1. Efficacy and Safety of Switching from Innovator Rituximab to Biosimilar CT-P10 Compared with Continued Treatment with CT-P10: Results of a 56-Week Open-Label Study in Patients with Rheumatoid Arthritis
- Author
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Eun Young Lee, Piotr Wiland, Volodymyr Kovalenko, Sung Hwan Kim, Sebastião Cezar Radominski, Leysan Myasoutova, Jung Yoon Choe, Chang Hee Suh, Mie Jin Lim, Seung Cheol Shim, Sławomir Jeka, Sung Young Lee, Dae Hyun Yoo, Won Park, Francisco G. Medina-Rodriguez, Paweł Hrycaj, Marina Stanislav, Pavel Shesternya, Francisco Fidencio Cons Molina, and Sang Joon Lee
- Subjects
0301 basic medicine ,Adult ,Male ,medicine.medical_specialty ,Arthritis ,law.invention ,Arthritis, Rheumatoid ,03 medical and health sciences ,Antibodies, Monoclonal, Murine-Derived ,0302 clinical medicine ,Pharmacotherapy ,Randomized controlled trial ,law ,Internal medicine ,medicine ,Humans ,Pharmacology (medical) ,Original Research Article ,skin and connective tissue diseases ,Biosimilar Pharmaceuticals ,030203 arthritis & rheumatology ,Pharmacology ,business.industry ,General Medicine ,Middle Aged ,medicine.disease ,Clinical trial ,030104 developmental biology ,Treatment Outcome ,Rheumatoid arthritis ,Antirheumatic Agents ,Physical therapy ,Population study ,Rituximab ,Female ,sense organs ,business ,Rheumatism ,Biotechnology ,medicine.drug - Abstract
Background CT-P10 is a biosimilar candidate of innovator rituximab (RTX) that demonstrated a comparable clinical profile to RTX in a phase I randomized controlled trial (RCT) in rheumatoid arthritis (RA) (ClinicalTrials.gov identifier: NCT01534884). Objective This open-label extension (OLE) study (NCT01873443) compared the efficacy and safety of CT-P10 in patients with RA who received CT-P10 from the outset (i.e., from the start of the RCT and also in the OLE; ‘maintenance group’) with those who received RTX during the RCT and switched to CT-P10 during the OLE (‘switch group’). Methods Patients who completed the RCT were recruited. Based on the Disease Activity Score using 28 joints (DAS28) and predefined safety criteria, patients could receive up to two courses of CT-P10 during the OLE. Efficacy [DAS28 and European League Against Rheumatism (EULAR) response], safety and immunogenicity were assessed. Results Eighty-seven patients were enrolled; 58 and 29 had previously received CT-P10 or RTX, respectively, in the RCT. Of these, 38 (65.5%) and 20 (69.0%) were treated with CT-P10 in the OLE and therefore comprised the maintenance and switch groups, respectively. The mean change in DAS28-erythrocyte sedimentation rate (ESR) from baseline (week 0 of RCT) at week 24 of the first OLE treatment course in the maintenance and switch groups was −2.7 and −2.4, respectively. The proportion of patients with good/moderate EULAR responses was also comparable between groups. Antidrug antibodies were detected in 13.2 and 15.0% of patients in the maintenance and switch groups, respectively, at week 24 of the first OLE course. CT-P10 treatment was well-tolerated when administered for up to 2 years or after switching from RTX. Conclusion In this study population, comparable efficacy and safety profiles were observed in patients who switched from RTX to CT-P10 and those maintained on CT-P10 throughout treatment. Electronic supplementary material The online version of this article (doi:10.1007/s40259-017-0233-6) contains supplementary material, which is available to authorized users.
- Published
- 2017