Efficacy and Safety of Rituximab Biosimilar, CT-P10, after a Single Switch from Innovator Rituximabs in Patients with Rheumatoid Arthritis: Results from Phase 3 Randomized Controlled Trial over 72 Weeks

Seung-Cheol Shim¹, Ljubinka Bozic Majstorovic², Alfredo Berrocal Kasay³, Elias Chalouhi El-Khouri⁴, Fedra Irazoque-Palazuelos⁵, Francisco Cons Molina⁶, Francisco G. Medina-Rodriguez⁷, Pedro Miranda⁸, Pavel Shesternya⁹, Jose Chavez Corrales¹⁰, Piotr Wiland¹¹, Slawomir Jeka¹², Olena Garmish¹³, Pawel Hrycaj¹⁴, Natalia Fomina¹⁵, Won Park¹⁶, Chang-Hee Suh¹⁷, Sang-Joon Lee¹⁸, Sung Young Lee¹⁹ and Dae-Hyun Yoo²⁰, ¹Department of Internal Medicine, Chungnam National University Hospital, Daejeon, Korea, Republic of (South), 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, ⁷Rheumatology, LaSalle University, Mexico City, Mexico, ⁸Centro De Estudios Reumatológicos, Santiago, Chile, ⁹Rheumatology Department, Krasnoyarsk State Medical University, Krasnoyarsk, Russia, ¹⁰Clinica San Borja, Lima, Peru, ¹¹Department and Clinic of Rheumatology and Internal Medicine, Medical University, Wroclaw, Poland, ¹²2nd University Hospital, CM UMK, Department of Rheumatology and Connective Tissue Diseases,, Bydgoszcz, Poland, ¹³Institute of Cardiology named by M.D. Strazhesko NAMS of Ukraine, Kyiv, Ukraine, ¹⁴Department of Rheumatology and Clinical Immunology, Poznan University of Medical Sciences, Poznan, Poland, ¹⁵Kemerovo Regional Clinical Hospital, Kemerovo, Russian Federation, ¹⁶Medicine/Rheumatology, Inha University Hospital, Incheon, Korea, Republic of (South), ¹⁷Ajou University School of Medicine, Suwon, Korea, Republic of (South), ¹⁸CELLTRION, Inc., Incheon, Korea, Republic of (South), ¹⁹Clinical Planning Department, CELLTRION, Inc., Incheon, Korea, Republic of (South), ²⁰Department of Rheumatology, Hanyang University Hospital for Rheumatic Diseases, Seoul, Korea, Republic of (South)

Meeting: ACR/ARHP Annual Meeting 2017

Date of first publication: September 18, 2017

Keywords: Biologics, biosimilars, monoclonal antibodies, rheumatoid arthritis (RA) and rituximab

Session Information

Date: Tuesday, November 7, 2017

Title: Rheumatoid Arthritis – Small Molecules, Biologics and Gene Therapy Poster III: Efficacy and Safety of Originator Biologics and Biosimilars

Session Type: ACR Poster Session C

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

Background/Purpose: Similarity of pharmacokinetic, efficacy and safety between CT-P10 and reference rituximab (RTX) were shown in the phase 3 randomized controlled trial (NCT02149121) up to 48 weeks in RA patients^1,2,3. This is to investigate efficacy and safety of CT-P10 when used for long term and after switching from RTX in the extension phase of above study.

Methods: Patients who completed up to 48 weeks (Main Period), entered into the Extension Period. Patients who had received CT-P10 or EU-RTX in the Main Period received CT-P10 and patients who had received US-RTX randomly assigned in a 1:1 ratio to receive CT-P10 or US-RTX at Extension Weeks 0 and 2. Efficacy, pharmacodynamics (PD), safety and immunogenicity were evaluated for 24 weeks.

Results: A total of 295 patients (122 CT-P10 Maintenance, 64 US-RTX Maintenance, 62 CT-P10 Switched from US-RTX and 47 CT-P10 Switched from EU-RTX groups) were treated in the Extension Period.

The mean changes of DAS28 from baseline of Main Period and ACR response rate were comparable among the groups (Figures 1 and 2).

B-cell depletion after the 1^st infusion was comparable and maintained until Extension Week 24 in all groups.

No remarkable changes in immunogenicity profile were observed following the drug switch. Two patients (1 patient each in the US-RTX Maintenance and CT-P10 Switched from US-RTX groups) had anti-drug antibody newly developed after Extension Week 0 infusion.

The safety profiles were also comparable among the groups (Table 1). All infusion related reactions were grade 1 or 2 intensity. Most frequent infections were upper respiratory and urinary tract infections. No malignancy, progressive multifocal leukoencephalopathy or death were reported.

Conclusion: Long term effectiveness and tolerability were achieved over 72-week treatment of CT-P10. The switched groups from RTX to CT-P10 were comparable to CT-P10 or US-RTX Maintenance groups in the efficacy, PD and safety profiles including immunogenicity.

Reference

1. Suh CH, et al. Arthritis Rheum 2016;68(Suppl 10): 2037-9

2. Yoo DH, et al. Arthritis Rheum 2016;68(Suppl 10): 2039-41

3. Suh CH, et al. Ann Rheum Dis 2017; 76(Suppl 2): 824-5

Disclosure: S. C. Shim, 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; F. G. Medina-Rodriguez, Celltrion Inc., 2; P. Miranda, Celltrion Inc., 2; P. Shesternya, Celltrion Inc., 2; J. Chavez Corrales, Celltrion Inc., 2; P. Wiland, Celltrion Inc., 2; S. Jeka, Celltrion Inc, 2; O. Garmish, Celltrion Inc., 2; P. Hrycaj, Celltrion Inc., 2; N. Fomina, Celltrion Inc., 2; W. Park, Celltrion Inc., 5; C. H. Suh, Celltrion Inc., 5; S. J. Lee, Celltrion Inc., 3; S. Y. Lee, Celltrion Inc., 3; D. H. Yoo, Celltrion Inc., 5.

To cite this abstract in AMA style:

Shim SC, Bozic Majstorovic L, Berrocal Kasay A, Chalouhi El-Khouri E, Irazoque-Palazuelos F, Cons Molina F, Medina-Rodriguez FG, Miranda P, Shesternya P, Chavez Corrales J, Wiland P, Jeka S, Garmish O, Hrycaj P, Fomina N, Park W, Suh CH, Lee SJ, Lee SY, Yoo DH. Efficacy and Safety of Rituximab Biosimilar, CT-P10, after a Single Switch from Innovator Rituximabs in Patients with Rheumatoid Arthritis: Results from Phase 3 Randomized Controlled Trial over 72 Weeks [abstract]. Arthritis Rheumatol. 2017; 69 (suppl 10). https://acrabstracts.org/abstract/efficacy-and-safety-of-rituximab-biosimilar-ct-p10-after-a-single-switch-from-innovator-rituximabs-in-patients-with-rheumatoid-arthritis-results-from-phase-3-randomized-controlled-trial-over-72-wee/. Accessed .

ACR Meeting Abstracts - https://acrabstracts.org/abstract/efficacy-and-safety-of-rituximab-biosimilar-ct-p10-after-a-single-switch-from-innovator-rituximabs-in-patients-with-rheumatoid-arthritis-results-from-phase-3-randomized-controlled-trial-over-72-wee/