Maintenance treatment using abatacept with dose reduction after achievement of low disease activity in patients with rheumatoid arthritis (MATADOR) - A prospective, multicenter, single arm pilot clinical trial.
OBJECTIVE
To preliminarily evaluate the feasibility of maintenance therapy with reduced dose of intravenous abatacept (ABT) to 250 mg/body/month after achieving remission or low disease activity (LDA).


METHODS
RA patients treated with ABT at 13 sites were enrolled in this prospective interventional pilot study during the period between March 2013 and March 2015. Inclusion criteria were (1) age at 20 years or older, (2) under treatment with monthly intravenous ABT at approved doses, (3) DAS28-CRP lower than 2.7 at least for 6 months, (4) agreed to join this trial with written informed consent and (5) body weight under 125 kg. Enrolled patients were maintained with intravenous monthly ABT at a reduced dose of 250 mg/body (MATADOR protocol). The primary end point was the proportion of the patients continued with MATADOR protocol at week 48. MATADOR protocol was discontinued upon disease flare or other reasons such as patients' request or severe adverse event (AE). Disease activities and structural changes were also evaluated.


RESULTS
Fifty-three patients fulfilled the entry criteria and were followed for 1-year. MATADOR protocol was continued for 1-year in 43 (81%) of the evaluated patients. Three patients experienced severe AEs. Mean DAS28-CRP and remission rate were 1.56 and 88% when ABT reduced and 1.80 and 81% at 1-year, respectively. Structural remission was achieved in 34 out of 42 evaluated patients.


CONCLUSIONS
Reduced dose of intravenous ABT was proposed as a feasible choice for maintenance therapy for RA after achievement of remission/LDA, although further randomized trials would be awaited.
a Division of Rheumatology, Endocrinology and Nephrology , Hokkaido University Graduate School of Medicine , Sapporo , Japan.
Shinsuke
S
Yasuda
a Division of Rheumatology, Endocrinology and Nephrology , Hokkaido University Graduate School of Medicine , Sapporo , Japan.
Kazumasa
K
Ohmura
b Department of Rheumatology , Aomori Prefectural Central Hospital , Aomori , Japan.
Hiroshi
H
Kanazawa
a Division of Rheumatology, Endocrinology and Nephrology , Hokkaido University Graduate School of Medicine , Sapporo , Japan.
Takashi
T
Kurita
c Department of Internal Medicine , Takikawa Municipal Hospital , Takikawa , Japan.
Yujiro
Y
Kon
d Department of Hematology and Rheumatology , Tohoku University Graduate School of Medicine , Sendai , Japan.
Tomonori
T
Ishii
a Division of Rheumatology, Endocrinology and Nephrology , Hokkaido University Graduate School of Medicine , Sapporo , Japan.|e Department of Internal Medicine , Tomakomai City Hospital , Tomakomai , Japan.
Yuichiro
Y
Fujieda
e Department of Internal Medicine , Tomakomai City Hospital , Tomakomai , Japan.
Satoshi
S
Jodo
f Hokkaido Medical Center for Rheumatic Diseases , Sapporo , Japan.
Kazuhide
K
Tanimura
g Department of Rheumatology and Orthopaedic Surgery , Hokkaido Orthopaedic Memorial Hospital , Sapporo , Japan.
Michio
M
Minami
h Higashisendai Rheumatic Disease Clinic , Sendai , Japan.
Tomomasa
T
Izumiyama
i Division of Rheumatology , Kin-ikyo Chuo Hospital , Sapporo , Japan.
Takumi
T
Matsumoto
j The Center for Rheumatic Diseases, Tonan Hospital , Sapporo , Japan.
Yoshiharu
Y
Amasaki
k Izumi Himawari Clinic , Sendai , Japan.
Yoko
Y
Suzuki
l NTT Sapporo Medical Center , Sapporo , Japan.
Hideki
H
Kasahara
m Kiyota Hospital , Sapporo , Japan.
Naofumi
N
Yamauchi
a Division of Rheumatology, Endocrinology and Nephrology , Hokkaido University Graduate School of Medicine , Sapporo , Japan.
Masaru
M
Kato
n Faculty of Health Sciences , Hokkaido University , Sapporo , Japan.
Tamotsu
T
Kamishima
c Department of Internal Medicine , Takikawa Municipal Hospital , Takikawa , Japan.
Akito
A
Tsutsumi
b Department of Rheumatology , Aomori Prefectural Central Hospital , Aomori , Japan.
Hiromitsu
H
Takemori
l NTT Sapporo Medical Center , Sapporo , Japan.
Takao
T
Koike
a Division of Rheumatology, Endocrinology and Nephrology , Hokkaido University Graduate School of Medicine , Sapporo , Japan.
Tatsuya
T
Atsumi
D000069594:Abatacept / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D000328:Adult; D000368:Aged; D018501:Antirheumatic Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D001172:Arthritis, Rheumatoid / Q000188:drug therapy*; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D010865:Pilot Projects; D012074:Remission Induction
D018501:Antirheumatic Agents; D000069594:Abatacept
Rheumatoid arthritis; abatacept; dose reduction; low disease activity; maintenance