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.

REDUCED HEALTH-RELATED QUALITY OF LIFE USING PROMIS IN PATIENTS WITH SYSTEMIC SCLEROSIS: A CROSS-SECTIONAL ANALYSIS FROM THE INTERNATIONAL COVAD-2 E-SURVEY

BackgroundThe second COVID-19 vaccination in autoimmune disease (COVAD-2) study [1] is an international, multicentre, self-reported e-survey designed to evaluate several facets covering COVID-19 infection and vaccination as well as validated patient-reported outcome measures (PROMs) in a variety of autoimmune diseases (AIDs), including systemic sclerosis (SSc). Detailed assessment of the health-related quality of life (HRQOL) and its drivers in patients with SSc is lacking.ObjectivesTo assess physical and mental health in a global cohort of SSc patients in comparison with non-SSc 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 from the COVAD-2 survey.MethodsThe COVAD-2 database was used to extract demographics, AID diagnosis, comorbidities, disease activity, current therapies, and PROMs. PROMIS global physical health (GPH), global mental health (GMH) scores, PROMIS physical function short form-10a (PROMIS PF-10a), pain visual analogue scale (VAS), and PROMIS Fatigue-4a scores were compared between SSc, non-SSc AIRDs, NRAIDs, and controls. Outcomes were also compared between diffuse cutaneous SSc (dcSSc) vs limited cutaneous SSc (lcSSc). Multivariable regression analysis was performed to identify factors influencing GPH and GMH scores in SSc.ResultsA total of 10,502 complete responses from 276 SSc, 6006 non-SSc AIRDs, 545 NRAIDs, and 3675 controls as of May 2022 were included in the analysis. Respondents with SSc were older [SSc vs. non-SSc AIRDs vs. NRAIDs vs. controls: 55 (14) vs. 51 (15) vs. 45 (14) vs. 40 (14) years old, mean (SD), p < 0.001]. Among patients with SSc, 129 (47%) had dcSSc and 147 (53%) had lcSSc. SSc patients reported a significantly higher prevalence of ILD [SSc vs. non-SSc AIRDs vs. NRAIDs vs. controls: 30.4% vs. 5.5% vs. 1.5% vs. 0.2%, p < 0.001], and treatment with MMF [SSc vs. non-SSc AIRDs vs. NRAIDs vs. controls: 26.4% vs. 9.5% vs. 1.1% vs. 0%, p < 0.001].Patients with SSc had lower GPH and PROMIS PF-10a scores [SSc vs. non-SSc AIRDs vs. NRAIDs vs. controls: 13 (11–15) vs. 13 (11–15) vs. 15 (13–17) vs. 17 (15–18), median (IQR), p < 0.001;39 (33–46) vs. 39 (32–45) vs. 47 (40–50) vs. 49 (45–50), p < 0.001, respectively] and higher Pain VAS and PROMIS Fatigue-4a scores compared to those with NRAIDs or controls [SSc vs. non-SSc AIRDs vs. NRAIDs vs. controls: 3 (2–5) vs. 3 (1–6) vs. 2 (0–4) vs. 0 (0–2), p < 0.001;11 (8–14) vs. 11 (8–14) vs. 9 (7–13) vs. 7 (4–10), p < 0.001, respectively]. Patients with AIDs including SSc had lower GMH scores compared to controls [SSc vs. non-SSc AIRDs vs. NRAIDs vs. controls: 12.5 (10–15) vs. 13 (10–15) vs. 13 (11–16) vs. 15 (13–17), p < 0.001].Among SSc patients, GPH, GMH, and PROMIS PF-10a scores were lower in dcSSc compared to lcSSc [dcSSc vs. lcSSc: 12 (10–14) vs. 14 (11–15), p < 0.001;12 (10-14) vs. 13 (10-15), p<0.001;38 (30–43) vs. 41 (34–47), p < 0.001, respectively]. Pain VAS and PROMIS Fatigue-4a scores were higher in dcSSc compared to lcSSc [4 (2–6) vs. 3 (1–5), p < 0.001;12 (8–15) vs. 9 (8–13), p < 0.001, respectively].The independent factors for lower GPH scores in SSc were older age, Asian ethnicity, glucocorticoid use, and higher pain and fatigue scales, while mental health disorders and higher pain and fatigue scales were independently associated with lower GMH scores.ConclusionIn a global cohort, patient-reported physical and mental health were significantly worse in patients with SSc in comparison to those with non-SSc AIDs and without AIDs. Our findings support the critical need for more attention to patient's subjective experiences including pain and fatigue to improve the HRQOL in patients with SSc.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.Acknowledgements:NIL.Disclosure of InterestsKeina Yomono: None declared, Yuan Li: None dec ared, Vahed Maroufy: None declared, Naveen Ravichandran: None declared, Akira Yoshida: None declared, Kshitij Jagtap: None declared, Tsvetelina Velikova Speakers bureau: Pfizer and AstraZeneca, Parikshit Sen: None declared, Lorenzo Cavagna: None declared, Vishwesh Agarwal: None declared, Johannes Knitza: None declared, Ashima Makol: None declared, Dey Dzifa: None declared, Carlos Enrique Toro Gutierrez: None declared, Tulika Chatterjee: None declared, Aarat Patel: None declared, Rohit Aggarwal Consultant of: 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 Therepeutics, Teva, Beigene, ANI Pharmaceuticals, Biogen, Nuvig, Capella Bioscience, and CabalettaBio, Grant/research support 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 Therepeutics, Teva, Beigene, ANI Pharmaceuticals, Biogen, Nuvig, Capella Bioscience, and CabalettaBio, Latika Gupta: None declared, Masataka Kuwana Speakers bureau: Abbvie, Asahi-Kasei, Astellas, Boehringer-Ingelheim, Chugai, Eisai, MBL, Mochida, Nippon Shinyaku, Ono Pharmaceuticals, Tanabe-Mitsubishi, Consultant of: Astra Zeneka, Boehringer-Ingelheim, Chugai, Corbus, GSK, Horizon, Tanabe-Mitsubishi, Grant/research support from: Boehringer-Ingelheim, Vikas Agarwal: None declared.

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 inflammatory 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 with improved validity and efficacy. The present study aims to investigate the physical function status of IIM patients compared to those with non-IIM autoimmune diseases (AIDs) and healthy controls (HCs) utilizing PROMIS Physical Function (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. Methods. The survey data regarding demographics, IIM and AID diagnosis, disease activity, fatigue and pain VAS, and PROMIS PF short form-10a 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 increased immunosuppression), (2) patient's assessment (active vs inactive as per patient), and (3) current steroid use. These 3 definitions 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), stratified by disease activity based on the 3 definitions stated above, employing negative binomial regression model, and the predicted PROMIS PF-10a score adjusted for age, gender, and ethnicity was calculated. Factors affecting PROMIS PF-10a scores other than disease activity were identified by multivariable regression analysis in the patients with inactive disease (IIMs or non-IIM AIDs). The association between fatigue or pain VAS and PROMIS PF-10a scores was also assessed. 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-synthetase syndrome (11.8%), overlap myositis (7.9%), and immune-mediated necrotizing myopathy (IMNM) (4.6%). The predicted mean of PROMIS PF-10a scores was significantly 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 (Figure 1). The results were consistent across analyses using different disease activity definitions (physician's assessment, patient's assessment, and steroid use), while the largest difference between active IIMs and non-IIM AIDs was observed when the disease activity was defined 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 significantly 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. Higher fatigue or pain VAS was associated with lower PROMIS PF-10a scores in each disease category (p<0.001), while the scores were still lower in IIMs compared to non-IIM AIDs even after being adjusted for fatigue and pain. Conclusion. Physical function is significantly 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.

Autoimmune multimorbidity and fatigue in women with idiopathic inflammatory myopathies: an international, patient-reported, e-survey

Background: Idiopathic inflammatory myopathies are a group of rare systemic autoimmune rheumatic diseases with substantial heterogeneity. We aimed to investigate gender differences in patient-reported outcomes and treatment regimens of people with idiopathic inflammatory myopathies. Method(s): This international, patient-reported, e-survey was conducted worldwide. We used data from 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 older than 18 years with autoimmune rheumatic diseases, including idiopathic inflammatory myopathies. The COVAD study was conducted in more than 80 health-care centres, including hospitals, clinics, and universities located in more than 50 countries worldwide and on social media platforms, such as Facebook and Twitter. The COVAD e-survey was open between April 1, 2021, and Dec 31, 2021. We extracted survey data regarding demographics;autoimmune rheumatic disease diagnosis;autoimmune multimorbidity (three or more autoimmune rheumatic disease diagnoses for each patient);current corticosteroid or immunosuppressant use;and patient-reported outcomes, including fatigue and pain Visual Analogue Scale (VAS), and PROMIS short form-physical function 10a (PF-10a). Gender was reported by participants with three options (men, women, or do not wish to disclose). Patient-reported outcomes and corticosteroid or immunosuppressant use were compared between men and women. Participants with inclusion body myositis were analysed separately due to the substantial difference in treatment and disease outcomes compared with other idiopathic inflammatory myopathy subtypes. Factors affecting each patient-reported outcome were determined using multivariable analysis. Finding(s): The survey data were extracted on Aug 31, 2021, and 1202 complete responses from participants with idiopathic inflammatory myopathies were analysed. Five patients who did not wish to disclose gender were excluded. 845 (70.6%) of the remaining 1197 were women. Women were younger than men (median 58 years [IQR 48-68] vs 69 years [58-75];p=0.00010). Autoimmune multimorbidity was more common in women than in men (94 [11.1%] of 845 vs 11 [3.1%] of 352;p<0.0001). Corticosteroid use was similar in men and women with idiopathic inflammatory myopathies (except for inclusion body myositis), whereas the distribution of immunosuppressants was different, with higher hydroxychloroquine use in women (131 [18.3%] of 717 vs 11 [6.9%] of 159 in men;p=0.0082). The median fatigue VAS was significantly higher in women than in men (5 [IQR 3-7] vs 4 [2-6];p=0.0036), whereas the gender difference in pain VAS (median 3 [IQR 1-5] in women vs 2 [0-4] in men;p=0.064) and PROMIS PF-10a scores (38 [31-45] vs 39 [30-47];p=0.29) was non-significant. There were no significant differences in patient-reported outcomes and treatment in participants with inclusion body myositis. The multivariable analysis of idiopathic inflammatory myopathies (except for inclusion body myositis) revealed that female sex, residence in high-income countries, a diagnosis of overlap myositis, and autoimmune multimorbidity were independent risk factors for higher fatigue VAS. Interpretation(s): Women with Idiopathic inflammatory myopathies frequently have autoimmune multimorbidity and increased fatigue compared with men, calling for greater attention and further research on targeted treatment approaches. Funding(s): None.Copyright © 2022 Elsevier Ltd

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).

A prospective ultrasonographic surveillance study on the incidence and recovery period of COVID-19 vaccination-related axillary lymphadenopathy following a booster shot

Background: COVID-19 vaccination-related lymphadenopathy is a frequent imaging finding that may be indistinguishable from malignant nodes and can lead to diagnostic difficulties in patients with cancer or healthy individuals on cancer screening. However, no prospective trials regarding COVID-19 vaccination- related lymphadenopathy following a booster shot have been conducted. The purpose of this study was to determine the incidence and imaging characteristics of COVID-19 vaccination-related axillary lymphadenopathy and assess the recovery period following a booster shot. Methods: We prospectively enrolled healthy women working at St. Luke's International Hospital, who would receive the third shot of the Pfizer-BioNTech COVID-19 vaccine between December 6 and 28, 2021. Women with a history of cancer, atopic dermatitis, auto-immune disease, or axillary surgery were excluded. All participants underwent ultrasound (US) examinations for the bilateral axilla at baseline (prior to the third shot), early phase (1-3 days after the shot), and late phase (6 weeks after the shot) if lymphadenopathy was detected at the early phase. We evaluated the incidence and US characteristics of lymphadenopathy. As for US characteristics mimicking a malignant node, focal cortical thickening, absence of the echogenic hilus, and vascularity were examined. In this study, abnormal lymphadenopathy was defined as [1] an increase in the short-axis size by more than 2 mm compared with the baseline, [2] an increase in the number of nodes with short-axis diameter more than 5 mm, and [3] demonstrating US characteristics mimicking malignant nodes. Results: A total of 100 women were enrolled in this study. The median age was 41 years (range 23-63). Abnormal axillary lymphadenopathy on the vaccinated side was observed in 59% of participants in the early phase and 8% in the late phase. In the contralateral axilla, abnormal lymphadenopathy was observed in 1% of participants in the early phase and 2% in the late phase. The median short-axis size of ipsilateral abnormal lymphadenopathy was 7.6 mm in the early phase and 5.7 mm in the late phase. In the early phase, US characteristics mimicking malignant nodes were observed, including focal cortical thickening in 54% of participants, absence of the echogenic hilus in 16%, and hypervascularity in 33%. Conclusions: COVID-19 vaccination-related axillary lymphadenopathy indistinguishable from malignant nodes was observed in more than half of the participants compared with the baseline, which improved in most cases within 6 weeks after the latest booster shot. To avoid a diagnostic conundrum, patients with breast cancer should be vaccinated on the arm contralateral to the cancer side. It is recommended that non-urgent imaging screening for the axilla should be scheduled after 6 weeks following the latest vaccination.

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.

Photochemical sensitivity to emissions and local meteorology in Bogota, Santiago, and Sao Paulo: An analysis of the initial COVID-19

This study delves into the photochemical atmospheric changes reported globally during the pandemic by analyzing the change in emissions from mobile sources and the contribution of local meteorology to ozone (O-3) and particle formation in Bogota (Colombia), Santiago (Chile), and Sao Paulo (Brazil). The impact of mobility reductions (50%-80%) produced by the early coronavirus-imposed lockdown was assessed through high-resolution vehicular emission inventories, surface measurements, aerosol optical depth and size, and satellite observations of tropospheric nitrogen dioxide (NO2) columns. A generalized additive model (GAM) technique was also used to separate the local meteorology and urban patterns from other drivers relevant for O-3 and NO2 formation. Volatile organic compounds, nitrogen oxides (NOx), and fine particulate matter (PM2.5) decreased significantly due to motorized trip reductions. In situ nitrogen oxide median surface mixing ratios declined by 70%, 67%, and 67% in Bogota, Santiago, and Sao Paulo, respectively. NO2 column medians from satellite observations decreased by 40%, 35%, and 47%, respectively, which was consistent with the changes in mobility and surface mixing ratio reductions of 34%, 25%, and 34%. However, the ambient NO2 to NOx ratio increased, denoting a shift of the O-3 formation regime that led to a 51%, 36%, and 30% increase in the median O-3 surface mixing ratios in the 3 respective cities. O-3 showed high sensitivity to slight temperature changes during the pandemic lockdown period analyzed. However, the GAM results indicate that O-3 increases were mainly caused by emission changes. The lockdown led to an increase in the median of the maximum daily 8-h average O-3 of between 56% and 90% in these cities.

Prospective ultrasonographic surveillance study for incidence and recovery period of COVID-19 vaccination-related axillary lymphadenopathy

Background: COVID-19 vaccination-related lymphadenopathy is a frequent imaging finding which may be indistinguishable from malignant nodal involvement and lead to diagnostic difficulties in patients with cancer or healthy individuals on cancer screening. An expert panel of the leading cancer centers in United States recommended routine imaging examinations should be scheduled at least 6 weeks after the final vaccination to allow for any reactive lymphadenopathy to resolve. However, there were no prospective trials regarding COVID-19 vaccination-related lymphadenopathy and the evidence was so limited. The purpose of this study was to determine the incidence and imaging characteristics of COVID-19 vaccination-related axillary lymphadenopathy and assess the recovery period. Methods: We prospectively enrolled healthy women working at the St. Luke's International Hospital who received Pfizer COVID-19 vaccination within 8 weeks before enrollment between May 10th and 27th, 2021. Women with a history of any type of cancer or axillary surgery, active atopic dermatitis and auto-immune disease were excluded. Participants underwent ultrasound examinations for bilateral axilla at the enrollment. Lymphadenopathy was defined as demonstrating an enlarged node(s) with more than 5mm in short axis by ultrasound imaging in this trial. As for imaging characteristics, status of cortical thickening, echogenic hilus and vascularity of lymph nodes were evaluated. Other side effects by vaccination were assessed by a questionnaire. If lymphadenopathy was detected, we followed the participant by ultrasound examination every three weeks until the lymphadenopathy was resolved. We evaluated theincidence rate and imaging characteristics of lymphadenopathy detected by ultrasound examination, and the recovery period required for improvement of the lymphadenopathy. We also validated the association of the lymphadenopathy with the participant characteristics and other side effects. Results: A total of 135 women were enrolled in this study. Participants' median age was 37 years (range 23-63). Median time from the latest vaccination to the enrollment was 45 days (range 8-56). In the ultrasound examination at enrollment, axillary lymphadenopathy was observed in 67 participants (50%) on the injected (ipsilateral) side. In the contralateral axilla, 13 participants (10%) showed lymphadenopathy. In the ipsilateral axilla, the number of enlarged node(s) was 1 node in 25 cases (19%), 2 nodes in 24 cases (18%), 3 nodes in 13 cases (10%), 4 nodes in 4 cases (3%) and 5 nodes in 1 case (1%). Regarding the ipsilateral enlarged lymph node, focal cortical thickening was observed in 58 cases (43%) and the absence of the echogenic hilus was observed in 15 cases (11%). Hypervascularity was observed in 15 cases (11%). Incidence of the lymphadenopathy was not statistically correlated with participant's age or incidence of fever due to vaccination. At 6 weeks after the latest vaccination, the rate of ipsilateral axillary lymphadenopathy was 48%, 40% at 8 weeks, and 6% at 12 weeks. In participants with lymphadenopathy, median recovery period to resolve the lymphadenopathy was 75 days from the latest vaccination. Conclusion: A half of participants showed COVID-19 vaccination-related axillary lymphadenopathy and the imaging characteristics were often indistinguishable from malignant nodal involvement. Therefore, patients with breast cancer should be vaccinated on the contralateral arm to the cancer side to avoid diagnostic conundrum. The lymphadenopathy was commonly observed even in 8 weeks, and mostly resolved after 12 weeks from the vaccination. Therefore, non-urgent imaging examinations such as screening would be recommended to be scheduled at least 12 weeks following the latest vaccination.

Early effects of acuity circle-based liver allocation during COVID-19 pandemic in the United States

Purpose: One month before the COVID-19 pandemic was declared, liver transplant (LT) allocation in the US was updated (February 4th, 2020), by introducing the acuity circle (AC)-based model. This study evaluated the early effects of the AC-based allocation on waitlist outcomes. Methods: Adult candidates listed between January 1st, 2019, and June 30th, 2020, were evaluated. Two periods were defined according to the listing date (pre- and post-AC), and 90-day waitlist outcomes were compared. Data was censored if none of the events had occurred before the end of the period. The median transplant MELD score of each state was calculated, and states were defined as low-(<25th%ile), mid- (25th-75th%ile), and high-(>75th%ile) MELD regions. In addition, transplanted patients were categorized into 3 groups according to their final MELD score (6-14, 15-28, 29+). Organ sharing and donor characteristics were compared between eras. Results: 12,546 and 3,932 candidates in pre and post-AC eras were eligible. The post-AC era was associated with significantly lower 90-day waitlist mortality (HR=0.75, 95%CI=0.62-0.90;p=0.002) and higher transplant probability (HR=1.19, 95%CI=1.10-1.29;p<0.001). When outcomes were assessed in each MELD region group, improvement in outcomes was significant in mid-MELD regions, but not in other MELD regions. Among 5,971 and 772 transplanted in the pre and post- AC eras, national sharing significantly increased in all groups (overall: 7.4% to 32.5%, P<0.001). In contrast, a significant increase and decrease in the proportion of donation-after-circulatory-death (DCD)-LT was observed in the low- and mid- MELD regions, respectively. Another subgroup analysis showed that national sharing significantly increased in those with a score of 15-28 (7.6% to 22.1%, P<0.001) and 29+ (5.0% to 39.6%, P<0.001), but not in those with score of 6-14 (15.7% to 22.7%, P=0.11). Patients with a MELD score 15-28 received DCD-LT more frequently in post-AC era, but not in those with a score of 29+. (Table). Conclusions: Despite the COVID-19 pandemic, AC-based allocation improved waitlist outcomes in mid-MELD regions. While other regions had comparable out comes, aggressive utilization of DCD might offset possible negative effects of the AC-based model and/or pandemic in low-MELD regions. Organ acceptance practice may be significantly changed in certain regions/patient populations such as DCD acceptance for patients with mid MELD score in lower MELD regions. It is crucial to carefully monitor possible effects of those changes on post-transplant outcomes. (Table Presented).