scholarly journals THU0253 FATIGUE AND PAIN REMAIN PROMINENT AND IMPACTFUL IN PATIENTS WITH SYSTEMIC LUPUS ERYTHEMATOSUS (SLE): A CROSS-SECTIONAL SURVEY OF SLE PATIENTS IN THE UNITED STATES

2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 353.2-354
Author(s):  
J. Birt ◽  
M. Hadi ◽  
N. Sargalo ◽  
E. Brookes ◽  
P. Swinburn ◽  
...  
Keyword(s):  
United States ◽  
Systemic Lupus Erythematosus ◽  
Lupus Erythematosus ◽  
Joint Pain ◽  
Disease Burden ◽  
Joint Stiffness ◽  
Systemic Lupus ◽  
Cross Sectional ◽  
Patient Reported ◽  
The Mean

Background:Systemic lupus erythematosus (SLE) is a chronic autoimmune inflammatory condition impacting multiple organ systems.1,2SLE affects approximately 1.5 million Americans, disproportionately females of reproductive age, and is more prevalent in non-Caucasian populations.3Fatigue and pain are some of the most prominent symptoms of SLE, contributing to the heavy disease burden and disruption to daily life.4This study aimed to further understand the burden of SLE. Lilly worked with the Lupus Foundation of America (LFA) and Evidera to develop the SLE-UPDATE (Understanding Preferences, Disease Activity and Treatment Expectations) survey.Objectives:To understand the patient-perceived symptom burden of SLE, in particular pain and fatigue, within the current landscape of therapeutic options. This study also focused on current treatment patterns in SLE patients.Methods:This was a cross-sectional, non-interventional, online survey study conducted in partnership with the LFA. English-speaking United States patients aged ≥18 years with a self-reported diagnosis of SLE completed the survey following online screening and informed consent. Descriptive data are presented by means (standard deviation [SD]) for continuous measures, and frequency (n, %) for dichotomous measures. Demographic, clinical, and patient-reported outcomes were collected including the FACIT-Fatigue (range 0-52, higher scores indicate less fatigue), Pain Numerical Rating Scale (NRS) (0 [none] to 10 [worst imaginable]), Worst Joint Pain NRS (0 [none] to 10 [worst imaginable]), and the LupusPRO, a validated, lupus-specific quality of life (QoL) instrument (range 0-100, higher scores indicate better QoL).Results:A total of 500 patients with SLE completed the survey. Patients were predominantly female (75%), white/Caucasian (76%), with a mean age of 42.6 years and mean disease duration of 11.1 years.Most patients with SLE rated their overall condition as either good (38%) or fair (31%), with 8% rating poor and 7% excellent. Current non-biologic prescription medication use included: antimalarials 42%, corticosteroids 33%, immunosuppressants 33%, nonsteroidal anti-inflammatory drugs (NSAID) 32%, other analgesics 15% and 10% were using tofacitinib. Biologic therapies were being used by only 19%, including intravenous (IV) Benlysta (37%),subcutaneous(SC) Benlysta (25%), rituximab (17%), and 22% were using other biologics. Fatigue was the most commonly reported symptom (69%), with 40% of patients ranking fatigue as their most bothersome SLE symptom. Forty eight percent of patients with current fatigue rated the severity as moderate and 33% as severe. The mean (SD) FACIT-Fatigue score was 22.9 (12.0). The next most commonly reported symptoms were joint stiffness (57%), sleep problems (55%), joint pain/swelling (53%), and muscle pain (52%). Sixty percent of patients reported experiencing pain all or most of the time over the past seven days. A total of 30% of patients with current joint pain/swelling rated it as severe, and 24% of patients with current joint stiffness rated it as severe. The mean scores for Worst pain NRS and Worst Joint Pain NRS were both 5.8 out of 10.The LupusPRO domains indicated by respondents as the most impacted by SLE were Emotional Health, Pain/Vitality, and Lupus Medications.Conclusion:Fatigue, followed by pain and joint stiffness, were the most common patient-reported symptoms contributing to the overall SLE disease burden. Further research could highlight the efforts required to address the inadequacies in treatment and management of pain and fatigue in this patient population.Disclosure of Interests:Julie Birt Shareholder of: Eli Lilly and Company, Employee of: Eli Lilly and Company, Monica Hadi: None declared, Nashmel Sargalo: None declared, Ella Brookes: None declared, Paul Swinburn: None declared, Leslie Hanrahan: None declared, Karin Tse: None declared, Natalia Bello Vega Shareholder of: Eli Lilly and Company, Employee of: Eli Lilly and Company, Kirstin Griffing Shareholder of: Eli Lilly and Company, Employee of: Eli Lilly and Company, Maria Silk Shareholder of: Eli Lilly and Company, Employee of: Eli Lilly and Company, Laure Delbecque Shareholder of: Eli Lilly and Company, Employee of: Eli Lilly and Company, Diane L Kamen Consultant of: Consulted on SLE survey development for Lilly and consulted on SLE trial protocol development for EMD Serono in 2019

Performance and psychometric properties of lupus impact tracker in assessing patient-reported outcomes in pediatric lupus: Report from a pilot study

Lupus ◽  
2020 ◽  
Vol 29 (13) ◽  
pp. 1781-1789
Author(s):  
Suhas K Ganguli ◽  
Joyce S Hui-Yuen ◽  
Meenakshi Jolly ◽  
Jane Cerise ◽  
Barbara Anne Eberhard
Keyword(s):  
Systemic Lupus Erythematosus ◽  
Pilot Study ◽  
Disease Activity ◽  
Lupus Erythematosus ◽  
Patient Reported Outcomes ◽  
Laboratory Data ◽  
Damage Index ◽  
Systemic Lupus ◽  
Patient Reported ◽  
The Mean

Objective To evaluate the reliability, validity, feasibility and psychometric performance of the Lupus Impact Tracker (LIT) as a patient reported outcome (PRO) measure tool in pediatric systemic lupus erythematosus (pSLE). Methods This is a prospective, observational, pilot study where patients aged between 12 and 25 years, fulfilling the 1997 ACR classification criteria for SLE, were enrolled. Over 3 consecutive, routine, clinical visits, the patients completed the LIT alongside the Patient-Reported Outcomes Measurement Information System-Short Forms (PROMIS-SFs), Childhood Health Assessment Questionnaire (CHAQ). Rheumatologists completed the Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) and the Systemic Lupus International Collaborating Clinics/American College of Rheumatology (SLICC-ACR) Damage Index. Demographic, clinical and laboratory data were also collected. Results Of 46 patients enrolled, 38 patients completed 2 visits and 31 completed all 3 visits. Seventy-eight percent were female, 33% African American, 28% Asian, 15% Caucasian and 17% Hispanic. The mean (SD) age was 17.2 (2.7) years, with a mean (SD) disease duration of 4.6 (3.1) years. The mean (SD) SLEDAI-2K at enrollment was 3.54 (2.96). In the 38 patients who completed two or more visits, intra-class correlation coefficient and Cronbach alpha were calculated to be 0.70 and 0.91 respectively, signifying good reliability of LIT. The LIT showed positive correlation with CHAQ-Disability Index and majority of the PROMIS-SFs parameters. Construct validity was established against clinical disease activity (SLEDAI-2K). Conclusion The preliminary results indicate that the LIT is a reliable and valid instrument to capture PRO in p-SLE. Prospective validation with a larger, multicenter cohort is the next step.

scholarly journals Increased thrombin generation and activity in patients with systemic lupus erythematosus and anticardiolipin antibodies: evidence for a prothrombotic state [see comments]

Blood ◽  
1993 ◽  
Vol 81 (11) ◽  
pp. 2958-2963
Author(s):  
JS Ginsberg ◽  
C Demers ◽  
P Brill-Edwards ◽  
M Johnston ◽  
R Bona ◽  
...  
Keyword(s):  
Systemic Lupus Erythematosus ◽  
Lupus Erythematosus ◽  
Thrombin Generation ◽  
Anticardiolipin Antibodies ◽  
Laboratory Evaluation ◽  
Prothrombotic State ◽  
Systemic Lupus ◽  
Cross Sectional ◽  
Significant Difference ◽  
The Mean

The objective of this study is to determine whether patients with systemic lupus erythematosus (SLE) and anticardiolipin antibodies (ACA) have biochemical evidence of an ongoing prothrombotic state. Using a cross-sectional analysis of a cohort design in an outpatient SLE clinic setting, 43 consecutive patients with SLE participated. Patients underwent clinical and laboratory evaluations on two separate occasions at least 3 months apart. As part of the clinical evaluation, the following were ascertained: (1) the ongoing use of warfarin therapy; (2) the presence of prior venous and arterial thromboembolic disease by history, critical review of objective tests, and examination for reflux in the deep veins of the legs as an indicator of venous thrombosis; and (3) disease-related activity by performing a lupus activity criteria count (LACC). As part of the laboratory evaluation, blood was taken on both occasions and assayed for prothrombin fragments (F1 + 2) and fibrinopeptide A (FPA), as indices of thrombin generation and activity, respectively, and ACA. For the analyses, patients were classified as ACA+ if the assay was abnormal on both occasions and ACA- if the assay was negative on both occasions or negative on one occasion and positive on the other. ACA+ patients had: (1) a significantly higher mean level of F1 + 2 (1.07 nmol/L) than ACA- patients (0.79 nmol/L; P = .02) and patients receiving warfarin (0.47 nmol/L; P = .009) and (2) a significantly higher mean level of FPA (1.01 nmol/L) than ACA- patients (0.45 nmol/L; P = .02). When patients with prior thromboembolism were excluded from the analysis, significant differences in the mean levels of F1 + 2 and FPA between ACA+ and ACA- patients were still seen, whereas when patients with prior thromboembolism and/or active disease were excluded from the analysis, a significant difference in the mean level of FPA and a nonsignificant trend in the mean level of F1 + 2 were seen. The results of this study support the hypothesis that the presence of ACA in SLE patients is associated with an ongoing prothrombotic state.

Evaluation of a Patient-Reported Frailty Tool in Women with Systemic Lupus Erythematosus

2021 ◽  
pp. jrheum.201466
Author(s):  
Sarah B. Lieber ◽  
Musarrat Nahid ◽  
Stephen Paget ◽  
Jessica R. Berman ◽  
Medha Barbhaiya ◽  
...  
Keyword(s):  
Systemic Lupus Erythematosus ◽  
Lupus Erythematosus ◽  
Point Of Care ◽  
High Sensitivity ◽  
Patient Reported Outcome Measures ◽  
Self Report ◽  
Adult Women ◽  
Systemic Lupus ◽  
Cross Sectional ◽  
Patient Reported

Objective Frailty is associated with mortality in systemic lupus erythematosus (SLE), but how best to measure frailty is unclear. We aimed to compare two frailty metrics, the self-reported FRAIL scale (FS) and the Fried phenotype (FP), in SLE to evaluate differences between frail and nonfrail women and whether frailty is associated with self-reported disability. Methods Adult women <70 years old with validated SLE and mild/moderate disease enrolled in this cross-sectional study between August 2018 and October 2019. Correlation and agreement between the FS and the FP were determined. Differences in sociodemographic and disease characteristics, patient-reported outcome measures (PROMs), and biomarkers between frail and non-frail participants were evaluated, as well as association of frailty with Valued Life Activities disability. Results Of 67 participants, 27% and 18% were frail according to the FS and the FP, respectively. Correlation (r=0.51; p<0.0001) and agreement (k=0.4627; p=0.0004) between the FS and the FP were significant. Frail women had greater disease damage, high-sensitivity C-reactive protein, and interleukin 6 and worse PROMs according to both frailty definitions. Both frailty measures were associated with self-reported disability after adjustment for age, comorbidity, and disease activity and damage; this relationship was attenuated for the FP. Conclusion Frailty prevalence was high in this cohort of women with SLE using both frailty definitions, suggesting that frailty may be accelerated in women with SLE, particularly when based exclusively on self-report. Frailty remained associated with self-reported disability in adjusted analyses. The FS may be an informative point-of-care tool to identify frail women with SLE.

scholarly journals Readability in printed education materials for Chinese patients with systemic lupus erythematosus: a mixed-method design

BMJ Open ◽  
2020 ◽  
Vol 10 (10) ◽  
pp. e038091
Author(s):  
Qiuyi Wang ◽  
Lunfang Xie ◽  
Lei Wang ◽  
Xing Li ◽  
Liangmei Xu ◽  
...  
Keyword(s):  
Systemic Lupus Erythematosus ◽  
Health Literacy ◽  
Lupus Erythematosus ◽  
Information Source ◽  
Chinese Patients ◽  
Plain Language ◽  
Systemic Lupus ◽  
Cross Sectional Survey ◽  
Cross Sectional ◽  
The Mean

ObjectivesTo assess the readability of printed education materials (PEMs) for patients with systemic lupus erythematosus (SLE) and to explore the perceptions of patients with SLE with different health literacy regarding the readability of PEMs.DesignA mixed-methods study, including a cross-sectional survey and semistructured interviews.SettingThe SLE PEMs were collected from 13 hospitals in China. The interviews were conducted in the Department of Rheumatology of a hospital in Hefei, China.ParticipantsIn the cross-sectional survey, convenience sampling was used to select the Chinese SLE PEMs, with 20 PEMs included. In the qualitative study, the patients with SLE were divided into two groups based on their health literacy. Then, purposive sampling was used to select participants in each group, with 18 patients recruited.Outcome measuresThe readability of PEMs was assessed by the language analysis technology and the Chinese version of the Suitability Assessment of Materials (SAM-C) instrument.ResultsFor text factors of readability, the mean Chinese language difficulty coefficient was 67.09±8.03, which indicates that the text of PEMs was difficult to read. For non-text factors, the mean SAM-C score was 45.62±9.51. Eight PEMs were rated not suitable, 12 were adequate and none were superior. In the interviews, eight categories were identified: information source, content, actionability, plain language, pictures, tables, numbers and layout. Patients with different health literacy had discrepant views on the detail of basic information, the necessity of question list, the location of functional pictures and the application of mathematical symbols.ConclusionsThe readability of Chinese SLE PEMs does not perform well, and it is necessary to reduce the difficulty of words, shorten the length of sentences and improve the picture design and actionability. To develop PEMs tailored to patients’ level of health literacy, patients’ unique view of readability should be integrated into the design of PEMs.

The Minimally Important Difference for Patient Reported Outcomes in Systemic Lupus Erythematosus Including the HAQ-DI, Pain, Fatigue, and SF-36

2009 ◽  
Vol 36 (10) ◽  
pp. 2231-2237 ◽  
Author(s):  
KIM J. COLANGELO ◽  
JANET E. POPE ◽  
CHRISTINE PESCHKEN
Keyword(s):  
Systemic Lupus Erythematosus ◽  
Health Status ◽  
Lupus Erythematosus ◽  
Minimally Important Difference ◽  
Systemic Lupus ◽  
Component Score ◽  
Sf 36 ◽  
Patient Reported ◽  
The Mean ◽  
Overall Health Status

Objective.We studied patients with systemic lupus erythematosus (SLE) in 1 clinical practice, and patients enrolled in the 1000 Canadian Faces of Lupus database, to determine the minimally important difference (MID) for pain, fatigue, sleep, Health Assessment Questionnaire-Disability Index (HAQ-DI), and Medical Outcomes Study Short Form-36 (SF-36) Physical Component Score (PCS) and SF-36 Mental Component Score (MCS) using a patient-reported overall health status anchor.Methods.Patients with SLE who had 2 consecutive clinic visits and completed a HAQ-DI and a pain, fatigue, and sleep visual analog scale (VAS) (0–100), and an overall health status question: “How would you describe your overall status since your last visit?”: much better, better, the same, worse, or much worse were included. Those who self-rated as better or worse were considered the “minimally changed” subgroups. Patients with 2 consecutive annual visits in the 1000 Canadian Faces of Lupus database who completed the SF-36 and health transition question were eligible.Results.There were 202 patients in London, Ontario (94% women, mean age 50 yrs, mean disease duration 10 yrs). MID for better and worse on a VAS (0–100) were: pain (−15.8, 8.5), fatigue (−13.9, 9.1), and sleep problems (−8.6, 7.6). The MID for HAQ-DI (scale 0 to 3) was −0.08 (better) and 0.14 (worse). The MID for SF-36 was 2.1 (better) and −2.2 (worse) for the PCS and 2.4 (better) and −1.2 (worse) in the MCS.Conclusion.The MID in patients with SLE may be different bidirectionally depending on the measured outcome. The mean change observed for those reporting better than worse outcome in pain and fatigue was greater for better versus worst, in contrast to the HAQ, where the mean change was greater for worsening.

scholarly journals THU0257 ESTIMATED 10-YEARS CARDIOVASCULAR RISK IN SYSTEMIC LUPUS ERYTHEMATOSUS PATIENTS: PRELIMINARY RESULTS FROM THE “CARDIOVASCULAR OBESITY AND RHEUMATIC DISEASE (CORDIS)” STUDY GROUP OF THE ITALIAN SOCIETY OF RHEUMATOLOGY.

2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 355.2-356
Author(s):  
F. Cacciapaglia ◽  
A. Manfredi ◽  
G. Erre ◽  
E. Bartoloni Bocci ◽  
G. Sakellariou ◽  
...  
Keyword(s):  
Systemic Lupus Erythematosus ◽  
High Risk ◽  
Lupus Erythematosus ◽  
Laboratory Data ◽  
Cross Sectional Study ◽  
Systemic Lupus ◽  
Cross Sectional ◽  
Female Age ◽  
The Mean ◽  
First Time

Background:Systemic lupus erythematosus (SLE) patients are at high risk for CV events, and EULAR recommends assessing the 10-year CV-risk using the Systematic Coronary Risk Evaluation (SCORE) [1]. The QRISK3, another score to assess CV-risk in UK population, considers different factors among which also SLE. The Progetto Cuore score (PCS) is validated to estimate CV risk in Italian people and largely replicates the SCORE project [2].Objectives:This cross-sectional study aimed to estimate CV-risk using SCORE, QRISK3 and, for the first time, PCS in a multicentric cohort of Italian SLE patients.Methods:During 2019 we evaluated 173 SLE patients (87.7% female; age 40±16 years; disease duration 138±105 months), fulfilling the 1997 ACR classification criteria. Clinical and laboratory data were registered, and individual CV-risk was calculated using suitable algorithms for the SCORE, QRISK3 and PCS. Statistical analysis was performed using Graphpad Instat 8.0 (San Diego, CA-USA).Results:In 13 (7%) SLE patients a previous CV event was recorded. Hypertension was present in 60 (37.5%) and diabetes in 27 (16.9%) patients. Mean total cholesterol was 184±39 mg/dL, HDLc 58±18 mg/dL, LDLc 124±37 mg/dL, triglycerides 105±63 mg/dL; dyslipidaemia was reported in 58 (36.2%) patients and 29 (18.1%) were on statin. Mean BMI was 24.9±5.3 Kg/sm, 60 (37.5%) and 23 (14.3%) patients were overweight and obese, while 25 (15.6%) patients were smokers. 87 (54.3%) SLE patients had a SLEDAI<4, 91% of patients were taken HCQ and 65% were on prednisone (mean dose 5.4±5.9 mg/day), but only 7.5% took >7.5 mg/day. The CV-risk of SLE patients according to SCORE, QRISK3 and PCS was 1.1±2.1%, 10.5±12.3% and 3.7±5.4%, respectively. Stratifying patients at low, moderate or high CV risk according to the PCS and SCORE a double proportion of patients was at moderate (8% vs 3.9%) or high (1.9% vs 0.9%) CV risk (p=0.03). Finally, CV-risk according to QRISK3 was higher than 20% (high risk) in 32/160 (20%) patients.Conclusion:This multicentre study demonstrated that the mean estimated CV-risk in SLE patients is globally low using the SCORE, QRISK3 and PCS. The PCS seems to better intercept those patients at moderate/high risk, at least in Italian SLE patients, while QRISK3 predicts the highest CV risk. The lack of disease-specific CV-risk factors (such as autoantibodies profile or organ involvement) probably account for the underestimation of CV risk using the SCORE and PCS.References:[1]ARD 2019;78(6):736-745.[2]ARD 2019;0:1–2.doi:10.1136/annrheumdis-2019-215715Disclosure of Interests:Fabio Cacciapaglia Speakers bureau: BMS; Roche; Pfizer; Abbvie, Andreina Manfredi: None declared, Gianluca Erre: None declared, Elena Bartoloni Bocci: None declared, Garifallia Sakellariou Speakers bureau: Abbvie, Novartis, MSD, Ombretta Viapiana: None declared, Sergio Colella: None declared, Anna Abbruzzese: None declared, Marco Fornaro: None declared, Giacomo Cafaro: None declared, Maria Antonietta Fenu: None declared, Bianca Lucia Palermo: None declared, Martina Dessì: None declared, Adalgisa Palermo: None declared, Alessandro Giollo: None declared, Elisa Gremese Consultant of: AbbVie, Bristol-Myers Squibb, Celgene, Eli Lilly, Janssen, Merck Sharp & Dohme, Novartis, Sanofi, UCB, Roche, Pfizer, Speakers bureau: AbbVie, Bristol-Myers Squibb, Celgene, Eli Lilly, Janssen, Merck Sharp & Dohme, Novartis, Sanofi, UCB, Roche, Pfizer, Francesca Romana Spinelli Grant/research support from: Pfizer, Speakers bureau: Lilly, BMS, Celgene, Fabiola Atzeni: None declared, Matteo Piga: None declared

scholarly journals Increased thrombin generation and activity in patients with systemic lupus erythematosus and anticardiolipin antibodies: evidence for a prothrombotic state [see comments]

Blood ◽  
1993 ◽  
Vol 81 (11) ◽  
pp. 2958-2963 ◽  
Author(s):  
JS Ginsberg ◽  
C Demers ◽  
P Brill-Edwards ◽  
M Johnston ◽  
R Bona ◽  
...  
Keyword(s):  
Systemic Lupus Erythematosus ◽  
Lupus Erythematosus ◽  
Thrombin Generation ◽  
Anticardiolipin Antibodies ◽  
Laboratory Evaluation ◽  
Prothrombotic State ◽  
Systemic Lupus ◽  
Cross Sectional ◽  
Significant Difference ◽  
The Mean

Abstract The objective of this study is to determine whether patients with systemic lupus erythematosus (SLE) and anticardiolipin antibodies (ACA) have biochemical evidence of an ongoing prothrombotic state. Using a cross-sectional analysis of a cohort design in an outpatient SLE clinic setting, 43 consecutive patients with SLE participated. Patients underwent clinical and laboratory evaluations on two separate occasions at least 3 months apart. As part of the clinical evaluation, the following were ascertained: (1) the ongoing use of warfarin therapy; (2) the presence of prior venous and arterial thromboembolic disease by history, critical review of objective tests, and examination for reflux in the deep veins of the legs as an indicator of venous thrombosis; and (3) disease-related activity by performing a lupus activity criteria count (LACC). As part of the laboratory evaluation, blood was taken on both occasions and assayed for prothrombin fragments (F1 + 2) and fibrinopeptide A (FPA), as indices of thrombin generation and activity, respectively, and ACA. For the analyses, patients were classified as ACA+ if the assay was abnormal on both occasions and ACA- if the assay was negative on both occasions or negative on one occasion and positive on the other. ACA+ patients had: (1) a significantly higher mean level of F1 + 2 (1.07 nmol/L) than ACA- patients (0.79 nmol/L; P = .02) and patients receiving warfarin (0.47 nmol/L; P = .009) and (2) a significantly higher mean level of FPA (1.01 nmol/L) than ACA- patients (0.45 nmol/L; P = .02). When patients with prior thromboembolism were excluded from the analysis, significant differences in the mean levels of F1 + 2 and FPA between ACA+ and ACA- patients were still seen, whereas when patients with prior thromboembolism and/or active disease were excluded from the analysis, a significant difference in the mean level of FPA and a nonsignificant trend in the mean level of F1 + 2 were seen. The results of this study support the hypothesis that the presence of ACA in SLE patients is associated with an ongoing prothrombotic state.

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