A recent national study led by Washington University School of Medicine in St. Louis has found that two commonly used drugs for inflammatory diseases, such as rheumatoid arthritis and psoriasis, did not shorten recovery time for patients hospitalized with severe COVID-19. However, these drugs did reduce the likelihood of death when compared to standard care alone. The study, published in JAMA, was coordinated by the National Center for Advancing Translational Sciences (NCATS) of the National Institutes of Health (NIH).
The study was part of the Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) initiative, launched by the NIH in April 2020 to expedite the development of effective COVID-19 treatments and vaccines. The clinical trial, called ACTIV-1 Immune Modulator (IM), compared three anti-inflammatory drugs—infliximab, abatacept, and cenicriviroc—added to standard care versus standard care alone in COVID-19 patients hospitalized with the disease. Standard care includes the use of remdesivir, an antiviral drug, and dexamethasone, a corticosteroid. The trial involved 1,971 patients from 95 hospitals in the U.S. and Latin America.
The study aimed to address the dysregulated immune response observed in severe cases of COVID-19, which can lead to pneumonia, respiratory failure, and other severe outcomes. The researchers wanted to determine whether existing anti-inflammatory drugs could dampen the inflammatory process associated with COVID-19.
The results showed that the immune modulators, when used alongside standard care, did not significantly reduce recovery time compared to the non-use of these medications. However, the study demonstrated clinical significance in terms of mortality. Fewer patients died when treated with standard care plus either infliximab or abatacept compared to those who received standard care plus a placebo. Treatment with cenicriviroc was discontinued early due to a lack of benefit.
Abatacept, marketed as Orencia, is used to treat symptoms of rheumatoid arthritis, including joint swelling, pain, and fatigue. Infliximab, sold as Remicade, is used to treat rheumatoid arthritis, chronic severe plaque psoriasis, and other conditions. Both drugs were administered via infusion in the ACTIV-1 trial.
The study reported that for COVID-19 patients treated with abatacept, the mortality rate was 11% (56 out of 509 patients) by day 28, compared to 15.1% (77 out of 510 patients) in the placebo group. This represents 21 fewer deaths among those who received abatacept. In the case of infliximab, the mortality rate was 10.1% (52 out of 517 patients) compared to 14.5% (75 out of 516 patients) in the placebo group. This represents 23 fewer deaths among those who received infliximab.
While the study did not find a significant difference in recovery time, the observed reduction in mortality is considered clinically important. The findings expand the potential treatment options for patients hospitalized with COVID-19. However, it is emphasized that prevention through vaccination remains the best approach to avoid severe COVID-19 cases.