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体重指数对依那西普作为类风湿关节炎一线生物制剂的临床应答的影响:来自为期 2 年、观察性、前瞻性 ACTION 研究的 6 个月结果。

The effect of body mass index on clinical response to abatacept as a first-line biologic for rheumatoid arthritis: 6-month results from the 2-year, observational, prospective ACTION study.

机构信息

Université Paris-Sud, Hôpitaux Universitaires Paris-Sud, INSERM U1184, 63, rue Gabriel-Péri, 94270 Le Kremlin-Bicêtre, France.

Schlosspark-Klinik University Medicine, 14059 Berlin, Germany.

出版信息

Joint Bone Spine. 2017 Oct;84(5):571-576. doi: 10.1016/j.jbspin.2016.10.011. Epub 2016 Dec 30.

DOI:10.1016/j.jbspin.2016.10.011
PMID:28043761
Abstract

OBJECTIVE

To assess the impact of baseline body mass index (BMI) on the efficacy and retention of intravenous abatacept at 6 months in biologic-naïve patients with rheumatoid arthritis (RA).

METHODS

This was a 6-month analysis of a 2-year, non-interventional, international, prospective study. Baseline characteristics, clinical response and retention rates were compared by BMI subgroup: underweight/normal, overweight and obese (<25, 25 to <30 and ≥30kg/m, respectively).

RESULTS

BMI was reported in 643/672 (96%) patients: 264 (41%) were underweight/normal, 224 (35%) overweight and 155 (24%) obese. At baseline, the obese group had more active disease (mean [95% confidence intervals] 28-joint Disease Activity Score [C-reactive protein; derived] 4.6 [4.5, 4.7], 4.8 [4.7, 5.0] and 5.1 [4.9, 5.2] for underweight/normal, overweight and obese groups, respectively), a higher prevalence of metabolic disorders, a greater proportion of women and a lower proportion of patients with rheumatoid factor positivity. There were no significant differences in the percentages of patients achieving a good/moderate European League Against Rheumatism response by BMI group (80.7, 86.1 and 77.0% for underweight/normal, overweight and obese groups, respectively; P=0.178). Overall retention rates at 6 months did not differ across groups (89, 92 and 89% for underweight/normal, overweight and obese groups, respectively; log-rank P=0.382). After adjustment for baseline characteristics, BMI was not significantly associated with risk of discontinuation (reference BMI<25kg/m; hazard ratio [95% confidence intervals] 0.46 [0.22, 0.99] and 0.69 [0.34, 1.41] for overweight and obese patients, respectively).

CONCLUSION

BMI does not impact abatacept clinical response or retention in biologic-naïve patients with RA.

摘要

目的

评估基线体重指数(BMI)对生物初治类风湿关节炎(RA)患者静脉注射阿巴西普 6 个月时疗效和保留率的影响。

方法

这是一项为期 2 年、非干预性、国际性、前瞻性研究的 6 个月分析。根据 BMI 亚组(体重不足/正常、超重和肥胖组(<25、25 至<30 和≥30kg/m 2 )比较基线特征、临床反应和保留率。

结果

报告了 643/672(96%)例患者的 BMI:264(41%)例体重不足/正常,224(35%)例超重,155(24%)例肥胖。基线时,肥胖组疾病活动度更高(28 关节疾病活动评分[C 反应蛋白;推算]分别为 4.6[4.5,4.7]、4.8[4.7,5.0]和 5.1[4.9,5.2]),代谢紊乱患病率较高,女性比例较高,类风湿因子阳性患者比例较低。BMI 组达到欧洲抗风湿病联盟良好/中度反应的患者比例无显著差异(体重不足/正常、超重和肥胖组分别为 80.7%、86.1%和 77.0%;P=0.178)。6 个月时的总体保留率在各组之间无差异(体重不足/正常、超重和肥胖组分别为 89%、92%和 89%;对数秩检验 P=0.382)。调整基线特征后,BMI 与停药风险无显著相关性(参考 BMI<25kg/m 2 ;超重和肥胖患者的危险比[95%置信区间]分别为 0.46[0.22,0.99]和 0.69[0.34,1.41])。

结论

BMI 不影响生物初治 RA 患者阿巴西普的临床反应或保留率。

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