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古塞库单抗治疗银屑病和银屑病关节炎患者的疗效和生存情况:西班牙银屑病学会的多中心分析。

Guselkumab effectiveness and survival in patients with psoriasis and psoriatic arthritis: Multicenter analysis in daily clinical practice by the Spanish Psoriasis Group.

机构信息

Hospital de Manacor, Mallorca, Spain.

Hospital del Mar, Barcelona, Spain.

出版信息

Dermatol Ther. 2022 Nov;35(11):e15865. doi: 10.1111/dth.15865. Epub 2022 Oct 9.

DOI:10.1111/dth.15865
PMID:36175141
Abstract

Guselkumab is a monoclonal antibody that selectively blocks the p19 subunit of interleukin 23 and has been approved for the treatment of moderate to severe psoriasis and active psoriatic arthritis in adult patients due to its efficacy in different clinical trials. Therefore, itis important to know the performance of guselkumab in this setting of patients in clinical practice given that a high percentage of them are not represented in these clinical trials. Our objective was to evaluate the effectiveness and tolerability of guselkumab in clinical practice in the first patients with psoriasis and psoriatic arthritis treated since the date of its approval for psoriasis in Spain, in joint dermatology-rheumatology clinics. A multicenter retrospective data collection was carried out, in which 14 hospitals participated, including a total of 90 patients with psoriatic arthritis confirmed by a rheumatologist. Data collection was recorded at baseline and at weeks 12, 24, and 52 for both the articular and cutaneous domains. Ninety PsA patients started treatment with guselkumab and therefore were included in this study. The vast majority had already failed to at least to one biologic therapyprior guselkumab prescription. The median age was 55 years, 61% were female and 46% had a BMI ≥ 30 kg/m . Sixty-nine percent suffered from peripheral arthritis, and in 34% an axial involvement was also detected; dactylitis or enthesitis was present in 24% and 29% of patients, respectively. Guselkumab was effective in controlling both articular and skin manifestations of PsA patients. Absolute PASI significantly decreased from 10.5 to 4.8, 1.9 and 1.3 at weeks 12, 24, and 52, respectively. In 29 out of 61 (48%) of cases, DAPSA was moderate or high, and patients showed a significant reduction in DAPSA at 12, 24, and 52 weeks of treatment (mean DAPSA values at baseline and follow up were 29, 20, 16, and 14, respectively). Patients with DAPSA in low activity or in remission at the time of initiation of guselkumab maintained response at the end of the study period. No new safety concerns were detected. Seventy-eight out of 90 patients (84.4%) persisted on treatment after 2 years follow-up. Our experience suggests that guselkumab isan effective drug for PsA and PsO patients in clinical practice with good tolerability and no additional safety signals, making it a new therapeutic alternative for the treatment of PsA and PsO patients.

摘要

古塞库单抗是一种单克隆抗体,选择性地阻断白细胞介素 23 的 p19 亚单位,由于其在不同临床试验中的疗效,已被批准用于治疗成人中度至重度银屑病和活动性银屑病关节炎。因此,了解古塞库单抗在这一患者群体中的表现非常重要,因为这些临床试验中并未纳入大量此类患者。我们的目的是评估古塞库单抗在西班牙批准用于银屑病后的首个接受治疗的银屑病和银屑病关节炎患者中的疗效和耐受性,这些患者均在皮肤科-风湿科联合诊所中接受治疗。进行了一项多中心回顾性数据收集,共有 14 家医院参与,共纳入 90 名经风湿病学家确诊的银屑病关节炎患者。在关节和皮肤两个领域,分别在基线时和第 12、24 和 52 周记录数据。90 名银屑病关节炎患者开始接受古塞库单抗治疗,因此被纳入本研究。绝大多数患者在接受古塞库单抗治疗前至少对一种生物制剂治疗方案无应答。中位年龄为 55 岁,61%为女性,46%的 BMI≥30kg/m2。69%的患者患有外周关节炎,34%的患者还存在中轴受累;24%和 29%的患者分别存在指(趾)炎或附着点炎。古塞库单抗能有效控制银屑病关节炎患者的关节和皮肤表现。绝对 PASI 评分从基线时的 10.5 分别显著下降至第 12、24 和 52 周时的 4.8、1.9 和 1.3。在 61 例患者中的 29 例(48%)中,DAPSA 为中重度,治疗 12、24 和 52 周后 DAPSA 显著降低(基线和随访时的平均 DAPSA 值分别为 29、20、16 和 14)。在开始接受古塞库单抗治疗时处于低活动度或缓解期的患者在研究结束时仍保持缓解。未发现新的安全性问题。在 2 年随访后,90 例患者中有 78 例(84.4%)继续接受治疗。我们的经验表明,古塞库单抗是一种有效的药物,用于治疗临床实践中的银屑病关节炎和银屑病患者,具有良好的耐受性,没有额外的安全性信号,为治疗银屑病关节炎和银屑病患者提供了新的治疗选择。

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