Rheumatology and Clinical Immunology, 4th Department of Medicine, "Attikon" University Hospital, Joint Academic Rheumatology Program, School of Medicine, National and Kapodistrian University of Athens, Athens, Greece-Medical School University of Cyprus, Nikosia, Cyprus.
Rheumatology, Clinical Immunology and Allergy, University Hospital of Heraklion, Heraklion, Greece.
Semin Arthritis Rheum. 2018 Dec;48(3):467-474. doi: 10.1016/j.semarthrit.2018.02.014. Epub 2018 Feb 23.
Low disease activity is a validated target of current systemic lupus erythematosus (SLE) therapy. The aim of this study was to assess the ability of belimumab to achieve low disease activity states in real-life settings.
Multicentre prospective observational study of consecutive SLE patients receiving belimumab for at least 3 months, due to active disease refractory to at least one conventional immunosuppressant. Disease activity, including the recently defined lupus low disease activity state (LLDAS) and remission (clinical SLEDAI-2K = 0), accrual of organ damage, flares and side effects were documented.
Ninety-one patients were included [94.5% women, mean (SD) age 45.9 (12.5) years]. Most frequent manifestations were arthritis (76.7%), rash (72.5%), serologic activity (low C3/C4 and/or high anti-dsDNA; 54.9%), hair loss (47.2%) and mucosal ulcers (27.5%). Median (range) duration of treatment was 10.5 (3.0-42.1) months. Belimumab significantly decreased average SLEDAI-2K, physician global assessment (PGA) and daily prednisone dose over time, as early as 3 months after initiation, with over 20% of patients discontinuing corticosteroids. Although reduction in clinical (i.e., excluding serology) SLEDAI-2K was more pronounced in patients who were serologically active (from 8 to 1.5 at 12 months) as compared to serologically inactive (from 6 to 4) at baseline, attainment of LLDAS did not differ between the two groups and was reached by more than 40% of completer patients after 9-12 months. In addition, the number of flares and severe flares was reduced by 62% and 50%, respectively, during the first 12 months of treatment. Twenty patients (22.0%) discontinued treatment due to inadequate response and two due to side effects potentially related to the drug.
In real-life, belimumab is efficacious in achieving low disease activity in over 40% of unselected patients, in combination with reduction of corticosteroid dosage and number of flares. Both serologically active and inactive patients respond to the drug.
低疾病活动度是当前系统性红斑狼疮（SLE）治疗的一个已验证的目标。本研究旨在评估贝利尤单抗在真实环境中实现低疾病活动状态的能力。
对至少接受贝利尤单抗治疗 3 个月的连续 SLE 患者进行多中心前瞻性观察研究，这些患者因至少一种传统免疫抑制剂治疗无效而患有活动性疾病。记录疾病活动度，包括最近定义的狼疮低疾病活动状态（LLDAS）和缓解（临床 SLEDAI-2K = 0）、器官损伤的累积、发作和副作用。
共纳入 91 例患者[94.5%为女性，平均（SD）年龄 45.9（12.5）岁]。最常见的表现为关节炎（76.7%）、皮疹（72.5%）、血清学活动（低 C3/C4 和/或高抗 dsDNA；54.9%）、脱发（47.2%）和黏膜溃疡（27.5%）。治疗中位数（范围）时间为 10.5（3.0-42.1）个月。贝利尤单抗治疗后，SLEDAI-2K、医生总体评估（PGA）和每日泼尼松剂量在 3 个月后开始显著下降，超过 20%的患者停止使用皮质类固醇。尽管与基线时血清学无活动的患者相比（从 8 降至 1.5，12 个月），血清学活动患者的临床（即排除血清学）SLEDAI-2K 降低更明显，但两组之间未达到 LLDAS 的差异，超过 40%的完成治疗患者在 9-12 个月后达到 LLDAS。此外，在治疗的前 12 个月内，发作次数和严重发作次数分别减少了 62%和 50%。由于治疗效果不佳，20 例（22.0%）患者停止治疗，2 例（2.2%）患者因可能与药物相关的副作用而停止治疗。
在真实环境中，贝利尤单抗联合减少皮质类固醇剂量和发作次数，可使超过 40%的未经选择的患者达到低疾病活动度，且有效。无论是血清学活动还是无活动的患者对药物均有反应。
