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(CNN) – Tocilizumab, a repurposed rheumatoid arthritis drug once considered a promising treatment for hospitalized Covid-19 patients, generally did not increase patients’ chances of survival or help them get better faster, according to three published trials this week.
However, a fourth trial found that the drug increased the chances of survival, but because it was an observational study, the results are considered less definitive.
Three of the trials were published Tuesday in the Journal of the American Medical Association and the other was published Wednesday in the New England Journal of Medicine.
While this leaves the landscape of tocilizumab use a bit confusing, studies taken together show that the drug is not a magic formula that should be used in all hospitalized Covid-19 patients, but leaves the door open for possible use. in a specific patient. groups.
“It is possible that upcoming results from other randomized trials will help us identify specific groups of people who will benefit. However, growing evidence supports current guidelines, which recommend not using tocilizumab outside of clinical trials,” said Dr. Jonathan Parr to CNN.
Parr, an assistant professor in the division of infectious diseases at the University of North Carolina at Chapel Hill, wrote an editorial that was published alongside the three studies in JAMA.
Tocilizumab, sold under the brand name Actemra and used to treat rheumatoid arthritis, blocks interleukin-6, a molecule that causes inflammation.
Early in the pandemic, the drug became widely used in the United States after reports from China and Europe seemed to show that it helped very sick patients who experienced a so-called cytokine storm by extinguishing the out-of-control inflammation that developed in response to coronavirus.
Study results begin to arrive
However, those early reports were mostly observational, meaning they took existing data and analyzed it rather than designing a trial specifically to evaluate tocilizumab.
But now the results of trials designed to look at the drug prospectively are beginning to appear.
The first of three JAMA studies found that hospitalized patients in Italy who were not yet in intensive care and who received tocilizumab did not do better than those who received standard care. The trial was stopped early due to “futility.”
A similar study in France found that tocilizumab may have led to slight improvements on day 14 over usual care, but there was no difference in survival at day 28.
The third study found that the risk of in-hospital death was about 30% lower in US patients who received tocilizumab during the first two days of ICU admission compared to those who did not receive the drug.
But because it was an observational trial, there could be factors that affected the results other than how well the drug itself worked.
“We specifically studied the administration of tocilizumab in very ill patients, all of whom required a level of care in the ICU. Rather, the [other two trials] they studied patients with much milder disease severity, “said Dr. Shruti Gupta of Brigham and Women’s Hospital in Boston, who led the study team.
Dr David Leaf, lead author of the trial, added: “We focus on the early use of tocilizumab, within the first two days of admission to the ICU. This may be the key to the efficacy of tocilizumab, given before the appearance of irreversible organ injury, “he said in an email.
Gupta said his findings need confirmation by a large randomized controlled trial.
The fourth study, published Wednesday in the New England Journal of Medicine, used the gold standard of trial design: It is a randomized, double-blind, placebo-controlled trial.
It enrolled 243 patients from seven Boston-area hospitals who were admitted with Covid-19 at the height of the increase in that region.
“The primary objective of the trial was to determine whether tocilizumab, given intravenously in a moderate stage of disease in patients, could prevent progression to intubation or death,” said Dr. John H. Stone, lead author of the study and director of Clinical Rheumatology. at Massachusetts General Hospital, he told CNN via email.
But the findings were not encouraging for the use of tocilizumab.
“Our data do not support the concept that early IL-6 receptor blockade is an effective treatment strategy in hospitalized moderately ill patients with Covid-19 infection,” Stone said.
The results show that the chances of intubation or death were similar in both groups, and patients in both groups took essentially the same amount of time to suspend supplemental oxygen.
So where does that leave tocilizumab?
“Tocilizumab may still play a role in COVID-19. Several large trials are expected to come out soon that will tell us more about how and when it should be used, if at all,” Parr said, noting that “no. it should be completely removed from the table, but we need more convincing evidence before we use it routinely. “
Stone agreed that the drug may still benefit other groups of patients, but stressed the importance of conducting these trials.
“An important point from our trial and the overall experience with IL-6 receptor blockade is that any such approach to treating COVID-19 must be randomized and blinded,” he said, adding that the trials they should be done “before the adoption of widespread use”.
This story was first published on CNN.com, “Rheumatoid arthritis drug falls short as treatment for hospitalized Covid-19 patients in three studies.”
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