Long-term efficacy of certolizumab pegol for the treatment of plaque psoriasis: 3-year results from two randomized phase III trials (CIMPASI-1 and CIMPASI-2).
Long-term efficacy of certolizumab pegol for the treatment of plaque psoriasis: 3-year results from two randomized phase III trials (CIMPASI-1 and CIMPASI-2).
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DOI：
10.1111/bjd.19393
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发表时间：
2021-04
期刊：
影响因子：
--
通讯作者：
Reich K
中科院分区：
文献类型：
--
作者：
Gordon KB;Warren RB;Gottlieb AB;Blauvelt A;Thaçi D;Leonardi C;Poulin Y;Boehnlein M;Brock F;Ecoffet C;Reich K
Certolizumab pegol（CZP）是一种不含Fc的聚乙二醇化抗肿瘤坏死因子生物制剂。报告CZP治疗斑块状银屑病的3年疗效，汇总CIMPASI-1（NCT 02326298）和CIMPASI-2（NCT 02326272）III期试验。患有中重度银屑病≥ 6个月的成人患者以2：2：1的比例随机分配至CZP 200 mg、CZP 400 mg或安慰剂组，每2周一次（Q2 W），持续48周。从双盲CZP进入开放标签期（第48-144周）的患者最初接受CZP 200 mg Q2 W。在第16周时，未实现银屑病面积和严重程度指数（PASI 50）改善≥ 50%的患者进入开放标签CZP 400 mg Q2 W逃逸组（第16-144周）。开放标签治疗期间允许根据PASI反应调整剂量。结局包括PASI 75、PASI 90和医师总体评估（PGA）0/1应答率，基于逻辑回归模型（缺失数据使用马尔可夫链蒙特卡罗方法插补）。共有186例患者随机分配至CZP 200 mg Q2 W组，175例患者随机分配至CZP 400 mg Q2 W组。第48周，随机分配至CZP 200 mg组的患者中有72.7%/51.3%达到PASI 75/90，随机分配至CZP 400 mg组的患者中有84.4%/62.7%达到PASI 75/90。在第48周从设盲治疗进入开放标签期的患者接受CZP 200 mg Q2 W。在第144周，随机分配至CZP 200 mg组的患者中有70.6%/48.7%达到PASI 75/90，随机分配至CZP 400 mg组的患者中有72.9%/42.7%达到PASI 75/90。第16周时，72例安慰剂随机化患者进入CZP 400 mg Q2 W逸搏治疗组;第144周时75.7%/58.5%的患者达到PASI 75/90。CZP 200 mg和400 mg Q2 W均表现出持续、持久的疗效，400 mg Q2 W的某些结局的缓解率在数值上更高。 关于这个话题我们已经知道了什么？ Certolizumab pegol是一种不含Fc的聚乙二醇化抗肿瘤坏死因子生物制剂，获批用于治疗中重度斑块状银屑病成人患者。来自III期试验前48周的疗效数据显示，塞妥珠单抗400 mg或200 mg每2周一次给药可显著改善银屑病的体征和症状。在接受较高剂量治疗的患者中观察到数值上更大的改善。 这项研究增加了什么？ 斑块型银屑病是一种慢性全身性疾病，需要长期管理和持续有效的治疗。CIMPASI-1和CIMPASI-2 III期试验汇总的3年疗效数据表明，塞妥珠单抗400 mg或200 mg每2周一次给药可产生持续和持久的应答。更高剂量可获得额外的长期临床获益。 链接评论：约翰逊等人，英国皮肤病学杂志2021; 184：588-589。
Certolizumab pegol (CZP) is an Fc‐free, PEGylated anti‐tumour necrosis factor biologic. To report the 3‐year efficacy of CZP in plaque psoriasis, pooled from the CIMPASI‐1 (NCT02326298) and CIMPASI‐2 (NCT02326272) phase III trials. Adults with moderate‐to‐severe psoriasis for ≥ 6 months were randomized 2 : 2 : 1 to CZP 200 mg, CZP 400 mg or placebo, every 2 weeks (Q2W) for up to 48 weeks. Patients entering the open‐label period (weeks 48–144) from double‐blinded CZP initially received CZP 200 mg Q2W. Patients not achieving ≥ 50% improvement in Psoriasis Area and Severity Index (PASI 50) at week 16 entered an open‐label CZP 400 mg Q2W escape arm (weeks 16–144). Dose adjustments based on PASI response were permitted during open‐label treatment. Outcomes included PASI 75, PASI 90 and Physician’s Global Assessment (PGA) 0/1 responder rates, based on a logistic regression model (missing data imputed using Markov Chain Monte Carlo methodology). In total, 186 patients were randomized to CZP 200 mg Q2W and 175 to CZP 400 mg Q2W. At week 48, PASI 75/90 was achieved by 72·7%/51·3% of patients randomized to CZP 200 mg and 84·4%/62·7% randomized to CZP 400 mg. Patients entering the open‐label period at week 48, from blinded treatment, received CZP 200 mg Q2W. At week 144, PASI 75/90 was achieved by 70·6%/48·7% patients randomized to CZP 200 mg and 72·9%/42·7% randomized to CZP 400 mg. At week 16, 72 placebo‐randomized patients entered the CZP 400 mg Q2W escape arm; 75.7%/58.5% achieved PASI 75/90 at week 144. Both CZP 200 mg and 400 mg Q2W demonstrated sustained, durable efficacy, with numerically higher responses for some outcomes with 400 mg Q2W. What is already known about this topic? Certolizumab pegol is an Fc‐free, PEGylated, anti‐tumour necrosis factor biologic approved for adults with moderate‐to‐severe plaque psoriasis. Efficacy data from the first 48 weeks of phase III trials have shown significant improvements in the signs and symptoms of psoriasis with certolizumab pegol dosed at either 400 mg or 200 mg every 2 weeks. Numerically greater improvements were observed for patients treated with the higher dose. What does this study add? Plaque psoriasis is a chronic, systemic disease that requires long‐term management and sustained efficacy of therapies. Three‐year efficacy data pooled from the CIMPASI‐1 and CIMPASI‐2 phase III trials demonstrate a sustained and durable response to certolizumab pegol dosed at either 400 mg or 200 mg every 2 weeks. Additional long‐term clinical benefits may be obtained from the higher dose. Linked Comment: Johnson et al. Br J Dermatol 2021; 184:588–589.
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