Efficacy and safety of biosimilar CT-P17 versus reference adalimumab in subjects with rheumatoid arthritis: 24-week results from a randomized study
| Autor: | Katarzyna Bartnicka-Maslowska, Jae Kyoung Yoo, Piotr Wiland, Magdalena Krajewska-Włodarczyk, Jakub Trefler, Yun Ju Bae, Jonathan Kay, Agnieszka Zielińska, Go Eun Yang, Janusz Jaworski, Sławomir Jeka, Daniel E. Furst, Rafał Wojciechowski, Sang Joon Lee, Anna Dudek, Marek Krogulec, Edward C. Keystone, Piotr Adrian Klimiuk |
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| Rok vydání: | 2021 |
| Předmět: |
musculoskeletal diseases
medicine.medical_specialty lcsh:Diseases of the musculoskeletal system Population Biologics law.invention Arthritis Rheumatoid Double-Blind Method Randomized controlled trial Pharmacokinetics law Internal medicine Clinical endpoint Adalimumab medicine Humans Rheumatoid arthritis skin and connective tissue diseases education Biosimilar Pharmaceuticals Biosimilars education.field_of_study business.industry medicine.disease Tumor necrosis factor inhibitors Immunogenicity Comparative effectiveness Confidence interval Rheumatology Treatment Outcome Antirheumatic Agents Monoclonal antibodies Safety lcsh:RC925-935 Tomography X-Ray Computed business Research Article medicine.drug |
| Zdroj: | Arthritis Research & Therapy, Vol 23, Iss 1, Pp 1-12 (2021) Arthritis Research & Therapy |
| ISSN: | 1478-6362 0378-9292 |
| DOI: | 10.1186/s13075-020-02394-7 |
| Popis: | Background To demonstrate equivalent efficacy of the proposed high-concentration (100 mg/ml), citrate-free adalimumab biosimilar CT-P17 to European Union-approved adalimumab (EU-adalimumab) in subjects with active rheumatoid arthritis (RA). Methods This randomized, double-blind phase III study (ClinicalTrials.gov, NCT03789292) randomized (1:1) subjects with active RA at 52 centers to receive CT-P17 or EU-adalimumab 40 mg subcutaneously every 2 weeks until week 52. Results to week 24 are reported here. The primary endpoint was 20% improvement by American College of Rheumatology criteria (ACR20) response rate at week 24. Equivalence was concluded if the corresponding confidence intervals (CIs) for the estimate of treatment difference were within predefined equivalence margins: − 15 to 15% (95% CI; European Medicines Agency assumption); − 12 to 15% (90% CI; Food and Drug Administration assumption). Additional efficacy, pharmacokinetic, usability, safety, and immunogenicity endpoints were evaluated. Results 648 subjects were randomized (324 CT-P17; 324 EU-adalimumab). The ACR20 response rate at week 24 was 82.7% (n = 268/324) in both groups (intention-to-treat population). The 95% CI (− 5.94 to 5.94) and 90% CI (− 4.98 to 4.98) were within predefined equivalence margins for both assumptions and equivalent efficacy was concluded. Additional endpoints and overall safety were comparable between groups. Mean trough serum concentrations of CT-P17 were slightly higher than those of EU-adalimumab. Immunogenicity was slightly lower numerically for the CT-P17 group than for the EU-adalimumab group. Conclusions CT-P17 and EU-adalimumab have equivalent efficacy and comparable safety and immunogenicity in subjects with active RA. Overall safety of CT-P17 is consistent with the known safety profile of reference adalimumab. Trial registration ClinicalTrials.gov, NCT03789292. Registered 28 December 2018—retrospectively registered. |
| Databáze: | OpenAIRE |
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