Table 1.
Patient characteristics and clinical outcomes following infliximab-abda
| TMC-OFF | TMC-001 | TMC-002 | TMC-003 | TMC-004 | TMC-005 | TMC-006 | TMC-007 | TMC-008 | TMC-009 | TMC-010 | TMC-011 | TMC-012 | TMC-013 | TMC-014 | TMC-015 | TMC-016 | TMC-017 | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age (range, years) | >60 | >60 | 21–40 | >60 | 41–60 | >60 | 41–60 | >60 | 41–60 | >60 | >60 | 41–60 | >60 | >60 | 41–60 | 41–60 | >60 | 41–60 |
| Sex | Female | Male | Male | Male | Male | Male | Female | Male | Male | Male | Male | Female | Male | Male | Female | Male | Male | Male |
| Race or ethnic group minority (Yes/No) | Yes | Yes | No | Yes | Yes | No | Yes | No | Yes | Yes | Yes | No | Yes | No | Yes | Yes | No | Yes |
| Charlson Comorbidity Index | 6 | 6 | 0 | 4 | 1 | 3 | 0 | 3 | 1 | 2 | 3 | 1 | 9 | 4 | 2 | 2 | 5 | 2 |
| Baseline laboratory values | ||||||||||||||||||
| Lymphocyte vount (K/ul) | 0.8 | 0.8 | 1.4 | 0.7 | 1.3 | 0.2 | 0.4 | 0.4 | 0.5 | 0.9 | 0.7 | 0.8 | 1 | 1.2 | 0.4 | 0.5 | 0.7 | 1 |
| LDH (IU/l) | 503 | 372 | 544 | 403 | 375 | 313 | 431 | 493 | 415 | 321 | 613 | 490 | 595 | 835 | 313 | 361 | 599 | 339 |
| Ferritin (ng/ml) | 4773 | 1407 | 2244 | 1598 | 1273 | 2013 | 352 | 2128 | 343 | 6279 | 2063 | 2008 | 2782 | 1898 | 221 | 2369 | 1122 | 626 |
| D-dimer (ng/ml) | 1969 | 710 | 264 | 420 | 183 | 353 | 343 | 267 | 491 | <150 | 485 | 998 | 2199 | 531 | 176 | 194 | 843 | <150 |
| CRP (mg/l) | 33.6 | 243.2 | 64.1 | 200.1 | 54.4 | 108.6 | 233.6 | 104.3 | 58.4 | 57.9 | 164.4 | 54.3 | 140.3 | 29.7 | 214.3 | 26.9 | 50.7 | 7.87 |
| Vasopressor support | Yes | No | No | Yes | No | Yes | No | No | No | No | No | No | No | Yes | No | No | No | No |
| Baseline SpO2/FiO2 | 230 | 188 | 332 | 111 | 214 | 145 | 261 | 209 | 196 | 182 | 134 | 271 | 110 | 93 | 336 | 220 | 243 | 139 |
| Oxygenation support* | ||||||||||||||||||
| Time of enrollment | MV | HFNC | NC | MV | NC | MV | HFNC | HFNC | MV | HFNC | MV | HFNC | ECMO | MV | NC | HFNC | HFNC | HFNC |
| Maximum support | MV | HFNC | NC | MV | NC | MV | HFNC | HFNC | MV | HFNC | MV | HFNC | ECMO | MV | NC | MV | MV | HFNC |
| Discharge or death | NC | RA | RA | RA | RA | RA† | RA | NC | RA | NC | MV | NC | RA† | MV | RA | RA† | MV | RA |
| Symptom onset to infliximab-abda (days) | 29 | 15 | 12 | 13 | 5 | 27 | 5 | 9 | 10 | 10 | 7 | 8 | 10 | 12 | 11 | 8 | 20 | 12 |
| Admission to Infliximab-abda (days) |
6 | 3 | 5 | 1 | 3 | 7 | 2 | 2 | 2 | 2 | 0 | 1 | 2 | 3 | 1 | 2 | 1 | 5 |
| Hospital duration following infliximab-abda (days) | 21 | 8 | 1 | 14 | 5 | 47 | 7 | 12 | 12 | 7 | 22 | 4 | 52 | 10 | 4 | 37 | 34 | 9 |
| Primary endpoint met (days) |
Yes (12) | Yes (3) | Yes (1) | Yes (3) | Yes (3) | Yes (3) | Yes (6) | No | Yes (6) | Yes (3) | Yes (6) | Yes (5) | Yes (4) | Yes (2) | Yes (4) | No | Yes (12) | Yes (4) |
| Secondary infections | Yes | No | No | Yes | No | Yes | No | No | No | No | Yes | No | Yes | Yes | No | Yes | Yes | No |
| Survival to discharge | No | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes | No | Yes | Yes | No | Yes | Yes‡ | No | Yes |
RA, Room air; NC, Nasal Cannula; HFNC, High-Flow Nasal Cannula; MV, mechanical ventilator; ECMO, Extracorporeal membrane oxygenation.
*
Within 24 h of trial enrollment.
†
Via tracheostomy.
‡
Ventilated at Day 28.