Effectiveness and safety of tocilizumab in achieving clinical and functional remission, and sustaining efficacy in biologics-naive patients with rheumatoid arthritis

The FIRST Bio study

Naoki Ishiguro, Tatsuya Atsumi, Masayoshi Harigai, Tsuneyo Mimori, Norihiro Nishimoto, Takayuki Sumida, Tsutomu Takeuchi, Yoshiya Tanaka, Ayako Nakasone, Nobuhiro Takagi, Hisashi Yamanaka

Research output: Contribution to journalArticle

7 Citations (Scopus)

Abstract

Objective: To evaluate effectiveness and safety of tocilizumab (TCZ) in biologic-naive Japanese patients with rheumatoid arthritis (RA) in real-world settings, and to analyze the relationship between disease duration and clinical outcomes. Methods: The FIRST Bio study was a postmarketing surveillance study of intravenous TCZ in biologics-naive patients who had a prior inadequate response or were intolerant to ≥1 conventional synthetic disease-modifying antirheumatic drug (csDMARD). Effectiveness, safety, and concomitant csDMARD administration were assessed. Results: Of the 839 patients analyzed, 72.3% completed 52 weeks of treatment. The Clinical Disease Activity Index (CDAI) remission rate at week 52 was 36.8%. Contributing factors for CDAI remission were younger age, early disease stage, and no comorbidities. Health Assessment Questionnaire Disability Index ≤0.5 was achieved in 65.1% of patients, and was significantly associated with disease duration. Discontinuation of concomitant methotrexate (MTX) and glucocorticoids (GCs) was possible in 19.3% and 34.1% of patients, respectively, without decreasing remission rate. The incidence (events/100 patient-years) of serious adverse events was 18.09, the most common being infection. Conclusion: These data validate the importance of TCZ treatment in the early stages of RA in biologic-naive patients to achieve increased effectiveness. The safety profile of TCZ was reconfirmed. Furthermore, TCZ therapy may allow discontinuation of concomitant MTX and GCs without affecting remission.

Original languageEnglish
Pages (from-to)1-10
Number of pages10
JournalModern Rheumatology
DOIs
Publication statusAccepted/In press - 2016 Jul 13

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Biological Products
Rheumatoid Arthritis
Safety
Antirheumatic Agents
Methotrexate
Glucocorticoids
tocilizumab
Comorbidity
Therapeutics
Incidence
Health
Infection

Keywords

  • Biologics-naive
  • Intravenous
  • Rheumatoid arthritis
  • Tocilizumab

ASJC Scopus subject areas

  • Rheumatology

Cite this

Effectiveness and safety of tocilizumab in achieving clinical and functional remission, and sustaining efficacy in biologics-naive patients with rheumatoid arthritis : The FIRST Bio study. / Ishiguro, Naoki; Atsumi, Tatsuya; Harigai, Masayoshi; Mimori, Tsuneyo; Nishimoto, Norihiro; Sumida, Takayuki; Takeuchi, Tsutomu; Tanaka, Yoshiya; Nakasone, Ayako; Takagi, Nobuhiro; Yamanaka, Hisashi.

In: Modern Rheumatology, 13.07.2016, p. 1-10.

Research output: Contribution to journalArticle

Ishiguro, Naoki ; Atsumi, Tatsuya ; Harigai, Masayoshi ; Mimori, Tsuneyo ; Nishimoto, Norihiro ; Sumida, Takayuki ; Takeuchi, Tsutomu ; Tanaka, Yoshiya ; Nakasone, Ayako ; Takagi, Nobuhiro ; Yamanaka, Hisashi. / Effectiveness and safety of tocilizumab in achieving clinical and functional remission, and sustaining efficacy in biologics-naive patients with rheumatoid arthritis : The FIRST Bio study. In: Modern Rheumatology. 2016 ; pp. 1-10.
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abstract = "Objective: To evaluate effectiveness and safety of tocilizumab (TCZ) in biologic-naive Japanese patients with rheumatoid arthritis (RA) in real-world settings, and to analyze the relationship between disease duration and clinical outcomes. Methods: The FIRST Bio study was a postmarketing surveillance study of intravenous TCZ in biologics-naive patients who had a prior inadequate response or were intolerant to ≥1 conventional synthetic disease-modifying antirheumatic drug (csDMARD). Effectiveness, safety, and concomitant csDMARD administration were assessed. Results: Of the 839 patients analyzed, 72.3{\%} completed 52 weeks of treatment. The Clinical Disease Activity Index (CDAI) remission rate at week 52 was 36.8{\%}. Contributing factors for CDAI remission were younger age, early disease stage, and no comorbidities. Health Assessment Questionnaire Disability Index ≤0.5 was achieved in 65.1{\%} of patients, and was significantly associated with disease duration. Discontinuation of concomitant methotrexate (MTX) and glucocorticoids (GCs) was possible in 19.3{\%} and 34.1{\%} of patients, respectively, without decreasing remission rate. The incidence (events/100 patient-years) of serious adverse events was 18.09, the most common being infection. Conclusion: These data validate the importance of TCZ treatment in the early stages of RA in biologic-naive patients to achieve increased effectiveness. The safety profile of TCZ was reconfirmed. Furthermore, TCZ therapy may allow discontinuation of concomitant MTX and GCs without affecting remission.",
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AU - Sumida, Takayuki

AU - Takeuchi, Tsutomu

AU - Tanaka, Yoshiya

AU - Nakasone, Ayako

AU - Takagi, Nobuhiro

AU - Yamanaka, Hisashi

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