A randomized, double-blind, placebo-controlled, phase III study of the human anti-tumor necrosis factor antibody adalimumab administered as subcutaneous injections in Korean rheumatoid arthritis patients treated with methotrexate
- Authors
- Kim, Ho-Youn; Lee, Soo-Kon; Song, Yeong Wook; Yoo, Dae Hyun; Koh, Eun-Mi; Yoo, Bin; Luo, Allison
- Issue Date
- Apr-2007
- Keywords
- Adalimumab; Efficacy; Methotrexate; Rheumatoid arthritis; Safety
- Citation
- APLAR Journal of Rheumatology, v.10, no.1, pp.9 - 16
- Indexed
- SCOPUS
- Journal Title
- APLAR Journal of Rheumatology
- Volume
- 10
- Number
- 1
- Start Page
- 9
- End Page
- 16
- URI
- https://scholarworks.bwise.kr/hanyang/handle/2021.sw.hanyang/172320
- DOI
- 10.1111/j.1479-8077.2007.00248.x
- ISSN
- 0219-0494
- Abstract
- Objective: Adalimumab is a fully human, monoclonal, antitumour necrosis factor antibody approved for the treatment of rheumatoid arthritis (RA) in more than 60 countries. We investigated the efficacy and safety of 40.mg every-other-week (eow) subcutaneous injections of adalimumab with methotrexate (MTX) versus placebo with MTX in Korean patients with RA with insufficient responses to MTX. Methods: This was a 24-week, randomized, double-blind, placebo-controlled, phase III study conducted at six sites in Korea. The primary efficacy endpoint was a 20% improvement in the American College of Rheumatology response criteria (ACR20) at week 24. Secondary endpoints included ACR50, ACR70, and individual ACR components. Beginning at week 18, non-responders (< 20% reduction in swollen and tender joint counts) could switch to rescue therapy with open-label adalimumab 40.mg eow. Results: Of the 128 patients enrolled, 65 received adalimumab and 63 received placebo. An ACR20 response at week 24 was achieved by 61.5% of patients receiving adalimumab versus 36.5% receiving placebo (P < 0.01). ACR50 and ACR70 responses were achieved by 43.1% and 21.5% of adalimumab patients versus 14.3% and 7.9% of placebo patients (P < 0.001 and P < 0.05, respectively). Adalimumab significantly improved all seven ACR core components. Statistically significant improvements in ACR20 were observed with adalimumab as early as week 2. Adalimumab was generally well tolerated; there were no significant differences in incidences of adverse events between groups. Conclusions: In Korean patients with RA with insufficient responses to MTX, combination therapy with adalimumab and MTX was more efficacious than placebo and MTX in reducing RA signs and symptoms.
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