Safety and effectiveness of subcutaneous tocilizumab in patients with rheumatoid arthritis in a real-world clinical setting

Tatsuya Atsumi, Keishi Fujio, Kunihiro Yamaoka, Minako Tomobe, Kazuyuki Kuroyanagi, Hideto Kameda

Research output: Contribution to journalArticle

3 Citations (Scopus)

Abstract

Objectives: The objective of this study is to evaluate the safety and effectiveness of subcutaneous tocilizumab (TCZ-SC) in a real-world clinical setting in Japan. Methods: This single arm, 26-week prospective observational study enrolled patients with RA who were either TCZ naïve or switched from TCZ-IV to TCZ-SC (TCZ-IV-SC group) (UMIN Clinical Trials Registry UMIN000011102). All patients received TCZ-SC 162 mg every 2 weeks and data were collected until week 26 or discontinuation. Results: Overall 784 (78.1%) were TCZ naïve and 219 (21.8%) were in the TCZ-IV-SC group. 70.9% received disease-modifying antirheumatic drugs at baseline. Adverse events (AEs) and serious AEs occurred in 28.2% and 4.9% of patients, respectively (TCZ-naïve: 29.5% and 5.2%; TCZ-IV-SC: 23.2% and 4.1%). Infections and infestations were the most common AEs (7.4%) and serious AEs (1.7%). Two TCZ-naïve patients died. TCZ-naïve patients had an improvement in median Clinical Disease Activity Index (CDAI) score and mean Disease Activity Score in 28 joints as measured by erythrocyte sedimentation rate (DAS28-ESR) from baseline to week 26. The TCZ-IV-SC group had similar median CDAI scores and mean DAS28-ESR over 26 weeks. Conclusions: There were no unexpected safety signals with TCZ-SC. TCZ-SC was effective in reducing disease activity in TCZ-naïve patients and maintaining remission in TCZ-IV-SC patients.

Original languageEnglish
Pages (from-to)1-9
Number of pages9
JournalModern Rheumatology
DOIs
Publication statusAccepted/In press - 2018 Jan 5

Fingerprint

Rheumatoid Arthritis
Safety
Antirheumatic Agents
Blood Sedimentation
tocilizumab
Observational Studies
Registries
Japan
Joints
Clinical Trials
Prospective Studies
Infection

Keywords

  • interleukin 6
  • postmarketing surveillance
  • Rheumatoid arthritis
  • subcutaneous
  • tocilizumab

ASJC Scopus subject areas

  • Rheumatology

Cite this

Safety and effectiveness of subcutaneous tocilizumab in patients with rheumatoid arthritis in a real-world clinical setting. / Atsumi, Tatsuya; Fujio, Keishi; Yamaoka, Kunihiro; Tomobe, Minako; Kuroyanagi, Kazuyuki; Kameda, Hideto.

In: Modern Rheumatology, 05.01.2018, p. 1-9.

Research output: Contribution to journalArticle

Atsumi, Tatsuya ; Fujio, Keishi ; Yamaoka, Kunihiro ; Tomobe, Minako ; Kuroyanagi, Kazuyuki ; Kameda, Hideto. / Safety and effectiveness of subcutaneous tocilizumab in patients with rheumatoid arthritis in a real-world clinical setting. In: Modern Rheumatology. 2018 ; pp. 1-9.
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abstract = "Objectives: The objective of this study is to evaluate the safety and effectiveness of subcutaneous tocilizumab (TCZ-SC) in a real-world clinical setting in Japan. Methods: This single arm, 26-week prospective observational study enrolled patients with RA who were either TCZ na{\"i}ve or switched from TCZ-IV to TCZ-SC (TCZ-IV-SC group) (UMIN Clinical Trials Registry UMIN000011102). All patients received TCZ-SC 162 mg every 2 weeks and data were collected until week 26 or discontinuation. Results: Overall 784 (78.1{\%}) were TCZ na{\"i}ve and 219 (21.8{\%}) were in the TCZ-IV-SC group. 70.9{\%} received disease-modifying antirheumatic drugs at baseline. Adverse events (AEs) and serious AEs occurred in 28.2{\%} and 4.9{\%} of patients, respectively (TCZ-na{\"i}ve: 29.5{\%} and 5.2{\%}; TCZ-IV-SC: 23.2{\%} and 4.1{\%}). Infections and infestations were the most common AEs (7.4{\%}) and serious AEs (1.7{\%}). Two TCZ-na{\"i}ve patients died. TCZ-na{\"i}ve patients had an improvement in median Clinical Disease Activity Index (CDAI) score and mean Disease Activity Score in 28 joints as measured by erythrocyte sedimentation rate (DAS28-ESR) from baseline to week 26. The TCZ-IV-SC group had similar median CDAI scores and mean DAS28-ESR over 26 weeks. Conclusions: There were no unexpected safety signals with TCZ-SC. TCZ-SC was effective in reducing disease activity in TCZ-na{\"i}ve patients and maintaining remission in TCZ-IV-SC patients.",
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AU - Yamaoka, Kunihiro

AU - Tomobe, Minako

AU - Kuroyanagi, Kazuyuki

AU - Kameda, Hideto

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N2 - Objectives: The objective of this study is to evaluate the safety and effectiveness of subcutaneous tocilizumab (TCZ-SC) in a real-world clinical setting in Japan. Methods: This single arm, 26-week prospective observational study enrolled patients with RA who were either TCZ naïve or switched from TCZ-IV to TCZ-SC (TCZ-IV-SC group) (UMIN Clinical Trials Registry UMIN000011102). All patients received TCZ-SC 162 mg every 2 weeks and data were collected until week 26 or discontinuation. Results: Overall 784 (78.1%) were TCZ naïve and 219 (21.8%) were in the TCZ-IV-SC group. 70.9% received disease-modifying antirheumatic drugs at baseline. Adverse events (AEs) and serious AEs occurred in 28.2% and 4.9% of patients, respectively (TCZ-naïve: 29.5% and 5.2%; TCZ-IV-SC: 23.2% and 4.1%). Infections and infestations were the most common AEs (7.4%) and serious AEs (1.7%). Two TCZ-naïve patients died. TCZ-naïve patients had an improvement in median Clinical Disease Activity Index (CDAI) score and mean Disease Activity Score in 28 joints as measured by erythrocyte sedimentation rate (DAS28-ESR) from baseline to week 26. The TCZ-IV-SC group had similar median CDAI scores and mean DAS28-ESR over 26 weeks. Conclusions: There were no unexpected safety signals with TCZ-SC. TCZ-SC was effective in reducing disease activity in TCZ-naïve patients and maintaining remission in TCZ-IV-SC patients.

AB - Objectives: The objective of this study is to evaluate the safety and effectiveness of subcutaneous tocilizumab (TCZ-SC) in a real-world clinical setting in Japan. Methods: This single arm, 26-week prospective observational study enrolled patients with RA who were either TCZ naïve or switched from TCZ-IV to TCZ-SC (TCZ-IV-SC group) (UMIN Clinical Trials Registry UMIN000011102). All patients received TCZ-SC 162 mg every 2 weeks and data were collected until week 26 or discontinuation. Results: Overall 784 (78.1%) were TCZ naïve and 219 (21.8%) were in the TCZ-IV-SC group. 70.9% received disease-modifying antirheumatic drugs at baseline. Adverse events (AEs) and serious AEs occurred in 28.2% and 4.9% of patients, respectively (TCZ-naïve: 29.5% and 5.2%; TCZ-IV-SC: 23.2% and 4.1%). Infections and infestations were the most common AEs (7.4%) and serious AEs (1.7%). Two TCZ-naïve patients died. TCZ-naïve patients had an improvement in median Clinical Disease Activity Index (CDAI) score and mean Disease Activity Score in 28 joints as measured by erythrocyte sedimentation rate (DAS28-ESR) from baseline to week 26. The TCZ-IV-SC group had similar median CDAI scores and mean DAS28-ESR over 26 weeks. Conclusions: There were no unexpected safety signals with TCZ-SC. TCZ-SC was effective in reducing disease activity in TCZ-naïve patients and maintaining remission in TCZ-IV-SC patients.

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KW - postmarketing surveillance

KW - Rheumatoid arthritis

KW - subcutaneous

KW - tocilizumab

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