Effectiveness and safety of initiating adalimumab plus ≥12 mg/week methotrexate with adjustable dosing in biologic-naïve patients with early rheumatoid arthritis

HAWK study postmarketing surveillance in Japan

Yoshiya Tanaka, Tsuneyo Mimori, Hisashi Yamanaka, Ryo Nakajima, Kazuo Morita, Junko Kimura, Tsutomu Takeuchi

Research output: Contribution to journalArticle

Abstract

Objectives: This real-world study assessed the effectiveness and safety outcomes of initiating adalimumab and methotrexate (≥12 mg/week) with adjustable dosing in Japanese patients with early rheumatoid arthritis (RA). Methods: This single-arm, prospective postmarketing observational study (conducted from September 2012 to March 2017 at 119 sites) enrolled biologic-naïve patients with early RA (≤2 years duration) and a Disease Activity Score in 28 joints using C-reactive protein (DAS28-CRP) >3.2 who were treated with methotrexate for ≥3 months and had initiated treatment with adalimumab and methotrexate (≥12 mg/week). This report presents 52-week data. The primary outcome was the proportion of patients who achieved DAS28-CRP scores <2.6 at week 52. Results: Overall, 293 of 346 enrolled patients were included in the effectiveness population: women, 73%; mean (standard deviation) age, 54.3 (13.9) years; DAS28-CRP score, 4.51 (0.90); and modified total Sharp score (mTSS), 7.69 (9.98). At week 52, 77% of patients achieved clinical remission (DAS28-CRP <2.6), 92.3% achieved low disease activity (DAS28-CRP ≤3.2), and 86% of evaluable patients experienced structural remission (ΔmTSS ≤0.5). Conclusion: Adalimumab plus methotrexate (≥12 mg/week) with adjustable dosing was well tolerated, and could be a beneficial treatment option for Japanese patients with early RA.

Original languageEnglish
JournalModern Rheumatology
DOIs
Publication statusAccepted/In press - 2018 Jan 1

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Biological Products
Methotrexate
Rheumatoid Arthritis
Japan
C-Reactive Protein
Safety
Joints
Adalimumab
Observational Studies
Therapeutics
Population

Keywords

  • Adalimumab
  • effectiveness
  • methotrexate
  • postmarketing surveillance
  • rheumatoid arthritis

ASJC Scopus subject areas

  • Rheumatology

Cite this

Effectiveness and safety of initiating adalimumab plus ≥12 mg/week methotrexate with adjustable dosing in biologic-naïve patients with early rheumatoid arthritis : HAWK study postmarketing surveillance in Japan. / Tanaka, Yoshiya; Mimori, Tsuneyo; Yamanaka, Hisashi; Nakajima, Ryo; Morita, Kazuo; Kimura, Junko; Takeuchi, Tsutomu.

In: Modern Rheumatology, 01.01.2018.

Research output: Contribution to journalArticle

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abstract = "Objectives: This real-world study assessed the effectiveness and safety outcomes of initiating adalimumab and methotrexate (≥12 mg/week) with adjustable dosing in Japanese patients with early rheumatoid arthritis (RA). Methods: This single-arm, prospective postmarketing observational study (conducted from September 2012 to March 2017 at 119 sites) enrolled biologic-na{\"i}ve patients with early RA (≤2 years duration) and a Disease Activity Score in 28 joints using C-reactive protein (DAS28-CRP) >3.2 who were treated with methotrexate for ≥3 months and had initiated treatment with adalimumab and methotrexate (≥12 mg/week). This report presents 52-week data. The primary outcome was the proportion of patients who achieved DAS28-CRP scores <2.6 at week 52. Results: Overall, 293 of 346 enrolled patients were included in the effectiveness population: women, 73{\%}; mean (standard deviation) age, 54.3 (13.9) years; DAS28-CRP score, 4.51 (0.90); and modified total Sharp score (mTSS), 7.69 (9.98). At week 52, 77{\%} of patients achieved clinical remission (DAS28-CRP <2.6), 92.3{\%} achieved low disease activity (DAS28-CRP ≤3.2), and 86{\%} of evaluable patients experienced structural remission (ΔmTSS ≤0.5). Conclusion: Adalimumab plus methotrexate (≥12 mg/week) with adjustable dosing was well tolerated, and could be a beneficial treatment option for Japanese patients with early RA.",
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