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司库奇尤单抗可显著改善合并甲损害患者的指甲银屑病、银屑病关节炎的体征和症状及放射学进展:III 期 FUTURE 5 研究 2 年结果。

Secukinumab provides sustained improvement in nail psoriasis, signs and symptoms of psoriatic arthritis and low rate of radiographic progression in patients with concomitant nail involvement: 2-year results from the Phase III FUTURE 5 study.

机构信息

School of Medicine, Griffith University, Queensland, Australia.

Swedish Medical Centre/Providence St. Joseph Health and University of Washington, Seattle, USA.

出版信息

Clin Exp Rheumatol. 2022 May;40(5):952-959. doi: 10.55563/clinexprheumatol/3nuz51. Epub 2021 Sep 3.

DOI:10.55563/clinexprheumatol/3nuz51
PMID:34494957
Abstract

OBJECTIVES

To evaluate the impact of secukinumab on nail psoriasis and other psoriatic disease manifestations in patients with psoriatic arthritis (PsA) with concomitant nail psoriasis from the FUTURE 5 study.

METHODS

Eligible patients were randomly allocated to receive subcutaneous secukinumab (300 mg load [300 mg], 150 mg load [150 mg], and 150 mg [no load]) or placebo weekly and then every 4 weeks starting Week 4. Key assessments through Week 104 in this post hoc analysis included modified Nail Psoriasis Severity (mNAPSI), Psoriasis Area and Severity Index (PASI 90), resolution of dactylitis and enthesitis, Dermatology Life Quality Index (DLQI) and radiographic progression (assessed by vdH-mTSS).

RESULTS

At baseline, 66.6% patients (663/996) had concomitant nail psoriasis. Baseline characteristics were balanced in the nail subset and comparable with the overall population. Secukinumab reduced mNAPSI score at Week 16 versus placebo: -8.71 (300 mg), -8.95 (150 mg), -7.55 (150 mg no load) versus -2.34 (placebo); all p<0.0001. Mean change from baseline in DLQI at Week 16 was -8.5 (300 mg), -7.4 (150 mg), -7.3 (150 mg no load) versus -2.4 (placebo); all p<0.0001. Overall, the improvements reported at Week 16 sustained through Week 104. The proportion of patients with no radiographic progression (change from baseline in vdH-mTSS≤0.5) at Week 104 was 91.9% (300 mg) 78.9% (150 mg), and 82.4% (150 mg no load).

CONCLUSIONS

Secukinumab provided sustained improvements in nail disease, signs and symptoms of PsA, and a low rate of radiographic progression through 2 years in patients with concomitant nail psoriasis.

摘要

目的

评估司库奇尤单抗对伴有指甲银屑病的银屑病关节炎(PsA)患者指甲银屑病和其他银屑病表现的影响,该研究来自 FUTURE 5 研究。

方法

符合条件的患者被随机分配接受皮下司库奇尤单抗(300mg 负荷量[300mg]、150mg 负荷量[150mg]和 150mg[无负荷量])或安慰剂,每周一次,然后从第 4 周开始每 4 周一次。本事后分析的关键评估指标包括改良指甲银屑病严重程度指数(mNAPSI)、银屑病面积和严重程度指数(PASI90)、指(趾)炎和附着点炎的缓解、皮肤病生活质量指数(DLQI)和放射学进展(vdH-mTSS 评估)。

结果

基线时,66.6%的患者(996 例中有 663 例)伴有指甲银屑病。指甲亚组的基线特征与总体人群平衡且可比。与安慰剂相比,司库奇尤单抗在第 16 周时降低了 mNAPSI 评分:-8.71(300mg)、-8.95(150mg)、-7.55(150mg 无负荷量)与-2.34(安慰剂);均<0.0001。第 16 周时,DLQI 从基线的平均变化为-8.5(300mg)、-7.4(150mg)、-7.3(150mg 无负荷量)与-2.4(安慰剂);均<0.0001。总体而言,第 16 周报告的改善持续到第 104 周。第 104 周时,无影像学进展(vdH-mTSS 从基线变化≤0.5)的患者比例为 91.9%(300mg)、78.9%(150mg)和 82.4%(150mg 无负荷量)。

结论

在伴有指甲银屑病的患者中,司库奇尤单抗在 2 年内持续改善指甲疾病、PsA 的体征和症状,且放射学进展的发生率较低。

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