Accelerated clinical trials evaluating hydroxychloroquine as a COVID-19 treatment have been inconclusive at best, but the sudden spotlight on the drug has prompted many in the rheumatology community to raise concerns about limited supplies as well as dangerous misconceptions regarding the drug’s prophylactic effect on COVID-19.
Because of unexpected demand for the drug in clinical trials and for hospital use, Duke rheumatologist David Leverenz, MD, says patients with lupus or rheumatoid arthritis face significant risks if the hydroxychloroquine pipeline is suddenly limited. On March 19, after President Donald Trump referenced hydroxychloroquine and a similar medicine, chloroquine, as COVID-19 therapies, prescriptions increased more than 46 times the rate of an average weekday, according to the New York Times.
“Many of our patients need these drugs for rheumatologic conditions, and particularly for lupus,” Leverenz says. “If hydroxychloroquine is limited, patients with lupus will flare and get sicker. We are already hearing from patients that they are having difficulty getting the prescriptions they need.”
Leverenz says rheumatologists also worry that patients may incorrectly interpret national commentary suggesting that hydroxychloroquine prevents infection from the coronavirus. A well-known rheumatology registry has disproved this theory, he points out. Many patients in this registry on hydroxychloroquine still contracted COVID-19, Leverenz says. “There are several ongoing clinical trials to determine if hydroxychloroquine has any benefit in preventing COVID-19,” Leverenz says. “But we already know it will not be a perfect solution.
From an ethical standpoint, the hydroxychloroquine supply should be protected for rheumatology patients, Leverenz says. “It’s very important that rheumatology patients for whom there are well-established indications be allowed to continue this medication.”
Hydroxychloroquine received limited approval for emergency use
Hydroxychloroquine received FDA approval for limited emergency use as a response to the COVID-19 pandemic in large part due to early results from a small study in France that suggested dramatic benefit. Leverenz says the results have been largely dismissed by many in the scientific community, however, as details emerged about the methodology and the lack of follow-up among patients. Many later reports of clinical trials also demonstrated that hydroxychloroquine showed no benefit in treating COVID-19. Most of these reports are “pre-print” editions, meaning they have not undergone comprehensive peer review and are not published in journals.
Another overlap between rheumatology and COVID-19 is the hyperinflammatory state that occurs in some patients with the virus. Usually described as a “cytokine storm,” it is thought to be one reason some patients with COVID-19 become severely ill.
Macrophage activation syndrome or secondary hemophagocytic lymph histiocytosis are similar hyperinflammatory states in rheumatologic diseases. Rheumatologists use scoring systems to identify the condition, but Leverenz and Duke rheumatology colleague, Teresa Tarrant, MD, have described the shortcomings of using these scores for COVID-19 in a recent correspondence published in The Lancet.
Biologic rheumatologic medications such as tocilizumab and sarilumab are being tested in ongoing trials to treat the hyperinflammatory state in severe COVID-19 infections, Leverenz says, but the results are not available.