Universitat Autònoma de Barcelona, Division of Rheumatology and Autoimmune Systemic Diseases, Hospital Universitari de la Santa Creu i Sant Pau, Barcelona, Spain.
Paris Descartes University, INSERM U1016, Sorbone Paris Cité, Rheumatology A Department, Cochin Hospital, Paris, France.
Semin Arthritis Rheum. 2020 Dec;50(6):1489-1493. doi: 10.1016/j.semarthrit.2019.12.004. Epub 2020 Feb 3.
To analyze the safety and effectiveness of abatacept (ABA) given in routine care to patients with systemic sclerosis (SSc).
Retrospective multicenter observational study that enrolled patients with SSc treated with ABA. We collected epidemiological data and clinical outcomes. First, we analyzed the frequency of adverse effects. Secondly, we compared the evolution of different organ manifestations during ABA treatment. We collected data from 6 months before start of therapy to the last follow-up the following parameters: modified Rodnan Skin Score (mRSS), joints, lung and gastrointestinal involvement, concomitant medications, and laboratory tests.
Data on twenty-seven patients with SSc were collected (93% females; 67% limited SSc). Rheumatoid arthritis was the most frequent concomitant autoimmune disease. ILD was present in 15 patients. Anti-Scl 70 antibodies were present in 13 patients and rheumatoid factor and ACPA antibodies were present in eight and seven patients respectively. The main indication to use abatacept was joint involvement (59%) followed by myositis (26%). A total of 16 adverse effects were reported in 28 months of abatacept treatment including five that required hospitalization. Most of them occurred in the first 3 months after starting abatacept. After 12 months, the number of tender and swollen joints decreased compared to baseline (p<0.03 and p<0.02 respectively). Moreover, a beneficial effect of abatacept on HAQ-DI at 3 and 6 months (p<0.05) and on morning stiffness at 6 and 12 months (p<0.03) was observed. We also observed a decrease in the modified Rodnan skin score (p<0.05). No changes in lung or gastrointestinal involvement were found.
ABA demonstrated a good safety profile and seems to have some effectiveness on joint involvement and related disability in SSc patients treated in routine care.
分析常规治疗中应用阿巴西普（ABA）治疗系统性硬化症（SSc）患者的安全性和有效性。
这是一项回顾性多中心观察性研究，纳入了接受 ABA 治疗的 SSc 患者。我们收集了流行病学数据和临床结局。首先，我们分析了不良反应的发生频率。其次，我们比较了 ABA 治疗期间不同器官表现的演变。我们收集了治疗开始前 6 个月至最后随访时的以下参数的数据：改良 Rodnan 皮肤评分（mRSS）、关节、肺部和胃肠道受累、伴随用药和实验室检查。
共收集了 27 例 SSc 患者的数据（93%为女性；67%为局限型 SSc）。最常见的伴随自身免疫性疾病是类风湿关节炎。15 例患者存在间质性肺病。13 例患者存在抗 Scl-70 抗体，8 例和 7 例患者存在类风湿因子和 ACPA 抗体。应用阿巴西普的主要指征是关节受累（59%），其次是肌炎（26%）。在 ABA 治疗的 28 个月中，共报告了 16 种不良反应，其中 5 种需要住院治疗。大多数不良反应发生在开始使用 ABA 后的前 3 个月。与基线相比，12 个月后，压痛关节和肿胀关节的数量减少（分别为 p<0.03 和 p<0.02）。此外，在 3 个月和 6 个月时观察到 ABA 对 HAQ-DI 有获益（p<0.05），在 6 个月和 12 个月时观察到对晨僵有获益（p<0.03）。我们还观察到改良 Rodnan 皮肤评分降低（p<0.05）。未发现肺部或胃肠道受累有变化。
ABA 显示出良好的安全性，并且似乎对常规治疗中 SSc 患者的关节受累和相关残疾有一定的疗效。
