依法利珠单抗治疗头皮、掌足底和指甲牛皮癣:一项为期24周的拉丁美洲研究的结果

María Denise Takahashi, Edgardo Néstor Chouela, Gladys Leon Dorantes, Ana Maria Roselino, Jesùs Santamaria, Miguel Angel Allevato, Tania Cestari, Maria Eugenia Manzanera De Aillaud, Fernando Miguel Stengel, Daiana Licu
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引用次数: 9

摘要

介绍。影响指甲、头皮、手或脚的斑块型牛皮癣通常很难治疗;例如,局部治疗和光疗可能不会穿透甲板或头皮。这项大型、国际、多中心研究的目的是调查efalizumab在拉丁美洲中度至重度慢性斑块性银屑病成年患者中的疗效,这些患者是全身治疗或光疗的候选人。符合条件的患者参加了一项为期24周,开放标签,单臂,IIIb/IV期研究,持续使用皮下法利珠单抗,1.0 mg/kg/周。指甲、头皮、手或脚的受损伤分别使用指甲银屑病严重程度指数(NAPSI)、银屑病头皮严重程度指数(PSSI)或掌跖脓疱病银屑病面积和严重程度指数(PPPASI)进行评估。缺失数据的处理采用最后一次观测结转或无应答者归算方法。在189名接受治疗的患者中,112名患者有指甲受累,172名患者有头皮受累,19名患者有掌足底疾病。在第24周,分别有31%、71%和68%的患者的NAPSI、PSSI和PPPASI改善≥50%,而分别有17%、52%和63%的患者的这些评分改善≥75%。描述性统计显示,基线评分越高的患者,NAPSI-75反应率越低,PSSI-75和-50反应率越高。这项开放标签、非对照研究为efalizumab治疗指甲、头皮和掌跖牛皮癣的潜力提供了支持性证据。
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Efalizumab in the Treatment of Scalp, Palmoplantar and Nail Psoriasis: Results of a 24-Week Latin American Study

Introduction. Plaque-type psoriasis affecting the nails, scalp, hands or feet can often be difficult to treat; for example, topical treatments and phototherapy may not penetrate the nail plate or scalp. The objective of this large, international, multicentre study was to investigate the efficacy of efalizumab in a Latin American population of adult patients with moderate-to-severe chronic plaque psoriasis who were candidates for systemic therapy or phototherapy.

Methods. Eligible patients were enrolled in a 24-week, open-label, single-arm, Phase IIIb/IV study of continuous treatment with subcutaneous efalizumab, 1.0 mg/kg/wk. Involvement of the nails, scalp, or hands or feet was assessed using the Nail Psoriasis Severity Index (NAPSI), the Psoriasis Scalp Severity Index (PSSI), or the Palmoplantar Pustulosis Psoriasis Area and Severity Index (PPPASI), respectively. Missing data were handled using a last observation carried forward or nonresponder imputation approach.

Results. Of the 189 patients who received treatment, 112 patients had nail involvement, 172 had scalp involvement, and 19 had palmoplantar disease at baseline. At Week 24, ≥50% improvement on the NAPSI, PSSI and PPPASI was observed in 31%, 71% and 68% of patients, respectively, whereas ≥75% improvement on these scores was observed in 17%, 52% and 63%, respectively. Descriptive statistics showed lower NAPSI-75 and higher PSSI-75 and -50 response rates among patients with higher baseline scores.

Conclusions. This open-label, uncontrolled study provides supportive evidence of the potential of efalizumab as a treatment for nail, scalp and palmoplantar psoriasis.

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