贝利尤单抗治疗系统性红斑狼疮患者肾脏结局的疗效：一项系统评价。
Efficacy of belimumab on renal outcomes in patients with systemic lupus erythematosus: A systematic review.
机构信息
Center of Research of Immunopathology and Rare Diseases, Coordinating Center of the Network for Rare Diseases of Piedmont and Aosta Valley, Department of Clinical and Biological Sciences, University of Turin, Turin, Italy; SCDU Nephrology and Dialysis, S. Giovanni Bosco Hospital, Department of Clinical and Biological Sciences, University of Turin, Turin, Italy.
Center of Research of Immunopathology and Rare Diseases, Coordinating Center of the Network for Rare Diseases of Piedmont and Aosta Valley, Department of Clinical and Biological Sciences, University of Turin, Turin, Italy.
出版信息
Autoimmun Rev. 2017 Mar;16(3):287-293. doi: 10.1016/j.autrev.2017.01.010. Epub 2017 Jan 29.
Both BLISS-52 and BLISS-76 international phase III trials in Systemic Lupus Erythematosus (SLE) met their primary outcomes; however, they were not designed to assess the efficacy of belimumab for the treatment of lupus nephritis (LN). LN is a frequent cause of SLE-associated morbidity and mortality, and emerging evidence suggests a potential therapeutic role for agents that target B lymphocyte stimulator (BLyS). We conducted a systematic review to identify data on the effect of belimumab on LN. A total of 2004 patients with SLE were identified from 11 studies. Three hundred and twenty-six patients had LN at baseline and 234 (71.8%) of those received belimumab. Thirteen patients out of 234 (5.5%) received belimumab for active LN. Due to the heterogeneous definitions of treatment response, clinical presentation and renal involvement, it was not possible to compare results using a single outcome parameter. However, the majority of these studies defined clinical response in terms of rates of renal flare, renal remission, and/or renal organ disease improvement. One hundred twenty-nine (55.1%) of the 234 patients with LN at baseline showed an improvement in renal parameters after treatment with belimumab. In patients with baseline proteinuria>0.2g/24h, (n=687), those receiving belimumab had a median reduction in proteinuria during follow-up as high as 38%. When focusing on patients with proteinuria≥1g/24h (n=228), 70.7% of those treated with belimumab (n=157) achieved a renal response. In the pooled population of patients receiving belimumab, we found an overall annual renal flare rate of 1.7% [24/1448, mean observation time 1,1years (0,5-3)]. Despite the limitations of the studies included in this analysis, available data are promising and provide preliminary support for targeting BlyS to induce or maintain a renal response. Further trials should examine whether belimumab (alone or following rituximab) represents an additional therapeutic option in the treatment of LN.
BLISS-52 和 BLISS-76 这两项系统性红斑狼疮（SLE）的国际 III 期临床试验均达到了主要终点；然而，这些试验并非专门用于评估贝利尤单抗治疗狼疮肾炎（LN）的疗效。LN 是导致 SLE 相关发病率和死亡率的常见原因，新出现的证据表明，针对 B 淋巴细胞刺激因子（BLyS）的药物可能具有治疗作用。我们进行了一项系统评价，以确定贝利尤单抗治疗 LN 的效果数据。从 11 项研究中确定了 2004 例 SLE 患者。基线时有 326 例患者患有 LN，其中 234 例（71.8%）接受了贝利尤单抗治疗。在这 234 例接受贝利尤单抗治疗的患者中，有 13 例（5.5%）患有活动性 LN。由于治疗反应、临床表现和肾脏受累的定义存在异质性，因此无法使用单一结果参数来比较结果。然而，这些研究中的大多数将临床反应定义为肾脏发作率、肾脏缓解率和/或肾脏器官疾病改善率。基线时有 LN 的 234 例患者中，有 129 例（55.1%）在接受贝利尤单抗治疗后肾脏参数有所改善。在基线蛋白尿>0.2g/24h 的患者（n=687）中，接受贝利尤单抗治疗的患者在随访期间蛋白尿中位数降低高达 38%。当关注蛋白尿≥1g/24h 的患者（n=228）时，接受贝利尤单抗治疗的患者中有 70.7%（n=157）达到了肾脏反应。在接受贝利尤单抗治疗的患者总体人群中，我们发现总的年肾脏发作率为 1.7%[24/1448，平均观察时间为 1.1 年（0.5-3）]。尽管纳入本分析的研究存在局限性，但现有数据很有希望，为针对 BlyS 诱导或维持肾脏反应提供了初步支持。进一步的试验应研究贝利尤单抗（单独使用或与利妥昔单抗联合使用）是否代表治疗 LN 的另一种治疗选择。
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