Preliminary Data on Post Market Safety Profiles of COVID 19 Vaccines in Rheumatic Diseases: Assessments on Various Vaccines in Use, Different Rheumatic Disease Subtypes, and Immunosuppressive Therapies: A Two-Centers Study
Abstract
:1. Introduction
2. Materials and Methods
2.1. Patients
2.2. Vaccination
2.3. Statistical Analysis
3. Results
3.1. Rheumatic Disease Activity and Adverse Events after Anti-COVID 19 Vaccinations
3.2. Adverse Events after Anti-COVID-19 Vaccinations in Autoimmune/Inflammatory Rheumatic Diseases and in Nonautoimmune/Noninflammatory Rheumatic Diseases
3.3. Adverse Events after Anti-COVID-19 Vaccinations and Immunosuppressive Drugs
3.4. Immunosuppressive Drugs Management before and after Anti-COVID-19 Vaccination, Adherence to International Treatment Recommendations and Antibodies Response
4. Discussion
5. Conclusions
Author Contributions
Funding
Institutional Review Board Statement
Informed Consent Statement
Data Availability Statement
Acknowledgments
Conflicts of Interest
References
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Characteristics | Au/cIn-RD n = 137 | Non-Au/cIn-RD n = 48 | p-Value | |
---|---|---|---|---|
Age (years) | 57.0 ± 14.0 | 66.8 ± 12.8 | 0.0001 | |
Sex female/male n (%) | 97 (70%)/40 (30%) | 43 (89%)/5 (11%) | 0.202 | |
Disease duration duration (years) | 9 ± 7.6 | 3.6 ± 5.9 | 0.207 | |
BMI | 26.3 ± 5.4 | 26 ± 4.3 | 0.765 | |
Arthritis n (%) | 107 (78%) | |||
Connective tissue diseases n (%) | 24 (18%) | |||
Vasculitis n (%) | 6 (4%) | |||
Osteoporosis n (%) | 20 (41%) | |||
Osteoarthrosis n (%) | 19 (40%) | |||
Fibromyalgia n (%) | 9 (19%) | |||
Steroid use n (%) | 37 (27%) | |||
Prednisone equivalent (mg) | 3.9 ± 1.2 | |||
cs-DMARDs n (%) | 60 (43%) | |||
cs-DMARDs n (%) | MTX | 42 (70%) | ||
SSZ | 1 (2%) | |||
MMF | 6 (10%) | |||
HCQ | 9 (15%) | |||
colchicine | 2 (3%) | |||
b/ts-DMARDs n (%) | 57 (42%) | |||
b/ts-DMARDs n (%) | Anti-TNF alpha | 29 (51%) | ||
Anti-IL17 | 11 (20%) | |||
Anti-IL6 | 6 (10%) | |||
Jak-i | 6 (10%) | |||
Abatacept | 5 (9%) | |||
IgIV n (%) | 1 (%) | |||
Combo therapy | 34 (30%) | |||
Vaccines | AstraZeneca | 30 (22%) | 11 (23%) | 0.986 |
BioNTech/Pfizer | 107 (78%) | 37 (77%) | 0.990 | |
Vaccine doses | One dose | 66 (48%) | 29 (60%) | 0.157 |
Second dose | 71 (52%) | 19 (40%) | 0.198 | |
Disease activity | Remission | 68 (50)% | ||
Low | 50 (36%) | |||
Moderate-high | 19 (14%) | |||
CCI | 0.67 ± 1 | 1.8 ± 1.6 | 0.036 |
Title | AstraZeneca | BioNTech-Pfizer | p-Value |
---|---|---|---|
Au/cIn-RD | n = 30 | n = 107 | |
Age (years) | 59.2 ± 12.4 | 57.4 ± 14.2 | 0.532 |
Sex female/male n | 21/9 | 76/31 | 0.950 |
Disease duration (years) | 6.9 ± 5.9 | 9.5 ± 7.5 | 0.090 |
BMI | 25 ± 4.6 | 26.8 ± 5.8 | 0.118 |
Steroid use n (%) | 9 (30%) | 28 (26%) | 0.674 |
Prednisone equivalent (mg) | 3.3 ± 1.2 | 4.5 ± 1.8 | 0.775 |
cs-DMARDs n (%) | 13 (53%) | 47 (44%) | 0.108 |
b/ts-DMARDs n (%) | 8 (27%) | 49 (46%) | 0.145 |
Combo immunosuppressive therapy | 8 (27%) | 26 (29%) | 0.858 |
Vaccine second dose | 6 (20%) | 65 (60%) | 0.001 |
Arthritis n (%) | 25 (83%) | 82 (76%) | 0.826 |
Connective tissue diseases n (%) | 5 (17%) | 19 (18%) | 0.421 |
Vasculitis n (%) | 0 (0%) | 3 (3%) | - |
Polymyalgia Rheumatica n (%) | 0 (0%) | 3 (3%) | - |
Disease activity | |||
Remission | 15 (50%) | 53 (49%) | 0.792 |
Low | 12 (40%) | 38 (35%) | 0.546 |
Moderate-high | 3 (10%) | 16 (15%) | 0.789 |
CCI | 0.5 ± 0.6 | 0.8 ± 1.4 | 0.297 |
AEs after 1 dose n (%) | 14 (56.7%) | 46 (43.4%) | 0.938 |
Serious/severe AEs after 1 dose n (%) | 0 (0%) | 0 (0%) | - |
RD relaps after I dose n (%) | 0 (0%) | 4 (3.8%) | 0.361 |
AEs after 2 doses n (%) | 0 (0%) | 20 (31%) | 0.253 |
Serious/severe AEs after 2 doses n (%) | 0 (0%) | 0 (0%) | - |
RD relapse after II dose n (%) | 0 (0%) | 0 (0%) | - |
No-Au/cIn-RD | n = 11 | n = 37 | |
Age (years) | 64.1 ± 9.9 | 67.8 ± 14 | 0.429 |
Sex female/male n | 11/0 | 32/5 | 0.319 |
Disease duration (years) | 3.0 ± 2.5 | 4.0 ± 6.9 | 0.672 |
BMI | 24.9 ± 2.8 | 26.1 ± 4.6 | 0.400 |
Osteoporosis n (%) | 4 (36%) | 16 (43%) | 0.589 |
Osteoarthrosis n (%) | 5 (45%) | 14 (38%) | 0.391 |
Fibromyalgia n (%) | 2 (18%) | 7 (19%) | 0.589 |
CCI | 0.5 ± 0.7 | 1.2 ± 1.5 | 0.840 |
Vaccine second dose | 1 (9%) | 18 (49%) | 0.270 |
AEs after 1 dose n (%) | 5 (45%) | 12 (33%) | 0.660 |
Serious/severe AEs after 1 dose n (%) | 0 (0%) | 0 (0%) | - |
AEs after 2 doses | 0 (0%) | 4 (20%) | 0.140 |
Serious/severe AEs after 2 doses n (%) | 0 (0%) | 0 (0%) | - |
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Rotondo, C.; Cantatore, F.P.; Fornaro, M.; Colia, R.; Busto, G.; Rella, V.; Sciacca, S.; Lops, L.; Cici, D.; Maruotti, N.; et al. Preliminary Data on Post Market Safety Profiles of COVID 19 Vaccines in Rheumatic Diseases: Assessments on Various Vaccines in Use, Different Rheumatic Disease Subtypes, and Immunosuppressive Therapies: A Two-Centers Study. Vaccines 2021, 9, 730. https://doi.org/10.3390/vaccines9070730
Rotondo C, Cantatore FP, Fornaro M, Colia R, Busto G, Rella V, Sciacca S, Lops L, Cici D, Maruotti N, et al. Preliminary Data on Post Market Safety Profiles of COVID 19 Vaccines in Rheumatic Diseases: Assessments on Various Vaccines in Use, Different Rheumatic Disease Subtypes, and Immunosuppressive Therapies: A Two-Centers Study. Vaccines. 2021; 9(7):730. https://doi.org/10.3390/vaccines9070730
Chicago/Turabian StyleRotondo, Cinzia, Francesco Paolo Cantatore, Marco Fornaro, Ripalta Colia, Giuseppe Busto, Valeria Rella, Stefania Sciacca, Lucia Lops, Daniela Cici, Nicola Maruotti, and et al. 2021. "Preliminary Data on Post Market Safety Profiles of COVID 19 Vaccines in Rheumatic Diseases: Assessments on Various Vaccines in Use, Different Rheumatic Disease Subtypes, and Immunosuppressive Therapies: A Two-Centers Study" Vaccines 9, no. 7: 730. https://doi.org/10.3390/vaccines9070730