Translational Research in Inflammatory Skin Diseases, Institute for Health Services Research in Dermatology and Nursing, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.
LEO Pharma, Ballerup, Denmark.
J Eur Acad Dermatol Venereol. 2021 Oct;35(10):2034-2044. doi: 10.1111/jdv.17433. Epub 2021 Jul 24.
The pathway for treatment of psoriasis is partly dependent upon disease severity, and patients may experience inadequate response at any point along the treatment pathway. Patients who repeatedly fail therapy represent a population in whom effective and well-tolerated treatment options are limited.
To investigate and describe patients achieving Psoriasis Area and Severity Index (PASI) 100 and cumulative treatment benefit over time in patients with moderate-to-severe psoriasis receiving brodalumab or ustekinumab by prior treatment.
We conducted a post hoc analysis of data from two phase 3, randomized, controlled, 52-week AMAGINE trials of brodalumab to describe patients who achieved complete clearance as measured by PASI 100 by prior treatment subgroup (naïve to systemic and biologic treatment, systemic-treated but biologic-naïve, biologic-treated without failure, and biologic-treated with failure). A competing risk model was used to assess cumulative incidence over a 52-week period with outcomes of PASI 100 or inadequate response. Cumulative clinical benefit of treatment was determined with an area under the curve analysis.
The 52-week cumulative incidence of patients achieving PASI 100 was consistently higher for brodalumab vs. ustekinumab across treatment pathway subgroups (76% vs. 58% in systemic/biologic-naïve patients, 78% vs. 55% in systemic-treated/biologic-naïve patients, 75% vs. 41% in biologic-treated patients without failure, and 70% vs. 30% in biologic-treated patients with failure). Rates of inadequate response were lower with brodalumab compared with ustekinumab across all subgroups. Cumulative treatment benefit was also higher for all subgroups treated with brodalumab compared with those treated with ustekinumab.
Treatment with brodalumab was associated with higher levels of complete clearance and greater cumulative benefit over time compared with ustekinumab, in patients with moderate-to-severe psoriasis, regardless of prior treatment experience.
银屑病的治疗途径部分取决于疾病的严重程度，患者在治疗过程中的任何阶段都可能出现治疗反应不足的情况。反复治疗失败的患者代表着有效且耐受良好的治疗选择有限的人群。
调查和描述接受过布罗达卢单抗或乌司奴单抗治疗的中重度银屑病患者，根据既往治疗情况，实现银屑病面积和严重程度指数（PASI）100 和累积治疗获益的时间。
我们对两项布罗达卢单抗治疗中重度银屑病的 3 期、随机、对照、52 周 AMAGINE 试验数据进行了事后分析，以描述既往治疗亚组（全身和生物治疗初治、全身治疗但生物治疗初治、生物治疗无失败和生物治疗失败）中达到 PASI 100 完全清除的患者。使用竞争风险模型评估 52 周期间 PASI 100 或治疗反应不足的累积发生率。通过曲线下面积分析确定治疗累积获益。
在所有治疗途径亚组中，与乌司奴单抗相比，布罗达卢单抗在第 52 周时达到 PASI 100 的患者累积发生率始终更高（全身/生物治疗初治患者为 76% vs. 58%，全身治疗/生物治疗初治患者为 78% vs. 55%，生物治疗无失败患者为 75% vs. 41%，生物治疗失败患者为 70% vs. 30%）。与乌司奴单抗相比，布罗达卢单抗在所有亚组中的治疗反应不足发生率均较低。与乌司奴单抗相比，所有亚组接受布罗达卢单抗治疗的累积治疗获益也更高。
与乌司奴单抗相比，在中重度银屑病患者中，无论既往治疗经验如何，布罗达卢单抗治疗与更高水平的完全清除率和随时间推移的更大累积获益相关。
