Inui Kentaro, Koike Tatsuya, Tada Masahiro, Sugioka Yuko, Okano Tadashi, Mamoto Kenji, Sakawa Akira, Fukushima Kenzo, Nakamura Hiroaki
Department of Rheumatosurgery Department of Orthopaedic Surgery Center for Senile Degenerative Disorders, Osaka City University Medical School, Abeno-ku, Osaka Search Institute for Bone and Arthritis Disease (SINBAD), Shirahama Foundation for Health and Welfare, Shirahama-cho, Wakayama Department of Orthopaedic Surgery, Osaka City General Hospital, Miyakojima-ku Department of Orthopaedic Surgery, Osaka City Juso Hospital, Yodogawa-ku Orthopaedic Surgery, Fujiidera Municipal Hospital, Fujiidera City, Osaka, Japan.
Medicine (Baltimore). 2018 Sep;97(38):e12462. doi: 10.1097/MD.0000000000012462.
To reduce costs of biological disease-modifying antirheumatic drugs (bDMARDs), we evaluated the efficacy of repeated etanercept (ETN) discontinuation and restarting in rheumatoid arthritis (RA) patients in a case-control study.Thirty-one bDMARD-naive RA patients with moderate to high disease activity received ETN until low disease activity (LDA) was achieved, after which ETN was discontinued. Upon flaring, ETN was readministered with observation every 2 months for 2 years, and radiographically evaluated in comparison with a historical control group treated continuously with ETN. Statistical methods including Fisher exact test, analysis of variance (ANOVA), Kruskal-Wallis test, multiple regression analysis, and Student t test were conducted as appropriate.Thirteen patients with inadequate response to ETN were withdrawn from the study, and 5 had no flare-up after ETN discontinuation. In the remaining 13 patients, ETN was used on-demand to maintain LDA. Multivariate analysis revealed that MTX was significantly correlated with ETN. All 13 patients achieved LDA at final follow-up. Although joint damage progressed in patients using ETN on-demand, structural damage progression in the on-demand group was not significantly different from that in controls.On-demand use of ETN for flaring reduced disease activity but not structural damage in 50% of patients (though not significantly). However, inhibition of joint damage was achieved in 50% of patients after 2 years, supporting on-demand use of ETN as a treatment option for patients with RA who cannot afford bDMARD or targeted synthetic DMARD therapy.
为降低生物性改善病情抗风湿药(bDMARDs)的成本,我们在一项病例对照研究中评估了类风湿关节炎(RA)患者重复停用和重新使用依那西普(ETN)的疗效。31例初治的中高疾病活动度RA患者接受ETN治疗,直至达到低疾病活动度(LDA),之后停用ETN。病情复发时,重新给予ETN,每2个月观察1次,持续2年,并与持续接受ETN治疗的历史对照组进行影像学评估。根据情况采用包括Fisher精确检验、方差分析(ANOVA)、Kruskal-Wallis检验、多元回归分析和Student t检验在内的统计方法。13例对ETN反应不足的患者退出研究,5例在停用ETN后未出现病情复发。在其余13例患者中,按需使用ETN以维持LDA。多变量分析显示甲氨蝶呤(MTX)与ETN显著相关。所有13例患者在末次随访时均达到LDA。尽管按需使用ETN的患者关节损伤有所进展,但按需使用组的结构损伤进展与对照组无显著差异。按需使用ETN治疗病情复发可降低50%患者的疾病活动度,但对结构损伤无明显改善(尽管差异不显著)。然而,2年后50%的患者关节损伤得到抑制,这支持按需使用ETN作为无法负担bDMARD或靶向合成DMARD治疗的RA患者的一种治疗选择。