Rheumatology International Rheumatology https://doi.org/10.1007/s00296-023-05345-y INTERNATIONAL OBSERVATIONAL RESEARCH Long‑term safety of COVID vaccination in individuals with idiopathic inflammatory myopathies: results from the COVAD study Bohdana Doskaliuk1  · Naveen Ravichandran2  · Parikshit Sen3  · Jessica Day4,5,6  · Mrudula Joshi7  · Arvind Nune8  · Elena Nikiphorou9,10  · Sreoshy Saha11  · Ai Lyn Tan12,13  · Samuel Katsuyuki Shinjo14  · Nelly Ziade15,16  · Tsvetelina Velikova17  · Marcin Milchert18  · Kshitij Jagtap19  · Ioannis Parodis20,21  · Abraham Edgar Gracia‑Ramos22  · Lorenzo Cavagna23  · Masataka Kuwana24  · Johannes Knitza25  · Yi Ming Chen26,27  · Ashima Makol28  · Vishwesh Agarwal29  · Aarat Patel30 · John D. Pauling31,32  · Chris Wincup33,34  · Bhupen Barman35  · Erick Adrian Zamora Tehozol36  · Jorge Rojas Serrano37  · Ignacio García‑De La Torre38  · Iris J. Colunga‑Pedraza39  · Javier Merayo‑Chalico40  · Okwara Celestine Chibuzo41  · Wanruchada Katchamart42  · Phonpen Akarawatcharangura Goo43  · Russka Shumnalieva44  · Leonardo Santos Hoff45  · Lina El Kibbi46  · Hussein Halabi47  · Binit Vaidya48  · Syahrul Sazliyana Shaharir49  · A. T. M. Tanveer Hasan50  · Dzifa Dey51  · Carlos Enrique Toro Gutiérrez52  · Carlo V. Caballero‑Uribe53  · James B. Lilleker54,55  · Babur Salim56  · Tamer Gheita57  · Tulika Chatterjee58  · Oliver Distler59  · Miguel A. Saavedra60  · COVAD study group · Hector Chinoy54,61,62  · Vikas Agarwal2  · Rohit Aggarwal63  · Latika Gupta54,64,65 Received: 18 April 2023 / Accepted: 10 May 2023 © The Author(s) 2023 Abstract Limited evidence on long-term COVID-19 vaccine safety in patients with idiopathic inflammatory myopathies (IIMs) continues to contribute to vaccine hesitancy. We studied delayed-onset vaccine adverse events (AEs) in patients with IIMs, other systemic autoimmune and inflammatory disorders (SAIDs), and healthy controls (HCs), using data from the second COVID-19 Vaccination in Autoimmune Diseases (COVAD) study. A validated self-reporting e-survey was circulated by the COVAD study group (157 collaborators, 106 countries) from Feb–June 2022. We collected data on demographics, comor- bidities, IIM/SAID details, COVID-19 history, and vaccination details. Delayed-onset (> 7 day) AEs were analyzed using regression models. A total of 15165 respondents undertook the survey, of whom 8759 responses from vaccinated individuals [median age 46 (35–58) years, 74.4% females, 45.4% Caucasians] were analyzed. Of these, 1390 (15.9%) had IIMs, 50.6% other SAIDs, and 33.5% HCs. Among IIMs, 16.3% and 10.2% patients reported minor and major AEs, respectively, and 0.72% (n = 10) required hospitalization. Notably patients with IIMs experienced fewer minor AEs than other SAIDs, though rashes were expectedly more than HCs [OR 4.0; 95% CI 2.2–7.0, p < 0.001]. IIM patients with active disease, overlap myosi- tis, autoimmune comorbidities, and ChadOx1 nCOV-19 (Oxford/AstraZeneca) recipients reported AEs more often, while those with inclusion body myositis, and BNT162b2 (Pfizer) recipients reported fewer AEs. Vaccination is reassuringly safe in individuals with IIMs, with AEs, hospitalizations comparable to SAIDs, and largely limited to those with autoimmune multimorbidity and active disease. These observations may inform guidelines to identify high-risk patients warranting close monitoring in the post-vaccination period. Keywords COVID-19 · Vaccination · Adverse event · Myositis · Autoimmunity · Surveys and questionnaires Introduction Rohit Aggarwal and Latika Gupta are co-senior authors. Vaccination has been one of the most effective measures in The complete list of authors part of the COVAD study group as well reducing the mortality and severe outcomes of COVID-19, as their affiliations are provided in the Supplement. significantly reducing the burden on the healthcare infra- structure [1]. However, it is concerning to note occasional Extended author information available on the last page of the article Vol.:(012 3456789) Rheumatology International reports of delayed adverse events (AEs), including exac- the second international COVAD patient self-reported erbation of underlying systemic autoimmune diseases multi-center e-survey [14]. (SAIDs), and even de novo induction of SAIDs associated with vaccination, as it is progressively introduced in vari- ous patients groups [2–6]. Methods Individuals living with idiopathic inflammatory myo- pathies (IIMs), many of whom receive disease modify- Study design ing drugs (DMARDs) and glucocorticoids, are particu- larly vulnerable to severe COVID-19 outcomes, and thus This study was conducted as part of the second COVAD improving vaccine uptake in this group may limit these study, an ongoing cross-sectional, multi-center patient severe outcomes [7]. However, owing to the rare nature of self-reported online survey [14]. Participants consented this disease, patients with IIM are scarcely represented, electronically after being informed via a cover letter in with only a few large-scale studies exploring the safety, lieu of written consent, and approval was obtained from tolerability, and immunogenicity of COVID-19 vaccines the local institutional ethics committee, we adhered to the in this group [8, 9]. The first COVID-19 Vaccination in Checklist for Reporting Results of the Internet E-Surveys Autoimmune Diseases (COVAD) study established the (CHERRIES) [15, 16]. short-term 7-day vaccine safety, with AEs being compa- rable between patients with IIMs, other SAIDs, and health Data collection controls (HCs). Most of the events were limited to individ- uals with active disease and autoimmune multimorbidity, a A validated questionnaire was hosted on the surveymon- group already predisposed to high background prevalence key.com online platform, following pilot testing, vetting, of rashes while individuals with inclusion body myositis and revision by an international team of experts, and trans- (IBM) reported fewer events [9, 10]. While the short-term lation into 18 languages, and was circulated extensively safety of vaccines is well characterized, a considerable gap by the COVAD study group of 157 collaborators across exists in our understanding of the delayed effects of vacci- 106 countries in their clinics, patient support groups, and nation in this vulnerable group, owing to a lack of follow- social media platforms from February to June 2022 [14]. up prospective studies evaluating delayed-onset AEs. We collected data on demographic details, comorbidi- This is a critical issue, potentially contributing to per- ties, SAID diagnosis, treatment details, current symptom sisting vaccine hesitancy among these patients. Recent status, COVID-19 infection history, course, and outcomes analysis from the second COVAD study revealed con- (including hospitalization and need for oxygen therapy), cerns over long-term vaccine safety had increased among COVID-19 vaccination details, short-term (< 7 day) and patients with IIMs and SAIDs, and remained a significant delayed-onset (> 7 day) post-vaccination AEs (based on cause of hesitancy [11]. This warrant concern, being an CDC criteria), and patient-reported outcomes as per the impediment achieving herd immunity in this high-risk Patient Reported Outcomes Measurement Information group. Interestingly, this pattern of hesitancy is not seen System (PROMIS) [17]. All individuals over the age of in response to other major inoculation campaigns such 18 years, including patients with multiple overlapping auto- as influenza [12]. Thus, we may infer that the hesitancy immune diseases were included in this study. Duplication of to COVID-19 vaccination in this patient group may not responses from a single respondent was averted due to the stem majorly from general antivaccination sentiments, but electronic protocols. Methods have been previously detailed rather in response to specific concerns regarding COVID- at length in the available COVAD study protocol [14]. 19 vaccines. Indeed, the lack of reliable information regarding the possible deterioration of disease course and development of AEs may lead to misinformation, and pre- Data extraction cipitate this hesitancy [13]. Thus, the further identification and analysis of possible delayed-onset and long-term AEs Data were extracted on 10th July 2022. Only responses of COVID-29 vaccination represent an urgent and largely from respondents who completed the survey in full and unmet need, being essential to providing evidence-based had received at least one dose of any COVID-19 vaccine information to reduce hesitancy and improve vaccination at the time of survey completion were included in the coverage in this patient group. Therefore, we analyzed the analysis (Fig. 1). Variables extracted included relevant delayed-onset (> 7 day) AEs of COVID-19 vaccination in outcome measures, delayed-onset self-reported vaccine patients with IIMs, other SAIDs, and HCs, using data from AEs, as well as baseline socio-demographic and clinical characteristics, and vaccination status. 1 3 Rheumatology International Fig. 1 Flow diagram of data extraction Active and inactive disease based on evidence from current literature and clinical judgment, including age, gender, ethnicity, comorbidity, Patients self-reported their disease activity as “inactive/ immunosuppressive therapy, number and type of vaccines remission”, “active and improving”, active but stable”, received and stratified by country of origin by Human “active and worsening”, “I am not sure”, or “other”. Dis- Development Index (HDI) (which served as a surrogate ease status was additionally verified based on reported marker for socioeconomic status) [19]. p < 0.05 was con- symptom status and treatment regime prior to vaccination. sidered significant. Statistical analysis was carried out using IBM SPSS version 26. Adverse events post‑vaccination Delayed-onset ADEs were those occurring > 7 days post- vaccination, and were categorized into minor AEs, major Results AEs requiring urgent medical attention (but not hospitali- zation), and hospitalizations [18]. Survey participants were Baseline characteristics able to report additional not listed AEs as “others” via an open-ended question. A total of 15165 respondents undertook the survey, of whom complete responses from 8759 vaccinated respond- Statistical analysis ents were included in the analysis (Fig. 1). The included participants had a median age of 46 (35–58) years, were The type of data distribution was determined by Kolmogo- mostly female (74.4%) and Caucasians (45.4%), with 1390 rov–Smirnov and Shapiro–Wilk tests. The continuous vari- (15.9%) having IIMs, while 50.6% had other SAIDs, and ables were distributed non-parametrically. Thus, descriptive 33.5% were HCs. In addition to IIMs, the most frequent statistics were represented as median (IQR). For analyzing SAIDs in our sample were rheumatoid arthritis (18.8%) the statistical difference between categorical and continu- and Sjogren’s syndrome (12.6%). Nearly all (97%) ous variables, Chi-square and Mann–Whitney-U tests were respondents received two COVID-19 vaccine doses, and used, respectively. Fisher test was applied to compare cat- 15.8% received four doses, with the majority of vaccine egorical data in case of variable frequency count less than 5. uptake contributed by the BNT162b2 (Pfizer)-BioNTech We compared differences in AEs between IIMs, SAIDs, and (61.1%) and the ChadOx1 nCOV-19 (Oxford/AstraZeneca) HCs with sub-group analysis by subtype of IIMs, vaccine (29.4%) vaccines. received, disease activity, autoimmune and non-autoimmune Among patients with IIMs, the dermatomyositis sub- comorbidities (in myositis patients), and immunosuppressive group was predominant (20.4%), followed by inclusion therapy received. body myositis (17.9%) and polymyositis (13.3%). Other The variables that were found significant in univariable socio-demographic and clinical characteristics are detailed analysis, and those suspected of being clinically important, in Table 1, and Supplementary Tables 1, 2, 3, and 9. were further evaluated in binary logistic regression anal- The country of origin of the respondents is detailed in ysis (BLR) with adjustment for factors deemed relevant Supplementary Table 11. 1 3 Rheumatology International Table 1 Socio-demographic and basic clinical features of the survey respondents Variable Total, n (%) IIM, n (%) SAIDs, n (%) HC, n (%) 8759 (100) 1390 (15.87) 4432 (50.60) 2937 (33.53) Age (median, IQR), years 46 (35–58) 62 (50–71) 47 (36–58) 38 (29–49) Gender F:M 6518:2189 (2.98:1) 990:393 (2.52:1) 3735:670 (5.57:1) 1788:1126 (1.59:1) Pregnancy (positive status), n (%) 62 (0.7) 5 (0.4) 28 (0.6) 29 (1.0) Lactating/breastfeeding (positive status), n (%) 118 (1.3) 11 (0.8) 57 (1.3) 50 (1.7) Ethnicity, n (%) African American or of African origin (Black) 376 (4.3) 56 (4.0) 255 (5.8) 65 (2.2) Asian 1843 (21.0) 97 (7.0) 984 (22.2) 762 (25.9) Caucasian (White) 3980 (45.4) 1113 (80.1) 2054 (46.3) 813 (27.7) Do not wish to disclose 293 (3,3) 19 (1.4) 153 (3.5) 121 (4.1) Hispanic 1481 (16.9) 55 (4.0) 579 (13.1) 847 (28.8) Native American/Indigenous/Pacific Islander 69 (0.8) 5 (0.4) 38 (0.9) 26 (0.9) Other 717 (8.2) 45 (3.2) 369 (8.3) 303 (10.3) Vaccines, n (%) BNT162b2 (Pfizer)-BioNTech 5354 (61.1) 883 (63.5) 2939 (66.3) 1532 (52.2) ChadOx1 nCOV-19 (Oxford/AstraZeneca) 2579 (29.4) 175 (12.6) 1507 (34.0) 897 (30.5) JNJ-78436735 (Johnson and Johnson) 268 (3.1) 53 (3.8) 111 (2.5) 104 (3.5) MRNA-1273 (Moderna) 1880 (21.5) 555 (39.9) 883 (19.9) 442 (15) NVX-CoV2373 (Novovax) 22 (0.3) 5 (0.4) 8 (0.2) 9 (0.3) ChAdOx1 nCoV-19 (Covishield Serum Institute 510 (5.8) 15 (1.1) 214 (4.8) 281 (9.6) India) BBV152 (Covaxin Bharat Biotech) 81 (0.9) 7 (0.5) 34 (0.8) 40 (1.4) Gam-COVID-Vac (Sputnik) 331 (3.8) 6 (0.4) 113 (2.5) 212 (7.2) BBIBP-CorV (Sinopharm) 579 (6.6) 24 (1.7) 243 (5.5) 312 (10.6) Sinovac-CoronaVac 695 (7.9) 29 (2.1) 361 (8.1) 305 (10.4) Not sure 117 (1.3) 6 (0.4) 57 (1.3) 54 (1.8) Minor ADEs duration, median (IQR), days 5 (2–10) 6 (3–13.3) 6 (3–13) 4 (2–7) Major ADEs duration, median (IQR), days 8 (3–35) 17 (5–90) 9 (3–35.5) 6 (2–17) HC healthy control, IIM idiopathic inflammatory myopathy, SAID systemic autoimmune and inflammatory disease Post‑COVID‑19 vaccination‑associated AEs rases than HCs [OR 4.0 (2.2–7.0), p < 0.001 and OR 2.1 in patients with IIM compared to SAIDs and HCs (1.2–3.5), p = 0.006 respectively], though reassuringly this increased risk was lost when the effect of immunosuppres- Among patients with IIMs, any minor delayed-onset AEs sive therapy was adjusted for in BLR suggesting possible were seen in 16.3% respondents, while major AEs were underlying confounding effect of active disease (Suppl. reported by 10.2%. Fatigue (8.8%) and local injection Table 5). site (arm) pain/ soreness (8.3%) were the most commonly AEs appeared relatively later among IIMs compared to reported minor AEs, while among major AEs, difficulty in SAIDs and HCs, with a longer post-vaccination median breathing (3.3%) was most frequent. Reassuringly, hospi- duration to appearance of AEs [17 (5–90) days in IIMs vs. 9 talizations associated with COVID-19 vaccination were (3–3.5) days in SAIDs and 6 (2–17) days in HCs] (Table 2). rare in patients with IIMs (0.72%). Notably patients with IIMs were at a lower risk of local Post‑COVID‑19 vaccination‑associated AEs injection site pain [OR 0.8 (0.6–1.0. p = 0.030]. joint pain in patients across different IIM subtypes [OR 0.6 (0.5–0.8), p < 0.001], headache [OR 0.6 (0.5–0.9), p = 0.002], fatigue [OR 0.7 (0.6–0.9)], p = 0.014], and diz- Among patients with IIMs, those with overlap myositis ziness [OR 0.7 (0.5–0.9), p = 0.024] than SAIDs (Suppl. (OM) had the highest absolute risk of minor [OR 4.4 Table 5). We noted with concern that patients with IIMs (2.8–6.9), p < 0.001] and major AEs [OR 4.1 (2.4–7.1), had a higher risk of development of both mild and severe p < 0.001] compared to other subtypes of IIMs (Table 3, Suppl. Table 5). Patients with OM were also at a higher 1 3 Rheumatology International 1 3 Table 2 Effects of COVID-19 vaccination in patients with IIMs vs. other SAIDs and HCs IIM SAIDs HCs OR1 (95%CI) OR2 p1 p2 (95%CI) N (1390) % N (4432) % N (2937) % (100) (100) (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 Rheumatology International 1 3 Table 3 COVID-19 vaccination-associated AEs across different IIM subtypes DM (283) IBM (249) PM (185) NM (60) JM (4) ASS (76) OM (94) N % N % N % N % N % N % N % Minor AEs 47 16.6 18***# 7.2 38 20.5 12 20 1 25.0 11 14.5 41***# 43.6 Injection site (arm) pain and soreness 26 9.2 8*** 3.2 17 9.2 9 15.0 0 0.0 6 7.9 17**# 18.1 Myalgia 23 8.1 5***# 2.0 18 9.7 4 6.7 0 0.0 5 6.6 18***# 19.1 Body ache 27 9.5 6*** 2.4 13 7.0 3 5.0 0 0.0 3 3.9 24***# 25.5 Joint pain 22 7.8 3***# 1.2 10 5.4 3 5.0 0 0.0 5 6.6 18***# 19.1 Fever 16 5.7 4* 1.6 6 3.2 1 1.7 0 0.0 4 5.3 14***# 14.9 Chills 20* 7.1 4* 1.6 4 2.2 1 1.7 0 0.0 4 5.3 13***# 13.8 Cough 5 1.8 0* 0.0 0 0.0 0 0.0 1*** 25.0 1 1.3 6***# 6.4 Difficulty in breathing or shortness of breath 10 3.5 2* 0.8 4 2.2 1 1.7 0 0.0 1 1.3 8***# 8.5 Nausea/vomiting 8 2.8 1* 0.4 1 0.5 1 1.7 0 0.0 1 1.3 7***# 7.4 Headache 19 6.7 4*** 1.6 13 7.0 3 5.0 0 0.0 3 3.9 18***# 19.1 Rash 16 5.7 1**# 0.4 8 4.3 0 0.0 0 0.0 1 1.3 11***# 11.7 Fatigue 29 10.2 9*** 3.6 14 7.6 5 8.3 0 0.0 7 9.2 23***# 24.5 Diarrhea 7 2.5 0* 0.0 2 1.1 1 1.7 0 0.0 0 0.0 5**# 5.3 Abdominal pain 6 2.1 1 0.4 1 0.5 1 1.7 0 0.0 1 1.3 5**# 5.3 High pulse rate or palpitations 10 3.5 1* 0.4 1 0.5 0 0.0 0 0.0 3 3.9 9***# 9.6 Rise in blood pressure 4 1.4 2 0.8 2 1.1 0 0.0 0 0.0 1 1.3 3 3.2 Fainting 1 0.4 0 0.0 0 0.0 0 0.0 0 0.0 0 0.0 1 1.1 Dizziness 10 3.5 3 1.2 5 2.7 0 0.0 0 0.0 2 2.6 8**# 8.5 Chest pain 5* 1.8 1 0.4 1 0.5 0 0.0 0 0.0 0 0.0 1 1.1 Swelling in the extremities 3 1.1 1 0.4 1 0.5 0 0.0 0 0.0 2* 2.6 0 0.0 Weakness and tingling in the feet and legs 6 2.1 1* 0.4 12** 6.5 1 1.7 0 0.0 0 0.0 8**# 8.5 Pricking or pins and needles sensations in the hands and feet 3 1.1 1* 0.4 7 3.8 1 1.7 0 0.0 1 1.3 7***# 7.4 Visual disturbances (loss of vision, blurring of vision, etc.) 4 1.4 1 0.4 3 1.6 0 0.0 0 0.0 0 0.0 3 3.2 Bleeding/bruising on the body 1 0.4 1 0.4 2 1.1 0 0.0 0 0.0 0 0.0 1 1.1 Petechial rash 2 0.7 0 0.0 0 0.0 0 0.0 0 0.0 0 0.0 4***# 4.3 Major AEs 24 8.5 13*# 5.2 17 9.2 6 10 1 25.0 3 3.9 23***# 24.5 Anaphylaxis 4 1.4 3 1.2 2 1.1 0 0.0 0 0.0 0 0.0 3 3.2 Marked difficulty in breathing 11 3.9 4 1.6 7 3.8 1 1.7 1* 25.0 1 1.3 7* 7.4 Throat closure 5 1.8 4 1.6 3 1.6 0 0.0 0 0.0 0 0.0 4* 4.3 Severe rashes 11 3.9 5 2.0 4 2.2 0 0.0 0 0.0 0 0.0 7*# 7.4 Hospitalization 7 2.5 4 1.6 4 2.2 3 5.0 0 0.0 1 1.3 8***# 8.5 Comparisons are between each IIM subtype vs. the rest of IIM subtypes. Bold indicates increased OR vs. the others. Bold + Underlined indicates decreased OR vs. the others. AE adverse events, ASS anti-synthetase syndrome, DM dermatomyositis, IBM inclusion body myositis, IIM idiopathic inflammatory myopathies, JDM juvenile dermatomyositis, NM necrotizing myositis, OM over- lap myositis, PM polymyositis # Significant in BLR (binary logistic regression) adjusted for age, gender, ethnicity, immunosuppressant dose, and stratified by country. *p < .05, **p < .005, ***p < .001 Rheumatology International risk of hospitalization [8.5% vs. 0–5%; OR 3.9 (1.4–11.0), [OR 0.7 (0.5–0.9), p = 0.004 and p = 0.007, respectively] p = 0.011], though reassuringly with small absolute num- compared to SAIDs, as well as visual disturbances [OR 0.5 bers (3–10) across all subtypes. Conversely, patients with (0.3–0.9), p = 0.018], though IIMs subgroups excluding IBM patients were relatively protected from AEs, hav- IBM were more likely to develop rashes [OR 1.8 (1.2–2.6), ing a lower risk of myalgia, joint pain, and rash (Suppl. p = 0.004] (Suppl. Table 9a, 9c). Table 5). Similar characteristics in terms of the risk profile between different vaccines were observed among patients with IIMs excluding IBM. The BNT162b2 (Pfizer) vac- Comparison of post‑COVID‑19 vaccination AE cine was associated with a lower risk of rashes [OR 0.5 among IIM patients by vaccine type (0.3–0.8), p = 0.009] and major AEs [OR 0.5 (0.3–0.7), p = 0.001] (Suppl. Table 9b, 9c). The ChadOx1 nCOV-19 Patients with IIMs who received the BNT162b2 (Pfizer) (Oxford/ AstraZeneca) was associated with a more fre- vaccine were at a lower risk of injection site pain/sore- quent incidence of injection site pain [OR 1.9 (1.1–3.3), ness [OR 0.6 (0.4–1.0), p = 0.039], petechial rash [OR p = 0.027] and body ache [OR 1.9 (1.0–3.3), p = 0.035], as 0.2 (0.04–0.8), p = 0.026], and certain other minor AEs well as other minor AEs, while a higher risk of major AEs compared to other vaccines (Table 4, Suppl. Table 6a). [OR 2.7 (1.1–6.8), p = 0.037] was observed among recipi- Post-vaccination flares of underlying autoimmune disease ents of the Sinovac-CoronaVac vaccine (Suppl. Table 9b, were also less frequent among IIMs than SAIDs [OR 0.8 9c). (0.6–1.0), p = 0.032]. However, we noted with concern that among BNT162b2 (Pfizer) vaccine recipients, patients Post‑COVID‑19 vaccination‑associated AEs with IIMs were at a threefold higher risk of rash compared in patients with active and inactive IIM to HCs [OR 3.0 (1.4–6.3), p = 0.004]. ChadOx1 nCOV-19 (Oxford/ AstraZeneca) vaccine While the absolute risk of nearly all long-term AEs was recipients were more prone to develop bleeding/bruising higher in patients with an active course of IIM compared on the body [OR 6.8 (2.0–22.9), p = 0.007] compared to to patients with inactive disease, statistically signifi- other vaccines albeit with wide confidence intervals. The cant differences were only observed in the occurrence risk of post-vaccination headache and rise in blood pres- of rashes, myalgia, headache, and fatigue (Supplemental sure was also higher (Suppl. Table 6d). table 7). The higher risk of rashes in patients with active We found myositis patients receiving the Sinovac- IIMs was particularly pronounced [OR 4.7 (1.1–19.7), CoronaVac and ChAdOx1 nCoV-19 (Covishield Serum p = 0.033], with the most common being Gottron's signs Institute India) vaccines to have a higher risk of major AEs (n = 26) and V signs (n = 24). Notably, merely two (0.9%) [OR 4.2 (1.7–10.4), p = 0.002 and OR 33.7 (3.0–374.3), individuals with inactive IIM developed a rash after p = 0.004] and hospitalizations [OR 4.6 (1.2–18.3), vaccination. p = 0.030 and OR 5.9 (1.5–23.2), p = 0.011] compared to other vaccines, though reassuringly, hospitalizations were Post‑COVID‑19 vaccination‑associated AEs rare (n = 5 and n = 4, respectively). These results should in patients with only IIM, IIM and non‑SAID be interpreted with caution given the small number of comorbidity, and IIM with SAID comorbidity recipients of these vaccines with IIMs (n = 15, and n = 29, respectively) and wide confidence intervals observed in Patients with IIMs and non-SAIDs comorbidities had a BLR (Table 4, Suppl. Table 4b, 6b and 4c, 6c). comparable risk of any minor and major AEs, and hospi- talizations to those with IIM alone, though with a higher risk of joint pain [OR 3.3 (1.5–7.0), p = 0.002] and nausea/ Post‑COVID‑19 vaccination‑associated AEs vomiting [OR 16.8 (1.9–150.8), p = 0.012] among patients in patients with IIMs, with IBM excluded with non-SAID comorbidities (Suppl. Table 8a and 8b). In contrast, autoimmune comorbidities conferred a sig- Given the relatively lower incidence of AEs among nificantly higher risk of delayed-onset AEs among IIMs, patients with IBM compared to other IIMs subgroups with patients with IIMs and co-existing SAIDs being at a which could skew the risk estimates for AEs in favor of fivefold higher risk of experiencing any minor AEs [ OR IIMs, we conducted additional analysis excluding these 5.2 (3.3–8.2), p < 0.001], and twice as likely to develop patients, to better understand the risk profile of other IIMs any major AEs [OR 2.1 (1.2–3.8), p = 0.008] compared to subgroups. It was reassuring to see that patients with IIMs patients with IIMs alone (Suppl. Table 8a and 8b). were still less likely to experience joint pain and headache 1 3 Rheumatology International 1 3 Table 4 AEs distribution according to the vaccines in IIM group BNT162b2 (Pfizer) ChadOx1 nCOV-19 mRNA-1273 (Moderna) ChAdOx1 nCoV-19 (Cov- Sinovac-CoronaVac (Oxford/ AstraZeneca) ishield Serum Institute India) N (883) % (100) N (175) % (100) N (555) % (100) N (15) % (100) N (29) % (100) Minor AEs 136 15.4 38* 21.7 84 15.1 4 26.7 9* 31.0 Injection site (arm) pain and soreness 65*# 7.4 22 12.6 10 1.8 1 6.7 6* 20.7 Myalgia 59 6.7 18 10.3 8 1.4 1 6.7 5* 17.2 Body ache 59* 6.7 20 11.4 8 1.4 2 13.3 6* 20.7 Joint pain 52 5.9 17 9.7 8 1.4 2 13.3 5*# 17.2 Fever 41 4.6 15 8.6 5 0.9 2 13.3 5* 17.2 Chills 44 5.0 13 7.4 6 1.1 1 6.7 3 10.3 Cough 13 1.5 1 0.6 1 0.2 1 6.7 3***# 10.3 Difficulty in breathing or shortness of breath 22 2.5 4 2.3 4 0.7 2* 13.3 2 6.9 Nausea/vomiting 13 1.5 5 2.9 1 0.2 0 0.0 0 0.0 Headache 55 6.2 17*# 9.7 5 0.9 0 0.0 3 10.3 Rash 24# 2.7 3 1.7 4 0.7 3***# 20.0 2 6.9 Fatigue 71 8.0 21 12.0 6 1.1 2 13.3 4 13.8 Diarrhea 16 1.8 6 3.4 2 0.4 1 6.7 1 3.4 Abdominal pain 10 1.1 4 2.3 2 0.4 1 6.7 3***# 10.3 High pulse rate or palpitations 25 2.8 5 2.9 1 0.2 2* 13.3 4***# 13.8 Rise in blood pressure 13 1.5 6*# 3.4 1 0.2 0 0.0 1 3.4 Fainting 2 0.2 2 1.1 1 0.2 1** 6.7 2***# 6.9 Dizziness 29 3.3 8 4.6 2 0.4 1 6.7 4**# 13.8 Chest pain 10 1.1 3 1.7 1 0.2 0 0.0 1 3.4 Swelling in the extremities 13 1.5 6 3.4 2 0.4 1 6.7 2* 6.9 Weakness and tingling in the feet and legs 27 3.1 10 5.7 2 0.4 1 6.7 4**# 13.8 Pricking or pins and needles sensations in the hands and feet 21 2.4 8 4.6 1 0.2 1 6.7 5***# 17.2 Visual disturbances (loss of vision, blurring of vision, etc.) 10 1.1 5 2.9 2 0.4 1 6.7 2*# 6.9 Bleeding/bruising on the body 10 1.1 6*# 3.4 1* 0.2 1 6.7 2* 6.9 Petechial rash 3*# 0.3 2 1.1 1 0.2 1* 6.7 2*** 6.9 Major AEs 72**# 8.2 22 12.6 61 11.0 7***# 46.7 10***# 34.5 Anaphylaxis 11* 1.2 5 2.9 9 1.6 3***# 20.0 5***# 17.2 Marked difficulty in breathing 26 2.9 7 4.0 10 1.8 5***# 33.3 4** 13.8 Throat closure 13** 1.5 6 3.4 9 1.6 3***# 20.0 5***# 17.2 Severe rashes 19**# 2.2 6 3.4 10 1.8 4***# 26.7 6***# 20.7 Hospitalization 21** 2.4 8 4.6 11 2.0 4***# 26.7 5***# 17.2 Bold indicates increased odds ratio vs. the remaining vaccines. Bold + Underlined indicates decreased odds ratio vs. remaining vaccines. AE adverse events, AID autoimmune disease, HC healthy control, IIM idiopathic inflammatory myopathy # Significant according to binary logistic regression adjusted for age, gender, ethnicity, and immunosuppressant dose, and stratified by country. *p < .05, **p < .005, ***p < .001 Rheumatology International Post‑COVID‑19 vaccination‑associated achieving optimum vaccination coverage and herd immu- AEs in patients with IIM considering nity in patients with IIMs, a high-risk group for severe the immunosuppressive therapy received COVID-19 outcomes [20]. Fear of long-term vaccine ADEs may be a cause of this hesitancy, precipitated by A considerable number of respondents with IIMs and a lack of long-term vaccine safety and tolerability data other SAIDs were receiving methotrexate (22.1%), iv or in this patient group from large prospective studies [21]. sq IG (14.1%), and rituximab (10.8%) prior to vaccination. We reassuringly found a low overall absolute risk of Patients on methotrexate therapy were more susceptible to most minor and major vaccine ADEs in patients with IIMs, post-vaccination anaphylaxis [OR 3.1 (1.3–7.7) p = 0.014], not exceeding 5% and 3% in most cases, respectively, while patients receiving rituximab were more likely and hospitalizations were rare. However, the percentage to experience difficulty in breathing [OR 2.4 (1.1–5.7), is higher in comparison to the incidence of short-term p = 0.038], though the absolute numbers of these AEs were ADEs explored in a previous analysis from the COVAD small (n = 10 and n-8, respectively) (Suppl. Table 5). study [9]. Notably, patients with IIMs had a lower risk of minor ADEs than other SAIDs, and for certain ADEs, COVID‑19 vaccination‑associated AEs with a onset had a lower risk even compared to HCs, but were more of 30 or more days post‑vaccination prone to develop rashes compared to HCs. Among patients with IIMs, those with active disease, overlap myositis, Minor AEs appearing 30 or more days post-COVID-19 and receiving ChadOx1 nCOV-19 (Oxford/AstraZeneca) vaccination predominantly included fatigue (64.2%) and were more vulnerable to ADEs, while those with inclusion myalgia (50.5%), while marked difficulty in breathing body myositis, and BNT162b2 (Pfizer) vaccine recipients (15.8%) was the most common major AE. Among patients were at a relatively lower risk. Autoimmune multimorbid- with AEs appearing 30 or more days post-vaccination, ity conferred a higher risk of post-vaccination ADEs in those with IIMs were less likely to develop joint pain [OR patients with IIMs. 0.4 (0.2–0.7)] compared to SAIDs (Suppl. Table 10a, 10b), Since certain vaccine ADEs may mimic constitutional though it was concerning to note that IIMs were more than symptoms of IIMs, patients with IIM may have found it dif- twice as likely to develop shortness of breath and rash [OR ficult to differentiate vaccine ADEs from features of their 2.5 (1.3–4.9), p = 0.007 and OR 2.7 (1.4–5.2), p = 0.002, underlying disease, leading to a possible under-reporting of respectively] (Suppl. Table 10b). vaccine ADEs such as injection site pain/soreness and fever, explaining the lower risk compared to HCs. Furthermore, Characteristics of patients with IIMs requiring the duration of minor ADEs did not differ between patients hospitalization post‑COVID‑19 vaccination with IIM and SAIDs. However, if individuals with IIM developed major ADEs, their duration tends to be almost two Ten patients with IIMs [aged median (IQR) 54.5 times longer than in the SAIDs group and almost three times (51.25–63.25) years, 7/10 females, 8/10 Caucasians] longer than among HCs. This emphasizes the need for close reported hospitalization potentially related to COVID- long-term follow-up and monitoring of IIMs patients after 19 vaccination, with severe weakness/fatigue (n = 4) and COVID-19 vaccination to minimize the delay in required dyspnea (n = 2) as the most frequent reasons for hospi- medical care. Particular caution, and perhaps relative con- talization, though most cases appeared to be related to traindication may be warranted in patients with a past history underlying myositis and not a consequence of vaccination. of cardiac and respiratory conditions in anticipation of a pos- Characteristics of myositis and SAIDs, and HCs requiring sible risk of hospitalization which may be vaccine related. hospitalization are detailed in Suppl. Table 12 (12a and The higher risk of ADEs in patients with overlap myosi- 12b). tis may be explained by the existent burden of not one but several autoimmune disorders with different pathogenesis. However, vaccine safety data in overlap myositis are rather Discussion scarce, and this heterogenous group warrants exploration in greater depth. The favorable risk profile of post-vaccine ADEs in IBM patients is consistent with previous studies While the COVID-19 gradually transitions from an acute exploring short-term ADEs [9]. This highlights the heteroge- cause of unprecedented morbidity and mortality to a neity in IIMs with a predominance of different pathogenetic largely endemic disease in many regions of the world, in patterns across various subtypes [22]. The interferon (IFN) a large part due to widespread vaccination efforts, vac- pathway plays a crucial role in myositis-related autoimmune cine hesitancy continues to be a significant impediment to 1 3 Rheumatology International mechanisms [23]. Along with that m,RNA and adenovirus- post-vaccination in anticipation of AEs, while mitigating based vaccines are prone to activate endosomal and cyto- hesitancy and improving vaccination rates. solic pattern-recognition receptors (PRRs) [24] and trigger consequently activation of type I interferon production [25]. Supplementary Information The online version contains supplemen-tary material available at https://d oi.o rg/1 0.1 007/s 00296-0 23-0 5345-y. However, as type I IFN is a key player for the DM subtype, the IBM phenotype depends predominantly on type II IFN Acknowledgements The authors are grateful to all respondents for involvement [26]. Therefore, it could be a possible explana- completing the questionnaire. The authors also thank the Myosi- tion for the special status of this IIM subtype. tis Association, Myositis India, Myositis UK, Myositis Support and Understanding, the Myositis Global Network, Deutsche Gesellschaft The association between immunosuppressive treatment für Muskelkranke e.V. (DGM), Dutch and Swedish Myositis patient and delayed-onset ADEs that was determined in this study support groups, Cure JM, Cure IBM, Sjögren’s India Foundation, should be interpreted with caution, since the numbers were Patients Engage, Scleroderma India, Lupus UK, Lupus Sweden, Emir- limited. Moreover, certain drugs, such as rituximab, can be ates Arthritis Foundation, EULAR PARE, ArLAR research group, AAAA patient group, Myositis Association of Australia, APLAR prescribed to patients with a more pronounced course or a myositis special interest group, Thai Rheumatism association, PAN- certain subtype of IIMs. LAR, AFLAR NRAS, Anti-Synthetase Syndrome support group, and The most preferred vaccine for patients with IIMs various other patient support groups and organizations for their con- appeared to be BNT162b2 (Pfizer), consistent with recent tribution to the dissemination of this survey. Finally, the authors wish to thank all members of the COVAD study group for their invaluable ACR guidelines [27]. Although recommendations do not role in the data collection. suggest one mRNA vaccine over another, our study depicts COVAD study group authors: Sinan Kardes, Laura Andreoli, greater expediency of BNT162b2 (Pfizer) in comparison to Daniele Lini, Karen Schreiber, Melinda Nagy Vince, Yogesh Preet mRNA-1273 (Moderna). Singh, Rajiv Ranjan, Avinash Jain, Sapan C Pandya, Rakesh Kumar Pilania, Aman Sharma, Manesh Manoj M, Vikas Gupta, Chengappa Our study explored delayed-onset COVID-19 vaccine G Kavadichanda, Pradeepta Sekhar Patro, Sajal Ajmani, Sanat Phatak, adverse events in a large geographically and ethnically Rudra Prosad Goswami, Abhra Chandra Chowdhury, Ashish Jacob diverse sample of patients with a wide range of SAIDs, Mathew, Padnamabha Shenoy, Ajay Asranna, Keerthi Talari Bomma- including large numbers of rare rheumatic diseases, as well kanti, Anuj Shukla, Arunkumar R Pande, Kunal Chandwar, Akank-sha Ghodke, Hiya Boro, Zoha Zahid Fazal, Döndü Üsküdar Cansu, as healthy controls, which gives generalizability and reliabil- Reşit Yıldırım, Armen Yuri Gasparyan, Nicoletta Del Papa, Gianluca ity to our study. We had a high rate of questionnaire comple- Sambataro, Atzeni Fabiola, Marcello Govoni, Simone Parisi, Elena tion and coupled with the patient self-reported anonymized Bartoloni Bocci, Gian Domenico Sebastiani, Enrico Fusaro, Marco nature of the survey, this offers a unique reflection of the Sebastiani, Luca Quartuccio, Franco Franceschini, Pier Paolo Sainaghi, Giovanni Orsolini, Rossella De Angelis, Maria Giovanna Danielli, Vin- unbiased patient voice. cenzo Venerito, Silvia Grignaschi, Alessandro Giollo, Alessia Alluno, However, owing to the patient self-reported design, our Florenzo Ioannone, Marco Fornaro, Lisa S Traboco, Suryo Anggoro study had the limitations of recall and reporting bias, con- Kusumo Wibowo, Jesús Loarce-Martos, Sergio Prieto-González, venience sampling, and the plausible underrepresentation of Raquel Aranega Gonzalez, Akira Yoshida, Ran Nakashima, Shinji Sato, Naoki Kimura, Yuko Kaneko, Takahisa Gono, Stylianos Tomaras, low-income patients without internet access and the severely Fabian Nikolai Proft, Marie-Therese Holzer, Margarita Aleksandrovna disabled. Additionally, individuals of African American or Gromova, Or Aharonov, Zoltán Griger, Ihsane Hmamouchi, Imane El African origin and Native American/Indigenous/Pacific bouchti, Zineb Baba, Margherita Giannini, François Maurier, Julien Islander ethnicity are under-represented in the cohort. Campagne, Alain Meyer, Daman Langguth, Vidya Limaye, Merrilee Needham, Nilesh Srivastav, Marie Hudson, Océane Landon-Cardinal, Nevertheless, our study provides valuable insights into Wilmer Gerardo Rojas Zuleta, Álvaro Arbeláez, Javier Cajas, José long-term ADEs of COVID-19 vaccination in the vulnerable António Pereira Silva, João Eurico Fonseca, Olena Zimba, Doskaliuk patient group of IIMs, which is understudied in the current Bohdana, Uyi Ima-Edomwonyi, Ibukunoluwa Dedeke, Emorinken literature, and supports that the benefits of vaccination in Airenakho, Nwankwo Henry Madu, Abubakar Yerima, Hakeem Ola-osebikan, Becky A., Oruma Devi Koussougbo, Elisa Palalane, Ho So, reducing severe COVID-19 outcomes in these patients out- Manuel Francisco Ugarte-Gil, Lyn Chinchay, José Proaño Bernaola, weigh the risk of potential AEs. Victorio Pimentel, Hanan Mohammed Fathi, Reem Hamdy A Moham- med, Ghita Harifi, Yurilís Fuentes-Silva, Karoll Cabriza, Jonathan Losanto, Nelly Colaman, Antonio Cachafeiro-Vilar, Generoso Guerra Bautista, Enrique Julio Giraldo Ho, Lilith Stange Nunez, Cristian Ver- Conclusion gara M, Jossiell Then Báez, Hugo Alonzo, Carlos Benito Santiago Pastelin, Rodrigo García Salinas, Alejandro Quiñónez Obiols, Nilmo Chávez, Andrea Bran Ordóñez, Gil Alberto Reyes Llerena, Radames Vaccination appeared to be reassuringly safe in patients Sierra-Zorita, Dina Arrieta, Eduardo Romero Hidalgo, Ricardo Saenz, with IIMs in the long term, with most delayed-onset AEs Idania Escalante M, Wendy Calapaqui, Ivonne Quezada, Gabriela minor, comparable to other SAIDs, and limited to those Arredondo with co-existent autoimmune diseases and active disease. Author contribution Conceptualisation: DB, LG, PS, and NR. Data These observations may be useful in informing guide- curation: all authors. Formal analysis: NR. Funding acquisition: N/A. lines to identify subgroups that warrant close monitoring Investigation: LG, DB, NR, and PS. Methodology: LG, DB, and NR; 1 3 Rheumatology International Software: LG. Validation: VA, RA, JBL, and HC. Visualization: RA, Disclaimer No part of this manuscript has been copied or published VA, and LG. Writing—original draft: DB, PS, and LG. Writing— elsewhere either in whole or in part. review and editing: all authors. Funding No specific funding was received from any funding bodies in Open Access This article is licensed under a Creative Commons Attri- the public, commercial or not-for-profit sectors to carry out the work bution 4.0 International License, which permits use, sharing, adapta- described in this manuscript. tion, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes Data availability The datasets generated and/or analyzed during the current study are not publicly available but are available from the cor- were made. The images or other third party material in this article are responding author upon reasonable request. included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not Declarations permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a Conflicts of interest ALT has received honoraria for advisory boards copy of this licence, visit http://c reati vecom mons.o rg/l icens es/b y/4.0 /. and speaking for Abbvie, Gilead, Janssen, Lilly, Novartis, Pfizer, and UCB. EN has received speaker honoraria/participated in advisory boards for Celltrion, Pfizer, Sanofi, Gilead, Galapagos, AbbVie, and Lilly, and holds research grants from Pfizer and Lilly. HC has received References grant support from Eli Lilly and UCB, consulting fees from Novartis, Eli Lilly, Orphazyme, Astra Zeneca, speaker for UCB, and Biogen. 1. Statement for healthcare professionals: How COVID-19 vaccines IP has received research funding and/or honoraria from Amgen, As- are regulated for safety and effectiveness (Revised March 2022). traZeneca, Aurinia Pharmaceuticals, Elli Lilly and Company, Gilead Joint Statement from the International Coalition of Medicines Sciences, GlaxoSmithKline, Janssen Pharmaceuticals, Novartis and F. Regulatory Authorities and World Health Organization. Accessed Hoffmann-La Roche AG. JBL has received speaker honoraria/partici- August 24, 2022. https:// www. who. int/ news/ item/ 17- 05- 2022- pated in advisory boards for Sanofi Genzyme, Roche, and Biogen. None state ment- for- healt hcare- profe ssion als- how- covid- 19- vacci nes- is related to this manuscript. JD has received research funding from are- regul ated- for-s afety- and- effec tiven ess CSL Limited. JDP has undertaken consultancy work and/or received 2. Doroftei B, Ciobica A, Ilie O-D, Maftei R, Ilea C (2021) Mini- speaker honoraria from Astra Zenaca, Boehringer Ingelgheim, So- review discussing the reliability and efficiency of COVID-19 vac- journix Pharma, Permeatus Inc, Janssen and IsoMab Pharmacueticals. cines. Diagnostics 11(4):579 MK has received speaker honoraria/participated in advisory boards for 3. Li X, Gao L, Tong X, Chan VKY, Chui CSL, Lai FTT et al (2022) Abbvie, Asahi-Kasei, Astellas, AstraZeneca, Boehringer-Ingelheim, Autoimmune conditions following mRNA (BNT162b2) and inac- Chugai, Corbus, Eisai, GSK, Horizon, Kissei, BML, Mochida, Nippon tivated (CoronaVac) COVID-19 vaccination: a descriptive cohort Shinyaku, Ono Pharmaceuticals, Tanabe-Mitsubishi. NZ has received study among 1.1 million vaccinated people in Hong Kong. J Auto- speaker fees, advisory board fees, and research grants from Pfizer, immun 130:102830 Roche, Abbvie, Eli Lilly, NewBridge, Sanofi-Aventis, Boehringer In- 4. Kim JH, Kim JH, Woo CG (2022) Clinicopathological charac- gelheim, Janssen, and Pierre Fabre; none are related to this manuscript. teristics of inflammatory myositis induced by COVID-19 vac- OD has/had consultancy relationship with and/or has received research cine (Pfizer-BioNTech BNT162b2): a case report. J Korean Med funding from and/or has served as a speaker for the following compa- Sci 37(11):e91 nies in the area of potential treatments for systemic sclerosis and its 5. 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RA has a consultancy relationship with 16(1):57 and/or has received research funding from the following companies: 7. Pakhchanian H, Khan H, Raiker R, Ahmed S, Kavadichanda C, Bristol Myers-Squibb, Pfizer, Genentech, Octapharma, CSL Behring, Abbasi M, Kardeş S, Agarwal V, Aggarwal R, Gupta L (2022) Mallinckrodt, AstraZeneca, Corbus, Kezar, Abbvie, Janssen, Kyverna COVID-19 outcomes in patients with dermatomyositis: a reg- Alexion, Argenx, Q32, EMD-Serono, Boehringer Ingelheim, Roivant, istry-based cohort analysis. Semin Arthritis Rheum 56:152034 Merck, Galapagos, Actigraph, Scipher, Horizon Therepeutics, Teva, 8. Furer V, Eviatar T, Zisman D, Peleg H, Paran D, Levartovsky Beigene, ANI Pharmaceuticals, Biogen, Nuvig, Capella Bioscience, D et al (2021) Immunogenicity and safety of the BNT162b2 and CabalettaBio. TV has received speaker honoraria from Pfizer and mRNA COVID-19 vaccine in adult patients with autoimmune AstraZeneca, non-related to the current manuscript. 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Kharbanda R, Ganatra K, Abbasi M, Agarwal V, Gupta L (2022) Patients with idiopathic inflammatory myopathies suffer from Authors and Affiliations Bohdana Doskaliuk1  · Naveen Ravichandran2  · Parikshit Sen3  · Jessica Day4,5,6  · Mrudula Joshi7  · Arvind Nune8  · Elena Nikiphorou9,10  · Sreoshy Saha11  · Ai Lyn Tan12,13  · Samuel Katsuyuki Shinjo14  · Nelly Ziade15,16  · Tsvetelina Velikova17  · Marcin Milchert18  · Kshitij Jagtap19  · Ioannis Parodis20,21  · Abraham Edgar Gracia‑Ramos22  · Lorenzo Cavagna23  · Masataka Kuwana24  · Johannes Knitza25  · Yi Ming Chen26,27  · Ashima Makol28  · Vishwesh Agarwal29  · Aarat Patel30 · John D. Pauling31,32  · Chris Wincup33,34  · Bhupen Barman35  · Erick Adrian Zamora Tehozol36  · Jorge Rojas Serrano37  · Ignacio García‑De La Torre38  · Iris J. Colunga‑Pedraza39  · Javier Merayo‑Chalico40  · Okwara Celestine Chibuzo41  · Wanruchada Katchamart42  · Phonpen Akarawatcharangura Goo43  · Russka Shumnalieva44  · Leonardo Santos Hoff45  · Lina El Kibbi46  · Hussein Halabi47  · Binit Vaidya48  · Syahrul Sazliyana Shaharir49  · A. T. M. Tanveer Hasan50  · Dzifa Dey51  · Carlos Enrique Toro Gutiérrez52  · Carlo V. Caballero‑Uribe53  · James B. Lilleker54,55  · Babur Salim56  · Tamer Gheita57  · Tulika Chatterjee58  · Oliver Distler59  · Miguel A. Saavedra60  · COVAD study group · Hector Chinoy54,61,62  · Vikas Agarwal2  · Rohit Aggarwal63  · Latika Gupta54,64,65 * Latika Gupta 3 Maulana Azad Medical College, 2-Bahadurshah Zafar Marg, drlatikagupta@gmail.com New Delhi, Delhi 110002, India 4 1 Department of Pathophysiology, Ivano-Frankivsk National Department of Rheumatology, Royal Melbourne Hospital, Medical University, Ivano-Frankivsk, Ukraine Parkville, VIC 3050, Australia 5 2 Department of Clinical Immunology and Rheumatology, Walter and Eliza Hall Institute of Medical Research, Sanjay Gandhi Postgraduate Institute of Medical Sciences, Parkville, VIC 3052, Australia Lucknow, India 1 3 Rheumatology International 6 Department of Medical Biology, University of Melbourne, 29 Mahatma Gandhi Mission Medical College, Navi Mumbai, Parkville, VIC 3052, Australia Maharashtra, India 7 Byramjee Jeejeebhoy Government Medical College 30 Bon Secours Rheumatology Center and Division of Pediatric and Sassoon General Hospitals, Pune, India RheumatologyDepartment of Pediatrics, University 8 Southport and Ormskirk Hospital NHS Trust, of Virginia School of Medicine, Charlottesville, VA, USA Southport PR8 6PN, UK 31 Bristol Medical School Translational Health Sciences, 9 Centre for Rheumatic Diseases, King’s College London, University of Bristol, Bristol, UK London, UK 32 Department of Rheumatology, North Bristol NHS Trust, 10 Rheumatology Department, King’s College Hospital, Bristol, UK London, UK 33 Division of Medicine, Rayne InstituteDepartment 11 Mymensingh Medical College, Mymensingh, Bangladesh of Rheumatology, University College London, London, UK 34 12 NIHR Leeds Biomedical Research Centre, Leeds Teaching Centre for Adolescent Rheumatology Versus Arthritis Hospitals Trust, Leeds, UK at UCL, UCLH, GOSH, London, UK 35 13 Leeds Institute of Rheumatic and Musculoskeletal Medicine, Department of General Medicine, All India Institute University of Leeds, Leeds, UK of Medical Sciences (AIIMS), Guwahati, India 36 14 Division of RheumatologyFaculdade de Medicina FMUSP, Rheumatology, Medical Care & Research, Centro Medico Universidade de Sao Paulo, Sao Paulo, SP, Brazil Pensiones Hospital, Instituto Mexicano del Seguro Social Delegación Yucatán, Yucatán, Mexico 15 Rheumatology Department, Saint-Joseph University, Beirut, 37 Lebanon Rheumatologist and Clinical InvestigatorInterstitial Lung Disease and Rheumatology Unit, Instituto Nacional de 16 Rheumatology Department, Hotel-Dieu de France Hospital, Enfermedades Respiratorias, Mexico City, Mexico Beirut, Lebanon 38 Departamento de Inmunología Y Reumatología, Hospital 17 Medical Faculty, Sofia University St. Kliment Ohridski, 1 General de Occidente and Universidad de Guadalajara, Kozyak Str, 1407 Sofia, Bulgaria Guadalajara, Jalisco, Mexico 18 Department of Internal Medicine, Rheumatology, 39 Hospital Universitario Dr Jose Eleuterio Gonzalez, Diabetology, Geriatrics and Clinical Immunology, Monterrey, Mexico Pomeranian Medical University in Szczecin, Ul Unii 40 Lubelskiej 1, 71-252, Szczecin, Poland Department of Immunology and Rheumatology, Instituto Nacional de Ciencias Médicas Y Nutrición Salvador Zubirán, 19 Seth Gordhandhas Sunderdas Medical College and King Mexico City, Mexico Edwards Memorial Hospital, Mumbai, Maharashtra, India 41 Department of Medicine, University of Nigeria Teaching 20 Division of RheumatologyDepartment of Medicine Solna, Hospital, Ituku-Ozalla/University of Nigeria, Enugu Campus, Karolinska Institutet and Karolinska University Hospital, Enugu, Nigeria Stockholm, Sweden 42 Division of RheumatologyDepartment of MedicineFaculty 21 Department of RheumatologyFaculty of Medicine of Medicine Siriraj Hospital, Mahidol University, Bangkok, and Health, Örebro University, Örebro, Sweden Thailand 22 Department of Internal Medicine, General Hospital, National 43 Department of Medicine, Queen Savang Vadhana Memorial Medical Center “La Raza”, Instituto Mexicano del Seguro Hospital, Chonburi, Thailand Social, Av. Jacaranda S/N, Col. La Raza, Del. Azcapotzalco, 44 C.P. 02990 Mexico City, Mexico Department of RheumatologyClinic of Rheumatology, University Hospital “St. Ivan Rilski”, Medical 23 Rheumatology UnitDipartimento Di Medicine Interna E University-Sofia, Sofia, Bulgaria Terapia Medica, Università Degli Studi Di Pavia, Pavia, 45 Lombardy, Italy School of Medicine, Universidade Potiguar (UnP), Natal, Brazil 24 Department of Allergy and Rheumatology, Nippon Medical 46 School Graduate School of Medicine, 1-1-5 Sendagi, Internal Medicine Department, Rheumatology Unit, Bunkyo-Ku, Tokyo 113-8602, Japan Specialized Medical Center, Riyadh, Saudi Arabia 47 25 Medizinische Klinik 3—Rheumatologie und Immunologie, Department of Internal MedicineSection of Rheumatology, Universitätsklinikum Erlangen, Friedrich-Alexander-Unive King Faisal Specialist Hospital and Research Center, Jeddah, rsität Erlangen-Nürnberg, Ulmenweg 18, 91054 Erlangen, Saudi Arabia Deutschland 48 National Center for Rheumatic Diseases (NCRD), Ratopul, 26 Division of Allergy, Immunology and Rheumatology, Kathmandu, Nepal Department of Internal Medicine, Taichung Veterans General 49 Faculty of Medicine, Universiti Kebangsaan Malaysia, Hospital, Taichung City, Taiwan 56000 Cheras, Kuala Lumpur, Malaysia 27 Department of Medical Research, Taichung Veterans General 50 Department of Rheumatology, Enam Medical College & Hospital, Taichung, Taiwan Hospital, Dhaka, Bangladesh 28 Division of Rheumatology, Mayo Clinic, Rochester, MN, USA 1 3 Rheumatology International 51 Department of Medicine and Therapeutics, Rheumatology 58 Department of Internal Medicine, University of Illinois Unit, University of Ghana Medical SchoolCollege of Health College of Medicine at Peoria, Peoria, IL, USA Sciences, Korle-Bu, Accra, Ghana 59 Department of Rheumatology, University Hospital Zurich, 52 Reference Center for Osteoporosis, Rheumatology University of Zurich, Zurich, Switzerland and Dermatology, Pontifica Universidad Javeriana Cali, Cali, 60 Colombia Departamento de Reumatología Hospital de Especialidades Dr. Antonio Fraga Mouret, Centro Médico Nacional La Raza, 53 Department of Medicine, Hospital Universidad del Norte, IMSS, Mexico City, Mexico Barranquilla, Atlantico, Colombia 61 National Institute for Health Research Manchester Biomedical 54 Division of Musculoskeletal and Dermatological Sciences, Research Centre, Manchester University NHS Foundation Centre for Musculoskeletal Research, School of Biological Trust, The University of Manchester, Manchester, UK Sciences, Faculty of Biology, Medicine and Health, 62 Manchester Academic Health Science Centre, The University Department of Rheumatology, Salford Royal Hospital, of Manchester, Manchester, UK Northern Care Alliance NHS Foundation Trust, Salford, UK 63 55 Manchester Centre for Clinical Neurosciences, Salford Royal Division of Rheumatology and Clinical Immunology, NHS Foundation Trust, Salford, UK University of Pittsburgh School of Medicine, Pittsburgh, PA, USA 56 Rheumatology Department, Fauji Foundation Hospital, 64 Rawalpindi, Pakistan Department of Rheumatology, Royal Wolverhampton Hospitals NHS Trust, Wolverhampton, UK 57 Rheumatology Department, Kasr Al Ainy School 65 of Medicine, Cairo University, Cairo, Egypt City Hospital, Sandwell and West Birmingham Hospitals NHS Trust, Birmingham, UK 1 3