Table 2.
Efficacy outcomes in the intention-to-treat population by day 28
| Baricitinib plus standard of care group (n=51) | Placebo plus standard of care group (n=50) | Baricitinib group compared with placebo (95% CI) | p value | ||
|---|---|---|---|---|---|
| All-cause mortality | |||||
| Deaths* | 20 (39%) | 29 (58%) | 0·54 (0·31 to 0·96) | 0·030 | |
| Kaplan-Meier estimates (95% CI) | 40·6% (25·8 to 59·7) | 59·0% (41·1 to 77·7) | .. | .. | |
| Time to mortality, days | NA (24·0 to NA) | 17·0 (11·0 to NA) | .. | .. | |
| Ventilator-free days, days† | 8·1 (10·2) | 5·5 (8·4) | 2·36 (−1·38 to 6·09) | 0·21 | |
| Likelihood of overall improvement on the NIAID-OS‡ | |||||
| Day 4 | .. | .. | 14·37 (1·79 to 115·65) | 0·012 | |
| Day 7 | .. | .. | 2·87 (1·12 to 7·36) | 0·028 | |
| Day 10 | .. | .. | 2·08 (0·96 to 4·49) | 0·062 | |
| Day 14 | .. | .. | 1·97 (0·95 to 4·09) | 0·068 | |
| Day 21 | .. | .. | 2·16 (1·04 to 4·49) | 0·040 | |
| Day 28 | .. | .. | 1·82 (0·87 to 3·81) | 0·11 | |
| ≥1-point improvement on NIAID-OS or live discharge from hospital‡ | |||||
| Day 4 | 6 (12%) | 1 (2%) | 6·89 (0·79 to 60·38) | 0·082 | |
| Day 7 | 8 (16%) | 5 (10%) | 1·85 (0·55 to 6·23) | 0·32 | |
| Day 10 | 13 (26%) | 8 (16%) | 1·80 (0·67 to 4·86) | 0·24 | |
| Day 14 | 16 (31%) | 13 (26%) | 1·27 (0·53 to 3·04) | 0·59 | |
| Day 21 | 19 (37%) | 15 (30%) | 1·29 (0·55 to 3·00) | 0·56 | |
| Day 28 | 23 (45%) | 15 (30%) | 1·80 (0·78 to 4·14) | 0·17 | |
| Duration of hospitalisation, days† | 23·7 (7·1) | 26·1 (3·9) | −2·30 (−4·59 to 0·00) | 0·050 | |
| Recovery§¶ | |||||
| Participants recovered | 19 (37%) | 13 (26%) | 1·57 (0·77 to 3·19) | 0·16 | |
| Kaplan-Meier estimates (95% CI) | 38·7% (18·8 to 52·6) | 27·0% (15·0 to 45·5) | .. | .. | |
| Time to recovery, days | NA (28·0 to NA) | NA (NA to NA) | .. | .. | |
Data are n (%), mean (SD), or median (95% CI) unless otherwise stated. Data were assessed from days 1 to 28, unless otherwise indicated. For dichotomous endpoints, a logistic regression model was used. For ordinal efficacy endpoints, a proportional odds model was used. For continuous endpoints, an analysis of variance was used. All of these analyses had age, geographical region, and treatment group in the model. For time-to-event endpoints, the p value was calculated using an unstratified log-rank test. Hazard ratios were calculated using a Cox proportional hazards model. p values are for comparisons of between the baricitinib group and the placebo group. All endpoints are exploratory due to the nature of the study. NA=not available. NIAID-OS=National Institute of Allergy and Infectious Disease ordinal scale.
Comparison is hazard ratio.
Comparisons are least square mean difference.
Comparisons are odds ratio.
Recovery was defined as clinical status of 1, 2, or 3 in the 8-point NIAID-OS (ie, not hospitalised or no longer requiring medical care).
Comparison is rate ratio.