Korean J Intern Med.
2019 Jul;34(4):917-931. 10.3904/kjim.2017.159.
Efficacy and safety of tocilizumab in Korean patients with active rheumatoid arthritis
- Affiliations
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- 1Division of Rheumatology, Department of Internal Medicine, Gachon University Gil Medical Center, Incheon, Korea.
- 2Division of Rheumatology, Department of Internal Medicine, Inha University Hospital, Incheon, Korea.
- 3Division of Rheumatology, Department of Internal Medicine, College of Medicine, Seoul St. Mary's Hospital, The Catholic University of Korea, Seoul, Korea.
- 4Division of Rheumatology, Department of Internal Medicine, Chungnam National University Hospital, Daejeon, Korea.
- 5Division of Rheumatology, Department of Internal Medicine, Hanyang University Seoul Hospital, Seoul, Korea.
- 6Division of Rheumatology, Department of Internal Medicine, Hallym University Sacred Heart Hospital, Anyang, Korea.
- 7Division of Rheumatology, Department of Internal Medicine, Severance Hospital, Yonsei University College of Medicine, Seoul, Korea.
- 8Division of Rheumatology, Department of Internal Medicine, Seoul National University Bundang Hospital, Seongnam, Korea.
- 9Division of Rheumatology, Department of Internal Medicine, Pusan National University Hospital, Busan, Korea.
- 10Division of Rheumatology, Department of Internal Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.
- 11Division of Rheumatology, Department of Internal Medicine, Seoul National University Hospital, Seoul, Korea. ysong@snu.ac.kr
- 12Department of Molecular Medicine and Biopharmaceutical Sciences, Graduate School of Convergence Science and Technology, Seoul National University, Seoul, Korea.
- 13Medical Research Center, Seoul National University College of Medicine, Seoul, Korea.
- KMID: 2457323
- DOI: http://doi.org/10.3904/kjim.2017.159
Abstract
- BACKGROUND/AIMS
To investigate the efficacy and safety of tocilizumab (TCZ) humanized anti-interleukin-6 receptor monoclonal antibody, in Korean patients with active rheumatoid arthritis (RA) refractory to conventional disease modifying anti-rheumatic drugs (DMARDs) including methotrexate (MTX)
METHODS
The main study was a 24-week, randomized, double-blind, controlled trial that was followed by a 48-week, open-labeled, extension phase. TCZ (8 mg/kg) or placebo was intravenously administered every 4 weeks.
RESULTS
Those treated with TCZ showed more favorable outcomes in terms of 20% according to the American College of Rheumatology response criteria (ACR20) and ACR50 responses, individual parameters of ACR core set, disease activity score in 28 joints (DAS28) remission, and European League Against Rheumatism (EULAR) response at week 24. These improvements were maintained or increased during the extension period. DAS28 remission at week 72 was associated with EULAR good response at week 12. The patients who experienced any adverse event (AE) were more frequent in the TCZ group compared to the placebo group. Most AEs were mild or moderate in intensity, although TCZ therapy had possible AEs including serious infection, abnormal liver function, and atherogenic lipid profile.
CONCLUSIONS
TCZ infusion add-on is highly efficacious and well-tolerated in Korean patients with active RA refractory to conventional DMARDs including MTX. EULAR good response at week 12 could predict DAS28 remission at week 72.
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