前沿进展丨贝利木单抗治疗难治性皮肤狼疮有效

吾系好银亦客 2017-09-30

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摘要

背景：贝利木单抗通过阻断人B细胞刺激因子(BLyS)结合于B细胞受体而起到降低B淋巴细胞活性的作用。贝利木单抗用于治疗难治性SLE皮肤损害尚无报道。我们首次报道了贝利木单抗成功治疗本中心皮肤狼疮的经验。

方法：本研究纳入5例重度SLE皮肤损害的患者。所有患者符合1997年ACR SLE诊断标准，且多种药物治疗其皮肤病变无效。用药前及用药后16周统计SLE疾病活动度指数（SLEDAI），皮肤狼疮疾病面积及严重度指数（CLASI）以及病人整体评估（PGA）。在常规治疗基础上加用贝利木单抗。

结果：所有5例患者在应用贝利木单抗治疗后临床情况显著改善。在初始治疗后平均改善时间为8-12周。SLEDAI评分 (中位数, 范围) 在所有患者中均改善((2, 2-6) to (0, 0-4); p = 0.025). PGA 评分(中位数, 范围) 所有患者中均改善 ((3, 2-3) to (1, 0-1); p = 0.039). CLASI 活动评分 (中位数, 范围) 在所有患者中均显著改善((17, 9-31) to (3, 2-14); p = 0.043). CLASI损害评分均无恶化。平均每日强的松用量由基线的31 mg (±18.8) 降至 3 mg (± 2.7) ( p = 0.042)。

结论：在本病例研究中，在基础治疗上加用贝利木单抗显著改善难治性皮肤狼疮的症状体征。对于传统治疗无效的重症SLE皮肤累及的患者，这是第一项关于贝利木单抗治疗上述患者有效的报道。应当完善贝利木单抗治疗皮肤狼疮的进一步临床研究。

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附原文：

BACKGROUND: Belimumab is a monoclonal antibody that reduces B lymphocyte survival by blocking the binding of soluble human B lymphocyte stimulator (BLyS) to its B cell receptors. The utility of belimumab for management of resistant systemic lupuserythematosus (SLE) skin manifestations has not been reported. We present our experience of using this novel molecule for the successful management of cutaneous lupus at our center.
METHODS: We studied five patients with significant SLE skin manifestations. All patients met 1997 American College of Rheumatology (ACR) SLE criteria and had failed multiple medications to control their skin disease. SLE disease activity indexes (SLEDAI), Cutaneous LE disease Area and Severity Index (CLASI) and patient's global assessment (PGA) were recorded before and 16 weeks after belimumab treatment. Belimumab was added to concomitant standard therapy.
RESULTS:All five patients demonstrated marked clinical improvement subsequent to belimumab treatment. The average time to clinical improvement after treatment initiation was 8-12 weeks. SLEDAI scores (median, range) improved in all the patients ((2, 2-6) to (0, 0-4); p = 0.025). PGA scores (median, range) were better in all patients ((3, 2-3) to (1, 0-1); p = 0.039). CLASI activity scores (median, range) improved dramatically in all patients ((17, 9-31) to (3, 2-14); p = 0.043). There was no worsening of the CLASI damage scores. The mean daily prednisone dose decreased significantly from 31 mg (±18.8) at baseline to 3 mg (± 2.7) ( p = 0.042).
CONCLUSION:In this case series, the addition of belimumab to standard therapy improved the signs and symptoms of refractorycutaneous lupus. This is one of the first reports highlighting the potential utility of this medication for the treatment of severe skin involvement in SLE refractory to conventional therapies. Additional studies need to be performed to assess the use of belimumab in the treatment of cutaneous lupus.