- Treatment with a repurposed arthritis drug from Eli Lilly and Incyte did not significantly lessen the risk of worsening disease among people hospitalized with COVID-19, the company announced Thursday, citing results from an international study of some 1,500 volunteers.
- In a somewhat paradoxical result, however, Lilly said its drug, called baricitinib and sold as Olumiant for rheumatoid arthritis, substantially reduced the risk of death by any cause in the trial, which compared the oral medicine to placebo when given on top of standard COVID-19 treatments like steroids and Gilead's Veklury.
- Roughly 8% of study participants given baricitinib along with standard care died by day 28 of the trial versus 13.1% who received placebo, a reduction of 38%. Researchers observed a benefit regardless of how sick volunteers were at the beginning of the study, Lilly said, and in pre-specified subgroups who were treated with or without steroids at the trial's start.
The Food and Drug Administration cleared baricitinib last November for emergency use alongside Veklury in treating hospitalized COVID-19 patients who also require breathing support. The decision made the drug one of only a few medicines available for people with severe disease.
The authorization was supported by results from a government-run study that showed using the two drugs together reduced the time to recovery from COVID-19 by one day. More convincingly, the data indicated treatment lowered the odds of a patient progressing to mechanical ventilation or dying.
The Phase 3 trial that's now read out preliminary results was designed to complement that National Institutes of Health-led study. Like many COVID-19 drug studies, the data are very much mixed, with an on-the-surface negative finding shaded by a more encouraging secondary result.
The study, dubbed COV-BARRIER, enrolled 1,525 hospitalized COVID-19 patients who were either not yet on breathing support or required supplemental oxygen or non-invasive ventilation. Participants were recruited from across the world, with volunteers in the U.S, the U.K., Brazil, India and eight other countries.
Study investigators gave participants 4 milligrams of baricitinib for up to two weeks on top of standard care — as defined locally — which could include steroids, Veklury, antimalarials or azithromycin. Roughly 80% were receiving steroid treatment like dexamethasone at the study's start, while about 20% were being given Veklury.
The main goal of the trial was to test whether baricitinib could help slow progression to ventilation or death. Baricitinib-treated patients were only 2.7% less likely to see their disease worsen, however, a difference that Lilly said was not statistically significant.
But treatment was consistently associated with a reduction in the risk of death, a finding that Vincent Marconi, an investigator and professor at Emory University School of Medicine, called "clinically important."
"This effect on mortality was seen with or without corticosteroids and/or remdesivir at the time of enrollment," he said in a statement provided by the Indianapolis drugmaker, referring to Veklury by its nonproprietary name.
As the primary goal of the study was missed, the significant reduction in mortality between the two arms was considered nominal.
The rate of side effects and serious adverse events were similar between the two study groups, according to Lilly, which said it would publish the full study findings in a medical journal.
The company will also share the data with regulators in the U.S., Europe and elsewhere to determine next steps for use of baricitinib in hospitalized COVID-19 patients.
Baricitinib belongs to a class of drugs known as JAK inhibitors, which work to counteract damaging inflammation in diseases like arthritis, eczema and colitis. Researchers early on speculated the drugs might be able to help treat COVID-19 that's advanced to later stages, triggering an inflammatory response that might be tamped down with medication. But only Lilly's drug, so far, has cleared to treat the disease.
Lilly licensed barictinib from Incyte, which discovered the drug.