Trial reportBioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy2019
Long-Term Efficacy and Safety of Biosimilar CT-P10 Versus Innovator Rituximab in Rheumatoid Arthritis: 48-Week Results from a Randomized Phase III Trial.
Trial report in BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02149121 (A Randomized, Controlled, Double-Blind, Parallel-Group, Phase 3 Study to Compare the Pharmacokinetics, Efficacy and Safety Between CT-P10, Rituxan and MabThera in Patients With Rheumatoid Arthritis), which is not on this map. Cited by 13 papers.
What it found
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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, Controlled, Double-Blind, Parallel-Group, Phase 3 Study to Compare the Pharmacokinetics, Efficacy and Safety Between CT-P10, Rituxan and MabThera in Patients With Rheumatoid Arthritis
Who cites it
13 citing papers in PubMed, 27 citations in OpenAlex.
- 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
- 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
- Real-world experience of rituximab biosimilar GP2013 in rheumatoid arthritis patients naïve to or switched from reference rituximab.Rheumatology international · 2023Observational
- Interchangeability and adverse events in originator-rituximab and its biosimilar (CT-P10) among rheumatic patients: a real-life experience.Internal and emergency medicine · 2023Article
- Article
- Osteoporosis in patients with rheumatoid arthritis is associated with serum immune regulatory cellular factors.Clinical rheumatology · 2022Article
- 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
- An Introduction to Biosimilars for the Treatment of Retinal Diseases: A Narrative Review.Ophthalmology and therapy · 2022Review
- Regulatory Evaluation of Biosimilars: Refinement of Principles Based on the Scientific Evidence and Clinical Experience.BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy · 2022Review
- A Developer's Perspective on Clinical Evidence and Benefits for Rituximab Biosimilar Uptake, with a Focus on CT-P10.Clinical drug investigation · 2022Review
- Impact of immunogenicity on clinical efficacy and toxicity profile of biologic agents used for treatment of inflammatory arthritis in children compared to adults.Therapeutic advances in musculoskeletal disease · 2021Review
- 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
- A comprehensive review of rituximab therapy in rheumatoid arthritis patients.Clinical rheumatology · 2019Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
26 authors at 19 institutions in 9 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectiveThe aim of this study was to investigate long-term clinical outcomes of extended treatment with CT-P10, a rituximab biosimilar, compared with rituximab reference products sourced from the USA and the EU (US-RTX and EU-RTX) in rheumatoid arthritis (RA) for up to 48 weeks.
methodsIn this multinational, randomized, double-blind trial, adults with active RA received up to two courses of CT-P10, US-RTX, or EU-RTX alongside methotrexate. Efficacy endpoints included Disease Activity Score 28-joint count (DAS28) and American College of Rheumatology (ACR) response rates. Pharmacokinetics, pharmacodynamics, immunogenicity, and safety were also assessed.
resultsOf 372 patients randomized to the study drug, 330 (88.7%) completed the second treatment course. Mean change from baseline to week 48 in DAS28-C-reactive protein was comparable in the CT-P10 and combined rituximab (US-RTX and EU-RTX) groups (- 2.7 and - 2.6, respectively). ACR20, ACR50, and ACR70 response rates at week 48 indicated no differences between groups (80.6%, 55.4%, and 31.7% vs. 79.8%, 53.9%, and 33.7% in the CT-P10 and combined rituximab groups, respectively). Similar improvements in the Health Assessment Questionnaire Disability Index and all medical outcomes in the Short Form 36-Item Health Survey, including physical and mental health, were seen in all groups. At week 48, antidrug antibodies were detected in 4.9%, 9.4%, and 8.6% of patients in the CT-P10, US-RTX, and EU-RTX groups, respectively. CT-P10 and rituximab displayed similar pharmacokinetic, pharmacodynamic, and safety profiles.
conclusionCT-P10 was similar to EU-RTX and US-RTX in terms of efficacy, pharmacokinetics, pharmacodynamics, immunogenicity, and safety up to week 48. CLINICALTRIALS. GOV IDENTIFIER: NCT02149121.
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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.