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In mid-November, a tricky-named arthritis drug hit a pandemic milestone – then fell back into relative obscurity.
The drug, baricitinib, has received emergency clearance from the Food and Drug Administration to treat a subset of hospital patients with Covid-19 in combination with another drug, the antiviral remdesivir. It is one of the few treatments to have received the green light from the agency.
But the reception of baricitinib by the medical community has been lukewarm. This does not work very well, on the one hand, and leads to side effects, such as blood clots. And at a cost of around $ 1,500 per patient, many doctors are unsure of when it would make sense to use the drug, which might have overlapping roles with cheap and widely available steroids like dexamethasone.
In a clinical trial sponsored by the National Institutes of Health, hospitalized Covid-19 patients treated with baricitinib and remdesivir recovered a day faster than patients who received remdesivir alone.
“I think it’s really a burger for nothing,” said Dr. Ilan Schwartz, an infectious disease specialist at the University of Alberta. “We’re talking about adding a drug that cuts clinical improvement time by one day, in a disease that takes weeks to heal.”
These findings, which were announced in a series of press releases by drugmaker Eli Lilly, have yet to be published in a peer-reviewed scientific journal. Kristen Porter Basu, a spokesperson for the company, wrote in an email that a “more detailed analysis” would be released “very soon.”
When an emergency clearance has been issued but the data has not been issued, doctors are caught “in a difficult situation,” said Dr Manuela Cernadas, intensive care physician at Brigham and Women’s Hospital in Boston. . “We don’t know exactly where this drug fits in our arsenal of drugs that we are comfortable using.”
Baricitinib is a reused arthritis treatment that, like a steroid, alleviates inflammation, which in severe cases of Covid-19 can get out of control and destroy healthy tissue. The drug acts as a molecular silencer, preventing cells from responding to warning signals that could cause the body’s immune response to get out of hand.
The NIH trial was designed to test whether baricitinib could increase the benefit of remdesivir, now the standard of care for patients with Covid-19. Remdesivir by itself accelerates recovery by several days. The researchers found that adding baricitinib reduced a patient’s recovery time an extra day and prevented a few more people from going without ventilators. But these and other results failed to impress experts, many of whom said the drug would need to have much greater benefits to outweigh its price and potential drawbacks.
“It seems more progressive than the blockbuster,” said Dr. Taison Bell, an intensive care physician at the University of Virginia, who participated in the clinical trial. Although Dr Bell described baricitinib as a reasonable addition to the Covid treatment toolkit, and even deserving of emergency approval, “I don’t think this is a game-changer,” he said.
Still, the results were enough to convince the FDA, which issued emergency clearance on November 19. The drug is now allowed to be combined with remdesivir, but only in hospital patients who need supplemental oxygen, mechanical ventilation or other respiratory support.
The agency’s limited clearance matches the subset of patients in the NIH trial who benefited the most from the two-drug combination, said Dr. Andre Kalil, an infectious disease physician at the Medical Center of the ‘University of Nebraska and one of the trial’s principal investigators. .
But that same patient population – people sick enough to need some form of respiratory support – would also be good candidates for steroids like dexamethasone, said Dr Phyllis Tien, an infectious disease physician at the University of California at San Francisco.
Dexamethasone, unlike baricitinib, has been shown in studies to reduce mortality in critically ill Covid-19 patients. A generic drug, it’s also cheap, costs pennies or dollars per day of treatment, and has been part of the coronavirus treatment manual for months.
“I wonder, ‘Who would I think of using baricitinib in addition to dexamethasone? ”Said Dr. Tien.
But Dr Boghuma Kabisen Titanji, an infectious disease physician at Emory University who initiated the first studies of baricitinib against the coronavirus, offered a more sober perspective on dexamethasone. Steroids are “blunt knives,” she said, suppressing inflammation on a larger scale than drugs like baricitinib. That’s why steroids come with a host of unwanted side effects, including exacerbating conditions like diabetes or osteoporosis, she said.
The family of drugs that include baricitinib, on the other hand, may offer greater therapeutic precision, Dr Titanji said. There is also some evidence that baricitinib could prevent the coronavirus from entering cells.
Yet baricitinib has its own issues, such as the increased risk of blood clots – already a problem in many cases of Covid-19. “It gives you a break,” Dr. Cernadas said.
Baricitinib and dexamethasone also weaken immune function, increasing the likelihood that other viruses or bacteria can enter the bodies of the people they are used in. But of the two, dexamethasone is “the devil you know,” said Dr. Lauren Henderson, a pediatric rheumatologist at Boston Children’s Hospital. “I probably wouldn’t go for baricitinib first-line.”
Dr Tien and other experts echoed this sentiment, saying they would likely choose dexamethasone over baricitinib when treating someone with a severe case of Covid-19, unless they didn’t. There is an obvious reason why their patient might respond poorly to steroids.
A direct comparison between baricitinib and dexamethasone might clarify which patients would be better placed to take one drug than another. In late November, the NIH announced a trial comparing outcomes between hospitalized Covid-19 patients who received either a combination of remdesivir and dexamethasone or a combination of remdesivir and baricitinib. But Dr Schwartz and others have raised ethical concerns about the trial, which he says would by definition deprive some patients of life-saving steroid therapy.
Eli Lilly is also leading a trial to study the effects of baricitinib alone in hospital patients. In this study, which likely won’t end until next summer, all participants will be given dexamethasone.
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