scholarly journals P193 Validation of the two-item UC patient-reported outcome (PRO2) against the simple clinical colitis activity index (SCCAI), measures of biochemical disease activity and quality of life

2020 ◽  
Vol 14 (Supplement_1) ◽  
pp. S234-S235
Author(s):  
M Samaan ◽  
G Cunningham ◽  
G Tamilarasan ◽  
S Ray ◽  
J Mawdsley ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Disease Activity ◽  
Induction Therapy ◽  
Activity Index ◽  
External Validation ◽  
Clinical Disease ◽  
Predictive Values ◽  
Clinical Disease Activity ◽  
Patient Reported

Abstract Background Patient-reported outcomes (PRO) have an increasingly important role in IBD. This is true of monitoring of disease activity in clinical practice and as well as the evaluation of new therapies, when used as clinical trial endpoints. An interim two-item PRO (PRO2) has been developed for UC that ranges from 0–6 and consist of the patient-derived items from the Mayo score (rectal bleeding and stool frequency). PRO2 was internally validated against endoscopic outcomes. We aimed to add external validation across a range of clinical, biochemical and quality of life outcomes. Methods Data were collected as part of the GO-LEVEL study, an open-label, phase IV, investigator-initiated study (NCT03124121) which included a prospective cohort of UC patients commencing golimumab induction therapy, as well as a cross-sectional cohort receiving maintenance treatment. Patients commencing induction therapy all had disease activity objectively confirmed and were evaluated at weeks 6, 10 and 14. Patients receiving maintenance therapy were recruited either at the point of flare or during stable remission. Clinical disease activity was evaluated using PRO2 and SCCAI, quality of life using IBD-Control as well as a 100mm visual analogue scale (IBD-Control-VAS), and biochemical activity using FC and CRP. Clinical remission was defined as a score of <3 using SCCAI, or 0 using PRO2. Correlations were calculated using Spearman’s correlation coefficient (rs) and contingency table analyses using Chi-square. Results GO-LEVEL included a total of 112 patients across the two study cohorts. A total of 217 PRO2 assessments were made with concurrent SCCAI and IBD-Control scores available at all timepoints. CRP measurements were available at 214 of these and FC at 207. Strong correlations were observed between PRO2 and SCCAI (rs = 0.94, p < 0.0001), as well as with IBD-Control (rs=−0.82, p < 0.0001) and IBD-Control-VAS (rs = −0.78, p < 0.0001). Significant correlations were also seen between PRO2 and FC (rs = 0.38, p < 0.0001) as well as PRO2 and CRP (rs=0.31, p < 0.0001). Of the 217 assessments, 109 were in SCCAI defined remission, 95 were in PRO2 defined remission and the two were highly contingent (p < 0.0001). The sensitivity and specificity of disease activity assessments made with PRO2 vs. SCCAI were 0.85 and 0.98, respectively. The positive and negative predictive values were 0.98 and 0.87, respectively. Conclusion The PRO2 performs well when validated against an established clinical disease activity index (SCCAI), quality-of-life assessments and biochemical markers of disease activity. PRO2 assessments have the benefit of being more rapid to administer (comprising of only two items) than SCCAI (6 items), whilst providing similar and accurate evaluations of remission status.

scholarly journals P454 Treatment with biologics improves disability from Inflammatory Bowel Disease in therapy responders

2021 ◽  
Vol 15 (Supplement_1) ◽  
pp. S448-S450
Author(s):  
G Castillo ◽  
K Sultan ◽  
J Kwah ◽  
L A Chen ◽  
J Axelrad
Keyword(s):  
Quality Of Life ◽  
Disease Activity ◽  
Activity Index ◽  
Illness Perception ◽  
Therapy Response ◽  
Quantitative Measure ◽  
Clinical Disease ◽  
Cross Sectional ◽  
Clinical Disease Activity

Abstract Background The IBD-Disability Index (IBD-DI) is a quantitative measure of disease impact on physical activity and social participation, with higher sores indicating greater disability. Prior studies have been cross-sectional, but few studies have longitudinally measured disability with IBD treatment. Methods Patients with Crohn’s disease (CD) and ulcerative colitis (UC) starting a new biologic or small molecule therapy were surveyed using the IBD-DI at induction, and 2- and 6-months. Surveys also included the Harvey Bradshaw Index (HBI), Simple Clinical Colitis Activity Index (SCCAI), partial Mayo score (pMayo), depression index (PHQ-9), quality of life index [Short IBD Questionnaire (SIBDQ)], and illness perception scale [Brief Illness Perception Questionnaire (BIPQ)]. Clinical data included endoscopic scores, biomarkers (ESR, CRP, calprotectin), comorbidities, and IBD history. Therapy response was defined as a reduction in HBI, pMayo, SCCAI ≥3 or total HBI ≤ 4, pMayo < 2, SCCAI ≤2 at survey 3. Results 111 patients (65 males and 46 females) completed survey 1, 79 completed survey 2, and 63 completed survey 3. There were no significant differences in baseline demographic, disease activity, or psychosocial scores between participants who completed only survey 1, and those who completed all 3 surveys. The median age was 31 years, 58% had CD, 42% had UC, and 32% were non-white (Table 1). At induction, the median IBD-DI score was 34.0 out of 100. IBD-DI scores did not correlate with age, race, sex, comorbidities, IBD-type, or surgery, but there was a weak correlation with prior biologic use, specifically anti-TNF therapy (Table 1). There was a moderate correlation between clinical disease activity scales and the IBD-DI [HBI, pMayo, and SCCAI (r=0.63, r= 0.56, r=0.55; p <0.001)] (Table 2). Endoscopic scores and biomarkers did not correlate with the IBD-DI. Psychosocial scales correlated strongly with the IBD-DI: SIBDQ, PHQ-9, and the wellbeing and emotional domains of the BIPQ (r=-0.83, r=0.78, r= 0.60, p <0.0001, respectively). Among therapy responders, there was a significant improvement in IBD-DI scores from survey 1 to 3 [median 32 (IQR, 20–43) to 24 (IQR, 14–38), p =0.04] (Table 3). This difference was not observed in treatment non-responders. Conclusion Disability is not commonly measured in clinical studies, but it plays a large role in patients’ overall wellbeing. In this longitudinal cohort, there was a strong correlation between IBD-DI, clinical disease activity, depression, and quality of life indices. Among therapy responders, there was a significant improvement in IBD-DI from a moderate to mild degree of disability. These findings further clarify the relationship between disability, disease activity, and therapeutic response in IBD.

scholarly journals P550 Short term effects of a combined lifestyle intervention in patients with Inflammatory Bowel Disease

2021 ◽  
Vol 15 (Supplement_1) ◽  
pp. S518-S518
Author(s):  
C R Lamers ◽  
N M de Roos ◽  
H H Heerink ◽  
L A van de Worp - Kalter ◽  
B J M Witteman
Keyword(s):  
Quality Of Life ◽  
Physical Activity ◽  
Disease Activity ◽  
Lifestyle Intervention ◽  
Daily Life ◽  
Clinical Disease ◽  
Clinical Disease Activity ◽  
Diet And Physical Activity ◽  
Inflammatory Bowel

Abstract Background Diet and physical activity might help to improve quality of life and maintain remission in patients with inflammatory bowel disease (IBD). In other conditions, interventions in which diet and physical activity are combined seem to be more effective than separate interventions. Therefore, we assessed the effect of a combined lifestyle intervention on the impact of disease on daily life, clinical disease activity, fatigue and quality of life in patients with Crohn’s disease (CD) or ulcerative colitis (UC). Methods A single arm intervention study was performed in IBD patients in remission or with mildly active disease. Participants received personal advice to improve their diet and level of physical activity by a dietician and a physiotherapist in one face-to-face and one telephone consult. These advices were supported by guidelines based on the Dutch dietary and physical activity guidelines, a recipe app and a booklet with physical activity exercises. IBD disability index (IBD-DI) to assess impact of disease on daily life, clinical disease activity questionnaires (P-HBI or P-SCCAI), IBD fatigue (IBD-F) patient self-assessment scale and IBD quality of life questionnaire (IBDQ) were completed. The Eetscore Food Frequency Questionnaire (Eetscore FFQ) and Short Questionnaire to Assess Health-enhancing physical activity (SQUASH) were used to assess diet and physical activity. Changes from baseline to 5 weeks after start were investigated by paired samples t-tests or Wilcoxon signed rank tests. Results We included 29 participants. At time of this preliminary analysis, 25 participants completed baseline and 5-week assessments (11 males, 11 CD, median age 36 years [IQR 29–53], median BMI 25 kg/m2 [IQR 24–28]). After 5 weeks, diet quality had significantly improved (p<0.001), but level of physical activity had not (p=0.509). Impact of disease on daily life (IBD-DI) decreased with 2.5 points (95%CI -5.5-0.4; p=0.09). Disease activity did not change significantly. There was a significant decrease in fatigue (median IBD-F 20 [IQR 8–29] to 15 [IQR 3–24; p=0.03]) and a significant increase in quality of life (median IBDQ 194 [IQR 179–206] to 196 [IQR 186–209; p=0.03]). Conclusion These preliminary results suggest that a combined lifestyle intervention is effective to reduce fatigue and to increase quality of life in patients with IBD, at least in the short term. Impact of disease on daily life and clinical disease activity did not improve significantly. Participants reported their level of physical activity to be restricted due to COVID-19 measures, which could explain the lack of effect on this outcome. This study is still ongoing and we expect follow-up data up till 1 year after start.

Patient adherence with a smartphone app for patient-reported outcomes in rheumatoid arthritis

Rheumatology ◽  
2020 ◽  
Vol 60 (1) ◽  
pp. 108-112 ◽  
Author(s):  
Josh Colls ◽  
Yvonne C Lee ◽  
Chang Xu ◽  
Cassandra Corrigan ◽  
Fengxin Lu ◽  
...  
Keyword(s):  
Disease Activity ◽  
Patient Reported Outcomes ◽  
Patient Adherence ◽  
Activity Index ◽  
Disease Activity Index ◽  
Clinical Disease Activity Index ◽  
Clinical Disease ◽  
Clinical Disease Activity ◽  
Patient Reported ◽  
To Receive

Abstract Objectives Electronic patient-reported outcomes (ePROs) transmitted digitally allow patients to communicate with their clinicians and track the activity of chronic diseases, such as RA. Several ePRO smartphone apps have been developed in rheumatology, yet few data have been reported regarding patient adherence. We developed a PRO app for RA and assessed adherence over 6 months. Methods We developed an app to deliver daily assessments to participants (RA App v.1.0). The app was tested as part of a randomized controlled trial examining potential clinical benefits. The current analyses focus on the adherence to the ePRO app for patients randomized to receive the app. We recruited RA patients from an academic rheumatology practice in the USA. Patients randomized to receive the app received daily notifications regarding ePROs. We examined adherence to the PRO questionnaires over the 6-month study and examined factors related to adherence. Results Seventy-eight patients received the app and have data included in these analyses: 63 (80.7%) were female, mean age was 55.2 years, 71% had attended college or beyond, and the mean Clinical Disease Activity Index at baseline was 9.7 (low disease activity). Median adherence to the daily questions was 79% (interquartile range 48–90%). Significant predictors of increased adherence were age ≥65 (P = 0.03) and low baseline Clinical Disease Activity Index (P = 0.02). Conclusion We developed and tested an ePRO app for RA over a 6-month study. Adherence to the app was strong. There was correlation between older age and better disease control and increased adherence. Trial registration ClinicalTrials.gov, https://clinicaltrials.gov/, NCT02822521.

scholarly journals Switching from originator infliximab to the biosimilar CT-P13 in 313 patients with inflammatory bowel disease

2018 ◽  
Vol 11 ◽  
pp. 175628481880124 ◽  
Author(s):  
Viktoria Bergqvist ◽  
Mohammad Kadivar ◽  
Daniel Molin ◽  
Leif Angelison ◽  
Per Hammarlund ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Inflammatory Bowel Disease ◽  
Adverse Events ◽  
Disease Activity ◽  
Bowel Disease ◽  
Clinical Disease ◽  
Clinical Disease Activity ◽  
Inflammatory Bowel ◽  
Trough Levels

Background: As the patents of originator biologics are expiring, biosimilar versions are becoming available for the treatment of inflammatory bowel disease (IBD). However, published switch studies of the first infliximab biosimilar, CT-P13, have delivered ambiguous results that could be interpreted as showing a trend towards inferior effectiveness in Crohn’s disease (CD) compared with ulcerative colitis (UC). The aim of this study was to investigate the effectiveness and safety of switching IBD patients from treatment with Remicade to CT-P13. Methods: In this prospective observational cohort study, all adult IBD patients on Remicade treatment, at four hospitals, were switched to CT-P13. The primary endpoint was change in clinical disease activity at 2, 6, and 12 months after the switch. Secondary endpoints were subgroup analyses of patients with and without concomitant immunomodulators; changes in biomarkers, quality of life, drug trough levels and anti-drug antibodies (ADAbs); and adverse events. Results: A total of 313 IBD patients were switched (195 CD; 118 UC). There were no significant changes in clinical disease activity, quality of life, biomarkers (except a small but significant increase in albumin in CD) including F-calprotectin, drug trough levels, or proportion of patients in remission. Disease worsening rates were 14.0% for CD and 13.8% for UC; and 2.7% developed ADAbs and 2.2% developed serious adverse events. Conclusions: This is the largest study of switched IBD patients published to date, and it demonstrates that switching from Remicade to CT-P13 may be done with preserved therapeutic effectiveness and safety in both CD and UC.

scholarly journals Disease Characteristics, Quality of Life, and Work Productivity by Enthesitis Site: Real- World Data From the US Corrona Psoriatic Arthritis/Spondyloarthritis Registry

2020 ◽  
pp. jrheum.191117
Author(s):  
Philip J. Mease ◽  
Mei Liu ◽  
Sabrina Rebello ◽  
Winnie Hua ◽  
Robert R. McLean ◽  
...  
Keyword(s):  
Psoriatic Arthritis ◽  
Disease Activity ◽  
Activity Index ◽  
Work Productivity ◽  
Disease Activity Index ◽  
Clinical Disease Activity Index ◽  
Clinical Disease ◽  
Work Impairment ◽  
Clinical Disease Activity ◽  
Patient Reported

Objective To assess the impact of clinical enthesitis by body site in patients with psoriatic arthritis (PsA). Methods Adults with PsA enrolled in the Corrona Psoriatic Arthritis/Spondyloarthritis Registry (March 2013–March 2018) were included. Enthesitis at enrollment was assessed via the Spondyloarthritis Research Consortium of Canada Enthesitis Index and classified by affected sites (upper, lower, or both). Disease activity (eg, Clinical Disease Activity Index, clinical Disease Activity Index for PsA), patient-reported outcomes (PROs; eg, patient-reported pain and fatigue), and work productivity were compared between those with and without enthesitis using t or Wilcoxon rank-sum tests for continuous variables and χ2 or Fisher exact tests for categorical variables. The association of enthesitis with disease activity and PRO measures vs no enthesitis was modeled using multivariable-adjusted linear or logistic regression. Results Of 2003 patients with PsA, 391 (19.5%) had enthesitis: 80 (20.5%) in upper sites only, 137 (35.0%) in lower sites only, and 174 (44.5%) in both. Regardless of location, disease activity and PROs were worse in patients with vs without enthesitis. In adjusted models, presence of enthesitis at any site was significantly associated with worse disease activity vs no enthesitis. Enthesitis in lower or both upper and lower sites was associated with higher pain and fatigue scores and greater work impairment vs no enthesitis. Conclusion Patients with clinical enthesitis had worse disease activity regardless of enthesitis location vs those without enthesitis, and patients with enthesitis in lower or both upper and lower sites had worse pain, fatigue, and work impairment.

scholarly journals A Comparison of the Correlation of Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) and Systemic Lupus Erythematosus Disease Activity Score (SLE-DAS) with Health-Related Quality of Life

2021 ◽  
Vol 10 (10) ◽  
pp. 2137
Author(s):  
Ning-Sheng Lai ◽  
Ming-Chi Lu ◽  
Hsiu-Hua Chang ◽  
Hui-Chin Lo ◽  
Chia-Wen Hsu ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Systemic Lupus Erythematosus ◽  
Disease Activity ◽  
Lupus Erythematosus ◽  
Activity Index ◽  
Disease Activity Index ◽  
Information Criterion ◽  
Systemic Lupus Erythematosus Disease ◽  
Systemic Lupus

Background and Aim: The aim of this study was to compare the correlation of a recently developed systemic lupus erythematosus disease activity score (SLE-DAS) with the SLE disease activity index 2000 (SLEDAI-2K) with the Lupus Quality of Life questionnaire (LupusQoL) in Taiwanese patients with SLE. Methods: A cross-sectional study was conducted in a regional teaching hospital in Taiwan from April to August 2019. Adult patients with a clinician-confirmed diagnosis of SLE based on the 1997 American College of Rheumatology revised criteria or the 2012 Systemic Lupus International Collaborating Clinics Classification Criteria were recruited. SLE disease activity was measured with both SLEDAI-2K and SLE-DAS. Disease-specific quality of life was assessed using the LupusQoL. Results: Of the 333 patients with SLE in this study, 90.4% were female and 40% were between the ages of 20 and 39 years. The median SLEDAI-2K score was 4.00 (interquartile range [IQR] 2.00–7.50) and the median SLE-DAS score was 2.08 (IQR 1.12–8.24) in our patients with SLE. After adjusting for sex and age intervals, both SLEDAI-2k and SLE-DAS were significantly and inversely associated with all eight domains of LupusQoL. The magnitudes of the mean absolute error, root mean square error, Akaike Information Criterion, Bayesian Information Criterion, and coefficient of determination were comparable between SLEDAI-2K and SLE-DAS. Conclusions: There were no clear differences in the use of SLE-DAS over SLEDAI-2K in assessing HRQoL in patients with SLE. We suggest that, in this aspect, both SLEDAI-2K and SLE-DAS are effective tools for measuring disease activity in patients with SLE.

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