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

被引:7
作者
Yasuda, Shinsuke [1 ]
Ohmura, Kazumasa [1 ]
Kanazawa, Hiroshi [2 ]
Kurita, Takashi [1 ]
Kon, Yujiro [3 ]
Ishii, Tomonori [4 ]
Fujieda, Yuichiro [1 ,5 ]
Jodo, Satoshi [5 ]
Tanimura, Kazuhide [6 ]
Minami, Michio [7 ]
Izumiyama, Tomomasa [8 ]
Matsumoto, Takumi [9 ]
Amasaki, Yoshiharu [10 ]
Suzuki, Yoko [11 ]
Kasahara, Hideki [12 ]
Yamauchi, Naofumi [13 ]
Kato, Masaru [1 ]
Kamishima, Tamotsu [14 ]
Tsutsumi, Akito [3 ]
Takemori, Hiromitsu [2 ]
Koike, Takao [12 ]
Atsumi, Tatsuya [1 ]
机构
[1] Hokkaido Univ, Grad Sch Med, Div Rheumatol Endocrinol & Nephrol, Kita Ku, Sapporo, Hokkaido N15 W7, Japan
[2] Aomori Prefectural Cent Hosp, Dept Rheumatol, Aomori, Japan
[3] Takikawa Municipal Hosp, Dept Internal Med, Takikawa, Hokkaido, Japan
[4] Tohoku Univ, Grad Sch Med, Dept Hematol & Rheumatol, Sendai, Miyagi, Japan
[5] Tomakomai City Hosp, Dept Internal Med, Tomakomai, Japan
[6] Hokkaido Med Ctr Rheumat Dis, Sapporo, Hokkaido, Japan
[7] Hokkaido Orthopaed Mem Hosp, Dept Rheumatol & Orthopaed Surg, Sapporo, Hokkaido, Japan
[8] Higashisendai Rheumat Dis Clin, Sendai, Miyagi, Japan
[9] Kinikyo Chuo Hosp, Div Rheumatol, Sapporo, Hokkaido, Japan
[10] Tonan Hosp, Ctr Rheumat Dis, Sapporo, Hokkaido, Japan
[11] Izumi Himawari Clin, Sendai, Miyagi, Japan
[12] NTT Sapporo Med Ctr, Sapporo, Hokkaido, Japan
[13] Kiyota Hosp, Sapporo, Hokkaido, Japan
[14] Hokkaido Univ, Fac Hlth Sci, Sapporo, Hokkaido, Japan
关键词
Rheumatoid arthritis; dose reduction; low disease activity; maintenance; abatacept; RHEUMATOLOGY/EUROPEAN LEAGUE; CLASSIFICATION CRITERIA; AMERICAN-COLLEGE; FREE REMISSION; DOUBLE-BLIND; DISCONTINUATION; POSITIVITY; ETANERCEPT; WITHDRAWAL; 12-MONTH;
D O I
10.1080/14397595.2017.1286714
中图分类号
R5 [内科学];
学科分类号
1002 ; 100201 ;
摘要
Objectives: To preliminarily evaluate the feasibility of maintenance therapy with reduced dose of intravenous abatacept (ABT) to 250mg/body/month after achieving remission or low disease activity (LDA).Patients and 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 125kg. Enrolled patients were maintained with intravenous monthly ABT at a reduced dose of 250mg/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.
引用
收藏
页码:930 / 937
页数:8
相关论文
共 22 条
[1]  
Aletaha D, 2010, ANN RHEUM DIS, V69, P1580, DOI [10.1136/ard.2010.138461, 10.1002/art.27584]
[2]   2010 Rheumatoid Arthritis Classification Criteria An American College of Rheumatology/European League Against Rheumatism Collaborative Initiative [J].
Aletaha, Daniel ;
Neogi, Tuhina ;
Silman, Alan J. ;
Funovits, Julia ;
Felson, David T. ;
Bingham, Clifton O., III ;
Birnbaum, Neal S. ;
Burmester, Gerd R. ;
Bykerk, Vivian P. ;
Cohen, Marc D. ;
Combe, Bernard ;
Costenbader, Karen H. ;
Dougados, Maxime ;
Emery, Paul ;
Ferraccioli, Gianfranco ;
Hazes, Johanna M. W. ;
Hobbs, Kathryn ;
Huizinga, Tom W. J. ;
Kavanaugh, Arthur ;
Kay, Jonathan ;
Kvien, Tore K. ;
Laing, Timothy ;
Mease, Philip ;
Menard, Henri A. ;
Moreland, Larry W. ;
Naden, Raymond L. ;
Pincus, Theodore ;
Smolen, Josef S. ;
Stanislawska-Biernat, Ewa ;
Symmons, Deborah ;
Tak, Paul P. ;
Upchurch, Katherine S. ;
Vencovsky, Jiri ;
Wolfe, Frederick ;
Hawker, Gillian .
ARTHRITIS AND RHEUMATISM, 2010, 62 (09) :2569-2581
[3]   Abatacept (CTLA-4IG) treatment reduces the migratory capacity of monocytes in patients with rheumatoid arthritis [J].
Bonelli, M. ;
Ferner, E. ;
Goeschl, L. ;
Blueml, S. ;
Hladik, A. ;
Karonitsch, T. ;
Kiener, H. P. ;
Byrne, R. ;
Niederreiter, B. ;
Steiner, C. W. ;
Rath, E. ;
Bergmann, M. ;
Smolen, J. S. ;
Scheinecker, C. .
ARTHRITIS AND RHEUMATISM, 2013, 65 (03) :599-607
[4]   T Cell Costimulation Molecules CD80/86 Inhibit Osteoclast Differentiation by Inducing the IDO/Tryptophan Pathway [J].
Bozec, Aline ;
Zaiss, Mario M. ;
Kagwiria, Rosebeth ;
Voll, Reinhard ;
Rauh, Manfred ;
Chen, Zhu ;
Mueller-Schmucker, Sandra ;
Kroczek, Richard A. ;
Heinzerling, Lucie ;
Moser, Muriel ;
Mellor, Andrew L. ;
David, Jean-Pierre ;
Schett, Georg .
SCIENCE TRANSLATIONAL MEDICINE, 2014, 6 (235)
[5]   A multicentre, randomised, controlled, open-label pilot study on the feasibility of discontinuation of adalimumab in established patients with rheumatoid arthritis in stable clinical remission [J].
Chatzidionysiou, Katerina ;
Turesson, Carl ;
Teleman, Annika ;
Knight, Ann ;
Lindqvist, Elisabet ;
Larsson, Per ;
Coster, Lars ;
Forslind, Kristina ;
van Vollenhoven, Ronald ;
Heimburger, Mikael .
RMD OPEN, 2016, 2 (01)
[6]   Evaluating drug-free remission with abatacept in early rheumatoid arthritis: results from the phase 3b, multicentre, randomised, active-controlled AVERT study of 24 months, with a 12-month, double-blind treatment period [J].
Emery, Paul ;
Burmester, Gerd R. ;
Bykerk, Vivian P. ;
Combe, Bernard G. ;
Furst, Daniel E. ;
Barre, Emilie ;
Karyekar, Chetan S. ;
Wong, Dennis A. ;
Huizinga, Tom W. J. .
ANNALS OF THE RHEUMATIC DISEASES, 2015, 74 (01) :19-26
[7]   Withdrawal of biologic agents in rheumatoid arthritis: a systematic review and meta-analysis [J].
Galvao, Tais Freire ;
Zimmermann, Ivan Ricardo ;
Henrique da Mota, Licia Maria ;
Silva, Marcus Tolentino ;
Pereira, Mauricio Gomes .
CLINICAL RHEUMATOLOGY, 2016, 35 (07) :1659-1668
[8]   Stopping Tumor Necrosis Factor Inhibitor Treatment in Patients With Established Rheumatoid Arthritis in Remission or With Stable Low Disease Activity [J].
Moghadam, Marjan Ghiti ;
Vonkeman, Harald E. ;
ten Klooster, Peter M. ;
Tekstra, Janneke ;
van Schaardenburg, Dirkjan ;
Starmans-Kool, Mirian ;
Brouwer, Elisabeth ;
Bos, Reinhard ;
Lems, Willem F. ;
Colin, Edgar M. ;
Allaart, Cornelia F. ;
Meek, Inger L. ;
Landewe, Robert ;
Moens, Hein J. Bernelot ;
van Riel, Piet L. C. M. ;
van de Laar, Mart A. F. J. ;
Jansen, Tim L. .
ARTHRITIS & RHEUMATOLOGY, 2016, 68 (08) :1810-1817
[9]   Association of Rheumatoid Factor and Anti-Citrullinated Protein Antibody Positivity With Better Effectiveness of Abatacept: Results From the Pan-European Registry Analysis [J].
Gottenberg, J. E. ;
Courvoisier, D. S. ;
Hernandez, M. V. ;
Iannone, F. ;
Lie, E. ;
Canhao, H. ;
Pavelka, K. ;
Hetland, M. L. ;
Turesson, C. ;
Mariette, X. ;
Finckh, A. .
ARTHRITIS & RHEUMATOLOGY, 2016, 68 (06) :1346-1352
[10]   Positivity for anti-cyclic citrullinated peptide is associated with a better response to abatacept: data from the 'Orencia and Rheumatoid Arthritis' registry [J].
Gottenberg, J. E. ;
Ravaud, P. ;
Cantagrel, A. ;
Combe, B. ;
Flipo, R. M. ;
Schaeverbeke, T. ;
Houvenagel, E. ;
Gaudin, P. ;
Loeuille, D. ;
Rist, S. ;
Dougados, M. ;
Sibilia, J. ;
Le Loet, X. ;
Marcelli, C. ;
Bardin, T. ;
Pane, I. ;
Baron, G. ;
Mariette, X. .
ANNALS OF THE RHEUMATIC DISEASES, 2012, 71 (11) :1815-1819