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司库奇尤单抗治疗难治性黏膜和关节型白塞病表型的长期疗效和安全性:一项多中心研究。

Long-term effectiveness and safety of secukinumab for treatment of refractory mucosal and articular Behçet's phenotype: a multicentre study.

机构信息

Department of Experimental and Clinical Medicine, University of Florence, Firenze, Italy.

Department of Neurosciences, Psychology, Drug Research and Child Health (NEUROFARBA), University of Firenze, Firenze, Italy.

出版信息

Ann Rheum Dis. 2020 Aug;79(8):1098-1104. doi: 10.1136/annrheumdis-2020-217108. Epub 2020 May 7.

Abstract

OBJECTIVE

To evaluate the effectiveness and safety of secukinumab in patients with a mucosal and articular Behçet's phenotype resistant to conventional and biologic treatment.

METHODS

A multicentre retrospective study was performed on 15 patients with a mucosal and articular phenotype of Behçet's syndrome fulfilling the International Criteria for Behçet's Disease and refractory to treatment with colchicine, disease-modifying antirheumatic drugs and at least one antitumour necrosis factor-α agent. Minimum follow-up was set at 6 months. Six patients with a polyarticular involvement were treated with secukinumab 300 mg/month, while all other cases received secukinumab 150 mg/month. Dose increase from 150 to 300 mg per month and shortening of administration frequency were allowed for poor disease control. Response evaluation was based on the number of oral ulcers in the previous 28 days and Disease Activity Score-28 for articular manifestations.

RESULTS

At 3 months of follow-up, nine (66.7%) patients achieved a response (complete or partial), and this proportion further increased to 86.7% at 6 months, 76.9% at 12 months, 90.0% at 18 months and 100.0% after 24 months. Notably, all patients who started with secukinumab 300 mg/month achieved complete response by month 6. Seven (46.7%) patients could achieve a response only after switching to a higher dosage.

CONCLUSIONS

Our study suggests that secukinumab at a dose of 150 and 300 mg per month is safe and effective for the long-term treatment of patients with Behçet's syndrome with a mucosal and articular phenotype refractory to previous treatments. Notably, secukinumab 300 mg/month resulted in superior complete mucosal and articular responses with no serious or dose-related adverse effects.

摘要

目的

评估司库奇尤单抗治疗对常规和生物制剂治疗抵抗的黏膜和关节型贝赫切特病患者的有效性和安全性。

方法

对 15 例满足贝赫切特病国际诊断标准且对秋水仙碱、改善病情抗风湿药和至少一种抗肿瘤坏死因子-α药物治疗抵抗的黏膜和关节型贝赫切特病患者进行了一项多中心回顾性研究。随访时间至少为 6 个月。6 例多关节受累患者接受司库奇尤单抗 300mg/月治疗,其余患者接受司库奇尤单抗 150mg/月治疗。对于疾病控制不佳的患者,允许剂量从 150mg 增加到 300mg/月,并缩短给药频率。根据过去 28 天的口腔溃疡数量和关节表现的疾病活动评分-28 来评估反应。

结果

在 3 个月的随访时,9 例(66.7%)患者达到了缓解(完全或部分缓解),这一比例在 6 个月时进一步增加到 86.7%,12 个月时为 76.9%,18 个月时为 90.0%,24 个月时为 100.0%。值得注意的是,所有开始使用司库奇尤单抗 300mg/月的患者在第 6 个月时均达到完全缓解。7 例(46.7%)患者仅在增加剂量后才能够缓解。

结论

我们的研究表明,司库奇尤单抗 150mg 和 300mg/月的剂量对于既往治疗抵抗的黏膜和关节型贝赫切特病患者的长期治疗是安全且有效的。值得注意的是,司库奇尤单抗 300mg/月治疗可更好地实现黏膜和关节的完全缓解,且无严重或与剂量相关的不良事件。

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