Arthritis & Rheumatism, Volume 63,
November 2011 Abstract Supplement

Abstracts of the American College of
Rheumatology/Association of Rheumatology Health Professionals
Annual Scientific Meeting
Chicago, Illinois November 4-9, 2011.

No Evidence of Increased Mortality in Rheumatoid Arthritis Patients Treated with Biologics: Results From a Multicenter Cohort in Japan.

Nakajima1,  Ayako, Kojima2,  Toshihisa, Fukuda3,  Wataru, Yoshio4,  Taku, Inoue1,  Eisuke, Amano5,  Koichi, Minota4,  Seiji

Tokyo Women's Medical University, Tokyo, Japan
Nagoya University, Nagoya, Japan
Japanese Red Cross Kyoto Daiichi Hospital, Kyoto, Japan
Jichi Medical University, Tochigi, Japan
Saitama Medical University, Saitama Medical Center, Saitama, Japan
University of Occupational & Environmental Health, Kitakyushu, Fukuoka, Japan
University of Occupational and Environmental Health, Japan, Kitakyushu, Fukuoka, Japan
Keio University School of Medicine, Tokyo, Japan


To investigate the association between treatment with biologics and mortality in patients with rheumatoid arthritis in a multicenter cohort in Japan.


All patients with rheumatoid arthritis (RA) who received at least one dose of any biologic agent targeting tumor necrosis factor (TNF), interleukin 6 (IL-6) or others at six large rheumatology institutes in Japan (Biologics cohort) were included and monitored until May 15, 2010 or death, whichever occurred first. Death information about the date and cause was received from affiliated hospitals. Active monitoring by phone or mail was conducted for patients who stopped clinic visits. Mortality of the Biologics cohort was compared to the general Japanese population and to a practical RA cohort (the IORRA cohort), using standardized mortality ratio (SMR) determination. To evaluate the effect of lost to follow-up, sensitivity analyses were conducted. Factors associated with mortality were assessed by Cox model, in which age, sex, disease duration, DAS28, and doses of methotrexate (MTX) and corticosteroids were evaluated.


Overall, 2,697 patients with RA were registered into the Biologics cohort; the median [IQD] age was 58.0 [47.2–66.1] years, 84.0% were women, and the median disease duration was 6.9 [2.3–14.8] years. Baseline disease activity indicated by dis DAS28 was 5.6 [4.8–6.4] and disability indicated by Japanese version of Health Association Questionnaire (J-HAQ) was 1.00 [0.50–1.75]. Biologics included infliximab (n=1,112), etanercept (n=1,053), adalimumab (n=345), and tocilizumab (n=173). MTX and corticosteroids were prescribed in 77.7% and 54.2% of patients, respectively. Thirty-eight deaths were recorded among 6,940.9 patient-years of follow-up in the Biologics cohort, and 540 patients (20.0%) were lost to follow-up. With weighting for patients lost to follow-up, the weighted SMR in this Biologics cohort was 1.08 (95% confidence interval [95%CI], 0.77–1.47) compared to the Japanese general population, and 0.93 (95%CI, 0.66–1.28) compared to the practical RA cohort. The main cause of death was respiratory diseases, including pneumonia and interstitial lung diseases (Table). Risk factors for mortality included male gender (hazard ratio [HR], 3.01 [95%CI, 1.24–6.25]), older age (HR, 1.07 [95%CI, 1.03–1.11]), and corticosteroid dose (HR, 1.08 [95%CI, 1.01–1.17]).

Table. Underlying causes of death classified according to WHO International Classification of Disease (ICD)-10 chapter number

ChapterBlocksChapter titleDeaths n = 38 (%)
IA00-B99Certain infections and parasitic diseases6 (15.8)
IIC00-D48Neoplasm5 (13.2)
IVE00-E90Endocrine, nutritional and metabolic diseases1 (2.6)
IXI00-I99Diseases of circulatory system5 (13.2)
 I20-I25Ischemic heart diseases1
 I60-I69Cerebrovascular diseases3
XJ00-J99Disease of respiratory system18 (47.4)
 J10-J18Influenza and pneumonia7
XVIIIR00-R99Symptoms, signs and abnormal clinical and laboratory findings, not elsewhere classified3 (7.9)


Biologics treatment in RA patients was not associated with increased mortality in a multicenter registry in Japan.

To cite this abstract, please use the following information:
Nakajima, Ayako, Kojima, Toshihisa, Fukuda, Wataru, Yoshio, Taku, Inoue, Eisuke, Amano, Koichi, et al; No Evidence of Increased Mortality in Rheumatoid Arthritis Patients Treated with Biologics: Results From a Multicenter Cohort in Japan. [abstract]. Arthritis Rheum 2011;63 Suppl 10 :1199

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