Institute of Infection, Immunity & Inflammation, University of Glasgow, Glasgow, UK.
Division of Rheumatology, IRCCS-Fondazione Policlinico Universitario A. Gemelli-Catholic University of the Sacred Heart, Rome, Italy.
RMD Open. 2019 May 30;5(1):e000934. doi: 10.1136/rmdopen-2019-000934. eCollection 2019.
This analysis of the phase III Active PSoriaTic Arthritis RAndomizEd TriAl (ASTRAEA) evaluated the effect of baseline body mass index (BMI) on subsequent response to subcutaneous (SC) abatacept in patients with psoriatic arthritis (PsA).
In ASTRAEA, patients with active PsA were randomised (1:1) to receive blinded weekly SC abatacept 125 mg or placebo for 24 weeks. Treatment response at week 24 was assessed by the proportions of patients achieving American College of Rheumatology 20% improvement response, Disease Activity Score in 28 joints (DAS28 (C reactive protein (CRP))) ≤3.6 and <2.6, Health Assessment Questionnaire-Disability Index reduction from baseline ≥0.35 and radiographic non-progression (defined as change from baseline ≤0 in PsA-modified total Sharp/van der Heijde score). Responses were stratified by baseline BMI (underweight/normal, <25 kg/m; overweight, 25-30 kg/m; obese, >30 kg/m) and compared in univariate and multivariate models.
Of 212/213 and 210/211 patients with baseline BMI data in the abatacept and placebo groups, respectively, 15% and 19% were underweight/normal, 36% and 27% were overweight, and 49% and 54% were obese. After adjusting for baseline characteristics, there were no significant differences for any outcome measure at week 24 with abatacept in the overweight or obese versus underweight/normal subgroup. In the placebo group, patients in the obese versus underweight/normal subgroup were significantly less likely to achieve DAS28 (CRP) <2.6 at week 24 (OR 0.26; 95% CI 0.08 to 0.87; p=0.03).
BMI does not impact clinical or radiographic response to SC abatacept in patients with PsA.
NCT01860976.
这项对 III 期主动银屑病关节炎随机化试验（ASTRAEA）的分析评估了基线体重指数（BMI）对接受皮下（SC）阿巴西普治疗的银屑病关节炎（PsA）患者后续反应的影响。
在 ASTRAEA 中，患有活动性 PsA 的患者按 1:1 比例随机分配，接受每周一次的 SC 阿巴西普 125mg 或安慰剂治疗 24 周。第 24 周时通过以下患者比例评估治疗反应：达到美国风湿病学会 20%改善反应、28 关节疾病活动度评分（DAS28（C 反应蛋白（CRP））≤3.6 和＜2.6、从基线起健康评估问卷残疾指数改善≥0.35 和影像学无进展（定义为从基线起 PsA 改良总 Sharp/van der Heijde 评分变化≤0）。根据基线 BMI（体重不足/正常，＜25kg/m；超重，25-30kg/m；肥胖，＞30kg/m）对反应进行分层，并在单变量和多变量模型中进行比较。
在接受阿巴西普和安慰剂治疗的患者中，分别有 212/213 和 210/211 名患者具有基线 BMI 数据，其中 15%和 19%体重不足/正常，36%和 27%超重，49%和 54%肥胖。在调整基线特征后，阿巴西普组在超重或肥胖亚组与体重不足/正常亚组相比，第 24 周时任何结局测量指标均无显著差异。在安慰剂组中，与体重不足/正常亚组相比，肥胖亚组患者第 24 周时达到 DAS28（CRP）＜2.6 的可能性显著更低（OR 0.26；95%CI 0.08 至 0.87；p=0.03）。
BMI 不影响接受 SC 阿巴西普治疗的 PsA 患者的临床或影像学反应。
NCT01860976。
