Bristol Myers Squibb Announces Topline Results Showing Treatment with Orencia (abatacept) Improved Survival in People Hospitalized with COVID-19

The Phase 3 ACTIV-1 Immune Modulators study was sponsored by the National Institutes of Health as part of the ACTIV initiative

Orencia was one of two immune modulators that improved survival for people hospitalized with COVID-19

Safety profile of Orencia remained consistent, with no new safety signals reported

Excerpt from the Press Release:

PRINCETON, N.J.–(BUSINESS WIRE)–Bristol Myers Squibb (NYSE: BMY) 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 Orencia (abatacept) IV (10 mg/kg) versus placebo when given with standard of care to determine if modulating the immune system’s response could speed recovery and reduce death in adults hospitalized with moderate to severe COVID-19.

Treatment with Orencia versus placebo displayed a strong but not statistically significant improvement in the primary endpoint of time to recovery as measured by day of hospital discharge. 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. The relative improvement in mortality was similar in both moderately and severely ill participants. People in the Orencia group had 34.2% better odds of clinical improvement than those in the placebo group. The safety profile of Orencia remained consistent, with no new safety signals reported in the study.

“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,” said Samit Hirawat, MD, chief medical officer, Bristol Myers Squibb.

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