Conclusions
In conclusion, this randomized, double-blind, active-controlled, multiple-dose, comparative clinical study showed that there were no clinically meaningful differences between ABP 710 and infliximab RP. In addition, this study demonstrated that the safety and immunogenicity of ABP 710 were similar to those of the RP and that efficacy and safety were not impacted by a single switch from infliximab RP to ABP 710. These results, along with the totality of evidence, which includes demonstration of similarity of ABP 710 with the infliximab RP in analytical assessments and PK and safety evaluation in healthy patients, confirm that ABP 710 is similar to infliximab RP.
Trial registration
ClinicalTrials.gov. Identifier: NCT02937701. Registered August 30, 2016.
Abbreviations
ADA: Antidrug antibody; AE: Adverse event; CI: Confidence interval; CRP: Creactive protein; DAS28: Disease Activity Score 28-joint count; IP: Investigational product; ITT: Intent-to-treat; IV: Intravenous; MTX: Methotrexate; NRI: Nonresponder imputation; PK: Pharmacokinetic; PP: Per protocol; RA: Rheumatoid arthritis; RD: Response difference; RP: Reference product; SAE: Serious adverse event; SD: Standard deviation
Acknowledgements
Medical writing assistance was provided by Sonya G. Lehto, PhD, Amgen, Inc., under the guidance of Monica Ramchandani, PhD, Amgen, Inc.
Availability of data and materials
There is a plan to share data. This may include de-identified individual patient data for variables necessary to address the specific research question in an approved data-sharing request; also related data dictionaries, study protocol, statistical analysis plan, informed consent form, and/or clinical study report. Data sharing requests relating to data in this manuscript will be considered after the publication date and (1) this product and indication (or other new use) have been granted marketing authorization in both the US and Europe or (2) clinical development discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for these data. Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labeling. A committee of internal advisors reviews requests. If not approved, a Data Sharing Independent Review Panel may arbitrate and make the final decision. Requests that pose a potential conflict of interest or an actual or potential competitive risk may be declined at Amgen's sole discretion and without further arbitration. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the following: http://www.amgen.com/datasharing.
Ethics approval and consent to participate
Prior to initiation at each study center, the study protocol was reviewed by an Institutional Review Board (IRB) or Institutional Ethics Committee (IEC). This study was conducted in accordance with International Conference on Harmonisation (ICH) regulations and guidelines regarding Good Clinical Practice (GCP), clinical safety data management, and scientific integrity; with United States (US) Food and Drug Administration (FDA) regulations set forth in 21 Code of Federal Regulations Parts 50, 56, and 312; and with European Union (EU) Community Directives 2001/20, 2001/83, 2003/94, and 2005/28 as enacted into local law. In addition, this study adhered to all local regulatory requirements and requirements for data protection.
All subjects provided written informed consent prior to entering the study and before initiation of any study-related procedure.
Consent for publication
N/A
Arthritis Res Ther. 2020;22(60) © 2020 BioMed Central, Ltd.
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Cite this: Comparative Clinical Efficacy and Safety of the Proposed Biosimilar ABP 710 With Infliximab Reference Product in Patients With Rheumatoid Arthritis - Medscape - Mar 01, 2020.
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