Immune Modulators Improved Survival for COVID-19 Hospitalized Patients
New Jersey-based Bristol Myers Squibb today announced topline results from the Phase 3 Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV-1) Immune Modulators clinical trial, sponsored by the National Institutes of Health (NIH).
The study evaluated the safety and efficacy of a single dose of immune modulators, including the U.S. FDA-approved Orencia (abatacept) IV (10 mg/kg) versus placebo when given with standard of care.
Treatment with Orencia versus placebo displayed a strong but not statistically significant improvement in the primary endpoint of time to recovery as measured by the day of hospital discharge.
However, analyses of the secondary endpoints, which included mortality and clinical status, demonstrated Orencia reduced participants’ risk of death and improved their clinical status at 28 days after entering the study when compared with placebo.
The risk of death was lower for participants who received Orencia at 11%, versus 15% for those who received placebo, and the odds of dying were 37.4% lower.
People in the Orencia group had 34.2% better odds of clinical improvement than those in the placebo group.
Samit Hirawat, MD, chief medical officer, Bristol Myers Squibb, commented in a press release issued on June 2, 2022, “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.”
Given the positive findings from the topline data, Bristol Myers Squibb plans to discuss these data and potential next steps with the U.S. FDA, stated the company.
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