Table 2.
Analysis of the cohort after stratification for specific autoimmune systemic disease.
| RA (n = 101) (a) |
SLE (n = 38) (b) |
SSc (n = 265) (c) |
CV (n = 61) (d) |
Other vasculitis (n = 13) (e) |
P value | |
|---|---|---|---|---|---|---|
| Age, years | 61 ± 12b, d | 46 ± 17a, c, d | 57 ± 15b, d | 74 ± 11a, b, c, e | 51 ± 18d | <0.0001 |
| Female gender, n (%) | 71 (70.3) | 36 (94.7)a, e | 236(89.1)a, e | 51(83.6) | 7(53.8) | <0.0001 |
| Disease duration, years | 8 ± 7b | 14 ± 12a, d | 10 ± 8 | 9 ± 6b | 4 ± 5 | 0.008 |
| Past COVID-19, n (%) | 5 (5.0) | 3 (7.9) | 7 (2.6) | 0 (0) | 0 (0) | 0.163 |
| ASD-related complications | ||||||
| Interstitial lung disease, n (%) | 2 (2.0) | 1 (2.6) | 107 (40.4)a, b | 0 (0) | 2 (15.4) | <0.0001 |
| Skin ulcers, n (%) | 0 (0) | 4 (10.5) | 78 (29.4)d | 5 (8.2) | 1 (7.7) | <0.0001 |
| Renal involvement, n (%) | 0 (0) | 6 (15.8)c | 4 (1.5) | 8 (13.1)c | 0 (0) | <0.0001 |
| Pulmonary art. hypert., n (%) | 0 (0) | 1 (2.6) | 18 (6.8) | 0 (0) | 0 (0) | 0.012 |
| Gastrointestinal inv., n (%) | 0 (0) | 0 (0) | 19 (7.2) | 0 (0) | 0 (0) | 0.003 |
| Treatment | ||||||
| Glucocorticoids, n (%) | 44(43.6) | 31 (81.6)a | 105 (39.8) | 16 (26.2)a | 8 (61.5) | <0.0001 |
| Methotrexate, n (%) | 57 (56.4)b,c | 3 (7.9) | 15 (5.7) | 0 (0) | 3 (23.1) | <0.0001 |
| Sulfasalazine, n (%) | 4 (4.0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 0.005 |
| Hydroxychloroquine, n (%) | 10 (9.9) | 25 (65.8)a, c, d, e | 75 (28.3) a, d | 1 (1.6) | 1 (7.7) | <0.0001 |
| Leflunomide, n (%) | 2 (2.0) | 1 (2.6) | 1 (0.4) | 0 (0) | 0 (0) | 0.359 |
| Mycophenolate, n (%) | 0 (0) | 4 (10.5) | 73 (27.5)a | 0 (0) | 2 (15.4) | <0.0001 |
| Azathioprine, n (%) | 0 (0) | 4 (10.5) | 15 (5.7) | 0 (0) | 3 (23.1)c | <0.0001 |
| TNF inhibitors, n (%) | 21 (20.8)c | 0 (0) | 1 (0.4) | 0 (0.0) | 1 (7.7)c | <0.0001 |
| Abatacept, n (%) | 6 (5.9)c | 0 (0) | 5 (1.9) | 0 (0) | 0 (0) | 0.067 |
| Rituximab, n (%) | 2 (2.0) | 0 (0) | 14 (5.3) | 8 (13.1)a | 2 (15.4) | 0.007 |
| IL-6 inhibitors, n (%) | 6 (5.9) | 0 (0) | 13 (4.9) | 0 (0) | 2 (15.4) | 0.060 |
| JAK inhibitors, n (%) | 14 (13.9) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | <0.0001 |
| Belimumab, n (%) | 0 (0) | 14 (36.8) | 0 (0) | 0 (0) | 0 (0) | <0.0001 |
| Vaccines administered | ||||||
| BNT162b2, n (%) | 93 (92.1) | 34 (89.5) | 253 (95.5) | 55 (90.2) | 13 (100) | 0.269 |
| mRNA-1273, n (%) | 8 (7.9) | 4 (10.5) | 12 (4.5) | 6 (9.8) | 0 (0) | 0.268 |
| Vaccine-related adverse events | ||||||
| No adverse events, n (%) | 56 (55.4)d | 21 (55.3)d | 125 (47.2)d | 15 (24.6) | 4 (30.8) | 0.002 |
| Pain at the injection site, n (%) | 33 (32.7) | 15 (39.5) | 96 (36.2) | 28 (45.9) | 10 (76.9)a,c | 0.021 |
| Fever, n (%) | 8 (7.9) | 5 (13.2) | 22 (8.3) | 4 (6.6) | 3 (23.1) | 0.312 |
| Headache, n (%) | 9 (8.9) | 6 (15.8)c | 8 (3.0) | 7 (11.5)c | 0 (0) | 0.004 |
| Fatigue, n (%) | 5 (5.0) | 1 (2.6) | 28 (10.6) | 2 (3.3) | 0 (0) | 0.077 |
| SARS-CoV-2 IgG NAb titre, BAU/mL | 153.05 [52.72–1140.23] | 455.87 [129.16–1028.31] | 349.48 [63.21–1224.2] | 245.08 [7.33–1072.00] | 118.83 [46.92–317.90] | 0.184 |
| Vaccine non-response, n (%) | 11 (10.9) | 5 (13.2) | 29 (10.9) | 15 (24.6) a, b, c | 3 (23.1)a, b, c | 0.047 |
Data are presented as mean ± standard deviation, number (percentage), or median [25th-75th percentile], as appropriate. P values have been calculated using one-way analysis of variance (ANOVA) for continuous variables or Kruskal–Wallis H test for binary variables. A letter has been assigned to each disease group as reported in first row; subscript letters have been used to highlight post-hoc contrasts between pairs; when a subscript letter is associated to an individual value it represents that the value differs from that observed in the group associated with the letter.
Legends: ASD, autoimmune systemic diseases; COVID-19, coronavirus disease 2019; CV, cryoglobulinemic vasculitis; IL-6, interleukin-6; JAK, Janus kinase; mRSS, modified Rodnan skin score; NAb, neutralizing antibodies; RA, rheumatoid arthritis; SLE, systemic lupus erythematosus; SSc, systemic sclerosis; TNF, tumor necrosis factor.