Experience of the use of baricitinib in COVID-19 pneumonia

ABSTRACT

Background and importance Baricitinib is an immunosuppressive agent included as one of the therapeutic options for COVID-19 in the Spanish protocol Agencia Española del Medicamento y Productos Sanitarios. Aim and objectives The objective was to assess the effectiveness of this drug in hospitalised but non-critically ill patients. Material and methods An observational retrospective study was conducted in a third level hospital from 26 March to 5 May. Inclusion criteria were hospitalised patients diagnosed with COVID-19 pneumonia and treated with baricitinib. Data collected were age, gender, comorbidities, severe pneumonia diagnosis, ferritin and interleukin 6 (IL-6) prior to the beginning of treatment with baricitinib, standard of care according to the hospital's protocol, concomitant treatment with anakinra, duration of treatment with baricitinib, average hospital stay (AHS), deaths and hospital discharges. The data were collected from the electronic medical records and the hospital's management department. Results 171 patients treated with baricitinib were included, with an average age of 69.5 (34-96) years. 71.3% (122) were men. 87.1% (149) had comorbidities and 73.1% (125) were diagnosed with a severe pneumonia, with 25% of them dying (31). Median duration of treatment with baricitinib was 5 days (1- 12). AHS for the baricitinib group was 14.60 (3-47) days, and AHS for the whole sample of patients diagnosed with COVID- 19 pneumonia was 17.2 days. 23.4% (40) of patients had high levels of ferritin (>2500 UI/L). Among them, 87.5% (35) were discharged and 12.5% (5) died. IL-6 levels were high (>40 U/ L) in 29.8% (51) of patients, <40 U/L in 37.4% (64) and not measured in 32.7% (56). In the group with high IL-6 levels, 70.6% (36) were discharged and 29.4% (15) died. Among those with normal levels of IL-6, 93.8% (60) were discharged and 6.3% (4) died. 84.2% (144) of baricitinib patients were also treated with the SoC. During the hospital stay, 31.0% (53) of patients were treated with anakinra and baricitinib, 83.0% (44) were discharged and 17.0% (9) died. Global mortality of the whole sample of patients diagnosed with COVID-19 pneumonia was 18.1% (31). Conclusion and relevance AHS for baricitinib patients was shorter than for the whole sample of COVID-19 patients. The percentage of patients with high levels of IL-6 was superior to that of patients with high ferritin, with mortality greater in patients with IL-6 >40 UI/L. Hence IL-6 level appears to be a better prognostic factor of mortality than ferritin. This could also be related to a greater patient's immune response. Regarding treatment effectiveness, mortality of patients who were treated with SoC plus baricitinib was similar to that of patients treated with anakinra plus baricitinib.