Borisova M A, Lukina G V, Sigidin Y A, Aronova E S, Luchihina E L, Karateev D E, Glukhova S V, Nasonov E L
V.A. Nasonova Research Institute of Rheumatology, laboratory of monitoring safety of antirheumatic treatment, Moscow, Russia.
Moscow Clinical Scientific Center named after Loginov A.S., Moscow, Russia.
Ter Arkh. 2018 May 11;90(5):44-49. doi: 10.26442/terarkh201890544-49.
This article reports 1-year clinical outcomes of patients with rheumatoid arthritis (RA) receiving abatacept (ABA) therapy.
Patients (n=91) with high RA activity (DAS28 = 5.1 ± 1.0) and an inadequate response on synthetic DMARDs (mainly methotrexate, 70.3%) and biologics (mainly TNF-α inhibitors, 93%) were included in the study. The majority of patients were middle-aged (49 ± 13.5) womens, RF (72.5%) and ACPA (77%) positive, with moderate functional impairment - HAQ = 1.4 (0.9-2). ABA were administered IV, 10 mg/kg according to the standard scheme. The evaluation of the effectiveness of the therapy was carried out according to the EULAR / ACR 2011 criteria using SDAI, CDAI, HAQ and the intention to treat approach.
ABA led to a significant (p <0.05) decrease activity of RA. Clinical improvement according to EULAR criteria after 6 months of treatment was registered in 70.9%, after 12 months 63%. Almost a third of patients (28.7%) achieved a good response after 3 months of therapy, 39,2% - after 6 months and 39% - after 12 months. The retention rate of ABA therapy after 6 months was 77%, after 12 months - 60%. There were no significant differences between "bio-naive", 1 Bio and ≥2 Bio groups in achieving EULAR response. A good response was achieved in 38%, 38% and 43%, respectively, but the lowest number of non-responders was registered in ≥2 Bio - 38%, 36% and 43%. ABA significantly improved functional status of patients, after 12 months a marked and moderate improvement in the HAQ was achieved in 39% and 21% of patients, respectively. Adverse events (AE) were registered in 22 patients. The most frequent AE were upper respiratory tract infections - 11 (12%) patients.
Abatacept was effective in the overall population, and in all subgroups of patients. It has shown significant improvement of clinical and functional status in patients who had an inadequate response to previous therapy. ABA has a good safety profile. AE were registered only in a small number of patients.
本文报告接受阿巴西普（ABA）治疗的类风湿关节炎（RA）患者的1年临床结局。
纳入高疾病活动度（DAS28 = 5.1±1.0）且对合成改善病情抗风湿药（主要是甲氨蝶呤，70.3%）和生物制剂（主要是肿瘤坏死因子-α抑制剂，93%）反应不足的患者（n = 91）。大多数患者为中年女性（49±13.5岁），类风湿因子（RF）阳性率为72.5%，抗环瓜氨酸肽抗体（ACPA）阳性率为77%，功能中度受损——健康评估问卷（HAQ）评分为1.4（0.9 - 2）。按照标准方案静脉注射ABA，剂量为10 mg/kg。根据2011年欧洲抗风湿病联盟（EULAR）/美国风湿病学会（ACR）标准，采用简化疾病活动指数（SDAI）、临床疾病活动指数（CDAI）、HAQ并采用意向性分析方法评估治疗效果。
ABA使RA活动度显著降低（p<0.05）。治疗6个月后，根据EULAR标准临床改善的患者占70.9%，12个月后为63%。近三分之一的患者（28.7%）在治疗3个月后获得良好反应，39.2%在6个月后获得良好反应，39%在12个月后获得良好反应。ABA治疗6个月后的保留率为77%，12个月后为60%。在达到EULAR反应方面，“未使用过生物制剂”组、使用过1种生物制剂组和使用过≥2种生物制剂组之间无显著差异。分别有38%、38%和43%的患者获得良好反应，但在使用过≥2种生物制剂组中无反应者比例最低——分别为38%、36%和43%。ABA显著改善了患者的功能状态，12个月后，分别有39%和21%的患者HAQ评分显著和中度改善。22例患者出现不良事件（AE）。最常见的AE是上呼吸道感染——11例（12%）患者。
阿巴西普在总体人群及所有患者亚组中均有效。它在对先前治疗反应不足的患者中显示出临床和功能状态的显著改善。ABA安全性良好。仅少数患者出现AE。
