Abstract
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.
| Original language | English |
|---|---|
| Article number | e000813 |
| Journal | RMD Open |
| Volume | 4 |
| Issue number | 2 |
| DOIs | |
| Publication status | Published - 2018 Dec 1 |
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ASJC Scopus subject areas
- Rheumatology
- Immunology and Allergy
- Immunology
Cite this
Abatacept in combination with methotrexate in Japanese biologic-naive patients with active rheumatoid arthritis : A randomised placebocontrolled phase IV study. / Matsubara, Tsukasa; Inoue, Hiroshi; Nakajima, Toshihiro; Tanimura, Kazuhide; Sagawa, Akira; Sato, Yukio; Osano, Kei; Nagano, Shuji; Ueki, Yukitaka; Hanyu, Tadamasa; Hashizume, Koichi; Amano, Norihito; Tanaka, Yoshiya; Takeuchi, Tsutomu.
In: RMD Open, Vol. 4, No. 2, e000813, 01.12.2018.Research output: Contribution to journal › Article
}
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
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.
UR - http://www.scopus.com/inward/record.url?scp=85058330048&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85058330048&partnerID=8YFLogxK
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 -