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环孢素A单药治疗银屑病关节炎患者的疗效:SYNERGY研究的亚组分析。

Efficacy of cyclosporine A as monotherapy in patients with psoriatic arthritis: a subgroup analysis of the SYNERGY Study.

作者信息

Colombo Delia, Chimenti Sergio, Grossi Paolo A, Marchesoni Antonio, Foti Rosario, Calzavara-Pinton Piergiacomo, Zagni Emanuela, Ori Alessandra, Bellia Gilberto

机构信息

Novartis Farma Italia, Origgio, Varese, Italy -

Tor Vergata Policlinic, Rome, Italy.

出版信息

G Ital Dermatol Venereol. 2017 Jun;152(3):297-301. doi: 10.23736/S0392-0488.16.05301-3. Epub 2016 Feb 2.

Abstract

BACKGROUND

The SYNERGY Study is an observational, multicenter Italian study, conducted in patients with diagnosis of psoriatic arthritis (PsA) treated from at least 3 months with cyclosporine and aimed at assessing patients' seropositivity for viral infections and efficacy and safety of cyclosporine, administered as monotherapy or in combination with other systemic drugs in the routine clinical practice. The aim of this subanalysis of the SYNERGY study was to evaluate the effects of CsA as monotherapy only in PsA over 12 months of observation.

METHODS

Psoriasis was evaluated by Body Surface Area and the Psoriasis Area Severity Index (PASI). PsA was evaluated by number of swollen and tender joints, painful entheses and fingers with dactylitis, the Bath Ankylosing Spondylitis Activity Index (BASDAI) and by patients' and physicians' global assessment on a 10-point Visual Analogue Scale.

RESULTS

Cyclosporine in monotherapy was effective in reducing all the measured disease parameters. The major indexes of cutaneous and spinal involvement, PASI and BASDAI were significantly reduced over the study period, as were the number of swollen and tender peripheral joints, and enthesitis and dactylitis.

CONCLUSIONS

Cyclosporine in monotherapy confirmed its efficacy in cutaneous psoriasis and suggested to be effective also on PsA, reducing spinal and peripheral joints' signs and symptoms.

摘要

背景

SYNERGY研究是一项观察性、多中心的意大利研究,针对诊断为银屑病关节炎(PsA)且至少接受环孢素治疗3个月的患者,旨在评估患者病毒感染的血清阳性率以及环孢素在常规临床实践中作为单一疗法或与其他全身药物联合使用时的疗效和安全性。SYNERGY研究的这项亚分析旨在评估仅将环孢素作为单一疗法治疗PsA 12个月的效果。

方法

通过体表面积和银屑病面积严重程度指数(PASI)评估银屑病。通过肿胀和压痛关节的数量、疼痛的附着点和指(趾)炎的手指数量、巴斯强直性脊柱炎活动指数(BASDAI)以及患者和医生在10分视觉模拟量表上的整体评估来评估PsA。

结果

环孢素单一疗法在降低所有测量的疾病参数方面有效。在研究期间,皮肤和脊柱受累的主要指标PASI和BASDAI显著降低,肿胀和压痛的外周关节数量、附着点炎和指(趾)炎也显著减少。

结论

环孢素单一疗法证实了其在皮肤银屑病中的疗效,并表明对PsA也有效,可减轻脊柱和外周关节的体征和症状。

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