Brodalumab治疗银屑病和银屑病关节炎的药物生存期和有效性的单中心真实世界研究。

IF 2.2 4区 医学 Q3 PHARMACOLOGY & PHARMACY Drugs in Research & Development Pub Date : 2023-06-01 DOI:10.1007/s40268-023-00422-w
Cathrine Dawn Büttner Elgaard, Lars Iversen, Kasper Fjellhaugen Hjuler
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引用次数: 1

摘要

背景:临床试验已经确定了brodalumab治疗银屑病和银屑病关节炎的疗效。需要真实的证据来充分评估这种药物。目的:在现实世界中,我们研究了brodalumab在银屑病和银屑病关节炎患者中的药物生存期和临床疗效。方法:这是一项回顾性单中心研究,纳入丹麦奥胡斯大学医院皮肤科接受brodalumab治疗牛皮癣的患者。主要终点是药物生存期、停药原因、达到银屑病面积和严重程度指数(PASI)≤2的患者百分比以及对银屑病关节炎的临床疗效。结果:纳入83例患者(平均年龄49.2±17.4岁,男性59.0%,bio-naïve 9.6%,平均基线PASI 10.9±6.9)。27例患者主要因无效和不良事件(ae)而停止治疗。kaplan - meier估计的1年药物生存率为65.7%。68.2%的患者在随访结束时达到绝对银屑病面积和严重程度指数(PASI)≤2,在12-17周时达到70.0%,在40-60周后达到76.2%。药物生存期和PASI≤2与基线PASI≥10、体重指数≥30、既往使用> 2种生物制剂或其他IL-17抑制剂均无相关性(P > 0.05)。18例银屑病关节炎患者中有10例获得缓解或部分缓解;治疗失败5例。结论:在现实世界中,Brodalumab对银屑病和银屑病关节炎有效。药物生存期低于其他现实环境的报道。
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Single-Centre Real-World Study on Drug Survival and Effectiveness of Brodalumab for Treatment of Psoriasis and Psoriatic Arthritis.

Background: Clinical trials have established the efficacy of brodalumab in treatment of psoriasis and psoriatic arthritis. Real-world evidence is needed to fully evaluate the drug.

Objective: Here we investigate drug survival and clinical effectiveness of brodalumab in patients with psoriasis and psoriatic arthritis in a real-world setting.

Methods: This was a retrospective single-centre study enrolling patients receiving brodalumab for psoriasis at the Department of Dermatology, Aarhus University Hospital, Denmark. The primary endpoints were drug survival, reasons for discontinuation, percentage of patients achieving a Psoriasis Area and Severity Index (PASI) ≤ 2 and clinical effectiveness against psoriatic arthritis.

Results: Eighty-three patients were included (mean age 49.2 ± 17.4 years, 59.0% male, 9.6% bio-naïve, mean baseline PASI 10.9 ± 6.9). Twenty-seven patients discontinued treatment primarily due to ineffectiveness and adverse events (AEs). Kaplan-Meier-estimated 1-year drug survival was 65.7%. An absolute Psoriasis Area and Severity Index (PASI) ≤ 2 was achieved by 68.2% of patients at end of follow-up, by 70.0% at weeks 12-17 and by 76.2% after 40-60 weeks of treatment. Neither drug survival nor PASI ≤ 2 was associated with baseline PASI ≥ 10, body mass index ≥ 30, previous treatment with > 2 biologics or other IL-17 inhibitors in particular (P > 0.05). Psoriatic arthritis remission or partial remission was achieved by 10 out of 18 patients with psoriatic arthritis; treatment failure was reported in 5 patients.

Conclusions: Brodalumab was effective against psoriasis and psoriatic arthritis in a real-world setting. The drug survival was lower than reported in other real-world settings.

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来源期刊
Drugs in Research & Development
Drugs in Research & Development Pharmacology, Toxicology and Pharmaceutics-Pharmacology
CiteScore
5.10
自引率
0.00%
发文量
31
审稿时长
8 weeks
期刊介绍: Drugs in R&D is an international, peer reviewed, open access, online only journal, and provides timely information from all phases of drug research and development that will inform clinical practice. Healthcare decision makers are thus provided with knowledge about the developing place of a drug in therapy. The Journal includes: Clinical research on new and established drugs; Preclinical research of direct relevance to clinical drug development; Short communications and case study reports that meet the above criteria will also be considered; Reviews may also be considered.
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