Randomised study of PF-06410293, an adalimumab (ADL) biosimilar, compared with reference ADL for the treatment of active rheumatoid arthritis: results from weeks 26-52, including a treatment switch from reference ADL to PF-06410293.
| Autor: | Fleischmann RM; Metroplex Clinical Research Center, University of Texas Southwestern Medical Center at Dallas, Dallas, Texas, USA rfleischmann@arthdocs.com., Alvarez DF; Global Product Development, Inflammation and Immunology, Pfizer Inc, Collegeville, Pennsylvania, USA., Bock AE; Global Product Development, Clinical Development and Operations, Pfizer Inc, Cambridge, Massachusetts, USA., Cronenberger C; Global Product Development, Inflammation and Immunology, Pfizer Inc, Collegeville, Pennsylvania, USA., Vranic I; Worldwide R&D, Safety Surveillance Risk Management, Pfizer Inc, Tadworth, UK., Zhang W; Global Product Development, Biometrics and Data Management, Pfizer Inc, Lake Forest, Illinois, USA., Alten R; University Medicine, Schlosspark Klinik, Berlin, Germany. |
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| Jazyk: | angličtina |
| Zdroj: | RMD open [RMD Open] 2021 Apr; Vol. 7 (2). |
| DOI: | 10.1136/rmdopen-2021-001578 |
| Abstrakt: | Objective: To investigate the efficacy, safety, immunogenicity and pharmacokinetics of biosimilar adalimumab (ADL) PF-06410293 (ADL-PF; adalimumab-afzb) versus EU-sourced reference ADL (ADL-EU) in patients with active rheumatoid arthritis (RA) on longer-term treatment and after being switched from ADL-EU to ADL-PF. Methods: In this multinational, double-blind study, patients with active RA were initially randomised to ADL-PF or ADL-EU for 26 weeks (treatment period (TP) 1). At the start of TP2 (weeks 26-52), patients in the ADL-EU arm were blindly re-randomised 1:1 to remain on ADL-EU (ADL-EU/ADL-EU; n=135) or switched to ADL-PF (ADL-EU/ADL-PF; n=134); patients receiving ADL-PF continued blinded treatment (ADL-PF/ADL-PF; n=283). Results: The American College of Rheumatology 20% improvement (ACR20) response rates were comparable between treatment groups at all visits during TP2. At week 52, ACR20 response rates were 82.7% (ADL-PF/ADL-PF), 79.3% (ADL-EU/ADL-EU) and 84.3% (ADL-EU/ADL-PF). Other measures of deep response (ACR50/70, ACR/EULAR-defined remission, EULAR good response, and Disease Activity Score in 28 Joints Based on High-Sensitivity C-Reactive Protein <2.6) and Health Assessment Questionnaire-Disability Index were maintained over TP2 and comparable between groups. Treatment-emergent adverse events were reported in 43.5% (ADL-PF/ADL-PF), 44.4% (ADL-EU/ADL-EU) and 38.3% (ADL-EU/ADL-PF) of patients; there were no clinically meaningful differences in the safety profiles between groups. The percentage of patients who were antidrug antibody positive was comparable overall among ADL-PF/ADL-PF (47.3%), ADL-EU/ADL-EU (54.1%) and ADL-EU/ADL-PF (45.9%). Conclusions: The similar efficacy, safety, immunogenicity and pharmacokinetics of ADL-PF and ADL-EU, maintained up to week 52, were unaffected by blinded treatment switch from ADL-EU to ADL-PF at week 26. Trial Registration Number: ClinicalTrials.gov identifier: NCT02480153; EudraCT number: 2014-000352-29. Competing Interests: Competing interests: DFA, AEB and IV are full-time employees of, and declare shareholdings, stock holdings and/or stock options from, Pfizer. CC was a full-time employee of Pfizer at the time of data generation and manuscript development and declares shareholdings, stock holdings and/or stock options from Pfizer. WZ is a full-time employee of Pfizer and declares shareholdings, stock holdings and/or stock options from Abbott, AbbVie and Pfizer. RMF has received research grants/support and consulting fees from Pfizer. RA has received research grants/support and consulting fees from AbbVie, Bristol-Myers Squibb, Gilead, Lilly, Novartis, Pfizer and UCB. (© Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.) |
| Databáze: | MEDLINE |
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