Практические Рекомендации По Управлению Иммуноопосредованными Нежелательными Явлениями

Protsenko, S.A. Protsenko; Антимоник, Н. Ю.; Берштейн, Л. М.; Жукова, Н. В.; Novik, A. V.; Носов, Д. А.; Петенко, Н. Н.; Семенова, А. И.; Чубенко, В. А.; Харкевич, Г. Ю.; Юдин, Д. И.

doi:10.18027/2224-5057-2020-10-3s2-50

Cited by 4 publications

(5 citation statements)

References 0 publications

Supporting

Mentioning

Contrasting

Unclassified

Order By: Relevance

“…Меры минимизации рисков развития иНЯ направлены на информирование медицинских работников о современных методах предотвращения и выявления данных осложнений, оказания медицинской помощи в случае их развития, а также об особенностях выбора индивидуального подхода к мониторингу состояния пациента с учетом знаний об индивидуальных факторах риска развития иНЯ. В настоящее время подробные рекомендации разработаны как онкологическим сообществом, включая Российское общество клинической онкологии (RUSSCO) [41], Общество специалистов поддерживающей терапии в онкологии (RASSC) 1 , Европейское общество медицинской онкологии (European Society for Medical Oncology, ESMO) [42], Национальную всеобщую онкологическую сеть (National Comprehensive Cancer Network, NCCN) 2 и др., так и специалистами Европейского альянса ревматологических ассоциаций (European Alliance of Associations for Rheumatology, EULAR) [43], что подчеркивает важность междисциплинарного подхода в терапии иНЯ. При этом должно тщательно оцениваться соотношение пользы и риска применения препарата для пациента, учитывая течение основного заболевания.…”

Section: характеристика иня при терапии ииктunclassified

“…O N L I N E F I R S T Чаще всего для управления иНЯ назначают глюкокортикоиды и прерывание терапии иИКТ. Согласно рекомендациям RUSSCO [41], при лечении всех иНЯ используется ступенчатый подход. Начальная ступень выбирается исходя из тяжести развившегося иНЯ, переход на более высокие ступени осуществляется при неэффективности проводимой терапии.…”

Section: характеристика иня при терапии ииктunclassified

“…При иммуноопосредованных эндокринопатиях, которые крайне редко могут угрожать жизни пациента, таких как гипотиреоз, может потребоваться только заместительная гормональная терапия [41].…”

Section: характеристика иня при терапии ииктunclassified

See 2 more Smart Citations

Toxicity Associated with Immune Checkpoint Inhibitors: Analysis of Immune-Related Adverse Events with a Pembrolizumab Biosimilar (Pembroria)

Fedyanin¹,

Snegovoy

Бредер³

et al. 2023

Bezopasnost' i risk farmakoterapii

View full text Add to dashboard Cite

In recent years, there has been a significant increase in the number of patients with malignancies treated with immune checkpoint inhibitors (ICIs), including the anti-programmed cell death protein 1 (anti–PD-1) agent pembrolizumab. One of the important aspects of conducting clinical trials with ICIs is the assessment of the risk of developing immune-related adverse events (irAEs).The aim of the study was to evaluate the safety of a pembrolizumab biosimilar (BCD-201, Pembroria) compared with a reference medicinal product using the results of a phase I clinical trial and the available medical literature.Materials and methods. A phase I double-blind, randomised, controlled clinical trial (BCD-201-1) has been conducted in patients with advanced melanoma and non-small-cell lung cancer (n=131). Patients were randomly allocated in a 1:1 ratio to receive either BCD-201 (Pembroria) or the reference medicinal product (Keytruda®), administered intravenously at a dose of 200 mg every 3 weeks for up to 24 weeks or until disease progression or unacceptable toxicity is observed. Since the trial results remain blinded at the time of this writing, treatment group data are masked.Results. The study demonstrated the equivalence of pharmacokinetics and comparable safety profiles of pembrolizumab biosimilar and reference medicinal products. Both medicinal products were well tolerated; the frequency of all-grade irAEs was comparable between treatment groups (21.2% in Group 1 vs 21.5% in Group 2). Most irAEs were mild to moderate, with the exception of a case of Grade 3 diarrhoea and immune-mediated enterocolitis in one study subject; there were no statistically significant differences in the median time to development of irAEs between treatment groups (Р=0.22, two-sided Wilcoxon test).Conclusions. The analysed period of the BCD-201-1 trial demonstrated comparable safety characteristics of Pembroria and Keytruda®, which is consistent with the published safety data on the latter. Information on the similarity of long-term safety profiles of the pembrolizumab biosimilar and the reference medicinal product will be obtained from ongoing clinical trials.

show abstract

Section: характеристика иня при терапии ииктunclassified

See 1 more Smart Citation

Toxicity Associated with Immune Checkpoint Inhibitors: Analysis of Immune-Related Adverse Events with a Pembrolizumab Biosimilar (Pembroria)

Fedyanin¹,

Snegovoy

Бредер³

et al. 2023

Bezopasnost' i risk farmakoterapii

View full text Add to dashboard Cite

show abstract

“…Необходимо также помнить, что для лечения практически всех иоНЯ, вызванных ИКТИО, используются системные глюкокортикоиды [32], которые, безусловно, могут нивелировать клинические проявления вторичной надпочечниковой недостаточности и приводить к ложноотрицательным результатам.…”

Section: гипофизит у пациентов получающих иктиоunclassified

Endocrine side effects during cancer treatment. Lecture for practitioners

2022

View full text Add to dashboard Cite

Targeted therapy and immune checkpoint inhibitors (ICI) are increasingly being used to treat many solid tumors. The use alpelisib and ICPI has a risk of side-effects, particularly endocrine dysfunctions. In this lecture, there are clearly stated: initial screening, monitoring, selection of therapy and emergency situations for each endocrinopathy, i.e. hyperglycemia during treatment with alpelisib and destructive thyroiditis and hypophysitis during treatment of ICI.

show abstract

“…В то же время в практических рекомендациях Российского общества клинической онкологии (RUSSCO) по управлению иммунноопосредованными нежелательными явлениями (2019 г.) общий анализ мочи предлагается выполнять перед каждым введением ингибиторов ИКТ наряду с оценкой функции почек и определением уровней электролитов [103].…”

Section: принципы диагностики и лечения ионя со стороны почекunclassified

Kidney injury associated with antitumor therapy: focus on the adverse events of modern immuno-oncological drugs

Bobkova

Sekacheva

2021

Terapevticheskii arkhiv

View full text Add to dashboard Cite

Immune checkpoint inhibitors (ICIs), including cytotoxic T-lymphocyte associated antigen 4 (CTLA-4) and programmed death protein 1 (PD-1) or its ligand (PD-L1), are a new generation of immuno-oncological drugs that to date have demonstrated efficacy in a number of malignancies. The mechanism of ICT inhibitors action consist in the potentiation of the immune response by eliminating the tumor cells inhibitory effect on the T-lymphocytes activation. However, excessive immune system activation can cause the development of a special class of immune-related adverse events (irAEs) involved a wide variety of organs and systems, including the kidneys. Despite the fact that immuno-mediated kidney injury caused by ICI therapy develops quite rarely, it can be serious and determine the patient's prognosis, which necessitates early diagnosis and timely start of treatment. In this regard, awareness of the manifestations of ICI-associated renal irAEs is particularly relevant not only for oncologists and for nephrologists, but for doctors of other specialties. In this review, we elucidated the main variants of immuno-mediated kidney injury caused by ICI therapy, discussed possible predictors and mechanisms of their development, and considers the general principles of diagnosis and management of patients according to the severity of irAEs.

show abstract

Практические Рекомендации По Управлению Иммуноопосредованными Нежелательными Явлениями

Abstract: .

Cited by 4 publications

References 0 publications

Toxicity Associated with Immune Checkpoint Inhibitors: Analysis of Immune-Related Adverse Events with a Pembrolizumab Biosimilar (Pembroria)

Toxicity Associated with Immune Checkpoint Inhibitors: Analysis of Immune-Related Adverse Events with a Pembrolizumab Biosimilar (Pembroria)

Endocrine side effects during cancer treatment. Lecture for practitioners

Kidney injury associated with antitumor therapy: focus on the adverse events of modern immuno-oncological drugs

Contact Info

Product

Resources

About