and predefined safety criteria, patients could receive up to two courses of CT-P10 during the OLE. Efficacy [DAS28 and European League Against Rheumatism (EULAR) response], safety and immunogenicity were assessed.
resultsEighty-seven patients were enrolled; 58 and 29 had previously received CT-P10 or RTX, respectively, in the RCT. Of these, 38 (65.5%) and 20 (69.0%) were treated with CT-P10 in the OLE and therefore comprised the maintenance and switch groups, respectively. The mean change in DAS28-erythrocyte sedimentation rate (ESR) from baseline (week 0 of RCT) at week 24 of the first OLE treatment course in the maintenance and switch groups was -2.7 and -2.4, respectively. The proportion of patients with good/moderate EULAR responses was also comparable between groups. Antidrug antibodies were detected in 13.2 and 15.0% of patients in the maintenance and switch groups, respectively, at week 24 of the first OLE course. CT-P10 treatment was well-tolerated when administered for up to 2 years or after switching from RTX.
conclusionIn this study population, comparable efficacy and safety profiles were observed in patients who switched from RTX to CT-P10 and those maintained on CT-P10 throughout treatment.
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