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

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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 languageEnglish
Article number74
JournalArthritis Research and Therapy
Volume17
Issue number1
DOIs
Publication statusPublished - 2015 Mar 23

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Biological Products
Registries
Rheumatoid Arthritis
Tumor Necrosis Factor-alpha
Safety
Infection
Confidence Intervals
Incidence
Regression Analysis
tocilizumab
Patient Safety
Adrenal Cortex Hormones
Cohort Studies
Prospective Studies
Therapeutics

ASJC Scopus subject areas

  • Rheumatology
  • Immunology
  • Immunology and Allergy

Cite this

@article{4566767f99d14944ad6cb0dcdf442e72,
title = "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",
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.",
author = "{for the REAL Study Group} and Ryoko Sakai and Cho, {Soo Kyung} and Toshihiro Nanki and Kaori Watanabe and Hayato Yamazaki and Michi Tanaka and Ryuji Koike and Yoshiya Tanaka and Kazuyoshi Saito and Shintaro Hirata and Koichi Amano and Hayato Nagasawa and Takayuki Sumida and Taichi Hayashi and Takahiko Sugihara and Hiroaki Dobashi and Shinsuke Yasuda and Tetsuji Sawada and Kazuhiko Ezawa and Atsuhisa Ueda and Takao Fujii and Kiyoshi Migita and Nobuyuki Miyasaka and Masayoshi Harigai and Tatsuya Atsumi and Yoshiaki Ishigatsubo and Atsushi Ihata and Tsuneyo Mimori and Yoshinari Takasaki and Naoto Tamura and Akira Hashiramoto and Syunichi Shiozawa and Hideto Kameda and Yuko Kaneko and Tsutomu Takeuchi and Sae Ochi and Yasushi Miura and Yoshinori Nonomura and Atsuo Nakajima and Kazuya Michishita and Kazuhiko Yamamoto and Yukitaka Ueki and Kenji Nagasaka and Akitomo Okada and Atsushi Kawakami and Shigeto Tohma and Ayako Nakajima and Hisashi Yamanaka",
year = "2015",
month = "3",
day = "23",
doi = "10.1186/s13075-015-0583-8",
language = "English",
volume = "17",
journal = "Arthritis Research and Therapy",
issn = "1478-6354",
publisher = "BioMed Central",
number = "1",

}

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.

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U2 - 10.1186/s13075-015-0583-8

DO - 10.1186/s13075-015-0583-8

M3 - Article

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AN - SCOPUS:84926435718

VL - 17

JO - Arthritis Research and Therapy

JF - Arthritis Research and Therapy

SN - 1478-6354

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