Rheumatology Department, Hospital Vall d'Hebron, Barcelona, Spain.
Rheumatology Department, Hospital Universitario Virgen de la Arrixaca, Murcia, Spain.
Reumatol Clin (Engl Ed). 2023 Jun-Jul;19(6):312-318. doi: 10.1016/j.reumae.2023.05.003.
This OBSErve Spain study, a part of the international OBSErve programme, evaluated belimumab real-world use and effectiveness following 6 months of treatment in patients with active systemic lupus erythematosus (SLE) in clinical practice in Spain.
In this retrospective, observational study (GSK Study 200883), eligible patients with SLE receiving intravenous belimumab (10mg/kg) had their disease activity (physician assessed), SELENA-SLEDAI scores, corticosteroid use, and healthcare resource utilisation (HCRU), assessed after 6 months of treatment versus index (belimumab initiation) or 6 months pre-index.
Overall, 64 patients initiated belimumab, mainly due to ineffectiveness of previous treatments (78.1%) and to reduce corticosteroid use (57.8%). Following 6 months of treatment, 73.4% of patients achieved ≥20% overall clinical improvement, while only 3.1% of patients worsened. Mean (standard deviation, SD) SELENA-SLEDAI score decreased from 10.1 (6.2) at index to 4.5 (3.7) 6 months post-index. HCRU decreased from 6 months pre-index to 6 months post-index, with fewer hospitalisations (10.9% vs 4.7% patients) and ER visits (23.4% vs 9.4% patients). Mean (SD) corticosteroid dose decreased from 14.5 (12.5)mg/day at index to 6.4 (5.1)mg/day 6 months post-index.
Patients with SLE receiving belimumab for 6 months in real-world clinical practice in Spain experienced clinical improvements and a reduction in HCRU and corticosteroid dose.
这项在西班牙开展的 OBSErve Spain 研究是国际 OBSErve 项目的一部分,评估了贝鲁单抗在西班牙真实临床环境中治疗活动性系统性红斑狼疮(SLE)患者 6 个月后的实际应用情况和疗效。
在这项回顾性、观察性研究(GSK 研究 200883)中,符合条件的 SLE 患者接受静脉注射贝鲁单抗(10mg/kg)治疗,在治疗 6 个月时与基线(贝鲁单抗起始)或 6 个月前相比,评估疾病活动度(医生评估)、SELENA-SLEDAI 评分、皮质类固醇使用情况和医疗资源利用(HCRU)。
总体而言,64 例患者开始接受贝鲁单抗治疗,主要原因是先前治疗无效(78.1%)和减少皮质类固醇使用(57.8%)。治疗 6 个月后,73.4%的患者实现了≥20%的整体临床改善,而只有 3.1%的患者病情恶化。平均(标准差,SD)SELENA-SLEDAI 评分从基线时的 10.1(6.2)降至治疗后 6 个月时的 4.5(3.7)。从基线前 6 个月到治疗后 6 个月,HCRU 减少,住院患者(10.9%比 4.7%的患者)和急诊就诊患者(23.4%比 9.4%的患者)减少。平均(SD)皮质类固醇剂量从基线时的 14.5(12.5)mg/天降至治疗后 6 个月时的 6.4(5.1)mg/天。
在西班牙真实临床环境中接受贝鲁单抗治疗 6 个月的 SLE 患者经历了临床改善,并减少了 HCRU 和皮质类固醇剂量。