scholarly journals Golimumab improves work productivity in patients suffering from moderate to severe ulcerative colitis: results of a prospective study over 24 months

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Niels Teich ◽  
Harald Grümmer ◽  
Eric Jörgensen ◽  
Thomas Liceni ◽  
Frank Holtkamp-Endemann ◽  
...  

Abstract Background Ulcerative colitis (UC) is a chronic inflammatory bowel disease with recurrent episodes of debilitating symptoms negatively affecting work productivity and health-related quality of life (HRQoL). The use of biologics in UC treatment improves work and HRQoL but prospective long-term data concerning the treatment with TNFα inhibitor golimumab in UC patients are still rare. Therefore, our study aimed to evaluate the change in work productivity, capacity for daily activities and HRQoL in UC patients treated with golimumab in Germany. Methods Using the Work Productivity and Activity Impairment questionnaire, the change in work productivity and in capacity for daily activities after 3 months and over the whole observational period of 24 months were assessed (both primary endpoints). Disease-specific and health-related quality of life (QoL) were analyzed with the Inflammatory Bowel Disease Questionnaire (IBDQ), the Short-Form 12 Health Survey Questionnaire (SF-12), and the Partial Mayo Score (secondary endpoints). Further, disease-related hospitalization rates were assessed. Results This prospective non-interventional study included 286 patients. Thereof, 212 patients were employed at baseline (modified intention to treat analysis set employed at baseline, mITTe). 61.3% of the mITTe patients had moderate and 17.0% had severe UC. Three months after initiation of golimumab therapy, total work productivity impairment (TWPI) score and activity impairment score improved significantly from baseline with a mean change of − 17.3% (p < 0.0001) and − 14.4% (p < 0.0001), respectively. Results persisted over 24 months (mean change TWPI score: − 24.5%, mean change activity impairment score: − 30.0%). Disease- and health-related QoL also improved significantly under golimumab treatment as indicated by increased IBDQ [mean change: 28.0 (SD: ± 36.1, month 3), 42.1 (SD: ± 39.5, month 24)] and SF-12 scores [PCS-12: 45.9 (SD: ± 8.5), MCS-12: 4.9 (SD: ± 10.6, month 3), PCS-12: 5.9 (SD: ± 9.0), MCS-12: 6.4 (SD: ± 11.1, month 24)]. Disease-related hospitalization rate decreased from 16.0% (BL) to 4.3% at month 24 and the mean number of missed working days due to UC decreased from 8.2 (SD: 17.6, BL) to 0.7 (SD: 2.1) after golimumab induction. Conclusions Golimumab leads to notable long-term improvements in work productivity, daily activity, HRQoL, and disease-related hospitalization rates in patients with moderate to severe UC. Trial registration: PEI (Paul-Ehrlich-Institute, Langen, Germany) Registration Nr: NIS#255 (https://www.pei.de/SharedDocs/awb/nis-0201-0300/0255.html)

2018 ◽  
Vol 23 (13) ◽  
pp. 1610-1623 ◽  
Author(s):  
Alain Joseph ◽  
Charlotte E. Kosmas ◽  
Chloe Patel ◽  
Helen Doll ◽  
Philip Asherson

Objective: The objective of this study was to assess health-related quality of life (HRQoL) in adult ADHD. Method: U.K. residents aged 18 to 55 years with ADHD and no major mental health comorbidities completed an online survey of disorder history, the EuroQoL 5-Dimensions 5-Level (EQ-5D-5L), and the Work Productivity and Activity Impairment Questionnaire: General Health (WPAI:GH). ADHD Rating Scale-IV (ADHD-RS-IV) score was assessed by telephone. Results: In total, 233 participants completed the study (mean age 32.6 years; 65.2% women). Mean ( SD) ADHD-RS-IV total score, EQ-5D utility, and visual analog scale (VAS) scores were 43.5 (7.88), 0.74 (.21), and 69.8 (17.76), respectively. Mean ( SD) WPAI:GH scores indicated that health problems caused 45.7% (29.9) overall work impairment and 45.8% (28.9) impairment in regular daily activities. Greater work and activity impairment were both significantly independently associated with lower utility after adjusting for age, gender, and somatic comorbidities. Conclusion: Adult ADHD impairs HRQoL, work productivity, and regular daily activities.


2021 ◽  
Vol 15 (Supplement_1) ◽  
pp. S430-S431
Author(s):  
G J Correa ◽  
M Yantorno ◽  
P Olivera Sendra ◽  
J S Lasa ◽  
P Lubrano ◽  
...  

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&lt;0.05; EQ5D [visual analogue scale]: 75.7±1.8 vs. 64.4±5.5, p&lt;0.05) and UC (180.2±32.9 vs. 132.9±43.8, p&lt;0.001; 77.1±1.3 vs. 57.7±5.3, p&lt;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&lt;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.


2020 ◽  
Vol 18 (1) ◽  
Author(s):  
Mark Verrill ◽  
Andrew M. Wardley ◽  
Jenny Retzler ◽  
Adam B. Smith ◽  
Catherine Bottomley ◽  
...  

Abstract Background The impact of different disease stages and treatment for human epidermal growth factor 2 positive (HER2-positive) breast cancer (BC) on work productivity and health-related quality of life (HRQoL) is poorly understood. Methods This was a UK cross-sectional study of 299 adult patients with HER2-positive early or metastatic BC (NCT03099200). Productivity was assessed using the work productivity and activity impairment scale; HRQoL was measured using EuroQol-5 Dimensions-5 levels (EQ-5D-5L), and Functional Assessment of Cancer Therapy Breast (FACT-G and -B) instruments. Three balanced patient groups were recruited: (1) early BC on treatment post-surgery, (2) early BC after completion of adjuvant treatment, (3) during metastatic BC treatment. Between-group comparisons were performed using an analysis of variance. Results Group 1 comprised 89 patients, Group 2, 108 and Group 3, 102. Age, ethnicity and comorbidities were similar across groups. Patients in Group 3 reported more often being unable to work (significant Bonferroni adjusted p < 0.003). Proportions of employed patients were 50.6%, 50.9% and 27.5% in Groups 1, 2 and 3, respectively. For patients in part-time employment, the number of hours worked was significantly higher in Group 2 patients versus Group 3 (p = 0.002). Group 2 also had significantly lower levels of work absenteeism and overall work impairment compared with Group 1 (p < 0.001). Patients in Group 3 reported worse health utility scores (p ≤ 0.002), moderate or worse problems in the EQ-5D-5L self-care and usual activity domains (p ≤ 0.001), and lower HRQoL as assessed by FACT summary scores (p < 0.001 for FACT-B and -G) than Groups 1 and 2. Poorer HRQoL was significantly associated with higher work impairment (p < 0.001), with the strongest relationships being observed between activity impairment and HRQoL (Pearson’s r: 0.67). Conclusions Metastatic disease and treatment of HER2-positive BC adversely impacted on work productivity and HRQoL. The results of this study support the idea that being able to delay or prevent the metastatic recurrence of BC, for example by extending the time patients are in remission or at early stage of BC, has wider benefits in terms of patient productivity and HRQoL.


Author(s):  
G Boudreau ◽  
WJ Becker ◽  
C Graboski ◽  
M Ong-Lam ◽  
I Finkelstein ◽  
...  

Background: We assessed long-term health-related quality of life (HRQoL) and functioning in adults receiving onabotulinumtoxinA for CM. Methods: Interim analysis of multicentre, prospective, observational study in adults naïve to botulinum toxin (NCT02502123). Mean change from baseline in Migraine-Specific Quality of Life (MSQ) score (primary); healthcare resource utilization (HRU) and work productivity (secondary) assessed in patients receiving 4 of 7 onabotulinumtoxinA treatments (Tx4; ~10 months). Results: Across treatments (baseline, n=196, post-Tx2, n=173, post-Tx4, n=137), the mean (SD) between-session interval and onabotulinumtoxinA dose was 13.1 weeks and 170.4 (17.2) U, respectively. MSQ scores increased significantly (P&lt;0.0001) (baseline to post-Tx4; all role function domains). Patient percentages declined from baseline to post-Tx2 and post-Tx4 for emergency room visits (17.3%; 9.3%; 6.6%), hospital admissions (3.6%; 2.9%; 1.5%), and headache-related diagnostic testing (35.9%; 15.9%; 8.1%). The percentages of patients employed at baseline (73.5%) and post-Tx4 (72.3%) were similar. Hours worked increased slightly from baseline to post-Tx4 (28.0 [SD=15.4]; 29.4 [SD=16.0]). Headache-related missed work hours decreased (5.9 [SD=9.5]; 2.5 [SD=5.9]). Patients reported less headache-related impact on work productivity from baseline to post-Tx4 (5.4 [SD=2.1] vs 3.9 [SD=2.6]) and ability to perform daily activities (6.1 [SD=2.1] vs 4.2 [SD=2.8]). Conclusions: OnabotulinumtoxinA for CM improved HRQoL and work productivity and reduced HRU.


2017 ◽  
Vol 41 (S1) ◽  
pp. S352-S352 ◽  
Author(s):  
P. Asherson ◽  
C. Kosmas ◽  
C. Patel ◽  
H. Doll ◽  
A. Joseph

IntroductionEuropean data on health-related quality of life (HRQoL) in adults with attention deficit/hyperactivity disorder (ADHD) in the general population is sparse.Aims and objectivesTo report HRQoL in UK adults with ADHD.MethodsUK residents aged 18–55 years with a diagnosis of adult ADHD completed an online, cross-sectional survey including questions on disease history, the EuroQol Five Dimensions questionnaire with five-levels (EQ-5D-5L) and the Work productivity and activity impairment questionnaire: general health (WPAI:GH). ADHD symptom severity was assessed by telephone using ADHD rating scale version IV with adult prompts (ADHD-RS-IV).ResultsThe survey was completed by 233 participants (65.2% women; 77.3% white British), mean age 32.6 years (standard deviation [SD] 9.5), mean ADHD-RS-IV total score 43.46 (SD 7.88). Their mean EQ-5D-5L utility score of 0.74 (SD 0.21) was lower than the UK population norm of 0.86 (SD 0.23).[1] WPAI:GH scores indicated that health problems resulted in impairments of 32.04% in work productivity and 45.79% in regular daily activities. Regression analyses adjusting for gender, age and comorbidities demonstrated associations between EQ-5D-5L utility scores and gender (men had lower scores, P < 0.001), work impairment due to health problems (increasing impairment was associated with lower scores, P = 0.005) and age (for each additional year of age, scores decreased by 0.007, P = 0.010).ConclusionsThese results highlight the impact on health utility, work productivity and regular daily activities, and add to the description of the disease burden of adult ADHD in the UK.This study was funded by Shire Development LLC.Disclosure of interestKings College London research support account for Asherson received honoraria for consultancy to Shire, Eli-Lilly and Novartis educational/research awards from Shire, Lilly, Novartis, Vifor Pharma, GW Pharma and QbTech speaker at sponsored events for Shire, Lilly and Novartis.


2020 ◽  
Vol 14 (Supplement_1) ◽  
pp. S575-S576
Author(s):  
G Parkes ◽  
A Akbar ◽  
I Beales ◽  
M Buckley ◽  
T Creed ◽  
...  

Abstract Background Patients with inflammatory bowel disease (IBD) experience substantial impairment in health-related quality of life (HRQoL), therefore HRQoL endpoints are considered important measures of treatment outcome. OCTAVO evaluated the effects of vedolizumab on HRQoL, work productivity and patient concerns in IBD patients in the UK and Ireland. Methods OCTAVO is an ongoing multicentre, observational study to evaluate the impact of vedolizumab on two cohorts. Cohort 1 examined the impact of vedolizumab on concomitant medications compared with anti-TNFs in biologic naïve patients with ulcerative colitis (UC). Cohort 2 was non-comparative and observed changes in patient reported outcomes (PROs) in patients with UC and Crohn’s disease (CD) prescribed vedolizumab at any point in the treatment pathway. PROs are assessed by Short Inflammatory Bowel Disease Questionnaire (SIBDQ), IBD-Control-8 (IBD-C-8), Work Productivity and Activity Impairment (WAPI) and Rating Form of IBD Patient Concerns (RFIPC). PROs are collected prospectively at baseline, Week 14, 6 months and 12 months post-initiation via online questionnaires. The results of an interim analysis of Week 14 PROs for patients aged ≥18 years newly initiated on vedolizumab enrolled across 7 hospital sites in Cohort 2 are reported here. Results Sixty-one patients (21 CD, 40 UC; 51% male) were recruited, with a median age of 39.0 (IQR 32.0–55.0); and median disease duration of 9.6 years (IQR 1.7–17.2) for CD and 5.6 years (IQR 1.3–17.4) for UC. Mean total SIBDQ scores at Week 14 were: 45.2 for CD; 50.0 for UC. Scores increased by 8.5 points in CD patients and 10.2 points in UC patients in the first 14 weeks of the study. Similarly, improvements in IBD-C-8, WPAI-UC/CD sub-scores and RFIPC were observed in both CD and UC (Table 1). Conclusion Vedolizumab treatment was associated with meaningful improvements in PROs at Week 14. Improvements were seen across all measures (SIBDQ, IBD-C-8, WPAI-CD/UC and RFIPC) and were similar between CD and UC. Further investigation of vedolizumab on PROs in the real world is required to assess impact in the longer-term, the full analysis of OCTAVO at months 6 and 12 will help to provide this.


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