A Clinical Trial and Extension Study of Infliximab in Korean Patients with Active Rheumatoid Arthritis despite Methotrexate Treatment

다국어 초록 (Multilingual Abstract)

Currently, infliximab is given for disease control for active rheumatoid arthritis (RA) patients despite methotrexate treatment. However, the efficacy and safety of infliximab in Korean patients has not been assessed appropriately. Therefore, we performed placebo-controlled, double-blind, randomized study and extension study. One-hundred forty-three patients with active RA were randomized to receive placebo or infliximab 3 mg/kg intravenously at week 0, 2, 6, 14, and 22 with methotrexate maintenance. Primary endpoint was American College of Rheumatology 20% improvement criteria (ACR20) at 30 week. After the clinical trial, patients on placebo (Group 1) and patients on infliximab who showed ACR20 response (Group 2) were treated with infliximab through another 84 week for evaluation of safety. During clinical trial, patients in infliximab group showed higher ACR20 at week 30 than patients in placebo group (50.1% vs 30.6%, P=0.014). A total of 92 patients participated in the extension study. The maintenance rate of infliximab was 62.0% at 84 weeks of extension study. The overall rate of adverse events was not different between Group 1 and Group 2. In Korean patients with active RA despite methotrexate treatment, infliximab in combination with methotrexate is effective and the long-term treatment with infliximab is well tolerated. (ClinicalTrials.gov No. NCT00202852, NCT00732875)

참고문헌 (Reference)

1 Gao GH, "Therapeutic effect of infliximab on moderate and severe active rheumatoid arthritis" 30 : 724-726, 2010

2 Uppsala Monitoring Centre, "The WHO adverse reaction terminology - WHO-ART"

3 Arnett FC, "The American Rheumatism Association 1987 revised criteria for the classification of rheumatoid arthritis" 31 : 315-324, 1988

4 Hochberg MC, "The American College of Rheumatology 1991 revised criteria for the classification of global functional status in rheumatoid arthritis" 35 : 498-502, 1992

5 Westhovens R, "START Study Group. The safety of infliximab, combined with background treatments, among patients with rheumatoid arthritis and various comorbidities: a large, randomized, placebo-controlled trial" 54 : 1075-1086, 2006

6 Yamanaka H, "Retrospective clinical study on the notable efficacy and related factors of infliximab therapy in a rheumatoid arthritis management group in Japan(RECONFIRM)" 17 : 28-32, 2007

7 Tanaka Y, "Retrospective clinical study on the notable efficacy and related factors of infliximab therapy in a rheumatoid arthritis management group in Japan : one-year clinical outcomes(RECONFIRM-2)" 18 : 146-152, 2008

8 Elliott MJ, "Randomised double-blind comparison of chimeric monoclonal antibody to tumour necrosis factor alpha(cA2)versus placebo in rheumatoid arthritis" 344 : 1105-1110, 1994

9 Smolen JS, "Infliximab: 12 years of experience" 13 : S2-, 2011

10 Maini R, "Infliximab(chimeric anti-tumour necrosis factor alpha monoclonal antibody)versus placebo in rheumatoid arthritis patients receiving concomitant methotrexate : a randomised phase III trial : ATTRACT Study Group" 354 : 1932-1939, 1999

11 Voulgari PV, "Infliximab therapy in established rheumatoid arthritis : an observational study" 118 : 515-520, 2005

12 Lipsky PE, "Infliximab and methotrexate in the treatment of rheumatoid arthritis : AntiTumor Necrosis Factor Trial in Rheumatoid Arthritis with Concomitant Therapy Study Group" 343 : 1594-1602, 2000

13 Listing J, "Infections in patients with rheumatoid arthritis treated with biologic agents" 52 : 3403-3412, 2005

14 Cope AP, "Increased levels of soluble tumor necrosis factor receptors in the sera and synovial fluid of patients with rheumatic diseases" 35 : 1160-1169, 1992

15 Firestein GS, "Evolving concepts of rheumatoid arthritis" 423 : 356-361, 2003

16 Feldmann M, "Cytokine production in the rheumatoid joint: implications for treatment" 49 : 480-486, 1990

17 Knight DM, "Construction and initial characterization of a mouse-human chimeric anti-TNF antibody" 30 : 1443-1453, 1993

18 Dixon WG, "British Society for Rheumatology Biologics Register. Rates of serious infection, including site-specific and bacterial intracellular infection, in rheumatoid arthritis patients receiving anti-tumor necrosis factor therapy: results from the British Society for Rheumatology Biologics Register" 54 : 2368-2376, 2006

19 Paulus HE, "Analysis of improvement in individual rheumatoid arthritis patients treated with disease-modifying antirheumatic drugs, based on the findings in patients treated with placebo: the Cooperative Systematic Studies of Rheumatic Diseases Group" 33 : 477-484, 1990