TY - JOUR
T1 - Abatacept in combination with methotrexate in Japanese biologic-naive patients with active rheumatoid arthritis
T2 - A randomised placebocontrolled phase IV study
AU - Matsubara, Tsukasa
AU - Inoue, Hiroshi
AU - Nakajima, Toshihiro
AU - Tanimura, Kazuhide
AU - Sagawa, Akira
AU - Sato, Yukio
AU - Osano, Kei
AU - Nagano, Shuji
AU - Ueki, Yukitaka
AU - Hanyu, Tadamasa
AU - Hashizume, Koichi
AU - Amano, Norihito
AU - Tanaka, Yoshiya
AU - Takeuchi, Tsutomu
N1 - Funding Information:
Competing interests tM received speaker honoraria from Pfizer Japan, nichi-iko, astellas, Meiji Seika, Bristol-Myers Squibb, abbVie gK, Janssen, chugai, eisai, aYUMi. Hi, aS, YS, KO, Sn and YU have nothing to disclose. tn received grants from Pfizer Japan, abbVie gK, eisai, aYUMi. Kt participated in speakers bureau for abbVie, astellas, Bristol-Myers Squibb, eisai, Mitsubishi tanabe. tH received grants from eli lilly, Bristol-Myers Squibb, abbVie. KH and na are employees of Bristol-Myers Squibb. Yt received speaking 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, taisho-toyama. tt received grants from astellas, chugai, Daiichi-Sankyo, takeda, abbVie gK, asahi Kasei, Mitsubishi tanabe, Pfizer Japan, eisai, aYUMi, nippon Kayaku, novartis K.K.; speaking fees from abbVie gK, Bristol-Myers Squibb K.K., chugai, Mitsubishi tanabe, Pfizer Japan, astellas, Daiichi-Sankyo, eisai, Sanofi K.K., teijin, takeda, novartis K.K. and consultant fees from astraZeneca K.K., eli lilly Japan K.K., novartis K.K., Mitsubishi tanabe, abbVie gK, nippon Kayaku, Janssen K.K., astellas, taiho, chugai, taisho toyama, glaxoSmithKline K.K., UcB Japan.
Funding Information:
1Department of Orthopedics, Matsubara Mayflower Hospital, Hyogo, Japan 2Department of Orthopaedic Surgery, inoue Hospital, gunma, Japan 3Department of rheumatology, Bay Side Misato Medical center, Kochi, Japan 4Department of locomotor Science, institute of Medical Science, tokyo Medical University, tokyo, Japan 5Department of rheumatology, Hokkaido Medical center for rheumatic Diseases, Sapporo, Japan 6akira Sagawa rheumatology clinic, Sapporo, Japan 7Sendai taihaku Hospital, Sendai, Japan 8Sendai Medical imaging clinic, Sendai, Japan 9Department of Orthopaedics, Fukuoka Mirai Hospital, Fukuoka, Japan 10Department of rheumatology, center for rheumatology, iizuka Hospital, Fukuoka, Japan 11rheumatic and collagen Disease center, Sasebo chuo Hospital, nagasaki, Japan 12Department of rheumatology, nagaoka red cross Hospital, niigata, Japan 13Bristol-Myers Squibb K.K, tokyo, Japan 14First Department of internal Medicine, University of Occupational and environmental Health, Kitakyushu, Japan 15Division of rheumatology, Department of internal Medicine, Keio University School of Medicine, tokyo, Japan Acknowledgements Professional medical writing and editorial assistance was provided by Sharon gladwin, PhD, and was funded by Bristol-Myers Squibb.
Publisher Copyright:
© Author(s) (or their employer(s)) 2018.
PY - 2018/12/1
Y1 - 2018/12/1
N2 - Objectives: To evaluate efficacy and safety of abatacept+methotrexate (MTX) in biologic-naive, anticitrullinated protein antibody (ACPA)-positive Japanese patients with active rheumatoid arthritis (RA) and early erosion versus placebo+MTX. Methods: In this phase IV, multicentre, double-blind study (NCT01758198), patients were randomised (1:1) to receive intravenous abatacept (~10 mg/kg) or placebo, plus MTX (≥6 mg/week). Primary efficacy objectives were to compare American College of Rheumatology 20 (ACR20) response rates at week 16 and mean change from baseline in van der Heijde-modified total Sharp score (vdH-mTSS) at week 24 between abatacept+MTX and placebo+MTX groups. Results: Overall, 203 and 202 patients received abatacept+MTX and placebo+MTX, respectively. At week 16, ACR20 response rates were higher in the abatacept (75.4%) versus placebo group (27.7%; p<0.001). Mean change from baseline in vdH-mTSS at week 24 was 0.84 in the abatacept and 1.26 in the placebo group (p=0.017). Radiographic nonprogression rates (change in vdH-mTSS≤smallest detectable change (2.4)) were 88.1% and 75.4% in abatacept and placebo groups, respectively. Adjusted mean change from baseline in Disease Activity Score 28 (C-reactive protein) (DAS28 (CRP)) at week 16 demonstrated a numerically greater reduction in the abatacept versus placebo group. Proportions of patients with DAS28 (CRP), Simplified Disease Activity Index and Clinical Disease Activity Index remission up to week 52 were higher in the abatacept versus placebo group. The abatacept safety profile was consistent with previous observations. Conclusions: C ompared with MTX alone, abatacept+MTX improved clinical symptoms and inhibited structural damage progression in ACPA-positive, Japanese patients with RA, early erosion and inadequate response to MTX.
AB - Objectives: To evaluate efficacy and safety of abatacept+methotrexate (MTX) in biologic-naive, anticitrullinated protein antibody (ACPA)-positive Japanese patients with active rheumatoid arthritis (RA) and early erosion versus placebo+MTX. Methods: In this phase IV, multicentre, double-blind study (NCT01758198), patients were randomised (1:1) to receive intravenous abatacept (~10 mg/kg) or placebo, plus MTX (≥6 mg/week). Primary efficacy objectives were to compare American College of Rheumatology 20 (ACR20) response rates at week 16 and mean change from baseline in van der Heijde-modified total Sharp score (vdH-mTSS) at week 24 between abatacept+MTX and placebo+MTX groups. Results: Overall, 203 and 202 patients received abatacept+MTX and placebo+MTX, respectively. At week 16, ACR20 response rates were higher in the abatacept (75.4%) versus placebo group (27.7%; p<0.001). Mean change from baseline in vdH-mTSS at week 24 was 0.84 in the abatacept and 1.26 in the placebo group (p=0.017). Radiographic nonprogression rates (change in vdH-mTSS≤smallest detectable change (2.4)) were 88.1% and 75.4% in abatacept and placebo groups, respectively. Adjusted mean change from baseline in Disease Activity Score 28 (C-reactive protein) (DAS28 (CRP)) at week 16 demonstrated a numerically greater reduction in the abatacept versus placebo group. Proportions of patients with DAS28 (CRP), Simplified Disease Activity Index and Clinical Disease Activity Index remission up to week 52 were higher in the abatacept versus placebo group. The abatacept safety profile was consistent with previous observations. Conclusions: C ompared with MTX alone, abatacept+MTX improved clinical symptoms and inhibited structural damage progression in ACPA-positive, Japanese patients with RA, early erosion and inadequate response to MTX.
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U2 - 10.1136/rmdopen-2018-000813
DO - 10.1136/rmdopen-2018-000813
M3 - Article
AN - SCOPUS:85058330048
VL - 4
JO - RMD Open
JF - RMD Open
SN - 2056-5933
IS - 2
M1 - e000813
ER -