J&J and BMS Drugs Reduce COVID-19 Deaths in Moderate-to-Severe Population

COVID-19 research

Bristol Myers Squibb’s Orencia (abatacept) and Johnson & Johnson’s Remicade (infliximab) improved survival rates for people hospitalized with COVID-19, according to a new report by the National Institutes of Health (NIH).

The results announced Thursday are part of the NIH’s Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) trial, and more specifically, its Active-1 Immune Modulators clinical trial. This trial was designed to determine if drugs that help minimize overactive immune responses might help treat COVID-19.

The study has three cohorts, one testing Johnson & Johnson’s Remicade; one for Bristol Myers Squibb’s Orencia and a third cohort testing AbbVie’s cenicriviroc that was halted in September 2021 over lack of efficacy. Cenicriviroc is being developed to treat HIV and non-alcoholic steatohepatitis.

The study found that Remicade demonstrated a strong, but not statistically significant, improvement in time to recovery by the day of discharge from the hospital. This was the primary endpoint of the study. There were also substantial improvements in the trial’s key secondary endpoints of mortality and clinical status at 28 days.

Remicade is indicated to treat several inflammatory conditions, including Crohn’s disease, ulcerative colitis, rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis and plaque psoriasis.

Of the 518 participants who received Remicade, there was a death rate of 10.0% compared to 14.5% in the 519 patients receiving a placebo. Statistically, this results in 40.5% lower adjusted odds of dying in those who take Remicade. The relative improvement in mortality was alike in participants who were both moderately and severely ill, with 43.8% better odds of clinical improvement compared to the placebo group. Remicade was developed and marketed by Janssen Biotech, a Johnson & Johnson company.

In the study of BMS’s Orencia, patients receiving the drug demonstrated a strong but not statistically significant improvement in time to recovery as measured by the day of discharge from the hospital. This was the trial’s primary endpoint. There were also substantial improvements for the key secondary endpoints. Of 509 patients receiving Orencia, there was a death rate of 11.0% compared to 15.0% for the 513 participants receiving a placebo. This comes to a 37.4% lower adjusted likelihood of dying. Again, it was about the same in people with either moderate or severe illness. People receiving the drug had 34.2% better odds of clinical improvement than the placebo cohort.

Orencia is used to treat adult rheumatoid arthritis, polyarticular juvenile idiopathic arthritis and adult psoriatic arthritis, and is used as prophylaxis for acute graft versus host disease.

Dr. Samit Hirawat, M.D., BMS’s chief medical officer, stated, “With the continued need across the globe for treatment options to address the threat of COVID-19, we are proud of our involvement in the ACTIV-1 Immune Modulators clinical trial and our scientific research related to the virus. The devastating resurgences associated with circulating and emerging COVID variants underscore the need for additional therapeutic options for those who are hospitalized with COVID-19. We are pleased with the data demonstrating the risk of death was lower for participants who received Orencia and look forward to continued collaboration with the NIH to assess the data and potentially bring this treatment option to those in need.”

The data has not been peer-reviewed for technical publication. BMS has indicated it plans to share the data with the U.S. Food and Drug Administration to discuss the pathway for clinical development.

 "When given in addition to standard of care treatments, like remdesivir and dexamethasone, infliximab and abatacept each offered a substantial reduction in mortality," Dr. William G. Powderly, trial protocol chair, director of the Institute for Clinical and Translational Sciences and co-director of the Division of Infectious Diseases at Washington University School of Medicine said. "These drugs could potentially add to the therapeutic options available for the treatment of patients hospitalized with COVID-19.”

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