Abstract
Introduction: The objective of this study was to directly compare the safety of tocilizumab (TCZ) and TNF inhibitors (TNFIs) in rheumatoid arthritis (RA) patients in clinical practice. Methods: This prospective cohort study included RA patients starting TCZ [TCZ group, n = 302, 224.68 patient-years (PY)] or TNFIs [TNFI group, n = 304, 231.01 PY] from 2008 to 2011 in the registry of Japanese RA patients on biologics for long-term safety registry. We assessed types and incidence rates (IRs) of serious adverse events (SAEs) and serious infections (SIs) during the first year of treatment. Risks of the biologics for SAEs or SIs were calculated using the Cox regression hazard analysis. Results: Patients in the TCZ group had longer disease duration (P <0.001), higher disease activity (P = 0.019) and more frequently used concomitant corticosteroids (P <0.001) than those in the TNFI group. The crude IR (/100 PY) of SIs [TCZ 10.68 vs. TNFI 3.03; IR ratio (95% confidence interval [CI]), 3.53 (1.52 to 8.18)], but not SAEs [21.36 vs. 14.72; 1.45 (0.94 to 2.25)], was significantly higher in the TCZ group compared with the TNFI group. However, after adjusting for covariates using the Cox regression hazard analysis, treatment with TCZ was not associated with higher risk for SAEs [hazard ratio (HR) 1.28, 95% CI 0.75 to 2.19] or SIs (HR 2.23, 95% CI 0.93 to 5.37). Conclusions: The adjusted risks for SAEs and SIs were not significantly different between TCZ and TNFIs, indicating an influence of clinical characteristics of the patients on the safety profile of the biologics in clinical practice.
| Original language | English |
|---|---|
| Article number | 74 |
| Journal | Arthritis Research and Therapy |
| Volume | 17 |
| Issue number | 1 |
| DOIs | |
| Publication status | Published - 2015 Mar 23 |
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ASJC Scopus subject areas
- Rheumatology
- Immunology
- Immunology and Allergy
Cite this
Head-to-head comparison of the safety of tocilizumab and tumor necrosis factor inhibitors in rheumatoid arthritis patients (RA) in clinical practice : Results from the registry of Japanese RA patients on biologics for long-term safety (REAL) registry. / for the REAL Study Group.
In: Arthritis Research and Therapy, Vol. 17, No. 1, 74, 23.03.2015.Research output: Contribution to journal › Article
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TY - JOUR
T1 - Head-to-head comparison of the safety of tocilizumab and tumor necrosis factor inhibitors in rheumatoid arthritis patients (RA) in clinical practice
T2 - Results from the registry of Japanese RA patients on biologics for long-term safety (REAL) registry
AU - for the REAL Study Group
AU - Sakai, Ryoko
AU - Cho, Soo Kyung
AU - Nanki, Toshihiro
AU - Watanabe, Kaori
AU - Yamazaki, Hayato
AU - Tanaka, Michi
AU - Koike, Ryuji
AU - Tanaka, Yoshiya
AU - Saito, Kazuyoshi
AU - Hirata, Shintaro
AU - Amano, Koichi
AU - Nagasawa, Hayato
AU - Sumida, Takayuki
AU - Hayashi, Taichi
AU - Sugihara, Takahiko
AU - Dobashi, Hiroaki
AU - Yasuda, Shinsuke
AU - Sawada, Tetsuji
AU - Ezawa, Kazuhiko
AU - Ueda, Atsuhisa
AU - Fujii, Takao
AU - Migita, Kiyoshi
AU - Miyasaka, Nobuyuki
AU - Harigai, Masayoshi
AU - Atsumi, Tatsuya
AU - Ishigatsubo, Yoshiaki
AU - Ihata, Atsushi
AU - Mimori, Tsuneyo
AU - Takasaki, Yoshinari
AU - Tamura, Naoto
AU - Hashiramoto, Akira
AU - Shiozawa, Syunichi
AU - Kameda, Hideto
AU - Kaneko, Yuko
AU - Takeuchi, Tsutomu
AU - Ochi, Sae
AU - Miura, Yasushi
AU - Nonomura, Yoshinori
AU - Nakajima, Atsuo
AU - Michishita, Kazuya
AU - Yamamoto, Kazuhiko
AU - Ueki, Yukitaka
AU - Nagasaka, Kenji
AU - Okada, Akitomo
AU - Kawakami, Atsushi
AU - Tohma, Shigeto
AU - Nakajima, Ayako
AU - Yamanaka, Hisashi
PY - 2015/3/23
Y1 - 2015/3/23
N2 - Introduction: The objective of this study was to directly compare the safety of tocilizumab (TCZ) and TNF inhibitors (TNFIs) in rheumatoid arthritis (RA) patients in clinical practice. Methods: This prospective cohort study included RA patients starting TCZ [TCZ group, n = 302, 224.68 patient-years (PY)] or TNFIs [TNFI group, n = 304, 231.01 PY] from 2008 to 2011 in the registry of Japanese RA patients on biologics for long-term safety registry. We assessed types and incidence rates (IRs) of serious adverse events (SAEs) and serious infections (SIs) during the first year of treatment. Risks of the biologics for SAEs or SIs were calculated using the Cox regression hazard analysis. Results: Patients in the TCZ group had longer disease duration (P <0.001), higher disease activity (P = 0.019) and more frequently used concomitant corticosteroids (P <0.001) than those in the TNFI group. The crude IR (/100 PY) of SIs [TCZ 10.68 vs. TNFI 3.03; IR ratio (95% confidence interval [CI]), 3.53 (1.52 to 8.18)], but not SAEs [21.36 vs. 14.72; 1.45 (0.94 to 2.25)], was significantly higher in the TCZ group compared with the TNFI group. However, after adjusting for covariates using the Cox regression hazard analysis, treatment with TCZ was not associated with higher risk for SAEs [hazard ratio (HR) 1.28, 95% CI 0.75 to 2.19] or SIs (HR 2.23, 95% CI 0.93 to 5.37). Conclusions: The adjusted risks for SAEs and SIs were not significantly different between TCZ and TNFIs, indicating an influence of clinical characteristics of the patients on the safety profile of the biologics in clinical practice.
AB - Introduction: The objective of this study was to directly compare the safety of tocilizumab (TCZ) and TNF inhibitors (TNFIs) in rheumatoid arthritis (RA) patients in clinical practice. Methods: This prospective cohort study included RA patients starting TCZ [TCZ group, n = 302, 224.68 patient-years (PY)] or TNFIs [TNFI group, n = 304, 231.01 PY] from 2008 to 2011 in the registry of Japanese RA patients on biologics for long-term safety registry. We assessed types and incidence rates (IRs) of serious adverse events (SAEs) and serious infections (SIs) during the first year of treatment. Risks of the biologics for SAEs or SIs were calculated using the Cox regression hazard analysis. Results: Patients in the TCZ group had longer disease duration (P <0.001), higher disease activity (P = 0.019) and more frequently used concomitant corticosteroids (P <0.001) than those in the TNFI group. The crude IR (/100 PY) of SIs [TCZ 10.68 vs. TNFI 3.03; IR ratio (95% confidence interval [CI]), 3.53 (1.52 to 8.18)], but not SAEs [21.36 vs. 14.72; 1.45 (0.94 to 2.25)], was significantly higher in the TCZ group compared with the TNFI group. However, after adjusting for covariates using the Cox regression hazard analysis, treatment with TCZ was not associated with higher risk for SAEs [hazard ratio (HR) 1.28, 95% CI 0.75 to 2.19] or SIs (HR 2.23, 95% CI 0.93 to 5.37). Conclusions: The adjusted risks for SAEs and SIs were not significantly different between TCZ and TNFIs, indicating an influence of clinical characteristics of the patients on the safety profile of the biologics in clinical practice.
UR - http://www.scopus.com/inward/record.url?scp=84926435718&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=84926435718&partnerID=8YFLogxK
U2 - 10.1186/s13075-015-0583-8
DO - 10.1186/s13075-015-0583-8
M3 - Article
C2 - 25880658
AN - SCOPUS:84926435718
VL - 17
JO - Arthritis Research and Therapy
JF - Arthritis Research and Therapy
SN - 1478-6354
IS - 1
M1 - 74
ER -