한빛사논문, 상위피인용논문
- 조회1,234
Abstract
Dae Hyun Yoo1,*, Nenad Prodanovic2, Janusz Jaworski3, Pedro Miranda4, Edgar Ramiterre5, Allan Lanzon6, Asta Baranauskaite7, Piotr Wiland8, Carlos Abud-Mendoza9, Boycho Oparanov10, Svitlana Smiyan11, HoUng Kim12, Sang Joon Lee12, SuYeon Kim12, Won Park13,*
1Hanyang University Hospital for Rheumatic Diseases, Seoul, Republic of Korea
2Clinical Center Banja Luka, Banja Luka, Bosnia
3Reumatika Centrum Reumatologi, Warszawa, Poland
4Universidad de Chile and Centro de Estudios Reumatologicos, Santiago de Chile, Chile
5Brokenshire Memorial Hospital, Davao City, Philippines
6Mary Mediatrix Medical Center, Batangas, Philippines
7Lithuanian University of Health Sciences, Kaunas, Lithuania
8Medical University of Wroclaw, Wroclaw, Poland
9Hospital Central and Faculty of Medicine, Universidad Autonoma de San Luis Potosi, San Luis Potosi, Mexico
10Military Medical Academy, Sofia, Bulgaria
11I.Ya. Horbachevsky Ternopil State Medical University, Municipal Institution of Ternopil Regional Council “Ternopil University Hospital”, Ternopil, Ukraine
12CELLTRION, Incheon, Republic of Korea
13IN-HA University, School of Medicine, Medicine/Rheumatology, Incheon, Republic of Korea
*Correspondence to
Professor Won Park, IN-HA University, School of Medicine, Medicine/Rheumatology, 366, Seohae-Daero, Jung-Gu, Incheon 22332, Republic of Korea; and Professor Dae Hyun Yoo, Division of Rheumatology, Hanyang University Hospital for Rheumatic Diseases, 222-1 Wangsimni-Ro, Seongdong-Gu, Seoul 04763, Republic of Korea;
Abstract
Objectives To assess the efficacy and safety of switching from the infliximab reference product (RP; Remicade) to its biosimilar CT-P13 (Remsima, Inflectra) or continuing CT-P13 in patients with rheumatoid arthritis (RA) for an additional six infusions.
Methods This open-label extension study recruited patients with RA who had completed the 54-week, randomised, parallel-group study comparing CT-P13 with RP (PLANETRA; NCT01217086). CT-P13 (3 mg/kg) was administered intravenously every 8 weeks from weeks 62 to 102. All patients received concomitant methotrexate. Endpoints included American College of Rheumatology 20% (ACR20) response, ACR50, ACR70, immunogenicity and safety. Data were analysed for patients who received CT-P13 for 102 weeks (maintenance group) and for those who received RP for 54 weeks and then switched to CT-P13 (switch group).
Results Overall, 302 of 455 patients who completed the PLANETRA study enrolled into the extension. Of these, 158 had received CT-P13 (maintenance group) and 144 RP (switch group). Response rates at week 102 for maintenance versus switch groups, respectively, were 71.7% vs 71.8% for ACR20, 48.0% vs 51.4% for ACR50 and 24.3% vs 26.1% for ACR70. The proportion of patients with antidrug antibodies was comparable between groups (week 102: 40.3% vs 44.8%, respectively). Treatment-emergent adverse events occurred in similar proportions of patients in the two groups during the extension study (53.5% and 53.8%, respectively).
Conclusions Comparable efficacy and tolerability were observed in patients who switched from RP to its biosimilar CT-P13 for an additional year and in those who had long-term CT-P13 treatment for 2 years.
Trial registration number NCT01571219; Results.
논문정보
- Research article
- 2017년 02월 (BRIC 등록일 2017-01-24)
- 국내(교신)+국외 연구진
- 60회 이상 인용된 논문 (상위피인용논문 등록일 2019-05-08)
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