Clinical effect of early administration of tocilizumab following the initiation of corticosteroid therapy for patients with COVID-19

Kawamata, Takaya; Tanino, Yoshinori; Nikaido, Takefumi; Minemura, Hiroyuki; Sato, Yuki; (, Ryuichi Togawa; Watanabe, Nobuhisa; R, Yamada; Sato, Riko; Onuma, Takumi; Tomita, Haruyoshi; Saito, Mikako; Rikimaru, Mami; Suzuki, Yasuhito; Tsukada, Yasuhiko; (, Kiwamu Nakamura; (, Keiji Kanemitsu; Iseki, Ken; Shibata, Yoko

doi:10.1016/j.jiac.2022.08.021

Cited by 2 publications

(2 citation statements)

References 30 publications

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“…Similarly, the secondary endpoints that included time to clinical improvement according to COVID-19 grade and time to hospital discharge did not show any significant difference between the two groups [ 26 ]. Additionally, although a few retrospective studies in Japan have evaluated the efficacy of tocilizumab using real-world data, none of them demonstrated a significant efficacy of tocilizumab over the SOC [ 27 , 28 ].…”

Section: Discussionmentioning

confidence: 99%

Comparative effectiveness of tocilizumab vs standard care in patients with severe COVID-19-related pneumonia: a retrospective cohort study utilizing registry data as a synthetic control

Uemura,

Ozaki,

Shinozaki

et al. 2023

BMC Infect Dis

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Background The severity of coronavirus disease 2019 (COVID-19) infections has led to the development of several therapeutic agents, with tocilizumab becoming increasingly used to treat patients with COVID-19-related pneumonia. This study compared the use of tocilizumab treatment with the standard of care (SOC) to determine its efficacy against severe COVID-19-related pneumonia in Japan. Methods This retrospective cohort study was designed to evaluate the efficacy of tocilizumab in two different databases: the JA42434 single-arm study and COVID-19 Registry Japan (COVIREGI-JP), with a synthetic control group from the COVIREGI-JP cohort as a benchmark for the tocilizumab group. The study’s primary objective was to evaluate the efficacy of tocilizumab in treating severe COVID-19-related pneumonia compared to the SOC among patients included in the above two databases. The SOC group was extracted as the synthetic control group using exact matching and a propensity score matching in sequence per subject. As a secondary objective, the efficacy of tocilizumab compared to the SOC was evaluated exclusively among patients included in the COVIREGI-JP database. In each objective, the primary endpoint was defined as the time to discharge or the status of awaiting discharge. Results For the primary endpoint, the hazard ratio (HR) of the tocilizumab group against the SOC group was 1.070 (95% confidence interval [CI]: 0.565–2.028). The median time from Study Day 1 to discharge or the state of awaiting discharge was 15 days in the tocilizumab group and 16 days in the SOC group. The HRs for the secondary endpoints, namely, time to improvement in the clinical state, time to clinical failure, and time to recovery, were 1.112 (95% CI: 0.596–2.075), 0.628 (95% CI: 0.202–1.953), and 1.019 (95% CI: 0.555–1.871), respectively. Similarly, the HR of the primary endpoint for the secondary objective was 0.846 (95% CI: 0.582–1.230). Conclusions Tocilizumab did not demonstrate a positive effect on time to discharge or the state of awaiting discharge. Furthermore, no statistically significant differences in other clinical outcomes, such as time to improvement in the clinical state, time to clinical failure, and time to recovery, were observed among the groups.

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Section: Discussionmentioning

confidence: 99%

Comparative effectiveness of tocilizumab vs standard care in patients with severe COVID-19-related pneumonia: a retrospective cohort study utilizing registry data as a synthetic control

Uemura,

Ozaki,

Shinozaki

et al. 2023

BMC Infect Dis

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“…Одноцентровое ретро-спективное наблюдательное исследование (Япония, n=50) оценивало эффективность двух режимов тоцилизумаба у пациентов с преимущественно тяжёлым течением COVID-19: раннего назначения (≤24 часов после старта терапии глюкокортикостероидами) и позднего назначения (>24 часов после старта терапии глюкокортикостероидами). Результаты обнаружили, что в группе раннего назначения тоцилизумаба (n=32) лечение приводило к более выраженному снижению лейкоцитоза, выраженности лихорадки, а также потребности в кислороде (наблюдалось значительно большее число дней без кислородной поддержки), хотя уровень СРБ оставался более высоким, чем в группе позднего назначения [32].…”

Section: эффективность раннего применения анти-ил-6 мат у пациентов с...unclassified

Efficacy of interleukin-6 inhibitors as a tool for preventive anti-inflammatory therapy for COVID-19

Zyryanov,

Butranova,

Abramova

2024

GCP

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The novel coronavirus infection (COVID-19) is characterized by damage, along with the lungs, to many other vital organs and systems. The prevalence and severity of the resulting lesions are determined by the ability of the SARS-CoV-2 virus to cause excessive activation of the immune response, accompanied by changes in both cellular and humoral components. Among humoral disorders, the most significant is the hypersecretion of cytokines, including interleukins (IL), in particular IL-6 and IL1β. Elevated levels of IL-6 are one of the main predictors of severe COVID-19 and death. So, blocking the effects of this cytokine is of fundamental importance for improving the clinical outcomes of patients. Monoclonal antibodies against human interleukin-6 receptor or against IL-6 have been widely studied in patients with extremely severe COVID-19, and to a lesser extent in mild and moderate severity. Regardless of the severity, maximum effectiveness is achieved when these drugs are administered as early as possible, which made it possible to create such a tool as preventive anti-inflammatory therapy. Preventive prescription of IL-6 inhibitors may be useful not only for hospitalized inpatients, but also for outpatients. This review is aimed to assess the effectiveness of early use of IL-6 inhibitors both in hospitalized and ambulatory patients with varying degrees of severity of COVID-19.

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Clinical effect of early administration of tocilizumab following the initiation of corticosteroid therapy for patients with COVID-19

Cited by 2 publications

References 30 publications

Comparative effectiveness of tocilizumab vs standard care in patients with severe COVID-19-related pneumonia: a retrospective cohort study utilizing registry data as a synthetic control

Comparative effectiveness of tocilizumab vs standard care in patients with severe COVID-19-related pneumonia: a retrospective cohort study utilizing registry data as a synthetic control

Efficacy of interleukin-6 inhibitors as a tool for preventive anti-inflammatory therapy for COVID-19

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