TY - JOUR
T1 - Effectiveness and safety of initiating adalimumab plus ≥12 mg/week methotrexate with adjustable dosing in biologic-naïve patients with early rheumatoid arthritis
T2 - HAWK study postmarketing surveillance in Japan
AU - Tanaka, Yoshiya
AU - Mimori, Tsuneyo
AU - Yamanaka, Hisashi
AU - Nakajima, Ryo
AU - Morita, Kazuo
AU - Kimura, Junko
AU - Takeuchi, Tsutomu
N1 - Funding Information:
Yoshiya Tanaka has received speaking fees and/or honoraria from Daiichi Sankyo, Astellas, Eli Lilly, Chugai, Sanofi, AbbVie, YL Biologics, Bristol-Myers Squibb, GlaxoSmithKline, UCB, Mitsubishi Tanabe, Novartis, Eisai, Takeda, Janssen, Asahi Kasei and has received research grants from Mitsubishi Tanabe, Bristol-Myers Squibb, Eisai, Chugai, Takeda, AbbVie, Astellas, Daiichi Sankyo, Ono, MSD, and Taisho Toyama.
Funding Information:
Hisashi Yamanaka has received research grants from AbbVie GK, Bristol-Myers Squibb, Chugai, Eisai, Janssen, Mitsubishi Tanabe, Otsuka, Pfizer, Takeda, and UCB; has received consulting fees from AbbVie GK, Bristol-Myers Squibb, Chugai, Eisai, Janssen, Mitsubishi Tanabe, Otsuka, Pfizer, Takeda, and UCB; and has received speakers bureau fees from AbbVie GK, Bristol-Myers Squibb, Chugai, Eisai, Janssen, Mitsubishi Tanabe, Otsuka, Pfizer, Takeda, and UCB.
Funding Information:
Tsuneyo Mimori has received grants and research supports from Astellas, AYUMI, Chugai, Daiichi Sankyo, Eisai, Nippon Kayaku, Mitsubishi Tanabe, Pfizer, and Sanofi, and has received speaker fees from Bristol-Myers Squibb, Chugai, and Mitsubishi Tanabe.
Funding Information:
Tsutomu Takeuchi has received research grants from Astellas, Chugai, Daiichi Sankyo, Takeda, AbbVie, Asahi Kasei, Mitsubishi Tanabe, Pfizer, Eisai, AYUMI, Nippon Kayaku, and Novartis; has received speaker fees from AbbVie, Bristol-Myers Squibb, Chugai, Mitsubishi Tanabe, Pfizer, Astellas, Daiichi Sankyo, Eisai, Sanofi, Teijin, Takeda, and Novartis; and has received consultant fees from AstraZeneca, Eli Lilly, Novartis, Mitsubishi Tanabe, AbbVie, Nippon Kayaku, Janssen, Astellas, Taiho, Chugai, Taisho Toyama, GlaxoSmithKline, and UCB.
Funding Information:
This study (NCT01736189) was funded by AbbVie GK and Eisai Co., Ltd. AbbVie participated in the collection, analysis, and interpretation of the data, and in the drafting, review, and approval of the manuscript. AbbVie GK and Eisai Co., Ltd. provided funding to EPS Corporation for data analysis and to Cactus Communications for editorial assistance.
PY - 2019/7/4
Y1 - 2019/7/4
N2 - 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.
AB - 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.
KW - Adalimumab
KW - effectiveness
KW - methotrexate
KW - postmarketing surveillance
KW - rheumatoid arthritis
UR - http://www.scopus.com/inward/record.url?scp=85053402357&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85053402357&partnerID=8YFLogxK
U2 - 10.1080/14397595.2018.1500979
DO - 10.1080/14397595.2018.1500979
M3 - Article
C2 - 30009649
AN - SCOPUS:85053402357
VL - 29
SP - 572
EP - 580
JO - Modern Rheumatology
JF - Modern Rheumatology
SN - 1439-7595
IS - 4
ER -