Arthritis & Rheumatism, Volume 62,
November 2010 Abstract Supplement
Abstracts of the American College of
Rheumatology/Association of Rheumatology Health Professionals
Annual Scientific Meeting
Atlanta, Georgia November 6-11, 2010.
Clinical, Structural and Functional Remission in the Treatment of Rheumatoid Arthritis with Tocilizumab in Daily Clinical Practice REACTION-2 Study.
Takeuchi2, Tsutomu, Tanaka5, Yoshiya, Amano1, Kouichi, Sato4, Eri, Nawata6, Masao, Nagasawa1, Hayato, Hoshi4, Daisuke
Division of Rheumatology and Clinical Immunology, Department of Internal Medicine, Saitama Medical Center, Saitama Medical University, Saitama, Japan
Division of Rheumatology, School of Medicine, Keio University, Tokyo, Japan
Division of Rheumatology, School of Medicine, Keio University, Tokyo, Japa
Institute of Rheumatology, Tokyo Women's Medical University, Tokyo, Japan
The First Department of Internal Medicine, School of Medicine, University of Occupational & Environmental Health, Kitakyusyu, Japan
The First Department of Internal Medicine, School of Medicine, University of Occupational & Environmental Health, Kitakyushu, Japan
Anti-IL-6 receptor monoclonal antibody, tocilizumab (TCZ), is increasingly recognized as a powerful biological agent for the treatment of rheumatoid arthritis (RA). Comprehensive effectiveness of TCZ in daily clinical practice, in which the patients are advanced and even refractory to TNF inhibitors, is not fully understood. In this report, we evaluated the effectiveness of TCZ in the three major rheumatology centers as judged by clinical, structural and functional remission at 52 weeks in the advanced RA patients.
Patients and Methods:
From May 2008 to March 2009, a total of 255 RA patients were enrolled and received 8 mg/kg every four weeks of TCZ treatment. Disease activity was assessed using DAS28-ESR, joint damage using the van der Heijde modified total Sharp score (mTSS), and functional disability using the health assessment questionnaire (HAQ) score. Safety was assessed by identifying adverse events for which a causal relationship with TCZ could not be ruled out. The last-observation-carried-forward method was used in each of the analyses.
The mean (± SD) of each parameter at baseline were as indicated below, age; 59.1 ± 13.3 years, duration of RA; 12.4 ± 11.1 years, mTSS; 140 ± 101, prior biologics user; 62.8%, concomitant methotrexate (MTX) user; 55.6% (the mean dose was 5.31 ± 4.8 mg/week), and concomitant corticosteroid user; 67.0% (the mean dose was 3.9 mg/day).
With the 52 weeks TCZ treatment, the mean DAS28-ESR was significantly improved from 5.72 at baseline to 3.2 at week 52, and clinical remission was achieved in 42% of patients, and 55% of the patients reached low disease activity criteria. The individual parameters of DAS28-ESR decreased significantly until 24 weeks after starting treatment with TCZ, and this efficacy was maintained until 52 weeks.
The estimated yearly progression of mTSS was also significantly improved from 26.0 at baseline to 1.1 at week 52 (p<0.0001). Cumulative probability analysis showed that progression of joint damage was inhibited in 61.7% of patients. Similarly, erosion was inhibited in 75.8% and joint space narrowing was inhibited in 71.1% of patients.
Based on the HAQ scores, extremely severe functional disability was evident before treatment, with a mean score of 1.56. After treatment with TCZ for 52 weeks, the HAQ score decreased to 1.29 with a gradual decline. Defined as HAQ score <= 0.5, functional remission was achieved by 26.4% of patients.
The 52-week retention rate was approximately 72%, independent of history of prior therapy with biologics. In contrast, the patients taking MTX achieved the higher continuation rate, compared to those without MTX.
This study showed that clinical remission was achieved in 42% of the patients with 12.4 years of disease duration and progression of joint damage is inhibited appreciably by treatment with TCZ in daily clinical practice. Given the results that functional remission was obtained about one fourth of the patients, which is apparently lower than that of clinical remission, early treatment with TCZ before irreversible and progressed disability by structural damage is important to achieve higher rate for all three remission criteria.
To cite this abstract, please use the following information:
Takeuchi, Tsutomu, Tanaka, Yoshiya, Amano, Kouichi, Sato, Eri, Nawata, Masao, Nagasawa, Hayato, et al; Clinical, Structural and Functional Remission in the Treatment of Rheumatoid Arthritis with Tocilizumab in Daily Clinical Practice REACTION-2 Study. [abstract]. Arthritis Rheum 2010;62 Suppl 10 :1793