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Roche arthritis drug reduces loss of life in hospitalized sufferers with extreme Covid, Oxford researchers say

A pharmacist shows a box of tocilizumab, which is used to treat rheumatoid arthritis, in the pharmacy of Cambrai Hospital in France on April 28, 2020.

Pascal Rossignol | Reuters

A drug used to treat people with rheumatoid arthritis appears to reduce the risk of death in hospitalized patients with severe Covid-19, especially when combined with the steroid dexamethasone, Oxford University researchers said Thursday.

Oxford researchers found that the drug tocilizumab, an intravenous drug of A department of the Swiss drug manufacturer Roche also shortened the length of stay for patients in hospitals and reduced the need for a ventilator. The study was part of the recovery study, which has tested a number of potential treatments for Covid-19 since March.

“Previous studies of tocilizumab had shown mixed results and it was unclear which patients might benefit from the treatment,” said Peter Horby, professor at Oxford University and co-investigator for the recovery study, in a statement. “We now know that tocilizumab benefits apply to all COVID patients with low oxygen levels and significant inflammation.”

A total of 2,022 patients were randomly selected to receive tocilizumab, sold under the brand name Actemra, by intravenous infusion and compared to 2,094 patients who were randomly selected to receive standard care alone. The researchers said 82% of patients were also taking a steroid like dexamethasone, another drug that was found to reduce deaths in the sickest Covid-19 patients.

Researchers said 596 patients in the tocilizumab group died within 28 days, compared with 694 patients in the standard care group. That means that for every 25 patients treated with tocilizumab, “an extra life would be saved,” said Oxford researchers.

The drug increased the chances of being discharged from 47% to 54% within 28 days, the researchers said. The benefits have been seen in all patients, including those who need mechanical ventilators in an intensive care unit, they added. In patients who were not given a ventilator prior to the start of the study, tocilizumab reduced the chance of getting invasive mechanical ventilation or death from 38% to 33%, the researchers said.

The researchers said that using tocilizumab in combination with dexamethasone reduced mortality by about a third in patients who require oxygen and by almost half in patients who require a ventilator.

The results of the Oxford study have not yet been published in a peer-reviewed journal.

Public health officials and infectious disease experts say world leaders will need a range of drugs and vaccines to end the pandemic that, according to Johns, will infect more than 107.4 million people in just over a year and has killed at least 2.3 million people at Hopkins University.

In the US, the Food and Drug Administration has approved Gilead Sciences’ antiviral drug Remdesivir for the treatment of Covid-19 patients who are 12 years or older and require hospitalization.

The FDA has approved the use of two monoclonal antibody treatments as well as two vaccines – from Pfizer and Moderna. A third vaccine from Johnson & Johnson is expected to receive FDA approval as early as this month.

The Covid-19 Therapy Randomized Evaluation, or Recovery Study, was launched in March by researchers at Oxford University to find treatments for Covid-19. The study previously showed that hydroxychloroquine, lopinavir ritonavir, azithromycin, and convalescent plasma had no benefits for patients hospitalized with Covid-19.

The study is currently investigating aspirin, the anti-inflammatory drugs baricitinib and colchicine, and Regeneron’s antibody cocktail.

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The Greatest Footwear for Knee Arthritis

Some experts recommend flat, flexible shoes for people with knee osteoarthritis, while others say sturdy, supportive shoes are better. Now a randomized study has found that the latter – a stiff and stable shoe with good cushioning – is better than a supple and pliable one.

Osteoarthritis is the most common joint disease in the United States. According to a recent estimate, 14 million Americans suffer from the pain and stiffness of knee arthritis.

Australian researchers randomly assigned 164 men and women, with an average age of 65 years, to wear a flexible or stiff shoe for at least six hours a day for six months. Shoes in the flat shoes category included the Merrell Bare Access, Vivobarefoot Primus Lite, Vivobarefoot Mata Canvas, Lacoste Marice, and Converse Dainty Low. The stable support groups included the ASICS Kayano, Merrell Jungle Moc, Rockport Edge Hill, Nike Air Max 90 Ultra, and New Balance 624.

Before and after the study, the researchers administered questionnaires and scales to measure pain, function, and comfort. The report is in the Annals of Internal Medicine.

The researchers found that 58 percent of those who wore sturdy shoes experienced clinically significant pain reduction compared to 40 percent who wore flexible shoes. When evaluating the function, 11 percent of the more stable shoe wearers reported improvements. Those who wore sturdy shoes were also less likely to report other problems: 15 percent of those who wore stable shoes reported problems such as knee swelling, ankle or foot pain, or pain in other parts of the body caused by the shoes, compared with 32 percent of those who did wear flexible shoes.

Senior author, Rana S. Hinman, professor of physical therapy at the University of Melbourne, said that while a supportive shoe is helpful, it is not a substitute for other effective strategies such as weight control and exercise.

Still, she said, “Based on our clinical study, people with knee osteoarthritis should rather wear sturdy, supportive shoes with thicker padded soles than flat shoes with thin, flexible soles without padding.”

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Covid Affected person Examine Reveals Some Profit From an Arthritis Drug

Adding an arthritis drug called baricitinib to Covid treatment regimens that contains the antiviral drug remdesivir can cut recovery times by a day or more, especially for those who are seriously ill, according to a study published Friday.

The results of a government-sponsored clinical trial were released more than three weeks after the Food and Drug Administration received an emergency approval for double treatment. Earlier this month, some experts said they were uncomfortable using medication without a chance to review the underlying data backing their performance. Last month, the World Health Organization also recommended rejecting remdesivir for treating Covid patients as there was no evidence of its use.

In previous press releases, limited results were disclosed showing that hospitalized Covid patients treated with baricitinib and remdesivir recovered one day faster than those who received remdesivir alone.

Some questioned the adoption of the combination treatment because baricitinib came at a high price – which could be around $ 1,500 per patient – and also cited side effects like blood clots. Several doctors also wondered if adding baricitinib would be worth it, since steroids like dexamethasone were cheap and widely available. Both baricitinib and dexamethasone are believed to suppress the excessive inflammation that causes many severe cases of Covid.

The new paper, published in the New England Journal of Medicine, adds some granularity to the results and shows that certain subsets of patients benefited far more from the addition of baricitinib than others. The study included more than 1,000 hospital patients with Covid, all of whom received remdesivir. People who were sick enough to need high doses of supplemental oxygen or non-invasive ventilation recovered eight days faster when baricitinib was included in their medication.

In these groups, “I think the data clearly support a role for baricitinib,” said Dr. Boghuma Kabisen Titanji, an infectious disease doctor at Emory University who pioneered early studies of baricitinib against the coronavirus.

Dr. Titanji also noted that the data suggested that certain patients may be less likely to die or need a ventilator when taking baricitinib in addition to remdesivir. However, like those showing faster recovery times, these results were inconsistent among study participants.

Dr. Lauren Henderson, a pediatric rheumatologist at Boston Children’s Hospital, said she was encouraged by the results and the prospect of another option in the coronavirus treatment arsenal.

She and several other experts added that they may still have a tendency to use dexamethasone as a treatment for seriously ill Covid-19 patients who needed respiratory support.

In contrast to baricitinib, studies have shown that dexamethasone inhibits mortality in seriously ill Covid patients. It’s also inexpensive and easy to get hold of, while baricitinib is more of a specialty drug and may pose barriers to the supply chain, said Dr. Erin McCreary, Infectious Disease Pharmacist at the University of Pittsburgh.

New treatments for Covid-19

Things to know about Covid-19 treatment

Confused By The Terms To Treat Covid-19? Let us help:

    • ACE-2: A protein that sits on the surface of certain types of human cells. The coronavirus has to bind to ACE-2 in order to enter cells.
    • Adverse event: A health problem that occurs in volunteers in a clinical trial with a vaccine or drug. An adverse event is not always caused by the treatment tested in the study.
    • Antibody: A protein produced by the immune system that can attach to a pathogen such as the coronavirus and prevent it from infecting cells.
    • Antiviral drug: A drug that affects the ability of a virus to replicate in cells. The first drug approved in the United States for Covid-19, Remdesivir, is antiviral.
    • Approval, Licensing, and Approval for Emergency Use: Medicines, vaccines and medical devices cannot be sold in the US for no profit approval by the Food and Drug Administration, also known as Licensing. After a company submits the results of clinical studies to the FDA for review, the agency decides whether the product is safe and effective. This process usually takes many months. If the country faces an emergency – like a pandemic – a company can file an application instead Emergency approvalthat can be granted much faster.
    • Compassionate Use: A term used to describe treatments given to seriously ill people even though they have not yet been approved for that use by the Food and Drug Administration.
    • Cytokine storm: An overactive immune system reaction that can lead to massive inflammation and tissue damage. Cytokine storms can be responsible for many of the severe cases of Covid-19, and a number of researchers are testing drugs that may calm them down.
    • Interferon: A molecule of the immune system. Certain types of interferons can cause inflammation in the body while others can contain it. Still other types can stimulate cells to strengthen their defenses against viruses. Researchers are investigating whether treating synthetic interferons can help people fight off the coronavirus.
    • Monoclonal Antibodies: Monoclonal antibodies made in a laboratory mimic the natural antibodies made by the immune system. A number of companies have developed these treatments for Covid-19. President Trump received Regeneron’s antibody treatment soon after the disease was diagnosed.
    • Phases 1, 2 and 3 studies: Clinical trials typically take place in three phases. Phase 1 studies typically involve a few dozen people to determine whether a vaccine or drug is safe. In Phase 2 trials that involve hundreds of people, researchers can try different doses and take more measurements of the vaccine’s effects on the immune system. Phase 3 trials, involving thousands or tens of thousands of volunteers, determine the safety and effectiveness of the vaccine or medicine by waiting to see how many people are protected from the disease it is intended to be used against.
    • Placebo: A substance with no therapeutic effect that is widely used in clinical trials. For example, to see if a vaccine can prevent Covid-19, researchers can inject the vaccine into half of their volunteers while the other half are given a placebo with salt water. You can then compare how many people are infected in each group.
    • Post-market surveillance: The surveillance that occurs after a vaccine or drug has been approved and regularly prescribed by doctors. This typically confirms that the treatment is safe. Rarely, side effects are noted in certain groups of people that were overlooked during clinical trials.
    • Preclinical Research: Studies that take place prior to the start of a clinical trial typically include experiments that test a treatment on cells or animals.
    • Test protocol: A series of procedures that must be performed during a clinical trial.
    • Retrospective study: A study that analyzes data collected in the past to determine how effective a treatment is. Retrospective studies can provide useful information, but they are not as definitive as randomized clinical studies.
    • Spike protein: A protein that sits on the surface of coronaviruses. The spike protein binds to the ACE-2 receptor on human cells using a region called the receptor binding domain (RBD). As soon as the protein accumulates, the virus can enter the cell. Many vaccines and monoclonal antibody treatments are designed to stick to the tip.
    • Standard of care: A treatment that is accepted by medical experts as an appropriate method to treat a specific type of disease. Once a standard for treating a disease is established, new experimental treatments are usually tested against it rather than a placebo.

Several experts pointed to another study by the National Institutes of Health that seeks to directly compare two combination treatment regimens: one in which hospital patients receive remdesivir and baricitinib, and one in which remdesivir is paired with dexamethasone. Dr. McCreary also noted the importance of studying patients receiving both baricitinib and dexamethasone “to see if there is any incremental benefit.”

Dr. Andre Kalil, an infectious disease doctor at the University of Nebraska Medical Center and lead researcher on the new paper, noted that while dexamethasone had already become a widely accepted treatment for Covid-19, the steroid still needed further study. He cited “a variety of serious safety issues” with the drug that warranted thorough investigation.

Like other steroids, dexamethasone, which largely reduces inflammation, can be associated with a variety of undesirable side effects, including worsening conditions like diabetes or osteoporosis.