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Patients with systemic lupus erythematosus depend on hydroxychloroquine to control disease activity, but demand for this drug, which was already in short supply, has spiked since President Trump championed its use for COVID-19 patients. The American College of Rheumatology has responded by issuing a series of recommendations. Learn more in this article.
The American College of Rheumatology has issued a series of recommendations to ensure a steady supply of hydroxychloroquine (Plaquenil, Sanofi) for patients with systemic lupus erythematosus who depend on the medication to control flares.
The demand for hydroxychloroquine (HCQ) spiked earlier this month after Philippe Gautret, M.D., Ph.D., Aix-Marseille University, France, published a small preliminary study of 20 patients (ranginig from asymptomatic to having upper or lower respiratory tract infections) suggesting that 600 mg of hydroxychloroquine daily was effective in treating COVID-19. The study, which was published on March 20 in the International Journal of Antimicrobial Agents, ultimately found that the combination of azithromycin and hydroxychloroquine was significantly more effective.
Previously, chloroquine and hydroxychloroquine were found to be efficient in treating SARS-CoV-2 cases, and other studies have shown that it was efficient in treating Chinese COV-19 patients. Another study reported that the antiviral medication remdesivir and the antimalarial chloroquine exhibited an inhibitor effect on SARS-CoV-2 in vitro. And, a clinical trial conducted in China found that chloroquine had a significant effect in improving outcomes or in removing the virus from COVID-19 patients. As a result, Chinese officials recommended that all COVID-19 patients, regardless of disease severity, be treated with 500 mg chloroquine twice a day for 10 days.
Prompted by the publication of the French study and the Chinese clincal trial, on March 19 President Trump championed the adoption of hydroxychloroquine and azithromycin to treat COVID-19 patients in the U.S. That led to concerns from the medical community pointing to flaws in the science and misinterpretations from the Gautret report.
Hydroxychloroquine was already on short supply before the press conference, according to a statement issued by the American College of Rheumatology.
"Shortages of hydroxychloroquine, a drug with relatively few regular manufacturers and a history of shortages and price spikes in the U.S., were noted before the press conference and became widely reported in the days that followed," the ACR stated.
Approximately 1.5 million people in the United States have systemic lupus erythematosus (SLE) which is an underlying cause of death annually for 2,061 people with SLE, according to the Centers for Disease Control and Prevention. For pregnant women with systemic lupus erythematosus (SLE), hydroxychloroquine is a cornertone essential treatment recommended for all women with SLE except for those with contraindications. "It is the only medication shown to increase survival in lupus patients. It has been shown to reduce lupus flares and prevent organ damage including cardiovascular events," wrote Andrea Fava and Michelle Petri in the Journal of Autoimmunity. For patients with stable SLE, the withdrawl of hydroxychloroquine, even for just two weeks, can lead to flares and severe exacerbation of disease activity, according to researchers writing in the New England Journal of Medicine.
The ACR suggests the Gautret study has a number of "serious flaws in its methods and data interpretation, does not provide a scientific justification for allocation of HCQ to COVID19 patients," but does justify the need for more controlled clinical trials in humans." But future clinical trials "should be carried out by experienced investigators equipped to generate and interpret reliable results while safeguarding patient safety and informed consent. The risk of adverse events in critically ill COVID-19 patients receiving HCQ in combination with other drugs underscores the need for HCQ trials to take place in a controlled setting."
The ACR has issued a series of recommendations to protect the hydroxychloroquine supply chain.See the next page for a snapshot of those recommendations.
Recommendations to protect the hydroxychloroquine supply chain