ABSTRACT
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.
ABSTRACT
BackgroundRheumatoid arthritis (RA) and spondyloarthritis, including either Psoriatic Arthritis (PsA) and Ankylosing Spondylitis (AS), are some of the most diagnosed autoimmune rheumatic diseases (AIRDs) in rheumatologists' routine clinical practice [1]. Understanding patients' health and functional status is crucial to provide personalized management strategies to optimize disease control and enhance the quality of life.ObjectivesWe aimed to compare disease burden in patients with RA, PsA or AS by assessing Patient-Reported Outcome Measurement Information System (PROMIS) Physical Health, Global Mental Health, Physical Function and Fatigue 4a together with VAS Pain.MethodsData were obtained in the international COVID vaccination in autoimmune rheumatic diseases study second e-survey (COVAD study). Demographics, AIRD diagnosis, disease activity, PROMIS Global Physical health, PROMIS Global Mental Health, PROMIS Physical Function SF10 and PROMIS Fatigue 4a score were extracted from the COVAD study database. For this study, we only included patients with self-reported RA or spondyloarthritis (either PsA or AS) undergoing active treatment with conventional synthetic disease-modifying drugs (DMARDs) and/or biologic DMARDs, who answered all the survey questions. Active disease was defined as the patient's perception of their disease as active in the four weeks before their first COVID-19 vaccine shot. Analysis of Variance with Bartlett's and Tukey's test was used to compare continuous variables between groups.ResultsFrom January to June 2022, n.1907 patients with RA, female 87.62% (1671/1907), with mean age (±SD) 50.95 ±13.67, n.311 patients with PsA, female 67.20% (209/311), with a mean age of 50.42 ±12.70, and n.336 patients with AS, male 51.31% (209/311), with a mean age of 43.13 ±12.75 years, responded to the COVAD e-survey.In those with active disease, neither physical health, global mental health, physical function, fatigue, nor pain were different among groups (Table 1, Figure 1). Patients with inactive AS had higher mean global physical health scores than RA patients (13.13 ±2.93 VS RA 12.48 ±2.90, p=0.01, Table 1). Those with inactive RA or PsA showed more severe fatigue (PsA 10.58 ±2.22, RA 10.45 ±4.08 VS 9.4 ±4.13, p =0.01 for both). Patients with inactive RA also reported poorer physical function and more residual pain than those with AS (37.79 ±8.86 VS 41.13 ±7.79, p<0.001;3.87 ±2.45 VS 3.34 ±2.39, p=0.01, respectively). Similarly, residual pain was perceived as higher in patients with inactive PsA than those with AS (4.04 ±2.50 VS 3.34 ±2.39, p=0.01)ConclusionDisease burden is roughly comparable in patients with active RA, PsA or AS. Patients with inactive RA and PsA suffer higher disease burden than those with inactive AS.Reference[1]Mease PJ, Liu M, Rebello S, Kang H, Yi E, Park Y, Greenberg JD. Comparative Disease Burden in Patients with Rheumatoid Arthritis, Psoriatic Arthritis, or Axial Spondyloarthritis: Data from Two Corrona Registries. Rheumatol Ther. 2019 Dec;6(4):529-542.Table 1.Patient-Reported Outcome Measures between groups.Inactive diseaseAS (n.185)PsA (n.179)RA (n.1167)MeanSDMeanSDMeanSDPROMIS Global Physical Health13.13*2.9512.433.2712.482.90p=0.01, VS RAPROMIS Global Mental Health13.313.3612.973.3312.843.17PROMIS Fatigue 4a9.44.1310.58*4.2210.45*4.08p=0.01, bothPROMIS Physical Function SF10 Score41.137.3939.279.0137.79*8.86p<0.001, VS ASVAS Pain3.342.394.04*2.503.87*2.45p=0.01, bothActive DiseaseAS (n.35)PsA (n.38)RA (n.189)MeanSDMeanSDMeanSDPROMIS Global Physical Health11.053.1910.102.7611.243.41PROMIS Global Mental Health11.313.2610.843.6311.893.30PROMIS Fatigue 4a12.944.8712.844.4211.754.68PROMIS Physical Function SF10 Score35.829.6233.528.7634.909.80VAS Pain4.682.775.02.544.682.61Figure 1.Violin plots showing kernel densities, quartiles and median for Patient-Reported Outcome Measures for patients with RA, PsA and AS, stratified by disease activity status.[Figure omitted. See PDF]Acknowledgements:NIL.Disclosure of InterestsVincenzo Venerito: None declared, Marc Fornaro: None declared, Florenzo Iannone: None declared, Lorenzo Cavagna: None declared, Masataka Kuwana: None declared, Vishwesh Agarwal: None declared, Naveen Ravichandran: None declared, Jessica Day Grant/research support from: JD has received research funding from CSL Limited., Mrudula Joshi: 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, Parikshit Sen: None declared, James B. Lilleker Speakers bureau: JBL has received speaker honoraria/participated in advisory boards for Sanofi Genzyme, Roche, and Biogen. None is related to this manuscript., Consultant of: JBL has received speaker honoraria/participated in advisory boards for Sanofi Genzyme, Roche, and Biogen. None is related to this manuscript., Arvind Nune: None declared, John Pauling: None declared, Chris Wincup: None declared, Ai Lyn Tan Speakers bureau: ALT has received honoraria for advisory boards and speaking for Abbvie, Gilead, Janssen, Lilly, Novartis, Pfizer, and UCB., Nelly Ziade Speakers bureau: NZ has received speaker fees, advisory board fees, and research grants from Pfizer, Roche, Abbvie, Eli Lilly, NewBridge, Sanofi-Aventis, Boehringer Ingelheim, Janssen, and Pierre Fabre;none are related to this manuscript, Grant/research support from: NZ has received speaker fees, advisory board fees, and research grants from Pfizer, Roche, Abbvie, Eli Lilly, NewBridge, Sanofi-Aventis, Boehringer Ingelheim, Janssen, and Pierre Fabre;none are related to this manuscript, Marcin Milchert: None declared, Abraham Edgar Gracia-Ramos: None declared, Carlo Vinicio Caballero: None declared, COVAD Study: None declared, Vikas Agarwal: None declared, Rohit Aggarwal Speakers bureau: RA has a consultancy relationship with and/or has received research funding from the following companies: Bristol Myers-Squibb, Pfizer, Genentech, Octapharma, CSL Behring, Mallinckrodt, AstraZeneca, Corbus, Kezar, Abbvie, Janssen, Alexion, Argenx, Q32, EMD-Serono, Boehringer Ingelheim, and Roivant., Grant/research support from: RA has a consultancy relationship with and/or has received research funding from the following companies: Bristol Myers-Squibb, Pfizer, Genentech, Octapharma, CSL Behring, Mallinckrodt, AstraZeneca, Corbus, Kezar, Abbvie, Janssen, Alexion, Argenx, Q32, EMD-Serono, Boehringer Ingelheim, and Roivant., Latika Gupta: None declared.
ABSTRACT
BackgroundWe have previously reported short term safety of the COVID-19 vaccination in patients with Systemic sclerosis (SSc) but delayed adverse events (ADEs) (occurring >7 days post-vaccination) are poorly characterized in this rare yet vulnerable disease group.ObjectivesWe analyzed delayed COVID-19 vaccine-related ADEs among patients with SSc, other systemic autoimmune and inflammatory disorders (SAIDs) and healthy controls (HC) using data from the ongoing 2nd global COVID-19 Vaccination in Autoimmune Diseases (COVAD-2) study [1].MethodsThe COVAD-2 study was a cross-sectional, patient self-reporting e-survey utilizing an extensively validated, pilot tested questionnaire, translated into 19 languages, circulated by a group of 157 physicians across 106 countries from February to June 2022.We captured data on demographics, SSc/SAID disease characteristics (including skin subset, treatment history and self-reported disease activity), autoimmune and non-autoimmune comorbidities, COVID-19 infection history and course, and vaccination details including delayed ADEs as defined by the CDC.Delayed ADEs were categorized into local injection site pain/soreness;minor and major systemic ADEs, and hospitalizations. We descriptively analyzed the risk factors for overall and specific ADEs in SSc and SAIDs, and further triangulated clinically significant variables in binominal logistic regression analysis with adjustment for age, gender, ethnicity, comorbidity, and immunosuppressive therapy to analyze the survey responses.ResultsFrom among 17 612 respondents, 10 041 patients (median age 51 (18-58) years, 73.4% females, 44.9% Caucasians) vaccinated against COVID-19 at least once (excluding incomplete responses and trial participants) were included for analysis. Of these, 2.6 % (n=258) had SSc, 63.7% other SAIDs, and 33.7% were HCs. BNT162b2 Pfizer (69.4%) was the most administered vaccine, followed by MRNA-1273 Moderna (32.25%) and ChadOx1 nCOV-19 Oxford/AstraZeneca (12.4%) vaccines.Among the patients with SSc, 18.9% reported minor while 8.5% experienced major delayed ADEs, and 4.6% reported hospitalization. These values were comparable to those of the ADEs reported in other SAIDs and HCs. Patients with SSc reported higher frequency of difficulty in breathing than HCs [OR=2.3 (1.0-5.1), p=0.042].Individuals receiving Oxford/AstraZeneca reported more minor ADEs [OR=2.5 (1.0-6.0), p=0.045];whereas patients receiving Moderna were less likely to develop myalgia and body ache [OR=0.1 (0.02-1.0), p=0.047 and OR=0.2 (0.05-1.0), p=0.044 respectively].Patients with diffuse cutaneous SSc experienced minor ADEs and specifically fatigue more frequently [OR=2.1 (1.1-4.4), p=0.036, and OR=3.9 (1.3-11.7), p=0.015] than those with limited cutaneous SSc. Self-reported active disease pre-vaccination did not confer any increased risk of vaccine ADEs in the adjusted analysis. Unlike our previous observations in myositis, autoimmune and non-autoimmune comorbidities did not affect the risk of delayed ADEs in SSc. SSc patients with concomitant myositis reported myalgia [OR=3.4 (1.1-10.7), p=0.035] more frequently, while those with thyroid disorders were more prone to report a higher frequency of joint pain [OR=5.5 (1.5-20.2), p=0.009] and dizziness [OR=5.9 (1.3-27.6), p=0.024] than patients with SSc alone. Patients with SSc-interstitial lung disease did not report increased frequency of ADEs.ConclusionA diagnosis of SSc did not confer a higher risk of delayed post COVID-19 vaccine-related ADEs than other SAIDs and HCs. Diffuse cutaneous phenotype and certain co-existing autoimmune conditions including myositis and thyroid disease can increase the risk of minor ADEs. These patients may benefit from pre-vaccination counselling, close monitoring, and early initiation of appropriate care in the post COVID-19 vaccination period.Reference[1]Fazal ZZ, Sen P, Joshi M, Ravichandran N, Lilleker JB, et al. COVAD survey 2 long-term outcomes: unmet need and protocol. Rheumatol Int 2022 Dec;42(12):2151-2158AcknowledgementsCOVAD Study Team.Disclosure of InterestsBo dana Doskaliuk: None declared, Parikshit Sen: None declared, Mrudula Joshi: None declared, Naveen Ravichandran: None declared, Ai Lyn Tan Speakers bureau: Abbvie, Gilead, Janssen, Lilly, Novartis, Pfizer, UCB, Consultant of: Abbvie, Gilead, Janssen, Lilly, Novartis, Pfizer, UCB, Samuel Katsuyuki Shinjo: None declared, Sreoshy Saha: None declared, Nelly Ziade Speakers bureau: Pfizer, Roche, Abbvie, Eli Lilly, NewBridge, Sanofi-Aventis,Boehringer Ingelheim, Janssen, and Pierre Fabre, Consultant of: Pfizer, Roche, Abbvie, Eli Lilly,NewBridge, Sanofi-Aventis, Boehringer Ingelheim, Janssen, and Pierre Fabre, Grant/research support from: Pfizer, Roche, Abbvie, Eli Lilly, NewBridge, Sanofi-Aventis, Boehringer Ingelheim, Janssen, and.Pierre Fabre, Tulika Chatterjee: None declared, Masataka Kuwana: None declared, Johannes Knitza: None declared, Oliver Distler Speakers bureau: 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 and Topadur, 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 and Topadur, Grant/research support from: 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 and Topadur, Rohit Aggarwal Consultant of: Mallinckrodt, Octapharma, CSL Behring, Bristol Myers-Squibb, EMD Serono, Kezar, Pfizer, AstraZeneca, Alexion, Argenx, Boehringer Ingelheim, Corbus, Janssen, Kyverna, Roivant, Merck, Galapagos, Actigraph, Abbvie, Scipher, Horizontal Therapeutics, Teva, Biogen, Beigene, ANI Pharmaceutical, Nuvig, Capella, CabalettaBio, Grant/research support from: Mallinckrodt, Pfizer, Bristol Myers-Squibb, Q32, EMD Serono, Janssen, Boehringer Ingelheim (BI), Ashima Makol: None declared, Latika Gupta: None declared, Vikas Agarwal: None declared.
ABSTRACT
BackgroundViral infections are known triggers of disease flares in idiopathic inflammatory myopathies (IIMs). Reports of post-COVID-19 flares of IIMs have raised suspicion of a possible role of SARS-COV-2 in their onset [1,2]. However, despite rising flare rates in this vulnerable patient group during the pandemic, the risk factors for post-COVID-19 IIMs flares remain unknown [3,4].ObjectivesDisease flares among patients with idiopathic inflammatory myopathies (IIMs) can lead to significant disability, though are poorly explored in the post-COVID-19 period. We analysed risk factors for post-COVID-19 flares in a global sample of IIM patients in a subset analysis as part of the ongoing COVID-19 Vaccination in Autoimmune Diseases (COVAD) study.MethodsA cross-sectional patient self-reporting survey was circulated by the international COVAD study group (157 collaborators, 106 countries) to patients with autoimmune diseases and healthy controls from February-June 2022. Data was collected on demographics, autoimmune disease details, treatment history, comorbidities, COVID-19 history and course and COVID-19 vaccination details. Patients with IIMs who flared post COVID-19 were compared to those who did not using the χ2 test, factors found significant in univariate analysis and deemed clinically important, underwent multivariable analysis (binary logistic regression using the Enter method) with adjustment for age, gender, ethnicity, vaccine type, immunosuppression, autoimmune and non-autoimmune comorbidities, COVID-19 antibody status, and clinical symptoms of COVID-19. Statistical analyses were performed using IBM SPSS version 28.0, with statistical significance considered at p<0.05.Results15,165 respondents completed the survey of whom 1,169 contracted COVID-19. Of these, 207 had IIMs [median (IQR) age 57.0 (47.0-67.0), 71% female, 74.4% Caucasian]. We noted with concern that nearly a third of patients with IIMs (63/207, 30.4%) reported experiencing a flare. A past medical history significant for Asthma, (34.9% vs 6.9%, multivariable OR: 7.1;95%CI: 3.1-16.4, p<0.001) and specific clinical symptoms during COVID-19 including joint pains (multivariable OR: 6.05;95%CI: 1.60-22.9, p=0.008), and difficulty in breathing (multivariable OR: 3.43;95%CI: 1.09-10.8, p=0.036) were found to confer conferred a higher risk of flares (Table 1).Table 1Patient Reported Flares following COVID-19 infection among IIM patientsTotal IIMs (n=207)IIMs with flare after COVID-19 (n=63)IIMs without flare after COVID-19 (n=144)OR (95%CI)PAge (median, IQR) years57.0 (47.0-67.0)53.0 (47.0-62.0)59.0 (47.0-69.0)-0.024GenderMale Female60 (29.0) 147 (71.0)7 (11.1) 56 (88.9)53 (36.8) 91 (63.2)0.2 (0.09-0.5)< 0.001ComorbiditiesAsthma ILD32 (15.5) 31 (15.0)22 (34.9) 11 (17.5)10 (6.9) 20 (13.9)7.1 (3.1-16.4) 1.3 (0.5-2.9)<0.001 00.508Clinical features in previous COVID-19 infectionFatigue Myalgia Arthralgia Difficulty in breathing134 (64.7) 94 (45.4) 56 (27.1) 41 (19.8)52 (82.5) 44 (69.8) 36 (57.1) 27 (42.9)82 (56.9) 50 (34.7) 20 (13.9) 14 (9.7)3.5 (1.7-7.4) 4.3 (2.3-8.2) 8.2 (4.1-16.4) 6.9 (3.3-14.6)<0.001 <0.001 <0.001 <0.001ConclusionWe observed a high frequency of patients with IIM experiencing post-COVID-19 disease flares. A past history of Asthma and those with certain acute COVID-19 symptoms were at higher risk.References[1]Saud A, Naveen R, Aggarwal R, Gupta L. COVID-19 and Myositis: What We Know So Far. Curr Rheumatol Rep 2021;23:63.[2]Gokhale Y, Patankar A, Holla U, Shilke M, Kalekar L, Karnik ND, et al. Dermatomyositis during COVID-19 Pandemic (A Case Series): Is there a Cause Effect Relationship? J Assoc Physicians India 2020;68:20–4.[3]Gupta L, Lilleker JB, Agarwal V, Chinoy H, Aggarwal R. COVID-19 and myositis - unique challenges for patients. Rheumatology (Oxford) 2021;60:907–10.[4]Naveen R, Sundaram TG, Agarwal V, Gupta L. Teleconsultation experience with the idiopathic inflammatory myopathies: a prospective observational cohort study during the COVID-19 pandemic. Rheumatol Int 2021;41:67–76.Acknowledgements:NIL.Disclosure of InterestsSa dia Sasha Ali: None declared, Naveen Ravichandran: None declared, Parikshit Sen: None declared, Jessica Day Grant/research support from: JD has received research funding from CSL Limited., Mrudula Joshi: None declared, Sreoshy Saha: None declared, Rohit Aggarwal Consultant of: RA has a consultancy relationship with and/or has received research funding from the following companies: Bristol Myers-Squibb, Pfizer, Genentech, Octapharma, CSL Behring, Mallinckrodt, AstraZeneca, Corbus, Kezar, Abbvie, Janssen, Alexion, Argenx, Q32, EMD-Serono, Boehringer Ingelheim, and Roivant., Grant/research support from: RA has a consultancy relationship with and/or has received research funding from the following companies: Bristol Myers-Squibb, Pfizer, Genentech, Octapharma, CSL Behring, Mallinckrodt, AstraZeneca, Corbus, Kezar, Abbvie, Janssen, Alexion, Argenx, Q32, EMD-Serono, Boehringer Ingelheim, and Roivant., Vikas Agarwal: None declared, Hector Chinoy Speakers bureau: Speaker for UCB, and Biogen. HC was supported by the National Institution for Health Research Manchester Biomedical Research Centre Funding Scheme., Grant/research support from: Has received grant support from Eli Lilly and UCB, consulting fees from Novartis, Eli Lilly, Orphazyme, Astra Zeneca, Oliver Distler Speakers bureau: OD has consultancy relationships with and/or has received research funding from or has served as a speaker for the following companies in the area of potential treatments for systemic sclerosis and its complications in the last three years: Abbvie, Acceleron, Alcimed, Amgen, AnaMar, Arxx, Baecon, Blade, Bayer, Boehringer Ingelheim, ChemomAb, Corbus, CSL Behring, Galapagos, Glenmark, GSK, Horizon (Curzion), Inventiva, iQvia, Kymera, Lupin, Medac, Medscape, Mitsubishi Tanabe, Novartis, Roche, Roivant, Sanofi, Serodapharm, Topadur and UCB. Patent issued "mir-29 for the treatment of systemic sclerosis” (US8247389, EP2331143)., Consultant of: OD has consultancy relationships with and/or has received research funding from or has served as a speaker for the following companies in the area of potential treatments for systemic sclerosis and its complications in the last three years: Abbvie, Acceleron, Alcimed, Amgen, AnaMar, Arxx, Baecon, Blade, Bayer, Boehringer Ingelheim, ChemomAb, Corbus, CSL Behring, Galapagos, Glenmark, GSK, Horizon (Curzion), Inventiva, iQvia, Kymera, Lupin, Medac, Medscape, Mitsubishi Tanabe, Novartis, Roche, Roivant, Sanofi, Serodapharm, Topadur and UCB. Patent issued "mir-29 for the treatment of systemic sclerosis” (US8247389, EP2331143)., Grant/research support from: OD has consultancy relationships with and/or has received research funding from or has served as a speaker for the following companies in the area of potential treatments for systemic sclerosis and its complications in the last three years: Abbvie, Acceleron, Alcimed, Amgen, AnaMar, Arxx, Baecon, Blade, Bayer, Boehringer Ingelheim, ChemomAb, Corbus, CSL Behring, Galapagos, Glenmark, GSK, Horizon (Curzion), Inventiva, iQvia, Kymera, Lupin, Medac, Medscape, Mitsubishi Tanabe, Novartis, Roche, Roivant, Sanofi, Serodapharm, Topadur and UCB. Patent issued "mir-29 for the treatment of systemic sclerosis” (US8247389, EP2331143)., Carlo Vinicio Caballero: None declared, Carlos Enrique Toro Gutierrez: None declared, Dey Dzifa: None declared, Ashima Makol: None declared, Ai Lyn Tan Speakers bureau: Has received honoraria for advisory boards and speaking for Abbvie, Gilead, Janssen, Lilly, Novartis, Pfizer, and UCB., Consultant of: has received honoraria for advisory boards and speaking for Abbvie, Gilead, Janssen, Lilly, Novartis, Pfizer, and UCB., Samuel Katsuyuki Shinjo: None declared, Vishwesh Agarwal: None declared, Latika Gupta: None declared.
ABSTRACT
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.
ABSTRACT
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.
ABSTRACT
The use and acceptance of online learning have increased following the COVID-19 pandemic. This mixed-methods study examined learners' preferences and performance in online learning interactions in relation to two factors: 'bite-sized' learning and 'presenter status' in instructional videos. University students (N = 18) without a mathematical background utilised bite-sized online learning episodes focusing on statistics. Each episode included a 10-minute instructional video followed by an assessment. The videos implemented three alternative 'presenter-status' conditions: lecturer, student-imitating-lecturer or student-peer-tutor. Individual students completed three episodes, one from each presenter-status condition (counterbalanced). Participants presented high performance in the post-episode assessments, irrespective of presenter status. Students also reported remarkably positive views towards bite-sized learning in user-satisfaction questionnaires. Finally, qualitative analysis of open-ended responses and interviews uncovered three main themes: positive learning experiences, divergent attitudes towards video-based learning, and differential preferences for presenter status. These findings have clear implications for teaching and learning in higher education.
ABSTRACT
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
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The 2022 Beijing Winter Olympics took place when American public opinion about China was already predominantly negative as media reports had a lot of highlights of human rights violations happening in China. Besides, earlier, the global image of China was undermined by the COVID-19 pandemic. In this study, we explored whether American public opinion about the Olympics and China can be influenced by images of the Olympics shared in the media. Findings from the 2 × 2 between-subject experimental design suggest that the opinions about the Olympics can be predicted by people's beliefs about China's role in the global pandemic. In addition to that, our findings suggest that pre-existing opinions and feelings held by most of the population can mitigate the effects of visual primes. © The Author(s) 2023.
ABSTRACT
Adjustments to life and learning following the COVID-19 pandemic have transformed user acceptance of online learning methods. It is, therefore, imperative to analyse factors relating to user performance and preferences for such interactions. In this study, we combined video-based learning with precision teaching to reinforce previously learnt statistics skills in university students without a mathematical background. We developed a learning design consisting of eight ‘bite-sized' online learning episodes. Each episode started with a brief learning video followed by a practice phase and an end-of-episode assessment. The practice phase differed in two groups of participants, matched on statistics attainment pre-intervention. A precision-teaching intervention group (N = 19) completed practice guided by a frequency-based approach aiming at building fluency in statistics. A control group (N = 19) completed self-directed practice for the same amount of time as the intervention group. All participants completed a statistics attainment test and a questionnaire on their attitudes towards statistics pre-and post-intervention, and a review of the learning materials post-intervention. The intervention group achieved, consistently, higher scores in all end-of-episode assessments compared to the control group. Both groups showed significant and comparable improvements in statistics attainment post-intervention. Both groups also reported more positive feelings towards statistics post-intervention, while the review of the learning materials suggested that the video-based learning design was well-received by students. Our results suggest that video-based learning has great potential to support, as a supplementary teaching aid, university students in learning statistics. We discuss future research directions and implications of the study. © The Author(s).
ABSTRACT
Background: Isotretinoin is an effective therapy for severe, recalcitrant, and nodular acne. Due to its teratogenic effects, isotretinoin requires strict adherence to the iPLEDGE risk management program and mandatory lab work. During the COVID-19 pandemic, the U.S. Food and Drug Administration lifted laboratory requirements, accepted remote pregnancy tests, and permitted telemedicine visits. This study examines the impact of reduced in-person evaluation and testing on physician likelihood of prescribing isotretinoin. Method(s): A retrospective review on demographics, acne history, and treatment was conducted on 142 patients <=18 years old who met inclusion criteria. Dates were divided into 1/1/2019-3/16/2020 (pre-MGH COVID shutdown and required in-person lab testing) and 5/25/2020-8/8/2021 (post-MGH COVID shutdown and paused lab testing requirements). Multivariate linear regression with backward elimination and Wilcoxon rank-sum tests were conducted. Result(s): The median number of dermatology visits to isotretinoin initiation was 3 visits pre-COVID and remained 3 visits during COVID (p=0.85). Backward elimination demonstrated gender (p<.0001) and the interaction between gender and acne severity (p=0.042) as significantly associated with increased number of visits before isotretinoin initiation, with female patients requiring more visits than males before starting isotretinoin at every acne severity level. Race, pre- or during COVID, and insurance type were removed as nonsignificant. Discussion(s): Removal of lab mandates during the COVID-19 pandemic did not result in fewer visits to initiation of isotretinoin. Female patients continue to face delays in receiving isotretinoin even with the acceptance of remote pregnancy tests and increased utilization of virtual visits, highlighting the persistent gender disparities in prescribing practices for pediatric patients with acne.Copyright © 2023
ABSTRACT
Hotel is an essential establishment that can offer lodging to travellers and accommodation for meetings/events. However due to the instability of the market in hotel, in addition to the COVID-19 pandemic, there is an increase of competition in the industry. In order to cope with this problem, hotels tend to increase its quality and services in order to meet the ideal preference of the customer. The study aimed to determine the combination of hotel attributes that the customer deemed preferred using a Conjoint Analysis Approach. The study specifically utilized attributes like price, accessibility to nearest landmark, inclusivity of breakfast, amenities, and dining options. The results show that the price was the most preferred attributes by the customer (40.787%), followed by the inclusivity of breakfast (32.913%), accessibility to nearest landmark (15.433%), hotel amenities (8.504%), and the least preferred is the dining options (2.362%). The outcome will be beneficial to the hotel owners and manager on the customer preference on the attributes. © 2022 ACM.
ABSTRACT
Objectives. This quantitative, cross-sectional, descriptive research aims to determine the level of satisfaction of doctors using telemedicine in Ophthalmology. Methods. An online questionnaire was sent to ophthalmologists at the Philippine General Hospital, a tertiary referral center, that partially shifted to ophthalmology telemedicine during the COVID-19 pandemic. Results. Respondents perceived telemedicine positively in terms of usefulness (Mean 2.92, Slightly Satisfied), ability to do quick follow-ups and patient updates (Mean 2.90, Slightly Satisfied), simplicity, and ease of use of technology (Mean 2.78, Slightly Satisfied). They were least satisfied with its effectiveness (Mean 2.37, Slightly Dissatisfied). Conclusion. Ophthalmologists expressed only slight satisfaction with telemedicine. The telemedicine platform was simple and useful for end-users, but some aspects may be improved based on questionnaire results. © 2023 University of the Philippines Manila. All rights reserved.
ABSTRACT
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).
ABSTRACT
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.
ABSTRACT
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.
ABSTRACT
The NHS workforce is exhausted. The fallout from the COVID-19 pandemic is ever present and likely to continue for the foreseeable future. We have been utilising appreciative inquiry methodology to redress the level of negativity, and restore wellbeing and cohesiveness within our elective theatre team. Appreciative inquiry is an asset-based philosophy that can be used as a change management tool. Two of the main principles of appreciative inquiry are: 'what we choose to focus on will expand', and 'we can create our future by how we interpret our current reality'. We wanted to channel these principles to help us focus on the specific contributions from team members and how those contributions create the atmosphere in our operating theatres. Methods Our elective theatre lists usually close with a debrief session, which now incorporate The Well (see Fig. 1). The Well helps to identify moments in the working day that were effective or went well. Each team member picks discussion points and shares the story of what they noticed that was successful. We also collected feedback on the new format for the debrief session. Results All the stories were collated, and the top three themes were: making connections, shared decision-making, communication. Two examples shared during the sessions: 'There was a change to the list order, but this did not impact on the running of the list. There was a flow of communication between us - we were in sync.' and 'Decisions were shared - there was a complex patient and the decisions needed to be made early. The dialogue between the team was open.' Feedback on the session format included: 'I enjoy the stories shared during The Well session and I pay more attention to what is going on around me during the list so I can contribute more to the discussion.' 'The Well feels purposeful and it shows a level of appreciation that was not captured by the usual "thank you for your help today".' Discussion The Well has been well received and feedback shows that the appreciative inquiry methodology has helped to create and deepen connections between team members. We hope by sharing the stories of what has gone well we can encourage these behaviours to happen more often and flourish within our workplace. (Figure Presented).
ABSTRACT
Background: Dacomitinib is a second generation EGFR tyrosine kinase inhibitor approved as first-line therapy in advanced EGFR mutated NSCLC. In the phase 3 ARCHER 1050 trial, PFS and OS were improved with dacomitinib compared to gefitinib. However, patients (pts) with central nervous system (CNS) metastases (mets) were ineligible to enroll into the study. ATORG-003 is an ongoing investigator-initiated single-arm phase 2 trial evaluating a dose titration strategy to improve the safety and tolerability of dacomitinib whilst maintaining efficacy. The intracranial activity of dacomitinib was evaluated in a prespecified subgroup analysis. Method(s): ATORG-003 (9 sites, 5 Asian countries) is enrolling newly diagnosed stage IIIB-IV NSCLC pts with EGFR mutations (exon 19 deletion [ex19del] or L858R). Pts receive dacomitinib 30 mg orally once daily for one cycle (4 weeks [wks]), after which pts with grade <=1 toxicity may escalate to 45 mg once daily (investigator/pt decision). A 24 pt subgroup with asymptomatic/controlled CNS mets completed enrollment in Jun2021. CNS mets were assessed by MRI scan at baseline and every 8 wks for 18 months (mo), then every 12 wks with MRI/CT. Key study secondary endpoints include intracranial objective response rate (iORR) and intracranial progression free survival (iPFS). Analyses were based on 7Jun2022 data cutoff date (median 18.7 mo follow-up). Result(s): Of 24 pts with CNS mets, median age was 65 years (range 33-78), ECOG PS 0/1 in 17%/83% and ex19del/L858R/both in 50%/46%/4%. 8/24 (33%) pts had prior intracranial radiotherapy. 2/24 pts dose escalated to 45 mg once daily after Cycle 1. There was measurable (>=10 mm target lesion) CNS mets in 9/24 (38%) pts. The iORR was 67% (1 intracranial CR [iCR], 5 intracranial PR), and median intracranial duration of response (iDoR) was not reached (NR). In 14 pts with non-measurable CNS mets only, iCR was seen in 6 (43%) pts. Median iPFS was NR with only n=5 CNS progression events in the entire cohort and n=7 remain on treatment. Overall (intra and extracranial) ORR was 67% and PFS rate at 12 mo was 42%. Conclusion(s): Dacomitinib has significant intracranial activity with observed durable responses in advanced EGFR mutated NSCLC with CNS mets. Clinical trial identification: NCT04027647. Legal entity responsible for the study: Asian Thoracic Oncology Research Group (ATORG). Funding(s): Pfizer. Disclosure: A. Tan: Financial Interests, Personal, Advisory Board: Amgen, Pfizer, Bayer. D. Kim: Financial Interests, Institutional, Principal Investigator: Alpha Biopharma, Amgen, Astrazeneca/Medimmune, Boehringer Ingelheim, BMS, Bridge BioTherapeutics, Chong Keun Dang, Daiichi-Sankyo, GSK, Hanmi, Janssen, Merck, Merus, Mirati Therapeutics, MSD, Novartis, ONO Pharmaceutical, Pfizer, Roche/Genentech, Takeda, TP Therapeutics, Xcovery, Yuhan;Financial Interests, Institutional, Funding: InnoN, Asia Thoracic Oncology Research Group;Non-Financial Interests, Personal, Advisory Role: Amgen, AstraZeneca, BMS/ONO Pharmaceuticals, Daiichi-Sankyo, GSK, Janssen, Merck, MSD, Oncobix, Pfizer, SK Biopharm, Takeda;Financial Interests, Personal, Advisory Role: Scientific advisor for Health insurance review and assessment service, Korea;Non-Financial Interests, Personal, Leadership Role: Asian Thoracic Oncology Research Group, Korean Association for Lung Cancer, Korean Cancer Association, Korean Society of Medical Oncology. T. Baisamut (Reungwetwattana): Financial Interests, Personal, Advisory Board, and speaker: Astrazeneca, Pfizer, Roche, MSD, Novartis, BMS, Amgen;Financial Interests, Personal, Advisory Board: Yuhan;Financial Interests, Institutional, Invited Speaker: Astrazeneca, Roche, Novartis, MSD. L. Yueh Ni: Financial Interests, Personal, Other, Panel of Discussion for Hepatocellular Carcinoma: AstraZeneca;Financial Interests, Personal, Advisory Board, Advisory Board Meeting for early breast cancer management in our current practice.: Roche;Financial Interests, Personal and Institutional, Invited Speaker, Research Title: A multicentre, open-label, single-arm, lecular profiling study of patient with EGFR mutation-positive locally advanced or metastatic NSCLC treated with Osimertinib: AstraZeneca;Financial Interests, Personal and Institutional, Invited Speaker, Research Title: A Phase 3 Double-blinded, Two-arm Study to Evaluate the Safety and Efficacy of Pembrolizumab (MK-3475) versus Placebo as Adjuvant Therapy in Participants with Hepatocellular Carcinoma and Complete Radiological Response after Surgical Resection or Local Ablation (KEYNOTE-937): MSD;Financial Interests, Personal and Institutional, Invited Speaker, Research Title: A Phase III, Randomized, Double-blind Study to Assess the Efficacy and Safety of Lazertinib versus Gefitinib as the First-line Treatment in Patients with Epidermal Growth Factor Receptor Sensitizing Mutation Positive, Locally Advanced or Metastatic Non-small Cell Lung Cancer: YUHAN;Financial Interests, Personal and Institutional, Invited Speaker, Research Title: A phase II randomized study of the combination of Ribociclib plus goserelin acetate with Hormonal Therapy versus physician choice chemotherapy in premenopausal or perimenopausal patients with hormone receptor-positive/HER2-negative inoperable locally advanced or metastatic breast cancer - RIGHT Choice Study: Novartis;Financial Interests, Personal and Institutional, Invited Speaker, Research Title: A Global, Randomized, Phase 3, Open-Label Study of REGN2810 (Anti-PD-1 Antibody) versus Platinum-Based Chemotherapy in First-Line Treatment of Patients with Advanced or Metastatic PD-L1+ Non-Small Cell Lung Cancer: Regeneron;Financial Interests, Personal and Institutional, Invited Speaker, Research Title: A Phase 3 study to Evaluate Zimberelimab (AB122) Monotherapy Compared to Standard Chemotherapy or Zimberelimab Combined with AB 154 in Front-Line, PD-L1 Positive, Locally Advanced or Metastatic Non-Small Cell Lung Cancer: Arcus;Financial Interests, Personal and Institutional, Invited Speaker, Research Title: A Prospective, Multicenter, Non-Interventional Genomic Profiling Study in Subjects with Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) using Foundation Medicine: Roche;Financial Interests, Personal and Institutional, Invited Speaker, Research Title: A Phase 3, randomize, double-blind trial of pembrolizumab (MK-3475) with or without lenvatinib (E7080/MK-7902) in participants with treatment naiv , metastatic non-small cell lung cancer (NSCLC) whose tumors have a tumor proportion score (TPS) greater than or equal to 1% (LEAP-007): MSD. G.F. Ho: Financial Interests, Personal, Advisory Board: Merck & Co., Inc., Novartis, AstraZeneca, Boehringer Ingelheim, Pfizer;Financial Interests, Personal, Invited Speaker: Roche, AstraZeneca, Pfizer, Merck & Co., Inc., Novartis, Roche, Boehringer Ingelheim;Financial Interests, Personal, Other, Chairperson: Bristol Myers Squibb;Financial Interests, Institutional, Invited Speaker: EliLily, Regeneron, Merck & Co., Inc., AB Science, Astellas, Tessa Therapeutics, Roche, Arcus Bioscience, AstraZeneca, Pfizer;Non-Financial Interests, Institutional, Product Samples: Pfizer, Eli Lilly, Novartis, Janssen Pharmaceuticals. L.M. Tho: Financial Interests, Personal, Invited Speaker: AstraZeneca, Boehringer Ingelheim, Roche, MSD, Pfizer. N. Prasongsook: Financial Interests, Personal, Advisory Board: Roche (Thailand), Novartis;Financial Interests, Personal, Invited Speaker: AstraZeneca. T.S.K. Mok: Financial Interests, Personal, Invited Speaker: AbbVie, ACEA Pharma, Alpha Biopharma, Amgen, Amoy Diagnostics, BeiGene, Boehringer Ingelheim, Bristol Myers Squibb, Eli Lilly, Daiichi Sankyo, Fishawack Facilitate, InMed Medical Communication, Lunit USA, Inc., Merck Serono, MSD, Roche, MD Health, Medscape/WebMD, PeerVoice, Permanyer SL, Prime Oncology, Research to Practice, Touch Medical Media, Sanofi-Aventis, Takeda, PER, Daz Group, Janssen Pharmaceutical NV, Jiahui Holdings Co., LiangYiHui Healthcare, Lucence Health Inc., Merck Pharmaceuticals HK Ltd., MiRXES, Novartis, OrigiMed Co. Ltd., Pfizer, Shanghai BeBirds Translation & Consulting Co., Ltd., Taih harmaceutical Co., Ltd., AstraZeneca;Financial Interests, Personal, Advisory Board: AbbVie, ACEA Pharma, Alpha Biopharma, Amgen, Amoy Diagnostics, BeiGene, Boehringer Ingelheim, Bristol Myers Squibb, Eli Lilly, Blueprint Medicines, Berry Oncology, CStone Pharma, Daiichi Sankyo, Fishawack Facilitate, Eisai, Gritstone Oncology, Guardant Health, G1 Therapeutics, Hengrui, Ignyta, IQVIA, Incyte Corporation, Inivata, Janssen, Loxo Oncology, Qiming Dev., Lunit USA, Inc., Merck Serono, MSD, Roche, Mirati Therapeutics, MoreHealth, Novartis, OrigiMed, Puma Tech., Sanofi-Aventis, Takeda, Virtus Medical, Yuhan, Curio Science, Bayer Healthcare Pharmaceuticals Ltd., Covidien LP, C4 Therapeutics, Cirina Ltd., Da Volterrra, F. Hoffmann-La Roche Ltd./Genentech, Gilead Sciences, Lucence Health Inc., Medscape LLC / WebMD, MiRXES, OSE Immunotherapeutics, Pfizer, SFJ Pharmaceutical Ltd., Synergy Research, Tigermed, Vertex Pharmaceuticals, Berry Oncology, D3 Bio Ltd., Lakeshore Biotech;Financial Interests, Personal, Officer, Chairman: ACT Genomics-Sanomics Group;Financial Interests, Personal, Invited Speaker, Former known as Hutchison Chi-Med: HutchMed;Financial Interests, Personal, Stocks/Shares: Sanomics Ltd., Biolidics Ltd., Aurora Tele-Oncology, AstraZeneca;Financial Interests, Personal, Stocks/Shares, Former known as Hutchison Chi-Med: HutchMed;Financial Interests, Institutional, Funding, For clinical trials performed at CUHK: AstraZeneca, BMS, Merck Serono, MSD, Novartis, Pfizer, Roche, SFJ Pharmaceuticals, XCovery, Takeda, G1 Therapeutics, Clovis Oncology;Non-Financial Interests, Personal, Advisory Role: geneDecode;Non-Financial Interests, Personal, Other, Invited Speaker: AstraZeneca, Aurora Tele-Oncology, Lunit USA, Inc., Sanomics Ltd.;Non-Financial Interests,Personal, Leadership Role, Term ended on 30 June 2022: American Society of Clinical Oncology (ASCO);Non-Financial Interests, Personal, Leadership Role: Asian Thoracic Oncology Research Group (ATORG), Chinese Lung Cancer Research Foundation Limited (CLCRF), Hong Kong Cancer Fund (HKCF), Hong Kong Cancer Therapy Society (HKCTS), St. Stephen's College & Prep. School (Hong Kong);Non-Financial Interests, Personal, Leadership Role, Term ended: Chinese Society of Clinical Oncology (CSCO);Non-Financial Interests, Personal, Leadership Role, Term ended on 30 April 2019: International Association for he Study of Lung Cancer (IASLC). D.S.W. Tan: Financial Interests, Personal, Invited Speaker: Merck, Pfizer, Novartis, Boehringer Ingelheim, Roche, Takeda;Financial Interests, Personal, Advisory Role: Novartis, Bayer, Boehringer Ingelheim, Celgene, AstraZeneca, Eli-Lilly, Loxo, GlaxoSmithKline, MSD;Financial Interests, Institutional, Funding: Novartis, AstraZeneca, Bayer, Pfizer, Amgen. H.H.F. Loong: Financial Interests, Institutional, Invited Speaker: Boehringer Ingelheim, MSD;Financial Interests, Personal, Invited Speaker: Eli-Lilly, Illumina, Bayer, Guardant Health;Financial Interests, Personal, Advisory Board: Novartis, Takeda. All other authors have declared no conflicts of interest. Copyright © 2022