Table 1.
Univariable and Multivariable Logistic Regression Analyses of Risk Factors for Coronavirus Disease 2019–Related Hospitalizations in 156 High-Risk Patients With Hematologic Malignancy Who Received Early Treatment With Sotrovimab a
| Characteristic | Admits Cases (No Admits) (n = 156) | Univariate Modelb | Multivariable Modelb | ||
|---|---|---|---|---|---|
| OR (95% CI) | P Value* | OR (95% CI) | P Value* | ||
| Age ≥65 y | 7 (60) | .92 (.33–2.56) | .876 | … | |
| Age <65 y | 10 (79) | 1.00 | … | ||
| Female sex | 8 (70) | .87 (.32–2.40) | .797 | … | |
| Male sex | 9 (69) | 1.00 | … | ||
| Days to sotrovimab from symptom onsetc | |||||
| ȃ>10 d | 2 (4) | 4.68 (.77–28.54) | .094 | … | |
| ȃ6–10 d | 3 (20) | 1.41 (.36–5.49) | .625 | … | |
| ȃ0–5 d | 11 (103) | 1.00 | NA | … | |
| Creatinine ≥1.1 mg/dLd | 3 (38) | .56 (.15–2.05) | .380 | … | |
| Creatinine <1.1 mg/dLd | 14 (99) | 1.00 | … | ||
| Lymphocyte count ≥500 cell/µLe | 13 (116) | .616 (.18–2.07) | .433 | … | |
| Lymphocyte count <500 cell/µLe | 4 (22) | 1.00 | … | ||
| CD3+CD4+ (T4 helper) cells, blood ≥200 cell/µLf | 4 (27) | .37 (.09–1.52) | .169 | … | |
| CD3+CD4+ (T4 helper) cells, blood <200 cells/µLf | 6 (15) | 1.00 | … | ||
| CD19 ≥50 cells/µLf | 2 (16) | .39 (.07–2.15) | .281 | … | |
| CD19 <50 cells/µLf | 7 (22) | 1.00 | … | ||
| Neutrophils ≥0.5 k/µLg | 16 (118) | .54 (.06–5.16) | .595 | … | |
| Neutrophils <0.5 k/µLg | 1 (4) | 1.00 | … | ||
| Total IgG ≥500 mg/dL | 8 (64) | 0.94 (0.26–3.36) | .921 | … | |
| Total IgG <500 mg/dL | 4 (30) | 1.00 | … | ||
| Anti-spike SARS-CoV-2 antibody level (Abbott)h | |||||
| ȃ ≥500 AU/mL | 3 (22) | 1.14 (.26–4.96) | .865 | … | |
| ȃ <500 AU/mL | 6 (50) | 1.00 | … | ||
| COVID-19 vaccination statusi | |||||
| ȃFully vaccinated | 14 (112) | 1.13 (.30–4.19) | .861 | … | |
| ȃNot fully vaccinated | 3 (27) | 1.00 | … | ||
| Comorbiditiesj | |||||
| ȃAt least 1 comorbidity | 11 (72) | 1.71 (.60–4.87) | .318 | … | |
| ȃNo comorbidity | 6 (67) | 1.00 | … | ||
| ȃAtrial fibrillation (yes) | 5 (10) | 5.38 (1.58–18.31) | .007* | 3.68 (.77–17.54) | .102 |
| ȃAtrial fibrillation (no) | 12 (129) | 1.00 | 1.00 | ||
| ȃCOPD (yes) | 2 (7) | 2.52 (.48–13.22) | .276 | … | |
| ȃCOPD (no) | 15 (132) | 1.00 | … | ||
| ȃHeart failure (yes) | 3 (3) | 9.71 (1.79–52.76) | .009* | 6.89 (.85–56.11) | .071 |
| ȃHeart failure (no) | 14 (136) | 1.00 | 1.00 | ||
| ȃHIV positive | 0 (2) | 1.57 (.04–67.0) | .814 | … | |
| ȃHIV negative | 17 (137) | 1.00 | … | ||
| ȃDiabetes (yes) | 4 (22) | 1.64 (.49–5.49) | .425 | … | |
| ȃDiabetes (no) | 13 (117) | 1.00 | … | ||
| ȃHypertension (yes) | 7 (49) | 1.29 (.46–3.59) | .631 | … | |
| ȃHypertension (no) | 10 (90) | 1.00 | … | ||
| ȃRenal failure (yes) | 4 (23) | 1.55 (.46–5.18) | .475 | … | |
| ȃRenal failure (no) | 13 (116) | 1.00 | … | ||
| Systemic steroids (yes)k | 8 (57) | 1.28 (.47–3.51) | .631 | … | |
| Systemic steroids (no)k | 9 (82) | 1.00 | … | ||
| Anti-CD20 therapy (yes)l | 9 (29) | 4.27 (1.51–12.03) | .006* | 5.59 (1.73–18.12) | .004* |
| Anti-CD20 therapy (no)l | 8 (110) | 1.00 | 1.00 | ||
| Cancer type | |||||
| ȃLeukemia/MDS | 5 (61) | .48 (.15–1.53) | .216 | … | |
| ȃMyeloma/amyloidosis | 3 (25) | .71 (.18–2.84) | .625 | … | |
| ȃLymphoma | 9 (53) | 1.00 | NA | … | |
| Chemotherapy (yes)m | 12 (82) | 1.67 (.56–5.00) | .36 | … | |
| Chemotherapy (no)m | 5 (57) | 1.00 | … | ||
| Relapse/refractory disease (yes) | 8 (28) | 3.52 (1.25–9.96) | .017* | 5.69 (1.69–19.16) | .005* |
| Relapse/refractory disease (no) | 9 (111) | 1.00 | 1.00 | ||
| BMT CAR-T (yes)n | 2 (22) | .71 (.15–3.34) | .663 | … | |
| BMT CAR-T (no)n | 15 (117) | 1.00 | … | ||
| BMI, kg/m2o | |||||
| ȃUnderweight (<18.5) | 0 (4) | .71 (.02–20.6) | .842 | … | |
| ȃNormal weight (18.5–24.9) | 6 (41) | 1.00 | NA | … | |
| ȃOverweight (25.0–29.9) | 8 (46) | 1.17 (.38–3.56) | .786 | … | |
| ȃObese (≥30.0) | 1 (40) | .24 (.04–1.50) | .126 | … | |
Abbreviations: Ab, antibody; BMI, body mass index; BMT, bone marrow transplant; CAR-T, chimeric antigen receptor T-cell; CI, confidence interval; COPD, chronic obstructive pulmonary disease; COVID-19, coronavirus disease 2019; HIV, human immunodeficiency virus; IgG, immunoglobulin G; MDS, myelodysplastic syndrome; NA, not applicable; OR, odds ratio; SARS-CoV-2, severe acute respiratory syndrome coronavirus 2.
Data include 2 patients who received pre-exposure prophylaxis with Evusheld prior to COVID-19 diagnosis.
ORs and P values calculated from logistic regression applying Firth correction, where appropriate.
Symptom onset is COVID-19 related. Onset date not available for 13 patients. Symptom onset to sotrovimab administration ranged from 0 to 16 days (median, 3 days).
Creatinine and IgG: Most recent values before COVID-19 diagnosis within the last 6 months.
Lymphocytes: Most recent 3 laboratory values within 12 months prior to COVID-19 diagnosis. All 3 counts must be <500 cells/µL to be in the “<500” category. At least 1 count of value ≥500 cells/µL is considered in the “≥500” category. One patient did not have 3 laboratory values prior to COVID-19 diagnosis.
CD4 and CD19: Most recent values before COVID-19 diagnosis within the last year.
Neutrophils: Most recent values before COVID-19 diagnosis within the last month.
Anti-spike antibody: Most recent test value before COVID-19 diagnosis within 1 year. Excludes 2 patients who received Evusheld prior to sotrovimab.
Study patients were considered fully vaccinated for COVID-19 ≥2 weeks after the final dose of a primary vaccination series. Not fully vaccinated: No vaccination records were available for these patients.
Comorbidities (atrial fibrillation, COPD, heart failure, HIV, hypertension, diabetes, renal failure) are based on International Classification of Diseases, Tenth Revision diagnosis codes within 12 months of study period.
Systemic steroids include patients who were on steroids within 30 days prior to COVID-19 diagnosis. Includes dexamethasone, methylprednisolone, hydrocortisone, and prednisone.
Anti-CD20 therapy within previous 12 months from receipt of sotrovimab. This includes rituximab, obinutuzumab, tafasitamab, hyaluronidase-rituximab, and ofatumumab.
Chemotherapy during study period.
BMT and CAR-T therapy combined. Service dates are prior to COVID-19 diagnosis and sotrovimab treatment and are within 1 year of study period.
Most recent value during past 12 months; 10 patients did not have BMI values.
Statistical significance at α = .05.