Ranganath Veena K, La Cava Antonio, Vangala Sitaram, Brook Jenny, Kermani Tanaz A, Furst Daniel E, Taylor Mihaela, Kaeley Gurjit S, Carpenter Catherine, Elashoff David A, Li Zhaoping
Department of Medicine, University of California, Los Angeles, David Geffen School of Medicine, Los Angeles, CA.
Department of Medicine, University of Washington, Seattle, WA, USA.
Rheumatology (Oxford). 2023 Feb 1;62(2):565-574. doi: 10.1093/rheumatology/keac307.
To examine whether a weight loss intervention programme improves RA disease activity and/or musculoskeletal ultrasound synovitis measures in obese RA patients.
We conducted a proof-of-concept, 12-week, single-blind, randomized controlled trial of obese RA patients (BMI ≥ 30) with 28-joint DAS (DAS28) ≥ 3.2 and with evidence of power Doppler synovitis. Forty patients were randomized to the diet intervention (n = 20) or control group (n = 20). Diet intervention consisted of a hypocaloric diet of 1000-1500 kcal/day and high protein meal replacements. Co-primary outcomes included change in DAS28 and power Doppler ultrasound (PDUS)-34. Clinical disease activity, imaging, biomarkers, adipokines and patient-reported outcomes were monitored throughout the trial. Recruitment terminated early. All analyses were based on intent-to-treat for a significance level of 0.05.
The diet intervention group lost an average 9.5 kg/patient, while the control group lost 0.5 kg (P < 0.001). Routine Assessment of Patient Index Data 3 (RAPID3) improved, serum leptin decreased and serum adiponectin increased significantly within the diet group and between the groups (all P < 0.03). DAS28 decreased, 5.2 to 4.2, within the diet group (P < 0.001; -0.51 [95% CI -1.01, 0.00], P = 0.056, between groups). HAQ-Disability Index (HAQ-DI) improved significantly within the diet group (P < 0.04; P = 0.065 between group). Ultrasound measures and the multi-biomarker disease activity score did not differ between groups (PDUS-34 -2.0 [95% CI -7.00, 3.1], P = 0.46 between groups).
Obese RA patients on the diet intervention achieved weight loss. There were significant between group improvements for RAPID3, adiponectin and leptin levels, and positive trends for DAS28 and HAQ-DI. Longer-term, larger weight loss studies are needed to validate these findings, and will allow for further investigative work to improve the clinical management of obese RA patients.
ClinicalTrials.gov, https://clinicaltrials.gov, NCT02881307.
研究减肥干预方案是否能改善肥胖类风湿关节炎（RA）患者的疾病活动度和/或肌肉骨骼超声滑膜炎指标。
我们对肥胖RA患者（体重指数[BMI]≥30）开展了一项概念验证性、为期12周的单盲随机对照试验，这些患者的28个关节疾病活动评分（DAS28）≥3.2且有能量多普勒滑膜炎证据。40例患者被随机分为饮食干预组（n = 20）或对照组（n = 20）。饮食干预包括每天1000 - 1500千卡的低热量饮食和高蛋白代餐。共同主要结局包括DAS28和能量多普勒超声（PDUS）-34的变化。在整个试验过程中监测临床疾病活动度、影像学、生物标志物、脂肪因子和患者报告的结局。招募提前终止。所有分析均基于意向性治疗，显著性水平为0.05。
饮食干预组患者平均体重减轻9.5千克/人，而对照组体重减轻0.5千克（P < 0.001）。饮食组内以及两组之间患者指数数据3（RAPID3）常规评估得到改善，血清瘦素降低，血清脂联素显著升高（所有P < 0.03）。饮食组内DAS28从5.2降至4.2（P < 0.001；组间差异为-0.51[95%置信区间-1.01, 0.00]，P = 0.056）。饮食组内健康评估问卷残疾指数（HAQ-DI）显著改善（P < 0.04；组间差异P = 0.065）。两组之间超声指标和多生物标志物疾病活动评分无差异（PDUS-34差异为-2.0[95%置信区间-7.00, 3.1]，组间差异P = 0.46）。
接受饮食干预的肥胖RA患者实现了体重减轻。两组之间在RAPID3、脂联素和瘦素水平方面有显著改善，DAS28和HAQ-DI有积极趋势。需要开展更长期、更大规模的减肥研究来验证这些发现，并将有助于开展进一步的调查工作以改善肥胖RA患者的临床管理。
ClinicalTrials.gov，https://clinicaltrials.gov，NCT02881307
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