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Background: SARS-CoV-2 virus is a novel coronavirus that causes COVID-19 disease, which in its most severe form produces life-threatening atypical pneumonia and ARDS. Coronaviruses induce dysregulation of the immune system resulting in a cytokine storm syndrome with activation of the macrophage mediated mainly by IL-1 and IL-6. Although there is no specific treatment to date, researchers have explored novel approaches through targeting both IL-6 and IL-1. Anakinra is a recombinant human IL-1 receptor antagonist that prevents IL-1β and IL-1α binding and therefore blocks signal transduction. Its high bioavailability, rapid action, relatively short half-life and good safety profile make it a promising drug.
Objectives: Analyse the experience of administering Anakinra for severe forms of COVID19 in patients hospitalised at a tertiary hospital.
Methods: Retrospective single-center study in which all patients admitted for COVID-19 and treated with Anakinra from April 1st to the end of the 1st wave (July 2020) were included. Medical records were reviewed to collect demographic, clinical and lab test data, using Brescia-COVID respiratory severity scale, SaFi, CRP, Ferritin, LDH and lymphocytes. Variables were assessed at baseline, 72h and 7 days after treatment initiation. Descriptive statistical analysis was performed, including a sub-analysis of patients who received anakinra as the only biological treatment.
Results: 54 patients were included, of which 37 male (68.5%) with a median age of 69.5 years (36-94). Comorbidities were lung disease 14 pts (25.9%), cardiovascular disease 39 pts (72.2%), Diabetes Mellitus 11 pts (20.4%), kidney disease and rheumatic disease each in 6 pts (11.1%), and immunosuppression 13 pts (24.1%). Each patient received a mean of 4.85 doses of anakinra (± 3.96). Other therapies included low-dose steroids (70.3%); high-dose steroids: 1mg/kg (87%), bolus (24%), Tocilizumab (57.4%), Infliximab (24.1%), Lopinavir/Ritonavir (48%), Hydroxychloroquine (94.4%), and Azithromycin (79.6%). Mortality was 22% overall, 75% due to COVID19, 8.3% due to infectious complications and 16.7% due to non-infectious complications. In the group receiving Anakinra as only biological drug, mortality accounted for 17.9% of patients, 75% due to COVID19 and 25% to non-infectious complications. No adverse effects related to anakinra were observed.
| General group (n=54 ) | Group receiving anakinra as only biological drug (n=23 ) | P | |||||
| Baseline | After 72h | After 7d | Baseline | After 72h | After 7d | ||
| Brescia-COVID | 1.65 (0.95 ) | 1.63 (1.13 ) | 1.73 (1.19 ) | 1.09 (0.8 ) | 0.91 (0.88 ) | 1.09 (0.8 ) | |
| Mean(SD ) | Values: | Values: | Values: | Values: | Values: | Values: | NS |
| 0: 11.1% | 0: 16.7% | 0: 7.9 % | 0: 26.1% | 0: 39.1% | 0: 8.7 % | ||
| 1: 31.5% | 1: 27.8% | 1: 52.6% | 1: 47.8% | 1: 34.8% | 1: 82.6% | ||
| 2: 42.6% | 2: 38.9% | 2: 18.4% | 2: 21.7% | 2: 21.7% | 2: 8.7% | ||
| 3: 53.7% | 3: 7.4% | 3: 7.9% | 3:4.34% | 3: 4.34% | 3: 0% | ||
| 4: 3.7% | 4: 9.3% | 4: 13.2% | 4: 0% | 4: 0% | 4: 0% | ||
| SaFi | 222.60 (115.2 ) | 240.51 (117.6 ) | 250.95 (102.6 ) | 306.35 (124.7 ) | 316.04 (129.8 ) | 300.36 (135.4 ) | NS |
| Mean (SD ) | Values: | Values: | Values: | Values: | Values: | Values: | |
| >300: | >300: | >300: | >300: | >300: | >300: | ||
| 25.9% | 24.5 % | 34.2 % | 56,52% | 52.2 % | 45.46 % | ||
| 201-299 | 201-299: | 201-299: | 201-299: | 201-299: | 201-299: | ||
| : 14.8% | 26.4% | 34.2% | 17.39% | 21.7% | 27.27% | ||
| <201: | <201: | <201: | <201: | <201: | <201: | ||
| 59.3% | 49% | 31.6% | 26.1% | 26.1% | 27.27% | ||
|
Lymphocytes, 10^3/microL
| 1.07 (1.5 ) | 5.16 (3.05 ) | 1.15 (2.49 ) | 0.88 (0.56 ) | 1.25 (0.79 ) | 1.15. (2.4 ) | NS |
|
Ferritine,
| 1098.4 (944.8 ) | 1080.23 (873.9 ) | 1069.19 (989.42 ) | 1112.76 (621.80 ) | 903.25 (385.49 ) | 704.14 (261.86 ) | NS |
|
C-reactive protein, mg/L
| 38.78 (37.58 ) | 21.46 (20.17 ) | 7 (6 ) | 50 (6.38 ) | 34.67 (23.3 ) | 19.96 (28.92 ) | NS |
|
LDH, U/L
| 387.64 (163.1 ) | 394.98 (209.32 ) | 374.26 (157.63 ) | 326.38 (111.66 ) | 308 (116.59 ) | 355 (151.96 ) | NS |
| Respiratory improvement* | N/A | 20.37% | 51.85% | N/A | 30.43% | 69.5% | .007 |
| Lab test improvement** | N/A | 51.85% | 77.78% | N/A | 60.87% | 78.2% | NS |
* SaFi normalised or increased 100 mmHg or more
** Improvement of 2 or more analytic variables
Conclusion: Anakinra in severe SARS-CoV-2 infection offers respiratory improvement and partial lab tests improvement. No adverse effects were observed.
Acknowledgements: We wish to acknowledge Puerta de Hierro Majadahonda COVID19 task force and all the patients and staff affected by the pandemic.
Disclosure of Interests: None declared