Fukuoka University, Fukuoka, Japan.
The Jikei University School of Medicine, Tokyo, Japan.
J Dermatol. 2021 Jun;48(6):844-852. doi: 10.1111/1346-8138.15763. Epub 2021 Feb 1.
The three part, double-blind, randomized, controlled reSURFACE 1 trial and extension study (NCT01722331) evaluated efficacy and safety of tildrakizumab in adults with moderate to severe plaque psoriasis. Patients with ≥50% improvement from baseline in Psoriasis Area and Severity Index (PASI 50) following treatment with tildrakizumab 100 mg (TIL100) or 200 mg (TIL200) could enter the optional long-term extension study and continue treatment at the same dose for an additional 192 weeks. This subgroup analysis assessed the long-term efficacy and safety of tildrakizumab treatment for Japanese patients enrolled in reSURFACE 1 for up to 5 years of treatment. The primary efficacy outcomes were the proportions of patients who maintained PASI 75 and Physician Global Assessment (PGA) clear or minimal with ≥2-grade reduction from baseline (PGA 0/1) from base study week 64 to extension week 192. Secondary outcomes were the proportion of patients who maintained PASI 90/100 from base study week 64 to extension week 192. Adverse events (AEs) were monitored throughout the study and for up to 20 weeks after the last study visit. Of the 120 Japanese patients who entered the reSURFACE 1 extension study, 43 (79.6%) patients receiving tildrakizumab 100 mg and 58 (87.9%) patients receiving tildrakizumab 200 mg completed the extension study. Of all Japanese patients with PASI 75/90/100 and PGA 0/1 at week 64, 85%/88% receiving TIL100/TIL200 maintained PASI 75, 70%/96% maintained PASI 90, 63%/67% maintained PASI 100, and 68%/72% maintained PGA 0/1 at extension week 192. AEs led to discontinuation in 1.7 patients per 100 patient-years (P100PY) receiving tildrakizumab 100 mg and 0.8 P100PY receiving tildrakizumab 200 mg. Incidences of severe infections, malignancies, confirmed major adverse cardiac events, and hypersensitivity reactions were low in both treatment groups. Through 5 years of treatment, tildrakizumab maintained efficacy and was well tolerated with low rates of AEs of special interest.
三项、双盲、随机、对照 reSURFACE 1 试验和扩展研究（NCT01722331）评估了替度鲁单抗在中重度斑块状银屑病成人患者中的疗效和安全性。接受替度鲁单抗 100mg（TIL100）或 200mg（TIL200）治疗后，从基线时银屑病面积和严重程度指数（PASI）改善≥50%的患者可以进入可选的长期扩展研究，并在同一剂量下再接受 192 周治疗。这项亚组分析评估了替度鲁单抗治疗日本患者的长期疗效和安全性，这些患者参加 reSURFACE 1 研究的时间长达 5 年。主要疗效结局是从基线开始，在扩展研究第 64 周至第 192 周时，维持 PASI75 和医师总体评估（PGA）清除或最小改善≥2 级（PGA0/1）的患者比例。次要结局是维持 PASI90/100 的患者比例。从基线开始，在扩展研究第 64 周至第 192 周。在整个研究期间和最后一次研究访视后最多 20 周监测不良事件（AE）。在进入 reSURFACE 1 扩展研究的 120 名日本患者中，43 名（79.6%）接受替度鲁单抗 100mg 的患者和 58 名（87.9%）接受替度鲁单抗 200mg 的患者完成了扩展研究。在所有 PASI75/90/100 和 PGA0/1 的日本患者中，85%/88%接受 TIL100/TIL200 的患者维持 PASI75，70%/96%维持 PASI90，63%/67%维持 PASI100，68%/72%维持 PGA0/1在扩展研究第 192 周。替度鲁单抗治疗的 100 患者-年（P100PY）有 1.7 例患者因 AE 停药，接受替度鲁单抗 200mg 治疗的患者有 0.8 例。两组的严重感染、恶性肿瘤、确诊的主要不良心脏事件和过敏反应发生率均较低。经过 5 年的治疗，替度鲁单抗保持了疗效，且 AE 发生率低，具有良好的耐受性。
