Title
Efficacy and safety of switching from rituximab to biosimilar CT-P10 in rheumatoid arthritis: 72-week data from a randomized Phase 3 trial
Date Issued
01 December 2019
Access level
open access
Resource Type
journal article
Author(s)
Shim S.C.
Božić-Majstorović L.
Berrocal Kasay A.
El-Khouri E.C.
Irazoque-Palazuelos F.
Cons Molina F.F.
Medina-Rodriguez F.G.
Miranda P.
Shesternya P.
Wiland P.
Jeka S.
Garmish O.
Hrycaj P.
Fomina N.
Park W.
Suh C.H.
Lee S.J.
Lee S.Y.
Bae Y.J.
Yoo D.H.
Clínica San Borja
Publisher(s)
Oxford University Press
Abstract
Objective: To evaluate the efficacy and safety of CT-P10, a rituximab biosimilar after a single switch, during a multinational, randomized, double-blind Phase 3 trial involving patients with RA. Methods: Patients received 48 weeks' treatment with CT-P10 or United States- or European Union-sourced reference rituximab (US-RTX and EU-RTX, respectively). Patients entering the extension period (weeks 48-72) remained on CT-P10 (CT-P10/CT-P10; n = 122) or US-RTX (US-RTX/US-RTX; n = 64), or switched to CT-P10 from US-RTX (US-RTX/CT-P10; n = 62) or EU-RTX (EU-RTX/CT-P10; n = 47) for an additional course. Efficacy endpoints included Disease Activity Score using 28 joints (DAS28), American College of Rheumatology (ACR) response rates, and quality of life-related parameters. Pharmacodynamics, immunogenicity and safety were also assessed. Results: At week 72, similar improvements were observed by disease activity parameters including DAS28 and ACR response rate in the four extension period treatment groups. Quality of life improvements at week 72 vs baseline were similarly shown during the extension period in all groups. Newly developed anti-drug antibodies were detected in two patients following study drug infusion in the extension period. Similar pharmacodynamic and safety profiles were observed across groups. Conclusion: Long-term use of CT-P10 up to 72 weeks was effective and well tolerated. Furthermore, switching from reference rituximab to CT-P10 in RA was well tolerated and did not result in any clinically meaningful differences in terms of efficacy, pharmacodynamics, immunogenicity and safety. Trail registration: ClinicalTrials.gov, http://clinicaltrials.gov, NCT02149121.
Start page
2193
End page
2202
Volume
58
Issue
12
Language
English
OCDE Knowledge area
Reumatología
Subjects
Scopus EID
2-s2.0-85070068083
PubMed ID
Source
Rheumatology (United Kingdom)
ISSN of the container
14620324
Sponsor(s)
We thank all patients and investigators involved in the study. Medical writing support (including development of a draft outline and subsequent drafts in consultation with the authors, assembling tables and figures, collating author comments, copyediting, fact checking and referencing) was provided by Duncan Campbell, PhD, CMPP at Aspire Scientific Limited (Bollington, UK), and funded by CELLTRION Inc. (Incheon, Republic of Korea). Most data are shown in the manuscript and supplementary files. Deidentified participant data from the study is freely available to the public through ClinicalTrials.gov (identifier: NCT02149121) and the EU Clinical Trials Register (EudraCT number: 2013-004555-21). Other additional documents related to the study (for example, protocol, statistical analysis plan, informed consent form) will not be available.
Funding: This work was supported by CELLTRION, Inc. (Incheon, Republic of Korea). The study sponsor was involved in the following: study design; the collection, analysis and interpretation of data; writing of the report; and the decision to submit the paper for publication.
Sources of information:
Directorio de Producción Científica
Scopus