Table 2.
Effects of COVID-19 vaccination in patients with IIMs vs. other SAIDs and HCs
| IIM | SAIDs | HCs | OR1 (95%CI) | OR2 (95%CI) |
p1 | p2 | ||||
|---|---|---|---|---|---|---|---|---|---|---|
| N (1390) | % (100) |
N (4432) | % (100) |
N (2937) | % (100) |
|||||
| Minor AEs | 227 | 16.3 | 948 | 21.4 | 561 | 19.1 | 0.7 (0.6–0.8) | 0.8 (0.7–1.0) | < .001 | 0.027 |
| Injection site (arm) pain and soreness | 115 | 8.3 | 558 | 12.6 | 365 | 12.4 | 0.6 (0.5–0.8)# | 0.6 (0.5–0.8) | < .001 | < .001 |
| Myalgia | 103 | 7.4 | 443 | 10.0 | 217 | 7.4 | 0.7 (0.6–0.9) | 0.004 | 0.980 | |
| Body ache | 108 | 7.8 | 488 | 11.0 | 238 | 8.1 | 0.7 (0.5–0.8) | 0.001 | 0.705 | |
| Joint pain | 91 | 6.5 | 486 | 11.0 | 165 | 5.6 | 0.6 (0.5–0.7)# | < .001 | 0.227 | |
| Fever | 71 | 5.1 | 359 | 8.1 | 248 | 8.4 | 0.6 (0.5–0.8) | 0.6 (0.4–0.8) | < .001 | < .001 |
| Chills | 72 | 5.2 | 285 | 6.4 | 162 | 5.5 | 0.09 | 0.648 | ||
| Cough | 23 | 1.7 | 111 | 2.5 | 54 | 1.8 | 0.065 | 0.669 | ||
| Difficulty in breathing or shortness of breath | 36 | 2.6 | 126 | 2.8 | 58 | 2.0 | 0.617 | 0.195 | ||
| Nausea/vomiting | 29 | 2.1 | 171 | 3.9 | 45 | 1.5 | 0.5 (0.4–0.8) | 0.002 | 0.189 | |
| Headache | 86 | 6.2 | 428 | 9.7 | 193 | 6.6 | 0.6 (0.5–0.8)# | < .001 | 0.631 | |
| Rash | 55 | 4.0 | 129 | 2.9 | 27 | 0.9 | 4.4 (2.8–7.1) | 0.052 | < .001 | |
| Fatigue | 122 | 8.8 | 507 | 11.4 | 198 | 6.7 | 0.7 (0.6–0.9)# | 1.3 (1.1–1.7) | 0.005 | 0.017 |
| Diarrhea | 25 | 1.8 | 117 | 2.6 | 42 | 1.4 | 0.076 | 0.359 | ||
| Abdominal pain | 24 | 1.7 | 101 | 2.3 | 33 | 1.1 | 0.215 | 0.104 | ||
| High pulse rate or palpitations | 36 | 2.6 | 167 | 3.8 | 73 | 2.5 | 0.7 (0.5–1.0) | 0.037 | 0.838 | |
| Rise in blood pressure | 19 | 1.4 | 86 | 1.9 | 30 | 1.0 | 0.161 | 0.316 | ||
| Fainting | 4 | 0.3 | 22 | 0.5 | 12 | 0.4 | 0.309 | 0.541 | ||
| Dizziness | 43 | 3.1 | 221 | 5.0 | 68 | 2.3 | 0.6 (0.4–0.8)# | 0.003 | 0.131 | |
| Chest pain | 16 | 1.2 | 120 | 2.7 | 30 | 1.0 | 0.4 (0.2–0.7) | 0.001 | 0.698 | |
| Swelling in the extremities | 21 | 1.5 | 100 | 2.3 | 29 | 1.0 | 0.089 | 0.133 | ||
| Weakness and tingling in the feet and legs | 47 | 3.4 | 166 | 3.7 | 65 | 2.2 | 1.5 (1.1–2.3) | 0.528 | 0.024 | |
| Pricking or pins and needles sensations in the hands and feet | 36 | 2.6 | 137 | 3.1 | 42 | 1.4 | 1.8 (1.2–2.9) | 0.337 | 0.007 | |
| Visual disturbances (loss of vision, blurring of vision, etc.) | 17 | 1.2 | 115 | 2.6 | 28 | 1.0 | 0.003 | 0.414 | ||
| Bleeding/bruising on the body | 14 | 1.0 | 67 | 1.5 | 15 | 0.5 | 0.161 | 0.062 | ||
| Petechial rash | 11 | 0.8 | 54 | 1.2 | 11 | 0.4 | 0.186 | 0.072 | ||
| Major AEs | 142 | 10.2 | 685 | 15.5 | 375 | 12.8 | 0.6 (0.5–0.8) | 0.8 (0.6–1.0) | < 0.001 | 0.016 |
| Anaphylaxis | 20 | 1.4 | 66 | 1.5 | 47 | 1.6 | 0.892 | 0.688 | ||
| Marked difficulty in breathing | 46 | 3.3 | 135 | 3.0 | 77 | 2.6 | 0.622 | 0.204 | ||
| Throat closure | 24 | 1.7 | 63 | 1.4 | 38 | 1.3 | 0.413 | 0.263 | ||
| Severe rashes | 42 | 3.0 | 108 | 2.4 | 54 | 1.8 | 1.7 (1.1–2.5) | 0.23 | 0.014 | |
| Hospitalization | 41 | 2.9 | 201 | 4.5 | 77 | 2.6 | 0.6 (0.5–0.9) | 0.01 | 0.536 | |
AE adverse event, CI confidence interval, HC healthy control, IIM idiopathic inflammatory myopathy, OR odds ratio, SAID systemic autoimmune and inflammatory disease
#Significant in BLR (binary logistic regression) adjusted for age, gender, ethnicity, immunosuppressant dose, and stratified by country
OR 1 and 2 compares AEs between IIM and SAIDs, and IIM and HCs, respectively