Department of Medicine, Rheumatology Unit, Karolinska Institutet, Karolinska University Hospital, Stockholm, Sweden.
Department of Clinical and Experimental Medicine, Rheumatology/Division of Neuro and Inflammation Sciences, Linköping University, Linköping, Sweden.
Autoimmun Rev. 2017 Apr;16(4):343-351. doi: 10.1016/j.autrev.2017.02.005. Epub 2017 Feb 13.
Belimumab is the first biologic drug approved for Systemic Lupus Erythematosus (SLE). Here, we aimed to investigate the effects of belimumab on clinical and serologic outcomes, and sought to identify predictors of treatment response in three Swedish real-life settings.
Fifty-eight patients were enrolled at initiation of belimumab and followed longitudinally for up to 53months. Surveillance outcomes included the SLE Disease Activity Index 2000 (SLEDAI-2K), 100mm Visual Analogue Scales for Physician's Global Assessment (PGA), fatigue, pain and general health, and the Systemic Lupus International Collaborating Clinics/American College of Rheumatology Damage Index (SDI). Assessment of treatment response included the SLE responder index (SRI). B lymphocyte stimulator (BLyS) levels were determined using ELISA.
SLEDAI-2K (median baseline score: 8.0; IQR: 4.0-13.8), PGA and corticosteroid use decreased during therapy, and patients reported improvements on fatigue, pain, and general health (p<0.0001 for all). SDI scores remained stable (p=0.08). Patients with baseline SDI scores >1 showed decreased probability and prolonged time to attain SRI response (HR: 0.449; 95% CI: 0.208-0.967), as did current smokers compared with non-smokers (HR: 0.103; 95% CI: 0.025-0.427). In contrast, baseline BLyS levels ≥1.2ng/mL predicted increased probability and shorter time to attain SRI response (HR: 2.566; 95% CI: 1.222-5.387).
Disease activity and corticosteroid usage decreased, patient-reported outcomes improved, and no significant organ damage was accrued during follow-up. Smoking and organ damage predicted reduced treatment efficacy. These findings might contribute to a better selection of patients who are likely to benefit from belimumab.
贝利尤单抗是首个获批用于系统性红斑狼疮（SLE）的生物制剂。本研究旨在探讨贝利尤单抗对临床和血清学结局的影响，并在瑞典三个真实环境中确定治疗反应的预测因子。
58 例患者在开始接受贝利尤单抗治疗时入组，并进行了长达 53 个月的纵向随访。监测结局包括系统性红斑狼疮疾病活动指数 2000 （SLEDAI-2K）、100mm 视觉模拟量表医生总体评估（PGA）、疲劳、疼痛和一般健康状况，以及系统性红斑狼疮国际合作临床中心/美国风湿病学会损害指数（SDI）。治疗反应评估包括系统性红斑狼疮应答指数（SRI）。采用 ELISA 法测定 B 淋巴细胞刺激物（BLyS）水平。
SLEDAI-2K（中位数基线评分：8.0；IQR：4.0-13.8）、PGA 和皮质类固醇的使用率在治疗过程中降低，患者报告疲劳、疼痛和一般健康状况改善（均<0.0001）。SDI 评分保持稳定（p=0.08）。基线 SDI 评分>1 的患者，SRI 反应的概率降低，达到 SRI 反应的时间延长（HR：0.449；95%CI：0.208-0.967），与非吸烟者相比，当前吸烟者也表现出更低的概率和更长的时间达到 SRI 反应（HR：0.103；95%CI：0.025-0.427）。相反，基线 BLyS 水平≥1.2ng/mL 预测 SRI 反应的概率增加，达到 SRI 反应的时间缩短（HR：2.566；95%CI：1.222-5.387）。
在随访期间，疾病活动度和皮质类固醇使用率降低，患者报告的结局改善，未发生显著的器官损伤。吸烟和器官损伤预测治疗效果降低。这些发现可能有助于更好地选择可能从贝利尤单抗中获益的患者。
