Ralph von Kiedrowski, Khusru Asadullah, Bernhard Korge, Konstantina Tsarovina, Matthias Augustin
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摘要

背景 银屑病患者通常患有肥胖症。然而,迄今为止,关于布达鲁单抗 210 毫克(一种与人类白细胞介素 17 受体亚基 A 结合的全人源单克隆免疫球蛋白 IgG2 抗体)在肥胖患者日常治疗中的疗效,只有有限的数据。 目的 对 LIBERO 研究进行亚组分析,比较体重≤100 和 >100 公斤的患者在约 12 周(W)和约 52 周(W)后使用布达鲁单抗的疗效。 方法 LIBERO 是一项大型前瞻性、多中心、非干预性、真实世界证据研究,研究对象包括接受布达鲁单抗 210 毫克治疗的斑块状银屑病成年患者。 结果 461 名体重不超过 100 千克的患者(非肥胖)和 161 名体重达 100 千克的患者(肥胖)被纳入该亚组分析。在基线期,两组患者中的大多数人都患有非常严重(12.6%;15.7%)或严重(49.4%;55.0%)的银屑病,这是由医生全球评估(PGA)来评估的。截至第二周,两组患者的平均 PASI 均有明显下降。体重≤100 千克的患者的平均 PASI 从 16.9 降至 9.0,到第 12 个月时进一步降至 2.6(p <0.001)。在体重为 100 千克的患者组中,PASI 在 ~W2 时从 17.9 降至 10.2(p < 0.001),在 ~W12 时进一步降至 3.9(p < 0.001)。然而,在~W12时,体重为100 kg的患者的PASI0-3绝对值低于体重≤100 kg的患者(68.4% vs. 80.5%,p = 0.006);在~W52/最后一次就诊时,两组患者在任何疗效参数上都没有统计学意义上的显著差异,例如,PGA0/1反应率分别为82.3% vs. 86.5%(p = 0.6089)。 结论 LIBERO 的这项亚组分析证实,在日常治疗中,体重为 100 kg 和小于 100 kg 的患者在银屑病的长期治疗中同样受益。
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Efficacy of brodalumab in psoriasis patients with a body weight >100 kg: Real-world evidence (RWE) from the LIBERO study

Background

Patients with psoriasis often suffer from obesity. However, only limited data are available on the efficacy of brodalumab 210 mg, a fully human monoclonal immunoglobulin IgG2 antibody binding to the human interleukin 17 receptor subunit A, in obese patients in daily practice, to date.

Objectives

A subgroup analysis from the LIBERO study was conducted to compare the effectiveness of brodalumab in patients weighing ≤100 and >100 kg after ~12 weeks (W) and ~52 W.

Methods

LIBERO is a large prospective, multicenter, non-interventional, real-world-evidence study including adult patients with plaque psoriasis treated with brodalumab 210 mg.

Results

Four hundred and sixty-one patients with a body weight up to 100 kg (nonobese) and 161 patients with >100 kg body weight (obese) were included in this subgroup analysis. At baseline, the majority of patients in both groups had very severe (12.6%; 15.7%) or severe (49.4%; 55.0%) psoriasis, as assessed by Physician Global Assessment (PGA). As of W2, a significant reduction of the mean PASI could be achieved in both groups. In patients weighing ≤100 kg mean PASI decreased from 16.9 to 9.0 and further improved to 2.6 at ~W12 (p < 0.001). In the patient group >100 kg, the PASI decreased from 17.9 to 10.2 at ~W2 (p < 0.001) and improved further to 3.9 at ~W12 (p < 0.001). However, at ~W12 absolute PASI0-3 rates were lower in patients >100 kg than in patients ≤100 kg (68.4% vs. 80.5%, p = 0.006); there was no statistically significant difference between the groups at ~W52/last visit any more in any of the effectiveness parameters with, for example, a PGA0/1 response of 82.3% versus 86.5% (p = 0.6089), respectively.

Conclusions

This subgroup analysis of LIBERO confirmed, that in daily practice brodalumab can be equally beneficial patients with >100 and ≤100 kg in the long-term management of psoriasis.

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