Puig Luís, Bakulev Andrey L, Kokhan Muza M, Samtsov Alexey V, Khairutdinov Vladislav R, Morozova Maria A, Zolkin Nikita A, Kuryshev Ivan V, Petrov Alexey N, Artemeva Antonina V, Zinkina-Orikhan Arina V
Department of Dermatology, Hospital de la Santa Creu i Sant Pau, Barcelona, Spain.
Saratov State Medical University, Saratov, Russia.
Dermatol Ther (Heidelb). 2021 Aug;11(4):1319-1332. doi: 10.1007/s13555-021-00554-4. Epub 2021 May 31.
Netakimab (NTK), an original humanized anti-interleukin-17 monoclonal antibody, showed therapeutic efficacy in moderate-to-severe plaque psoriasis in a phase 2 clinical study. Herein we report the results of 54 weeks of a phase 3 PLANETA trial aimed to evaluate the efficacy and safety of two NTK regimens vs. placebo.
Two hundred thirteen patients with moderate-to-severe plaque psoriasis were randomly assigned to receive NTK 120 mg once every 2 weeks (NTK Q2W), NTK 120 mg once every 4 weeks (NTK Q4W) or placebo. During the first 3 weeks, patients received subcutaneous injections of NTK or placebo (according to the allocation) once a week. Patients in the NTK Q2W group then received NTK at weeks 4, 6, 8 and 10. Subjects in the NTK Q4W group received NTK at weeks 6 and 10 and placebo at weeks 4 and 8. Patients in the placebo group received placebo injections at weeks 4, 6, 8 and 10. Treatment was unblinded at week 12. During the open-label phase, patients in both NTK groups continued to receive NTK Q4W. The primary efficacy endpoint was the proportion of patients in each group who achieved a ≥ 75% reduction from baseline in psoriasis area and severity index (PASI 75) at week 12.
A total of 77.7%, 83.3% and 0% of patients had a PASI 75 response at week 12 in the NTK Q2W, NTK Q4W and placebo groups, respectively (P < 0.0001, Fisher's exact test, ITT). The effect was maintained throughout the 1-year treatment. NTK showed a good safety profile and low immunogenicity.
Treatment with NTK results in high rates of sustained clinical response in patients with moderate-to-severe plaque psoriasis. The study is ongoing; thus, long-term use efficacy and safety data are forthcoming.
The trial is registered at the US National Institutes of Health (ClinicalTrials.gov; NCT03390101).
奈他奇单抗（NTK）是一种新型人源化抗白细胞介素-17单克隆抗体，在一项2期临床研究中显示出对中度至重度斑块状银屑病的治疗效果。在此，我们报告一项3期PLANETA试验54周的结果，该试验旨在评估两种NTK治疗方案与安慰剂相比的疗效和安全性。
213例中度至重度斑块状银屑病患者被随机分配接受每2周一次120mg的NTK（NTK Q2W）、每4周一次120mg的NTK（NTK Q4W）或安慰剂。在最初3周内，患者每周接受一次NTK或安慰剂的皮下注射（根据分配情况）。NTK Q2W组的患者随后在第4、6、8和10周接受NTK。NTK Q4W组的受试者在第6和10周接受NTK，在第4和8周接受安慰剂。安慰剂组的患者在第4、6、8和10周接受安慰剂注射。治疗在第12周时揭盲。在开放标签阶段，两个NTK组的患者继续接受每4周一次的NTK治疗。主要疗效终点是每组在第12周时银屑病面积和严重程度指数（PASI 75）较基线降低≥75%的患者比例。
在第12周时，NTK Q2W组、NTK Q4W组和安慰剂组分别有77.7%、83.3%和0%的患者达到PASI 75缓解（P＜0.0001，Fisher精确检验，意向性分析）。该效果在整个1年治疗期间得以维持。NTK显示出良好的安全性和低免疫原性。
NTK治疗可使中度至重度斑块状银屑病患者获得较高的持续临床缓解率。该研究正在进行中；因此，长期使用的疗效和安全性数据即将公布。
该试验已在美国国立卫生研究院注册（ClinicalTrials.gov；NCT03390101）。
