Standard univariate statistical tests were performed to compare baricitinib-treated patients to age- and sex-matched controls. These consisted of the Mann-Whitney U test for pairwise comparisons, the Wilcoxon test for paired data, and Fisher’s exact test for categorical variables. Kaplan-Meier product-limit estimation and the log-rank test were used to perform a survival analysis between groups. A dose of 4 mg daily of baricitinib was given for 14 days. SpO2, peripheral capillary oxygen saturation; SBP, systolic blood pressure; DBP, diastolic blood pressure; WBC, white blood cells; MEWS, modified early warning score; CVD, cardiovascular disease; NA, not applicable; IQR, interquartile range; ICU, intensive care unit.
| Features at baseline (all patients received hydroxychloroquine and lopinavir/ritonavir) | Baricitinib group | Control group* | P value |
| Patient number, N (%) | 23 (100) | 18 (100) | |
| Male/female, N (%) | 20/3 (87/13) | 14/4 (78/22) | 0.679 |
| Age years, median (IQR) | 62.5 (57.75–72.25) | 64.1 (55.7–70.1) | 0.776 |
| Days interval from symptoms onset and therapy starting | 6 (4–6.25) | 5.5 (4–5.25) | 0.924 |
| Cough, N (%) | 17 (73.9) | 15 (83.3) | 0.709 |
| Dyspnea, N (%) | 20 (86.9) | 14 (77.8) | 0.679 |
| Sputum production, N (%) | 7(30.4) | 9 (50) | 0.334 |
| Headache, N (%) | 8 (34.8) | 7 (38.9) | 0.757 |
| Diarrhea, N (%) | 5 (21.7) | 5 (27.8) | 0.524 |
| Ageusia/anosmia, N (%) | 9 (39.1) | 8 (44.4) | 0.860 |
| Hypertension, N (%) | 5 (21.7) | 6 (33.3) | 0.489 |
| Diabetes, N (%) | 6 (26) | 4 (22.2) | 1.000 |
| COPD, N (%) | 5 (21.7) | 4 (22.2) | 1.000 |
| CVD, N (%) | 4 (17.4) | 2 /11.1) | 0.679 |
| Malignancy, N (%) | 1 (4.3) | 1 (5.5) | 1.000 |
| Fever (°C) | 38 (37.5–38.6) | 37.9 (37.6–38.9) | 0.912 |
| Respiratory rate (N/min) | 18 (16.5–23.2) | 21 (18–24) | 0.524 |
| SpO2 (%) | 94 (90–95.5) | 92 (91–93) | 0.357 |
| PaO2/FiO2, median (IQR) | 293 (199–296) | 271.4 (264–283) | 0.356 |
| Pulse rate, median (IQR) | 84 (72.3–89.1) | 88 (86–94.5) | 0.129 |
| SBP mm/Hg, median (IQR) | 110 (100–130) | 105 (98–115.6) | 0.789 |
| DBP mm/Hg, median (IQR) | 70 (60–84) | 65.5 (60–68.5) | 0.589 |
| WBC (×109/liter), median (IQR) | 7.6 (5.7–10.4) | 7.9 (7.1–8.6) | 0.757 |
| Neutrophils (×109/liter), median (IQR) | 6,3 (4.2–7.8) | 7.1 (6.4–8.1) | 0.224 |
| Lymphocytes (×109/liter), median (IQR) | 0.6 (0.5–1.1) | 0.72 (0.6–0.8) | 0.524 |
| Hemoglobin (g/liter), median (IQR) | 116 (102–133.2) | 127 (108–136) | 0.565 |
| Platelets (×109/liter), median (IQR) | 207 (174–232) | 368 (340–415) | 0.002 |
| ALT (IU/liter), median (IQR)† | 27.6 (22.7–53.1) | 44 (36–50) | 0.176 |
| AST (IU/liter), median (IQR) | 31 (25.2–47.3) | 44 (34.7–48) | 0.235 |
| ALT (IU/liter) > upper normal limit N (%) | 8 (34.7) | 9 (50) | 0.358 |
| ALT (IU/liter) > upper normal limit, median (IQR) | 50 (45.5–62.7) | 55 (45–68) | 0.707 |
| AST (IU/liter) > upper normal limit N/% | 10 | 11 | 0.350 |
| AST (IU/liter) > upper normal limit, median (IQR) | 51.5 (44.5–76.5) | 67 (55–80) | 0.302 |
| Creatinine (mg/dl), median (IQR) | 1.0 (0.9–1.3) | 1.1 (0.9–1.2) | 0.789 |
| CRP (mg/dl), median (IQR) | 9.12 (5.9–16.5) | 4.3 (1.5–5.2) | 0.001 |
| Procalcitonin (ng/ml), median (IQR) | 0.5 (0.3–1.0) | 1.1 (0.8–2.2) | 0.589 |
| IL-6 (pg/ml)‡, median (IQR) | 29.2 (7.1–39.4) | 24.2 (5.2–27.6) | 0.189 |
| MEWS, median (IQR) | 2 (1–3.1) | 3 (3–4) | 0.544 |
| Results at 2 weeks after therapy | |||
| ICU admission N (%) | 0 | 5 (33) | 0.011 |
| Discharged, N (%) | 18 (78.2) | 1 (5.5) | <0.0001 |
| SpO2, median (IQR) | 97 (94.8–98.1) | 92.4 (85.5–93.2) | <0.0001 |
| PaO2/FiO2 value, median (IQR) | 428.7 (306.1–457) | 277.8 (144–345) | 0.002 |
| Lymphocytes (×109/liter), median (IQR) | 1.3 (1.2–1.9) | 0.8 (0.6–0.9) | 0.019 |
| CRP (mg/dl), median (IQR) | 0.87 (0.58–2.9) | 5.2 (2.1–12.3) | <0.0001 |
| IL-6 (pg/ml)‡, median (IQR) | 6.1 (3.2–7.4) | NA | NA |
| ALT (IU/liter), median (IQR) | 37 (24.1–57.4 | NA | NA |
| AST (IU/liter), median (IQR) | 55.4 (28–64.3) | NA | NA |
*Standard therapy group: Patients with COVID-19 under standard respiratory therapy commenced antiretrovirals (Kaletra) and hydroxychloroquine before starting the therapy with baricitinib.
†Normal ALT and AST values: 10 to 40 IU/liter.
‡IL-6 normal value: <7 pg/ml.