RT Journal Article
SR Electronic
T1 Abatacept in combination with methotrexate in Japanese biologic-naive patients with active rheumatoid arthritis: a randomised placebo-controlled phase IV study
JF RMD Open
JO RMD Open
FD EULAR
SP e000813
DO 10.1136/rmdopen-2018-000813
VO 4
IS 2
A1 Matsubara, Tsukasa
A1 Inoue, Hiroshi
A1 Nakajima, Toshihiro
A1 Tanimura, Kazuhide
A1 Sagawa, Akira
A1 Sato, Yukio
A1 Osano, Kei
A1 Nagano, Shuji
A1 Ueki, Yukitaka
A1 Hanyu, Tadamasa
A1 Hashizume, Koichi
A1 Amano, Norihito
A1 Tanaka, Yoshiya
A1 Takeuchi, Tsutomu
YR 2018
UL http://rmdopen.bmj.com/content/4/2/e000813.abstract
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 non-progression rates (change in vdH-mTSS≤smallest detectable change (1.9)) 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 Compared 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.