TABLE 1.
General characteristics of kidney transplant recipients at high risk and low risk of moderate-to-severe COVID-19 according to early treatment with tixagevimab-cilgavimab
| High-risk group (n = 61) | Patient who did not receive curative tixagevimab-cilgavimab (n = 35) | Patient who received curative tixagevimab-cilgavimab (n = 26) | P value | Statistical test | Low-risk group (n = 73) | Patient who did not receive curative tixagevimab-cilgavimab (n = 63) | Patient who received curative tixagevimab-cilgavimab (n = 10) | P value | Statistical test | |
|---|---|---|---|---|---|---|---|---|---|---|
| Age, y | 61.0 [52.0–71.0] | 60 [52–71.5] | 65.5 [51.2–70.8] | 0.75 | Welch test | 49.0 [38–57] | 49 [38–57.5] | 49.5 [41.5–55.5] | 0.83 | Welch test |
| Men, n, %) | 42 (69%) | 25 (71%) | 17 (65%) | 0.61 | χ2 | 49 (67%) | 44 (70%) | 5 (50%) | 0.28 | Fisher exact test |
| BMI, kg/m2 | 28.4 [25.0–30.9] | 27.6 [24.9–30.6] | 28.5 [25.3–31.6] | 0.74 | Welch test | 25.1 [22.0–29.7] | 25.3 [22.1–30] | 24.9 [21.7–27.1] | 0.47 | Welch test |
| Serum creatinine, μmol/L | 133 [115–173] | 140 [116–186] | 125 [98–159] | 0.22 | Mann-Whitney U test | 115 [96–146] | 121 [96.0–146] | 98.5 [85.3–195] | 0.46 | Mann-Whitney U test |
| Cardiovascular disease, n, % | 21 (34%) | 8 (23%) | 13 (50%) | 0.03 | χ2 | 14 (19%) | 14 (22%) | 0 (0%) | 0.19 | Fisher exact test |
| Diabetes, n, % | 34 (56%) | 20 (57%) | 14 (54%) | 0.8 | χ2 | 18 (25%) | 18 (29%) | 0 (0%) | 0.06 | Fisher exact test |
| High blood pressure, n, % | 50 (82%) | 29 (83%) | 21 (81%) | 1 | Fisher exact test | 61 (84%) | 53 (84%) | 8 (80%) | 0.67 | Fisher exact test |
| First kidney transplantation, n, % | 54 (89%) | 33 (94%) | 21 (81%) | 0.13 | Fisher exact test | 62 (85%) | 54 (86%) | 8 (80%) | 0.64 | Fisher exact test |
| Time from kidney transplantation, y | 4.50 [1.75–8.73] | 2.9 [1.39–5.65] | 7.49 [266–12.5] | 0.02 | Mann-Whitney U test | 7.06 [4.14–11.8] | 7.06 [3.46–11.0] | 7.28 [5.40–17.6] | 0.5 | Mann-Whitney U test |
| Immunosuppressive drugs at diagnosis, n, % | ||||||||||
| Tacrolimus | 40 (66%) | 23 (66%) | 17 (65%) | 0.98 | χ2 | 48 (66%) | 41 (65%) | 7 (70%) | 1 | Fisher exact test |
| Cyclosporine | 14 (23%) | 7 (20%) | 7 (27%) | 0.52 | χ2 | 20 (27%) | 17 (27%) | 3 (30%) | 1 | Fisher exact test |
| MMF/MPA | 53 (87%) | 33 (87%) | 23 (85%) | 1 | Fisher exact test | 60 (82%) | 53 (84%) | 7 (70%) | 0.37 | Fisher exact test |
| mTOR inhibitors | 7 (11%) | 4 (11%) | 3 (12%) | 1 | Fisher exact test | 8 (11%) | 7 (11%) | 1 (10%) | 1 | Fisher exact test |
| Steroids | 45 (74%) | 26 (74%) | 19 (73%) | 0.92 | χ2 | 50 (68%) | 44 (70%) | 6 (60%) | 0.72 | Fisher exact test |
| Belatacept | 7 (11%) | 5 (14%) | 2 (7.7%) | 0.69 | Fisher exact test | 4 (5.5%) | 4 (6.3%) | 0 (0%) | 1 | Fisher exact test |
| Azathioprine | 0 | 0 | 0 | 5 (6.8%) | 4 (6.3%) | 1 (10%) | 0.53 | Fisher exact test | ||
| COVID-19 prevention, n, % | ||||||||||
| Vaccination | 57 (93%) | 32 (91%) | 25 (96%) | 0.64 | Fisher exact test | 69 (95%) | 60 (95%) | 9 (90%) | 0.45 | Fisher exact test |
| Pre-exposure tixagevimab-cilgavimab prophylaxis | 24 (39%) | 19 (54%) | 5 (19%) | <0.01 | χ2 | 7 (9.6%) | 7 (11%) | 0 (0%) | 0.58 | Fisher exact test |
| Pre-exposure casirivimab-imdevimab prophylaxis | 28 (46%) | 16 (46%) | 12 (46%) | 0.97 | χ2 | 8 (11%) | 6 (9.5%) | 2 (20%) | 0.3 | Fisher exact test |
| Antibody titer, BAU/mLa | 33 [1–117] | 8 [0–70] | 47 [16–133] | 0.12 | Mann-Whitney U test | 710 [240–1627] | 945 [285–1722] | 281 [47–407] | 0.02 | Mann-Whitney U test |
| History of COVID-19, n, % | 3 (4.9%) | 2 (5.7%) | 1 (3.8%) | 1 | Fisher exact test | 7 (9.6%) | 7 (11%) | 0 (0%) | 0.58 | Fisher exact test |
| COVID-19 presentation and clinical evolution, n, % | ||||||||||
| Symptomatic COVID-19 | 55 (92%) | 32 (94%) | 23 (88%) | 0.64 | Fisher exact test | 58 (88%) | 51 (88%) | 9 (90%) | 1 | Fisher exact test |
| COVID-19–related hospitalization | 13 (21%) | 12 (34%) | 1 (3.8%) | <0.01 | Log-rank | 3 (4.1%) | 2 (3.2%) | 1 (10%) | 0.31 | Log-rank |
| Oxygen need | 9 (5%) | 8 (23%) | 1 (3.8%) | 0.04 | Log-rank | 1 (1.4%) | 0 (0%) | 1 (10%) | 0.69 | Log-rank |
| ICU admission | 6 (9.8%) | 5 (14.3%) | 1 (3.8%) | 0.17 | Log-rank | 0 (0%) | 0 (0%) | 0 (0%) | 1 | Log-rank |
| Death | 3 (4.9%) | 3 (8.6%) | 0 (0%) | 0.13 | Log-rank | 0 (0%) | 0 (0%) | 0 (0%) | 1 | Log-rank |
| COVID-19 management, n, % | ||||||||||
| Dexamethasone | 7 (11%) | 6 (17%) | 1 (3.8%) | 0.22 | Fisher exact test | 1 (1.4%) | 1 (1.6%) | 0 (0%) | 1 | Fisher exact test |
| Immunosuppressive therapy reduction | 24 (41%) | 12 (36%) | 12 (46%) | 0.45 | χ2 | 7 (9.9%) | 4 (6.6%) | 3 (30%) | 0.06 | Fisher exact test |
| Early immunosuppressive therapy reductionb | 15 (24.6%) | 4 (1.1%) | 11 (42.3%) | 0.006 | χ2 | 5 (8.1%) | 2 (5.7%) | 3 (30%) | 0.016 | Fisher exact test |
Continuous variables are presented as medians (interquartile ranges), whereas categorical variables are presented as counts (percentages).
aOnly for patients not previously treated with casirivimab-imdevimab or tixagevimab-cilgavimab for pre-exposure prophylaxis.
bPatients who benefitted from a reduction of immunosuppression on hospitalization were excluded.
BAU, binding antibody unit; BMI, body mass index; ICU, intensive care unit; MMF, mycophenolate mofetil; MPA, mycophenolic acid; mTOR, mammalian target of rapamycin.