Tolerability and efficacy of abatacept in Japanese patients with rheumatoid arthritis: a phase I study

被引：9

作者：

Matsubara, Tsukasa ^{[1
]}

Yamana, Seizo ^{[2
]}

Tohma, Shigeto ^{[3
]}

Takeuchi, Tsutomu ^{[4
]}

Kondo, Hirobumi ^{[5
]}

Kohsaka, Hitoshi ^{[6
,7
]}

Ozaki, Shoichi ^{[8
]}

Hashimoto, Hiroshi ^{[9
]}

Miyasaka, Nobuyuki ^{[6
,7
]}

Yamamoto, Ami ^{[10
]}

Hiraoka, Masaki ^{[10
]}

Abe, Tohru ^{[11
]}

机构：

[1] Matsubara Mayflower Hosp, Dept Orthoped, Kato, Hyogo 6731462, Japan

[2] Higashihiroshima Mem Hosp, Ctr Rheumat Dis, Higashihiroshima, Hiroshima 7390002, Japan

[3] Natl Hosp Org, Sagamihara Natl Hosp, Clin Res Ctr Allergy & Rheumatol, Dept Rheumatol,Minami Ku, Sagamihara, Kanagawa 2520392, Japan

[4] Keio Univ, Sch Med, Dept Internal Med, Div Rheumatol,Shinjuku Ku, Tokyo 1608582, Japan

[5] Kitasato Univ, Sch Med, Dept Internal Med, Sagamihara, Kanagawa 2288555, Japan

[6] Tokyo Med & Dent Univ, Dept Med & Rheumatol, Bunkyo Ku, Tokyo 1138519, Japan

[7] Tokyo Med & Dent Univ, Grad Sch Med & Dent Sci, Global Ctr Excellence, Bunkyo Ku, Tokyo 1138519, Japan

[8] St Marianna Univ, Sch Med, Dept Internal Med, Div Rheumatol & Allergol,Miyamae Ku, Kawasaki, Kanagawa 2168511, Japan

[9] Juntendo Tokyo Koto Geriatr Med Ctr, Dept Rheumatol, Koto Ku, Tokyo 1360075, Japan

[10] Bristol Myers KK, Shinjuku Ku, Tokyo 1631328, Japan

[11] Saitama Med Ctr Sch, Div Rheumatol, Kawagoe, Saitama 3508550, Japan

来源：

MODERN RHEUMATOLOGY | 2013年 / 23卷 / 04期

关键词：

Abatacept; Immunogenicity; Phase I study; Rheumatoid arthritis; Tolerability; COSTIMULATION MODULATOR ABATACEPT; ANTITUMOR NECROSIS FACTOR; FUSION PROTEIN; CONCOMITANT METHOTREXATE; MONOCLONAL-ANTIBODY; REVISED CRITERIA; CLASSIFICATION; IMPROVEMENT; INFLIXIMAB; PLACEBO;

D O I：

10.1007/s10165-012-0722-x

中图分类号：

R5 [内科学];

学科分类号：

1002 ; 100201 ;

摘要：

Objective The primary objective of this study was to evaluate the tolerability of single and multiple doses of abatacept in Japanese patients with rheumatoid arthritis. Secondary objectives included evaluating its pharmacokinetics, pharmacodynamics, immunogenicity, and efficacy. Methods This dose-escalation, single- and multiple-dose, multicenter, open-label study was conducted at nine sites in Japan. Seven patients were enrolled at each of three dose levels (2, 8 and 16 mg/kg) and received a single intravenous dose of abatacept on day 1 of the single-dose phase. The multiple-dose phase, at the same dose, started once the patients had completed the single-dose phase and when it was confirmed that there were no safety issues. Results Twenty patients started the single-dose phase. Single and multiple doses of abatacept were well tolerated, and adverse events were of mild to moderate intensity. There were no discontinuations or deaths due to adverse events. The pharmacokinetics of abatacept were linear, with no notable accumulation. There were no immunogenic effects on the safety, efficacy, or pharmacokinetics of abatacept. Multiple doses of abatacept improved individual items of the American College of Rheumatology core set. Conclusion Single and multiple doses of abatacept showed favorable tolerability and efficacy in Japanese patients with rheumatoid arthritis.

引用

页码：634 / 645

页数：12

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