Japanese rapid/living recommendations on drug management for COVID‐19: updated guidelines (September 2021)

Yamamoto, Ryo; Terayama, Takero; Hashimoto, Hideki; Ishihara, Tadashi; Ishimaru, Go; Imura, Haruki; Okano, Hiromu; Narita, Chihiro; Mayumi, Takuya; Yasuda, Hideto; Yamada, Kohei; Yamada, Hiroyuki; Kawasaki, Tatsuya; Shime, Nobuaki; Doi, Kent; Egi, Moritoki; Ogura, Hiroshi; Aihara, Morio; Kushimoto, Shigeki; Nishida, Osamu

doi:10.1002/ams2.706

Cited by 18 publications

(27 citation statements)

References 42 publications

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“…In conclusion, in the USA 126 and Japan 127 (in consideration by the EMA) baricitinib in combination with low-dose dexamethasone is currently recommended for the treatment of COVID-19 patients requiring high-flow oxygen or non-invasive ventilation or low-flow oxygen but with significantly elevated inflammatory markers. The same conclusions were reached by the WHO from the eighth version of its ‘A living WHO guideline on drugs for COVID-19’ from January 2022, which strongly recommended baricitinib for patients with severe or critical COVID-19 in combination with corticosteroids.…”

Section: Introductionmentioning

confidence: 99%

JAK inhibitors and COVID-19

Levy

Guglielmelli

Langmuir

et al. 2022

J Immunother Cancer

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During SARS-CoV-2 infection, the innate immune response can be inhibited or delayed, and the subsequent persistent viral replication can induce emergency signals that may culminate in a cytokine storm contributing to the severe evolution of COVID-19. Cytokines are key regulators of the immune response and virus clearance, and, as such, are linked to the—possibly altered—response to the SARS-CoV-2. They act via a family of more than 40 transmembrane receptors that are coupled to one or several of the 4 Janus kinases (JAKs) coded by the human genome, namely JAK1, JAK2, JAK3, and TYK2. Once activated, JAKs act on pathways for either survival, proliferation, differentiation, immune regulation or, in the case of type I interferons, antiviral and antiproliferative effects. Studies of graft-versus-host and systemic rheumatic diseases indicated that JAK inhibitors (JAKi) exert immunosuppressive effects that are non-redundant with those of corticotherapy. Therefore, they hold the potential to cut-off pathological reactions in COVID-19. Significant clinical experience already exists with several JAKi in COVID-19, such as baricitinib, ruxolitinib, tofacitinib, and nezulcitinib, which were suggested by a meta-analysis (Patoulias et al.) to exert a benefit in terms of risk reduction concerning major outcomes when added to standard of care in patients with COVID-19. Yet, only baricitinib is recommended in first line for severe COVID-19 treatment by the WHO, as it is the only JAKi that has proven efficient to reduce mortality in individual randomized clinical trials (RCT), especially the Adaptive COVID-19 Treatment Trial (ACTT-2) and COV-BARRIER phase 3 trials. As for secondary effects of JAKi treatment, the main caution with baricitinib consists in the induced immunosuppression as long-term side effects should not be an issue in patients treated for COVID-19.We discuss whether a class effect of JAKi may be emerging in COVID-19 treatment, although at the moment the convincing data are for baricitinib only. Given the key role of JAK1 in both type I IFN action and signaling by cytokines involved in pathogenic effects, establishing the precise timing of treatment will be very important in future trials, along with the control of viral replication by associating antiviral molecules.

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Section: Introductionmentioning

confidence: 99%

JAK inhibitors and COVID-19

Levy

Guglielmelli

Langmuir

et al. 2022

J Immunother Cancer

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“…Among those published or updated since 2021, the year that RCTs comparing different intensities of anticoagulation were first published, both the Japanese living guidelines on drug management for COVID-19 23 and the European Respiratory Society living guidelines 24 recommend anticoagulation in patients with COVID-19-related critical illness, but do not specify an intensity. By contrast, the French guideline 25 suggests that patients with severe COVID-19 (oxygen requirement greater than 6 L/min or mechanical ventilation) should receive at least intermediate dose prophylactic anticoagulation, although these guidelines were written before the publication of the multiplatform 18 [27][28][29] Major differences between the ASH guidelines and these other documents include use of high-quality systematic reviews and EtD frameworks, marker states to estimate the relative importance of key outcomes to patients, and decision thresholds to facilitate judgments about the magnitude of desirable and undesirable effects.…”

Section: What Are Others Saying and What Is New In These Guidelines?mentioning

confidence: 99%

American Society of Hematology living guidelines on the use of anticoagulation for thromboprophylaxis for patients with COVID-19: March 2022 update on the use of anticoagulation in critically ill patients

et al. 2022

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Background: COVID-19 related critical illness is associated with an increased risk of venous thromboembolism (VTE). Objective: These evidence-based guidelines of the American Society of Hematology (ASH) are intended to support patients, clinicians, and other health care professionals in decisions about the use of anticoagulation in patients with COVID-19. Methods: ASH formed a multidisciplinary guideline panel, including three patient representatives, and applied strategies to minimize potential bias from conflicts of interest. The McMaster University GRADE Centre supported the guideline development process, including performing systematic evidence reviews (up to January 2022). The panel prioritized clinical questions and outcomes according to their importance for clinicians and patients. The panel used the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach to assess evidence and make recommendations, which were subject to public comment. This is an update to guidelines published in February 2021 and May 2021 as part of the living phase of these guidelines. Results: The panel made one additional recommendation, a conditional recommendation for the use of prophylactic-intensity over therapeutic-intensity anticoagulation in patients with COVID-19-related critical illness who do not have suspected or confirmed VTE. The panel emphasized the need for an individualized assessment of thrombotic and bleeding risk. Conclusions: This conditional recommendation was based on very low certainty in the evidence, underscoring the need for additional, high-quality, randomized controlled trials comparing different intensities of anticoagulation in patients with COVID-19-related critical illness.

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“…Consequently, these authors concluded that a quite different hematological phenotype is present in COVID-19-induced coagulopathy compared with that seen in typical sepsis-induced DIC, in which local thrombus formation might be promoted in severe COVID-19. Now, even though a clear treatment option using anticoagulants is available to patients with moderate-to-severe COVID-19 [ 5 , 6 , 7 ], a further clarification of the mechanisms of the coagulation abnormality is still warranted.…”

Section: Etiology and Pathophysiology Of Dicmentioning

confidence: 99%