| Flare (patient self-reported) . | Total IIM (n = 1278) . | IIM patients with flare following vaccination (n = 123), N (%) . | IIM patients without flare following vaccination (n = 1155), N (%) . | P . |
|---|---|---|---|---|
| Age, mean (s.d.), years | 60.6 (14.3) | 54.6 (14.0) | 60.6 (14.2) | <0.001 |
| Age, median (IQR), years | 63 (50–71) | 55 (46–66) | 64 (51–71) | <0.001 |
| Gender | 0.001 | |||
| Male | 373 (29.2) | 17 (13.8) | 356 (30.8) | |
| Female | 899 (70.3) | 105 (85.4) | 794 (68.7) | |
| Ethnicity | 0.009 | |||
| Caucasian | 1032 (80.8) | 88 (71.5) | 944 (81.7) | |
| Asian | 92 (7.2) | 11 (8.9) | 81 (7.0) | |
| Native American | 2 (0.2) | 1 (0.8) | 1 (0.1) | |
| African American or African origin | 48 (3.8) | 7 (5.7) | 41 (3.5) | |
| Hispanic | 52 (4.1) | 8 (6.5) | 44 (3.8) | |
| Mixed | 22 (1.7) | 6 (4.9) | 16 (1.4) | |
| Others | 15 (1.2) | 2 (1.6) | 13 (1.1) | |
| I do not want to disclose | 15 (1.2) | 0 (0) | 15 (1.3) | |
| Type of vaccine taken (first and second dose) | 0.017 | |||
| Pfizer | 639 (50.0) | 65 (52.8) | 574 (49.7) | |
| Moderna | 420 (32.9) | 40 (32.5) | 380 (32.9) | |
| Oxford | 137 (10.7) | 8 (6.5) | 129 (11.2) | |
| Sinopharm | 17 (1.3) | 0 (0) | 17 (1.5) | |
| Covishield | 10 (0.8) | 2 (1.6) | 8 (0.7) | |
| Covaxin | 3 (0.2) | 0 (0) | 3 (0.3) | |
| Sputnik | 1 (0.1) | 0 (0) | 1 (0.1) | |
| Johnson and Johnson | 23 (1.8) | 1 (0.8) | 22 (1.9) | |
| IS received prior to vaccination | ||||
| MTX | 283 (22.1) | 28 (22.8) | 255 (22.1) | 0.862 |
| MMF | 239 (18.7) | 23 (18.7) | 216 (18.7) | 1.000 |
| AZA | 123 (9.6) | 6 (4.9) | 117 (10.1) | 0.060 |
| HCQ | 204 (16.0) | 18 (14.6) | 186 (16.1) | 0.672 |
| SSZ | 14 (1.1) | 3 (2.4) | 11 (1.0) | 0.132 |
| LEF | 8 (0.6) | 2 (1.6) | 6 (0.5) | 0.139 |
| Oral tacrolimus | 23 (1.8) | 4 (3.3) | 19 (1.6) | 0.202 |
| Ciclosporin | 28 (2.2) | 3 (2.4) | 25 (2.2) | 0.843 |
| IVIGs | 181 (14.2) | 13 (10.6) | 168 (14.5) | 0.229 |
| CYC | 12 (0.9) | 0 (0) | 12 (1.0) | 0.256 |
| Rituximab | 138 (10.8) | 7 (5.7) | 131 (11.3) | 0.055 |
| Anti-TNF agents | 13 (1.0) | 5 (4.1) | 8 (0.7) | <0.001 |
| JAK inhibitors | 14 (1.1) | 2 (1.6) | 12 (1.0) | 0.552 |
| Glucocorticoids (prednisolone equivalents) | 0.766 | |||
| None | 749 (58.6) | 77 (62.6) | 672 (58.2) | |
| <10 mg a day | 344 (26.9) | 30 (24.4) | 314 (27.2) | |
| 10–20 mg a day | 104 (8.1) | 8 (6.5) | 96 (8.3) | |
| >20 mg a day | 81 (6.3) | 8 (6.5) | 73 (6.3) | |
| Comorbidities | ||||
| Asthma | 181 (14.2) | 27 (22.0) | 154 (13.3) | 0.009 |
| CKD | 45 (3.5) | 5 (4.1) | 40 (88.9) | 0.731 |
| CLD | 17 (1.3) | 3 (2.4) | 14 (1.2) | 0.259 |
| COPD | 48 (3.8) | 6 (4.9) | 42 (3.6) | 0.491 |
| ILD | 229 (17.9) | 25 (20.3) | 204 (17.7) | 0.464 |
| CAD | 107 (8.4) | 6 (4.9) | 101 (8.7) | 0.141 |
| Diabetes mellitus | 176 (13.8) | 10 (8.1) | 166 (14.4) | 0.056 |
| Epilepsy | 7 (0.5) | 0 (0) | 7 (0.6) | 0.387 |
| Dyslipidaemia | 324 (25.4) | 26 (21.1) | 298 (25.8) | 0.258 |
| HIV-AIDS | 7 (0.5) | 0 (0) | 7 (0.6) | 0.387 |
| Hypertension | 420 (32.9) | 33 (26.8) | 387 (33.5) | 0.134 |
| Stroke | 25 (2.0) | 2 (1.6) | 23 (2.0) | 0.781 |
| Tuberculosis | 6 (0.5) | 1 (0.8) | 5 (0.4) | 0.558 |
| Organ transplant | 2 (0.2) | 0 (0) | 2 (0.2) | 0.644 |
| Mental health disorders | 429 (33.6) | 59 (48.0) | 370 (32.0) | <0.001 |
| Anxiety | 270 (21.1) | 43 (35.0) | 227 (19.7) | <0.001 |
| Bipolar disorder | 14 (1.1) | 3 (2.4) | 11 (1.0) | 0.132 |
| Depression | 246 (19.2) | 33 (26.8) | 213 (18.4) | 0.025 |
| Eating disorder | 17 (1.3) | 3 (2.4) | 14 (1.2) | 0.259 |
| Insomnia | 104 (8.1) | 19 (15.4) | 85 (7.4) | 0.002 |
| Schizophrenia | 1 (0.1) | 0 (0) | 1 (0.1) | 0.744 |
| Substance use disorders | 4 (0.3) | 1 (0.3) | 1 (0.8) | 0.296 |
| AID comorbidities | ||||
| Yes | 373 (29.2) | 51 (41.5) | 322 (27.9) | 0.002 |
| IIM subtypes | 0.054 | |||
| ASSD | 70 (5.5) | 5 (4.1) | 65 (5.6) | |
| DM | 272 (21.3) | 35 (28.5) | 237 (20.5) | 0.042 |
| IBM | 235 (18.4) | 10 (8.1) | 225 (19.5) | 0.002 |
| JDM | 4 (0.3) | 1 (0.8) | 2 (0.3) | |
| NAM | 57 (4.5) | 5 (4.1) | 52 (4.5) | |
| PM | 173 (13.5) | 20 (16.3) | 153 (13.2) | |
| OM | 461 (36.1) | 46 (37.4) | 415 (35.9) | |
| COVID-19 antibody status | ||||
| Antibodies present | 47/68 (69.1) | 9/14 (64.2) | 38/54 (70.3) | 0.661 |
| PROMIS PF10a, median (IQR) | ||||
| Global physical health score | 12.0 (11–14) | 13.0 (11–14) | 12.0 (10–14) | 0.086 |
| Global mental health score | 13.0 (10–15) | 12.0 (10–14) | 13.0 (11–15) | 0.001 |
| Fatigue VAS | 3 (3–4) | 3 (2–3) | 3 (3–4) | <0.001 |
| Pain VAS | 3 (3–5) | 4 (2–6) | 3 (3–5) | <0.001 |
| Disease activity status before first dose of vaccine | ||||
| Overall active disease | 857/1083 (79.1) | 61/91 (67.0) | 796/993 (80.1) | <0.001 |
| Disease was inactive/remission | 246 (19.2) | 37 (30.1) | 209 (18.1) | 0.001 |
| Disease was active and worsening | 204 (12.1) | 9 (7.3) | 195 (16.9) | 0.006 |
| Disease was active but stable | 599 (46.9) | 48 (39.0) | 551 (47.7) | 0.067 |
| Disease was active and improving | 76 (5.9) | 11 (8.9) | 65 (5.6) | 0.139 |
| I am not sure | 107 (8.4) | 13 (10.6) | 94 (8.1) | 0.355 |
| Flare (patient self-reported) . | Total IIM (n = 1278) . | IIM patients with flare following vaccination (n = 123), N (%) . | IIM patients without flare following vaccination (n = 1155), N (%) . | P . |
|---|---|---|---|---|
| Age, mean (s.d.), years | 60.6 (14.3) | 54.6 (14.0) | 60.6 (14.2) | <0.001 |
| Age, median (IQR), years | 63 (50–71) | 55 (46–66) | 64 (51–71) | <0.001 |
| Gender | 0.001 | |||
| Male | 373 (29.2) | 17 (13.8) | 356 (30.8) | |
| Female | 899 (70.3) | 105 (85.4) | 794 (68.7) | |
| Ethnicity | 0.009 | |||
| Caucasian | 1032 (80.8) | 88 (71.5) | 944 (81.7) | |
| Asian | 92 (7.2) | 11 (8.9) | 81 (7.0) | |
| Native American | 2 (0.2) | 1 (0.8) | 1 (0.1) | |
| African American or African origin | 48 (3.8) | 7 (5.7) | 41 (3.5) | |
| Hispanic | 52 (4.1) | 8 (6.5) | 44 (3.8) | |
| Mixed | 22 (1.7) | 6 (4.9) | 16 (1.4) | |
| Others | 15 (1.2) | 2 (1.6) | 13 (1.1) | |
| I do not want to disclose | 15 (1.2) | 0 (0) | 15 (1.3) | |
| Type of vaccine taken (first and second dose) | 0.017 | |||
| Pfizer | 639 (50.0) | 65 (52.8) | 574 (49.7) | |
| Moderna | 420 (32.9) | 40 (32.5) | 380 (32.9) | |
| Oxford | 137 (10.7) | 8 (6.5) | 129 (11.2) | |
| Sinopharm | 17 (1.3) | 0 (0) | 17 (1.5) | |
| Covishield | 10 (0.8) | 2 (1.6) | 8 (0.7) | |
| Covaxin | 3 (0.2) | 0 (0) | 3 (0.3) | |
| Sputnik | 1 (0.1) | 0 (0) | 1 (0.1) | |
| Johnson and Johnson | 23 (1.8) | 1 (0.8) | 22 (1.9) | |
| IS received prior to vaccination | ||||
| MTX | 283 (22.1) | 28 (22.8) | 255 (22.1) | 0.862 |
| MMF | 239 (18.7) | 23 (18.7) | 216 (18.7) | 1.000 |
| AZA | 123 (9.6) | 6 (4.9) | 117 (10.1) | 0.060 |
| HCQ | 204 (16.0) | 18 (14.6) | 186 (16.1) | 0.672 |
| SSZ | 14 (1.1) | 3 (2.4) | 11 (1.0) | 0.132 |
| LEF | 8 (0.6) | 2 (1.6) | 6 (0.5) | 0.139 |
| Oral tacrolimus | 23 (1.8) | 4 (3.3) | 19 (1.6) | 0.202 |
| Ciclosporin | 28 (2.2) | 3 (2.4) | 25 (2.2) | 0.843 |
| IVIGs | 181 (14.2) | 13 (10.6) | 168 (14.5) | 0.229 |
| CYC | 12 (0.9) | 0 (0) | 12 (1.0) | 0.256 |
| Rituximab | 138 (10.8) | 7 (5.7) | 131 (11.3) | 0.055 |
| Anti-TNF agents | 13 (1.0) | 5 (4.1) | 8 (0.7) | <0.001 |
| JAK inhibitors | 14 (1.1) | 2 (1.6) | 12 (1.0) | 0.552 |
| Glucocorticoids (prednisolone equivalents) | 0.766 | |||
| None | 749 (58.6) | 77 (62.6) | 672 (58.2) | |
| <10 mg a day | 344 (26.9) | 30 (24.4) | 314 (27.2) | |
| 10–20 mg a day | 104 (8.1) | 8 (6.5) | 96 (8.3) | |
| >20 mg a day | 81 (6.3) | 8 (6.5) | 73 (6.3) | |
| Comorbidities | ||||
| Asthma | 181 (14.2) | 27 (22.0) | 154 (13.3) | 0.009 |
| CKD | 45 (3.5) | 5 (4.1) | 40 (88.9) | 0.731 |
| CLD | 17 (1.3) | 3 (2.4) | 14 (1.2) | 0.259 |
| COPD | 48 (3.8) | 6 (4.9) | 42 (3.6) | 0.491 |
| ILD | 229 (17.9) | 25 (20.3) | 204 (17.7) | 0.464 |
| CAD | 107 (8.4) | 6 (4.9) | 101 (8.7) | 0.141 |
| Diabetes mellitus | 176 (13.8) | 10 (8.1) | 166 (14.4) | 0.056 |
| Epilepsy | 7 (0.5) | 0 (0) | 7 (0.6) | 0.387 |
| Dyslipidaemia | 324 (25.4) | 26 (21.1) | 298 (25.8) | 0.258 |
| HIV-AIDS | 7 (0.5) | 0 (0) | 7 (0.6) | 0.387 |
| Hypertension | 420 (32.9) | 33 (26.8) | 387 (33.5) | 0.134 |
| Stroke | 25 (2.0) | 2 (1.6) | 23 (2.0) | 0.781 |
| Tuberculosis | 6 (0.5) | 1 (0.8) | 5 (0.4) | 0.558 |
| Organ transplant | 2 (0.2) | 0 (0) | 2 (0.2) | 0.644 |
| Mental health disorders | 429 (33.6) | 59 (48.0) | 370 (32.0) | <0.001 |
| Anxiety | 270 (21.1) | 43 (35.0) | 227 (19.7) | <0.001 |
| Bipolar disorder | 14 (1.1) | 3 (2.4) | 11 (1.0) | 0.132 |
| Depression | 246 (19.2) | 33 (26.8) | 213 (18.4) | 0.025 |
| Eating disorder | 17 (1.3) | 3 (2.4) | 14 (1.2) | 0.259 |
| Insomnia | 104 (8.1) | 19 (15.4) | 85 (7.4) | 0.002 |
| Schizophrenia | 1 (0.1) | 0 (0) | 1 (0.1) | 0.744 |
| Substance use disorders | 4 (0.3) | 1 (0.3) | 1 (0.8) | 0.296 |
| AID comorbidities | ||||
| Yes | 373 (29.2) | 51 (41.5) | 322 (27.9) | 0.002 |
| IIM subtypes | 0.054 | |||
| ASSD | 70 (5.5) | 5 (4.1) | 65 (5.6) | |
| DM | 272 (21.3) | 35 (28.5) | 237 (20.5) | 0.042 |
| IBM | 235 (18.4) | 10 (8.1) | 225 (19.5) | 0.002 |
| JDM | 4 (0.3) | 1 (0.8) | 2 (0.3) | |
| NAM | 57 (4.5) | 5 (4.1) | 52 (4.5) | |
| PM | 173 (13.5) | 20 (16.3) | 153 (13.2) | |
| OM | 461 (36.1) | 46 (37.4) | 415 (35.9) | |
| COVID-19 antibody status | ||||
| Antibodies present | 47/68 (69.1) | 9/14 (64.2) | 38/54 (70.3) | 0.661 |
| PROMIS PF10a, median (IQR) | ||||
| Global physical health score | 12.0 (11–14) | 13.0 (11–14) | 12.0 (10–14) | 0.086 |
| Global mental health score | 13.0 (10–15) | 12.0 (10–14) | 13.0 (11–15) | 0.001 |
| Fatigue VAS | 3 (3–4) | 3 (2–3) | 3 (3–4) | <0.001 |
| Pain VAS | 3 (3–5) | 4 (2–6) | 3 (3–5) | <0.001 |
| Disease activity status before first dose of vaccine | ||||
| Overall active disease | 857/1083 (79.1) | 61/91 (67.0) | 796/993 (80.1) | <0.001 |
| Disease was inactive/remission | 246 (19.2) | 37 (30.1) | 209 (18.1) | 0.001 |
| Disease was active and worsening | 204 (12.1) | 9 (7.3) | 195 (16.9) | 0.006 |
| Disease was active but stable | 599 (46.9) | 48 (39.0) | 551 (47.7) | 0.067 |
| Disease was active and improving | 76 (5.9) | 11 (8.9) | 65 (5.6) | 0.139 |
| I am not sure | 107 (8.4) | 13 (10.6) | 94 (8.1) | 0.355 |
IIM: idiopathic inflammatory myopathies; IQR: interquartile range; IS: immunosuppression; JAK: janus kinase; CKD: chronic kidney disease; CLD: chronic liver disease; COPD: chronic obstructive pulmonary disorder; ILD: interstitial lung disease; CAD: coronary artery disease/ischemic heart disease (history of any heart attack, congestive heart failure, bypass surgery, or any heart stent in the past); HIV-AIDS: human immunodeficiency virus-acquired immunodeficiency syndrome; AID: autoimmune disease; ASSD: anti-synthetase syndrome; NAM: necrotizing myositis; OM: overlap myositis; COVID-19: coronavirus disease 2019; PROMIS PF10a: Patient-Reported Outcomes Measurement Information System 10 Item Patient-Reported Measure of Physical Function; VAS: visual analogue score.
| Flare (patient self-reported) . | Total IIM (n = 1278) . | IIM patients with flare following vaccination (n = 123), N (%) . | IIM patients without flare following vaccination (n = 1155), N (%) . | P . |
|---|---|---|---|---|
| Age, mean (s.d.), years | 60.6 (14.3) | 54.6 (14.0) | 60.6 (14.2) | <0.001 |
| Age, median (IQR), years | 63 (50–71) | 55 (46–66) | 64 (51–71) | <0.001 |
| Gender | 0.001 | |||
| Male | 373 (29.2) | 17 (13.8) | 356 (30.8) | |
| Female | 899 (70.3) | 105 (85.4) | 794 (68.7) | |
| Ethnicity | 0.009 | |||
| Caucasian | 1032 (80.8) | 88 (71.5) | 944 (81.7) | |
| Asian | 92 (7.2) | 11 (8.9) | 81 (7.0) | |
| Native American | 2 (0.2) | 1 (0.8) | 1 (0.1) | |
| African American or African origin | 48 (3.8) | 7 (5.7) | 41 (3.5) | |
| Hispanic | 52 (4.1) | 8 (6.5) | 44 (3.8) | |
| Mixed | 22 (1.7) | 6 (4.9) | 16 (1.4) | |
| Others | 15 (1.2) | 2 (1.6) | 13 (1.1) | |
| I do not want to disclose | 15 (1.2) | 0 (0) | 15 (1.3) | |
| Type of vaccine taken (first and second dose) | 0.017 | |||
| Pfizer | 639 (50.0) | 65 (52.8) | 574 (49.7) | |
| Moderna | 420 (32.9) | 40 (32.5) | 380 (32.9) | |
| Oxford | 137 (10.7) | 8 (6.5) | 129 (11.2) | |
| Sinopharm | 17 (1.3) | 0 (0) | 17 (1.5) | |
| Covishield | 10 (0.8) | 2 (1.6) | 8 (0.7) | |
| Covaxin | 3 (0.2) | 0 (0) | 3 (0.3) | |
| Sputnik | 1 (0.1) | 0 (0) | 1 (0.1) | |
| Johnson and Johnson | 23 (1.8) | 1 (0.8) | 22 (1.9) | |
| IS received prior to vaccination | ||||
| MTX | 283 (22.1) | 28 (22.8) | 255 (22.1) | 0.862 |
| MMF | 239 (18.7) | 23 (18.7) | 216 (18.7) | 1.000 |
| AZA | 123 (9.6) | 6 (4.9) | 117 (10.1) | 0.060 |
| HCQ | 204 (16.0) | 18 (14.6) | 186 (16.1) | 0.672 |
| SSZ | 14 (1.1) | 3 (2.4) | 11 (1.0) | 0.132 |
| LEF | 8 (0.6) | 2 (1.6) | 6 (0.5) | 0.139 |
| Oral tacrolimus | 23 (1.8) | 4 (3.3) | 19 (1.6) | 0.202 |
| Ciclosporin | 28 (2.2) | 3 (2.4) | 25 (2.2) | 0.843 |
| IVIGs | 181 (14.2) | 13 (10.6) | 168 (14.5) | 0.229 |
| CYC | 12 (0.9) | 0 (0) | 12 (1.0) | 0.256 |
| Rituximab | 138 (10.8) | 7 (5.7) | 131 (11.3) | 0.055 |
| Anti-TNF agents | 13 (1.0) | 5 (4.1) | 8 (0.7) | <0.001 |
| JAK inhibitors | 14 (1.1) | 2 (1.6) | 12 (1.0) | 0.552 |
| Glucocorticoids (prednisolone equivalents) | 0.766 | |||
| None | 749 (58.6) | 77 (62.6) | 672 (58.2) | |
| <10 mg a day | 344 (26.9) | 30 (24.4) | 314 (27.2) | |
| 10–20 mg a day | 104 (8.1) | 8 (6.5) | 96 (8.3) | |
| >20 mg a day | 81 (6.3) | 8 (6.5) | 73 (6.3) | |
| Comorbidities | ||||
| Asthma | 181 (14.2) | 27 (22.0) | 154 (13.3) | 0.009 |
| CKD | 45 (3.5) | 5 (4.1) | 40 (88.9) | 0.731 |
| CLD | 17 (1.3) | 3 (2.4) | 14 (1.2) | 0.259 |
| COPD | 48 (3.8) | 6 (4.9) | 42 (3.6) | 0.491 |
| ILD | 229 (17.9) | 25 (20.3) | 204 (17.7) | 0.464 |
| CAD | 107 (8.4) | 6 (4.9) | 101 (8.7) | 0.141 |
| Diabetes mellitus | 176 (13.8) | 10 (8.1) | 166 (14.4) | 0.056 |
| Epilepsy | 7 (0.5) | 0 (0) | 7 (0.6) | 0.387 |
| Dyslipidaemia | 324 (25.4) | 26 (21.1) | 298 (25.8) | 0.258 |
| HIV-AIDS | 7 (0.5) | 0 (0) | 7 (0.6) | 0.387 |
| Hypertension | 420 (32.9) | 33 (26.8) | 387 (33.5) | 0.134 |
| Stroke | 25 (2.0) | 2 (1.6) | 23 (2.0) | 0.781 |
| Tuberculosis | 6 (0.5) | 1 (0.8) | 5 (0.4) | 0.558 |
| Organ transplant | 2 (0.2) | 0 (0) | 2 (0.2) | 0.644 |
| Mental health disorders | 429 (33.6) | 59 (48.0) | 370 (32.0) | <0.001 |
| Anxiety | 270 (21.1) | 43 (35.0) | 227 (19.7) | <0.001 |
| Bipolar disorder | 14 (1.1) | 3 (2.4) | 11 (1.0) | 0.132 |
| Depression | 246 (19.2) | 33 (26.8) | 213 (18.4) | 0.025 |
| Eating disorder | 17 (1.3) | 3 (2.4) | 14 (1.2) | 0.259 |
| Insomnia | 104 (8.1) | 19 (15.4) | 85 (7.4) | 0.002 |
| Schizophrenia | 1 (0.1) | 0 (0) | 1 (0.1) | 0.744 |
| Substance use disorders | 4 (0.3) | 1 (0.3) | 1 (0.8) | 0.296 |
| AID comorbidities | ||||
| Yes | 373 (29.2) | 51 (41.5) | 322 (27.9) | 0.002 |
| IIM subtypes | 0.054 | |||
| ASSD | 70 (5.5) | 5 (4.1) | 65 (5.6) | |
| DM | 272 (21.3) | 35 (28.5) | 237 (20.5) | 0.042 |
| IBM | 235 (18.4) | 10 (8.1) | 225 (19.5) | 0.002 |
| JDM | 4 (0.3) | 1 (0.8) | 2 (0.3) | |
| NAM | 57 (4.5) | 5 (4.1) | 52 (4.5) | |
| PM | 173 (13.5) | 20 (16.3) | 153 (13.2) | |
| OM | 461 (36.1) | 46 (37.4) | 415 (35.9) | |
| COVID-19 antibody status | ||||
| Antibodies present | 47/68 (69.1) | 9/14 (64.2) | 38/54 (70.3) | 0.661 |
| PROMIS PF10a, median (IQR) | ||||
| Global physical health score | 12.0 (11–14) | 13.0 (11–14) | 12.0 (10–14) | 0.086 |
| Global mental health score | 13.0 (10–15) | 12.0 (10–14) | 13.0 (11–15) | 0.001 |
| Fatigue VAS | 3 (3–4) | 3 (2–3) | 3 (3–4) | <0.001 |
| Pain VAS | 3 (3–5) | 4 (2–6) | 3 (3–5) | <0.001 |
| Disease activity status before first dose of vaccine | ||||
| Overall active disease | 857/1083 (79.1) | 61/91 (67.0) | 796/993 (80.1) | <0.001 |
| Disease was inactive/remission | 246 (19.2) | 37 (30.1) | 209 (18.1) | 0.001 |
| Disease was active and worsening | 204 (12.1) | 9 (7.3) | 195 (16.9) | 0.006 |
| Disease was active but stable | 599 (46.9) | 48 (39.0) | 551 (47.7) | 0.067 |
| Disease was active and improving | 76 (5.9) | 11 (8.9) | 65 (5.6) | 0.139 |
| I am not sure | 107 (8.4) | 13 (10.6) | 94 (8.1) | 0.355 |
| Flare (patient self-reported) . | Total IIM (n = 1278) . | IIM patients with flare following vaccination (n = 123), N (%) . | IIM patients without flare following vaccination (n = 1155), N (%) . | P . |
|---|---|---|---|---|
| Age, mean (s.d.), years | 60.6 (14.3) | 54.6 (14.0) | 60.6 (14.2) | <0.001 |
| Age, median (IQR), years | 63 (50–71) | 55 (46–66) | 64 (51–71) | <0.001 |
| Gender | 0.001 | |||
| Male | 373 (29.2) | 17 (13.8) | 356 (30.8) | |
| Female | 899 (70.3) | 105 (85.4) | 794 (68.7) | |
| Ethnicity | 0.009 | |||
| Caucasian | 1032 (80.8) | 88 (71.5) | 944 (81.7) | |
| Asian | 92 (7.2) | 11 (8.9) | 81 (7.0) | |
| Native American | 2 (0.2) | 1 (0.8) | 1 (0.1) | |
| African American or African origin | 48 (3.8) | 7 (5.7) | 41 (3.5) | |
| Hispanic | 52 (4.1) | 8 (6.5) | 44 (3.8) | |
| Mixed | 22 (1.7) | 6 (4.9) | 16 (1.4) | |
| Others | 15 (1.2) | 2 (1.6) | 13 (1.1) | |
| I do not want to disclose | 15 (1.2) | 0 (0) | 15 (1.3) | |
| Type of vaccine taken (first and second dose) | 0.017 | |||
| Pfizer | 639 (50.0) | 65 (52.8) | 574 (49.7) | |
| Moderna | 420 (32.9) | 40 (32.5) | 380 (32.9) | |
| Oxford | 137 (10.7) | 8 (6.5) | 129 (11.2) | |
| Sinopharm | 17 (1.3) | 0 (0) | 17 (1.5) | |
| Covishield | 10 (0.8) | 2 (1.6) | 8 (0.7) | |
| Covaxin | 3 (0.2) | 0 (0) | 3 (0.3) | |
| Sputnik | 1 (0.1) | 0 (0) | 1 (0.1) | |
| Johnson and Johnson | 23 (1.8) | 1 (0.8) | 22 (1.9) | |
| IS received prior to vaccination | ||||
| MTX | 283 (22.1) | 28 (22.8) | 255 (22.1) | 0.862 |
| MMF | 239 (18.7) | 23 (18.7) | 216 (18.7) | 1.000 |
| AZA | 123 (9.6) | 6 (4.9) | 117 (10.1) | 0.060 |
| HCQ | 204 (16.0) | 18 (14.6) | 186 (16.1) | 0.672 |
| SSZ | 14 (1.1) | 3 (2.4) | 11 (1.0) | 0.132 |
| LEF | 8 (0.6) | 2 (1.6) | 6 (0.5) | 0.139 |
| Oral tacrolimus | 23 (1.8) | 4 (3.3) | 19 (1.6) | 0.202 |
| Ciclosporin | 28 (2.2) | 3 (2.4) | 25 (2.2) | 0.843 |
| IVIGs | 181 (14.2) | 13 (10.6) | 168 (14.5) | 0.229 |
| CYC | 12 (0.9) | 0 (0) | 12 (1.0) | 0.256 |
| Rituximab | 138 (10.8) | 7 (5.7) | 131 (11.3) | 0.055 |
| Anti-TNF agents | 13 (1.0) | 5 (4.1) | 8 (0.7) | <0.001 |
| JAK inhibitors | 14 (1.1) | 2 (1.6) | 12 (1.0) | 0.552 |
| Glucocorticoids (prednisolone equivalents) | 0.766 | |||
| None | 749 (58.6) | 77 (62.6) | 672 (58.2) | |
| <10 mg a day | 344 (26.9) | 30 (24.4) | 314 (27.2) | |
| 10–20 mg a day | 104 (8.1) | 8 (6.5) | 96 (8.3) | |
| >20 mg a day | 81 (6.3) | 8 (6.5) | 73 (6.3) | |
| Comorbidities | ||||
| Asthma | 181 (14.2) | 27 (22.0) | 154 (13.3) | 0.009 |
| CKD | 45 (3.5) | 5 (4.1) | 40 (88.9) | 0.731 |
| CLD | 17 (1.3) | 3 (2.4) | 14 (1.2) | 0.259 |
| COPD | 48 (3.8) | 6 (4.9) | 42 (3.6) | 0.491 |
| ILD | 229 (17.9) | 25 (20.3) | 204 (17.7) | 0.464 |
| CAD | 107 (8.4) | 6 (4.9) | 101 (8.7) | 0.141 |
| Diabetes mellitus | 176 (13.8) | 10 (8.1) | 166 (14.4) | 0.056 |
| Epilepsy | 7 (0.5) | 0 (0) | 7 (0.6) | 0.387 |
| Dyslipidaemia | 324 (25.4) | 26 (21.1) | 298 (25.8) | 0.258 |
| HIV-AIDS | 7 (0.5) | 0 (0) | 7 (0.6) | 0.387 |
| Hypertension | 420 (32.9) | 33 (26.8) | 387 (33.5) | 0.134 |
| Stroke | 25 (2.0) | 2 (1.6) | 23 (2.0) | 0.781 |
| Tuberculosis | 6 (0.5) | 1 (0.8) | 5 (0.4) | 0.558 |
| Organ transplant | 2 (0.2) | 0 (0) | 2 (0.2) | 0.644 |
| Mental health disorders | 429 (33.6) | 59 (48.0) | 370 (32.0) | <0.001 |
| Anxiety | 270 (21.1) | 43 (35.0) | 227 (19.7) | <0.001 |
| Bipolar disorder | 14 (1.1) | 3 (2.4) | 11 (1.0) | 0.132 |
| Depression | 246 (19.2) | 33 (26.8) | 213 (18.4) | 0.025 |
| Eating disorder | 17 (1.3) | 3 (2.4) | 14 (1.2) | 0.259 |
| Insomnia | 104 (8.1) | 19 (15.4) | 85 (7.4) | 0.002 |
| Schizophrenia | 1 (0.1) | 0 (0) | 1 (0.1) | 0.744 |
| Substance use disorders | 4 (0.3) | 1 (0.3) | 1 (0.8) | 0.296 |
| AID comorbidities | ||||
| Yes | 373 (29.2) | 51 (41.5) | 322 (27.9) | 0.002 |
| IIM subtypes | 0.054 | |||
| ASSD | 70 (5.5) | 5 (4.1) | 65 (5.6) | |
| DM | 272 (21.3) | 35 (28.5) | 237 (20.5) | 0.042 |
| IBM | 235 (18.4) | 10 (8.1) | 225 (19.5) | 0.002 |
| JDM | 4 (0.3) | 1 (0.8) | 2 (0.3) | |
| NAM | 57 (4.5) | 5 (4.1) | 52 (4.5) | |
| PM | 173 (13.5) | 20 (16.3) | 153 (13.2) | |
| OM | 461 (36.1) | 46 (37.4) | 415 (35.9) | |
| COVID-19 antibody status | ||||
| Antibodies present | 47/68 (69.1) | 9/14 (64.2) | 38/54 (70.3) | 0.661 |
| PROMIS PF10a, median (IQR) | ||||
| Global physical health score | 12.0 (11–14) | 13.0 (11–14) | 12.0 (10–14) | 0.086 |
| Global mental health score | 13.0 (10–15) | 12.0 (10–14) | 13.0 (11–15) | 0.001 |
| Fatigue VAS | 3 (3–4) | 3 (2–3) | 3 (3–4) | <0.001 |
| Pain VAS | 3 (3–5) | 4 (2–6) | 3 (3–5) | <0.001 |
| Disease activity status before first dose of vaccine | ||||
| Overall active disease | 857/1083 (79.1) | 61/91 (67.0) | 796/993 (80.1) | <0.001 |
| Disease was inactive/remission | 246 (19.2) | 37 (30.1) | 209 (18.1) | 0.001 |
| Disease was active and worsening | 204 (12.1) | 9 (7.3) | 195 (16.9) | 0.006 |
| Disease was active but stable | 599 (46.9) | 48 (39.0) | 551 (47.7) | 0.067 |
| Disease was active and improving | 76 (5.9) | 11 (8.9) | 65 (5.6) | 0.139 |
| I am not sure | 107 (8.4) | 13 (10.6) | 94 (8.1) | 0.355 |
IIM: idiopathic inflammatory myopathies; IQR: interquartile range; IS: immunosuppression; JAK: janus kinase; CKD: chronic kidney disease; CLD: chronic liver disease; COPD: chronic obstructive pulmonary disorder; ILD: interstitial lung disease; CAD: coronary artery disease/ischemic heart disease (history of any heart attack, congestive heart failure, bypass surgery, or any heart stent in the past); HIV-AIDS: human immunodeficiency virus-acquired immunodeficiency syndrome; AID: autoimmune disease; ASSD: anti-synthetase syndrome; NAM: necrotizing myositis; OM: overlap myositis; COVID-19: coronavirus disease 2019; PROMIS PF10a: Patient-Reported Outcomes Measurement Information System 10 Item Patient-Reported Measure of Physical Function; VAS: visual analogue score.
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