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Effectiveness and safety of initiating adalimumab plus ≥12mg/week methotrexate with adjustable dosing in biologic-naïve patients with early rheumatoid arthritis: HAWK study postmarketing surveillance in Japan.
- Source :
-
Modern Rheumatology . Jul2019, Vol. 29 Issue 4, p572-580. 9p. - Publication Year :
- 2019
-
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. [ABSTRACT FROM AUTHOR]
- Subjects :
- *ADALIMUMAB
*METHOTREXATE
*RHEUMATOID arthritis
*C-reactive protein
*PATIENTS
Subjects
Details
- Language :
- English
- ISSN :
- 14397595
- Volume :
- 29
- Issue :
- 4
- Database :
- Academic Search Index
- Journal :
- Modern Rheumatology
- Publication Type :
- Academic Journal
- Accession number :
- 152608379
- Full Text :
- https://doi.org/10.1080/14397595.2018.1500979