COVID-19 Vaccine Does Not Increase the Risk of Disease Flare-Ups among Patients with Autoimmune and Immune-Mediated Diseases
Abstract
:1. Introduction
2. Materials and Methods
2.1. Participants
2.2. Data Sources/Measurement
2.3. Sample Size
2.4. Data Analysis
3. Results
4. Discussion
5. Conclusions
Supplementary Materials
Author Contributions
Funding
Institutional Review Board Statement
Informed Consent Statement
Conflicts of Interest
References
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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 | - |
1st Dose (n = 416) | 2nd Dose (n = 407) | |||||||
---|---|---|---|---|---|---|---|---|
Non-AIRD 1 (n = 134, 75.7%) | AIRD (n = 173, 72.4%) | p Value (0.499) | Total Adverse Events (n = 307) | Non-AIRD (n = 125, 70.6%) | AIRD (n = 148, 61.9%) | p Value (0.076) | Total Adverse Events (n = 273) | |
Pain in injection site | 81 (45.3%) | 99 (41.4%) | 0.485 | 180 | 86 (48%) | 82 (34.3%) | 0.005 | 168 |
Local swelling | 9 (5%) | 6 (2.5%) | 0.192 | 15 | 6 (3.4%) | 4 (1.7%) | 0.338 | 10 |
Local redness | 22 (12.3%) | 23 (9.6%) | 0.427 | 45 | 8 (4.5%) | 7 (2.9%) | 0.435 | 15 |
Fatigue | 46 (25.7%) | 51 (21.3%) | 0.349 | 97 | 41 (22.9%) | 52 (21.8%) | 0.813 | 93 |
Headache | 33 (18.4%) | 44 (18.4%) | 1 | 77 | 24 (13.4%) | 25 (10.5%) | 0.361 | 49 |
Myalgia | 24 (13.4%) | 35 (14.6) | 0.777 | 59 | 25 (14%) | 25 (10.5%) | 0.289 | 50 |
New/increased joint pain | 25 (14%) | 35 (14.7%) | 0.888 | 60 | 10 (5.6%) | 20 (8.4%) | 0.340 | 30 |
Chills | 24 (13.4%) | 35 (14.6%) | 0.777 | 59 | 28 (15.6%) | 34 (14.5%) | 0.782 | 62 |
Fever | 8 (4.5%) | 13 (5.4%) | 0.822 | 21 | 22 (12.3%) | 24 (10%) | 0.528 | 46 |
Allergic reactions | 3 (1.7%) | 2 (0.8%) | 0.655 | 5 | 1 (0.6%) | 0 (0%) | 0.427 | 1 |
Skin rash | 3 (1.7%) | 3 (1.3%) | 1 | 6 | 1 (0.6%) | 0(0%) | 0.428 | 1 |
Anaphylactic shock | 0 (0%) | 0 (0%) | 0 | 0 | 0 (0%) | 1 (0.4%) | 1 | 1 |
Lymphadenopathy | 4 (2.2%) | 5 (2.1%) | 1 | 9 | 5 (2.9%) | 4 (1.7%) | 0.501 | 9 |
Paresthesia | 1 (0.6%) | 6 (2.5%) | 0.247 | 7 | 2 (1.2%) | 5 (2.1%) | 0.704 | 7 |
Digestive symptoms | 4 (2.2%) | 5 (2.1%) | 1 | 9 | 7 (4%) | 12 (5%) | 0.813 | 19 |
Dizziness | 2 (1.1%) | 7 (2.9%) | 0.311 | 9 | 6 (3.5%) | 6(2.5%) | 0.569 | 12 |
Cough | 3 (1.7%) | 0 (0%) | 0.078 | 3 | 1 (0.6%) | 0 (0%) | 0.420 | 1 |
Variable | B | p | OR with 95%CI 1 |
---|---|---|---|
More than one immune disease | 0.667 | 0.079 | 1.9 (0.92–4.09) |
Corticotherapy | 0.438 | 0.255 | 1.5 (0.73–3.3) |
Vaccine | −0.630 | 0.094 | 0.53 (0.25–1.11) |
Flare-up during the previous year | 0.972 | 0.019 | 2.64 (1.17–5.97) |
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Share and Cite
Pinte, L.; Negoi, F.; Ionescu, G.D.; Caraiola, S.; Balaban, D.V.; Badea, C.; Mazilu, D.; Dumitrescu, B.; Mateescu, B.; Ionescu, R.; Parvu, M.I.; Baicus, C. COVID-19 Vaccine Does Not Increase the Risk of Disease Flare-Ups among Patients with Autoimmune and Immune-Mediated Diseases. J. Pers. Med. 2021, 11, 1283. https://doi.org/10.3390/jpm11121283
Pinte L, Negoi F, Ionescu GD, Caraiola S, Balaban DV, Badea C, Mazilu D, Dumitrescu B, Mateescu B, Ionescu R, Parvu MI, Baicus C. COVID-19 Vaccine Does Not Increase the Risk of Disease Flare-Ups among Patients with Autoimmune and Immune-Mediated Diseases. Journal of Personalized Medicine. 2021; 11(12):1283. https://doi.org/10.3390/jpm11121283
Chicago/Turabian StylePinte, Larisa, Florentina Negoi, Georgeta Daniela Ionescu, Simona Caraiola, Daniel Vasile Balaban, Camelia Badea, Diana Mazilu, Bianca Dumitrescu, Bogdan Mateescu, Ruxandra Ionescu, Magda Ileana Parvu, and Cristian Baicus. 2021. "COVID-19 Vaccine Does Not Increase the Risk of Disease Flare-Ups among Patients with Autoimmune and Immune-Mediated Diseases" Journal of Personalized Medicine 11, no. 12: 1283. https://doi.org/10.3390/jpm11121283