GY48LS6

Кеймбридж
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Барицитиниб (Baricitinib; LY3127804)
Международное непатентованное наименование Барицитиниб (Baricitinib; LY3127804)
Торговое наименование Olumiant, Baricinix
Производитель, страна Eli Lilly and Company, USA
Лекарственная форма film-coated tablets, 2 mg & 4 mg
Механизм действия

Janus kinases are intracellular enzymes that transmit signals arising from cytokine or growth factor receptor interactions on the cellular membrane to influence cellular processes of immune cell function and hematopoiesis. JAK-mediated signaling is pivotal in immune activation, as cytokine receptors are expressed on most immune cells. Within the signaling pathway, JAKs phosphorylate and activate signal transducers and activators of transcription proteins (STATs), which modulate intracellular activity including gene expression. Baricitinib modulates the signaling pathway at the point of JAKs, preventing the phosphorylation and activation of STATs. Cytokine signaling is transmitted through pairing of JAKs. Baricitinib has greater affinity for JAK1, JAK2, and TYK2, relative to JAK3. In human leukocytes, baricitinib inhibits cytokine induced STAT phosphorylation mediated by JAK1/JAK2, JAK1/JAK3, JAK1/TYK2, or JAK2/TYK2 with comparable potencies

Опыт использования

Data regarding clinical efficacy for COVID-19 are being evaluated.

 

Safety Concerns:

  • Thrombosis, including deep vein thrombosis (DVT) and pulmonary embolism (PE)
  • Risk of GI perforation o Caution in patients with neutropenia, lymphopenia, and anemia 
  • Monitor for elevated liver function tests (LFTs)
Публикации COVID-19

D.Praveen, Ranadheer Chowdary Puvvada, Vijey Aanandhi M. Janus kinase inhibitor baricitinib is not an ideal option for management of COVID-19. International Journal of Antimicrobial Agents. 4 April 2020, 105967. DOI: 10.1016/j.ijantimicag.2020.105967.

 

Ennio G Favalli, Martina Biggioggero et al. Baricitinib for COVID-19: a suitable treatment? Lancet 2020 Apr 3:S1473-3099(20)30262-0.

 

Richardson P, Griffin I, Tucker C, Smith D, Oechsle O, Phelan A, Stebbing J. et al. Baricitinib as Potential Treatment for 2019-nCoV Acute Respiratory Disease. Lancet 2020 Feb 15;395(10223).

 

Zhang C, Wu Z, Li JW, et al. The cytokine release syndrome (CRS) of severe COVID-19 and Interleukin-6 receptor (IL-6R) antagonist tocilizumab may be the key to reduce the mortality. Int J Antimicrob Agents. 2020. PMID: 32234467.

 

Zhang W, Zhao Y, Zhang F, et al. The use of anti-inflammatory drugs in the treatment of people with severe coronavirus disease 2019 (COVID-19): the perspectives of clinical immunologists from China. Clin Immunol. 2020. PMID: 32222466.

 

Zhou F, Yu T, Du R, et al. Clinical course and risk factors for mortality of adult inpatients with COVID-19 in Wuhan, China: a retrospective cohort study. Lancet 2020 Mar 11. PMID: 32171076.

 

Stebbing J, Phelan A, Griffin I, et al. COVID-19: combining antiviral and anti-inflammatory treatments. Lancet Infect Dis. 2020. PMID: 32113509

Клинические исследования
1.
Название протокола Рандомизированное, двойное слепое, плацебо-контролируемое исследование III фазы в параллельных группах по оценке результатов применения барицитиниба у пациентов с инфекцией COVID-19
Дата начала и окончания КИ June 19, 2020 - December 31, 2020
Название организации, проводящей КИ Eli Lilly and Company
Страны Россия
Фаза III
Кол-во пациентов 60
2.
Название протокола BARICIVID-19 STUDY: MultiCentre, Randomised, Phase IIa Clinical Trial Evaluating Efficacy and Tolerability of Baricitinib as add-on Treatment of In-patients With COVID-19 Compared to Standard Therapy
Дата начала и окончания КИ May 20, 2020 - July 30, 2020
Название организации, проводящей КИ Universitaria Pisana
Страны Italy
Фаза II
Кол-во пациентов 126
3.
Название протокола An Open-Label, Phase II of Antiviral Therapy Combined With Baricitinib in Moderate and Severe Patients With COVID-19
Дата начала и окончания КИ May 18, 2020 - April 24, 2022
Название организации, проводящей КИ University of Southern California
Страны USA
Фаза II
Кол-во пациентов 59
4.
Название протокола mulTi-Arm Therapeutic Study in Pre-ICu Patients Admitted With Covid-19 - Repurposed Drugs (TACTIC-R)
Дата начала и окончания КИ May 8, 2020 - May 1, 2022
Название организации, проводящей КИ Cambridge University Hospitals NHS Foundation Trust
Страны United Kingdom
Фаза IV
Кол-во пациентов 1167
5.
Название протокола Efficacy and Safety of Novel Treatment Options for Adults With COVID-19 Pneumonia. A Double-blinded, Randomized, Multi-stage, 6-armed Placebo-controlled Trial in the Framework of an Adaptive Trial Platform
Дата начала и окончания КИ April 20, 2020 - June 15, 2021
Название организации, проводящей КИ Hvidovre University Hospital
Страны Denmark
Фаза III
Кол-во пациентов 1500
6.
Название протокола A Randomized, Double-blind, Placebo-controlled, Clinical Trial of LY3127804 in Patients Who Are Hospitalized With Pneumonia and Presumed or Confirmed COVID-19
Дата начала и окончания КИ April 20, 2020 - July 16, 2020
Название организации, проводящей КИ Eli Lilly and Company
Страны USA
Фаза II
Кол-во пациентов 200
7.
Название протокола Treatment of Moderate to Severe Coronavirus Disease (COVID-19) in Hospitalized Patients
Дата начала и окончания КИ April 2020 - July 2021
Название организации, проводящей КИ Nova Scotia Health Authority
Страны Canada
Фаза II
Кол-во пациентов 1000
8.
Название протокола Safety and Efficacy of Baricitinib for COVID-19
Дата начала и окончания КИ April 2020 - October 2020
Название организации, проводящей КИ University of Colorado, Denver
Страны USA
Фаза II-III
Кол-во пациентов 80
9.
Название протокола Clinical-epidemiological Characterization of COVID-19 Disease in Hospitalized Older Adults
Дата начала и окончания КИ April 20, 2020 - July 31, 2020
Название организации, проводящей КИ Complejo Hospitalario Universitario de Albacete
Страны Spain
Фаза -
Кол-во пациентов 576
10.
Название протокола Prospective, Phase II, Randomized, Open-label, Parallel Group Study to Evaluate the Efficacy of Hydroxychloroquine Together With Baricitinib, Imatinib or Early Lopinavir / Ritonavir in Patients With SARS Cov2 Pneumonia
Дата начала и окончания КИ April 13, 2020 - September 2020
Название организации, проводящей КИ Hospital Universitario de Fuenlabrada
Страны Spain
Фаза II
Кол-во пациентов 165
11.
Название протокола Baricitinib Therapy in COVID-19: A Pilot Study on Safety and Clinical Impact
Дата начала и окончания КИ March 16, 2020 - April 7, 2020
Название организации, проводящей КИ Hospital of Prato
Страны Italy
Фаза II-III
Кол-во пациентов 12