Tuckwell Katie, Collinson Neil, Dimonaco Sophie, Klearman Micki, Blockmans Daniel, Brouwer Elisabeth, Cid Maria C, Dasgupta Bhaskar, Rech Juergen, Salvarani Carlo, Unizony Sebastian H, Stone John H
Roche Products Ltd., Welwyn Garden City, UK.
Genentech, South San Francisco, CA.
Semin Arthritis Rheum. 2017 Apr;46(5):657-664. doi: 10.1016/j.semarthrit.2016.11.002. Epub 2016 Nov 15.
To report entry criteria and clinical features of patients with newly diagnosed and relapsing giant cell arteritis (GCA) enrolled in a randomized trial of tocilizumab, an interleukin-6 receptor-alpha inhibitor.
Newly diagnosed GCA was defined as diagnosis ≤6 weeks before baseline. Relapsing GCA was defined as diagnosis >6 weeks before baseline with ≥2 consecutive weeks of prednisone ≥40mg/day. All patients had active GCA within 6 weeks of baseline. All statistical results are exploratory.
Of 251 patients, 119 (47%) had newly diagnosed and 132 (53%) had relapsing GCA. Mean age was 69 years in both subsets; 75% were women. Relapsing patients were heavier [difference in means (95% CI): women, 4.18kg (0.49-7.87, P = 0.027); men, 8.25kg (1.42-15.09, P = 0.019)] and had higher mean body mass index [difference in means (95% CI): women, 1.72kg/m (0.44-2.99, P = 0.009); men, 2.85kg/m (0.3-5.37, P = 0.028)]. Relapsers had higher baseline prevalence of depression (16% vs. 4%) and osteopenia/osteoporosis (33% vs. 23%, P = 0.002 and P = 0.062, respectively). At diagnosis, 67% had new-onset headaches; 34% had mouth pain/jaw claudication. One-fifth had polymyalgia rheumatica symptoms but no cranial manifestations; 62% had positive temporal artery biopsy findings; 37% were enrolled on the basis of cross-sectional imaging study findings.
Demographics of the GiACTA population reflect the epidemiologic profile of GCA. Baseline comorbidities associated with glucocorticoids were more prevalent among relapsing patients than among those with newly diagnosed disease, highlighting the need for new GCA treatment options. More than one-third of patients were enrolled based on large-vessel imaging.
报告参与一项关于托珠单抗（一种白细胞介素-6受体α抑制剂）的随机试验的新诊断和复发巨细胞动脉炎（GCA）患者的入选标准及临床特征。
新诊断的GCA定义为在基线前≤6周确诊。复发的GCA定义为在基线前>6周确诊且连续≥2周使用泼尼松≥40mg/天。所有患者在基线后6周内患有活动性GCA。所有统计结果均为探索性的。
251例患者中，119例（47%）为新诊断，132例（53%）为复发的GCA。两个亚组的平均年龄均为69岁；75%为女性。复发患者体重更重[均值差异（95%CI）：女性，4.18kg（0.49 - 7.87，P = 0.027）；男性，8.25kg（1.42 - 15.09，P = 0.019）]，且平均体重指数更高[均值差异（95%CI）：女性，1.72kg/m²（0.44 - 2.99，P = 0.009）；男性，2.85kg/m²（0.3 - 5.37，P = 0.028）]。复发患者中抑郁症的基线患病率更高（16%对4%），骨质疏松症/骨质减少的患病率也更高（33%对23%，P分别为0.002和0.062）。诊断时，67%有新发头痛；34%有口腔疼痛/颌部跛行。五分之一有风湿性多肌痛症状但无颅部表现；62%颞动脉活检结果为阳性；37%是根据横断面影像学研究结果入选的。
GiACTA研究人群的人口统计学特征反映了GCA的流行病学概况。与糖皮质激素相关的基线合并症在复发患者中比新诊断疾病患者中更普遍，这凸显了对新的GCA治疗方案的需求。超过三分之一的患者是基于大血管影像学入选的。
