巴瑞克替尼对于新冠和湿疹有效吗？

Baricitinib is effective for COVID-19 and eczema. Baricitinib, an oral selective Janus kinase 1 and 2 inhibitor, effectively reduced disease severity in moderate to severe atopic dermatitis (AD), a specific type of eczema, in two Phase 3 monotherapy studies. Baricitinib's indications include COVID-19, and studies have shown that baricitinib can reduce the mortality rate in hospitalized patients with COVID-19 by about one-fifth.

Baricitinib Drug Overview

It is a JAK1/2 inhibitor that was initially approved for the treatment of moderate to severe rheumatoid arthritis (RA) but has since shown considerable efficacy in controlling the excessive inflammatory response seen in a variety of diseases.

There is growing evidence from clinical trials and case reports that patients taking baricitinib experience improvements in clinical and clinical symptoms, including graft-versus-host disease, diabetic nephropathy, atopic dermatitis, alopecia areata, as well as coronavirus disease-19, RA, systemic lupus erythematosus, psoriasis, and interferon-mediated autoinflammatory diseases.

Baricitinib is effective against COVID-19

Background: Baricitinib is an oral selective Janus kinase 1/2 inhibitor with known anti-inflammatory properties. One study evaluated the efficacy and safety of baricitinib in combination with standard care in adults hospitalized with COVID-19.

Methods: In this phase 3, double-blind, randomized, placebo-controlled trial, hospitalized adult patients with COVID-19 receiving standard of care were randomly assigned (1:1) to receive once-daily baricitinib (4 mg) or matching placebo for up to 14 days.

The standard of care includes systemic corticosteroids, such as dexamethasone, and antiviral drugs, including remdesivir. The composite primary endpoint was the proportion of patients who progressed to high-flow oxygen, noninvasive ventilation, invasive mechanical ventilation, or death at day 28 as assessed in the intention-to-treat population. All-cause mortality at day 28 was a key secondary endpoint and all-cause mortality at day 60 was an exploratory endpoint; both were assessed in the intention-to-treat population.

Study results: Between June 11, 2020, and January 15, 2021, 1,525 participants were randomly assigned to the baricitinib group (n=764) or the placebo group (n=761). Of 1518 participants with available data, 1204 were receiving systemic corticosteroids at baseline, including 1099 receiving dexamethasone; 287 participants were receiving remdesivir.

Overall, 27.8% of participants who received baricitinib and 30.5% of those who received placebo met the primary endpoint, for an absolute risk difference of -2.7 percentage points. The 28-day all-cause mortality in the baricitinib group and the placebo group were 8% and 13% respectively, with a relative mortality reduction of 38.2%. The 60-day all-cause mortality rates were 10% in the baricitinib group and 15% in the placebo group.

Serious adverse events The rates of serious infections and venous thromboembolic events were similar between the two groups.

Conclusions: Although there was no significant reduction in the frequency of disease progression overall, treatment with baricitinib in combination with standard of care (including dexamethasone) had a similar safety profile to standard of care alone and was associated with reduced mortality in adults hospitalized with COVID-19.

Baricitinib is effective in treating eczema

Atopic dermatitis is a common chronic relapsing inflammatory skin disease and a special type of eczema that often appears in childhood but can persist into adulthood.

A study evaluated the efficacy and safety of baricitinib 4 mg and 2 mg combined with background topical corticosteroids (TCS) in the treatment of adult patients with moderate to severe AD who had previously failed to respond to TCS therapy.

Design, setting, and participants: The double-blind, placebo-controlled, phase 3 randomized clinical trial BREEZE-AD7 (baricitinib plus topical corticosteroids in adults with moderate-to-severe atopic dermatitis) was conducted from November 16, 2018, to August 22, 2019, at 68 centers in 10 countries in Asia, Australia, Europe, and South America. Patients aged 18 years or older with moderate to severe AD and inadequate response to TCSs were included. After completing the study, patients were followed for up to 4 weeks or enrolled in a long-term extension study.

Intervention: Patients were randomly assigned (1:1:1) to receive baricitinib 2 mg once daily, baricitinib 4 mg once daily, or placebo for 16 weeks. TCSs of low to moderate potency are allowed.

The primary endpoint is the proportion of patients who achieve a valid Atopic Dermatitis Investigator's Global Assessment score of 0 (clear) or 1 (almost clear) and an improvement of 2 points or greater from baseline at week 16.

Results: Among 329 patients, 34 patients who received baricitinib 4 mg and 26 patients who received baricitinib 2 mg had a vIGA-AD score of 0 (clear) or 1 (almost clear) at week 16, compared with 16 patients who received placebo. Treatment-emergent adverse events were reported by 64 of 111 patients in the 4-mg group, 61 of 109 patients in the 2-mg group, and 41 of 108 patients in the placebo group.

Serious adverse events were reported in 4 patients in the 4-mg group, 2 patients in the 2-mg group, and 4 patients in the placebo group. The most common adverse events were nasopharyngitis, upper respiratory tract infection, and folliculitis.

Conclusion and Relevance: Treatment with 4 mg of baricitinib combined with background TCS significantly improved the signs and symptoms of moderate to severe AD, and its safety profile was consistent with previous studies of baricitinib in the treatment of AD.

Summary

Baricitinib can alleviate COVID-19 and eczema to a certain extent. Among hospitalized patients receiving COVID-19 treatment, baricitinib significantly reduces the risk of death. For patients with eczema, baricitinib can relieve skin symptoms and improve the patient's quality of life.

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