Section of Dermatology-Department of Clinical Medicine and Surgery, University of Naples Federico II, Via Pansini 5, 80131, Napoli, Italy.
Arch Dermatol Res. 2022 Aug;314(6):619-623. doi: 10.1007/s00403-021-02200-7. Epub 2021 Feb 20.
No data on real-life experiences of risankizumab efficacy and safety are reported, apart from two isolated case reports. We carried out a single-centre, prospective study to assess the efficacy and safety of risankizumab. Fourteen patients were included (mean age 44.5 ± 14.2 years). Mean PASI decreased from 12.3 ± 5.2 (baseline) to 4.4 ± 2.7 at week 4 (p < 0.01), and to 2.7 ± 1.7 at week 16 (p < 0.001). A similar trend was observed for BSA. In patients previously treated with biologics (71.4%, n = 10) versus the naïve ones, mean baseline PASI was similar (12.7 ± 5.8 vs 11.3 ± 3.8). Mean BSA was higher in multifailure (23.5 ± 11.8 vs 15.5 ± 11.8). At 4 and 16 weeks, a significant improvement in PASI and BSA was observed in both groups. An improvement in NAPSI score, mean scalp, and palmo-plantar area reduction was noticed during follow-up. No AEs were reported up to week 16 and few and mild grade laboratory tests were reported. Our initial data confirm the promising results on efficacy and safety of Risankizumab, even in a more challenging and "real" population, composed of a high percentage of multi-failure psoriatic patients who have benefitted from a new class agent.
目前除了两例孤立病例报告外，尚无关于 risankizumab 疗效和安全性的真实临床经验数据。我们进行了一项单中心前瞻性研究，以评估 risankizumab 的疗效和安全性。共纳入 14 例患者（平均年龄 44.5 ± 14.2 岁）。平均 PASI 从基线时的 12.3 ± 5.2 降至第 4 周的 4.4 ± 2.7（p < 0.01），并在第 16 周降至 2.7 ± 1.7（p < 0.001）。BSA 也呈现出类似的趋势。在先前接受过生物制剂治疗的患者（71.4%，n = 10）与未接受过生物制剂治疗的患者相比，平均基线 PASI 相似（12.7 ± 5.8 比 11.3 ± 3.8）。多线治疗失败患者的平均 BSA 更高（23.5 ± 11.8 比 15.5 ± 11.8）。在第 4 周和第 16 周，两组患者的 PASI 和 BSA 均有显著改善。在随访过程中，NAPSI 评分、头皮和掌跖面积均有改善。至第 16 周，未报告任何不良事件（AE），仅报告了少数轻微程度的实验室检查异常。我们的初步数据证实了 risankizumab 疗效和安全性的良好结果，即使在更具挑战性且“真实”的人群中，该人群由高比例的多线治疗失败的银屑病患者组成，他们受益于一种新的治疗药物。
