Objectives
To analyse the effectiveness and safety of baricitinib for severe COVID-19 in cytokine storm syndrome based on its potential role as an anti-inflammatory immunomodulator and inhibitor of viral endocytosis.
Methods
This was an observational retrospective study of hospitalised patients treated with baricitinib for severe COVID-19. Outcomes were clinical improvement on an ordinal scale of 1–8 on day 1 of baricitinib compared with day 14 (where 8=death and 1=not hospitalised with no limitations of activities), overall survival, time to recovery since baricitinib treatment started (days until hospital discharge) and laboratory parameters related to COVID-19 poor prognosis. Adverse events related to baricitinib during the admission period were also reported.
Results
Forty-three patients (70% men, mean age 70 years (IQR 54–79)) treated with baricitinib daily for 6 days (IQR 5–7) were included. Thirty-six patients were treated with corticosteroids (84%). Clinical improvement was 3 points (IQR 1–4) in patients on an ordinal scale of 4–6, overall survival was 100% at day 30 and day 60 with a mean time to recovery of 12 days (IQR 9–25) from start of baricitinib treatment. No adverse events of interest were found and all poor prognosis risk factors improved at day 14: interleukin-6, C-reactive protein, ferritin, lymphocytes, platelets and D-dimers.
Conclusions
Patients treated with baricitinib for severe COVID-19 showed improvements in clinical and analytical values without relevant adverse events and 100% overall survival. Clinical randomised trials are needed to confirm the clinical benefit of baricitinib.
The estimated annual cost was calculated based on the dosage of omalizumab and compared with the estimated annual cost applying the protocol, which indicated that for treatment of IgE mediated SA and eosinophilia >300 cells/mL, the drug used would be selected according to efficiency criteria. The variables collected were weight, dosage and level of IgE and eosinophils at the start of treatment. The SAP application was used for data extraction. Costs were calculated from the sales price of the laboratory (PVL) applying the Spanish Royal Decree discount (À7.5%) and the discount offered to the hospital. Results A total of 65 patients were analysed, 71% (46) of whom met the criteria for IgE mediated SA and eosinophilia >300 cells/mL. Median patient weight was 74.5 kg (45-120), median IgE was 219.5 IU/mL (46-1500) and median eosinophils were 630 cells/mL (310-1783). The estimated annual cost according to the dosage for omalizumab was 582 541.95C ¼ while the cost applying the treatment protocol by efficiency criteria was 384 945.81C ¼ , an annual saving of 197 596.14C ¼. Conclusion and relevance Multidisciplinary protocols allow strengthening of partnerships between hospital departments, improve best health outcomes and maintain economic sustainability.
difference can be explained by the already high level. This study highlights the positive impact of MC on patient knowledge of their SC bDMARDs, as well as patient satisfaction.
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