Self-reported Flare Research Articles

Building a composite score for patient self-report of flare in osteoarthritis: a comparison of methods with the Flare-OA-16 questionnaire

ObjectivesThis study aims to compare methods of constructing a composite score for the Flare-OA-16 self-reported questionnaire. MethodsParticipants with knee and hip osteoarthritis (OA) completed a validated 16-item questionnaire assessing five domains of flare. Three estimation methods were compared: (i) second-order confirmatory factor analysis (CFA); (ii) logistic regression, according to the participant's self-report of flare (yes/no); and (iii) Rasch method, with weighted scores in each dimension. The distribution (floor effect [FF] and ceiling effect [CF]) were described and the known-group validity (by self-reported flare) tested by Wilcoxon rank-sum test. Similarity between the scores was analyzed by intraclass correlation coefficient (ICC) and their performance against self-report compared by areas under ROC curves (AUC). Intrascore test-retest reliability at 14 days was assessed by ICC. ResultsIn a sample of 381 participants, 247 reported having a flare. CFA showed fit indices (comparative fit index [CFI] = 0.95; root mean square error of approximation [RMSEA] = 0.08) and estimated composite mean score = 4.33(SD = 2.85) (FF = 14.9%, CF = 0%). For the logistic regression estimation, the mean composite score was 6.48 (SD = 3.13) (FF = 0%; CF = 0%). With Rasch model, the mean composite score was 4.35 (SD = 2.60) (FF = 14.9%; CF = 0%). Similarity analysis indicated a greater concordance between CFA and Rasch scores (ICC = 0.98) than between logistic regression score and the two others (ICC = 0.88 with Rasch score and 0.90 with CFA score). The AUC indicated similar performance of all methods: logistic model (AUC = 0.89 [0.85–0.92]), CFA, and Rasch model (AUC = 0.86 [0.82–0.90]). The difference between groups was significant (P < .05) for scores estimated by CFA (3.98), Rasch model (4.95), and logistic regression (4.30). The reproducibility was ICC = 0.84 (0.75–0.90) for Rasch and CFA scores and ICC = 0.78(0.66–86) for logistic model. ConclusionThree alternatives explored to build a composite score showed similar construct validity. Some metric superiority (better score distribution and reproducibility) of the Rasch model is promising for the detection of occurrence and assessment of severity of a flare in OA.

B- and T-Lymphocyte Attenuator in Systemic Lupus Erythematosus Disease Pathogenesis.

B- and T-lymphocyte attenuator (BTLA; CD272) is an immunoglobulin superfamily member and part of a family of checkpoint inhibitory receptors that negatively regulate immune cell activation. The natural ligand for BTLA is herpes virus entry mediator (HVEM; TNFRSF14), and binding of HVEM to BTLA leads to attenuation of lymphocyte activation. In this study, we evaluated the role of BTLA and HVEM expression in the pathogenesis of systemic lupus erythematosus (SLE), a multisystem autoimmune disease. Peripheral blood mononuclear cells from healthy volunteers (N = 7) were evaluated by mass cytometry by time-of-flight to establish baseline expression of BTLA and HVEM on human lymphocytes compared with patients with SLE during a self-reported flare (N = 5). High levels of BTLA protein were observed on B cells, CD4+, and CD8+ T cells, and plasmacytoid dendritic cells in healthy participants. HVEM protein levels were lower in patients with SLE compared with healthy participants, while BTLA levels were similar between SLE and healthy groups. Correlations of BTLA-HVEM hub genes' expression with patient and disease characteristics were also analyzed using whole blood gene expression data from patients with SLE (N = 1,760) and compared with healthy participants (N = 60). HVEM, being one of the SLE-associated genes, showed an exceptionally strong negative association with disease activity. Several other genes in the BTLA-HVEM signaling network were strongly (negative or positive) correlated, while BTLA had a low association with disease activity. Collectively, these data provide a clinical rationale for targeting BTLA with an agonist in SLE patients with low HVEM expression.

P174 Identifying patterns of fatigue across flares in patients with axial spondyloarthritis

Abstract Background/Aims Fatigue is a common and debilitating symptom of axial spondyloarthritis and has a significant negative impact on quality of life for these patients. Previous qualitative and quantitative research indicates that fatigue significantly worsens during flares. There remains uncertainty around the quality and intensity of fatigue before a flare compared with during and after. This understanding could help in diminishing the unpredictability of flares and fatigue which has been identified as a key issue for patients and may aid self-management. The main aim of the current analysis was to determine whether there would be any significant differences in the distribution of fatigue scores depending on patients’ self-reported flare status. Methods The current project involved secondary analysis of patient data collected through the Royal National Hospital for Rheumatic Diseases. A Kruskal Wallis test was conducted utilising anonymised Project Nightingale data from 286 patients collected via a mobile app. Data from a single time point for each patient were analysed. Fatigue was measured via responses to a 5-point scale. Patients’ data were organised into five categories depending on their self-reported flare status. This included flare started, flare continued, flare stopped and no flare. A fifth group was created where patients had reported their fatigue scores the day before a flare started. Results 43% percent of patients were female and 57% percent were male. There was at least one significant difference in rank totals between categories, H (4, n = 286) = 48.38, p &amp;lt; .001. Dunn’s post hoc tests were subsequently performed with Bonferroni adjusted p values for pairwise comparisons and are displayed in the table below. Fatigue was significantly higher in the flare continued category than in the no flare (p &amp;lt;.001), day before flare started (p = .008) and the flare stopped categories (p = .028). Inspection of medians and interquartile ranges suggested that fatigue appeared to be slightly higher the day before a flare started compared with no flare, however there were no other statistically significant differences between categories. Conclusion The results indicate that fatigue was highest during the middle of a flare as opposed to the start or end of a flare or the day before a flare. Future studies could include data at more time points including prior to, during and after flares. As previous literature implies that there may be two types of flare associated with different levels of fatigue, future studies could compare levels of fatigue between patients within these subgroups. This research could facilitate the refinement of interventions with the aim of minimising the unpredictability and impact of fatigue in axSpA patients. Disclosure S. Patel: None. R. Barnett: None. C. Cavill: None. R. Sengupta: Honoraria; R.S. has received honoraria from Abbvie, Biogen, BMS, Eli Lilly, MSD, Novartis, Pfizer, Roche and UCB, all unrelated to this abstract.

Towards a patient-centred definition for atopic dermatitis flare: a qualitative study of adults with atopic dermatitis.

The term 'flare' is used across multiple diseases, including atopic dermatitis (AD), to describe increased disease activity. While several definitions of an AD flare have been proposed, no single definition of AD flare is widely accepted and it is unclear what the term 'AD flare' means from the patient perspective. To understand AD flares from the adult patient perspective and to explore how adults with AD define an AD flare. Participants were adults with AD recruited from the National Eczema Association Ambassadors programme, a volunteer patient-engagement programme. They participated in online focus groups to discuss how they describe AD flares from their perspective, how they define its start and stop, and how they relate to existing definitions of flare. Using a grounded theory approach, transcripts were analysed and coded using an iterative process to identify concepts to support a patient-centred conceptual framework of 'flare'. Six 90-min focus groups of 3-8 participants each were conducted with 29 US adults (≥ 18 years of age) with AD who had at least one self-reported AD flare in the past year. When participants were presented with examples of previously published definitions of AD flare, participants found them problematic and unrelatable. Specifically, they felt that flare is hard to quantify or put on a numerical scale, definitions cannot solely be about skin symptoms and clinical verbiage does not resonate with patients' lived experiences. Concepts identified by patients as important to a definition of flare were changes from patient's baseline/patient's normal, mental/emotional/social consequences, physical changes in skin, attention needed/all-consuming focus, itch-scratch-burn cycle and control/loss of control/quality of life. Figuring out the trigger that initiated a flare was an underlying concept of the experience of flare but was not considered a contributor to the definition. The results highlight the complexity and diversity of AD flare experiences from the adult patient perspective. Previously published definitions of AD flares did not resonate with patients, suggesting a need for a patient-centred flare definition to support care conversations and AD management.

COVID-19 Vaccine Uptake, Hesitancy, and Flare in a Large Rheumatology Practice Network.

The goal of this study was to ascertain COVID-19 vaccine uptake, reasons for hesitancy, and self-reported flare in a large rheumatology practice-based network. A tablet-based survey was deployed by 108 rheumatology practices from December 2021 to December 2022. Patients were asked about COVID-19 vaccine status and why they might not receive a vaccine or booster. We used descriptive statistics to explore the differences between vaccination status and vaccine and booster hesitancy, comparing patients with and without autoimmune and inflammatory rheumatic diseases (AIIRDs). We used multivariable logistic regression to examine the association between vaccine uptake and AIIRD status and self-reported flare and AIIRD status. We reported adjusted odds ratios (aORs). Of the 61,158 patients, 89% reported at least one dose of vaccine; of the vaccinated, 68% reported at least one booster. Vaccinated patients were less likely to have AIIRDs (44% vs 56%). A greater proportion of patients with AIIRDs were vaccine hesitant (14% vs 10%) and booster hesitant (21% vs 16%) compared to patients without AIIRDs. Safety concerns (28%) and side effects (23%) were the main reasons for vaccine hesitancy, whereas a lack of recommendation from the physician was the primary factor for booster hesitancy (23%). Patients with AIIRD did not have increased odds of self-reported flare or worsening disease compared to patients without with AIIRD (aOR 0.99, 95% confidence interval [CI] 0.94-1.05). Among the patients who were vaccine hesitant and booster hesitant, 12% and 39% later reported receiving a respective dose. Patients with AIIRD were 32% less likely to receive a vaccine (aOR 0.68, 95% CI 0.65-0.72) versus patients without AIIRD. Some patients who are vaccine and booster hesitant eventually receive a vaccine dose, and future interventions tailored to patients with AIIRD may be fruitful.

Skin-Related Quality of Life During Autoimmune Bullous Disease Course

Autoimmune bullous diseases (AIBDs) are chronic relapsing-remitting conditions with significant morbidity. Skin-related quality of life (SRQL) may vary by AIBD subtype and disease type. Disease severity and flare severity can be difficult to define; SRQL can offer a key insight. To investigate the Skindex-16 score as an SRQL measure in AIBD subtypes during flare and nonflare states and to evaluate Skindex-16 construct validity. This retrospective cross-sectional study was conducted from September 1, 2016, to February 1, 2020, among 192 patients at the University of Utah Health autoimmune dermatology clinic with pemphigoid, pemphigus, dermatitis herpetiformis, and linear immunoglobulin A disease. Patients had an encounter-associated diagnosis, Skindex-16 scores, and self-reported flare status. Statistical analysis was performed from March 2022 to June 2023. Autoimmune bullous disease subtype and patient-reported flare status. Skindex-16 domain scores (emotions, symptoms, and functioning; range, 0-100, where 0 indicates no effect on SRQL and 100 maximum effect) and individual item scores were described by disease and flare status. Flare scores were expected to be higher by at least the standard error of measurement (SEm). Convergent validity was assessed using Spearman correlation among Skindex-16 scores, serologic titers, and other patient-reported outcome measures. Floor or ceiling domain scores (<20% of sample scoring either lowest or highest possible domain scores, respectively) were assessed for Skindex-16. Structural validity was assessed using confirmatory factor analysis (CFA). The study included 192 patients with 212 visits (median age, 68 years [IQR, 58-76 years]; 123 of 212 women [58.0%]) with Skindex-16 scores (64 in flare state and 148 in nonflare state). Median Skindex-16 domain scores were higher for all disease categories among patients in the flare state compared with those in the nonflare state (pemphigoid [emotions: flare, 52.4 (IQR, 38.1-69.0); nonflare, 7 (IQR, 0-17); symptoms: flare, 37.5 (IQR, 29.2-58.0); nonflare, 13 (IQR, 0-25); functioning: flare, 26.7 (IQR, 10.0-56.7); nonflare, 0 (IQR, 0-3)]; pemphigus [emotions: flare, 54.8 (IQR, 31.0-81.0; nonflare, 0 (IQR, 0-19); symptoms: flare, 58.3 (IQR, 41.7-70.8); nonflare, 4 (IQR, 0-12.5); functioning: flare, 26.7 (IQR, 13.3-83.3); nonflare, 0 (IQR, 0-3.33)]; dermatitis herpetiformis [emotions: flare, 72.6 (IQR, 34.7-90.5); nonflare, 14.3 (IQR, 2.4-26.2); symptoms: flare, 69 (IQR, 31.3-85.4); nonflare, 12.5 (IQR, 0-29.2); functioning: flare, 38.3 (IQR, 5.0-63.2); nonflare, 0 (IQR, 0-13.3)]. This difference exceeded SEm cut points. Cronbach α was greater than 0.80 for all domains and AIBDs. Moderate or low correlations were seen with desmoglein 1 and bullous pemphigoid 180 titers. Moderate correlation existed between Skindex-16 and Patient-Reported Outcomes Measurement Information System Depression scores (emotions: ρ = 0.40; symptoms: ρ = 0.41; functioning: ρ = 0.48), and strong correlation existed between Skindex-16 and patient-reported disease severity (emotions: ρ = 0.71; symptoms: ρ = 0.73; functioning: ρ = 0.66). Floor domain scores greater than 20% were seen among patients in the nonflare state, but ceiling domain scores were rare (<10% for all domains); CFA model fit was poor. In this cross-sectional study, SRQL was highly associated with flare of AIBDs. Skin-related quality of life was worse during periods without flare among patients with pemphigoid and dermatitis herpetiformis compared with pemphigus, highlighting residual SRQL morbidity. Skindex-16 showed good construct validity, but the poor CFA model fit needs further research. Clinical measurement of SRQL in AIBDs can add critical disease-severity information.

Immunogenicity and safety of mixed COVID-19 vaccine regimens in patients with immune-mediated inflammatory diseases: a single-centre prospective cohort study

ObjectiveAmong persons with immune-mediated inflammatory diseases (IMIDs) who received SARS-CoV-2 vaccines, we compared postvaccine antibody responses and IMID disease activity/states.DesignSingle-centre prospective cohort study.SettingSpecialty ambulatory clinics in central Canada.ParticipantsPeople with inflammatory...

OA29 Flares following COVID-19 vaccination in patients with idiopathic inflammatory myopathies: combined analysis from the COVID-19 Vaccination in Autoimmune Diseases (COVAD) studies

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 &amp;lt; 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. Disclosure L. Gupta: None. N. R: None. Z. Griger: None. V. Agarwal: None. P. Sen: None. M. Joshi: None. S. Saha: None. K. Jagtap: None. O. Distler: Honoraria; 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. E. Nikiphorou: Honoraria; Celltrion, Pfizer, Sanofi, Gilead, Galapagos, AbbVie, and Lilly. Grants/research support; Pfizer and Lilly. A. Tan: Honoraria; Abbvie, Gilead, Janssen, Lilly, Novartis, Pfizer, and UCB. S. Shinjo: None. N. Ziade: Honoraria; Pfizer, Roche, Abbvie, Eli Lilly, NewBridge, Sanofi-Aventis, Boehringer Ingelheim, Janssen, and Pierre Fabre. M. Milchert: None. I. Parodis: Honoraria; Amgen, AstraZeneca, Aurinia Pharmaceuticals, Elli Lilly and Company, Gilead Sciences, GlaxoSmithKline, Janssen Pharmaceuticals, Novartis and F. Hoffmann-La Roche AG. M. Kuwana: None. A. Makol: None. J. Pauling: None. C. Wincup: None. J. Lilleker: Honoraria; Sanofi Genzyme, Roche, and Biogen. A. Nune: None. J. Day: Grants/research support; CSL Limited. H. Chinoy: Consultancies; Novartis, Eli Lilly, Orphazyme, Astra Zeneca. Honoraria; UCB, and Biogen. Grants/research support; Eli Lilly and UCB. V. Agarwal: None. R. Aggarwal: Consultancies; Bristol Myers-Squibb, Pfizer, Genentech, Octapharma, CSL Behring, Mallinckrodt, AstraZeneca, Corbus, Kezar, Abbvie, Janssen, Alexion, Argenx, Q32, EMD-Serono, Boehringer Ingelheim, and Roivant.

A74 URGENCY FOR BOWEL MOVEMENTS IS A HIGHLY DISCRIMINATORY SYMPTOM FOR ACTIVE DISEASE IN PERSONS WITH IBD (THE MANITOBA LIVING WITH IBD STUDY)

Abstract Background The Inflammatory Bowel Disease Symptom Inventory (IBDSI) is a validated patient self-reported measure used to assess IBD disease activity. Purpose We aimed to assess the prevalence of symptoms, and examine which symptoms are most associated with disease activity as measured by a symptom index and objective measure of inflammation. Method The Manitoba Living with IBD Study is a prospective study of 156 participants with confirmed IBD who completed bi-weekly Inflammatory Bowel Disease Symptom Inventory (IBDSI) surveys. Relative risks (RR) (with 95% confidence interval (CI)), positive and negative predictive values (PPV, NPV), and area under receiver operator curve (AUC) were reported for each symptom to predict active disease defined as: (1) active IBDSI, (2) self-reported flare, and (3) elevated fecal calprotectin (FCAL) (&amp;gt;250µg/g). Analyses were undertaken following stratification based on sex, and disease type (Crohn’s disease (CD) and ulcerative colitis (UC)). Result(s) In total, 69.2% of participants were female; 64.7% had CD. Fatigue was the most prevalent symptom in both inactive and active disease, across all 3 disease measures (IBDSI: 24.5% and 75.1%, self-reported flare: 42.2% and 72.2%, FCAL: 46.0% and 60.6%). Absence of fatigue had a high NPV for active IBDSI and self-reporting a flare in both CD and UC. Urgency had a consistently strong NPV, RR and AUC across all three disease measures in both IBD subtypes and sexes. The number of loose/liquid bowel movements predicted elevated FCAL in UC (RR in men = 3.5, 95% CI 1.2-9.9, RR in women = 1.8, 95% CI 1.2-2.7, AUC in men = 0.73, 95% CI 0.59-0.84, AUC in women = 0.65, 95% CI 0.56-0.72), as did blood in stool in females with UC (RR = 1.8, 95% CI 1.2-2.7). In men with CD, excessive bowel gas (RR = 2.0, 95% CI 1.2-3.4) and urgency (RR = 3.9, 95% CI 1.6-9.3) best predicted an elevated FCAL. No symptom was strongly predictive of elevated FCAL in females with CD. Conclusion(s) Fatigue was the most prevalent symptom irrespective of disease activity. Urgency stood out as being consistently associated with disease activity, irrespective of the disease measure. Individual symptoms have different impacts on subjective (IBDSI) and objective (FCAL) measures in IBD. Please acknowledge all funding agencies by checking the applicable boxes below None Disclosure of Interest None Declared

Urgency for bowel movements is a highly discriminatory symptom of active disease in persons with IBD (the Manitoba Living with IBD study).

The Inflammatory Bowel Disease Symptom Inventory (IBDSI) is a validated patient self-reported measure used to assess IBD disease activity. There have yet to be more granular analyses on which symptoms are most associated with active disease. To assess the prevalence of symptoms, and to examine which are most associated with disease activity as measured by a symptom index and objective measure of inflammation METHODS: The Manitoba Living with IBD Study is a prospective study of 156 participants with confirmed IBD who completed bi-weekly IBDSI. Relative risks (RR) and predictive values (NPV and PPV) were reported for each symptom to predict active disease defined as active IBDSI, self-reported flare and elevated faecal calprotectin (FCAL) (>250 μg/g). Analyses were undertaken following stratification based on sex, and disease type (Crohn's disease [CD] and ulcerative colitis [UC]). In total, 69.2% were female; 64.7% had CD. Fatigue was the most prevalent symptom in both inactive and active disease, across all three disease measures (IBDSI: 24.5% and 75.1%, self-reported flare: 42.2% and 72.2%, FCAL: 46.0% and 60.6%). The absence of fatigue had a high NPV for active IBDSI and self-reporting a flare in both CD and UC. Urgency had a consistently strong NPV and RR across all three disease measures in both IBD subtypes and sexes. The number of loose/liquid bowel movements predicted elevated FCAL in UC (RR males=3.5, 95% CI 1.2-9.9, RR females=1.8, 95% CI 1.2-2.7), as did blood in stool in UC females (RR=1.8, 95% CI 1.2-2.7). In males with CD, excessive bowel gas (RR=2.0, 95% CI 1.2-3.4) and urgency (RR=3.9, 95% CI 1.6-9.3) best predicted an elevated FCAL. No symptom was strongly predictive of an elevated FCAL in CD females. Urgency was consistently associated with disease activity, irrespective of the disease measure. Fatigue was the most prevalent symptom irrespective of disease activity measure. Individual symptoms have different impacts on subjective (IBDSI) and objective (FCAL) measures in IBD.

34524 The association between patient-reported outcomes skin flaring in autoimmune blistering diseases

Background: Autoimmune bullous diseases (ABDs) are chronic relapsing-remitting dermatologic diseases that exert significant impacts on quality of life (QOL). Using Skindex-16, we evaluated the impact of self-reported ABD flares on patients’ QOL. Methods: Skindex-16 is a dermatology-specific QOL measure that assesses skin disease impact on symptoms, emotions and functioning (range 0-100, higher scores = greater QOL impact). Demographic and clinical data for each visit were linked to PRO scores via manual chart review. Associations between PRO score and self-reported flare (“Are you flaring today? Yes/No”) were performed for each disease category (subepiderma, pemphigus, and dermatitis herpetiformis (DH)). Comparisons of Skindex-16 scores and individual item distributions by flaring status were compared using Somers’ D test. Odds of flare was calculated with univariable and multivariable logistic regression. Discrimination of indirect immunofluorescence lab values versus PRO scores was compared with c-index. Results: Between September 2016 and January 2020, we identified 193 patients with 317 visits. On average, patients took 2.44 minutes to complete the Skindex-16. Patients reported flaring at 29.0% of visits. Overall and individual item Skindex-16 were higher for all disease categories when flaring compared with non-flaring (P = .80 for all). Conclusions: ABDs have high morbidity. Flares are common and negatively impact QoL. These results highlight the clinical potential for serial Skindex-16 monitoring to signal clinical changes in patients with ABD.

Impact of Physician-Defined Flares on Quality of Life and Work Impairment: An International Survey of 2238 Patients With Psoriatic Arthritis.

To describe psoriatic arthritis (PsA) flares and their effect on patient-reported outcomes (PROs). Cross-sectional surveys of rheumatologists/dermatologists and their patients with PsA were conducted in France, Germany, Italy, Spain, the United Kingdom, and the United States, capturing data on physician-reported patient flare status, demographics, PsA severity, and clinical outcomes. Patient-completed surveys captured data on PROs: 5-level EuroQol 5-dimension, Work Productivity and Activity Impairment questionnaire, Health Assessment Questionnaire-Disability Index, and 12-item Psoriatic Arthritis Impact of Disease questionnaire. Patients were compared by flare status using parametric and nonparametric tests. Multivariate regression was used to identify flare associations. Multivariate logistic regression adjusted for patient demographics and physician specialty assessed the effect of flare status. Among 2238 patients (586 from the US, 1652 from Europe) managed by 572 physicians, physician-reported flare was present for 168 patients (7.5%), and self-reported flare was present for 95 patients (10% of available data). Mean (SD) flare count over 12 months was 2.2 (4.9), lasting on average 16.4 (16.2) days. Flare status was linked to worse PROs. Patients who had not flared in the last 12 months or had never flared had a higher quality of life, lower overall work impairment, and a lower degree of disability compared with patients who were currently experiencing a flare (all; P < 0.01). Actively experiencing a flare adversely affected QOL, disability, and work productivity. PsA flares should be routinely assessed and managed in clinical care.

Low incidence and transient elevation of autoantibodies post mRNA COVID-19 vaccination in inflammatory arthritis.

ObjectivesAutoantibody seroconversion has been extensively studied in the context of COVID-19 infection but data regarding post-vaccination autoantibody production is lacking. Here we aimed to determine the incidence of common autoantibody formation following mRNA COVID-19 vaccines in patients with inflammatory arthritis (IA) and in healthy controls.MethodsAutoantibody seroconversion was measured by serum ELISA in a longitudinal cohort of IA participants and healthy controls before and after COVID-19 mRNA-based immunization.ResultsOverall, there was a significantly lower incidence of ANA seroconversion in participants who did not contract COVID-19 prior to vaccination compared with those who been previously infected (7.4% vs 24.1%, P = 0.014). Incidence of de novo anti-CCP seroconversion in all participants was low at 4.9%. Autoantibody levels were typically of low titre, transient, and not associated with increase in IA flares.ConclusionsIn both health and inflammatory arthritis, the risk of autoantibody seroconversion is lower following mRNA-based immunization than following natural SARS-CoV-2 infection. Importantly, seroconversion does not correlate with self-reported IA disease flare risk, further supporting the encouragement of mRNA-based COVID-19 immunization in the IA population.

Self-reported flares among people living with inflammatory bowel disease are associated with stress and worry but not associated with recent diet changes: The Manitoba Living with IBD Study.

In this matched case-control longitudinal study among people living with inflammatory bowel disease (IBD), we investigated beliefs about what triggers a flare. Adults with confirmed IBD and active disease within 2 years were enrolled in the Manitoba Living with IBD Study and followed biweekly with online surveys for 1 year. The 7-point IBD Symptom Change Indicator was used for participant identification of a flare. Flare cases were matched to non-flare controls by sex and disease type. Members of each matched pair completed supplementary information on diet changes and psychological functioning in the previous 2 weeks and provided stool samples to assess fecal calprotectin (FCAL). Of 128 enrolled participants, 95 matched flare/non-flare pairs were created. Those reporting a flare were more likely to have elevated FCAL (51% vs 34% among non-flares, P = 0.043). Although 61% of study participants believed at baseline that a food may trigger flares, and 25% of those in a flare believed that a food may have triggered their current flare, there was no difference in consumption of assessed foods between flares and non-flares in the previous 2 weeks. Patients with flares were more likely to be having difficulties in emotional state than controls (40% vs 18%, P = 0.001) and more likely to be stressed or worried (64% vs 33%, P = 0.001). Although a majority of individuals with IBD believe that specific foods trigger their disease flares, this was not supported by the current findings. Recent psychological functioning was associated with self-reported IBD flare.

Are objective measures of sleep and sedentary behaviours related to low back pain flares?

Risk factors for low back pain (LBP) flares have been considered about self-reported measures. This case-crossover study aimed to investigate whether (1) objective measures of physical activity and sleep were associated with the risk of experiencing LBP flares and (2) these associations differed for flares defined as pain 2 or more points greater than average pain over the period using an 11-point Numerical rating scale (0-no pain and 10-worst pain imaginable) (pain-defined flare: PDF) and flares identified by participants according to a broader definition that considered emotions or coping (self-reported flare [SRF]). We included 126 participants who had experienced LBP for >3 months. Physical activity and sleep were monitored for 28 days using wearable sensors. Occurrence of flares (PDF or SRF) was assessed daily using a smartphone application. Data on exposure to risk factors 1, 2, and 3 days preceding PDF or SRF were compared with nonflare control periods. Conditional logistic regression determined association between each factor and flares. Data show that day-to-day variation in physical activity and in-bed time are associated with the risk of LBP flares, but associations differ depending on how flare is defined. Longer in-bed time increased the risk of PDF but not SRF. Although physical activity was not associated with the risk of PDF, greater sedentary behaviour increased the risk of SRF and being more physically active decreased the risk for SRF. These results highlight the potential role of targeting sleep and physical activity in interventions to prevent LBP flares and indicate that risk factors differ depending on how LBP flares are defined.

Using patient-reported data from a smartphone app to capture and characterize real-time patient-reported flares in rheumatoid arthritis.

ObjectiveWe aimed to explore the frequency of self-reported flares and their association with preceding symptoms collected through a smartphone app by people with RA.MethodsWe used data from the Remote Monitoring of RA study, in which patients tracked their daily symptoms and weekly flares on an app. We summarized the number of self-reported flare weeks. For each week preceding a flare question, we calculated three summary features for daily symptoms: mean, variability and slope. Mixed effects logistic regression models quantified associations between flare weeks and symptom summary features. Pain was used as an example symptom for multivariate modelling.ResultsTwenty patients tracked their symptoms for a median of 81 days (interquartile range 80, 82). Fifteen of 20 participants reported at least one flare week, adding up to 54 flare weeks out of 198 participant weeks in total. Univariate mixed effects models showed that higher mean and steeper upward slopes in symptom scores in the week preceding the flare increased the likelihood of flare occurrence, but the association with variability was less strong. Multivariate modelling showed that for pain, mean scores and variability were associated with higher odds of flare, with odds ratios 1.83 (95% CI, 1.15, 2.97) and 3.12 (95% CI, 1.07, 9.13), respectively.ConclusionOur study suggests that patient-reported flares are common and are associated with higher daily RA symptom scores in the preceding week. Enabling patients to collect daily symptom data on their smartphones might, ultimately, facilitate prediction and more timely management of imminent flares.

Understanding flare in axial spondyloarthritis: novel insights from daily self-reported flare experience.

ObjectivesOur objective was to explore daily self-reported experiences of axial SpA (axSpA) flare based on data entered into the Project Nightingale smartphone app (www.projectnightingale.org), between 5 April 2018 and 1 April 2020.MethodsPaired t-tests were conducted for mean_flare_on and mean_flare_off scores for each recorded variable. The mean estimated difference between flare and non-flare values for each variable was calculated with 95% CIs. Mean, S.d. and range were reported for flare duration and frequency. Participants with ≥10 days of data entry were included for affinity propagation cluster analysis. Baseline characteristics and mean flare on vs mean flare off values were reported for each cluster. Welch’s t-test was used to assess differences between clusters.ResultsA total of 143/189 (75.7%) participants recorded at least one flare. Each flare lasted a mean of 4.30 days (S.d. 6.82, range 1–78), with a mean frequency of once every 35.32 days (S.d. 65.73, range 1–677). Significant relationships were identified between flare status and variable scores. Two clusters of participants were identified with distinct flare profiles. Group 1 experienced less severe worsening of symptoms during flare in comparison to group 2 (P < 0.01). However, they experienced significantly longer flare duration (7.2 vs 3.5 days; P < 0.01), perhaps indicating a prolonged, yet less intense flare experience. Groups were similar in terms of flare frequency and clinical characteristics.ConclusionsTwo clusters of participants were identified with distinct flare experiences but similar baseline clinical characteristics. Smartphone technologies capture subtle changes in disease experience not currently considered in clinical practice.

POS0055 SARS-COV-2 OUTBREAK IN AUTOIMMUNE DISEASES: THE EURO-COVIMID STUDY

Background:Coronavirus disease 2019 (COVID-19), has raised several questions in patients with immune-mediated inflammatory diseases (IMID). Whether the seroprevalence and factors associated with symptomatic COVID-19 are similar in IMID patients and in the general population is still unknown.Objectives:To assess the serological and clinical prevalence of COVID-19 in European IMID patients, along with the factors associated with its risk and the impacts the pandemic had on the IMID management.Methods:Prospective multicentre cross-sectional study among patients with five IMID (i.e. systemic lupus erythematous, Sjögren’s syndrome, rheumatoid arthritis, axial spondylarthritis or giant cell arteritis) from six tertiary-referral centers from France, Germany, Italy, Portugal, Spain and United Kingdom. Demographics, comorbidities, IMID, treatments, flares and COVID-19 details were collected. Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) serological tests were systematically performed.Results:Between June 7 and December 8, 2020, 3028 patients were included (median age 58 years, 73.9% females). SARS-CoV-2 antibodies were detected in 166 (5.5%) patients. Symptomatic COVID-19 was seen in 122 patients (prevalence: 4.0%, 95% CI 3.4-4.8%); 23 (24.2%) of them were hospitalized and four (3.2%) died. In multivariate logistic regression analysis, symptomatic COVID-19 was more likely to be observed in patients with higher levels of C-reactive protein (OR: 1.18; 95% CI 1.05-1.33; p = 0.006), and increased with the number of IMID flares (OR: 1.27; 95% CI 1.02-1.58; p = 0.03). Conversely, it was less likely to occur in patients treated with biological therapy (OR: 0.51; 95% CI 0.32-0.82; p = 0.006). During the pandemic, at least one self-reported disease flare was seen in 654 (21.6%) patients. Also, 519 (20.6%) patients experienced changes in their treatment, with 125 of these (24.1%) being due to COVID-19.Conclusion:The SARS-CoV-2 prevalence in IMID patients over the study period seems to be similar to that of the general population1. The IMID inflammatory status seems to be independently associated with the development of COVID-19.

Low Back Pain Flares

Objective: The term flare is commonly used to describe low back pain (LBP) fluctuations, but individuals with LBP consider that it does not always correspond to increased pain. This case cross-over study aimed to: (1) determine the extent to which days with a flare identified according to a multidimensional definition (self-reported flare, SRF) corresponded to days with greater than average pain (pain-defined flare, PDF) and (2) to investigate whether physical and psychosocial features differ between PDF and SRF. Materials and Methods: Individuals with LBP for ≥3 months (N=126) provided data on flares, physical, and psychosocial features daily for 28 days using a smartphone application. Results: Most days with SRF (68%) did not have greater than average pain (ie, PDF), but most days with greater than average pain (64%) were reported as an SRF. On days with SRF-only all physical and psychosocial features were worse than nonflare days. SRF+PDF had lower sleep quality and higher pain intensity, fatigue, disability, pain catastrophizing, and fear avoidance than SRF-only. SRF+PDF had higher pain in the afternoon and evening, disability and pain catastrophizing than PDF-only. Self-efficacy at work and during leisure activities was worse on SRF+PDF days than SRF-only and PDF-only days. Discussion: These findings highlight that when individuals with LBP consider they have a flare, they do not always have greater than average pain, but have worse psychosocial features. This emphasizes that flare has broader dimensions than pain alone. Consideration of flare according to broad dimensions is important when investigating symptom fluctuations across different LBP trajectories.

ISSLS PRIZE IN CLINICAL SCIENCE 2021: What are the risk factors for low back pain flares and does this depend on how flare is defined?

Although risk factors for new low back pain (LBP) episodes and acute-to-chronic transition have been identified, risk factors for flares of LBP remain largely unknown. This case-crossover study aimed to identify: (1) risk factors LBP flares and (2) whether risk factors differed when flare is defined by pain increase (pain-defined flare: PDF) or identified by participants according to a broader flare definition that considered emotions and coping (self-reported flare: SRF). One hundred and twenty-six participants with LBP for > 3months were included. Candidate risk factors and flares (PDF/SRF) were assessed daily using a smartphone application for 28days. Data on exposure to risk factors one, two and three days preceding PDF/SRF were compared to control periods. Conditional logistic regression estimated associations between risk factors and PDF/SRF. Odds of PDF and SRF were increased by poor sleep quality and morning pain. Good sleep quality reduced odds of flare. Odds for increased pain (PDF), but not SRF, were increased after days with higher afternoon and evening pain, fatigue, fear of physical activity and leisure physical activity. LBP flare has been largely ignored but is more reflective of the LBP experience than conventional definitions of acute, sub-acute and chronic LBP. This study highlights risk factors for flare and that these differ depending on whether flare is defined by pain alone (PDF) or a broad multidimensional definition (SRF). Potential targets to reduce the intensity/frequency of LBP flares are identified, with strong indication for the potential role of sleep intervention to mitigate LBP flare risk.