Department of Dermatology, Aarhus University Hospital, Palle Juul-Jensens Boulevard 67, 8200, Aarhus N, Denmark.
Danish National Centre for Autoimmune Diseases, Aarhus University Hospital, Aarhus, Denmark.
Drugs R D. 2023 Jun;23(2):155-163. doi: 10.1007/s40268-023-00422-w. Epub 2023 May 8.
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.
Here we investigate drug survival and clinical effectiveness of brodalumab in patients with psoriasis and psoriatic arthritis in a real-world setting.
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.
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.
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.
临床试验已经证实了布罗达卢单抗治疗银屑病和银屑病关节炎的疗效。需要真实世界的证据来全面评估该药物。
本研究旨在调查布罗达卢单抗治疗银屑病和银屑病关节炎患者的药物生存情况和临床疗效。
这是一项回顾性单中心研究，纳入了丹麦奥胡斯大学医院皮肤科接受布罗达卢单抗治疗银屑病的患者。主要终点是药物生存时间、停药原因、达到银屑病面积和严重程度指数（PASI）≤2的患者比例以及对银屑病关节炎的临床疗效。
共纳入 83 例患者（平均年龄 49.2±17.4 岁，59.0%为男性，9.6%为生物制剂初治患者，基线 PASI 平均为 10.9±6.9）。27 例患者主要因无效和不良反应（AE）停药。Kaplan-Meier 估计的 1 年药物生存率为 65.7%。随访结束时，68.2%的患者达到绝对 PASI≤2，12-17 周时为 70.0%，40-60 周时为 76.2%。药物生存时间和 PASI≤2与基线 PASI≥10、BMI≥30、既往接受>2 种生物制剂或特定的其他 IL-17 抑制剂治疗无关（P>0.05）。18 例银屑病关节炎患者中有 10 例达到关节炎缓解或部分缓解；5 例报告治疗失败。
布罗达卢单抗在真实世界环境中对银屑病和银屑病关节炎有效。该药物的生存时间低于其他真实世界环境中的报道。
