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
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 AD...
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| Format: | Article |
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BMJ Publishing Group
2021-08-01
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| Series: | RMD Open |
| Online Access: | https://rmdopen.bmj.com/content/7/2/e001578.full |
| _version_ | 1818356645842911232 |
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| author | Rieke Alten Carol Cronenberger Daniel F Alvarez Amy E Bock Ivana Vranic Wuyan Zhang |
| author_facet | Rieke Alten Carol Cronenberger Daniel F Alvarez Amy E Bock Ivana Vranic Wuyan Zhang |
| author_sort | Rieke Alten |
| collection | DOAJ |
| description | 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. |
| first_indexed | 2024-12-13T20:00:31Z |
| format | Article |
| id | doaj.art-7b89df7d1f944a94a3f3b1c2fa434ccb |
| institution | Directory Open Access Journal |
| issn | 2056-5933 |
| language | English |
| last_indexed | 2024-12-13T20:00:31Z |
| publishDate | 2021-08-01 |
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| spelling | doaj.art-7b89df7d1f944a94a3f3b1c2fa434ccb2022-12-21T23:33:11ZengBMJ Publishing GroupRMD Open2056-59332021-08-017210.1136/rmdopen-2021-001578Randomised 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-06410293Rieke Alten0Carol Cronenberger1Daniel F Alvarez2Amy E Bock3Ivana Vranic4Wuyan Zhang56 University Medicine, Schlosspark Klinik, Berlin, Germany 2 Global Product Development, Inflammation and Immunology, Pfizer Inc, Collegeville, Pennsylvania, USA 2 Global Product Development, Inflammation and Immunology, Pfizer Inc, Collegeville, Pennsylvania, USA3 Global Product Development, Clinical Development and Operations, Pfizer Inc, Cambridge, Massachusetts, USA4 Worldwide R&D, Safety Surveillance Risk Management, Pfizer Inc, Tadworth, UK5 Global Product Development, Biometrics and Data Management, Pfizer Inc, Lake Forest, Illinois, USAObjective 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.https://rmdopen.bmj.com/content/7/2/e001578.full |
| spellingShingle | Rieke Alten Carol Cronenberger Daniel F Alvarez Amy E Bock Ivana Vranic Wuyan Zhang 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 RMD Open |
| title | 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 |
| title_full | 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 |
| title_fullStr | 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 |
| title_full_unstemmed | 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 |
| title_short | 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 |
| title_sort | 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 |
| url | https://rmdopen.bmj.com/content/7/2/e001578.full |
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