The World Health Organization (WHO) has backed the use of interleukin (IL)-6 receptor blockers as a COVID-19 treatment for severely or critically ill patients with the infection, alongside corticosteroids. The IL-6 receptor antagonists are used to treat rheumatoid arthritis and include drugs such as Roche’s Actemra (tocilizumab) and Regeneron/Sanofi’s Kevzara (sarilumab).
The WHO added the class of drugs to its patient care guidelines, deeming the medications to be a lifesaving COVID-19 treatment in combination with corticosteroids.
The drugs are monoclonal antibodies against the IL-6 receptor. Patients with severe COVID-19 often have an overactivation of the immune system, which involves the increased release of cytokines (cytokine release syndrome) such as IL-6. By blocking the cytokine from binding to its receptor, the hyperactive immune response can be tamed.
Monoclonal antibodies generally do not come cheap. Given this, the WHO has also called on manufacturers to reduce the cost of the drugs because they are too expensive to be deployed in many parts of the world, the agency said.
This is the first class of drugs that the WHO has approved for COVID-19 treatment since it last gave the nod to the use of corticosteroids like dexamethasone in September 2020.
IL-6 receptor antagonists for COVID-19 treatment had yielded mixed results earlier. However, over time, accumulated data now shows that the drugs can offer benefit in improving patient outcomes including survival. And despite COVID-19 vaccinations picking up around the world, there remains a need for effective treatments, particularly in parts of the world with increasing infections and low vaccine supplies.
The WHO’s COVID-19 treatment update is based on data from a prospective and a living network meta-analysis initiated by WHO, the largest analysis on the drugs to date. The analyses involved data from over 10, 000 patients enrolled in 27 clinical trials. The studies showed that the drugs reduced the odds of death by 13 percent and cut the risk of progressing to mechanical ventilation by 28 percent among severe and critically ill patients, compared with standard of care. This means 23 fewer patients out of a thousand would need mechanical ventilation.
The WHO’s recommendation follows the FDA’s authorization of Actemra two weeks ago for COVID-19 patients requiring some oxygen support. Last November, the FDA also backed the use of another rheumatoid arthritis treatment, Eli Lilly’s Olumiant, in combination with Gilead’s antiviral Veklury for patients requiring oxygen.
Similarly in the UK, the use of Actemra and Kevzara for severely ill COVID-19 patients was given the green light in January.
Despite the recent authorizations and recommendations, many doctors had already been using these drugs as a last resort for severely ill COVID-19 patients, according to Fierce Pharma.
The rheumatoid arthritis drugs don’t come cheap and are profitable business for Roche and Sanofi. A 20 mg dose of Actemra costs $491 while a 150 mg dose of Kevzara is $700.
Actemra sales reached $3.12 billion last year, a 32 percent increase from 2019 due to COVID-19. Similarly, Sanofi reported a 30 percent jump in sales for Kevzara.
The WHO expressed concern over the price of the drugs as they are currently unaffordable and inaccessible in many parts of the world.
“These drugs offer hope,” WHO director general Tedros Adhanom Ghenbreyesus said in a statement from the global health agency. “But IL-6 receptor blockers remain inaccessible and unaffordable for the majority of the world.”
To increase access and affordability of the life-saving COVID-19 treatment, the WHO called on manufacturers “to reduce prices and make supplies available to low- and middle-income countries, especially where COVID-19 is surging.”
“The inequitable distribution of vaccines means that people in low- and middle-income countries are most susceptible to severe forms of COVID-19,” Ghenbreyesus said. “The greatest need for these drugs is in countries that currently have the least access. We must urgently change this.”
The global aid group Doctors Without Borders has also echoed the WHO’s call to lower prices.
The WHO has also launched an expression of interest for prequalification of manufacturers of IL-6 receptor blockers. The goal of prequalification of innovator and biosimilar products is to expand availability and increase access of products through market competition, and lower prices to meet urgent public health needs, says the WHO.