Table 1.
The distribution of the variables in the flare-up and non-flare-up groups as well in the vaccinated/non-vaccinated groups.
| Patients with and without Flare | Vaccinated and Non-Vaccinated Patients | |||||||
|---|---|---|---|---|---|---|---|---|
| Flare-Up (n = 42) |
Non-Flare-Up (n = 581) |
p Value | Missing | Vaccinated (n = 416) |
Non-Vaccinated (n = 207) |
p Value | Missing | |
| Enrolled online | 31 (73.8%) | 30 (63.7%) | 0.243 | 299 (71.9%) | 102 (49.3%) | <0.001 | ||
| Vaccinared | 25 (59.5%) | 391 (67.3%) | 0.312 | - | - | - | ||
| Gender (F) | 37 (88.1%) | 485 (83.5%) | 0.522 | 339 (81.5%) | 183 (88.4%) | 0.028 | ||
| Age (y) | 46 (21, 83) | 49 (19, 88) | 0.126 | 50 (21, 88) | 48 (19, 73) | 0.290 | ||
| Immune disease and comorbidities | ||||||||
| Charlson index | 2 (0, 6) | 1 (0, 10) | 0.512 | 1 (0, 9) | 1 (0, 10) | 0.354 | ||
| More than one immune disease | 16 (38.1%) | 118 (20.3%) | 0.011 | 83 (20%) | 51 (24.6%) | 0.180 | ||
| Number of immune diseases/patient | 1 (1, 4) | 1 (1, 6) | 0.006 | 1 (1, 4) | 1 (1, 6) | 0.142 | ||
| Immune pulmonary involvement | 6 (14.3%) | 59 (10.2%) | 0.429 | 40 (9.6%) | 25 (12.1%) | 0.404 | ||
| AIRD 1 | 26 (61.9%) | 369 (63.5%) | 0.869 | 239 (57.5%) | 156 (75.4%) | <0.001 | ||
| Rheumatoid arthritis | 7 (16.7%) | 91 (15.7%) | 0.827 | 59 (14.2%) | 39 (18.8%) | 0.161 | ||
| Systemic lupus erythematosus | 9 (21.4%) | 88 (15.1%) | 0.273 | 48 (11.5%) | 49 (23.7%) | <0.001 | ||
| Sjögren’s syndrome/Sicca 2 | 7 (16.7%) | 71 (12.2%) | 0.466 | 50 (12%) | 28 (13.5%) | 0.608 | ||
| Ankylosing spondylitis | 2 (4.8%) | 63 (10.8%) | 0.298 | 48 (11.5%) | 17 (8.2%) | 0.214 | ||
| Psoriatic arthritis/psoriasis | 4 (9.5%) | 49 (8.4%) | 0.774 | 32 (7.7%) | 21 (10.1%) | 0.360 | ||
| Systemic sclerosis/limited scleroderma | 1 (2.4%) | 30 (5.2%) | 0.714 | 14 (3.4%) | 17 (8.2%) | 0.011 | ||
| Antiphospholipid syndrome | 3 (7.1%) | 22 (3.8%) | 0.234 | 12 (2.9%) | 13 (6.3%) | 0.051 | ||
| Systemic vasculitis | 2 (4.8%) | 15 (2.6%) | 0.320 | 8 (1.9%) | 9 (4.3%) | 0.114 | ||
| Other AIRD 3 | 1 (2.4%) | 14 (2.4%) | 1 | 9 (2.2%) | 6 (2.9%) | 0.586 | ||
| Non-AIRD | 16 (38.1%) | 212 (36.5%) | 0.869 | 177 (42.5%) | 51 (24.6%) | <0.001 | ||
| Inflammatory bowel disease | 5 (11.9%) | 39 (6.7%) | 0.207 | 34 (8.2%) | 10 (4.8%) | 0.138 | ||
| Celiac disease | 1 (2.4%) | 18 (3.1%) | 1 | 14 (3.4%) | 5 (2.4%) | 0.626 | ||
| Primary biliary cholangitis | 1 (2.4%) | 8 (1.4%) | 0.469 | 4 (1%) | 5 (2.4%) | 0.167 | ||
| Autoimmune hepatitis | 0 (0%) | 11 (1.9%) | 1 | 8 (1.9%) | 3 (1.4%) | 1 | ||
| Myasthenia gravis | 6 (14.3%) | 22 (3.8%) | 0.008 | 15 (3.6%) | 13 (6.3%) | 0.151 | ||
| Multiple sclerosis | 1 (2.4%) | 24 (4.1%) | 1 | 17 (4.1%) | 8 (3.9%) | 1 | ||
| Hematological diseases 4 | 1 (2.4%) | 4 (0.7%) | 0.295 | 4 (1%) | 1 (0.5%) | 1 | ||
| Cutaneous diseases 5 | 1 (2.4%) | 16 (2.8%) | 1 | 12 (2.9%) | 5 (2.4%) | 1 | ||
| Autoimmune thyroid disease | 9 (21.4%) | 128 (22%) | 1 | 109 (26.2%) | 28 (13.5%) | <0.001 | ||
| Other non-AIRD 6 | 6 (14.3%) | 44 (6.7%) | 0.136 | 40 (9.6%) | 10 (4.8%) | 0.042 | ||
| Treatment | ||||||||
| Corticosteroids | 16 (38.1%) | 120 (20.7%) | 0.012 | 71 (17.1%) | 65 (31.4%) | <0.001 | ||
| Corticosteroid dose (mg) | 10 (5, 45) | 10 (2,5, 40) | 0.015 | 29 | 6.25 (5, 20) | 10 (3, 45) | <0.001 | 29 |
| Synthetic DMARDs 7 | 12 (28.6%) | 226 (38.9%) | 0.194 | 143 (34.4%) | 95 (45.9%) | 0.007 | ||
| Hydroxychloroquine | 8 (19%) | 125 (21.5%) | 0.846 | 81 (19.5%) | 52 (25.1%) | 0.119 | ||
| Methotrexate | 2 (4.8%) | 64 (11%) | 0.298 | 42 (10.1%) | 24 (11.6%) | 0.582 | ||
| Sulfasalazine | 2 (4.8%) | 48 (8.3%) | 0.566 | 34 (8.2%) | 16 (7.7%) | 1 | ||
| Leflunomide | 1 (2.4%) | 20 (3.4%) | 1 | 10 (2.4%) | 11 (5.3%) | 0.096 | ||
| Biologic DMARDs 7 | 10 (23.8%) | 119 (20.6%) | 0.561 | 89 (21.4%) | 40 (19.4%) | 0.600 | ||
| Mycophenolate mofetil | 1 (2.4%) | 17 (2.9%) | 1 | 13 (3.1%) | 5 (2.4%) | 0.801 | ||
| Azathioprine | 5 (11.9%) | 40 (6.9%) | 0.216 | 23 (5.5%) | 22 (10.6%) | 0.031 | ||
| Flare-up-related variables | ||||||||
| Disease diagnosis-enrollement/vaccine (years) |
11 (1, 40) | 9 (0, 56) | 0.608 | 29 | 9 (0, 50) | 10 (0, 56) | 0.999 | 29 |
| Flare-up in the year prior enrolement/vaccination | 22 (73.3%) | 189 (47.4%) | 0.007 | 194 | 130 (46.8%) | 81 (53.6%) | 0.189 | 194 |
| Enrollment/vaccination-flare-up timelaps (months) | - | - | - | 6.13 (0, 8) | 5.57 (1, 8) | <0.001 | ||
| COVID-19 8
prior enrollement/vaccine |
4 (9.5%) | 81 (13.9%) | 0.640 | 75 (18%) | 10 (4.8%) | <0.001 | ||
| Adverse events after dose 1 | 24 (92.3%) | 283 (72.4%) | 0.022 | 307/416 | - | - | ||
| Adverse events after dose 2 | 21 (80.8%) | 252 (64.5%) | 0.134 | 273/416 | - | - | ||
| Treatment adjustment before vaccination | 4 (16%) | 27 (6.9%) | 0.105 | 31/416 | - | - | ||
| Treatment adjustment before flare | 3/42 (7.1%) | - | - | 1 (4%) | 2 (11.8%) | 0.556 | ||
| Average length of flare-up (days) | 30 (4, 164) | - | - | 4 | 30 (4, 149) | 27.5 (14, 164) | 0.803 | 4 |
| Still having flare-up at the last assessment | 19 (45.2%) | 18 (3.2%) | <0.001 | 21 | 18 (4.5%) | 19 (9.6%) | 0.018 | 21 |
| Flare-up management | ||||||||
| Hospitalization | 15/42 | - | - | 10/25 | 5/17 | - | ||
| Treatment adjustment | 36/42 | - | - | 21/25 | 15/17 | - | ||
1 AIRD—autoimmune rheumatic diseases; 2 Sicca-Sicca syndrome (xerostomia, xeroftalmia); 3 Other AIRD—dermatomyositis/polymyositis and mixed connective tissue disease; 4 Hematological diseases—hemolytic anemia, paroxysmal nocturnal hemoglobinuria, idiopathic thrombocytopenia; 5 Cutaneous diseases—vitiligo, cutaneous lupus, cutaneous vasculitis, pemphigus; 6 Other non AIRD—sarcoidosis, type-1 diabetes mellitus, hyper IgD syndrome; 7 DMARDs-disease-modifying anti-rheumatic drugs; 8 COVID-19-Coronavirus disease 2019. Statistical significant values are marked with Bold.