Efficacy and safety of belimumab given for 12 months in primary Sjogren's syndrome: the BELISS open-label phase II study
Efficacy and safety of belimumab given for 12 months in primary Sjogren's syndrome: the BELISS open-label phase II study
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DOI：
10.1093/rheumatology/kev257
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发表时间：
2015-12-01
期刊：
影响因子：
5.5
通讯作者：
Mariette, Xavier
中科院分区：
文献类型：
--
作者：
De Vita, Salvatore;Quartuccio, Luca;Mariette, Xavier
目标。报道靶向b细胞活化因子的贝利单抗长期治疗SS的疗效和安全性。原发性SS患者被纳入BELISS开放标签II期研究，这是一项为期1年的开放标签试验，如果他们的抗ssa或抗ssb抗体呈阳性，并且有系统性并发症或持续的唾液腺肿大或早期疾病或b细胞活化的生物标志物。他们在第0、2和4周接受贝利单抗，10 mg/kg静脉注射，然后每4周一次；如果在第28周观察到反应，或者如果临床医生和患者同意在没有副作用的情况下继续研究，则继续治疗1年。分析1年治疗期间的疗效和安全性。在招募的30名患者中，28名患者在第28周进行了评估。19人终止了为期52周的研究，其中15人在第28周有反应，4人无反应。在第28周，15名应答者中有13名在第52周也有应答（86.7%）。在第28周观察到的EULAR干燥综合征疾病活动指数和EULAR干燥综合征患者报告指数评分的改善在第52周有进一步改善的趋势，并且特殊的EULAR干燥综合征疾病活动指数域（腺体、淋巴结病、关节）的改善显得特别相关。在第28周观察到的b细胞活化生物标志物的下降一直持续到第52周，RF进一步下降。唾液流量、Schirmer试验及涎腺活检病灶评分无变化。治疗安全性好。长期使用贝利单抗治疗可能对SS有益。鼓励在更大的人群中进行随机、双盲、对照研究。
Objective. To report the efficacy and safety of long-term treatment of SS with belimumab, targeting the B-cell-activating factor.Methods. Patients with primary SS were included in the BELISS open-label phase II study, a 1-year open-label trial, if they were positive for anti-SSA or anti-SSB antibodies and had systemic complications or persistent salivary gland enlargement or early disease or biomarkers of B-cell activation. They received belimumab, 10 mg/kg i.v., at weeks 0, 2 and 4 and then every 4 weeks; if response was observed at week 28, or if the clinician and the patient agreed to continue the study in the absence of side effects, treatment was continued for 1 year. Efficacy and safety were analysed during the 1-year period of treatment.Results. Among the 30 patients recruited, 28 were evaluated at week 28 as already reported. Nineteen terminated the 52-week study, 15 of them being responders and 4 non-responders at week 28. Thirteen of the 15 responders at week 28 also responded at week 52 (86.7%). The improvement in the EULAR Sjogren's Syndrome Disease Activity Index and EULAR Sjogren's Syndrome Patient Reported Index scores observed at week 28 showed a trend to further improvement at week 52, and the amelioration of peculiar EULAR Sjogren's Syndrome Disease Activity Index domains (glandular, lymphadenopathy, articular) appeared of particular relevance. The decrease in biomarkers of B-cell activation observed at week 28 persisted unchanged until week 52, with RF decreasing further. Salivary flow, Schirmer's test and the focus score of salivary biopsy did not change. Safety of treatment was good.Conclusion. Long-term treatment with belimumab may be beneficial in SS. Randomized, double-blind, controlled studies in larger populations are encouraged.