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 C 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.
Военно-медицинская академия им. С. М. Кирова Министерства обороны Российской Федерации 194044, Российская Федерация, Санкт-Петербург, ул. Академика Лебедева, д. 6При хронических дерматозах значительно увеличивается обсемененность кожи различными бакте-риями и грибами, которые могут оказывать негативное влияние на течение воспалительного процес-са. Крем «Кандидерм» является современным комбинированным топическим препаратом, оказыва-ющим противовоспалительное, антибактериальное и противогрибковое действие. Целью исследования была оценка эффективности, безопасности и переносимости крема «Канди-дерм» в терапии больных экземой и атопическим дерматитом. Материал и методы. Обследовано 37 пациентов с АД и 28 больных экземой. Применяли крем «Кан-дидерм» 2 раза в сутки, который наносили на пораженные участки кожи. До начала и на 14-е сутки терапии проводилось бактериологическое исследование микрофлоры кожи в области высыпаний. Результаты: на 14-е сутки у больных экземой ремиссия была достигнута у 17 (61 %) пациентов, зна-чительное улучшение -6 (21 %), улучшение -4 (14 %), отсутствие эффекта -1 (4 %); у больных АД ремиссия наблюдалась у 23 (62 %) пациентов, значительное улучшение -7 (19 %), улучшение -5 (14 %), отсутствие эффекта -2 (5 %). Выводы: высокая клиническая эффективность крема «Кандидерм» позволяет рекомендовать его для топической терапии больных нейроаллергодерматозами.
BACKGROUNDPsoriasis is a common immune-mediated chronic inflammatory disease of the skin and joints, affecting 1-3% of the population. It is generally accepted that the pathogenesis of psoriasis involves accumulation of effector T-cells within lymph nodes and their subsequent migration into the skin through the blood system. Here we provide evidence that psoriatic plaque itself may serve as a source of inflammatory T-cells.OBJECTIVEWe examined the intradermal proliferation of T-cells and the number of effector/memory (CD45RO+) T-cells in the skin of psoriatic patients at different periods of the disease.METHODSSkin samples were obtained from 41 patients with progressive psoriatic lesions; 18 of these patients also donated skin specimens during the remission of the disease. The control group consisted of 16 healthy subjects. Ki-67 immunohistochemical staining was applied to detect proliferating cells, CD3ε served as a T-cell marker, and CD45RA and CD45RO antibodies were utilized to discriminate between naive and effector/memory T-cells, respectively.RESULTSProgressive psoriatic lesions demonstrated Ki67 staining both in keratinocytes and in the CD3ε+ cells of dermal infiltrate. Median count of CD45RO+ cells per microscopic field was 15 in healthy controls, 59 in patients in remission and 208 in progressive psoriatic plaques. The observed differences demonstrated high level of statistical significance.STUDY LIMITATIONSLimited number of analyzed patients.CONCLUSIONProgressive phase of psoriasis is characterized by intradermal proliferation of T-cells. Spots of regressed psoriatic lesions contain high number of CD45RO+ cells, which are likely to render an immunological memory.
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