Department of Dermatology and Venereology, Aarhus University Hospital, Aarhus, Denmark.
Department of Dermatology, CHUV University Hospital and University of Lausanne (UNIL), Lausanne, Switzerland.
J Eur Acad Dermatol Venereol. 2023 May;37(5):1004-1016. doi: 10.1111/jdv.18846. Epub 2023 Jan 27.
Biologic treatments have been studied mainly in patients with a long-term history of psoriasis and previous treatment failures.
The purpose of this primary analysis of the STEPIn study is to determine whether early intervention with secukinumab in patients with new-onset moderate to severe plaque psoriasis is superior to standard of care treatment with narrow band ultraviolet B (nb-UVB) phototherapy.
The STEPIn study is a randomized, open-label, multicentre study to investigate early intervention with 52 weeks of secukinumab 300 mg administered subcutaneously versus standard treatment with nb-UVB phototherapy in patients with new-onset (≤12 months) moderate to severe plaque psoriasis (NCT03020199). The primary and additional secondary endpoints were ≥90% improvement in Psoriasis Area and Severity Index (PASI 90) at Week 52 and Investigator's Global Assessment (IGA mod 2011) 0/1 response at Week 52, respectively.
In the secukinumab and nb-UVB study arms, 77/80 and 76/80 randomized patients received at least one dose of study treatment, respectively. The primary endpoint was achieved: 91.1% (70/77) of patients achieved a PASI 90 response at Week 52 in the secukinumab arm versus 42.3% (32/76) in the nb-UVB arm (p < 0.0001, odds ratio [OR] estimate [95% confidence intervals, CI] = 16.3 [5.6, 46.9]). The additional secondary endpoint was also achieved: 85.7% of patients achieved an IGA 0/1 response at Week 52 in the secukinumab arm versus 36.8% in the nb-UVB arm (p < 0.0001). The safety data were consistent with the safety profiles of secukinumab and nb-UVB with no new or unexpected safety signals.
Secukinumab was superior to nb-UVB in treating patients with new-onset moderate to severe plaque psoriasis. The high and sustained skin clearance observed indicates that biologic treatment for psoriasis may be more effective if used early in the disease course.
生物制剂主要在有长期银屑病病史和既往治疗失败的患者中进行研究。
本研究的主要目的是确定新发病的中重度斑块型银屑病患者早期使用司库奇尤单抗治疗是否优于窄谱紫外线 B（nb-UVB）光疗的标准治疗。
STEPI 研究是一项随机、开放标签、多中心研究，旨在评估新发病（≤12 个月）中重度斑块型银屑病患者使用司库奇尤单抗 300mg 皮下注射 52 周与 nb-UVB 光疗标准治疗的早期干预效果（NCT03020199）。主要和次要次要终点分别为第 52 周时达到银屑病面积和严重程度指数（PASI 90）改善≥90%和第 52 周时研究者全球评估（IGA mod 2011）0/1 缓解。
在司库奇尤单抗和 nb-UVB 研究组中，分别有 77/80 和 76/80 名随机患者接受了至少一剂研究药物。主要终点达到：第 52 周时，司库奇尤单抗组 91.1%（70/77）的患者达到 PASI 90 缓解，而 nb-UVB 组为 42.3%（32/76）（p<0.0001，优势比[OR]估计值[95%置信区间，CI]为 16.3[5.6, 46.9]）。次要次要终点也达到：第 52 周时，司库奇尤单抗组 85.7%的患者达到 IGA 0/1 缓解，而 nb-UVB 组为 36.8%（p<0.0001）。安全性数据与司库奇尤单抗和 nb-UVB 的安全性特征一致，没有新的或意外的安全性信号。
司库奇尤单抗在治疗新发病的中重度斑块型银屑病患者中优于 nb-UVB。观察到的高且持续的皮肤清除率表明，如果在疾病早期使用生物制剂治疗银屑病，可能会更有效。
