No increased mortality in patients with rheumatoid arthritis treated with biologics: results from the biologics register of six rheumatology institutes in Japan
Ayako Nakajima1 , Kazuyoshi Saito2 , Toshihisa Kojima3 , Koichi Amano4 , Taku Yoshio6 , Wataru Fukuda7 , Eisuke Inoue1 , Atsuo Taniguchi1 , Shigeki Momohara1 , Seiji Minota6 , Tsutomu Takeuchi4, 5 , Naoki Ishiguro3
17 May 2012
10 September 2012
17 October 2012
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Objective To investigate the influence of biologics on
mortality and risk factors for death in rheumatoid arthritis
(RA) patients.
Methods RA patients treated with at least one dose of
biologics in daily practice in six large rheumatology
institutes (‘‘biologics cohort’’) were observed until 15 May
2010 or death, whichever occurred first. Mortality of the
biologics cohort and the ‘‘comparator cohort’’ (comprising
patients among the IORRA cohort who had never been
treated with biologics) was compared to that of the Japanese
general population. Factors associated with mortality
were assessed by a Cox model.
Results Among 2683 patients with 6913.0 patient-years
of observation, 38 deaths were identified in the biologics
cohort. The probability of death in patients lost to followup,
calculated using the weighted standardized mortality
ratio (SMR), was 1.08 [95 % confidence interval (CI)
0.77?1.47] in the biologics cohort and 1.28 (95 % CI
1.17?1.41) in the comparator cohort. Pulmonary involvement
was the main cause of death (47.4 %), and the disease-
specific SMR of pneumonia was 4.19 (95 % CI
1.81?8.25). Risk factors for death included male gender
[hazard ratio (HR) 2.78 (95 % CI 1.24?6.22)], advanced
age (HR 1.07, 95 % CI 1.03?1.11), and corticosteroid dose
(HR 1.08, 95 % CI 1.01?1.17).
Conclusion Mortality in RA patients exposed to biologics
did not exceed that in patients not exposed to biologics, but
death from pulmonary manifestations was proportionally
increased in RA patients exposed to biologics.
Biologics, Cause of death, Mortality, Rheumatoid arthritis, Standardized mortality ratio