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.

Autor: Park W; School of Medicine, IN-HA University, Incheon, Republic of Korea., Suh CH; Ajou University School of Medicine, Suwon, Republic of Korea., Shim SC; Chungnam National University Hospital, Daejeon, Republic of Korea., Molina FFC; Centro de Investigación en Artritis y Osteoporosis, Mexicali, Mexico., Jeka S; University Hospital No. 2, Collegium Medicum UMK, Bydgoszcz, Poland., Medina-Rodriguez FG; La Salle University, Mexico City, Mexico., Hrycaj P; Poznań University of Medical Sciences, Poznań, Poland., Wiland P; Medical University of Wrocław, Wrocław, Poland., Lee EY; Seoul National University College of Medicine, Seoul, Republic of Korea., Shesternya P; Krasnoyarsk State Medical University, Krasnoyarsk, Russia., Kovalenko V; National Scientific Center, Kiev, Ukraine., Myasoutova L; Research Medical Complex Vashe Zdorovie, Kazan, Russia., Stanislav M; Research Rheumatology Institute n. a. V.A. Nassonova, Moscow, Russia., Radominski S; Universidade Federal do Paraná, Curitiba, Brazil., Lim MJ; School of Medicine, IN-HA University, Incheon, Republic of Korea., Choe JY; School of Medicine, Catholic University of Daegu, Daegu, Republic of Korea., Lee SJ; CELLTRION, Inc., Incheon, Republic of Korea., Lee SY; CELLTRION, Inc., Incheon, Republic of Korea., Kim SH; CELLTRION, Inc., Incheon, Republic of Korea., Yoo DH; Division of Rheumatology, Hanyang University Hospital for Rheumatic Diseases, 222-1 Wangsimni-Ro, Seongdong-Gu, Seoul, 04763, Republic of Korea. dhyoo@hanyang.ac.kr.
Jazyk: angličtina
Zdroj: BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy [BioDrugs] 2017 Aug; Vol. 31 (4), pp. 369-377.
DOI: 10.1007/s40259-017-0233-6
Abstrakt: 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.
Databáze: MEDLINE
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