Efficacy and Safety of Netakimab, A Novel Anti-IL-17 Monoclonal Antibody, in Patients with Moderate to Severe Plaque Psoriasis. Results of A 54-Week Randomized Double-Blind Placebo-Controlled PLANETA Clinical Trial
Puig Sanz, Lluís (Institut d'Investigació Biomèdica Sant Pau)
Bakulev, Andrey L. (Saratov State Medical University)
Kokhan, Muza M. (Ural Research Institute of Dermatovenerology and Immunopathology)
Samtsov, Alexey V. (S. M. Kirov Military Medical Academy)
Khairutdinov, Vladislav R. (S. M. Kirov Military Medical Academy)
Morozova, Maria A. (JSC BIOCAD)
Zolkin, Nikita A. (JSC BIOCAD)
Kuryshev, Ivan V. (JSC BIOCAD)
Petrov, Alexey N. (JSC BIOCAD)
Artemeva, Antonina V. (JSC BIOCAD)
Zinkina-Orikhan, Arina V. (JSC BIOCAD)

Data:	2021
Resum:	Introduction: 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. Methods: 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. Results: 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. Conclusion: 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. Clinical Trial Registration: The trial is registered at the US National Institutes of Health (ClinicalTrials. gov; NCT03390101).
Nota:	Altres ajuts: Sponsorship for this study and the Rapid Service Fee were funded by JSC BIOCAD, Ul. Italianskaya 17, St Petersburg, Russia, 191186
Drets:	Aquest document està subjecte a una llicència d'ús Creative Commons. Es permet la reproducció total o parcial, la distribució, la comunicació pública de l'obra i la creació d'obres derivades, sempre que no sigui amb finalitats comercials, i sempre que es reconegui l'autoria de l'obra original.
Llengua:	Anglès
Document:	Article ; recerca ; Versió publicada
Matèria:	Netakimab ; Psoriasis ; Interleukin-17 inhibitors
Publicat a:	Dermatology and Therapy, Vol. 11 Núm. 4 (august 2021) , p. 1319-1332, ISSN 2190-9172

DOI: 10.1007/s13555-021-00554-4
PMID: 34060012

14 p, 632.2 KB

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