Table 5.
Distribution of baseline demographic and SLE patient characteristics according to disease flare after SARS-CoV-2 vaccination.
| Disease Flare after Vaccine (n = 19) |
No Disease Flare after Vaccine (n = 430) |
p-Value (<0.05) | |
|---|---|---|---|
| Age, years, median (IQR) | 52 (39.5–56.0) | 48 (35.0–56.9) | 0.8487 |
| Disease duration, months, median (IQR) | 144 (122–242.5) | 127 (73–195) | 0.2489 |
| Musculoskeletal involvement, % (n) | 78.9 (15) | 84.8 (367) | 0.5142 |
| Mucocutaneus involvement, % (n) | 57.9 (11) | 64.5 (283) | 0.6237 |
| Renal involvement, % (n) | 52.6 (10) | 49.4 (214) | 0.8187 |
| NPSLE, % (n) | 5.3 (1) | 10.4 (45) | 0.708 |
| Cardiopulmonary involvement, % (n) | 26.3 (5) | 20.3 (88) | 0.5617 |
| Haematological involvement, % (n) | 42.1 (8) | 32.6 (141) | 0.4554 |
| Constitutional symptoms, % (n) | 26.3 (5) | 35.3 (153) | 0.473 |
| Gastrointestinal involvement, % (n) | 5.3 (1) | 3.5 (15) | 0.5029 |
| Ophthalmic involvement, % (n) | 0 (0) | 2.8 (12) | 1.00 |
| Secondary anti-phospholipid syndrome, % (n) | 5.3 (1) | 10.9 (47) | 0.7079 |
| Anti-phospholipid antibodies positivity, % (n) | 26.3 (5) | 31.9 (138) | 0.802 |
| Anti-dsDNA positivity, % (n) | 55.6 (10) | 27.1 (113) | 0.01419 * |
| Anti-Sm positivity, % (n) | 15.8 (3) | 10.4 (45) | 0.4414 |
| Low complement (C3 and/or C4), % (n) | 52.6 (10) | 34.2 (149) | 0.1391 |
| ESR, mm/h, median (IQR) | 19 (10–24.5) | 13 (7–21) | 0.1247 |
| CRP, mg/dL, median (IQR) | 0.42 (0.135–0.50) | 0.50 (0.30–0.53) | 0.4638 |
| Presence of urinary abnormalities, % (n) | 21.1 (4) | 18.5 (80) | 0.7643 |
| Moderate or high DAS before vaccine, % (n) | 26.3 (5) | 10.4 (45) | 0.04739 * |
| No therapy before vaccine, % (n) | 0 (0) | 2.8 (12) | 1.00 |
| At least 1 immunosuppressant #, % (n) | 73.7 (14) | 50.1 (217) | 0.0593 |
| Mycophenolate, % (n) | 42.1 (8) | 24.7 (107) | 0.106 |
| Methotrexate, % (n) | 5.3 (1) | 6.5 (28) | 1.00 |
| Belimumab, % (n) | 36.8 (7) | 14.8 (64) | 0.01838 * |
| Rituximab ever, % (n) | 5.3 (1) | 13.4 (58) | 0.4904 |
| Prednisone therapy, % (n) | 78.9 (15) | 70.9 (307) | 0.6069 |
| Side effects after vaccination, % (n) | 63.2 (12) | 24.7 (107) | 0.00062 * |
* p-Value < 0.05. # Azatiopryne, mycophenolate, belimumab, cyclophosphamide, leflunomide, adalimumab, rituximab, tocilizumab, IMP, tacrolimus. IQR: interquartile range. ESR: erythrocyte sedimentation rate. CRP: C-reactive protein. NPSLE: neuropsychiatric involvement in systemic lupus erythematosus. DAS: disease activity score.