Sarilumab may be associated with faster recovery in patients with severe coronavirus disease 19 (COVID-19) characterized by systemic hyperinflammation, according to study results published in Annals of the Rheumatic Diseases.
Early evidence suggests that hyperinflammation in COVID-19 may drive the development of severe disease and respiratory failure. Therefore, in this study, researchers aimed to evaluate whether the interleukin (IL)-6 antagonist sarilumab can safely and effectively be used to treat patients with severe COVID-19 and systemic hyperinflammation.
The study was performed at San Raffaele Hospital in Milan, Italy, where a total of 28 patients received an intravenous infusion of 400 mg of sarilumab in addition to standard care; 28 matched participants received standard care only. Outcomes of interest were overall survival and clinical improvement, including changes in oxygen-support requirements, hospital discharge, mechanical ventilation-free survival, and death.
The survival rate among patients who received sarilumab (93%) was numerically higher than that among patients who received standard care only (82%), but this difference was not statistically significant (P =.21). However, the median time to death was significantly longer in the sarilumab group (19 days) than in the standard care group (4 days; P =.006). There was no significant difference in the median time to clinical improvement, median length from hospitalization to discharge, and mechanical ventilation-free survival at 28 days between the groups.
At 28 days, C-reactive protein (CRP) levels were normalized in 86% of patients who received sarilumab compared with 61% of patients who received standard care only, but this difference was nonsignificant. All patients in both groups achieved fever resolution (P =.99). Time to CRP normalization and fever resolution were significantly lower in the sarilumab group vs standard care group (6 vs 12 days; P <.0001 and 1 vs 4 days; P <.0001, respectively).
Infections represented the most frequently occurring adverse events in both groups. Neutropenia and an increase in liver enzymes occurred exclusively in the sarilumab group. There was no significant difference in the rate of infections or any other adverse events between groups.
In patients who received sarilumab vs standard care only, a baseline PaO2/FiO2 ratio >100mm Hg was associated with a shorter median time to clinical improvement (7 days) compared with a baseline ratio ≤100 mg Hg (28 days; hazard ratio, 0.18; 95% CI, 0.02-0.26; P =.0001). Lung consolidation of <17% at computed tomography (CT) scan was also predictive of clinical improvement with 100% sensitivity and 75% specificity (P =.006).
Investigators noted that the nonrandomized nature of the study and the small sample size represented limitations of the study.
“Sarilumab was associated with faster recovery in a subset of patients showing minor lung consolidation at baseline,” the researchers concluded. “This study indicates that sarilumab is safe and effective in a specific subset of patients with severe hyperinflamed COVID-19 presenting with low percentage of lung consolidation on CT scan.”
Della-Torre E, Campochiaro C, Cavalli G, et al. Interleukin-6 blockade with sarilumab in severe COVID-19 pneumonia with systemic hyperinflammation: an open-label cohort study [published online July 3, 2020]. Ann Rheum Dis. doi:10.1136/annrheumdis-2020-218122