scholarly journals P269 Real-world impact of biological therapies on work impairment and quality of life in Inflammatory Bowel Disease patients

2021 ◽  
Vol 15 (Supplement_1) ◽  
pp. S303-S304
Author(s):  
P Thomas ◽  
N Den Broeder ◽  
R West ◽  
M Russel ◽  
J Jansen ◽  
...  
Keyword(s):  
Disease Activity ◽  
Biological Therapy ◽  
Work Productivity ◽  
Clinical Disease ◽  
Total Work ◽  
Activity Impairment ◽  
Work Impairment ◽  
Clinical Disease Activity ◽  
Inflammatory Bowel

Abstract Background Randomised controlled trials have reported improvement of work productivity and activity impairment (WPAI) as well as quality of life in biological-treated inflammatory bowel disease (IBD) patients. However, data beyond clinical trials are limited. Methods This multicentre prospective cohort study evaluated the effect of initiating biological or small molecule therapy on work impairment in IBD patients. Subjects completed the WPAI questionnaire and Short IBD questionnaire (SIBDQ) at biological therapy initiation and at week 26. Clinical disease activity was assessed using the Harvey Bradshaw Index and Simple Clinical Colitis Activity Index. Biochemical disease activity was assessed using C-reactive protein and faecal calprotectin. Data are presented as mean ± standard deviation. Results In total, 156 IBD patients were included for analysis (median age 40 years, 55% male, 55% Crohn’s disease). Of these patients, 28% started infliximab, 33% adalimumab, 19% vedolizumab, 18% ustekinumab, 1% tofacitinib and 1% golimumab. Concomitant medication use at baseline included 28% prednisone, 12% budesonide, 34% mesalamine, and 46% immunomodulator. At baseline, 58% had clinical disease activity and 58% had biochemical disease activity. In our cohort, 111 (71%) were employed and 17 (11%) patients reported partial or full occupational disability. The mean total work impairment at baseline was 52% ± 36%. During follow-up, 7 patients lost their job and 8 patients started employment. For the entire cohort, improvements in all WPAI domains were observed: mean 11%-points decrease in missed working hours, 4%-points decrease in impairment while working, 15%-points decrease in total work impairment and 15%-points decrease in total activity impairment. Parallel improvements were seen in SIBDQ scores (mean improvement 7.6 ± 11.3). At week 26, 66 (42%) patients achieved the minimal clinical important difference in total work impairment (improvement ≥7%-points). Patients with clinical disease activity at baseline and clinical response to the biological (n=32) showed a larger improvement in total work impairment compared with other subjects (n=86) (mean difference 29%-points versus 10%-points; p=0.036 (T-test)). Similarly, these patients showed greater improvement in SIBDQ scores compared to other subjects (mean 13.8 versus 5.4, respectively; p<0.001 (T-test)). Conclusion IBD patients experienced substantial work impairment prior to initiating biological treatment. Improved work impairment scores were seen after initiation of biological therapy and patients with clinical response showed even greater improvements. These results underline the importance of IBD disease control to improve work productivity and participation.

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.

scholarly journals P365 Correlation between patient-reported outcomes (PROs) and patient-reported disease activity in Ulcerative Colitis (UC): Findings from the ICONIC study

2021 ◽  
Vol 15 (Supplement_1) ◽  
pp. S382-S383
Author(s):  
S Ghosh ◽  
F Casellas ◽  
K Kligys PhD ◽  
Y Sanchez Gonzalez ◽  
L Peyrin-Biroulet
Keyword(s):  
Inflammatory Bowel Disease ◽  
Disease Activity ◽  
Bowel Disease ◽  
Patient Reported Outcomes ◽  
Work Productivity ◽  
Total Activity ◽  
Total Work ◽  
Activity Impairment ◽  
Patient Reported ◽  
Inflammatory Bowel

Abstract Background This analysis aimed to examine the correlation of patient-reported outcomes (PROs) with patient-reported disease activity, and to identify individual questions of the Patient Simple Clinical Colitis Activity Index (P-SCCAI) associated with Work Productivity and Activity Impairment (WPAI) questionnaire domains in patients from the ICONIC study.1 Methods ICONIC enrolled unselected outpatients (N=1804) with recent-onset UC.1 Correlations between PRO measures (Rating Form of Inflammatory Bowel Disease Patient Concerns [RFIPC], Patient Health Questionnaire-9 [PHQ-9], and Short Inflammatory Bowel Disease Questionnaire [SIBDQ]) at baseline (visit [V]1) and 2 years (V5) were assessed using Spearman’s rank correlation coefficient. WPAI domains and PHQ-9 were evaluated at V1 and V5 using a multivariable logistic regression model with individual P-SCCAI questions. Results Significantly higher work productivity impairment scores, lower reported quality of life (QoL), and higher worries/concerns at V1 and V5 were observed in patients with active disease (P-SCCAI ≥5) vs inactive disease (P-SCCAI <5) (Figures 1 and 2). A strong correlation (0.70–0.89) was found between the SIBDQ and the P-SCCAI and PHQ-9 (Table 1). WPAI presenteeism, total activity impairment and total work productivity impairment were moderately correlated (0.40–0.69) with P-SCCAI and PHQ-9 (Table 1). At V1, a significant positive association of disease severity and nocturnal bowel urgency was observed with WPAI presenteeism, absenteeism, and total activity impairment. At V1 and V5, lower patient-assessed PHQ-9 scores were significantly associated with female gender, no bowel urgency, and no joint pain. Conclusion These observational data in patients with UC suggest strong correlations between some PRO measures and patient-reported disease activity. Nocturnal bowel urgency was a key driver of total work productivity impairment, suggesting it is an important PRO to monitor when assessing overall patient QoL. Reference

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 P426 Health-Related Quality of Life and Work Productivity in patients with moderate-to-severe Inflammatory Bowel Disease in Argentina: Data from the RISE AR study

2021 ◽  
Vol 15 (Supplement_1) ◽  
pp. S430-S431
Author(s):  
G J Correa ◽  
M Yantorno ◽  
P Olivera Sendra ◽  
J S Lasa ◽  
P Lubrano ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Inflammatory Bowel Disease ◽  
Disease Activity ◽  
Work Productivity ◽  
Health Related Quality ◽  
Activity Impairment ◽  
Related Quality ◽  
Health Related ◽  
Inflammatory Bowel

Abstract Background Patient-reported outcomes (PROs) are increasingly recognized as complementary to objective markers of disease activity, yet evidence on PROs in inflammatory bowel disease (IBD) in the real-world setting in Latin America is limited. Herein, we describe health-related quality of life (HRQoL) and work productivity and activity impairment (WPAI) of IBD patients (pts) in Argentina. Methods RISE-AR (NCT03488030) was a non-interventional study with a cross-sectional evaluation and a 3-year retrospective chart review conducted in 7 centres in Argentina (12/2018-05/2019) to assess healthcare resource utilisation, HRQoL and WPAI. Adult pts (≥18 yr old) with a previous diagnosis of moderate-to-severe (Mod/Sev) ulcerative colitis (UC) or Crohn′s disease (CD) based on clinical, endoscopic or imaging criteria ≥6 months prior to enrolment, were included. HRQoL (IBD Questionnaire [IBDQ], 5-dimensional EuroQoL measure [EQ5D]) and WPAI instruments were administered at screening. Disease activity at enrolment was classified as Mod/Sev (Harvey Bradshaw Index ≥8 or partial Mayo Score ≥5) vs. “no-or-mild” (No/Mild). A p-value ≤0.05 was considered statistically significant (Mann-Whitney U test). Results Overall, 246 pts were included (41.1% CD; 58.9% UC). At enrolment, median (range) age (years) was 39.5 (18.2-74.0) for CD (51.2% female) and 41.9 (18.0-80.4) for UC (55.2% female) pts; 20 pts (9.3% CD; 7.7% UC; excluding 4 ostomized pts) had Mod/Sev disease activity. During the previous 3 years, 17.8% (CD) and 1.4% (UC) of pts required ≥1 surgery, and 33.7% (CD) and 21.4% (UC) were hospitalized. No/Mild pts showed significantly higher overall HRQoL scores (mean±SD) vs. Mod/Sev pts in CD (IBDQ: 178.1±35.4 vs. 140.0±43.5, p<0.05; EQ5D [visual analogue scale]: 75.7±1.8 vs. 64.4±5.5, p<0.05) and UC (180.2±32.9 vs. 132.9±43.8, p<0.001; 77.1±1.3 vs. 57.7±5.3, p<0.001), respectively. Activity impairment was reported by 55.4% and 58.6% of CD and UC pts, respectively, while 37.9% and 43.9% of CD and UC employed pts (67 CD, 92 UC; Mod/Sev: 5 CD, 6 UC) reported work impairment. Mod/Sev IBD pts had higher absenteeism (30.8% vs. 6.3%, p<0.05) and presenteeism (20.0% vs. 7.5%, p=0.149) vs. No/Mild pts. Female gender, surgeries and hospitalizations were associated with lower QoL in the overall IBD population. Conclusion This is the first study to evaluate QoL and WPAI in IBD pts in Argentina. Pts with Mod/Sev activity showed impaired QoL and WPAI compared to No/Mild pts. Whilst, less than 10% of IBD pts had Mod/Sev disease activity at enrolment, nearly 60% of the overall IBD population reported either work or activity impairment. Thus, disease activity scores alone may fail to assess the real burden of IBD, suggesting a relevant role for PROs in disease management.

Loss of Work Productivity and Quality of Life in Patients With Autoimmune Bullous Dermatoses

2015 ◽  
Vol 19 (6) ◽  
pp. 546-554 ◽  
Author(s):  
K. Heelan ◽  
S. L. Hitzig ◽  
S. Knowles ◽  
A. M. Drucker ◽  
N. Mittmann ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Dermatology Life Quality Index ◽  
Quality Index ◽  
Life Quality ◽  
Work Productivity ◽  
Activity Impairment ◽  
Work Impairment ◽  
Life Quality Index ◽  
The Impact

Background: Little is known about quality of life and work productivity in autoimmune bullous dermatoses (AIBDs). Objective: To determine the impact of AIBDs on quality of life and work productivity. Methods: An observational cross-sectional study took place between February and May 2013 at an AIBD tertiary referral centre. Ninety-four patients were included. All participants completed the Dermatology Life Quality Index and the Work Productivity and Activity Impairment–Specific Health Problem questionnaires. Results: Responders to treatment had less impairment ( P < .001) than nonresponders. Patients with severe AIBD had significantly more impairment that those with mild ( P < .001) and moderate ( P = .002) AIBD. Greater impairment was associated with higher percentage of work missed. Those with a higher Dermatology Life Quality Index score had greater work impairment and overall activity impairment ( P = .041, P = .024). Nonresponders had increased impairment while working ( P < .001), overall work impairment ( P < .001), and activity impairment ( P < .001). Severely affected patients had worse impairment in all Work Productivity and Activity Impairment Questionnaire domains. Conclusions: AIBD has the potential to be a large burden on ability to work and quality of life. Larger studies are needed to clarify how these domains change over time and whether or not they improve with treatment.

scholarly journals Correlating Gastrointestinal Histopathologic Changes to Clinical Disease Activity in Dogs With Idiopathic Inflammatory Bowel Disease

2018 ◽  
Vol 56 (3) ◽  
pp. 435-443 ◽  
Author(s):  
Karin A. Allenspach ◽  
Jonathan P. Mochel ◽  
Yingzhou Du ◽  
Simon L. Priestnall ◽  
Frances Moore ◽  
...  
Keyword(s):  
Inflammatory Bowel Disease ◽  
Disease Activity ◽  
Bowel Disease ◽  
Scoring System ◽  
Activity Index ◽  
Clinical Disease ◽  
Clinical Activity ◽  
Clinical Disease Activity ◽  
Inflammatory Bowel ◽  
Histopathologic Changes

Prior studies have failed to detect a convincing association between histologic lesions of inflammation and clinical activity in dogs with inflammatory bowel disease (IBD). We hypothesized that use of a simplified histopathologic scoring system would improve the consistency of interpretation among pathologists when describing histologic lesions of gastrointestinal inflammation. Our aim was to evaluate the correlation of histopathologic changes to clinical activity in dogs with IBD using this new system. Forty-two dogs with IBD and 19 healthy control dogs were enrolled in this retrospective study. Endoscopic biopsies from the stomach, duodenum, ileum, and colon were independently scored by 8 pathologists. Clinical disease activity was scored using the Canine Inflammatory Bowel Disease Activity Index (CIBDAI) or the Canine Chronic Enteropathy Clinical Activity Index (CCECAI), depending on the individual study center. Summative histopathological scores and clinical activity were calculated for each tissue (stomach, duodenum, ileum, and colon) and each tissue histologic score (inflammatory/morphologic feature). The correlation between CCECAI/CIBDAI and summative histopathologic score was significant ( P < .05) for duodenum ( r = 0.42) and colon ( r = 0.33). In evaluating the relationship between histopathologic scores and clinical activity, significant ( P < .05) correlations were observed for crypt dilation ( r = 0.42), lamina propria (LP) lymphocytes ( r = 0.40), LP neutrophils ( r = 0.45), mucosal fibrosis ( r = 0.47), lacteal dilation ( r = 0.39), and villus stunting ( r = 0.43). Compared to earlier grading schemes, the simplified scoring system shows improved utility in correlating histopathologic features (both summative histology scores and select histologic scores) to IBD clinical activity.

scholarly journals Real-world evidence of the impact of adalimumab on work productivity and sleep measures in patients with rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis

2020 ◽  
Vol 12 ◽  
pp. 1759720X2094908
Author(s):  
Maria G. Tektonidou ◽  
Gkikas Katsifis ◽  
Athanasios Georgountzos ◽  
Athina Theodoridou ◽  
Eftychia-Maria Koukli ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Psoriatic Arthritis ◽  
Ankylosing Spondylitis ◽  
Disease Activity ◽  
Real World ◽  
Sleep Problems ◽  
Work Productivity ◽  
Routine Care ◽  
Activity Impairment ◽  
Work Impairment

Objective: Our aim was to evaluate the effect of adalimumab on work productivity measures, overall activity impairment, and sleep quality in patients with active moderate to severe rheumatoid arthritis (RA), psoriatic arthritis (PsA), or ankylosing spondylitis (AS) treated in routine care settings in Greece and determine factors associated with work impairment and sleep disturbance. Methods: Patients with active moderate to severe RA ( n = 184), PsA ( n = 166), and AS ( n = 150) were enrolled in this 24-month, prospective, observational study at 80 hospital outpatient clinics and private practices throughout Greece. Patients received adalimumab alone or in combination with standard antirheumatic therapies according to routine care. Work productivity and sleep were assessed through two patient-reported outcome measures: the Work Productivity and Activity Impairment–General Health questionnaire and the Medical Outcomes Study Sleep Scale (MOS-SS). Pearson correlation coefficients were estimated to assess the association of work impairment and sleep disturbances with disease activity scores. Results: In the overall population, adalimumab significantly lowered absenteeism [mean (95% confidence interval) reduction, 18.9% (13.3–24.5%); n = 100]; presenteeism [40.0% (33.8–46.3%); n = 98], overall work productivity impairment [46.8% (40.4–53.2%); n = 94], activity impairment [47.0% (44.3–49.6); n = 421], and the MOS-SS sleep problems index [31.6 (29.5–34.1); n = 421] after 24-month treatment ( p < 0.001). Significant improvements were also noted across the RA, PsA, and AS subpopulations ( p < 0.05). Improvements in overall work impairment and sleep disturbance positively correlated with improvements in disease activity measures. Conclusion: Adalimumab improves work productivity and sleep problems while lowering disease activity in patients with moderate to severe RA, PsA, and AS managed in real-world settings.

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