IMPAIRED HEALTH-RELATED QUALITY OF LIFE IN PATIENTS WITH IDIOPATHIC INFLAMMATORY MYOPATHIES: A CROSS-SECTIONAL ANALYSIS FROM AN INTERNATIONAL E-SURVEY

BackgroundComprehensive and large-scale assessment of health-related quality of life in patients with idiopathic inflammatory myopathies (IIMs) worldwide is lacking. The second COVID-19 vaccination in autoimmune disease (COVAD-2) study [1] is an international, multicentre, self-reported e-survey assessing several aspects of COVID-19 infection and vaccination as well as validated patient-reported outcome measures (PROMs) to outline patient experience in various autoimmune diseases (AIDs), with a particular focus on IIMs.ObjectivesTo investigate physical and mental health in a global cohort of IIM patients compared to those with non-IIM autoimmune inflammatory rheumatic diseases (AIRDs), non-rheumatic AIDs (NRAIDs), and those without AIDs (controls), using Patient-Reported Outcome Measurement Information System (PROMIS) global health data obtained from the COVAD-2 survey.MethodsDemographics, AID diagnoses, comorbidities, disease activity, treatments, and PROMs were extracted from the COVAD-2 database. The primary outcomes were PROMIS Global Physical Health (GPH) and Global Mental Health (GMH) scores. Secondary outcomes included PROMIS physical function short form-10a (PROMIS PF-10a), pain visual analogue scale (VAS), and PROMIS Fatigue-4a scores. Each outcome was compared between IIMs, non-IIM AIRDs, NRAIDs, and controls. Factors affecting GPH and GMH scores in IIMs were identified using multivariable regression analysis.ResultsA total of 10,502 complete responses from 1582 IIMs, 4700 non-IIM AIRDs, 545 NRAIDs, and 3675 controls, which accrued as of May 2022, were analysed. Patients with IIMs were older [59±14 (IIMs) vs. 48±14 (non-IIM AIRDs) vs. 45±14 (NRAIDs) vs. 40±14 (controls) years, p<0.001] and more likely to be Caucasian [82.7% (IIMs) vs. 53.2% (non-IIM AIRDs) vs. 62.4% (NRAIDs) vs. 34.5% (controls), p<0.001]. Among IIMs, dermatomyositis (DM) and juvenile DM were the most common (31.4%), followed by inclusion body myositis (IBM) (24.9%). Patients with IIMs were more likely to have comorbidities [68.1% (IIMs) vs. 45.7% (non-IIM AIRDs) vs. 45.1% (NRAIDs) vs. 26.3% (controls), p<0.001] including mental disorders [33.4% (IIMs) vs. 28.2% (non-IIM AIRDs) vs. 28.4% (NRAIDs) vs. 17.9% (controls), p<0.001].GPH median scores were lower in IIMs compared to NRAIDs or controls [13 (interquartile range 10–15) IIMs vs. 13 (11–15) non-IIM AIRDs vs. 15 (13–17) NRAIDs vs. 17 (15–18) controls, p<0.001] and PROMIS PF-10a median scores were the lowest in IIMs [34 (25–43) IIMs vs. 40 (34–46) non-IIM AIRDs vs. 47 (40–50) NRAIDs vs. 49 (45–50) controls, p<0.001]. GMH median scores were lower in AIDs including IIMs compared to controls [13 (10–15) IIMs vs. 13 (10–15) non-IIM AIRDs vs. 13 (11–16) NRAIDs vs. 15 (13–17) controls, p<0.001]. Pain VAS median scores were higher in AIDs compared to controls [3 (1–5) IIMs vs. 4 (2–6) non-IIM AIRDs vs. 2 (0–4) NRAIDs vs. 0 (0–2) controls, p<0.001]. Of note, PROMIS Fatigue-4a median scores were the highest in IIMs [11 (8–14) IIMs vs. 8 (10–14) non-IIM AIRDs vs. 9 (7–13) NRAIDs vs. 7 (4–10) controls, p<0.001].Multivariable regression analysis in IIMs identified older age, male sex, IBM, comorbidities including hypertension and diabetes, active disease, glucocorticoid use, increased pain and fatigue as the independent factors for lower GPH scores, whereas coexistence of interstitial lung disease, mental disorders including anxiety disorder and depression, active disease, increased pain and fatigue were the independent factors for lower GMH scores.ConclusionBoth physical and mental health are significantly impaired in patients with IIMs compared to those with non-IIM AIDs or those without AIDs. Our results call for greater attention to patient-reported experience and comorbidities including mental disorders to provide targeted approaches and optimise global well-being in patients with IIMs.Reference[1]Fazal ZZ, Sen P, Joshi M, et al. COVAD survey 2 long-term outcomes: unmet need and protocol. Rheumatol Int. 2022;42:2151–58.AcknowledgementsThe authors a e grateful to all respondents for completing the questionnaire. The authors also thank The Myositis Association, Myositis India, Myositis UK, the Myositis Global Network, Cure JM, Cure IBM, Sjögren's India Foundation, EULAR PARE for their contribution to the dissemination of the survey. Finally, the authors wish to thank all members of the COVAD study group for their invaluable role in the data collection.Disclosure of InterestsAkira Yoshida: None declared, Yuan Li: None declared, Vahed Maroufy: None declared, Masataka Kuwana Speakers bureau: Boehringer Ingelheim, Ono Pharmaceuticals, AbbVie, Janssen, Astellas, Bayer, Asahi Kasei Pharma, Chugai, Eisai, Mitsubishi Tanabe, Nippon Shinyaku, Pfizer, Consultant of: Corbus, Mochida, Grant/research support from: Boehringer Ingelheim, Ono Pharmaceuticals, Naveen Ravichandran: None declared, Ashima Makol Consultant of: Boehringer-Ingelheim, Parikshit Sen: None declared, James B. Lilleker: None declared, Vishwesh Agarwal: None declared, Sinan Kardes: None declared, Jessica Day Grant/research support from: CSL Limited, Marcin Milchert: None declared, Mrudula Joshi: None declared, Tamer A Gheita: None declared, Babur Salim: None declared, Tsvetelina Velikova: None declared, Abraham Edgar Gracia-Ramos: None declared, Ioannis Parodis Grant/research support from: Amgen, AstraZeneca, Aurinia Pharmaceuticals, Eli Lilly, Gilead Sciences, GlaxoSmithKline, Janssen Pharmaceuticals, Novartis, and F. Hoffmann-La Roche, Elena Nikiphorou Speakers bureau: Celltrion, Pfizer, Sanofi, Gilead, Galapagos, AbbVie, Eli Lilly, Consultant of: Celltrion, Pfizer, Sanofi, Gilead, Galapagos, AbbVie, Eli Lilly, Grant/research support from: Pfizer, Eli Lilly, Ai Lyn Tan Speakers bureau: AbbVie, Gilead, Janssen, Eli Lilly, Novartis, Pfizer, UCB, Consultant of: AbbVie, Gilead, Janssen, Eli Lilly, Novartis, Pfizer, UCB, Arvind Nune: None declared, Lorenzo Cavagna: None declared, Miguel A Saavedra Consultant of: AbbVie, GlaxoSmithKline, Samuel Katsuyuki Shinjo: None declared, Nelly Ziade Speakers bureau: AbbVie, Boehringer-Ingelheim, Eli Lilly, Janssen, Pfizer, Roche, Consultant of: AbbVie, Boehringer-Ingelheim, Eli Lilly, Janssen, Pfizer, Roche, Grant/research support from: AbbVie, Boehringer-Ingelheim, Eli Lilly, Janssen, Pfizer, Roche, Johannes Knitza: None declared, Oliver Distler Speakers bureau: AbbVie, Amgen, Bayer, Boehringer Ingelheim, Janssen, Medscape, Novartis, Consultant of: 4P-Pharma, AbbVie, Acceleron, Alcimed, Altavant, Amgen, AnaMar, Arxx, AstraZeneca, Baecon, Blade, Bayer, Boehringer Ingelheim, Corbus, CSL Behring, Galderma, Galapagos, Glenmark, Gossamer, iQvia, Horizon, Inventiva, Janssen, Kymera, Lupin, Medscape, Merck, Miltenyi Biotec, Mitsubishi Tanabe, Novartis, Prometheus, Redxpharma, Roivant, Sanofi, Topadur, Grant/research support from: AbbVie, Amgen, Boehringer Ingelheim, Kymera, Mitsubishi Tanabe, Novartis, Roche, Hector Chinoy Grant/research support from: Eli Lilly, UCB, Vikas Agarwal: None declared, Rohit Aggarwal Consultant of: Mallinckrodt, Octapharma, CSL Behring, Bristol Myers-Squibb, EMD Serono, Kezar, Pfizer, AstraZeneca, Alexion, Argenx, Boehringer Ingelheim (BI), Corbus, Janssen, Kyverna, Roivant, Merck, Galapagos, Actigraph, Abbvie, Scipher, Horizontal Therapeutics, Teva, Biogen, Beigene, ANI Pharmaceutical, Nuvig, Capella, CabalettaBio, Grant/research support from: Bristol Myers-Squibb, Pfizer, Mallinckrodt, Janssen, Q32, EMD Serono, Boehringer Ingelheim, Latika Gupta: None declared.

COVID-19 VACCINE SAFETY DURING PREGNANCY IN WOMEN WITH SYSTEMIC LUPUS ERYTHEMATOSUS

BackgroundVaccinations comprise a part of the antenatal care of pregnant women, including patients with systemic lupus erythematosus (SLE) who are at increased risk of adverse pregnancy outcomes (APOs). While COVID-19 vaccination has been shown to be safe in patients with SLE, data on vaccine-associated adverse events (AEs) during the antenatal and lactation period are scarce or lacking.ObjectivesTo investigate the association between COVID-19 vaccination and AEs in pregnant SLE patients.MethodsA total of 9201 complete responses were extracted on June 21st, 2022 from the COVID-19 Vaccination in Autoimmune Diseases (COVAD) 2 database, a global e-survey involving 157 collaborators from 106 countries. Among respondents, 6787 (73.8%) were women. We identified 70 (1.1%) women who were exposed to at least one COVID-19 vaccine dose during pregnancy, among those 11 with SLE. Delayed onset (>7 days) vaccine-related AEs were extracted and triangulated with disease activity, treatment changes due to flare after vaccination, and COVID-19 infections in vaccinated pregnant women with SLE. Additionally, information on health-related quality of life and physical function was recorded using PROMIS at the time of survey completion.ResultsThe age of patients ranged from 28 to 39 years;5/11 women were of Asian origin. None of these patients reported major vaccine AEs, including four patients with self-reported active SLE prior to the vaccination. None of them reported any change in the status of their autoimmune disease, and no hospitalisation or special treatment was recorded. Six women experienced minor vaccine AEs;two of them had active disease prior to vaccination. Four patients reported COVID-19 infection;two of them while they were pregnant and post-vaccination and two prior to pregnancy and vaccination. All four patients experienced symptoms of their disease, but no overt SLE flare was reported. At the time of survey completion, all patients reported their general health as being good to excellent in all aspects evaluated. Importantly, no APOs were reported.None of the patients reported thrombotic events post-vaccination, which provides some reassurance regarding COVID-19 vaccination in a patient population with a high risk for cardiovascular comorbidity and thrombosis, especially in the presence of antiphospholipid antibodies or in patients diagnosed with the antiphospholipid syndrome, a considerable portion within SLE populations. Moreover, it was reassuring to note an absence of association between experienced vaccine AEs and active disease prior to vaccination. Although minor AEs were common, they did not impair daily functioning, and the symptoms resolved in all patients after a median of 3 (IQR: 2.5–5.0) days.ConclusionOur report adds relevant evidence concerning the sensitive issue of COVID-19 vaccine AEs and flares in SLE patients during the antenatal and lactation period. Despite the small sample size, the findings provide some reassurance and can contribute to informed decisions regarding vaccination in patients with SLE and high-risk pregnancies due to their background autoimmune disease. Based on the present data, the risk/benefit ration of COVID-19 vaccination appears favourable, with vaccines both providing passive immunisation to the fetus and active immunisation to the mother with no signals of exacerbation of the mother's autoimmune disease.Figure 1.Timeline showing COVID-19 vaccination and vaccination-related minor adverse events in relation to gestational and post-partum periods in eleven pregnant/lactating women with systemic lupus erythematosus.[Figure omitted. See PDF]AcknowledgementsThe authors thank all survey respondents, as well as patient associations and all members of the COVAD study group for their invaluable role in the data collection.Disclosure of InterestsNefeli Giannopoulou: None declared, Latika Gupta: None declared, Laura Andreoli: None declared, Daniele Lini: None declared, Elena Nikiphorou: None declared, Rohit Aggarwal Grant/research support from: R.A. has a consultancy relationshi with and/or has received research funding from Bristol Myers-Squibb, Pfizer, Genentech, Octapharma, CSL Behring, Mallinckrodt, AstraZeneca, Corbus, Kezar, Abbvie, Janssen, Kyverna Alexion, Argenx, Q32, EMD-Serono, Boehringer Ingelheim, Roivant, Merck, Galapagos, Actigraph, Scipher, Horizon Therapeutics, Teva, Beigene, ANI Pharmaceuticals, Biogen, Nuvig, Capella Bioscience, and CabalettaBio., Vikas Agarwal: None declared, Ioannis Parodis Grant/research support from: I.P. has received research funding and/or honoraria from Amgen, AstraZeneca, Aurinia Pharmaceuticals, Elli Lilly and Company, Gilead Sciences, GlaxoSmithKline, Janssen Pharmaceuticals, Novartis, and F. Hoffmann-La Roche AG.

BREAKTHROUGH SARS-COV-2 INFECTION IN FULLY VACCINATED PATIENTS WITH SYSTEMIC LUPUS ERYTHEMATOSUS: RESULTS FROM THE COVID-19 VACCINATION IN AUTOIMMUNE DISEASE (COVAD) STUDY

BackgroundAlthough many studies have been conducted on COVID-19 in recent years, there are still unanswered questions regarding breakthrough infections (BTIs), particularly in patients with systemic lupus erythematosus (SLE).ObjectivesThis study aimed to determine the occurrence of breakthrough COVID-19 infections in patients with SLE versus other autoimmune rheumatic diseases (AIRDs), non-rheumatic autoimmune diseases (nrAIDs), and healthy controls (HCs).MethodsThe study was based on data from the COVAD questionnaire which amassed a total of 10,783 complete responses from patients with SLE, AIRD, or nrAIRD, and HCs. After exclusion of individuals who were unvaccinated, those who received one vaccine dose only, and those with uncertain responses regarding the vaccine doses, a total of 9,595 patients formed the study population of the present investigation. If a COVID-19 infection occurred after the initial two vaccine doses and at least one booster dose (at least three doses in total, herein termed full vaccination), it was considered a BTI. Data were analysed using multivariable regression models. Statistically significant results were denoted by p values <0.05.ResultsA total of 7,016/9,595 (73.1%) individuals were fully vaccinated. Among those, 1,002 (14.2%) reported at least one BTI, and 166 (2.3%) reported at least two BTIs. Among SLE patients, 867/1,218 (71.2%) were fully vaccinated. Among fully vaccinated SLE patients, 137 (15.8%) reported at least one BTI while 28 (3.2%) reported at least two BTIs. BTI frequencies in fully vaccinated SLE patients were comparable to those of other AIRDs (OR: 1.0;95% CI: 0.8–1.3;p=0.447) and nrAIDS (OR: 0.9;95% CI: 0.6–1.3;p=0.856) but higher compared with HCs (OR: 1.2;95% CI: 1.0–1.6;p=0.022).For SLE patients with three vaccine doses, 113/137 (82.5%) reported at least one BTI while the corresponding number for four vaccine doses was 24/137 (17.5%). Compared with HCs (OR: 10.6;95% CI: 1.2–93.0;p=0.032) and other AIRDs (OR: 3.5;95% CI: 1.08–11.5;p=0.036), SLE patients showed higher frequencies of hospitalisation.AID multimorbidity was associated with a 15-fold increased risk for a need of advanced treatment for COVID-19 (OR: 15.3;95% CI: 2.6–88.2;p=0.002).ConclusionCOVID-19 BTIs occurred in nearly 1 every 6th fully vaccinated patient with SLE, and 20% more frequently in this patient population compared with fully vaccinated HCs. Moreover, BTIs in SLE patients were more severe compared with BTIs in HCs or patients with AIRDs other than SLE, resulting in a greater need for hospitalisation. AID multimorbidity contributed to a more severe COVID-19 BTI requiring advanced management. These insights call for greater attention to vaccination in the vulnerable group of SLE patients, with appropriate risk stratification towards optimised vaccination strategies.Figure 1.Survival analysis across patients with SLE, AIRDs, or nrAIDs, and HCs. SLE: systemic lupus erythematosus;AIRD: autoimmune rheumatic disease;nrAID: non-rheumatic autoimmune disease;HC: healthy control.[Figure omitted. See PDF]AcknowledgementsThe authors thank all survey respondents, as well as patient associations and all members of the COVAD study group for their invaluable role in the data collection.Disclosure of InterestsEmelie Kihlgren Olsson: None declared, Naveen Ravichandran: None declared, Elena Nikiphorou Speakers bureau: EN has received speaker honoraria/participated in advisory boards for Celltrion, Pfizer, Sanofi, Gilead, Galapagos, AbbVie, and Lilly., Consultant of: EN has received speaker honoraria/participated in advisory boards for Celltrion, Pfizer, Sanofi, Gilead, Galapagos, AbbVie, and Lilly., Grant/research support from: EN holds research grants from Pfizer and Lilly., Julius Lindblom: None declared, Sreoshy Saha: None declared, Syahrul Sazliyana Shaharir: None declared, Wanruchada Katchamart: None declared, Phonpen Akarawatcharangura Goo: None declared, Lisa Traboco: None declared, Yi-Ming Chen: None declared, Kshitij Jagtap: None declared, James B. Lilleker Speakers bureau:

COVID-19 VACCINE SAFETY DURING PREGNANCY AND BREASTFEEDING IN WOMEN WITH AUTOIMMUNE DISEASES: RESULTS FROM THE COVAD STUDY

Background:COVID-19 vaccine hesitancy among pregnant and breastfeeding women with autoimmune diseases (AID) is often attributed to the fear of adverse events (AE) and disease flares (DF). No data are available regarding COVID-19 vaccine safety in this population.Objectives:We aimed at describing delayed-onset (>7 days) vaccine-related AE (minor and major), DF, and related AID treatment modifications from the COVID-19 Vaccination in Autoimmune Diseases (COVAD) study.Methods:Among complete responses from 9201 participants as of June 21, 2022, 6787 (73.8%) were women. Six subgroups were identified upon diagnosis of AID vs healthy controls (HC) and their pregnancy/breastfeeding status at the time of any dose of vaccine (Figure 1).Figure 1.Flowchart of the study. AID: autoimmune diseases;HC: healthy controls;rAID: rheumatic AID;nrAID: non-rheumatic AID.[Figure omitted. See PDF]ResultsForty pregnant and 52 breastfeeding AID patients were identified and their vaccination rates (at least one dose) was 100% and 96.2%, respectively (Table 1). Overall AE, minor AE, and major AE were reported significantly more frequently by pregnant than non-pregnant patients (45% vs. 26%, p=0.01;40% vs. 25.9%, p=0.03;17.5% vs. 4.6%, p<0.01), but no difference was found in comparison with pregnant HC. No difference was observed between breastfeeding patients and HC. Post-vaccination DF were reported by 17.5% of pregnant and 20% of breastfeeding patients, and by 18% of age- and disease-matched control patients (n=2315). All DF in pregnant/breastfeeding patients were managed with glucocorticoids and a fifth of them required initiation or change in immunosuppressive treatment.Table 1.Characteristics of female subjects according to groups. Percentages in parenthesis. *Pregnancy/breastfeeding status at the time of the survey and/or at the time of at least one dose of COVID-19 vaccine. Chi squared test: ~ p=0.01;° p=0.03;§ p<0.01.Total Women (n=6787)Group A Non-pregnant, non-breastfeeding with AID (n=4862)Group B Pregnant with AID* (n=40)Group C Breastfeeding with AID* (n=52)Group D Non-pregnant, non-breastfeeding HC (n=1749)Group E Pregnant HC* (n=31)Group F Breastfeeding HC* (n=53)Age (median, IQR)47, 35-5850, 38-6134, 31-35.2533, 30-3539, 29-4934, 30-36.533, 30-36Caucasian3225 (47.5)2634 (54.1)12 (30)22 (42.3)538 (30.8)7 (22.6)12 (22.6)No comorbidities3027 (44.6)1815 (37.3)19 (47.5)36 (69.2)1102 (63)17 (54.8)38 (71.7)Number of vaccinated women, n (%)6632 (97.7)4753 (97.8)40 (100)50 (96.2)1710 (97.8)30 (96.8)49 (92.5)≥3 doses4850 (71.5%)3583 (73.7%)26 (65%)33 (63.5%)1155 (66%)23 (74.2%)30 (56.6%)No AE4950 (74.6)3517 (74)~22 (55)~36 (72)1312 (76.7)22 (73.3)36 (73.5)Injection site (arm) pain and soreness630 (9.5)471 (9.9)7 (17.5)7 (14)138 (8.1)2 (6.7)5 (10.2)Minor AE1614 (24.3)1232 (25.9)°16 (40)°12 (24)338 (19.8)7 (23.3)10 (20.4)Major AE285 (4.3)196 (4.6)§7 (17.5)§1 (2)77 (4.5)1 (3.3)3 (6.1)Hospitalization74 (1.1)51 (1.1)2 (5)0 (0)20 (1.2)0 (0)1 (2)ConclusionThis study provides the first insights into the safety of COVID-19 vaccination during the antenatal period in women with AID. While AEs were more commonly reported by pregnant patients with AID, these were no higher than among pregnant healthy controls without AID. These observations are reassuring, likely to strengthen physician-patient communication and overcome hesitancy as the benefits for the mother and fetus by passive immunization are likely to overweigh the potential risks of AE and DF.Reference[1]Fazal ZZ, et al;COVAD Study Group. COVAD survey 2 long-term outcomes: unmet need and protocol. Rheumatol Int 2022;42:2151-2158.AcknowledgementsThe authors are grateful to all respondents, to all patients support groups, and to all COVAD Study Group collaborators from 106 Countries.Disclosure of InterestsNone Declared.

Post Covid-19 Syndrome in Patients with Autoimmune Rheumatic Diseases: Results from the Covid-19 Vaccination in Autoimmune Diseases (Covad) Study

Background/Aims Post COVID-19 syndrome (PCS) is an emerging cause of morbidity and poor quality of life in COVID-19 survivors. We aimed to assess the prevalence, risk factors, outcomes, and association with disease flares of PCS in patients with autoimmune rheumatic diseases (AIRDs) and non-rheumatic autoimmune diseases (nrAIDs), both vulnerable groups understudied in the current literature using data from the 2nd COVID-19 Vaccination in Autoimmune Diseases (COVAD) global multicentre patient self-reported e-survey. Methods The survey was circulated from February to July 2022 by the international COVAD Study Group (157 collaborators from 106 countries), and demographics, comorbidities, AIRD/nrAID status, COVID-19 history, vaccination details, and PROMIS physical and mental function were recorded. PCS was defined as symptom resolution time >90 days following acute COVID-19. Predictors of PCS were analysed using regression models for the different groups. Results 7666 total respondents completed the survey. Of these, 2650 respondents with complete responses had positive COVID-19 infection, and 1677 (45.0% AIRDs, 12.5% nrAIDs, 42.5% HCs) completed the survey >90 days post acute COVID-19. Of these, 136 (8.1%) had PCS. Prevalence of PCS was higher in AIRDs (10.8%) than healthy controls HCs (5.3%) (OR: 2.1;95%CI: 1.4-3.1, p=0.002). Across the entire cohort, a higher risk of PCS was seen in women (OR: 2.9;95%CI: 1.1-7.7, p=0.037), patients with long duration of AIRDs/ nrAIDs (OR 1.01;95%CI: 1.0-1.02, p=0.016), those with comorbidities (OR: 2.8;95%CI: 1.4-5.7, p=0.005), and patients requiring oxygen supplementation for severe acute COVID-19 (OR: 3.8;95%CI: 1.1- 13.6, p=0.039). Among patients with AIRDs, comorbidities (OR 2.0;95%CI: 1.08-3.6, p=0.026), and advanced treatment (OR: 1.9;95%CI: 1.08-3.3, p=0.024), or intensive care (OR: 3.8;95%CI: 1.01-14.4, p=0.047) for severe COVID-19 were risk factors for PCS. Notably, patients who developed PCS had poorer PROMIS global physical [15 (12-17) vs 12 (9-15)] and mental health [14 (11-16) vs 11 (8-14)] scores than those without PCS. Conclusion Individuals with AIRDs have a greater risk of PCS than HCs. Associated comorbid conditions, and advanced treatment or intensive care unit admission for severe COVID-19 confer a higher risk of PCS. It is imperative to identify risk factors for PCS for immediate multidisciplinary management in anticipation of poor physical and mental health.

Flares Following Covid-19 Vaccination in Patients with Idiopathic Inflammatory Myopathies: Combined Analysis from the Covid-19 Vaccination in Autoimmune Diseases (Covad) Studies

Background/Aims Flares following COVID-19 vaccination are an emerging concern among patients with rare rheumatic disease like idiopathic inflammatory myositis (IIMs), whereas data and understanding of this is rather limited. We aimed to study the prevalence, characteristics and determinants of IIM flares following COVID-19 vaccination. Methods CoVAD (COVID-19 Vaccination In Autoimmune Diseases) surveys are global patient self-reported e-surveys from 109 countries conducted in 2021 and 2022. Flares of IIM were defined by 4 definitions;a. patient self-reported, b. physician and immunosuppression (IS) denoted, c. sign directed (new erythematous rash, or worsening myositis or arthritis), d. MCID worsening of PROMISPF10a score between the patients who had taken both surveys. Descriptive statistics and multivariate regression were used to describe the predictors of flare. Cox-regression analysis was used to differentiate flares by IIM subtypes. Results Among the 1,278 IIM patients, aged 63 (50-71) years, 276 (21.5%) were dermatomyositis, 237 (18.5%) IBM, 899 (70.3%) were female and most were Caucasian (80.8%). Flares of IIM were seen in 123/1278 (9.6%), 163/1278 (12.7%), 112/1278 (8.7%), and 16/96 (19.6%) by definitions a-d respectively with median time to flare being 71.5 (10.7- 235) days. Muscle weakness (69.1%), and fatigue (56.9%) were the most common symptoms of flare. The predictors of self-reported flare were: inactive/disease in remission prior to first dose of vaccine (OR=4.3, 95%CI=2.4-7.6), and anxiety disorder (OR=2.2, 95%CI=1.1-4.7). Rituximab use (OR=0.3, 95%CI=0.1-0.7) and IBM (OR=0.3, 95%CI=0.1-0.7) were protective. Physician defined flares were seen more often in females, mixed ethnicity, and those with asthma, ILD, and anxiety disorder (OR ranging 1.6-7.0, all p<0.05). Notably, overlap myositis (OM) had higher HR for flare compared to polymyositis (HR=2.3, 95%CI=1.2-4.4, p=0.010). Conclusion Nearly one in ten individuals with IIM develop flares after vaccination, more so among women, those with overlap myositis, and inactive disease prior to vaccination. Formal definition of flares in IIM is needed.

Autoimmune multimorbidity and higher fatigue VAS in women with idiopathic inflammatory myopathies: Results from the international COVAD patient-reported e-survey

Background/Purpose: Idiopathic inflammatory myopathies (IIMs) are a group of rare systemic autoimmune rheumatic diseases (AIRDs) with considerable heterogeneity. Little is reported about gender difference in patient-reported outcomes (PROs) of those with IIMs, which have a significant impact on health-related quality of life. We aimed to investigate the gender difference in PROs and treatment regimens of IIM patients utilizing data obtained in the COVID-19 vaccination in autoimmune disease (COVAD) study, a large-scale, international self-reported e-survey assessing the safety of COVID-19 vaccination in patients with various AIRDs including IIMs. Method(s): The COVAD study was launched in April 2021 and continued until December 31, 2021. The survey data regarding demographics, AIRD diagnosis, autoimmune multimorbidity (defined as three or more AIRD diagnoses for each patient), disease activity, current corticosteroid or immunosuppressant use, and PROs including fatigue and pain VAS, PROMIS Short Form -Physical Function 10a (PROMIS PF-10a), general health status, and ability to carry out routine activities were extracted from the COVAD database. Each PRO, disease activity, and treatments were compared between women and men. Patients with inclusion body myositis (IBM) were analyzed separately due to significant difference in treatment regimens and outcomes compared to other IIM subtypes. Factors affecting each PRO were determined by multivariable analysis. Result(s): 1197 complete responses from IIM patients as of August 2021 were analyzed. 845 (70.6%) patients were women. Women were younger (58 [48-68] vs. 69 [58-75] years old, median [interquartile range (IQR)], P0.001), and more likely to suffer from autoimmune multimorbidity compared to men (11.1% vs. 3.1%, P 0.001;Table 1). In patients with non-IBM IIMs, disease activity and corticosteroid use were comparable in both genders, while the distribution of immunosuppressant use was different (P = 0.002), with more hydroxychloroquine use in women (18.3% vs. 6.9%). The median fatigue VAS was significantly higher in women than in men (5 [IQR 3-7] vs. 4 [IQR 2-6], P = 0.004), whereas gender difference in the other PROs was not statistically significant (Table 2). In patients with IBM, on the other hand, no significant gender differences in PROs and treatment regimens were observed. The multivariable analysis in non-IBM IIMs revealed women, living in high-income countries, overlap myositis, and autoimmune multimorbidity as independent factors for higher fatigue VAS. Conclusion(s): Women with IIMs frequently suffer from autoimmune multimorbidity, and also experience more fatigue compared to men, calling for greater attention and further research on targeted treatment approaches. (Table Presented).

COVID19 vaccination-related short-term adverse events in patients with idiopathic inflammatory myositis and autoimmune multimorbidity: Results from the COVAD survey

Background: COVID-19 vaccines are safe & effective, though patients with rheumatic diseases like idiopathic inflammatory myositis (IIMs), and those with multiple comorbidities continue to be hesitant. Adverse events after vaccination are not extensively studied in those with multiple coexisting autoimmune diseases. Patients with IIM often have multiple autoimmune rheumatic and autoimmune non-rheumatic comorbidities (IIM-AIDs), with potentially increased risk of AEs. The COVAD study aimed to assess COVID-19 vaccination-related AEs till 7 days post-vaccination in IIM-AIDs compared to IIMs and healthy controls (HCs) group. Method(s): T he C OVAD s tudy g roup c omprised > 110 c ollaborators across 94 countries. The study was conducted from March-December 2021. A survey monkey platform-based self-reported online survey captured data related to COVID-19 vaccination-related AEs in IIMs, AIDs, and HCs. We compared COVID-19 vaccination-related AEs among IIM-AID patients and IIM alone and HCs, adjusting for age, gender, ethnicity, vaccine type, immunosuppression, and numbers of AIDs, using binary logistic regression. Statistically significant results following multivariate regression are reported. Result(s): Among 6099 participants, 1387 (22.7%) IIM, 4712 (77.2%) HC, 66.3% females, were included from 18 882 respondents: 573 (41.0%) people with IIM-AIDs;814 (59.0%) with IIM without other AIDs;and 4712 HCs. People with IIM were older [median 54 (45-66) IIM-AIDs, 64 (50-73) IIM, 34 (26-47) HC years, P < 0.001]. BNT162b2 (Pfizer) (37.5%) and ChAdOx1nCoV-19 (Oxford) (11.1%) were the most common vaccines. When compared to IIM alone, IIM-AID patients reported higher overall AEs [OR 1.5 (1.1-2.1)], minor AE [OR 1.5 (1.1-2.1)] &major AE [OR 3 (1.5-5.8)]. IIM-AIDs patients also reported higher body ache, nausea, headache, & fatigue (OR ranging 1.3-2.3). After adjusting for the number of AIDs, the major AEs equalized but overall AEs, & minor AEs, such as fatigue remained higher. When compared to HCs, IIM-AIDs patients reported similar overall AEs, minor AEs but higher major AEs [OR 2 (1.2-3.3)] nausea/ vomiting [OR 1.4 (1.01-2)], headache [OR 1.2 (1.01-1.6)], and fatigue [OR 1.3 (1.03-1.6)]. Dermatomyositis with AIDs (n = 183) reported higher major AEs [OR 4.3 (1.5-12)] compared to DM alone (n = 293). Active IIM with AIDs (n = 482) reported higher overall AEs [OR 1.5 (1.1-2.2)], minor AEs [OR 1.5 (1.1-2.2)] and major AEs [OR 2.6 (1.2-5.2)] compared to active IIM alone (n = 643). Conclusion(s): COVID-19 vaccination is safe with minimal to no risks of short-term AEs in patients with IIM without other concomitant autoimmune diseases. The presence of autoimmune multimorbidity conferred higher self-reported short-term risks of overall, major, and minor COVID-19 vaccination-related AEs 7 days post-vaccination, particularly in those with active IIM.

Vaccine hesitancy among patients with idiopathic inflammatory myopathies and rheumatic diseases patients in 2021-2022: Covad survey

Background: Patients with comorbidities and active rheumatic disease have increased morbidity and hospitalization following SARS-CoV- 2 infection. While vaccination has decreased this, many unknown factors still influence COVID-19 vaccine hesitancy. The data on predictors of vaccine hesitancy is regional and scarce. We aimed to analyze the factors influencing vaccine hesitancy in 2022 and compare them with those in 2021 through multicentre international e-surveys (The COVID-19 Vaccination in Autoimmune Diseases Studies -COVAD study 1 and 2). Method(s): COVAD 1 and 2 are multi-centre international e-survey with 152 collaborators in 106 countries including patients with idiopathic inflammatory myopathies (IIM), autoimmune rheumatic diseases (AIRDs), other autoimmune diseases (AIDs), and healthy controls (HCs) conducted in March-December 2021 and February-June 2022 (ongoing), respectively. Descriptive and multivariable regression adjusting for age, gender, ethnicity, and stratified by country of residence was performed. Result(s): Among the 18 882 (2021) and 7666 complete responses (2022), and 3109 (16.5%) and 387 (5.1%) did not receive any COVID-19 vaccine, respectively. The prevalence of vaccine hesitancy has decreased [OR 0.26 (0.24-0.3), P < 0.001]. Among the 387 vaccine non-recipients in 2022, numbers were as follows: IIM 69 (17%), AIRDs 179 (46%), other AIDs 80 (20.6%), and HC 59 (15%). The reasons for vaccine hesitancy in 2022 included: doctor advising against it 47 (12%), do not believe in the science behind the vaccine 79 (21%), long-term safety concerns 152 (39%), awaiting more safety data 105 (27%), and not recommended due to recent infection 30 (7%). Compared to AIRDs and HCs, IIM patients were more disbelievers of the science behind the vaccine [OR 1.8 (1.08-3.2), P = 0.023 AIRDs, OR 4 (1.9-8.1), P < 0.001 HC], had more long-term safety concerns [OR 1.9 (1.2-2.9), P = 0.001 AIRDs, OR 5.4 (3-9.6), P < 0.001 HC] and had more doctors recommending against the vaccine [OR 12.9 (2.8-59), P < 0.001 HC]. Vaccine non-recipients had higher pain visual analog score (VAS) (P < 0.001), lower fatigue VAS (P = 0.003), lower PROMIS10a physical health (P < 0.001), and mental health scores (P = 0.015). The factors predicting vaccine hesitancy in regression were lower PROMIS10a global physical health score [OR 0.9 (0.8-0.97), P = 0.014] and Caucasian ethnicity [OR 4.2 (1.7-10.3), P = 0.001]. Compared to 2021, doctor's advising against vaccination [OR 2.5 (1.8-3.6), P < 0.001] and long-term safety concerns [OR 3.6 (2.9-4.6), P < 0.001] were more frequent causes of vaccine hesitancy overall whereas vaccine non-availability [OR 0.05 (0.02-0.11), P < 0.001] and have scheduled the vaccination but not received [OR 0.1 (0.06-0.3), P < 0.001] were less frequent causes in 2022. Conclusion(s): Overall, the prevalence of COVID-19 vaccine hesitancy has decreased. Long-term safety concerns and the need for more safety data are now the major reasons for vaccine hesitancy. Caucasian ethnicity and lower physical health scores are predictors of vaccine hesitancy. The increase in physicians recommending against vaccination calls for more physician awareness to mitigate vaccine hesitancy.

COVID-19 VACCINATION-RELATED ADVERSE EVENTS among AUTOIMMUNE DISEASE PATIENTS: RESULTS from the COVID-19 VACCINATION in AUTOIMMUNE DISEASES (COVAD) STUDY

Background: COVID-19 vaccines have been proven to be safe and effective in the healthy population at large. However, signifcant gaps remain in the evidence of their safety in patients with systemic autoimmune and infammatory disorders (SAIDs). Patients and rheumatologists have expressed concerns regarding vaccination triggered allergic reactions, thrombogenic events, and other adverse events (ADEs) contributing to vaccine hesitancy (1) Objectives: This study aimed to assess and compare short term COVID-19 vaccination associated ADEs in patients with SAIDs and healthy controls (HC) seven days post-vaccination, as well as between patients with SAIDs receiving different vaccines. Methods: We developed an comprehensive, patient self-reporting electronic-survey to collect respondent demographics, SAID details, COVID-19 infection history, COVID-19 vaccination details, 7-day post vaccination adverse events and patient reported outcome measures using the PROMIS tool. After pilot testing, validation, translation into 18 languages on the online platform surveymonkey.com, and vetting by international experts, the survey was circulated in early 2021 by a multicenter study group of >110 collaborators in 94 countries. ADEs were categorized as injection site pain, minor ADEs, major ADEs, and hospitalizations. We analyzed data from the baseline survey for descriptive and intergroup comparative statistics based on data distribution and variable type (data as median, IQR). Results: 10900 respondents [42 (30-55) years, 74% females and 45% Caucasians] were analyzed. 5,867 patients (54%) with SAIDs were compared with 5033 HCs. All respondents included in the fnal analysis had received a single dose of the vaccine and 69% had received 2 primary doses. Pfzer (39.8%) was the most common vaccine received, followed by Oxford/AstraZeneca (13.4%), and Covishield (10.9%). Baseline demographics differed by an older SAID population (mean age 42 vs. 33 years) and a greater female predominance (M:F= 1:4.7 vs. 1:1.8) compared to HCs. 79% had minor and only 3% had major vaccine ADEs requiring urgent medical attention overall. In adjusted analysis, among minor ADEs, abdominal pain [mul-tivariate OR 1. 6 (1.14-2.3)], dizziness [multivariate OR 1. 3 (1.2-1.5)], and headache [multivariate OR 1.67 (1.3-2.2)], were more frequent in SAIDs than HCs. Overall major ADEs [multivariate OR 1. 9 (1.6-2.2)], and throat closure [multivar-iate OR 5.7 (2.9-11.3)] were more frequent in SAIDs though absolute risk was small (0-4%) and rates of hospitalization were similarly small in both groups, with a small absolute risk (0-4%). Specific minor ADEs frequencies were different among different vaccine types, however, major ADEs and hospitalizations overall were rare (0-4%) and comparable across vaccine types in patients with SAIDs (Figure 1). Conclusion: Vaccination against COVID-19 is relatively safe and tolerable in patients with SAIDs. Certain minor vaccine ADEs are more frequent in SAIDs than HCs in this study, though are not severe and do not require urgent medical attention. SAIDs were at a higher risk of major ADEs than HCs, though absolute risk was small, and did not lead to increased hospitalizations. There are small differences in minor ADEs between vaccine types in patients with SAIDs.

HIGH FATIGUE SCORES in PATIENTS with IDIOPATHIC INFLAMMATORY MYOPATHIES: A MULTIGROUP COMPARATIVE STUDY from the COVAD E-SURVEY

Background: Idiopathic inflammatory myopathies (IIM) are a rare, multisystem, heterogeneous diseases, and contribute to high psychological burden. The patients' perception of physical health, deteriorating independence and social and environmental relationships may not always be a direct function of disease activity. To face with these aspects, several worldwide specialized organization have recommended the use of patient reported outcome measures (PROMs) both in clinical trials and observational studies to highlight patient's perception of the disease (1). Unfortunately, data on fatigue scores in IIM is limited. Objectives: We compared fatigue VAS scores in patients with IIM, autoimmune diseases (AIDs) and healthy controls (HCs) and triangulated them with PROMIS physical function in a large international cohort made up of answers from the e-survey regarding the COVID-19 Vaccination in Autoimmune Diseases (COVAD) study. Methods: Data of 16327 respondents was extracted from the COVAD database on August 31th 2021. VAS fatigue scores were compared between AID, HC and IIM using univariate followed by multivariate analysis after adjusting for baseline differences. We further performed a propensity score matched analysis on 1827 subjects after adjusting for age, gender and ethnicity. The Kruskal-Wallis test was used for continuous variables and chi-square test for categorical variables, and Bonferroni's correction was applied for the post hoc analyses considering IIMs as a reference group. Results: We analyzed answers from 6988 patients, with a mean age of 43.8 years (SD 16.2). The overall percentage of female was 72% and the population ethnicity was mainly composed of White (55.1%), followed by Asian (24.6%), and Hispanic (13.8%). The overall fatigue VAS was 3.6 mm (SD 2.7). IIMs VAS was 4.8 mm (SD 2.6), AIDs 4.5 mm (SD 2.6), and HC 2.8 mm (SD 2.6) (P <0,001). VAS fatigue scores of IIMs were comparable with AIDs (P 0.084), albeit signifcantly higher than the HCs (P <0,001). Notably, fatigue VAS was lower in IIMs than AIDs in two distinct subsets: inactive disease as defned by the patient's perception and the 'excellent' general health condition group, where IIMs had worse scores (P <0,05). Interestingly, fatigue VAS was comparable in active disease defned by physician assessment, patient perception, based on general functional status, or when defned by steroid dose being prescribed. Notably, after propensity matched analysis of patients adjusting for gender, age and ethnicity (1.827 answers, I.e. 609 subjects per group, P =1) the differences disappeared and IIMs and AIDs had comparable fatigue levels across all levels of disease activity, although the fatigue discrepancies with HCs were substantially confrmed. After application of a multivariate linear regression analysis we found that lower fatigue VAS scores were related to HC (P <0,001), male gender (P <0,001), Asian and Hispanic ethnicities (P <0,001 and 0,003). Conclusion: Our study confrms that there is a higher prevalence of fatigue in all the AIDs patients, with comparable VAS scores between IIMs and other AIDs. We can also read our data commenting that females and/or Caucasians patients suffer a higher impact of this manifestation of chronic autoimmune diseases upon their lives. This is why these subjects, to our judgement, should be carefully evaluated during outpatients visits and to whom we should spend some extra time to discuss health related issues and how to improve them.

COVID-19 SEVERITY and VACCINE BREAKTHROUGH INFECTIONS in IDIOPATHIC INFLAMMATORY MYOPATHIES, OTHER SYSTEMIC AUTOIMMUNE and INFLAMMATORY DISEASES, and HEALTHY INDIVIDUALS: RESULTS from the COVID-19 VACCINATION in AUTOIMMUNE DISEASES (COVAD) STUDY

Background: Signifcant gaps are present in the evidence of the spectrum and severity of COVID-19 infection in idiopathic infammatory myopathies (IIM). IIM patients typically require immunosuppressive therapy, may have multiple disease sequelae, and frequent comorbidities, and thus may be more susceptible to severe COVID-19 infection and complications (1). The possibility of attenuated immunogenicity and reduced efficacy of COVID-19 vaccines due to concomitant immunosuppressive medication is a major concern in these patients, and there is little data available on COVID-19 vaccine breakthrough infections (BI) in IIM (2). Objectives: This study aimed to compare disease spectrum and severity and COVID-19 BI in patients with IIM, other systemic autoimmune and infammatory diseases (SAIDs) and healthy controls (HCs). Methods: We developed an extensive self-reporting electronic-survey (COVAD survey) featuring 36 questions to collect respondent demographics, SAID details, COVID-19 infection history, COVID-19 vaccination details, 7-day post vaccination adverse events and patient reported outcome measures using the PROMIS tool. After pilot testing, validation, translation into 18 languages on the online platform surveymonkey.com, and vetting by international experts, the COVAD survey was circulated in early 2021 by a multicenter study group of >110 collaborators in 94 countries. BI was defned as COVID-19 infection occurring more than 2 weeks after receiving 1st or 2nd dose of a COVID-19 vaccine. We analyzed data from the baseline survey for descriptive and intergroup comparative statistics based on data distribution and variable type. Results: 10900 respondents [mean age 42 (30-55) years, 74% females and 45% Caucasians] were analyzed. 1,227 (11.2%) had IIM, 4,640 (42.6%) had other SAIDs, and 5,033 (46.2%) were HC. All respondents included in the fnal analysis had received a single dose of the vaccine and 69% had received 2 primary doses. Pfzer (39.8%) was the most common vaccine received, followed by Oxford/AstraZeneca (13.4%), and Covishield (10.9%). IIM patients were older, had a higher Caucasian representation and higher Pfzer uptake than other SAIDs, and HC. A higher proportion of IIM patients received immu-nosuppressants than other SAIDs. IIMs were at a lower risk of symptomatic pre-vaccination COVID-19 infection compared to SAIDs [multivariate OR 0.6 (0.4-0.8)] and HCs [multivariate OR 0.39 (0.28-0.54)], yet at a higher risk of hospitalization due to COVID-19 compared to SAIDs [univariate OR 2.3 (1.2-3.5)] and HCs [multivariate OR 2.5 (1.1-5.8)]. BIs were very uncommon in IIM patients, with only 17 (1.4%) reporting BI. IIM patients were at a higher risk of contracting COVID-19 prior to vaccination than ≤2 weeks of vaccination [univariate OR 8 (4.1-15)] or BI [univariate OR 4.6 (2.7-8.0)]. BIs were equally severe compared to when they occurred prior to vaccination in IIMs, and were comparable between IIM, SAIDs, and HC (Figure 1), though BI disease duration was shorter in IIMs than SAIDs (7 vs 11 days, p 0.027). 13/17 IIM patients with BI were on immunosuppressants. Conclusion: IIM patients experienced COVID-19 infection less frequently prior to vaccination but were at a higher risk of hospitalization and requirement for oxygen therapy compared with patients with HC. Breakthrough COVID-19 infections were rare (1.4%) in vaccinated IIM patients, and were similar to HC and SAIDs, except for shorter disease duration in IIM.

IMPAIRED PROMIS PHYSICAL FUNCTION in IDIOPATHIC INFLAMMATORY MYOPATHY PATIENTS: RESULTS from the MULTICENTER COVAD PATIENT REPORTED E-SURVEY

Background: Evaluation of physical function is fundamental in the management of idiopathic infammatory myopathies (IIMs). Patient-Reported Outcome Measurement Information System (PROMIS) is a National Institute of Health initiative established in 2004 to develop patient-reported outcome measures (PROMs) with improved validity and efficacy. PROMIS Physical Function (PF) short forms have been validated for use in IIMs [1]. Objectives: To investigate the physical function status of IIM patients compared to those with non-IIM autoimmune diseases (AIDs) and healthy controls (HCs) utilizing PROMIS PF data obtained in the coronavirus disease-2019 (COVID-19) Vaccination in Autoimmune Diseases (COVAD) study, a large-scale, international self-reported e-survey assessing the safety of COVID-19 vaccines in AID patients [2]. Methods: The survey data regarding demographics, IIM and AID diagnosis, disease activity, and PROMIS PF short form-10a scores were extracted from the COVAD study database. The disease activity (active vs inactive) of each patient was assessed in 3 different ways: (1) physician's assessment (active if there was an increased immunosuppression), (2) patient's assessment (active vs inactive as per patient), and (3) current steroid use. These 3 defnitions of disease activity were applied independently to each patient. PROMIS PF-10a scores were compared between each disease category (IIMs vs non-IIM AIDs vs HCs), stratifed by disease activity based on the 3 defnitions stated above, employing negative binominal regression model. Multivariable regression analysis adjusted for age, gender, and ethnicity was performed clustering countries, and the predicted PROMIS PF-10a score was calculated based on the regression result. Factors affecting PROMIS PF-10a scores other than disease activity were identifed by another multivariable regression analysis in the patients with inactive disease (IIMs or non-IIM AIDs). Results: 1057 IIM patients, 3635 non-IIM AID patients, and 3981 HCs responded to the COVAD survey until August 2021. The median age of the respondents was 43 [IQR 30-56] years old, and 74.8% were female. Among IIM patients, dermatomyositis was the most prevalent diagnosis (34.8%), followed by inclusion body myositis (IBM) (23.6%), polymyositis (PM) (16.2%), anti-syn-thetase syndrome (11.8%), overlap myositis (7.9%), and immune-mediated necrotizing myopathy (IMNM) (4.6%). The predicted mean of PROMIS PF-10a scores was signifcantly lower in IIMs compared to non-IIM AIDs or HCs (36.3 [95% (CI) 35.5-37.1] vs 41.3 [95% CI 40.2-42.5] vs 46.2 [95% CI 45.8-46.6], P < 0.001), irrespective of disease activity or the defnitions of disease activity used (physician's assessment, patient's assessment, or steroid use) (Figure 1). The largest difference between active IIMs and non-IIM AIDs was observed when the disease activity was defned by patient's assessment (35.0 [95% CI 34.1-35.9] vs 40.1 [95% CI 38.7-41.5]). Considering the subgroups of IIMs, the scores were signifcantly lower in IBM in comparison with non-IBM IIMs (P < 0.001). The independent factors associated with low PROMIS PF-10a scores in the patients with inactive disease were older age, female gender, and the disease category being IBM, PM, or IMNM. Conclusion: Physical function is signifcantly impaired in IIMs compared to non-IIM AIDs or HCs, even in patients with inactive disease. The elderly, women, and IBM groups are the worst affected, suggesting that developing targeted strategies to minimize functional disability in certain groups may improve patient reported physical function and disease outcomes.