Peer-Reviewed Phase 3 Results of Baricitinib-Remdesivir Combo Published in NEJM

COVID-19 patients treated with Eli Lilly’s rheumatoid arthritis drug Olumiant (baricitinib) in combination with Gilead Sciences’ antiviral Veklury (remdesivir) were less likely to die after 28 days than those receiving remdesivir alone, according to peer-reviewed phase 3 trial results published online Friday in the New England Journal of Medicine.

Eli Lilly said the peer-reviewed data bolster the FDA’s Emergency Use Authorization (EUA) for baricitinib in combination with remdesivir, which the agency granted Nov. 19 for hospitalized COVID-19 patients who require supplemental oxygen (DID, Nov. 23).

The 28-day mortality rate was 5.1 percent in the combination therapy group and 7.8 percent in the control group. Those who got baricitinib also had a 30 percent better chance of improvement in their clinical status after 15 days, were less likely to suffer serious adverse events (16 percent vs. 21 percent), and had fewer new infections (5.9 percent versus 11.2 percent). The study authors also report that patients receiving high-flow oxygen or noninvasive ventilation when they were enrolled had a time to recovery of 10 days with combination treatment and 18 days in the control group.

The study confirms the previously announced news that the combination therapy reduced COVID-19 patient recovery time (until discharged from the hospital or no longer requiring ongoing medical care) by 12.5 percent, or from eight to seven days, vs. remdesivir alone.

But the drug’s use in treating COVID-19 has stirred controversy because the one-day reduction in recovery time comes with serious side effects in some patients, including blood clots (DID, Dec. 8).

The results published in the study come from the Adaptive COVID-19 Treatment Trial (ACTT-2) sponsored by the National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health. The phase 3 study began on May 8 and enrolled 1,033 patients in eight countries, with 515 assigned to combination treatment and 518 to the control group.

Baricitinib was developed by Incyte and licensed to Eli Lilly. — Martin Berman-Gorvine