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

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 o...

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Vydáno v:Dermatology and therapy Ročník 11; číslo 4; s. 1319 - 1332
Hlavní autoři: 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.
Médium: Journal Article
Jazyk:angličtina
Vydáno: Cheshire Springer Healthcare 01.08.2021
Springer
Springer Nature B.V
Témata:
Analysis
Arthritis
Clinical trials
Cytokines
Dermatology
Development and progression
Dosage and administration
Drug dosages
Drug therapy
Hypotheses
Interleukins
Internal Medicine
Light therapy
Medicine
Medicine & Public Health
Monoclonal antibodies
NCT
NCT03390101
Oral and Maxillofacial Surgery
Original Research
Patients
Plastic Surgery
Psoriasis
Quality of Life Research
Response rates
Sample size
Skin
Statistical analysis
Tuberculosis
Russia
Belarus
Psoriasis
Interleukin-17 inhibitors
Netakimab
ISSN:2193-8210, 2190-9172
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Shrnutí: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).
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ISSN:2193-8210
2190-9172
DOI:10.1007/s13555-021-00554-4