PSYCHOLOGICAL DISTRESS OVER 12 MONTHS POST-DIAGNOSIS IN A NATIONAL EARLY INFLAMMATORY ARTHRITIS COHORT

BackgroundIn inflammatory arthritis patients, the concomitant decline of their mental wellbeing is an increasing concern[1,2]. It is important to not only describe the trajectory of psychological distress in early disease stages, but also understand which clinical outcome measures are most associated with these changes.ObjectivesUsing data from the National Early Inflammatory Arthritis Audit (NEIAA), we assessed trends in psychological wellbeing over 12 months after initial diagnosis and mapped these against clinical outcomes to identify significant associations.MethodsNEIAA collects data from patients referred with suspected early inflammatory arthritis in rheumatology services in England and Wales. We used data provided by 20,472 patients eligible for follow-up (diagnosis of inflammatory arthritis) between May 1st, 2018, and April 1st, 2022. Data items included baseline demographics e.g., age and gender, and clinical variables e.g., rheumatic disease comorbidity index (RDCI), DAS28, and patient reported outcomes.Psychological distress was measured by the sum score of Patient Health Questionnaire Anxiety and Depression Screener (PHQ4ADS). Using mixed effects regression models, we analysed the co-variability of PHQ4ADS with demographic factors and clinical outcomes over 12 months. Time was included as a dummy-coded covariant.ResultsThe analysis included 36% of patients (7,378 out of 20,472) who completed the baseline patient outcome survey. In this cohort, PHQ4ADS scores decreased from a baseline average of 4.7 (CI: [4.6, 4.8]) to 2.62 (CI: [2.5, 2.8]) at 12 months post-diagnosis. The proportion of patients screening positive decreased from 50.0% (CI: [48.9, 51.1]) at baseline to 23.8% (CI: [21.8, 25.9]) at 12 months.At baseline, psychological distress correlated significantly with age, gender, ethnicity, RDCI, prior depression diagnosis, and baseline DAS28 (Figure 1). No significant correlations were found between psychological distress and working diagnosis, seropositivity, or the assessment being recorded after the start of the COVID-19 pandemic. Younger ages were nonlinearly associated with higher distress levels (coefficient per decade: -0.006;p<0.001;CI: [-0.009, -0.003]) (Figure 1a). Distress levels in females were higher than that of males (coefficient: 0.5;p<0.001;CI: [0.4, 0.7]) (Figure 1b). White patients reported lower PHQ4ADS scores compared to non-white patients (coefficient: -0.7;p<0.001;CI: [-1.0, -0.4]) (Figure 1c). Higher distress levels were also associated with higher RDCI (coefficient: 0.2;p<0.001;CI: [0.1, 0.3]) and prior diagnosis of depression (coefficient: 1.8;p<0.001;CI: [1.5, 2.2]) (Figure 1d, 1e). Furthermore, higher baseline DAS28 scores correlated with more severe psychological distress (coefficient: 0.8;p<0.001;CI: [0.7, 0.8]) (Figure 1f).By 12-months, psychological distress decreased significantly overall, which correlated significantly with ethnicity (coefficient: 0.8;p=0.005;CI: [0.3, 1.4]) and baseline DAS28 (coefficient: -0.5;p<0.001;CI: [-0.6, -0.4]). Compared to white patients, the reduction was significantly greater for non-white patients, but the level of distress was no longer different at 12 months (Figure 1c). While those with higher baseline DAS28 showed a greater reduction in psychological distress, the distress levels remained higher at 12 months (Figure 1f).Figure 1.Changes in psychological distress correlated with age, gender, ethnicity, RDCI, prior depression diagnosis, and baseline DAS28.[Figure omitted. See PDF]ConclusionIn this early inflammatory arthritis cohort, mental health burden was high. Age, gender, ethnicity, RDCI, prior depression diagnosis and baseline DAS28 significantly correlated with psychological distress at baseline. Supporting mental health should be a focus of clinical care for this population and it may be beneficial to use an approach that is culturally valid for non-white patients and accounts for multimorbidity.References[1]Euesden, J, et al. Psychosomatic medicine 79.6 (2017): 638.[2]Lwin, MN, et al. Rheumatology and therapy 7.3 (2020): 457-471.AcknowledgementsThe authors would like to thank the Healthcare Quality Improvement Partnership (HQIP) as the commisioner of NEIAA, British Society for Rheumatology as the audit providers, Net Solving as the audit platform developers, and the Wellcome Trust (ST12406) for funding to support L.Z..Disclosure of InterestsLucy Zhao: None declared, James Galloway Speakers bureau: Has received honoraria from AbbVie Celgene, Chugai, Gillead, Janssen, Eli Lilly, Pfizer, Roche, and UCB, Jo Ledingham: None declared, Sarah Gallagher: None declared, Neena Garnavos: None declared, Paul Amlani-Hatcher: None declared, Nicky Wilson: None declared, Lewis Carpenter Consultant of: Statistical consultancy for Pfizer, Kirsty Bannister: None declared, Sam Norton Speakers bureau: Has received honoraria from Janssen and Pfizer.

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.

THE SWEDISH OSTEOARTHRITIS REGISTRY. TRENDS IN SWEDISH OSTEOARTHRITIS HEALTH CARE BETWEEN 2008- 2021

BackgroundIn 2012 the Swedish national guidelines for osteoarthritis (OA) were published. The guidelines implicit that all patients with OA should obtain information and supervised exercise as first-line intervention and that OA is a clinical, not radiological diagnosis. The Swedish OA registry contains data which measure compliance to the guidelines since 2008 [2].ObjectivesTo describe the trends over time from 2008 to 2021 for patients who have received first-line interventions for hip and knee OA in Sweden and adherence of the healthcare staff to the national guidelines.MethodsDescriptive registry-based study including patients with hip or knee OA who participated in first-line interventions including education and exercise. Data were extracted from the Swedish OA registry between January 1st, 2008, and December 31, 2021. The registry contains patient-reported outcomes and physiotherapist-reported outcomes. In this study the following physiotherapist-reported outcomes were described over time: radiological examination before first-line intervention, if the first-line intervention was given the first time the patient seek health care caused of OA, which explanation patients had been given about their disease, intake of painkillers before the start of first-line intervention and the percent who got supervised exercise >10 times according to the guidelines of OA in Sweden. The following patient-reported outcomes were described over time: mean BMI at the first visit, and mean age at the first visit. To be included in the study, participants had to meet the following criteria: i) clinical diagnosis of OA, with hip or knee OA as the most symptomatic joint, ii) provided 3-month follow-up.ResultsA total of 175 764 participants with hip or knee OA were included in the study.The trends from 2008-2021 showed that the proportion of patients who had a radiological examination before entering the first-line intervention decreased from 97 % to 65 % in men and from 95% to 62 % in women. The proportion of patients who get assess to first-line intervention the first time they seek for their symptoms increased from 4 % to 10 % both in men and women. People that get the correct information about OA increased from 15% to 40 %, and patients that get the explanation that OA was a tear and wear disease decreased from 30 % to 5%. The mean BMI (28) is unchanged over time. The mean age increased from 64 years to 67 years between 2008-2020 but decreased during the covid-19 pandemic to 64 years. The percentage that was given supervised exercise more than 10 times was constant between 2012-2020 at 30 % but decreased during the covid-19 pandemic to 20%.ConclusionThe results implicit that the implementation of a supported OA self-management program in Sweden has been successful and changed the care given to patients with OA in Sweden. However, the national guidelines for OA, have still not been fully implemented. We need to keep implementing the guidelines so all patients with OA get the first-line intervention at the right time.References[1]Anon. (2012). Nationella riktlinjer för rörelseorganens sjukdomar 2012 - stöd för styrning och ledning. Socialstyrelsen.[2]Thorstensson CA, Garellick G, Rystedt H, Dahlberg LE. Better Management of Patients with Osteoarthritis: Development and Nationwide Implementation of an Evidence-Based Supported Osteoarthritis Self-Management Programme. Musculoskeletal Care. 2015 Jun;13(2):67-75. doi: 10.1002/msc.1085. Epub 2014 Oct 24. PMID: 25345913.Acknowledgements:NIL.Disclosure of InterestsNone Declared.

COMPARATIVE DISEASE BURDEN IN PATIENTS WITH RHEUMATOID ARTHRITIS, PSORIATIC ARTHRITIS OR ANKYLOSING SPONDYLITIS: DATA FROM COVAD PATIENT-REPORTED E-SURVEY

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.

Correlation Between the Suitability of Empirical and Definitive Therapies According to Culture Results with the Clinical Outcomes of Patients with Bacteremia Due to Carbapenem- Resistant Acinetobacter baumannii (CRAB) at Dr. Soetomo Tertiary Referral Hospital

Carbapenem administration is an important therapy for nosocomial infections due to MDRO, especially Acinetobacter baumannii. The global increase in carbapenem-resistant A. baumannii (CRAB) that causes this pathogen has significantly threatened public health due to the lack of adequate treatment options due to the very few currently available antimicrobial agents that actively fight CRAB. Antimicrobial resistance is a major negative impact of inappropriate antimicrobial prescribing. Ineffective empiric treatment (initial antibiotic regimen not sensitive to identified pathogens based on in vitro sensitivity test results) is associated with a higher rate of deaths compared to effective empiric treatment. In this study, we analyzed the correlation between the suitability of empiric and definitive antibiotics and the clinical outcomes of patients with bacteremia due to CRAB treated in the inpatient ward of Dr. Soetomo Tertiary Referral Hospital, Surabaya. There were 227 isolates of bacteremia due to CRAB, consisting of 156 carbapenem-resistant A. baumanni and 71 carbapenem-sensitive A. baumannii. There were 88 isolates that met the inclusion and exclusion criteria, and all of them were resistant to ceftriaxone, cefepime, and ciprofloxacin. A total of 29.5% of the isolates were sensitive to cotrimoxazole, 3.4% of the isolates were sensitive to tigecycline, and 2.3% of the isolates were sensitive to amikacin, levofloxacin, and cefoperazone sulbactam. Adequate empirical antibiotics and definitive antibiotics (sensitive based on culture sensitivity test) amounted to 12.5% and 27.3%, respectively. There is no significant correlation between the suitability of empiric and definitive therapies with the patients' clinical outcomes (death and length of stay).Copyright © 2022 Phcogj.Com.

IMPROVEMENTS IN PATIENT-REPORTED OUTCOMES AMONG PATIENTS WITH RESOLUTION OF ENTHESITIS AND/OR DACTYLITIS: POST HOC ANALYSES FROM THE KEEPSAKE 1 AND 2 TRIALS OF RISANKIZUMAB IN PATIENTS WITH ACTIVE PSORIATIC ARTHRITIS

BackgroundEnthesitis and dactylitis are associated with greater disease activity and reduced quality of life. Results from the phase 3 randomized, placebo-controlled KEEPsAKE 1 and 2 studies (NCT03675308;NCT03671148) of risankizumab in active PsA showed greater resolution of enthesitis and dactylitis with risankizumab 150 mg vs placebo at week 24.ObjectivesThis post hoc analysis evaluated improvements in patient-reported outcomes (PROs) among patients who had enthesitis (n=444), dactylitis (n=188), or both (n=128) at baseline and achieved resolution of enthesitis, dactylitis, or both with blinded risankizumab at weeks 0, 4, 16, and open-label risankizumab every 12 weeks thereafter.MethodsAssessments included achievement of minimal clinically important differences (MCID) in pain (≥10-mm decrease on visual analog scale), Health Assessment Questionnaire-Disability Index (HAQ-DI;≥0.35-unit decrease), and Functional Assessment of Chronic Illness Therapy (FACIT-Fatigue;≥4-point increase). Nonresponder imputation (with multiple imputation for COVID-19–related missing data at week 24) was used.ResultsMany patients who achieved resolution of enthesitis at week 24;week 52 also achieved MCID in pain (66.4%;71.4%), HAQ-DI (58.2%;63.4%), and FACIT-Fatigue (59.0%;72.1%). Many patients who achieved resolution of dactylitis at week 24;week 52 also achieved MCID in pain, (72.2%;81.7%), HAQ-DI (56.3%;66.2%), and FACIT-Fatigue (67.7%;69.9%). Many patients who achieved resolution of both enthesitis and dactylitis at week 24;week 52 also achieved MCID in pain (82.1%;86.4%) HAQ-DI (66.7%;69.2%), and FACIT-Fatigue (71.4%;74.6%). PRO results for patients for who did not achieve resolution of enthesitis and/or dactylitis will be presented.ConclusionMajority of patients who achieved resolution of enthesitis and/or dactylitis with risankizumab also reported improvements in pain, disability, and fatigue.AcknowledgementsAbbVie and the authors thank the patients who participated in the study and all study investigators for their contributions. Medical writing assistance, funded by AbbVie, was provided by Lisa M Pitchford, PhD, of JB Ashtin.Disclosure of InterestsShawn Kwatra Consultant of: AbbVie, Aslan Pharmaceuticals, Arcutis, Celldex, Galderma, Genzada Pharmaceuticals, Incyte, Johnson & Johnson, Novartis, Pfizer, Regeneron, and Sanofi., Grant/research support from: Galderma, Incyte, Pfizer, and Sanofi., Saakshi Khattri Speakers bureau: AbbVie, Eli Lilly, Janssen, Novartis, and UCB, Grant/research support from: Bristol Myers Squibb, LEO Pharma, Novartis, and Pfizer, Ahmad Amin Consultant of: AbbVie, Amgen, Bristol Myers Squibb, Dermavant, Eli Lilly, Janssen, LEO Pharma, Regeneron, Sanofi/Genzyme, Pfizer, and UCB, Ran Liu Shareholder of: AbbVie, Employee of: AbbVie, Byron Padilla Shareholder of: AbbVie, Employee of: AbbVie, Ahmed M. Soliman Shareholder of: AbbVie, Employee of: AbbVie, Blair Kaplan Shareholder of: AbbVie, Employee of: AbbVie, Dennis McGonagle Speakers bureau: AbbVie, Janssen, Novartis, and Pfizer., Grant/research support from: AbbVie, Janssen, Novartis, and Pfizer, UCB, BMS, Celgene.

VASCULITIS DISEASE ACTIVITY SCORES BEFORE AND DURING THE COVID-19 PANDEMIC: A COMPARISON OF FACE-TO-FACE CLINICIAN SCORING AND PROMS COLLECTED USING REMOTE MONITORING IN A SINGLE-CENTRE COHORT

BackgroundDuring the COVID-19 pandemic, asynchronous consultations were introduced for patients with vasculitis. To assess disease activity without of face-to-face clinical reviews and blood testing, patients submitted patient reported outcome measures (PROMs) via electronic survey forms, which were subsequently triaged by clinicians.Objectives1. To investigate how patients' vasculitis disease activity was affected by the COVID-19 pandemic through retrospective comparison of clinician-assessed scores recorded pre-pandemic with intra-pandemic self-reported patient reported outcome measures (PROMs) and disease scores submitted by patients remotely.2. To assess patients' clinical outcomes, including allocation of follow-up and further management/treatment escalation during this period.3. To validate self-reported BVAS scores against an existing PROM.MethodsThis is a retrospectively study of patients with a known diagnosis of vasculitis under the care of the Nuffield Orthopaedic Centre, Oxford. For the purposes of this study, we included patients with all vasculitis diagnoses.Clinician-reported scores (Bristol Vasculitis Activity score v.3, BVAS) were recorded during in-person clinics pre-pandemic (defined as 01/01/2019-31/12/2019) [1].Patients' self-reported BVAS (SR-BVAS) and AAV-PRO (ANCA-associated vasculitis patient-reported outcomes) scores were submitted by patients via electronic forms containing the requisite questionnaires sent out during-pandemic (defined as 01/12/2020-31/03/22) [2].SR-BVAS has not been validated but was collected to allow clinical comparison to disease activity scores completed by clinicians. Response were stored and analysed in a secure database. Score comparison was performed using Wilcoxon Sign Rank testing. Clinical outcome data was collected from the local Electronic Patient Record. Data analysis was performed in Microsoft Excel and R (version 4.2.1).ResultsWe noted a significantly higher overall level of patient-reported disease activity during the pandemic than was recorded in clinics prior. In the total cohort of all vasculitis patients for whom we had data, the median BVAS increased from 2 pre-pandemic (N = 335, range 0-21) to 6 intra-pandemic (N = 143, range 0-42) (p <0.001). The overall proportion of patients with severe/active disease (defined as BVAS ≥4) increased from 27% to 36% during the pandemic period.In a smaller cohort of 64 patients for whom we had paired pre- and during-pandemic scores, increased disease activity was reported (p<0.01). Notably, the number with a BVAS consistent with severe disease increased from 7 (11%) to 19 (30%).There was a significant positive correlation between SR-BVAS and AAV-PRO (r=0.61, p< 0.001) submitted by patients during-pandemic;however, at low BVAS (≤3), the AAV-PRO ranged widely (28-87)Follow-up data was available for all 64 patients in this cohort: 8/19 (42%) with a during-pandemic SR-BVAS ≥4 were seen in clinic within 3 months (telemedicine or face-to-face).ConclusionPatients reported worsening of vasculitis disease activity during the COVID-19 pandemic. This may be attributable to impacts on well-being or access to healthcare services. We note that disease activity scores in vasculitis may be limited in their ability to capture the whole picture disease activity in the absence of clinical assessment [3]. 42% of patients with self-reported high disease activity were seen within 3 months. There was a significant positive correlation between AAV-PRO and SR-BVAS, suggesting it has some use as a PROM.References[1]Mukhtyar C, Lee R, Brown D, Carruthers D, Dasgupta B, Dubey S, et al.. Ann Rheum Dis. 2009 Dec;68(12):1827–32.[2]Malley T, Jackman J, Manderson S, Saldana Pena L, Evans E, Barrett J, et al. Ann Rheum Dis. 2021 Jun 1;80(Suppl 1):289.[3]Luqmani RA. Nephrology Dialysis Transplantation. 2015 Apr 1;30(suppl_1):i76–82.Acknowledgements:NIL.Disclosure of InterestsNone Declared.

COVID-19 OUTCOMES IN KOREAN PATIENTS WITH GOUT

BackgroundPatients with autoimmune inflammatory rheumatic diseases are at higher risk for coronavirus disease (COVID)-19 hospitalization and worse clinical outcomes compared with the general population. However, data on the association between COVID-19 outcomes and gout, or gout-related medications are still lacking.ObjectivesWe aimed to compare COVID-19 related clinical outcomes in gout vs. non-gout patients.MethodsWe conducted a retrospective cohort study using the electronic health record-based databases of Seoul National University hospital (SNUH) from January 2021 to April 2022 mapped to a common data model. Patients with gout and without gout were matched using a large-scale propensity score (PS) algorithm. The clinical outcomes of interest were COVID-19 infection, severe COVID-19 outcomes defined as the use of mechanical ventilation, tracheostomy or extracorporeal membrane oxygenation, and death within 30 days of COVID-19 diagnosis. The hazard ratio (HR) for gout vs. non-gout patients derived by Cox proportional hazard models were estimated utilizing a 1:5 PS-matched cohort.Results2,683 patients with gout and 417,035 patients without gout were identified among the patients who visited SNUH. After 1:5 PS matching, 1,363 gout patients and 4,030 non-gout patients remained for the analysis. The risk of COVID-19 infection was not significantly different between patients with gout and those without gout (HR 1.07 [95% CI 0.59-1.84]). Within the first month after the COVID-19 diagnosis, there was also no significant difference in the risk of hospitalization (HR 0.57 [95% CI 0.03-3.90], severe COVID-19 outcomes (HR 2.90 [95% CI 0.54-13.71]), or death (HR 1.35 [95% CI 0.06-16.24]).ConclusionPatients with gout did not have an increased risk of COVID-19 infection or worse clinical outcomes. Updates of temporal trends of COVID-19 outcomes in gout patients are yet warranted as new SARS-CoV-2 variants emerge.References[1]Shin YH, et al. Autoimmune inflammatory rheumatic diseases and COVID-19 outcomes in South Korea: a nationwide cohort study. Lancet Rheumatol. 2021 Oct;3(10):e698-e706.[2]Topless RK, et al. Gout and the risk of COVID-19 diagnosis and death in the UK Biobank: a population-based study. Lancet Rheumatol. 2022 Apr;4(4):e274-e281.[3]Xie D, et al. Gout and Excess Risk of Severe SARS-CoV-2 Infection Among Vaccinated Individuals: A General Population Study. Arthritis Rheumatol.2023 Jan;75(1):122-132.Table 1.Clinical outcomes of COVID-19 infection in patients with goutOutcomesUnmatched populationPopulation with PS stratification using 10 strata1:5 PS matched populationHazard ratio (95% CI)p-valueHazard ratio (95% CI)p-valueHazard ratio (95% CI)p-valueCOVID-19 infection1.68 (1.03-2.57)0.031.20 (0.72-1.87)0.461.07 (0.59-1.84)0.82Hospitalization due to COVID-191.92 (0.32-6.05)0.391.63 (0.26-5.77)0.540.57 (0.03-3.90)0.66Severe COVID-19 infection4.72 (1.44-11.28)<0.014.22 (1.17-12.21)0.022.90 (0.54-13.71)0.20Death due to COVID-191.15 (0.07-5.18)0.900.77 (0.04-3.81)0.821.35 (0.06-16.24)0.84Acknowledgements:NIL.Disclosure of InterestsNone Declared.

IMPROVING THE UPTAKE OF ELECTRONIC PATIENT REPORTED OUTCOME MEASURES IN A SPECIALISED AXIAL SPONDYLOARTHROPATHY CLINIC

BackgroundSheffield Teaching Hospitals (STH), UK, has a specialised axial spondyloarthropathy (axSpa) clinic run by a rheumatology consultant and physiotherapist with special interest in this area. BASDAI and BASFI patient reported outcome measures are used to assess disease activity and response to treatment, in line with national guidelines. STH has invested in MyPathway (MP), an electronic patient messaging system used for patient information, appointments and electronic patient reported outcome measures (ePROMs). The data can also be viewed at a system level on a clinician dashboard. Prior to 2020 the uptake of ePROMs was low in the axSpa clinic. The move primarily to telephone consultations in March 2020, due to the COVID-19 pandemic, created an opportunity for increasing the use of MP for ePROMs collection to enable improved remote monitoring of patients with axSpa.ObjectivesThis quality improvement project aimed to increase the use of electronic BASDAI and BASFI (ePROMs) in the axSpa clinic.MethodsA multi-pronged approach has been taken since March 2020 to increase ePROMs completion and improve their use. Each appointment was used as an opportunity to discuss and recruit patients to MP. Clinicians invited each patient to join MP and sent them a link after their appointment. QR codes were then added to all rheumatology patient letters encouraging patients to register. A pathway was set up that automatically sent a prompt to patients registered on MP to complete their BASDAI and BASFI questionnaires prior to clinic appointments. Clinicians began logging into MP to view scores during appointments to provide patients with real-time feedback.A mixed methods approach was used to assess the uptake of ePROMs over time. We tracked MP registration rates and BASDAI completion rates as the key outcome measures, using a run chart to assess special cause variation. We undertook a patient focus group to explore attitudes towards ePROMs, key barriers and opportunities for further improvement.ResultsThe total number of axSpa patients seen in the specialised clinic (named LADAS) who have registered with MP has increased from 56 (35.9%) in January 2019 to 200 (58.9%) in September 2022. There has been an improvement in the BASDAI completion rate, with 80% of patients completing more than one BASDAI in 2022, compared to 24% in 2019, as illustrated on a run chart (Figure 1). Patients can complete BASDAI forms sent to them in a previous month, therefore the completion rate some months exceeds 100%.In a dedicated focus group, patients reported that ePROMs were generally more convenient, and provided a useful record to refer back to. This could be further improved by development of a graph function to view scores over-time and the ability for patients to complete a questionnaire between appointments when they feel their disease is more active. A key theme for improving the use of ePROMs was the need for more discussion about their utility and around individual patient's scores. There is concern that the BASDAI and BASFI scores are arbitrary and lack nuance, and that the importance of these scores at an individual patient level is not clear. This may be rectified by more discussion with clinicians in appointments, to add meaning to these scores. There was also concern that sleep and other generic health measures are not covered in the BASDAI or BASFI. The EQ-5D, a generic questionnaire, is also sent to axSpa patients, but there seems to be a lack of patient awareness regarding it. There is an appetite to improve and standardise the amount of patient information accessible on MP, for example disease information and links to patient support groups.ConclusionThere has been a clear improvement in the completion of ePROMs in the dedicated axSpa clinic at STH, over the last three years. Patient feedback has highlighted key areas for further improvement to maximise the potential of ePROMs, including more discussion around PROM scores to increase understanding and add individual patient meaning and nuance.Figure 1.AcknowledgementsI have no acknowledgements to declare.Disclosure of InterestsJudith Jade: None declared, Zoe Cox: None declared, Emily Fox: None declared, Rachel Tattersall Speakers bureau: honoraria as speaker for Abbvie, Lisa Dunkley Speakers bureau: honoraria as speaker/ teaching for UCB/ Abbvie/ Pfizer.

Non-steroidal anti-inflammatory drugs amid COVID-19 pandemic: An ally or an enemy?

As the current global pandemic of the novel coronavirus diseases 2019 (COVID-19) continues to rage, the scientific and medical worlds are working to establish an effective therapy against the illness. Recently questions regarding non-steroidal anti-inflammatory drugs (NSAIDs) as a potential therapeutic option for COVID-19 have surfaced. While some studies hint towards the possible benefit of NSAIDs against SARS-CoV-2 infection, the current body of evidence also sheds light on the potential risk of using NSAIDs in COVID-19 patients. Thus, the available literature does not provide conclusive evidence for or against the use of NSAIDs for treating COVID-19 patients. Given the limited data available, we suggest cautionary approaches for the public to avoid possible harm until further evidence emerges. NSAIDs should not be used as the first-line agents for COVID-19 unlessunder medical supervision. Moreover, patients with chronic inflammatory conditions should continue the NSAIDs as per their regular prescriptions.

DATA COLLECTION

According to an informal poll of the eCOA provider member firms of the eCOA Consortium, device failure is attributed to less than 1% of devices used in the field. FDA encouraged clinical trial sponsors to embrace alternative methods of data collection, including remote eCOA data capture.6 In response to that guidance, the eCOA Consortium offered web-based eCOA as one of the viable options to mitigate risk and reduce missing data7, and some eCOA providers repurposed their web-based backup solutions to provide this alternative primary solution. Howry C, Elash CA, Crescioni M, Eremenco S, O'Donohoe P, Rothrock T. Best practices for avoiding paper backup when implementing electronic approaches to patient-reported outcome data collection in clinical trials.

Vaccination and Factors Related to the Clinical Outcome of COVID-19 in Healthcare Workers-A Romanian Front-Line Hospital's Experience.

The study aims to describe the frequency of COVID-19 in healthcare workers (HCWs) in a designated hospital for COVID-19 treatment in Bucharest, Romania, and to explore COVID-19 vaccination and other factors associated with the clinical outcome. We actively surveyed all HCWs from 26 February 2020 to 31 December 2021. Cases were laboratory-confirmed with RT-PCR or rapid test antigen. Epidemiological, demographic, clinical outcomes, vaccination status, and co-morbidities data were collected. Data were analyzed using Microsoft Excel, SPSS, and MedCalc. A total of 490 cases of COVID-19 in HCWs were diagnosed. The comparison groups were related to the severity of the clinical outcome: the non-severe group (279, 64.65%) included mild and asymptomatic cases, and the potentially severe group included moderate and severe cases. Significant differences between groups were registered for high-risk departments (p = 0.0003), exposure to COVID-19 patients (p = 0.0003, vaccination (p = 0.0003), and the presence of co-morbidities (p < 0.0001). Age, obesity, anemia, and exposure to COVID-19 patients predicted the severity of the clinical outcomes (χ2 (4, n = 425) = 65.69, p < 0.001). The strongest predictors were anemia and obesity (OR 5.82 and 4.94, respectively). In HCWs, mild COVID-19 cases were more frequent than severe cases. Vaccination history, exposure, and individual risk influenced the clinical outcome suggesting that measures to protect HCWs and occupational medicine are important for pandemic preparedness.

COVID-19 ARDS MANAGEMENT IN AN INTENSIVE CARE WARD USING ANTI-CD6 MONOCLONAL ANTIBODY: A CASE SERIES

Background: Covid-19 ARDS is a common presentation in the emergency ward and needs quick assessment and treatment. Material and Methods: This case series was aggregated from patients admitted to the emergency ward, with a diagnosis of mild to moderate ARDS with impending cytokine release syndrome (CRS). Results: These 10 patients were treated with antiCD6 monoclonal antibody, Itolizumab as it had been given emergency use approval for critically ill patients on CRS. Of the 10 patients, 8 received Itolizumab on day 2 while 2 received it on day 1. Nine out of ten patients recovered and were discharged, while one patient died. Patients' progress was monitored by daily evaluation of patients' CRP and cytokine (IL-6) levels, LDH, and clinical and radiological assessment. All 10 patients were observed for oxygen delivery parameters including days of ventilation support, and total oxygen delivery. Conclusion: The administration of antiCD6 monoclonal antibody, itolizumab early has shown to reduce the duration of ventilation support to 5.4 days, total oxygen requirements to 12 days, and hospital stay to 13.3 days. [ FROM AUTHOR] Copyright of Journal of Cardiovascular Disease Research (Journal of Cardiovascular Disease Research) is the property of Journal of Cardiovascular Disease Research and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full . (Copyright applies to all s.)

Management of autoimmune retinopathy treated with intravitreal dexamethasone implant.

PURPOSE: The purpose of this study is to evaluate clinical outcomes of autoimmune retinopathy (AIR) in the patients treated with intravitreal dexamethasone implant (IDI). METHOD: Twenty-one eyes of 11 AIR patients treated with at least 1 injection of IDI were retrospectively reviewed. Clinical outcomes before and after treatment, including best corrected visual acuity (BCVA), optic coherence tomography (OCT), fundus autofluorescence (FAF), full-field electroretinography (ff-ERG), and visual field (VF) at last visit within 6 and/or 12 months, were recorded. RESULTS: Among all the patients, 3 had cancer-associated retinopathy (CAR) and 8 had non-paraneoplastic-AIR (npAIR) with mean followed up of 8.52 ± 3.03 months (range 4-12 months). All patients achieved improved or stable BCVA within 6 and/or 12 months after the treatment. Cystoid macular edema (CME) in 2 eyes and significant retinal inflammation in 4 eyes were markedly resolved after single injection. Central retinal thickness (CFT) in all eyes without CME, ellipsoid zone (EZ) on OCT in 71.4% of eyes, ERG response in 55% of eyes, and VF in 50% of eyes were stable or improved within 6 months after treatment. At last visit within 12 months, both BCVA and CFT remained stable in the eyes treated with either single or repeated IDI; however, progression of EZ loss and damage of ERG response occurred in some patients with single IDI. CONCLUSION: Clinical outcomes, including BCVA and parameters of OCT, ERG, and VF, were stable or improved after IDI in a majority of AIR patients. Local treatment of AIR with IDI was a good option to initiate the management or an alternative for the patients' refractory to the systemic therapy but with limited side effect.

Computed Tomography Severity Score in COVID-19: Association with Inflammatory Markers and Patient Outcome

Objective: To associate CT severity score with inflammatory markers and to determine outcomes of COVID-19 patients admitted to CMH Lahore. Study Design: Comparative cross-sectional study. Place and Duration of Study: Combined Military Hospital, Lahore Pakistan, from Mar to Jun 2021. Methodology: Patients of COVID-19 age 18 and above, with a positive RT-PCR, were included in the study Clinical and radiological data of 200 patients was retrieved and analysed from the hospital registry. Results: In the present study, we studied the role of inflammatory markers in predicting the severity of COVID-19. We have compared the levels of LDH, CRP, IL-6 and serum Ferritin between the two groups. LDH (p=0.015), IL-6 (p=0.001) and Ferritin (p=0.001) were significantly different between the two groups, but CRP was not (p=0.811) significant. Conclusion: CT severity score associates well with the COVID-19 clinical severity. Our data suggest that the chest CT scoring system can predict the severity of COVID-19 disease and significantly associates with inflammatory markers.

Respiratory disorders and their association with clinical outcomes in COVID-19: a narrative review of current literature.

BACKGROUND AND OBJECTIVE: The coronavirus disease 2019, also known as COVID-19, has caused significant worldwide morbidity and mortality. Given the direct effect of severe acute respiratory syndrome virus-2 (SARS-CoV-2) on the respiratory system, it is important that clinicians who manage chronic respiratory conditions are familiar with the pathophysiology and impact of COVID-19 on pre-existing respiratory disease. METHODS: Literature review relating to COVID-19 and respiratory disorders from PubMed and Google Scholar was conducted, with aim to encompass all publications relating to the most commonly encountered respiratory diseases in clinical practice, namely chronic obstructive lung disease (COPD), asthma, interstitial lung disease (ILD), obstructive sleep apnea (OSA), as well as obesity given it's known effect on both gas exchange and mechanistic aspects of respiration. The publications were analyzed for relevance to clinical implications and pathophysiologic mechanisms. Additional manual literature review was conducted based on citations from large review articles and society guidelines/statement papers. KEY CONTENT AND FINDINGS: Certain respiratory disorders such as COPD, ILD, OSA, and obesity carry higher burden of morbidity and mortality associated with COVID-19. Surprisingly, and in contrast to previously studied viral epidemics, asthma does not carry increased associated risk of contracting the virus or worse clinical outcomes. CONCLUSIONS: A thorough understanding of the mechanisms responsible for control of breathing and the effect of COVID-19 on pulmonary pathophysiology will allow clinicians who manage chronic respiratory disease to effectively predict associated clinical outcomes as well as improve management strategies.

Examining the Determinants of COVID-19 Severity: A Cohort Study in Morocco of 915 Patients.

INTRODUCTION: Coronavirus disease 2019 (COVID-19) is unpredictable and it varies from mild to severe and critical forms that are associated with a higher mortality rate. Risk factors associated with severe forms of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection have been investigated worldwide. We aimed to evaluate the clinical course of severe COVID-19 patients and to compare them with the non-severe patients concerning clinical and epidemiological characteristics, biological parameters and outcomes and thus, highlight the factors associated with severe forms of COVID-19 in our country. METHODS: This is a single-center, ambidirectional cohort study, conducted in Tangier's COVID-19 care premises. We included diagnosed COVID-19 patients between August 2020 and October 2021. Sampling was performed through stratification according to clinical forms. All patients were followed-up throughout disease evolution, until remission for mild to moderate forms and 30 days after discharge for hospitalized patient's group (severe to critical forms). Data were collected using the WHO International Severe Acute Respiratory and Emerging Infection (ISARIC) case report form (CRF) and extracted from medical records alongside with interviews with patients and their relatives. RESULTS: Among 915 included COVID-19 patients in Tangier, the non-severe group comprised 344 (37.6%) patients and the severe group comprised 571 (62.4%) patients. Some 514 were males (56.2%) and 401 were females (43.8%) and the mean age was 56.01 years (±16.76). The mean delay from onset of symptoms to diagnosis was 6.65 days ±4.68 in the severe group and 5.4 days ±4.57 in the non-severe group (p<0.001). Among the severe patient's group, 230 (40.3%) patients were admitted to the resuscitation unit, 258 (45.2%) patients were deceased during hospitalization, 313 (54.8%) were discharged alive, and 16 deaths occurred after discharge. Demographic, clinical, and biological characteristics showed significant differences between non-severe group and severe group. Multivariable logistic regression analysis showed increased odds of severity with male gender (adjusted odds ratio, aOR=2.91, p<0.003), age over 65 years old (aOR=2.68, p<0.001), diabetes (aOR=2.18, p<0.03), elevated D-dimers (>1 mg/mL) (aOR=6.09, p<0.001), superinfection (aOR=3.78, p<0.001), and baseline lymphopenia < 1000c/mm3 (aOR=8.66, p<0.001). CONCLUSION: The high-risk factors for developing severe COVID-19 are age > 65 years, male gender, diabetes, elevated D-dimers, baseline lymphopenia, and superinfection. To predict severe and fatal COVID-19, factors identified may be used in the development of prediction tools for COVID-19 prognosis and risk stratification. Recalling the importance of considering at-risk populations, the management of epidemics must be planned in conjunction with the specificity of each community. Findings from our study may serve for health economic analyses and research in order to assist public health decisions in the future and should be integrated into health emergency preparedness and response strategies ensuring a resilient health system.

Prevalence of gastro-intestinal symptoms among COVID-19 patients and the association with disease clinical outcomes.

Aim: This study examined the various manifestations of COVID-19 in people's gastro-intestinal system and how gastro-intestinal involvement relates to the progression and outcome of the disease. Methodology: A questionnaire survey was used to collect data from 561 COVID-19 patients between February 6 and 6 April 2022. Laboratory data and clinical outcomes were obtained from the patients' medical records. Results: 39.9% of patients presented gastro-intestinal symptoms, mainly loss of appetite, nausea, vomiting and diarrhea. Gastro-intestinal symptoms were not linked to poorer outcomes such as mortality, ICU admission or length of hospital stays. Conclusion: gastro-intestinal symptoms were common among patients and may manifest with respiratory symptoms. We recommended clinicians to watch out for gastro-intestinal symptoms as related to COVID-19 infection.

COVID-19 mainly affects the respiratory system. However, it has been previously reported that the disease can impact other organ systems, particularly the gastro-intestinal system. A prospective descriptive study design which involved 561 COVID-19 patients was performed to identify the various manifestations of COVID-19 in people's gastro-intestinal system and how gastro-intestinal involvement influenced the progression and outcome of the disease. Almost 40% of patients presented with gastro-intestinal symptoms, mainly loss of appetite, nausea, vomiting and diarrhea. However, the presence of gastro-intestinal symptoms was not linked to poorer outcomes such as mortality, ICU admission, length of hospital stays and increased mechanical intubation of COVID-19 patients.

A CTS Team Approach to Topological Data Analysis of Electronic Health Records for Subtyping and Clinical Outcomes Prediction in Patients with COVID-19

OBJECTIVES/GOALS: Analysis and modeling of large, complex clinical data remain challenging despite modern advances in biomedical informatics. We aim to explore the potential of topological data analysis (TDA) to address such challenges in the context of COVID-19 outcomes using electronic health records (EHRs). METHODS/STUDY POPULATION: In this work, we develop TDA approaches to characterize subtypes and predict outcomes in patients with COVID-19 infection. First, data for >70,000 COVID-19 patients were extracted from the OneFlorida EHR database. Next, enhancements to the TDA algorithm Mapper were designed and implemented to adapt the technique to this type of data. Clinical variables, including patient demographics, vital signs, and lab values, were then used as input to conduct a population-level exploratory analysis with an emphasis on identifying phenotypic subtypes at increased risk of adverse outcomes such as major adverse cardiovascular events (MACE), mechanical ventilation, and death. RESULTS/ANTICIPATED RESULTS: Preliminary Mapper experiments have produced visual representations of the COVID-19 patient population that are well-suited to exploratory analysis. Such visualizations facilitate easy identification of phenotypic subnetworks that differ from the general population in terms of baseline variables or clinical outcomes. In this and subsequent work, we aim to fully characterize and quantify differences between these subnetworks to identify factors that may confer increased risk (or protection from) adverse outcomes. We also plan to validate and rigorously compare the efficacy of this TDA-based approach to common alternatives such as clustering, principal component analysis, and machine learning. DISCUSSION/SIGNIFICANCE: This work demonstrates the potential utility of TDA for the characterization of complex biomedical data. Mapper provides a novel means of exploring EHR data, which are otherwise difficult to visualize and can aid in identifying or characterizing patient subtypes in diseases such as COVID-19.