Efficacy and safety of switching from reference adalimumab to CT-P17 (100 mg/ml): 52-week randomized, double-blind study in rheumatoid arthritis
| Autor: | Sung Hyun Kim, Go Eun Yang, Marek Krogulec, Janusz Jaworski, Sang Joon Lee, Jonathan Kay, Anna Dudek, Edward C. Keystone, Yun Ju Bae, Jae Kyoung Yoo, Piotr Adrian Klimiuk, Piotr Wiland, Rafał Wojciechowski, Daniel E. Furst, Sławomir Jeka, Magdalena Krajewska-Włodarczyk, Jakub Trefler, Agnieszka Zielińska, Katarzyna Bartnicka-Maslowska |
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| Rok vydání: | 2021 |
| Předmět: |
0301 basic medicine
2019-20 coronavirus outbreak medicine.medical_specialty Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) Arthritis Rheumatoid 03 medical and health sciences 0302 clinical medicine Rheumatology Pharmacokinetics Double-Blind Method Internal medicine Adalimumab medicine Humans Pharmacology (medical) Biosimilar Pharmaceuticals 030203 arthritis & rheumatology business.industry medicine.disease Treatment period 030104 developmental biology Treatment Outcome Rheumatoid arthritis Antirheumatic Agents Joint damage business Tomography X-Ray Computed medicine.drug |
| Zdroj: | Rheumatology (Oxford, England). 61(4) |
| ISSN: | 1462-0332 0378-9292 |
| Popis: | Objective To compare the safety and efficacy of switching from reference adalimumab to adalimumab biosimilar CT-P17 with continuing reference adalimumab/CT-P17 in active RA. Methods This double-blind, phase III study randomized (1:1) subjects with active RA to receive 40 mg (100 mg/ml) CT-P17 or European Union-sourced reference adalimumab subcutaneously every 2 weeks (Q2W) until week (W) 24 [treatment period (TP) 1]. Thereafter, subjects receiving reference adalimumab were randomized (1:1) to continue reference adalimumab or switch to CT-P17 from W26 (both Q2W until W48; TP2). Subjects receiving CT-P17 in TP1 continued CT-P17. W0–W24 results were previously reported; we present W26–W52 findings. End points were efficacy (including joint damage progression), pharmacokinetics, safety and immunogenicity. Results Of 607 subjects who initiated TP2 treatment, 303 continued CT-P17, 153 continued reference adalimumab and 151 switched to CT-P17. Efficacy improvements up to W24 were maintained during TP2; efficacy was comparable among groups. At W52, 20% improvement in ACR response rates were 80.5% (continued CT-P17), 77.8% (continued reference adalimumab) and 82.2% (switched to CT-P17). Joint damage progression was minimal. Mean trough serum adalimumab concentrations were similar among groups. CT-P17 and reference adalimumab safety profiles were numerically similar and switching did not affect immunogenicity. At W52, 28.4% (continued CT-P17), 27.0% (continued reference adalimumab) and 28.3% (switched to CT-P17) of subjects were anti-drug antibody-positive. Conclusion Efficacy, pharmacokinetics, safety and immunogenicity of CT-P17 and reference adalimumab were comparable after 1 year of treatment, including after switching from reference adalimumab to CT-P17. Trial registration ClinicalTrials.gov, http://clinicaltrials.gov, NCT03789292. |
| Databáze: | OpenAIRE |
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