Sapienza University of Rome, II School of Medicine, S. Andrea University Hospital, Chair and Division of Allergy, Clinical Immunology, and Rheumatology, Rome, Italy.
J Biol Regul Homeost Agents. 2011 Jul-Sep;25(3):397-403.
To retrospectively evaluate safety and efficacy of long-term treatment with Cyclosporine A (CSA) in patients with systemic lupus erythematosus (SLE) poorly responsive to treatment with corticosteroids (CCS) and/or conventional disease-modifying anti-rheumatic drugs (DMARDs), SLE patients who had received CSA-based induction and maintenance regimens according to disease activity were recorded. Efficacy was assessed using the SLE Disease Activity Index (SLEDAI) and laboratory analyses. Forty SLE patients (including 18 with lupus nephritis, 11 with neurological involvement and 7 with overlap syndromes (4 Sjögren's syndrome, 2 myasthenia gravis and 1 Behçet's disease) were recorded. According to baseline SLEDAI, 30 patients had severe and 10 moderate SLE. Mean SLEDAI scores and relevant laboratory values significantly reduced from baseline (22∓10 vs 5∓6; P < 0.002) during the follow-up period (8∓2 years; range 1-15). Twenty-three (57.5 percent) patients achieved excellent (improvement in the range 70-100 percent) response to treatment (10 of whom were subsequently maintained on CSA monotherapy), 14 (35 percent) had good-fair (improvement in the range 25-69 percent) response and 3 (7.5 percent) had to interrupt therapy (including CSA) for disease worsening. Mild and transient adverse events occurred in 15 (37 percent) patients, including hypertrichosis (17.5 percent), gum hypertrophy (17.5 percent) hypertension (12.5 percent), abdominal pain (7.5 percent), and dyslipidemia (5 percent), but treatment interruption was not required. Low-dose CSA together with other drugs is effective to induce, or as monotherapy to maintain, long-term (at least 2 years) remission, and is generally well tolerated in patients with moderate or severe SLE poorly responsive to CCS and/or conventional DMARDs. Furthermore, the favourable effect of CSA treatment may allow to spare more cytotoxic drugs.
回顾性评估长期应用环孢素 A（CSA）治疗对皮质类固醇（CCS）和/或传统改善病情抗风湿药（DMARDs）治疗反应不佳的系统性红斑狼疮（SLE）患者的安全性和疗效，根据疾病活动情况，对接受 CSA 诱导和维持方案的 SLE 患者进行记录。采用 SLE 疾病活动指数（SLEDAI）和实验室分析评估疗效。共记录了 40 例 SLE 患者（包括狼疮肾炎 18 例、神经系统受累 11 例和重叠综合征（4 例干燥综合征、2 例重症肌无力和 1 例贝赫切特病）7 例）。根据基线 SLEDAI，30 例患者为重度，10 例为中度。在随访期间（8±2 年；范围 1-15 年），SLEDAI 评分和相关实验室值从基线显著降低（22±10 与 5±6；P<0.002）。23 例（57.5%）患者对治疗有极好的反应（改善幅度 70-100%）（其中 10 例随后继续接受 CSA 单药治疗），14 例（35%）有良好-尚可反应（改善幅度 25-69%），3 例（7.5%）因病情恶化而中断治疗（包括 CSA）。15 例（37%）患者出现轻微且短暂的不良反应，包括多毛症（17.5%）、牙龈肥大（17.5%）、高血压（12.5%）、腹痛（7.5%）和血脂异常（5%），但无需中断治疗。低剂量 CSA 联合其他药物可有效诱导或单药维持中重度（CCS 和/或传统 DMARDs 治疗反应不佳）SLE 患者的长期（至少 2 年）缓解，且总体耐受性良好。此外，CSA 治疗的有利效果可能允许减少更多细胞毒性药物的使用。
