The results of a French study found favorable outcomes for COVID-19 patients with moderate to severe pneumonia treated with tocilizumab, a drug commonly prescribed to treat arthritis, according to reports.
The French CORIMUNO-TOCI trial was conducted by the public assistance-hospitals of Paris (AP-HP). The results have yet to be published, but the outcomes were reported in a press release and by various news outlets. It included patients who were hospitalized with COVID-19 moderate to severe pneumonia in intensive care or at high risk of requiring intensive care but did not need resuscitation upon admission. The study included 129 patients who were randomized to either usual treatment plus tocilizumab (n=65) or usual treatment alone (n=64). The main outcome measure was the need for ventilation or death at 14 days—for which tocilizumab significantly reduced the risk.
The unpublished study will reportedly be submitted for journal publication. According to a press release, the researchers stated that the results must be peer-reviewed and confirmed in further trials, but given the emergent need created by the pandemic, they felt it was important to communicate the results.
Tocilizumab, Sarilumab: Too Soon to Tell?
CORIMUNO is exploring other medicines in COVID-19 patients, too, including sarilumab. Although both are anti-IL-6 drugs, tocilizumab is administered intravenously, while sarilumab is administered subcutaneously.
The results of a phase 2 trial studying sarilumab in COVID-19 patients found the drug was not beneficial for patients hospitalized but not on ventilators, according to results from Regeneron and Sanofi, who manufacture the drug.
The trial of sarilumab, manufactured and sold under the brand name Kevzara, was modeled off of a 21-person study in China of tocilizumab, which optimistically concluded that patient’s symptoms—including fever—were significantly reduced and they were able to be discharged from the hospital. With these promising outcomes in mind, “Regeneron and Sanofi moved rapidly to evaluate Kevzara in a prospective, randomized, placebo-controlled adaptively-designed U.S. Phase 2/3 trial,” according to a press release from the companies.
“Even in a pandemic setting, it’s both crucial and possible to obtain controlled data in adequately-sized trials to provide the evidence needed to inform optimal medical care,” said George D. Yancopoulos, MD, PhD, co-founder, president, and chief scientific officer of Regeneron, in the release. “Emerging evidence with Kevzara and other repurposed drugs in the COVID-19 crisis highlight the challenges of making decisions about existing medicines for new viral threats using small, uncontrolled studies. We await results of the ongoing Phase 3 trial to learn more about COVID-19, and better understand whether some patients may benefit from Kevzara treatment. In addition, there is an acute need for tailored approaches that specifically target this virus. To that end, Regeneron is rapidly advancing our targeted anti-SARS-CoV-2 antibody cocktail and we plan to initiate clinical trials in June.”
The New York Times reported that Dr. Yancopoulos “was not optimistic” about the trial because the drugs in questioned were made to treat arthritis, not COVID-19.
“Repurposing existing drugs has not had a history of success in the pharmaceutical industry,” he reportedly said.