ACR Meeting Abstracts

ACR Meeting Abstracts

Abstract Number: 1635

Efficacy and Safety of CT-P10, Rituximab Biosimilar Candidate, and Innovator Rituximab in Patients with Rheumatoid Arthritis: Results from Phase 3 Randomized Controlled Trial over 24 Weeks

Dae-Hyun Yoo1, Ljubinka Bozic Majstorovic2, Alfredo Berrocal Kasay3, Elias Chalouhi El-Khouri4, Fedra Irazoque-Palazuelos5, Francisco Cons Molina6, Pedro Miranda7, Pavel Shesternya8, Francisco G. Medina-Rodriguez9, Piotr Wiland10, Slawomir Jeka11, Olena Garmish12, Pawel Hrycaj13, Dmytro Rekalov14, Natalia Fomina15, Devy Zisman16, Yong-Beom Park17, Young Mo Kang18, Chang-Hee Suh19, Seung Cheol Shim20, Sang Joon Lee21, Sung Young Lee22 and Won Park23, 1Department of Rheumatology, Hanyang University Hospital for Rheumatic Diseases, Seoul, South Korea, 2Clinical Centre Banja Luka, Bonja Luka, Bosnia and Herzegovina, 3ABK Reuma SRL – Medicentro Biociencias, Lima, Peru, 4Clinica Internacional, Lima, Peru, 5Centro de Invstigacion y Tratamiento Reumatologico S.C, Mexico City, Mexico, 6Centro de Investigacion en Artritis y Osteoporosis, Mexicali, Mexico, 7Centro De Estudios Reumatológicos, Santiago, Chile, 8State Budgetary Educational Institution of High Professional Education "Krasnoyarsk state medical university n.a. professor V.F.Voino-Yasenetsky" Ministry of Health of Russian Federation, Krasnoyarsk, Russian Federation, 9Biologics Especializados SA, Mexico City, Mexico, 10Uniwersytecki Szpital Kliniczny im. Jana Mikulicza- Radeckigo, Wroclaw, Poland, 11Department of Rheumatology and Connective Tissue Diseases, 2nd University Hospital, CM UMK, Bydgoszcz, Poland, 12Institute of Cardiology named by M.D. Strazhesko NAMS of Ukraine, Kyiv, Ukraine, 13Rheumatology and Clinical Immunology, Poznañ University of Medical Sciences, Poznan, Poland, 14Department of Internal Diseases, Zaporizhzhia Regional Hospital, Zaporozhe, Ukraine, 15Kemerovo Regional Clinical Hospital, Kemerovo, Russian Federation, 16The Lady Davis, Haifa, Israel, 17Dept of Internal Medicine, Severance Hospital, Seoul, Korea, The Republic of, 18Division of Rheumatology, Department of Internal Medicine, Kyungpook National University School of Medicine, Daegu, Korea, Republic of, 19Department of Rheumatology, Ajou University School of Medicine, Suwon, Korea, The Republic of, 20Department of Internal Medicine, Chungnam National University Hospital, Daejeon, South Korea, 21CELLTRION, Inc., Incheon, South Korea, 22Clinical Planning Department, CELLTRION, Inc., Incheon, South Korea, 23Division of Rheumatology, Department of Internal Medicine, Inha University Hospital, Incheon, South Korea

Meeting: 2016 ACR/ARHP Annual Meeting

Date of first publication: September 28, 2016

Keywords: , , ,

Session Information

Date: Monday, November 14, 2016

Title: Rheumatoid Arthritis – Small Molecules, Biologics and Gene Therapy - Poster II

Session Type: ACR Poster Session B

Session Time: 9:00AM-11:00AM

Efficacy and Safety of CT-P10, Rituximab Biosimilar Candidate, and Innovator Rituximab in Patients with Rheumatoid Arthritis: Result from Phase 3 Randomized Controlled Trial over 24 Weeks

Background/Purpose: Pharmacokinetic (PK) equivalence was demonstrated, and similar safety profiles of CT-P10 to EU-sourced innovator rituximab (EU-RTX) were shown in the phase 1 studies up to 2 years in RA patients including switching to CT-P10 from EU-RTX.1,2 The purpose of this study was to demonstrate efficacy equivalence and compare safety profiles of CT-P10 to reference products (combined EU and US–sourced RTX) in RA patients up to 24 weeks.

Methods: In this randomized, controlled phase 3 study, RA patients were randomized to receive CT-P10 or reference products (NCT02149121). The primary efficacy endpoint, change of DAS28–CRP from baseline to week 24, was evaluated and analyzed by using an analysis of covariance (ANCOVA). Therapeutic equivalence is to be concluded if the 95% confidence interval (CI) for the treatment difference in the change of DAS28-CRP from baseline to Week 24 is entirely within the pre-specified equivalence margin of +/-0.60. Additional efficacy, pharmacodynamics (PD) and safety were also evaluated.

Results: A total of 372 RA patients (161 patients and 211 patients in CT-P10 and reference products groups, respectively) were enrolled. Overall efficacy, PD and safety profiles were similar between CT-P10 and reference products groups. The adjusted mean change of DAS28-CRP/ESR from baseline to week 24 was similar between the groups. The 95% CI for the estimate of treatment difference in DAS28-CRP/ESR was entirely within the equivalence margin which indicated therapeutic equivalence between the treatment groups (Table 1). Additional efficacy including ACR and EULAR responses was also shown to be comparable between 2 groups (Table 2). Rapid and complete depletion of B-cell counts were observed immediately after the first infusion, and B-cell kinetics over 24 weeks were similar between the groups. Adverse events (AEs) related to study drug were reported with a similar proportion in each treatment group; 49 (30.4%) and 59 (28.0%) patients in CT-P10 and reference products groups, respectively. Infection related to study drug was reported in 13 (8.1%) and 22 (10.4%) patients in CT-P10 and reference products groups, respectively. No malignancy, progressive multifocal leukoencephalopathy, and serious infusion-related reaction were reported.

Conclusion: CT-P10 showed highly similar efficacy, PD and safety profiles to reference products up to 24 weeks. Reference

1.        Yoo DH, et al. Arthritis Rheum 2013;65(Suppl 10): S736

2.        Yoo DH, et al. Arthritis Rheum 2015;67(Suppl 10): 2449-2452

Disclosure: D. H. Yoo, CELLTRION, Inc., 5; L. Bozic Majstorovic, CELLTRION, Inc., 2; A. Berrocal Kasay, CELLTRION, Inc., 2; E. Chalouhi El-Khouri, CELLTRION, Inc., 2; F. Irazoque-Palazuelos, CELLTRION, Inc., 2; F. Cons Molina, CELLTRION, Inc., 2; P. Miranda, CELLTRION, Inc., 2; P. Shesternya, CELLTRION, Inc., 2; F. G. Medina-Rodriguez, CELLTRION, Inc., 2; P. Wiland, CELLTRION, Inc., 2; S. Jeka, CELLTRION, Inc., 2; O. Garmish, CELLTRION, Inc., 2; P. Hrycaj, CELLTRION, Inc., 2; D. Rekalov, CELLTRION, Inc., 2; N. Fomina, CELLTRION, Inc., 2; D. Zisman, CELLTRION, Inc., 2; Y. B. Park, CELLTRION, Inc., 2; Y. M. Kang, CELLTRION, Inc., 2; C. H. Suh, CELLTRION, Inc., 5; S. C. Shim, CELLTRION, Inc., 5; S. J. Lee, CELLTRION, Inc., 3; S. Y. Lee, CELLTRION, Inc., 3; W. Park, CELLTRION, Inc., 5.

To cite this abstract in AMA style:

Yoo DH, Bozic Majstorovic L, Berrocal Kasay A, Chalouhi El-Khouri E, Irazoque-Palazuelos F, Cons Molina F, Miranda P, Shesternya P, Medina-Rodriguez FG, Wiland P, Jeka S, Garmish O, Hrycaj P, Rekalov D, Fomina N, Zisman D, Park YB, Kang YM, Suh CH, Shim SC, Lee SJ, Lee SY, Park W. Efficacy and Safety of CT-P10, Rituximab Biosimilar Candidate, and Innovator Rituximab in Patients with Rheumatoid Arthritis: Results from Phase 3 Randomized Controlled Trial over 24 Weeks [abstract]. Arthritis Rheumatol. 2016; 68 (suppl 10). https://acrabstracts.org/abstract/efficacy-and-safety-of-ct-p10-rituximab-biosimilar-candidate-and-innovator-rituximab-in-patients-with-rheumatoid-arthritis-results-from-phase-3-randomized-controlled-trial-over-24-weeks/. Accessed .

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