- The World Health Organization (WHO) continually updates a “living guideline” on drug treatments for COVID-19.
- The latest update strongly recommends an arthritis drug called baricitinib for patients with severe or critical disease.
- The recommendation follows a review by an expert panel of the latest evidence from clinical trials.
- The update also recommends the monoclonal antibody sotrovimab for individuals who do not have severe COVID-19 but are at high risk of hospitalization.
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The drug belongs to a class of medications known as Janus kinase (JAK) inhibitors, which block the activity of immune signaling molecules called cytokines.
After reviewing the latest results from clinical trials, a panel of experts at the WHO concluded that there is good evidence that baricitinib improves survival, reduces the need for mechanical ventilation, and decreases duration of hospitalization.
The drug does not appear to cause any increase in adverse events.
The panel recommends a treatment combination of baricitinib and corticosteroids, which also calm the immune response.
However, the panel advises against combining baricitinib with arthritis drugs called interleukin-6 inhibitors, which have a similar effect on the immune system.
Instead, it recommends that doctors choose either baricitinib or an interleukin-6 inhibitor on the basis of cost, availability, and their clinical experience.
Athimalaipet Ramanan, professor of pediatric rheumatology at the University of Bristol in the United Kingdom, welcomed the new guidance.
“The strong recommendation from WHO comes at much needed time, as many low and middle income countries continue to struggle with the pandemic,” he told the Science Media Centre in London.
“The short half-life, oral administration, and lower cost make this more attractive across the world, compared to tocilizumab, the other agent shown to be effective in a similar setting,” he added.
The panel advises against the use of two other JAK inhibitors ruxolitinib and tofacitinib for people with severe or critical COVID-19. Small clinical trials found no evidence of benefit from the drugs and suggest a possible increase in serious side effects with tofacitinib.
The panel’s recommendations are based on three randomized controlled trials (RCTs) of baricitinib with a total of 2,659 participants, two RCTs of ruxolitinib with 475 participants, and one RCT of tofacitinib with 289 participants.
RCTs are the gold standard for evidence of the safety and efficacy of treatments.
The panel made a “conditional” recommendation for the monoclonal antibody sotrovimab to treat people who do not have severe COVID-19 but are at high risk of hospitalization.
Possible reasons for high risk that the guidance mentions include:
- lack of vaccination
- older age
- weakened immunity
- preexisting chronic conditions, such as diabetes
The panel based its recommendation regarding sotrovimab on one RCT involving 1,057 participants.
The trial found a substantial reduction in hospitalization among individuals at high risk, but “trivial” benefits among people at lower risk.
However, the trial finished before the Omicron variant emerged.
The panel reports that laboratory experiments suggest that sotrovimab can neutralize the new variant but that higher concentrations are required than with the previous variants.
The living guideline already contained a conditional recommendation for using a combination of two other monoclonal antibodies, casirivimab and imdevimab.
New evidence from laboratory-based tests suggests, however, that casirivimab-imdevimab may not neutralize Omicron.
The authors conclude:
“More data are required to ascertain whether efficacy against the Omicron variant will be maintained at the studied doses of monoclonal antibodies, and these living guidelines will be updated when additional data becomes available.”
The number of people who qualify for treatment with monoclonal antibodies under the WHO guidelines is likely to remain very low.
“The WHO is unlikely to ever provide a strong recommendation for a monoclonal antibody,” said Dr. Gordon Guyatt, distinguished professor of health research methods, evidence, and impact at McMaster University in Hamilton, Canada, and one of the authors of the guidelines.
“The reason is that almost all vaccinated patients with initial COVID-19 symptoms, particularly now with Omicron, are at extremely low risk of any serious consequences, including hospitalization, [and] at an infinitesimal risk of dying from COVID-19,” he explained to Medical News Today.
This means that they are not good candidates for treatment with any monoclonal antibody, he stated.
“Thus, the recommendation for these agents will almost certainly always be conditional on baseline risk: they should be reserved for higher risk groups among those with early symptoms,” he added.
In keeping with earlier versions, the latest update of the living guideline recommends against the use of convalescent plasma, ivermectin, and hydroxychloroquine in people with COVID-19, regardless of disease severity.
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