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Guselkumab 在中重度斑块状银屑病患者亚组人群中的疗效:III 期 VOYAGE 1 和 VOYAGE 2 研究的汇总分析。

Efficacy of guselkumab in subpopulations of patients with moderate-to-severe plaque psoriasis: a pooled analysis of the phase III VOYAGE 1 and VOYAGE 2 studies.

机构信息

Medical College of Wisconsin, Milwaukee, WI, U.S.A.

Oregon Medical Research Center, Portland, OR, U.S.A.

出版信息

Br J Dermatol. 2018 Jan;178(1):132-139. doi: 10.1111/bjd.16008. Epub 2017 Dec 14.

Abstract

BACKGROUND

Significant advances have been made in the treatment of moderate-to-severe plaque psoriasis with biological therapies; however, these agents may not work equally in all populations.

OBJECTIVES

To evaluate the efficacy of guselkumab in patient subgroups with moderate-to-severe psoriasis from the pooled guselkumab VOYAGE 1 and VOYAGE 2 phase III studies.

METHODS

Using data from the pooled VOYAGE 1 and VOYAGE 2 psoriasis studies, analyses were performed to evaluate the consistency of efficacy [Investigator's Global Assessment (IGA) 0/1 (cleared or minimal psoriasis) and IGA 0 (cleared)] across subpopulations defined by demographics, baseline disease characteristics and previous psoriasis treatment.

RESULTS

A total of 1829 patients were randomized. Baseline demographics, disease characteristics and previous psoriasis treatment were comparable across treatment groups in the pooled population. Guselkumab, an anti-interleukin (IL)-23 monoclonal antibody that binds to the p19 subunit of IL-23, provided substantial benefit across almost all subpopulations, with greater proportions of patients achieving IGA 0/1 vs. placebo at week 16, and vs. adalimumab (an antitumour necrosis factor monoclonal antibody) at week 24. Patients treated with guselkumab achieved greater efficacy (IGA 0/1 and IGA 0) compared with adalimumab at week 24 across all weight quartiles, most notably among patients weighing ≥ 100 kg.

CONCLUSIONS

This analysis demonstrates a high degree of efficacy with guselkumab treatment compared with placebo at week 16 and with adalimumab at week 24 among broad subpopulations of patients with varying baseline demographics, disease characteristics and previous psoriasis treatments.

摘要

背景

生物疗法在治疗中重度斑块状银屑病方面取得了重大进展;然而,这些药物在所有人群中的效果可能并不相同。

目的

评估古斯库单抗在来自 pooled guselkumab VOYAGE 1 和 VOYAGE 2 三期研究的中重度银屑病患者亚组中的疗效。

方法

使用 pooled VOYAGE 1 和 VOYAGE 2 银屑病研究的数据,进行分析以评估疗效[研究者全球评估(IGA)0/1(清除或最小银屑病)和 IGA 0(清除)]在根据人口统计学、基线疾病特征和既往银屑病治疗定义的亚组中的一致性。

结果

共有 1829 名患者被随机分组。在 pooled 人群中,各组之间的基线人口统计学、疾病特征和既往银屑病治疗情况相似。古斯库单抗是一种抗白细胞介素(IL)-23 单克隆抗体,与 IL-23 的 p19 亚基结合,在几乎所有亚组中都提供了显著的益处,与安慰剂相比,在第 16 周时,更多的患者达到 IGA 0/1,与阿达木单抗(一种抗肿瘤坏死因子单克隆抗体)相比,在第 24 周时也更多。与阿达木单抗相比,在第 24 周时,接受古斯库单抗治疗的患者在所有体重四分位数中都取得了更高的疗效(IGA 0/1 和 IGA 0),在体重≥100kg 的患者中尤为明显。

结论

这项分析表明,与安慰剂相比,在第 16 周时,与阿达木单抗相比,在第 24 周时,古斯库单抗治疗在具有不同基线人口统计学、疾病特征和既往银屑病治疗的广泛患者亚组中具有高度疗效。

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