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Combination Therapy of High-dose Intravenous Anakinra and Baricitinib in Patients with Critical COVID-19: Promising Results from Retrospective Observational Study
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  • Murat Bektas,
  • Mustafa Ay,
  • Muhammed Hamdi Uyar,
  • Muhammed İkbal Kılıç
Murat Bektas
Aksaray Universitesi Tip Fakultesi

Corresponding Author:murat.b88@hotmail.com

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Mustafa Ay
Aksaray Universitesi Tip Fakultesi
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Muhammed Hamdi Uyar
Aksaray Universitesi Tip Fakultesi
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Muhammed İkbal Kılıç
Aksaray Universitesi Dahili Tip Bilimleri Bolumu
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Abstract

Background: The leading cause in COVID-19 patients is development of cytokine storm .    Material and Methods: This study was conducted in a tertiary center with diagnosis of COVID-19 patients. Clinical and laboratory features of patients were obtained from their medical cards and hospital software system and evaluated by retrospectively.                    Statistical analysis: In our study, 21.0 version (IBM, Armonk, NY, USA) of the SPSS (Statistical Package for the Social Sciences) program was used for statistical analysis of data. Descriptive statistics, discrete and continuous numerical variables were expressed as mean, ± standard deviation or median and interquartile range (IQR). Categorical variables were expressed as number of cases and (%). Cross table statistics were used to compare categorical variables (Chi-Square, Fisher exact test). Normally distributed parametric data were compared with Student’s t-test and Paired t-test; non-parametric data that did not meet normal distribution were compared with Mann Whitney U and Kruskal Wallis tests. Multiple intergroup comparisons were made by Post Hoc Tukey analysis. Kaplan-Meier and log-rank methods were used for survival analysis. Multivariable analysis was performed by using logistic regression. Correlation analysis was performed with Pearson or Spearman method according to normality distribution.  p<0.05 value was considered statistically significant.   Results: Data of 15 patients in combination group and 43 patients in control group were evaluated and included into the study. Of these patients 73.3% was male in combination arm and 72.1% in control group (p=0.9). Demographic findings and frequency of comorbidities were similar between two groups (table 1). Overall mortality was 46.7% (n=7) in combination arm and 69.8% (n=30) in control group although it was not statistically significant (p=0.1). Similarly, need of intubation was also lower in combination arm (46.7%) compared to control group (69.8%), it was not significantly different (p=0.1). ICU admission was significantly lower in combination (46.7%, n=7) arm than control group (76.7%, n=33) (p=0.03, Odds ratio [OR]:4.7). Development of severe infection (20%, n=3 vs 25%, n=9/36), pulmonary embolism (6.7%, n=1 vs 0), myocardial infarction (6.7%, n=1 vs 2.6%, n=1/38) and pneumothorax (13.3%, n=2 vs 2.6%, n=1/38) were not different between two groups (p=0.7, p=0.3, p=0.5 and p=0.2). In multivariable analysis only cHIS score was associated with high mortality (p=0.018, OR:2.8, [95% confidence interval: 1.2-6.6]). In survival analysis, mortality rate was significantly lower in combination arm than control group (Log-Rank:p=0.04;figure 1). In conclusion, combination therapy of high-dose anakinra and baricitinib may be an adequate treatment option in patients with COVID-19 who had critical disease and no additional safety signal.