Concomitant iguratimod therapy in patients with active rheumatoid arthritis despite stable doses of methotrexate: a randomized, double-blind, placebo-controlled trial

被引：113

作者：

Ishiguro, Naoki ^{[1
]}

Yamamoto, Kazuhiko ^{[2
]}

Katayama, Kou ^{[3
]}

Kondo, Masakazu ^{[4
]}

Sumida, Takayuki ^{[5
]}

Mimori, Tsuneyo ^{[6
]}

Soen, Satoshi ^{[7
]}

Nagai, Kota ^{[8
]}

Yamaguchi, Tomonobu ^{[9
]}

Hara, Masako ^{[10
]}

机构：

[1] Nagoya Univ, Grad Sch Med, Dept Orthopaed Surg & Rheumatol, Showa Ku, Nagoya, Aichi 4668550, Japan

[2] Univ Tokyo, Grad Sch Med, Dept Allergy & Rheumatol, Tokyo, Japan

[3] Katayama Orthoped Rheumatol Clin, Asahikawa, Hokkaido, Japan

[4] Kondo Clin Rheumatol & Orthopaed Surg, Fukuoka, Japan

[5] Univ Tsukuba, Fac Med, Dept Internal Med, Tsukuba, Ibaraki, Japan

[6] Kyoto Univ, Grad Sch Med, Dept Rheumatol & Clin Immunol, Kyoto, Japan

[7] Kinki Univ, Sch Med, Dept Orthopaed Surg & Rheumatol, Nara Hosp, Ikoma, Japan

[8] Eisai & Co Ltd, Tokyo, Japan

[9] Toyama Chem Co Ltd, Tokyo, Japan

[10] Tokyo Womens Med Univ, Inst Rheumatol, Tokyo, Japan

来源：

MODERN RHEUMATOLOGY | 2013年 / 23卷 / 03期

关键词：

Disease-modifying antirheumatic drug; Iguratimod; Methotrexate; Rheumatoid arthritis; T-614; KAPPA-B ACTIVATION; CYTOKINE PRODUCTION; AGENT T-614; RECOMMENDATIONS; CELLS; DRUG;

D O I：

10.1007/s10165-012-0724-8

中图分类号：

R5 [内科学];

学科分类号：

100201 [内科学];

摘要：

To investigate the efficacy and safety of iguratimod (T-614) in Japanese patients with active rheumatoid arthritis who had inadequate response to stable background methotrexate (MTX) alone. In this multicenter, double-blind, controlled trial, a total of 253 patients were randomized at 2:1 ratio to either the iguratimod group or the placebo group. Iguratimod was orally administered at dosages of 25 mg/day for the first 4 weeks (25 mg once daily) and 50 mg/day for the subsequent 20 weeks (25 mg twice daily). MTX at dosage of 6 or 8 mg/week was administered to patients in both groups. The rate of 20 % improvement in American College of Rheumatology criteria (ACR20) at week 24 was 69.5 % in the iguratimod group compared with 30.7 % in the placebo group (P < 0.001). Significant improvements in the ACR50, ACR70, Health Assessment Questionnaire Disability Index, Disease Activity Score 28 < 3.2, and rheumatoid factor were also observed. The most commonly reported adverse events (AEs) were blood iron decrease, nasopharyngitis, and lymphocyte decrease. These AEs were mild or moderate in severity. No deaths occurred. The study results suggest that iguratimod in combination with MTX was efficacious and had a manageable safety profile.

引用

页码：430 / 439

页数：10

共 29 条

[1]

An anti-rheumatic agent T-614 inhibits NF-κB activation in LPS- and TNF-α-stimulated THP-1 cells without interfering with 1κBα degradation [J].