Cleveland Clinic, Cleveland, Ohio, USA.
Boston University, Boston, Massachusetts, USA.
Ann Rheum Dis. 2014 Jul;73(7):1376-9. doi: 10.1136/annrheumdis-2013-204164. Epub 2013 Dec 9.
To determine the safety and efficacy of abatacept in non-severe relapsing granulomatosis with polyangiitis (Wegener's)(GPA).
An open-label trial of intravenous abatacept was conducted in 20 patients with non-severe relapsing GPA. Prednisone up to 30 mg daily was permitted within the first 2 months, and patients on methotrexate, azathioprine, or mycophenolate mofetil continued these agents. Patients remained on study until common closing or early termination.
Of the 20 patients, 18 (90%) had disease improvement, 16 (80%) achieved remission (BVAS/WG=0) at a median of 1.9 months, and 14 (70%) reached common closing. Six patients (30%) met criteria for early termination due to increased disease activity; 3 of 6 achieved remission and relapsed at a median of 8.6 months. The median duration of remission before common closing was 14.4 months, with the median duration of time on study for all patients being 12.3 months (range 2-35 months). Eleven of the 15 (73%) patients on prednisone reached 0 mg. Nine severe adverse events occurred in 7 patients, including 7 infections that were successfully treated.
In this study of patients with non-severe relapsing GPA, abatacept was well tolerated and was associated with a high frequency of disease remission and prednisone discontinuation.
评估阿巴西普在非重症复发性肉芽肿性多血管炎（韦格纳氏）（GPA）中的安全性和疗效。
对 20 例非重症复发性 GPA 患者进行了阿巴西普静脉注射的开放性试验。在前 2 个月内允许使用 30mg/天的泼尼松，同时继续使用甲氨蝶呤、硫唑嘌呤或吗替麦考酚酯的患者继续使用这些药物。患者继续接受研究，直至共同关闭或提前终止。
在 20 例患者中，18 例（90%）病情改善，16 例（80%）在中位数为 1.9 个月时达到缓解（BVAS/WG=0），14 例（70%）达到共同关闭。6 例（30%）因疾病活动增加而符合提前终止标准；其中 3 例达到缓解，在中位数为 8.6 个月时复发。在共同关闭前，缓解的中位数持续时间为 14.4 个月，所有患者的中位数研究时间为 12.3 个月（范围 2-35 个月）。在服用泼尼松的 15 例患者中有 11 例（73%）达到 0mg。7 例患者发生了 9 次严重不良事件，包括 7 次成功治疗的感染。
在这项非重症复发性 GPA 患者的研究中，阿巴西普耐受性良好，与疾病缓解和泼尼松停药的高频率相关。
