SLE Patients Stake a Claim on Hydroxychloroquine

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

• Due to the absence of strong data from clinical trials, the ACR does not support unrestricted access to HCQ for COVID-19 patients.

• Every effort must be made to ensure there is an adequate supply of HCQ for all patients who need it, including SLE patients, especially pregnant SLE patients.

• Rheumatologists and rheumatology health professionals should consult with their patients about the possibility of the need to adopted HCQ dose reduction strategies and extend HCQ dosing intervals if a shortage should become problematic.

• For patients prescribed HCQ prior to COVID-19, refills should be limited to 30 days if reasonable to do so and necessary.

• There may be a need to restrict new prescriptions for HCQ in outpatient settings, but these decisions should be made by rheumatologists, dermatologists or other rheumatology or dermatology health professional.

• "During HCQ shortages we urge insurers to exempt rheumatology patients from prior authorization, step therapy protocols, and other utilization management practices so that they may more readily gain access to appropriate alternatives as determined by their rheumatologist or rheumatology health professional."

• Restrictions in importing HCQ should be relaxed during the COVID-19 pandemic to support the demand in need in the U.S.

• Efforts to increase production and distribution of HCQ for rheumatology and COVID-19 patients should be supported.

• Efforts to protect the supply chain from manufacturer to wholesaler, wholesaler to pharmacy and final distribution should be adopted.

• HCQ supplies should be prioritized, but not limited to clinical trials that should focus on preexposure prophylaxis, post-exposure prophylaxis, and as a therapeuatic treatment for all levels of COVID-19 infections.

• HCQ allocation should be done locally with input from appropriate experts, not by individual dispensing pharmacies. Experts should consider recommendations from rheumatologists and rheumatology health professionals who are experts in managing HCQ for rheumatologic conditions.

• The ACR recommends against pharmacy-level restrictions for new HCQ prescriptions for SLE patients.

• Regulatory authorities should take actions against predatory price increases or cost-sharing requirements.

Click here for the complete list of recommendations from the ACR.