Table N° 5. Ruxolitinib in COVID-19: State of the art.
| Cao Y, et al 7 | La Rosee F, et al 17 | Capochiani E, et al 18 | Vannucchi A, et al 19 | Iastrebner M, et al (*) | |
|---|---|---|---|---|---|
| Design | Prospective, single blind, multicenter, randomized, controlled phase II study. | Retrospective, single center study. | Retrospective, multicenter study. | Prospective, observational, compassionate-use, add-on study. | Prospective, single-arm, add-on, multicenter, control open label, no randomized, compared with historical arm study. |
| Patients (n) | Soc (21) vs Ruxo (20) | Ruxo (14) | Ruxo (18) | Ruxo (34) | Soc (51) vs Ruxo (51) |
| Primary endpoint | Time to clinical improvement (time from randomization to an improvement of 2 points) | CIS improvement (day 7) > 25% | Rapid reduction of respiratory impairment degree | Clinical improvement (decrease ≥2 points in an ordinal scale) from first dose of Ruxo up to day 28 | Proportion of patients who become critically ill or required mechanical ventilation |
| Age, years (median, range) | 63 (range 58 - 68) | 66 (range 55 - 81) | 62 (range 28 - 86) | 80 (range 70-85) | 57 (range 28 - 79) |
| Male gender (%) | 58% | 79% | 67% | 53% | 73% |
| Ruxo initial dose | 5 mg BID | 7,5 mg BID | 20 mg BID | 5 mg BID | 5 mg BID |
| Dose adjustment | No | Yes (maximum 15 mg) | Yes (tapering 10 to 5 mg BID, every 48 h) | Yes, an increase of 10 mg every 48 h (maximum 25 mg) BID | Yes, 5 or 10 mg every 72 h (maximum 20 mg BID) |
| Mortality rate | 0% (Ruxo arm) vs 14,3% (Soc arm) | 7.14% (1/14 cases) | 0% | 5.9% | 0% (Ruxo group) vs 10% (SoC group) |
| Findings and comments | Faster clinical recovery. | COVID-19 Inflammation Score (CIS) | Rapid restoration of PaO2/FiO2 in 2 days (2nd endpoint) | IL6 and CRP at day +14 | Critical ill patients as the most benefited. |
| Decrease of 7 cytokines | Elderly patients with severe comorbidities were the most benefited | Febrile patterns associated to superinfections. | |||
| IgM first recovery | Ruxo sensibly ameliorate the course of the disease | Dose adjustment model. | |||
| Normal virus clearance time | Thrombocytosis, Lymphocytopenia improvement associated with clinical recovery |
(*)
Ruxolitinib in Severe Covid-19. Results of a Multi-Center, Single Arm, Control Open-label Clinical Study to Investigate the Efficacy and Safety of Ruxolitinib in Patients with COVID-19 and Severe Acute Respiratory Syndrome [In press]