Anakinra not effective in patients with severe Covid infection: JAMA

Anakinra combined with standard of care (SoC) did not eliminate the requirement for mechanical ventilation in hospitalized patients with severe COVID-19 pneumonia and hyperinflammation or lower mortality risk when compared to SoC alone, says an article published in the Journal of American Medical Association.

Hyperinflammation is frequently linked with COVID-19 pneumonia. Anakinra has not yet been proven to be safe and effective in treating individuals with severe COVID-19 pneumonia and hyperinflammation. In order to compare anakinra to standard of therapy on its own for patients with severe COVID-19 pneumonia and hyperinflammation, Patricia Fanlo and colleagues undertook this study.

Phase 2/3 multicenter, randomized, open-label, 2-group clinical study with a 1-month follow-up was undertaken at 12 hospitals in Spain between May 8, 2020, and March 1, 2021 under the name "Clinical Trial of the Usage of Anakinra in Cytokine Storm Syndrome Due to COVID-19" (ANA-COVID-GEAS). Patients in the adult population who had significant COVID-19 pneumonia and inflammation participated. Interleukin-6 larger than 40 pg/mL, ferritin greater than 500 ng/mL, C-reactive protein greater than 3 mg/dL (rationale, 5 upper normal limit), and/or lactate dehydrogenase greater than 300 U/L were all considered indicators of hyperinflammation. The proportion of patients who did not need mechanical breathing up to 15 days after therapy started, as determined on an intention-to-treat basis, was the main outcome.

The key findings of this study were:

1. 179 patients in total were randomly allocated to the SoC group (87 patients) or the anakinra group (92 patients).

2. The percentage of patients who did not require mechanical breathing by day 15 did not differ substantially across groups.

3. Anakinra had no impact on the duration of mechanical ventilation.

4. Up to day 15, there was no discernible difference between the groups in the percentage of patients who did not require invasive mechanical breathing.

In conclusion, anakinra may play a function as an early therapy for individuals with less severe illness and inflammation, despite the fact that the primary and important secondary endpoints were not fulfilled.

Reference:

Fanlo, P., Gracia-Tello, B. del C., Fonseca Aizpuru, E., Álvarez-Troncoso, J., Gonzalez, A., Prieto-González, S., Freire, M., Argibay, A. B., Pallarés, L., Todolí, J. A., Pérez, M., Buján-Rivas, S., Sanchez, J., Zabalza, E., Garcia-Rey, R., … Gonzalo, M. (2023). Efficacy and Safety of Anakinra Plus Standard of Care for Patients With Severe COVID-19. In JAMA Network Open (Vol. 6, Issue 4, p. e237243). American Medical Association (AMA). https://doi.org/10.1001/jamanetworkopen.2023.7243