Effectiveness and safety of tocilizumab: Postmarketing surveillance of 7901 patients with rheumatoid arthritis in Japan

Takao Koike, Masayoshi Harigai, Shigeko Inokuma, Naoki Ishiguro, Junnosuke Ryu, Tsutomu Takeuchi, Syuji Takei, Yoshiya Tanaka, Yoko Sano, Hitomi Yaguramaki, Hisashi Yamanaka

Research output: Contribution to journalArticle

75 Citations (Scopus)

Abstract

Objective. An all-patient postmarketing surveillance program was conducted to evaluate the safety and effectiveness of tocilizumab (TCZ) for rheumatoid arthritis (RA) in the real-world clinical setting in Japan. Methods. Patients received 8 mg/kg TCZ every 4 weeks and were observed for 28 weeks. Data were collected on patient characteristics, and drug safety and effectiveness. Results. A total of 7901 patients were enrolled. Percentages of total and serious adverse events (AE) were 43.9% and 9.6%, respectively. The most common serious AE were infections (3.8%). Logistic regression analysis identified the following risk factors for the development of serious infection: age ≥ 65 years, disease duration ≥ 10 years, previous or concurrent respiratory disease, and concomitant corticosteroid dose > 5 mg/day (prednisolone equivalent). The incidence rate of serious infections in patients with ≥ 3 risk factors was 11.2%, compared with 1.2% for patients without risk factors. The Week 28 rates of 28-joint Disease Activity Score-erythrocyte sedimentation rate remission, Boolean remission, and European League Against Rheumatism (EULAR) Good Response were 47.6%, 15.1%, and 59.4%, respectively. Contributing factors for effectiveness were body weight ≥ 40 kg, less advanced RA, no previous biologics, no concomitant corticosteroids or nonsteroidal antiinflammatory drugs, and low disease activity at baseline. From the benefit-risk balance analysis, patients with a high probability of remission and a low probability of developing serious infection were most likely to have less advanced RA and to have not received biologics previously. Conclusion. These data confirm the safety and effectiveness of TCZ in patients with RA in the real-world clinical setting in Japan and identify factors that contribute to the successful use of TCZ for RA. The Journal of Rheumatology

Original languageEnglish
Pages (from-to)15-23
Number of pages9
JournalJournal of Rheumatology
Volume41
Issue number1
DOIs
Publication statusPublished - 2014 Jan

Fingerprint

Rheumatoid Arthritis
Japan
Safety
Infection
Biological Products
Adrenal Cortex Hormones
tocilizumab
Joint Diseases
Blood Sedimentation
Rheumatology
Prednisolone
Pharmaceutical Preparations
Anti-Inflammatory Agents
Logistic Models
Body Weight
Regression Analysis
Incidence

Keywords

  • Benefit risk assessment
  • Biological products
  • Interleukins
  • Postmarketing
  • Rheumatoid arthritis
  • Risk factors

ASJC Scopus subject areas

  • Rheumatology
  • Immunology
  • Immunology and Allergy

Cite this

Effectiveness and safety of tocilizumab : Postmarketing surveillance of 7901 patients with rheumatoid arthritis in Japan. / Koike, Takao; Harigai, Masayoshi; Inokuma, Shigeko; Ishiguro, Naoki; Ryu, Junnosuke; Takeuchi, Tsutomu; Takei, Syuji; Tanaka, Yoshiya; Sano, Yoko; Yaguramaki, Hitomi; Yamanaka, Hisashi.

In: Journal of Rheumatology, Vol. 41, No. 1, 01.2014, p. 15-23.

Research output: Contribution to journalArticle

Koike, T, Harigai, M, Inokuma, S, Ishiguro, N, Ryu, J, Takeuchi, T, Takei, S, Tanaka, Y, Sano, Y, Yaguramaki, H & Yamanaka, H 2014, 'Effectiveness and safety of tocilizumab: Postmarketing surveillance of 7901 patients with rheumatoid arthritis in Japan', Journal of Rheumatology, vol. 41, no. 1, pp. 15-23. https://doi.org/10.3899/jrheum.130466
Koike, Takao ; Harigai, Masayoshi ; Inokuma, Shigeko ; Ishiguro, Naoki ; Ryu, Junnosuke ; Takeuchi, Tsutomu ; Takei, Syuji ; Tanaka, Yoshiya ; Sano, Yoko ; Yaguramaki, Hitomi ; Yamanaka, Hisashi. / Effectiveness and safety of tocilizumab : Postmarketing surveillance of 7901 patients with rheumatoid arthritis in Japan. In: Journal of Rheumatology. 2014 ; Vol. 41, No. 1. pp. 15-23.
@article{e2e7053459334cd296315c8458ddb26e,
title = "Effectiveness and safety of tocilizumab: Postmarketing surveillance of 7901 patients with rheumatoid arthritis in Japan",
abstract = "Objective. An all-patient postmarketing surveillance program was conducted to evaluate the safety and effectiveness of tocilizumab (TCZ) for rheumatoid arthritis (RA) in the real-world clinical setting in Japan. Methods. Patients received 8 mg/kg TCZ every 4 weeks and were observed for 28 weeks. Data were collected on patient characteristics, and drug safety and effectiveness. Results. A total of 7901 patients were enrolled. Percentages of total and serious adverse events (AE) were 43.9{\%} and 9.6{\%}, respectively. The most common serious AE were infections (3.8{\%}). Logistic regression analysis identified the following risk factors for the development of serious infection: age ≥ 65 years, disease duration ≥ 10 years, previous or concurrent respiratory disease, and concomitant corticosteroid dose > 5 mg/day (prednisolone equivalent). The incidence rate of serious infections in patients with ≥ 3 risk factors was 11.2{\%}, compared with 1.2{\%} for patients without risk factors. The Week 28 rates of 28-joint Disease Activity Score-erythrocyte sedimentation rate remission, Boolean remission, and European League Against Rheumatism (EULAR) Good Response were 47.6{\%}, 15.1{\%}, and 59.4{\%}, respectively. Contributing factors for effectiveness were body weight ≥ 40 kg, less advanced RA, no previous biologics, no concomitant corticosteroids or nonsteroidal antiinflammatory drugs, and low disease activity at baseline. From the benefit-risk balance analysis, patients with a high probability of remission and a low probability of developing serious infection were most likely to have less advanced RA and to have not received biologics previously. Conclusion. These data confirm the safety and effectiveness of TCZ in patients with RA in the real-world clinical setting in Japan and identify factors that contribute to the successful use of TCZ for RA. The Journal of Rheumatology",
keywords = "Benefit risk assessment, Biological products, Interleukins, Postmarketing, Rheumatoid arthritis, Risk factors",
author = "Takao Koike and Masayoshi Harigai and Shigeko Inokuma and Naoki Ishiguro and Junnosuke Ryu and Tsutomu Takeuchi and Syuji Takei and Yoshiya Tanaka and Yoko Sano and Hitomi Yaguramaki and Hisashi Yamanaka",
year = "2014",
month = "1",
doi = "10.3899/jrheum.130466",
language = "English",
volume = "41",
pages = "15--23",
journal = "Journal of Rheumatology",
issn = "0315-162X",
publisher = "Journal of Rheumatology",
number = "1",

}

TY - JOUR

T1 - Effectiveness and safety of tocilizumab

T2 - Postmarketing surveillance of 7901 patients with rheumatoid arthritis in Japan

AU - Koike, Takao

AU - Harigai, Masayoshi

AU - Inokuma, Shigeko

AU - Ishiguro, Naoki

AU - Ryu, Junnosuke

AU - Takeuchi, Tsutomu

AU - Takei, Syuji

AU - Tanaka, Yoshiya

AU - Sano, Yoko

AU - Yaguramaki, Hitomi

AU - Yamanaka, Hisashi

PY - 2014/1

Y1 - 2014/1

N2 - Objective. An all-patient postmarketing surveillance program was conducted to evaluate the safety and effectiveness of tocilizumab (TCZ) for rheumatoid arthritis (RA) in the real-world clinical setting in Japan. Methods. Patients received 8 mg/kg TCZ every 4 weeks and were observed for 28 weeks. Data were collected on patient characteristics, and drug safety and effectiveness. Results. A total of 7901 patients were enrolled. Percentages of total and serious adverse events (AE) were 43.9% and 9.6%, respectively. The most common serious AE were infections (3.8%). Logistic regression analysis identified the following risk factors for the development of serious infection: age ≥ 65 years, disease duration ≥ 10 years, previous or concurrent respiratory disease, and concomitant corticosteroid dose > 5 mg/day (prednisolone equivalent). The incidence rate of serious infections in patients with ≥ 3 risk factors was 11.2%, compared with 1.2% for patients without risk factors. The Week 28 rates of 28-joint Disease Activity Score-erythrocyte sedimentation rate remission, Boolean remission, and European League Against Rheumatism (EULAR) Good Response were 47.6%, 15.1%, and 59.4%, respectively. Contributing factors for effectiveness were body weight ≥ 40 kg, less advanced RA, no previous biologics, no concomitant corticosteroids or nonsteroidal antiinflammatory drugs, and low disease activity at baseline. From the benefit-risk balance analysis, patients with a high probability of remission and a low probability of developing serious infection were most likely to have less advanced RA and to have not received biologics previously. Conclusion. These data confirm the safety and effectiveness of TCZ in patients with RA in the real-world clinical setting in Japan and identify factors that contribute to the successful use of TCZ for RA. The Journal of Rheumatology

AB - Objective. An all-patient postmarketing surveillance program was conducted to evaluate the safety and effectiveness of tocilizumab (TCZ) for rheumatoid arthritis (RA) in the real-world clinical setting in Japan. Methods. Patients received 8 mg/kg TCZ every 4 weeks and were observed for 28 weeks. Data were collected on patient characteristics, and drug safety and effectiveness. Results. A total of 7901 patients were enrolled. Percentages of total and serious adverse events (AE) were 43.9% and 9.6%, respectively. The most common serious AE were infections (3.8%). Logistic regression analysis identified the following risk factors for the development of serious infection: age ≥ 65 years, disease duration ≥ 10 years, previous or concurrent respiratory disease, and concomitant corticosteroid dose > 5 mg/day (prednisolone equivalent). The incidence rate of serious infections in patients with ≥ 3 risk factors was 11.2%, compared with 1.2% for patients without risk factors. The Week 28 rates of 28-joint Disease Activity Score-erythrocyte sedimentation rate remission, Boolean remission, and European League Against Rheumatism (EULAR) Good Response were 47.6%, 15.1%, and 59.4%, respectively. Contributing factors for effectiveness were body weight ≥ 40 kg, less advanced RA, no previous biologics, no concomitant corticosteroids or nonsteroidal antiinflammatory drugs, and low disease activity at baseline. From the benefit-risk balance analysis, patients with a high probability of remission and a low probability of developing serious infection were most likely to have less advanced RA and to have not received biologics previously. Conclusion. These data confirm the safety and effectiveness of TCZ in patients with RA in the real-world clinical setting in Japan and identify factors that contribute to the successful use of TCZ for RA. The Journal of Rheumatology

KW - Benefit risk assessment

KW - Biological products

KW - Interleukins

KW - Postmarketing

KW - Rheumatoid arthritis

KW - Risk factors

UR - http://www.scopus.com/inward/record.url?scp=84891795508&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=84891795508&partnerID=8YFLogxK

U2 - 10.3899/jrheum.130466

DO - 10.3899/jrheum.130466

M3 - Article

C2 - 24187110

AN - SCOPUS:84891795508

VL - 41

SP - 15

EP - 23

JO - Journal of Rheumatology

JF - Journal of Rheumatology

SN - 0315-162X

IS - 1

ER -