Rheumatologists and their patients have been hit especially hard with drug shortages during the COVID-19 pandemic.

The American College of Rheumatology (ACR) recently expressed concern about shortages of tocilizumab, marketed as Actemra, which was okayed for use by the FDA earlier in the summer.

"Demand for tocilizumab has outpaced supply, with demand increasing after the FDA's June 24 Emergency Use Authorization (EUA) for tocilizumab to be used for the treatment of COVID-19 in some hospitalized adult and pediatric patients," the ACR writes in a press release.

The FDA issued an emergency use authorization (EUA) for tocilizumab for the treatment of hospitalized adults and pediatric patients aged 2 years and older who are receiving systemic corticosteroids and require supplemental oxygen, noninvasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO). The FDA emphasizes that the drug is not authorized for use in outpatients with COVID-19.

In clinical trials of hospitalized patients with COVID-19, tocilizumab demonstrated an ability to reduce the risk of death through 28 days of follow-up, decrease the amount of time patients remained hospitalized, and lower the risk of ventilator use during that time period. The drug was administered in addition to the routine care patients received for treatment of COVID-19, which included corticosteroid therapy,

Actemra is a monoclonal antibody that reduces inflammation by blocking the interleukin-6 receptor. It is FDA-approved for multiple inflammatory diseases, including rheumatoid arthritis.

Formulations of tocilizumab not covered under the EUA, such as pens and prefilled syringes, were still available.

The ACR finalized guiding principles on the allocation of IV tocilizumab, stating that adequate supplies of tocilizumab should be allocated for patients with rheumatologic conditions, especially those in whom drug holidays would be reasonably expected to cause a flare of their disease or require a switch to an alternative regimen that is less efficacious, less safe, or unproven.

When the IV formulation of tocilizumab is not available, the specialty group says it supports the substitution of the SC form in place of the IV formulation with no increased cost to the patient.

According to media reports, the U.S. Department of Health & Human Services asked public health leaders from seven Southern states to reduce their orders of monoclonal antibody treatments by about 30% due to limited supply. States, especially along the Gulf Coast, are using about 70% of the nation's distribution of monoclonal antibodies because of overwhelming outbreaks of the novel coronavirus's delta variant, especially among the unvaccinated.

Drug shortages extend beyond the U.S., however. The European Alliance of Associations for Rheumatology (EULAR) recently issued a press release on that issue.

"EULAR is aware that more and more EU member states are experiencing shortages of essential anti-inflammatory drugs and that certain manufacturers have highlighted the prospect of global shortages in the upcoming months," writes EULAR President Annamaria Iagnocco, MD.

"While recognizing that many drugs traditionally used to treat rheumatic and musculoskeletal diseases (RMDs) have become leading COVID (CV)-19 therapeutics, manufacturers and governments must take urgent steps to ensure that this increased demand does not impact the lives and livelihoods of Europeans with RMDs," Dr. Iagnocco states.

The association points out that those medications are essential for rheumatology patients with conditions such as arthritis and vasculitis and not only help to relieve symptoms but can also mitigate against the development of common comorbidities such as cancer, diabetes, and cardiovascular disease.

EULAR notes that a "balanced approach is essential to ensure that we meet the ongoing pandemic imperatives and respect the needs of those already benefiting from the use of this medicine, for some of whom it is an essential medication."

Availability of glucocorticoids is especially an issue, Dr. Iagnocco explains.

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