A study presented at IDWeek 2023 showed significantly more patients in the treatment group were alive and oxygen-free by day 29 and day 60 compared to those in the placebo group.
Data presented at IDWeek 2023 demonstrates the utility of added fostamatinib to standard of care for reducing mortality and morbidity among people hospitalized with COVID-19 who require oxygen supplementation.1
The oral therapy is a potent and selective inhibitor of spleen tyrosine kinase (SYK)—a pathway involved in the host immune response to severe COVID-19. SYK is currently approved in the US, as well as Canada, Japan, and Europe for the treatment of chronic immune thrombocytopenia.
In order to better understand the potential benefit of adding fostamatinib to standard of care in this population, Deepa B. Gotur, MD, of Weill Cornell Medical College and Houston Methodist Hospital, in Texas, and colleagues conducted a phase 3, double-blind, randomized, placebo-controlled clinical trial in 280 adults hospitalized with severe COVID-19 who required supplemental oxygen.
Participants were randomly assigned 1:1 to receive fostamatinib 150 mg twice daily plus standard of care or placebo plus standard of care for 14 days, with the primary end point being days on oxygen. Ultimately, 141 participants were assigned to receive the intervention and 139 received placebo.
Overall, results showed that those treated with fostamatinib (4.8 days) had lower mean days on oxygen compared with those who received placebo (7.6 days), meeting the primary end point (P =.01). Additionally, treatment with fostamatinib showed significant improvement or trends toward significance in several secondary outcome measures, including change from baseline in clinical status based on 8-point ordinal scale (P =.0092). Notably, 6 patients (3 in each cohort) who had a baseline ordinal score of 6 saw significant differences in mortality, with all 3 patients in the treatment group surviving compared with all 3 patients in the control group dying by Day 30. Similarly, significantly more patients in the treatment group were alive and oxygen-free by day 29 and day 60 compared to those in the placebo group (P =.02 and P =0.02, respectively.) A greater proportion of patients in the treatment group were also discharged from the hospital by day 15 compared with placebo (P =.002).
Previous studies have also demonstrated the benefits of additional therapies for reducing mortality in patients hospitalized with COVID-19. Research presented earlier this year at the 30th Conference on Retroviruses and Opportunistic Infections (CROI 2023) showed that treatment with remdesivir, the broad-spectrum antiviral that received emergency use authorization during the height of the COVID-19 pandemic, reduced mortality regardless of oxygen status, with data showing it was associated with less time to recovery, less time hospitalized, and help preventing infection resurgence. This was also apparent in immunocompromised patients, according to study author Mark Thrun, MD. In an interview with Contagion at the time, Thrun said, "It was nice to see that this antiviral, when given appropriately early, truly made a benefit for patients,” adding that “it was pleasant to know that we’re making an impact not just on patients, but also on health care resource utilization.”