Anakinra, a drug developed to treat rheumatoid arthritis, or RA, might help patients who developed acute respiratory distress syndrome caused by COVID-19, a small study published Thursday by The Lancet Rheumatology has found.
The drug was approved by the U.S. Food and Drug Administration in 2001 to treat RA. It is the latest prescription medication developed for another purpose to be evaluated for use in people with the disease caused by the new coronavirus, SARS-CoV-2.
“Until a vaccine is available, we urgently need to find a way to help people survive the most severe symptoms of COVID-19, and to do that without overwhelming the intensive care capacity of hospitals,” study co-author Lorenzo Dagna said in a press release.
“A treatment that has already met strict safety tests and that is available in sufficient quantities to meet the needs of the current pandemic is ideal,” said Dagna, head of immunology, rheumatology, allergy and rare diseases at San Raffaele Hospital and Vita-Salute San Raffaele University in Italy. The research was performed there.
COVID-19 has infected nearly 3.8 million people globally, and more than 260,000 people have died, according to figures from Johns Hopkins University. Most people with COVID-19 experience mild symptoms, but in those with serious illness, the immune system overreacts, causing rapid production of immune proteins called cytokines.
This so-called “cytokine storm” leads to hyper-inflammation in the lungs and acute respiratory distress syndrome, or ARDS, as well as reduced oxygen levels in the blood. ARDS is the main cause of death from COVID-19.
In RA, an autoimmune form of arthritis, anakinra works by blocking the pro-inflammatory cytokine IL-1, which is why Dagna and his colleagues tried it on patients with severe COVID-19, many of whom had other underlying health conditions.
For the trial, 29 patients who had ARDS and hyper-inflammation received intravenously a daily regimen of 10 milligrams per kilogram of body weight, as well as “standard treatment” for the virus — non-invasive ventilation, or CPAP, and the anti-malarial drug hydroxychloroquine — for 21 days.
The study authors noted that this is considered a high dose for the drug, as the recommended dose for patients with RA is 100 mg. daily.
That high dose resulted in progressive improvements in respiratory function in 21 of the 29 patients. In all, 26 of the 29 recovered from COVID-19.
Both of these results are significant improvements over those experienced by patients who received only standard treatment, the researchers said. Of 16 patients who received standard treatment, respiratory function improved in only half, and nine ultimately died from the virus.
“While great attention has been focused so far on viral control, inflammation control might also be as crucial for the treatment of COVID-19, and it seems to have allowed us to postpone or avoid intubation in most patients,” said co-author Chiara Tassan Din, of the Department of Infectious Diseases at San Raffaele Hospital.
The authors reported that high-dose anakinra generally was safe. However they noted that this was not a randomized, controlled trial — the gold standard for proving the safety and effectiveness of a treatment.
A randomized, controlled trial of the drug in COVID-19 is underway, but it is assessing lower doses and does not include patients with ARDS.
“Our study is the first to suggest that a high dose of the arthritis drug anakinra may be able to block the overreaction of the immune system caused by COVID-19,” said co-author Dr. Giulio Cavalli, of San Raffaele Hospital. “The results are interesting and the drug deserves controlled testing in large randomized trials.”