(Fernando Zhiminaicela, Pixabay. https://pixabay.com/photos/medical-equipment-medicine-lab-4099429/)
9 Apr. 2021. A clinical trial shows a drug designed to reduce inflammation in autoimmune disease patients does not clearly help patients hospitalized with Covid-19 disease. Findings from the trial were released by pharmaceutical companies Incyte in Wilmington, Delaware that developed the drug baricitinib, and Eli Lilly and Co. in Indianapolis that licenses baricitinib from Incyte.
Incyte and Lilly developed baricitinib as a treatment for autoimmune disorders rheumatoid arthritis, marketed under the brand name Olumiant, and are testing the drug in clinical trials as a therapy for systemic lupus erythematosus, commonly known as lupus, and alopecia areata that causes patchy hair loss. Baricitinib is among a class of small-molecule, or low molecular weight, drugs known as Janus kinase or JAK inhibitors that block the actions of enzymes interrupting the immune system. Limiting the pathway for signals from JAK enzymes helps treat autoimmune diseases like rheumatoid arthritis, by reducing the signals that encourage inflammation. The drug is designed to be taken as a once-a-day pill.
The companies proposed a test of baricitinib as a treatment for patients hospitalized with severe Covid-19 lung inflammation. The late-stage clinical trial enrolled 1,525 participants hospitalized at 98 sites worldwide with Covid-19 infections, and biological indicators of inflammation. Participants were randomly assigned to receive a daily 4 milligram dose of baricitinib plus standard care, or standard care alone. Standard care included corticosteroids or the drug remdesivir.
Difference not large enough for statistical reliability
The study team from the companies looked primarily at the percentage of participants who need non-invasive ventilation, high-flow oxygen, invasive mechanical ventilation, or who died up to 28 days after treatment. Baricitinib recipients were 2.7 percent less likely to require any of these ventilation/oxygen treatments or die than patients receiving the standard care, but the difference was not large enough for statistical reliability.
The companies report, however, that the death rate in the trial for baricitinib recipients within 28 days from any cause (8%) was lower than for standard care recipients (13%), a statistically reliable difference. In addition, rates for all adverse effects and serious adverse effects were similar among baricitinib recipients (45% and 15%, respectively) and recipients of standard care alone (44% and 18%, respectively).
“Even though the study did not show a statistically-significant benefit on the primary endpoint,” says Ilya Yuffa, president of Lilly Bio-Medicines in a statement, “this trial showed the largest effect reported to date for reduction in mortality observed for this patient population with Covid-19. As there remains an urgent need to reduce Covid-related deaths in hospitalized patients, we hope these results will provide further understanding and support for baricitinib’s potential role in treatment on top of the current standard of care.”
Baricitinib continues to be assessed in clinical trials as a treatment for patients hospitalized with Covid-19 infections in combinations or against other drugs, or standard care. The studies are mid- to late-stage trials in the U.S. sponsored by National Institute of Allergy and Infectious Diseases, part of National Institutes of Health, and in the U.K. by University of Oxford.
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