Imafuku Shinichi, Tada Yayoi, Umezawa Yoshinori, Sakurai Shinya, Hoshii Naoki, Nakagawa Hidemi
Department of Dermatology, Fukuoka University, Fukuoka, Japan.
Department of Dermatology, Teikyo University, Tokyo, Japan.
Dermatol Ther (Heidelb). 2022 Jan;12(1):121-135. doi: 10.1007/s13555-021-00645-2. Epub 2021 Nov 26.
We present certolizumab pegol (CZP) efficacy data across patient demographic and baseline disease characteristic subgroups from a phase 2/3 trial investigating CZP treatment in Japanese patients with moderate to severe plaque psoriasis (PSO; ClinicalTrials.gov identifier: NCT03051217).
Patients were randomised 1:2:2 to placebo once every 2 weeks (Q2W), CZP 400 mg Q2W and CZP 200 mg Q2W (400 mg weeks 0, 2 and 4) for 16 weeks. Patients who achieved ≥ 50% reduction in their baseline Psoriasis Area and Severity Index (PASI 50) score at week 16 continued therapy to week 52. PASI 75/90 (75% and 90% reduction, respectively) and Physician's Global Assessment (PGA) 0/1 responder rates at weeks 16 and 52 were reported for patient demographic and baseline disease characteristic subgroups, including body mass index (BMI), PASI, disease duration and prior biologic use. Non-responder imputation was used.
Of the randomised patients, 2/26 patients in the placebo group, 47/53 patients in the CZP 400 mg Q2W group and and 39/48 patients in the CZP 200 mg Q2W group completed week 52. In the subgroups evaluated, week 16 efficacy was generally maintained through week 52. At week 52, PASI 75 was achieved by 84.2, 85.7 and 80.0% of patients receiving CZP 400 mg Q2W in the low (15.0-23.7 kg/m)/intermediate (> 23.7-27.4 kg/m)/high (> 27.4-47.0 kg/m) BMI subgroups, respectively, and by 77.8, 70.6 and 69.2%, respectively of patients treated with CZP 200 mg Q2W. PASI 75 at week 52 was achieved by 92.9, 75.0 and 84.2% of patients receiving CZP 400 mg Q2W in the low (12.0-18.0)/intermediate (> 18.0-27.0)/high (> 27.0-67.2) baseline PASI subgroups, respectively, and by 85.0, 58.3 and 68.8% of patients receiving CZP 200 mg Q2W, respectively. Similar responses were observed across other subgroups evaluated for both CZP doses in PASI 75/90 and PGA 0/1.
Clinically meaningful improvements in signs and symptoms of PSO were maintained through week 52 for CZP dosed at 400 mg Q2W or 200 mg Q2W, across patient subgroups. In general, a numerically greater response was observed for patients receiving CZP 400 mg Q2W versus those receiving CZP 200 mg Q2W across patient subgroups.
ClinicalTrials.gov identifier, NCT03051217.
我们展示了赛妥珠单抗聚乙二醇（CZP）在一项2/3期试验中的疗效数据，该试验针对中度至重度斑块状银屑病（PSO）日本患者研究CZP治疗（ClinicalTrials.gov标识符：NCT03051217），数据涉及患者人口统计学和基线疾病特征亚组。
患者按1:2:2随机分组，分别接受每2周一次的安慰剂（Q2W）、400mg Q2W的CZP和200mg Q2W的CZP（第0、2和4周给予400mg），治疗16周。在第16周时银屑病面积和严重程度指数（PASI）得分较基线降低≥50%（PASI 50）的患者继续治疗至第52周。报告了第16周和第52周时患者人口统计学和基线疾病特征亚组（包括体重指数（BMI）、PASI、疾病持续时间和既往生物制剂使用情况）的PASI 75/90（分别降低75%和90%）和医生整体评估（PGA）0/1缓解率。采用无应答者填补法。
在随机分组的患者中，安慰剂组2/26例患者、400mg Q2W的CZP组47/53例患者和200mg Q2W的CZP组39/48例患者完成了第52周治疗。在评估的亚组中，第16周的疗效一般维持到第52周。在第52周时，低（15.0 - 23.7kg/m²）/中（>23.7 - 27.4kg/m²）/高（>27.4 - 47.0kg/m²）BMI亚组中，接受400mg Q2W的CZP治疗的患者分别有84.2%、85.7%和80.0%达到PASI 75，接受200mg Q2W的CZP治疗的患者分别为77.8%、70.6%和69.2%。在低（12.0 - 18.0）/中（>18.0 - 27.0）/高（>27.0 - 67.2）基线PASI亚组中，接受400mg Q2W的CZP治疗的患者分别有92.9%、75.0%和84.2%在第52周达到PASI 75，接受200mg Q2W的CZP治疗的患者分别为85.0%、58.3%和68.8%。在针对两种CZP剂量评估的PASI 75/90和PGA 0/1的其他亚组中也观察到了类似的反应。
对于接受400mg Q2W或200mg Q2W剂量CZP治疗的患者，PSO的体征和症状在各患者亚组中至第52周均维持了具有临床意义的改善。总体而言，在各患者亚组中，接受400mg Q2W的CZP治疗的患者与接受200mg Q2W的CZP治疗的患者相比，在数值上观察到的反应更大。
ClinicalTrials.gov标识符，NCT03051217。
