A non-interventional, post-marketing surveillance study evaluating the safety and effectiveness of biosimilar rituximab (CT-P10) during routine clinical practice in the Republic of Korea

ABSTRACT

Background

CT-P10 was the first licensed rituximab biosimilar. This Korean post-marketing surveillance study evaluated CT-P10 safety and effectiveness in approved indications.

Research design and methods

This prospective, open-label, observational, phase 4 study collected routine clinical practice data across 27 centers in the Republic of Korea. Patients received their first CT-P10 treatment, per prescribing information, for non-Hodgkin’s lymphoma (NHL), chronic lymphocytic leukemia (CLL), rheumatoid arthritis (RA), granulomatosis with polyangiitis (GPA), or microscopic polyangiitis (MPA) during the surveillance period (16 November 2016–15 November 2020). Safety (including adverse events [AEs] and adverse drug reactions [ADRs]) and disease-specific clinical response (by best overall response [NHL/CLL], Disease Activity Score in 28-joints [RA], or Birmingham Vasculitis Activity Score for Wegener’s Granulomatosis [GPA/MPA]) were assessed for ≤1 year (NHL/CLL) or ≤24 weeks (RA/GPA/MPA).

Results

The safety population comprised 677 patients (604 NHL, 16 CLL, 42 RA, 7 GPA, 8 MPA). AEs/ADRs were reported for 68.4%/27.7% (NHL/CLL), 31.0%/14.3% (RA), and 86.7%/13.3% (GPA/MPA) of patients. Serious AEs and unexpected ADRs did not raise new safety signals. Pneumonia was the most frequent serious ADR overall. Positive effectiveness outcomes were observed.

Conclusions

Findings were consistent with the known CT-P10/reference rituximab safety profile, with high effectiveness observed in NHL/CLL and RA.

KEYWORDS:

• Chronic lymphocytic leukemia
• CT-P10
• granulomatosis with polyangiitis
• microscopic polyangiitis
• non-Hodgkin’s lymphoma
• rheumatoid arthritis
• rituximab

Abbreviations

ADR Adverse drug reaction AE Adverse event BOR Best overall response BSA Body surface area CHOP Cyclophosphamide, doxorubicin, vincristine, prednisone CI Confidence interval CLL Chronic lymphocytic leukemia CR Complete response DAS28 Disease Activity Score in 28 joints DLBCL Diffuse large B-cell lymphoma EMA European Medicines Agency EU European Union FDA Food and Drug Administration FL Follicular lymphoma GPA Granulomatosis with polyangiitis IRR Infusion-related reaction MPA Microscopic polyangiitis NHL Non-Hodgkin’s lymphoma PMS Post-marketing surveillance PR Partial response RA Rheumatoid arthritis SD Standard deviation

Acknowledgments

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 Beatrice Tyrrell and Julianna Solomons at Aspire Scientific Limited (Bollington, UK), and funded by Celltrion, Inc. (Incheon, Republic of Korea).

Declaration of interest

DH Yoon has acted as a consultant for Ab Clone, GI Cell, and Pharos iBio; has received research funding from Beigene, Boryung, Celltrion, Janssen, Kirin, Samyang, and Sanofi; and has received honoraria from Amgen, BMS, Boryung, Celltrion, GSK, Janssen, Kirin Pharma, Novartis, Roche, Samyang, and Takeda. SH Kim, KY Ahn, TH Park, H Ju, and S Kwon are employees of and shareholders in Celltrion, Inc. SG Cho has received research funding from Celltrion and is a shareholder in LUCASBIO. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

Reviewer disclosures

Peer reviewers on this manuscript have no relevant financial or other relationships to disclose.

Ethical approval

The authors state that this study adhered to the ethical principles of the Declaration of Helsinki for the conduct of medical research involving human subjects, and that ethical approval was obtained from appropriate local institutional review boards at each of the 27 study sites. All participants provided written informed consent.

Author contributions

JC Jo, Y Jeon, DJ Kim, DH Yang, WS Lee, YS Choi, JH Yi, DH Yoon, JH Kong, JY Choe, and SG Cho contributed to data collection and the interpretation of study data. SH Kim and KY Ahn contributed to the design of the study and the analysis or interpretation of study data. TH Park contributed to the analysis or interpretation of study data. H Ju contributed to data collection and the analysis or interpretation of study data. S Kwon contributed to the analysis or interpretation of study data. All authors reviewed and critically revised the manuscript, approved the final draft, and are accountable for the accuracy and integrity of the research.

Data availability statement

The data that support the findings of this study are available from the corresponding author, SG Cho, upon reasonable request.

Supplementary material

Supplemental data for this article can be accessed online at https://doi.org/10.1080/14712598.2023.2177101

Additional information

Funding

This work was funded by Celltrion, Inc.