背景:调节性T细胞(Tregs)在大疱性类天疱疮(BP)患者的外周血和皮肤病变中减少。低剂量IL-2治疗可以特异性刺激Tregs,提示治疗BP的潜力。
目的:评价低剂量IL-2治疗中重度BP的疗效。
方法:纳入43例中度至重度BP患者。治疗包括全身糖皮质激素,初始剂量为中度0.5mg/kg/d,重度疾病为1.0mg/kg/d。联合允许的免疫抑制剂作为对照组,而除了同样的皮质类固醇治疗,对于治疗组,每隔一天皮下施用IL-2(50万IU),持续8周。主要结果是实现疾病控制所需的天数。次要结果包括其他临床反应。
结果:治疗组达到疾病控制所需的天数为(7.60±3.00),短于对照组(10.43±3.06)(p=0.008)。治疗组全身性糖皮质激素总量较少,未发现严重感染。
结论:单中心,开放标签研究,持续时间短,体积小。
结论:我们的试验支持低剂量IL-2治疗中度至重度BP患者的潜力,显示较早的治疗反应。
BACKGROUND: Regulatory T cells (Tregs) are reduced in the peripheral blood and skin lesions of bullous pemphigoid (BP) patients. Low-dose IL-2 therapy can stimulate Tregs specifically, suggesting potential for the treatment of BP.
OBJECTIVE: To evaluate the response to low-dose IL-2 therapy in the treatment of moderate to severe BP.
METHODS: 43 patients with moderate to severe BP were included. The therapy included systemic corticosteroids with initial dose of 0.5mg/kg/d for moderate and 1.0mg/kg/d for severe disease respectively, combined with allowed immunosuppressants for control group, while in addition to the same corticosteroids therapy, IL-2 (half million IU) was administered subcutaneously every other day for treatment group for 8 weeks. The primary outcome was the number of days required to achieve disease control. Secondary outcomes included other clinical responses.
RESULTS: The number of days required to achieve disease control with treatment group was (7.60±3.00), which was shorter than in the control group (10.43±3.06) (p=0.008). The total amount of systemic corticosteroids was less and no serious infections were detected in the treatment group.
CONCLUSIONS: Single center, open-label study with short duration and small size.
CONCLUSIONS: Our trial supports the potential of low-dose IL-2 therapy for patients with moderate to severe BP, which showed earlier treatment responses.