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Despite Qualms, Arthritis Drug Is to Be Tested in Coronavirus Study Despite Qualms, Arthritis Drug Is to Be Tested in Coronavirus Study
(about 16 hours later)
An Eli Lilly drug for rheumatoid arthritis carries a warning on its label saying patients with infections should not take it because it can make infections worse. Yet the National Institutes of Health is about to test it in people hospitalized with coronavirus infections.An Eli Lilly drug for rheumatoid arthritis carries a warning on its label saying patients with infections should not take it because it can make infections worse. Yet the National Institutes of Health is about to test it in people hospitalized with coronavirus infections.
The study, whose innovative design is meant to find out — fast — what works, began at the end of February with the antiviral drug remdesivir made by Gilead Sciences. Four hundred patients have been treated either with remdesivir or a placebo. The results are now being analyzed and will be known within a few weeks.The study, whose innovative design is meant to find out — fast — what works, began at the end of February with the antiviral drug remdesivir made by Gilead Sciences. Four hundred patients have been treated either with remdesivir or a placebo. The results are now being analyzed and will be known within a few weeks.
Then the study will move on to baricitinib, made by Eli Lilly and Company, the company said.Then the study will move on to baricitinib, made by Eli Lilly and Company, the company said.
Jennifer Routh, a spokeswoman at the National Institute of Allergy and Infectious Diseases, confirmed that the drug would now be tested in the federal trial but said the institute could offer no further comment.Jennifer Routh, a spokeswoman at the National Institute of Allergy and Infectious Diseases, confirmed that the drug would now be tested in the federal trial but said the institute could offer no further comment.
Dan Skovronsky, chief scientific officer at Lilly, explained how and why baricitinib was chosen.Dan Skovronsky, chief scientific officer at Lilly, explained how and why baricitinib was chosen.
In February, when the new coronavirus was emerging as a pandemic threat, a company in the United Kingdom called Benevolent AI began using its artificial intelligence system to look for approved drugs that could possibly help people with coronavirus infections. It pointed toward baricitinib precisely because it suppresses the immune system. That, the company suggested, might allow it to quell a cytokine storm, a disastrous immune system response that kills patients.In February, when the new coronavirus was emerging as a pandemic threat, a company in the United Kingdom called Benevolent AI began using its artificial intelligence system to look for approved drugs that could possibly help people with coronavirus infections. It pointed toward baricitinib precisely because it suppresses the immune system. That, the company suggested, might allow it to quell a cytokine storm, a disastrous immune system response that kills patients.
As a coronavirus infection progresses, the amount of the virus infecting cells does not appear to be extremely high. But the immune system in some people goes into overdrive, sending out vast amounts of small proteins — cytokines — that trigger inflammation. Cytokine storms can kill patients with other diseases, including flu. This immune overreaction, some scientists think, could explain why some people infected with coronavirus have only mild symptoms while others have severe or fatal illnesses.As a coronavirus infection progresses, the amount of the virus infecting cells does not appear to be extremely high. But the immune system in some people goes into overdrive, sending out vast amounts of small proteins — cytokines — that trigger inflammation. Cytokine storms can kill patients with other diseases, including flu. This immune overreaction, some scientists think, could explain why some people infected with coronavirus have only mild symptoms while others have severe or fatal illnesses.
Benevolent AI also noted another potential advantage of baricitinib, said Dr. Vincent Marconi of Emory University, a key investigator in the federal trial. The drug might have anti-viral activity. That, plus the chance of subduing cytokine storms, Dr. Marconi said, “made a compelling case for baricitinib to be explored further in a clinical trial.”Benevolent AI also noted another potential advantage of baricitinib, said Dr. Vincent Marconi of Emory University, a key investigator in the federal trial. The drug might have anti-viral activity. That, plus the chance of subduing cytokine storms, Dr. Marconi said, “made a compelling case for baricitinib to be explored further in a clinical trial.”
At Lilly, executives were a bit skeptical.At Lilly, executives were a bit skeptical.
“Our initial reaction was, ‘Does it make sense to immunosuppress when patients are trying to fight off an infection?’” Dr. Skovronsky said. The warning label on the drug, he added, “tempered our enthusiasm.”“Our initial reaction was, ‘Does it make sense to immunosuppress when patients are trying to fight off an infection?’” Dr. Skovronsky said. The warning label on the drug, he added, “tempered our enthusiasm.”
As Covid-19 spread, some doctors started giving patients the drug anyway. It is a pill and there is a huge supply, making it easy for doctors to prescribe it off-label.As Covid-19 spread, some doctors started giving patients the drug anyway. It is a pill and there is a huge supply, making it easy for doctors to prescribe it off-label.
Dr. Skovronsky and his colleagues at Lilly were concerned.Dr. Skovronsky and his colleagues at Lilly were concerned.
“We are extremely cautious,” said Patrik Jonsson, Lilly’s president of biomedicines. “We cannot encourage use.”“We are extremely cautious,” said Patrik Jonsson, Lilly’s president of biomedicines. “We cannot encourage use.”
But such warnings were not enough.But such warnings were not enough.
“In desperate times, doctors are trying everything,” Dr. Skovronsky said. “Various drugs are just being tried on patients in clinical trials without a control. It is really hard to interpret those kinds of data.”“In desperate times, doctors are trying everything,” Dr. Skovronsky said. “Various drugs are just being tried on patients in clinical trials without a control. It is really hard to interpret those kinds of data.”
The company realized it had to accept the offer to contribute its drug for the federal trial.The company realized it had to accept the offer to contribute its drug for the federal trial.
Dr. Andre Kalil, a principal investigator in the federal trial, urged doctors and patients to refrain from using baricitinib until the results of the federal trial are known, which should be in a matter of months.Dr. Andre Kalil, a principal investigator in the federal trial, urged doctors and patients to refrain from using baricitinib until the results of the federal trial are known, which should be in a matter of months.
Updated June 16, 2020Updated June 16, 2020
The steroid, dexamethasone, is the first treatment shown to reduce mortality in severely ill patients, according to scientists in Britain. The drug appears to reduce inflammation caused by the immune system, protecting the tissues. In the study, dexamethasone reduced deaths of patients on ventilators by one-third, and deaths of patients on oxygen by one-fifth.
The coronavirus emergency relief package gives many American workers paid leave if they need to take time off because of the virus. It gives qualified workers two weeks of paid sick leave if they are ill, quarantined or seeking diagnosis or preventive care for coronavirus, or if they are caring for sick family members. It gives 12 weeks of paid leave to people caring for children whose schools are closed or whose child care provider is unavailable because of the coronavirus. It is the first time the United States has had widespread federally mandated paid leave, and includes people who don’t typically get such benefits, like part-time and gig economy workers. But the measure excludes at least half of private-sector workers, including those at the country’s largest employers, and gives small employers significant leeway to deny leave.The coronavirus emergency relief package gives many American workers paid leave if they need to take time off because of the virus. It gives qualified workers two weeks of paid sick leave if they are ill, quarantined or seeking diagnosis or preventive care for coronavirus, or if they are caring for sick family members. It gives 12 weeks of paid leave to people caring for children whose schools are closed or whose child care provider is unavailable because of the coronavirus. It is the first time the United States has had widespread federally mandated paid leave, and includes people who don’t typically get such benefits, like part-time and gig economy workers. But the measure excludes at least half of private-sector workers, including those at the country’s largest employers, and gives small employers significant leeway to deny leave.
So far, the evidence seems to show it does. A widely cited paper published in April suggests that people are most infectious about two days before the onset of coronavirus symptoms and estimated that 44 percent of new infections were a result of transmission from people who were not yet showing symptoms. Recently, a top expert at the World Health Organization stated that transmission of the coronavirus by people who did not have symptoms was “very rare,” but she later walked back that statement.So far, the evidence seems to show it does. A widely cited paper published in April suggests that people are most infectious about two days before the onset of coronavirus symptoms and estimated that 44 percent of new infections were a result of transmission from people who were not yet showing symptoms. Recently, a top expert at the World Health Organization stated that transmission of the coronavirus by people who did not have symptoms was “very rare,” but she later walked back that statement.
Touching contaminated objects and then infecting ourselves with the germs is not typically how the virus spreads. But it can happen. A number of studies of flu, rhinovirus, coronavirus and other microbes have shown that respiratory illnesses, including the new coronavirus, can spread by touching contaminated surfaces, particularly in places like day care centers, offices and hospitals. But a long chain of events has to happen for the disease to spread that way. The best way to protect yourself from coronavirus — whether it’s surface transmission or close human contact — is still social distancing, washing your hands, not touching your face and wearing masks.Touching contaminated objects and then infecting ourselves with the germs is not typically how the virus spreads. But it can happen. A number of studies of flu, rhinovirus, coronavirus and other microbes have shown that respiratory illnesses, including the new coronavirus, can spread by touching contaminated surfaces, particularly in places like day care centers, offices and hospitals. But a long chain of events has to happen for the disease to spread that way. The best way to protect yourself from coronavirus — whether it’s surface transmission or close human contact — is still social distancing, washing your hands, not touching your face and wearing masks.
A study by European scientists is the first to document a strong statistical link between genetic variations and Covid-19, the illness caused by the coronavirus. Having Type A blood was linked to a 50 percent increase in the likelihood that a patient would need to get oxygen or to go on a ventilator, according to the new study.A study by European scientists is the first to document a strong statistical link between genetic variations and Covid-19, the illness caused by the coronavirus. Having Type A blood was linked to a 50 percent increase in the likelihood that a patient would need to get oxygen or to go on a ventilator, according to the new study.
The unemployment rate fell to 13.3 percent in May, the Labor Department said on June 5, an unexpected improvement in the nation’s job market as hiring rebounded faster than economists expected. Economists had forecast the unemployment rate to increase to as much as 20 percent, after it hit 14.7 percent in April, which was the highest since the government began keeping official statistics after World War II. But the unemployment rate dipped instead, with employers adding 2.5 million jobs, after more than 20 million jobs were lost in April.The unemployment rate fell to 13.3 percent in May, the Labor Department said on June 5, an unexpected improvement in the nation’s job market as hiring rebounded faster than economists expected. Economists had forecast the unemployment rate to increase to as much as 20 percent, after it hit 14.7 percent in April, which was the highest since the government began keeping official statistics after World War II. But the unemployment rate dipped instead, with employers adding 2.5 million jobs, after more than 20 million jobs were lost in April.
Mass protests against police brutality that have brought thousands of people onto the streets in cities across America are raising the specter of new coronavirus outbreaks, prompting political leaders, physicians and public health experts to warn that the crowds could cause a surge in cases. While many political leaders affirmed the right of protesters to express themselves, they urged the demonstrators to wear face masks and maintain social distancing, both to protect themselves and to prevent further community spread of the virus. Some infectious disease experts were reassured by the fact that the protests were held outdoors, saying the open air settings could mitigate the risk of transmission.Mass protests against police brutality that have brought thousands of people onto the streets in cities across America are raising the specter of new coronavirus outbreaks, prompting political leaders, physicians and public health experts to warn that the crowds could cause a surge in cases. While many political leaders affirmed the right of protesters to express themselves, they urged the demonstrators to wear face masks and maintain social distancing, both to protect themselves and to prevent further community spread of the virus. Some infectious disease experts were reassured by the fact that the protests were held outdoors, saying the open air settings could mitigate the risk of transmission.
States are reopening bit by bit. This means that more public spaces are available for use and more and more businesses are being allowed to open again. The federal government is largely leaving the decision up to states, and some state leaders are leaving the decision up to local authorities. Even if you aren’t being told to stay at home, it’s still a good idea to limit trips outside and your interaction with other people.States are reopening bit by bit. This means that more public spaces are available for use and more and more businesses are being allowed to open again. The federal government is largely leaving the decision up to states, and some state leaders are leaving the decision up to local authorities. Even if you aren’t being told to stay at home, it’s still a good idea to limit trips outside and your interaction with other people.
Common symptoms include fever, a dry cough, fatigue and difficulty breathing or shortness of breath. Some of these symptoms overlap with those of the flu, making detection difficult, but runny noses and stuffy sinuses are less common. The C.D.C. has also added chills, muscle pain, sore throat, headache and a new loss of the sense of taste or smell as symptoms to look out for. Most people fall ill five to seven days after exposure, but symptoms may appear in as few as two days or as many as 14 days.Common symptoms include fever, a dry cough, fatigue and difficulty breathing or shortness of breath. Some of these symptoms overlap with those of the flu, making detection difficult, but runny noses and stuffy sinuses are less common. The C.D.C. has also added chills, muscle pain, sore throat, headache and a new loss of the sense of taste or smell as symptoms to look out for. Most people fall ill five to seven days after exposure, but symptoms may appear in as few as two days or as many as 14 days.
If air travel is unavoidable, there are some steps you can take to protect yourself. Most important: Wash your hands often, and stop touching your face. If possible, choose a window seat. A study from Emory University found that during flu season, the safest place to sit on a plane is by a window, as people sitting in window seats had less contact with potentially sick people. Disinfect hard surfaces. When you get to your seat and your hands are clean, use disinfecting wipes to clean the hard surfaces at your seat like the head and arm rest, the seatbelt buckle, the remote, screen, seat back pocket and the tray table. If the seat is hard and nonporous or leather or pleather, you can wipe that down, too. (Using wipes on upholstered seats could lead to a wet seat and spreading of germs rather than killing them.)If air travel is unavoidable, there are some steps you can take to protect yourself. Most important: Wash your hands often, and stop touching your face. If possible, choose a window seat. A study from Emory University found that during flu season, the safest place to sit on a plane is by a window, as people sitting in window seats had less contact with potentially sick people. Disinfect hard surfaces. When you get to your seat and your hands are clean, use disinfecting wipes to clean the hard surfaces at your seat like the head and arm rest, the seatbelt buckle, the remote, screen, seat back pocket and the tray table. If the seat is hard and nonporous or leather or pleather, you can wipe that down, too. (Using wipes on upholstered seats could lead to a wet seat and spreading of germs rather than killing them.)
Taking one’s temperature to look for signs of fever is not as easy as it sounds, as “normal” temperature numbers can vary, but generally, keep an eye out for a temperature of 100.5 degrees Fahrenheit or higher. If you don’t have a thermometer (they can be pricey these days), there are other ways to figure out if you have a fever, or are at risk of Covid-19 complications.Taking one’s temperature to look for signs of fever is not as easy as it sounds, as “normal” temperature numbers can vary, but generally, keep an eye out for a temperature of 100.5 degrees Fahrenheit or higher. If you don’t have a thermometer (they can be pricey these days), there are other ways to figure out if you have a fever, or are at risk of Covid-19 complications.
The C.D.C. has recommended that all Americans wear cloth masks if they go out in public. This is a shift in federal guidance reflecting new concerns that the coronavirus is being spread by infected people who have no symptoms. Until now, the C.D.C., like the W.H.O., has advised that ordinary people don’t need to wear masks unless they are sick and coughing. Part of the reason was to preserve medical-grade masks for health care workers who desperately need them at a time when they are in continuously short supply. Masks don’t replace hand washing and social distancing.The C.D.C. has recommended that all Americans wear cloth masks if they go out in public. This is a shift in federal guidance reflecting new concerns that the coronavirus is being spread by infected people who have no symptoms. Until now, the C.D.C., like the W.H.O., has advised that ordinary people don’t need to wear masks unless they are sick and coughing. Part of the reason was to preserve medical-grade masks for health care workers who desperately need them at a time when they are in continuously short supply. Masks don’t replace hand washing and social distancing.
If you’ve been exposed to the coronavirus or think you have, and have a fever or symptoms like a cough or difficulty breathing, call a doctor. They should give you advice on whether you should be tested, how to get tested, and how to seek medical treatment without potentially infecting or exposing others.If you’ve been exposed to the coronavirus or think you have, and have a fever or symptoms like a cough or difficulty breathing, call a doctor. They should give you advice on whether you should be tested, how to get tested, and how to seek medical treatment without potentially infecting or exposing others.
If you’re sick and you think you’ve been exposed to the new coronavirus, the C.D.C. recommends that you call your healthcare provider and explain your symptoms and fears. They will decide if you need to be tested. Keep in mind that there’s a chance — because of a lack of testing kits or because you’re asymptomatic, for instance — you won’t be able to get tested.If you’re sick and you think you’ve been exposed to the new coronavirus, the C.D.C. recommends that you call your healthcare provider and explain your symptoms and fears. They will decide if you need to be tested. Keep in mind that there’s a chance — because of a lack of testing kits or because you’re asymptomatic, for instance — you won’t be able to get tested.
“This is a drug that has never been used before in this situation,” he said. “That is why it needs to be tested in a randomized clinical trial. We don’t know if it will help or harm. We have so much uncertainty.”“This is a drug that has never been used before in this situation,” he said. “That is why it needs to be tested in a randomized clinical trial. We don’t know if it will help or harm. We have so much uncertainty.”
The final design of the next phase of the federal trial is still being worked out, but the expectation is that it will include 600 to 800 patients, Dr. Marconi said. If the first phase of the study finds that remdesivir seems to help patients, half of the patients in the second phase will take remdesivir plus a placebo pill, and half will get remdesivir plus baricitinib.The final design of the next phase of the federal trial is still being worked out, but the expectation is that it will include 600 to 800 patients, Dr. Marconi said. If the first phase of the study finds that remdesivir seems to help patients, half of the patients in the second phase will take remdesivir plus a placebo pill, and half will get remdesivir plus baricitinib.
If remdesivir is no better than or even worse than placebo — a very real possibility given the progress so far of a company-sponsored study in China — one group of patients will get a placebo pill and the other group will get baricitinib.If remdesivir is no better than or even worse than placebo — a very real possibility given the progress so far of a company-sponsored study in China — one group of patients will get a placebo pill and the other group will get baricitinib.
“We are looking for a strong effect,” Dr. Skovronsky said. “If it works, it will be big. If it doesn’t, we will move on.”“We are looking for a strong effect,” Dr. Skovronsky said. “If it works, it will be big. If it doesn’t, we will move on.”
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