Rheumatoid arthritis drug shows promise in fighting Covid-19
An anti-inflammatory drug can help reduce the risk of death in people hospitalized with Covid-19, a new clinical trial indicates, reviving hopes - and debate.
An anti-inflammatory drug can help reduce the risk of death in people hospitalized with Covid-19, a new clinical trial indicates, reviving hopes -- and debate -- about a medicine that many physicians had abandoned after earlier clinical-trial failures.
A U.K. study of more than 4,000 hospitalized patients showed that people who received the rheumatoid arthritis drug tocilizumab plus steroids had a 20% lower risk of death after 28 days compared with patients who received steroids and standard care only, according to preliminary results posted online this month.
The results haven’t been published yet in a peer-reviewed scientific journal, but U.S. scientists are paying attention to them because of the reputation of the University of Oxford researchers who conducted the study. In June, the same Oxford researchers were the first to prove that the cheap and widely available steroid dexamethasone significantly reduced Covid-19 deaths, a finding that led to the drug becoming a standard treatment for most hospitalized patients.
Researchers say Oxford’s study may have succeeded where others failed because it included a much larger number of patients, whose average age was about 63, and included only patients with high inflammation measured in lab tests and low blood-oxygen. The data could lead to the drugs becoming more widely used, especially if they are included as suggested or recommended treatments in guidelines crafted by influential organizations such as the U.S. National Institutes of Health.
On Monday, the Infectious Diseases Society of America updated its guidelines to suggest the use of tocilizumab in addition to steroids in severe or critically ill patients “There have been a lot of studies before this one that suggested a possible benefit and others that seemed not quite as compelling,” said Francis Collins, director of the National Institutes of Health. “I think what we were waiting for was a really large scale, well-designed study -- and I think we may now have that.” Some doctors say the results show tocilizumab provides only a modest improvement over steroids alone, and that the potential side effects, such as fungal infections, are uncertain. Among patients who received steroids alone, the death rate was 33%, compared with 27% of those who also received tocilizumab.
Still, the drug could provide another option for patients who may not get better on standard therapies, doctors say.
Tocilizumab is sold under the brand name Actemra by Genentech, a unit of Roche Holding AG, for the treatment of rheumatoid arthritis, as well as a severe inflammatory condition, sometimes called “cytokine storm,” that can result as a side effect of certain cancer treatments.
Doctors say some of the sickest Covid-19 patients suffer from an immune reaction similar to cytokine storm that can damage the lungs and lead to respiratory failure. In the spring, doctors in the U.S. and Europe began using tocilizumab in certain hospitalized Covid-19 patients after a report by Chinese doctors indicating that the drug had helped drive dramatic turnarounds in patients infected by the virus.
In early May, nearly 16% of hospitalized patients were being treated with tocilizumab, according to an analysis of hospital admissions by electronic health records provider Epic Systems Corp. and its health research network, done at the request of The Wall Street Journal.
But when formal clinical trials were done, the results were disappointing and failed to show a definitive reduction in deaths. Use of the drug plummeted, with just 1% of Covid-19 hospital admissions receiving tocilizumab in the final week of 2020, according to the Epic data.
“After the first five or six trials [ failed to reduce deaths], hardly anyone used any toci,” said Adarsh Bhimraj, an infectious disease specialist at Cleveland Clinic. “And nobody ever thought it was going to make a comeback.” That changed after results from the new U.K. study, known as the Recovery trial, were posted early this month in a “preprint” article, an early version of a scientific paper before it has gone through peer review to be published in a journal. Researchers have made increasing use of preprint databases to disseminate information quickly to clinicians.
Dr. Bhimraj said the effectiveness of tocilizumab doesn’t appear overwhelming, but that it adds another tool for treating the sickest patients, particularly those who don’t appear to be getting better with dexamethasone alone.
“We don’t have anything for those patients and this is at least one thing that is available which might have a modest benefit,” Dr. Bhimraj said.
One factor that may limit use of tocilizumab is its cost, particularly for low-income countries. Dexamethasone is a cheap generic drug that most doctors are familiar with. The list price of tocilizumab is $2,300 per dose, according to Genentech.
“Tocilizumab is currently at a price that is unaffordable for most people throughout the world and that needs to change,” said Peter Horby, joint chief investigator for the Recovery trial and professor of emerging infectious diseases at Oxford’s Nuffield Department of Medicine.
Dow Jones Newswires