University of Nebraska Medical Center, Omaha, NE, USA.
FORWARD, The National Databank for Rheumatic Diseases, Wichita, KS, USA.
Arthritis Res Ther. 2019 Jun 7;21(1):141. doi: 10.1186/s13075-019-1921-z.
To assess the risks of malignancies, infections and autoimmune diseases in patients with rheumatoid arthritis (RA) treated with abatacept compared with other biologic (b) disease-modifying antirheumatic drugs (DMARDs) or conventional synthetic (cs)DMARDs, in a US-wide observational RA cohort METHODS: Data were reviewed from patients (≥ 18 years) with RA who were registered with FORWARD, the National Databank for Rheumatic Diseases, and who initiated abatacept, other bDMARDs or csDMARDs between 2005 and 2015. Patients who switched treatment during the study could be allocated to more than one group. The incidence rates (IRs) by treatment were calculated for malignancies, hospitalized infections and autoimmune diseases identified by six monthly questionnaires and medical records. The hazard ratios (HRs) (95% confidence intervals [CIs]) for all outcomes with abatacept compared with other bDMARDs or csDMARDs were determined using marginal structural models adjusted for clinical confounders.
In the study sample, 1496 initiated abatacept, 3490 initiated another bDMARD and 1520 initiated a csDMARD. The risk of malignancies with abatacept was not statistically significant versus other bDMARDs (HR [95% CI)] 1.89 [0.93, 3.84]) or versus csDMARDs (HR [95% CI] 0.93 [0.20, 4.27]). Patients receiving abatacept versus other bDMARDs were at a lower risk of hospitalized infections (HR [95% CI] 0.37 [0.18, 0.75]); the risk versus csDMARDs was lower with wide CIs (HR [95% CI] 0.31 [0.09, 1.05]). The relative risks for psoriasis were similar between treatment groups (HR [95% CI] 1.46 [0.76, 2.81] and HR [95% CI] 2.05 [0.59, 7.16] for abatacept versus other bDMARDs and versus csDMARDS, respectively). The IR (95% CI) of severe infusion/injection reactions was lower with abatacept compared with other bDMARDs (1.57 [1.11, 2.17] vs 2.31 [1.87, 2.82] per 100 patient-years, respectively).
In this analysis, abatacept was well tolerated and did not result in an overall increased risk of malignancies, infections or autoimmune diseases compared with other bDMARDs or csDMARDs.
为了评估在接受阿巴西普治疗的类风湿关节炎（RA）患者中与其他生物制剂（b）疾病修饰抗风湿药物（DMARDs）或常规合成（cs）DMARDs 相比，恶性肿瘤、感染和自身免疫性疾病的风险，在美国进行了一项广泛的观察性 RA 队列研究。
研究数据来自 2005 年至 2015 年间在国家风湿病数据库（National Databank for Rheumatic Diseases）登记的、接受阿巴西普、其他 bDMARDs 或 csDMARDs 治疗的≥18 岁 RA 患者。在研究期间换药的患者可被分配到多个组中。通过每六个月一次的问卷调查和病历记录，计算出恶性肿瘤、住院感染和自身免疫性疾病的发病率（IRs）。使用调整了临床混杂因素的边缘结构模型，确定了与其他 bDMARDs 或 csDMARDs 相比，阿巴西普治疗的所有结局的风险比（HR）（95%置信区间[CI]）。
在研究样本中，1496 例患者开始使用阿巴西普，3490 例患者开始使用另一种 bDMARD，1520 例患者开始使用 csDMARD。与其他 bDMARDs（HR[95%CI]1.89[0.93，3.84]）或 csDMARDs（HR[95%CI]0.93[0.20，4.27]）相比，阿巴西普治疗的恶性肿瘤风险无统计学意义。与其他 bDMARDs 相比，接受阿巴西普治疗的患者住院感染风险较低（HR[95%CI]0.37[0.18，0.75]）；与 csDMARDs 相比，风险较低，但置信区间较宽（HR[95%CI]0.31[0.09，1.05]）。与治疗组相比，银屑病的相对风险相似（HR[95%CI]1.46[0.76，2.81]和 HR[95%CI]2.05[0.59，7.16]，分别为阿巴西普与其他 bDMARDs 和 csDMARDs 相比）。与其他 bDMARDs 相比，阿巴西普治疗的严重输注/注射反应发生率较低（1.57[1.11，2.17]与 2.31[1.87，2.82]每 100 患者年，分别）。
在这项分析中，与其他 bDMARDs 或 csDMARDs 相比，阿巴西普治疗的耐受性良好，且不会导致恶性肿瘤、感染或自身免疫性疾病的总体风险增加。
