Work Productivity And Activity Impairment Research Articles

The socio-economic burden of H1-antihistamine-refractory chronic spontaneous urticaria in Germany.

Data from the AWARE study (A Worldwide Antihistamine-Refractory chronic urticaria patient Evaluation) illustrate a substantial disease burden in German patients with H1-antihistamine (-H1-AH)-refractory chronic spontaneous urticaria (CSU). Detrimental effects on patients' quality of life, poor disease control and impairment in the ability to work and perform other daily activities are reported. Based on these findings, this study aims to quantify the epidemiological and socio-economic burden of H1-AH-refractory CSU in Germany. To determine the epidemiological burden of H1-AH-refractory CSU, the age- and gender-specific prevalence of CSU and the proportion of H1-AH-refractory patients in Germany anonymized data from the InGef research database have been used. In a second step, the socio-economic burden in terms of lost numbers of hours in paid and unpaid work was calculated by extrapolating the age- and gender-specific work productivity and activity impairment (WPAI) observed in AWARE to the H1-AH-refractory CSU population in Germany. Finally, productivity losses in paid and unpaid work were monetized using the human capital and the friction cost approach respectively. Moreover, socio-economic burden was calculated depending on symptom control of the patients (measured by urticaria control test [UCT]). In Germany, over 203,000 patients (20 years or older) had H1-AH-refractory CSU in 2018. The avoided lost paid and unpaid work hours attributable to H1-AH-refractory CSU summed up to over 100 million. Overall, the socio-economic burden of H1-AH-refractory CSU in monetary terms was evaluated at € 2.2 billion and the majority of this was due to unpaid work loss. Patients with poor disease control, as indicated by UCT score < 12, were more likely to suffer from high impairment than patients with controlled disease, resulting in a higher socio-economic burden. The results of our analyses picture the substantial socio-economic burden of H1-AH-refractory CSU and therefore the tremendous impact it has on daily lives of individuals and society overall.

Real-world clinical evaluation of natural and induced vasomotor symptoms in the USA and Europe

Objective This study aimed to examine physicians’ and patients’ perceptions regarding symptom burden and impact in women experiencing natural vasomotor symptoms (nVMS) or vasomotor symptoms induced by endocrine therapy for breast cancer (iVMS). Methods The cross-sectional survey based on real-world clinical consultations was conducted in the USA and five European countries. Obstetrician–gynecologists, primary-care physicians and oncologists provided demographic and symptom data for patients experiencing VMS; patients optionally self-reported their experiences via questionnaires, including their symptom profile and work/activity burden through the Menopause Quality of Life (MENQOL) and Work Productivity and Activity Impairment (WPAI) tools. Results Physicians completed survey forms on 2451 consulting patients; patients completed 1029 questionnaires. nVMS and iVMS severity was significantly associated with the severity of mood symptoms and sleep disturbances (p < 0.0001). However, around half of the patients with mild nVMS/iVMS also experienced moderate–severe mood changes (55.4%/43.7%) or sleep disturbances (42.4%/40.4%). Presence of mood/sleep disturbances alongside nVMS increased MENQOL vasomotor scores (p = 0.004/p < 0.001). Presence of sleep disturbances increased WPAI activity impairment (p < 0.001) but mood changes did not. Similar findings were reported for iVMS patients. Conclusion Significant burden from the triad of natural or induced menopausal symptoms, sleep disturbances and mood changes affected women’s daily activities, work and quality of life more than vasomotor symptoms alone.

Work Productivity Impairment in Persons with Inflammatory Bowel Diseases: A Systematic Review and Meta-analysis.

The impact of inflammatory bowel disease (IBD) on work productivity remains unclear. In this systematic review and meta-analysis, we quantify work-related outcomes and employment data among persons with IBD. A systematic literature search was conducted in MEDLINE, EMBASE, the Cochrane library, Scopus, ProQuest, and clinicaltrials.gov from inception to February 2023 to identify studies on work productivity in persons with IBD aged >18 years. Work productivity was defined primarily by the Work Productivity and Activity Impairment (WPAI) questionnaire which includes absenteeism, presenteeism, overall work impairment, and non-work activity impairment. In addition, we included data on employment, sick leaves, disability pensions, and indirect costs due to productivity loss. Pooled effect analysis was conducted using a random-effects model for pooled estimates of continuous and proportional data with 95% confidence intervals. Among all patients with IBD, the pooled estimates were 16.4% for absenteeism, 35.9% for presenteeism, 39.4% for overall work impairment, and 46.0% for non-work activity impairment. Indirect costs from overall work impairment were 5,131.09 euros/patient/year. Only two thirds of IBD patients were employed and 1 in 3 patients lost their jobs due to IBD. Among those employed, 39.5% report sick days, 21.3% report work disability, and 12.3% receive disability pensions. Most studies demonstrate clinically meaningful improvements in work productivity with medical and/or surgical therapies. Persons with IBD experience significant work impairment and associated indirect costs. This highlights the need for appropriate workplace accommodations and timely medical therapy to alleviate the burden of disease and improve work outcomes.

Racial and Ethnic Disparities in Health-Related Outcomes in Crohn's Disease: Results From the National Health and Wellness Survey.

Crohn's disease (CD) is a chronic inflammatory condition affecting the entire gastrointestinal tract that is associated with significant humanistic, clinical, and economic burdens. Few studies have assessed the association between CD severity and patient-reported outcomes (PROs), healthcare resource utilization (HCRU), and medical costs; even fewer have examined differences in disease outcomes among patients of various racial/ethnic groups. In this cross-sectional study, sociodemographic data, PROs, and economic outcomes for participants with self-reported CD were collected from the National Health and Wellness Survey (2018-2020). Multivariable analyses were used to assess the association of CD severity and race/ethnicity with health-related quality of life (HRQoL), work productivity and activity impairment (WPAI), HCRU, and medical costs. Analyses included 1077 participants with CD (818 non-Hispanic White, 109 non-Hispanic Black, and 150 Hispanic). Participants with self-reported moderate/severe CD reported significantly worse HRQoL and WPAI, greater HCRU, and higher medical costs than those with self-reported mild CD. Non-Hispanic Black participants reported better HRQoL and fewer healthcare provider visits than non-Hispanic White participants. There were no significant differences in PROs between non-Hispanic White and Hispanic groups. Interactions between race/ethnicity and CD severity emerged for some, but not all groups: Specifically, non-Hispanic Black participants with moderate/severe CD reported greater absenteeism and more gastroenterologist visits than non-Hispanic Black participants with mild CD. Participants with moderate/severe CD reported worse PROs, greater HCRU, and higher medical costs than those with mild CD. Additionally, racial/ethnic differences were found across several HCRU and economic outcomes. Further research is needed to better understand factors contributing to burden among patients with varying CD severity across racial/ethnic groups.

Quality of life and work functionality in severe asthma patients: the impact of biological therapies

BackgroundSevere asthma can cause poor health status, poor health-related quality of life (HRQoL) and an impaired functioning at work. However, to date, limited data are available on the impact of the biological therapies on such outcomes. Therefore, aim of the present study was to prospectively assess the clinical, quality of life and work functionality issues in severe asthma patients both at baseline and after 6 months of biological therapies and determine which individual, pathological and occupational factors can influence such parameters.MethodsFifty-two patients were enrolled between December 2022 and June 2023. Patients’ personal, clinical, functional and occupational features were assessed. The Short Form Health Survey (SF-12), the Work Productivity and Activity Impairment (WPAI) questionnaire and the Work Ability Index (WAI) were employed to assess HRQoL, the employee’s productivity and perception of work ability, respectively.ResultsAmong the enrolled patients, 30 (57.70%) were employed. Biological therapy induced a significant improvement in clinical and functional parameters, e.g., FEV1% (72 ± 12 vs.87 ± 13%; 72 ± 14 vs. 86 ± 14%), FVC% (92 ± 11 vs. 101 ± 11%; 90 ± 13 vs. 98 ± 14%) and FEV1/FVC (62 ± 11 vs. 71 ± 8%; 64 ± 9 vs. 70 ± 8%) in workers and non-workers, respectively (P < 0.001). Comparably, the perception of life quality significantly improved, as physical and mental health scores, in the overall cohort, increased from 40.7 ± 10.3 and 48.5 ± 8.5 to 46.8 ± 8.6 and 51.6 ± 6.4, respectively (P < 0.001). The work ability perception significantly improved from a moderate to a good one (34 ± 6 vs. 40 ± 6, P = 0.001). A significant reduction in the absenteeism (19 ± 15 vs. 3 ± 11%; P < 0.001) and presenteeism rate (53 ± 24 vs. 29 ± 26%; P < 0.001), and an improvement in daily (40 ± 27.5% vs. 28.9 ± 24.7%, P < 0.001, in the overall population) and work activities (57 ± 25 vs. 29 ± 27%, P < 0.001) was determined. Gender, age, symptoms control and pulmonary functionality were correlated with the physical and mental health perception, daily activity impairment and work ability.ConclusionsOur study pointed out that biological therapies improved clinical, general life and occupational outcomes in patients with severe asthma. The correlation between clinical aspects and psychological and occupational issues suggest the relevance for a multidisciplinary management of the disease for an effective participation of patients in the world of work.

Patient acceptable symptom state and treatment failure threshold values for work productivity and activity Impairment and EQ-5D-5L in osteoarthritis

ObjectiveTo estimate patient acceptable symptom state (PASS) and treatment failure (TF) threshold values for Work Productivity and Activity Impairment (WPAI) measure and EQ-5D-5L among people with hip or knee osteoarthritis (OA) 3 and 12 months following participation in a digital self-management intervention (Joint Academy®).MethodsAmong the participants, we computed work and activity impairments scores (both 0–100, with a higher value reflecting higher impairment) and the Swedish hypothetical- (range: − 0.314 to 1) and experience-based (range: 0.243–0.976) EQ-5D-5L index scores (a higher score indicates better health status) at 3- (n = 14,607) and 12-month (n = 2707) follow-ups. Threshold values for PASS and TF were calculated using anchor-based adjusted predictive modeling. We also explored the baseline dependency of threshold values according to pain severity at baseline.ResultsAround 42.0% and 48.3% of the participants rated their current state as acceptable, while 4.2% and 2.8% considered the treatment had failed at 3 and 12 months, respectively. The 3-month PASS/TF thresholds were 16/29 (work impairment), 26/50 (activity impairment), 0.92/0.77 (hypothetical EQ-5D-5L), and 0.87/0.77 (the experience-based EQ-5D-5L). The thresholds at 12 months were generally comparable to those estimated at 3 months. There were baseline dependencies in PASS/TF thresholds with participants with more severe baseline pain considering poorer (more severe) level of WPAI/EQ-5D-5L as satisfactory.ConclusionPASS and TF threshold values for WPAI and EQ-5D-5L might be useful for meaningful interpretation of these measures among people with OA. The observed baseline dependency of estimated thresholds limits their generalizability and values should be applied with great caution in other settings/populations.

A117 WORK PRODUCTIVITY IMPAIRMENT IN PERSONS WITH INFLAMMATORY BOWEL DISEASES: A SYSTEMATIC REVIEW AND META-ANALYSIS

Abstract Background Inflammatory bowel diseases (IBD), which include Crohn’s disease (CD) and ulcerative colitis (UC), are chronic disorders that affect approximately 6.8 million people globally. IBD often develops at an early age and can have a significant impact on employment outcomes and work productivity. Individuals with IBD have higher rates of unemployment, sick leave, and work disability compared to the general population. Nevertheless, there remains a paucity of standardized reporting on work productivity impairment and the associated indirect costs in patients with IBD. Aims In this systematic review and meta-analysis, we evaluate work-related outcomes and employment data among patients with IBD. This may inform clinical and policy decisions to facilitate workplace accomodations for patients with IBD and improve their work productivity. Methods A systematic literature search was conducted in MEDLINE, EMBASE, and the Cochrane library, in addition to Scopus, ProQuest, and clinicaltrials.gov from inception to February 2023. We included full-texts and abstracts of observational and clinical trials that reported work-related outcomes in patients with IBD aged ampersand:003E18 years. We collected work-related data as described by the Work Productivity and Activity Impairment (WPAI) tool, in addition to other outcomes including employment, sick leaves, disability pensions, and indirect costs due to productivity loss. Pooled effect analysis was conducted using a random-effects model for pooled estimates of continuous and proportional data with 95% confidence intervals (CIs). Odds ratios (ORs) and mean differences were used to compare data between patients with active disease vs. remission. Results We included 134 studies (96 full-text articles and 38 abstracts). Among all patients with IBD, the pooled estimates were 16.41% [13.89-18.93] for absenteeism, 35.91% [31.11-40.72] for presenteeism, 39.41% [33.93-44.88] for overall productivity loss, and 45.96% [39.46-52.46] for non-work related activity impairment. Indirect costs were estimated at 1,813.9, 3,562.49, and 5,131.09 euros/patient/year for absenteeism, presenteeism, and overall work impairment respectively. For other non-WPAI outcomes, the pooled estimate for employment was 65.6%, 39.5% of patients reported sick days, 21.3% reported disability at work due to IBD directly, 12.3% received disability pensions, and 29.6% had lost jobs due to IBD. Overall, patients with active disease had worse WPAI and employment outcomes than those in remission. Conclusions IBD may result in significant work productivity impairment, lower employment, and significant indirect costs due to productivity loss. Larger studies with standardized definitions for work outcomes are needed to better evaluate the impact of IBD on work productivity. Funding Agencies Mount Sinai Resident Research Funding

The impact of myasthenia gravis severity on work and daily activities.

People with myasthenia gravis (MG) experience impaired quality of life. However, the impact of MG symptoms on work productivity has not been well-studied. We aimed to evaluate this impact and to examine associations between disease severity and the degree of impairment. Data were drawn from the Adelphi MG Disease-Specific Programme™, a multinational (USA, France, Germany, Italy, Spain, UK) survey completed by physicians and their patients with MG in 2020. Patient-reported measures included the Work Productivity and Activity Impairment (WPAI): Specific Health Problem questionnaire. The WPAI questionnaire was completed by 330 patients. Among those currently employed, the mean percentage of work time missed (absenteeism) was 13.3% (N = 116), percentage impairment of productivity at work (presenteeism) was 26.7% (N = 121), and overall work impairment was 30.0% (N = 110). Across all patients, impairment of non-work-related activities due to health problems (ADL impairment) was 39.2% (N = 330). Regression analysis indicated that impairment differed according to MG Foundation of America (MGFA) class (p = .0147, p < .0001, p < .0001 and p < .0001 for absenteeism, presenteeism, overall work impairment and ADL impairment, respectively). Being MGFA class III/IV was a predictor of presenteeism, overall work impairment and ADL impairment in a predictor model. Patients with MG experience substantial work impairment particularly those with more severe symptoms, highlighting an important way in which patient quality of life is negatively affected. More effective treatment strategies would enable patients to lead more productive lives and could impact decisions relating to work and career.

The comparative burden of chronic spontaneous urticaria, atopic dermatitis and psoriasis in five European countries

AbstractBackgroundSkin diseases can have a significant impact on the physical, psychological and social well‐being of patients. Quantification of the burden of chronic spontaneous urticaria (CSU) compared to other dermatological conditions is limited.ObjectivesTo evaluate the comparative humanistic and economic burden of CSU, atopic dermatitis (AD), and psoriasis (PSO) in five European countries (EU5).MethodsThis cross‐sectional analysis compared data from adult respondents with a physician diagnosis of CSU, AD and PSO from the 2020 National Health and Wellness Survey in EU5 (France, Germany, Italy, Spain and the United Kingdom). Outcomes included Short Form (SF)‐12v2 [mental (MCS) and physical component (PCS) summary scores], SF‐6D, EQ‐5D, EQ‐Visual Analogue Scale (VAS), Dermatology Life Quality Index (DLQI), General Anxiety Disorder‐7 (GAD‐7), Patient Health Questionnaire‐9 (PHQ‐9), Work Productivity and Activity Impairment (WPAI) and healthcare resource utilization (HRU). Multivariable analyses comparing CSU to AD and PSO, respectively, were conducted for each outcome.ResultsThis analysis included 379 CSU, 788 AD and 2,636 PSO patients. Adjusted MCS and PCS scores were lower among CSU patients than AD (MCS, p = 0.006; PCS, p &lt; 0.001) and PSO (p &lt; 0.001 for all). SF‐6D and EQ‐5D scores were consistently lower among CSU patients versus AD and PSO (p &lt; 0.001 for all), whereas the EQ VAS was lower in CSU cohort versus PSO cohort (p = 0.003). Higher DLQI scores were reported in the CSU cohort versus AD and PSO (p &lt; 0.001 for both) and the proportion of patients with anxiety and depression, respectively, (GAD‐7 and PHQ‐9 scores ≥5) was greater among the CSU cohort versus AD and PSO (p &lt; 0.001 for all). Finally, higher HRUs and worse WPAI scores (p &lt; 0.005) were observed in the CSU cohort relative to AD and PSO cohort.ConclusionsCSU is associated with significantly worse health‐related quality of life, more mental comorbidities, negative impact on patients' daily lives and the ability to work, ultimately leading to higher HRU compared with AD and PSO.

P209 Work productivity and unmet needs of treated ulcerative colitis patients: A Japan National Health and Wellness Survey study

Abstract Background Ulcerative colitis (UC), a subset of inflammatory bowel disease (IBD), is a chronic, immune-mediated disease process which causes inflammation and ulceration of the large intestine. In Japan, the annual prevalence of UC in 2014 showed a ten-fold increase in more than 10 years. Despite current treatments, patient-reported disease challenges persist. This study investigated the disease burden and unmet needs of treated UC patients in Japan. Methods This cross-sectional, observational study used existing data from the online, self-administered Japan National Health and Wellness Survey conducted in 2017, 2019, and 2021. Respondents were aged ≥18 years, with self-reported UC and had undergone/were on treatment [5-Aminoslicyclic acid (5-ASA), steroids, immunomodulators (IMs), biologics (Bio)/Janus kinase inhibitors (JAKi), or others]. Data pertaining to demographics and clinical characteristics, medication adherence, health-related quality of life (HRQoL), work productivity and activity impairment (WPAI), and indirect cost were collected and analysed. Results Among 293 treated UC patients in Japan, most were conventional treatment users (84%) and 29% were living with UC for ≥15 years. Despite active treatment, 91% of patients reported UC as bothersome to a certain degree, 35% reported having moderate-to-severe disease severity post-treatment, and 55% reported ≥1 persisting UC symptom. Treated patients reported EuroQoL-5-dimension visual analogue scale scores of 68. Depression and anxiety were reported in ≥35% of patients and majority (68%) of employed patients reported work productivity impairment. On average, employed UC patients reported 30-40% WPAI on a weekly basis, resulting in a mean indirect cost of 1.12 million Japanese yen (€8,799) per patient annually. Males, moderate-to-severe disease activity, and low treatment adherence (&amp;lt;80%) were associated with increased WPAI (p&amp;lt;0.05). In comparison to 5-ASA users, Bio/JAKi users had the highest work impairment, while steroid and IM users had higher activity impairment (p&amp;lt;0.05). Conclusion The overall HRQoL scores were lower than the average Japanese healthy population and the indirect cost due to work productivity impairment was high, equating to approximately 1/5 of the average household income. Those with lower treatment adherence consistently reported the highest work and activity impairment. The findings implicate a high disease burden and unmet needs affecting Japanese UC patients despite currently available treatments, suggesting the importance of a new convenient treatment for optimising UC outcomes. Additionally, workplace accommodations and understanding of employers on UC could assist in improving work productivity of UC patients.

P580 Iron deficiency anaemia and quality of life in Inflammatory Bowel Disease: Prospective cohort study of ferric derisomaltose on quality of life and work productivity in patients with IBD

Abstract Background Iron-deficiency anaemia is a frequent complication of inflammatory bowel disease (IBD), affecting approximately 10% of patients at any one time. Quality of life scores in patients with IBD and anaemia are similar to those reported in malignancy. ECCO guidelines recommend assessment and treatment of iron deficiency anaemia, with a goal of normalising haemoglobin and iron stores. Methods We conducted a prospective observational cohort study of patients with IBD being treated for iron deficiency anaemia with ferric derisomaltose. Patients were included who were anaemic as per World Health Organisation criteria with a ferritin of &amp;lt;30 µg/L and/or a transferrin saturation of &amp;lt;18%. Variables collected included haematological parameters, the 12-item Short Form survey (SF-12) as a generic health-related quality of life measure, the Work Productivity and Activity Impairment (WPAI) questionnaire and the Short Inflammatory Bowel Disease Questionnaire (SIBDQ) as a disease-specific quality of life measure. Patients were assessed at baseline, 12 weeks and 52 weeks. We present here the outcomes at week 12. Comparative statistics have been conducted using Wilcoxon signed rank tests and Pearson’s correlation coefficient. Results We recruited 124 patients given between 700 and 1900 mg of ferric derisomaltose, each as a single infusion. Of these, 60% (74/124) were female and the median age was 43 years (IQR 31 – 58). Just under half (46%) of participants had Crohn’s disease, the remainder had ulcerative colitis (49%) or IBD unclassified (5%). Median (IQR) baseline haemoglobin was 114 (109 – 123) g/L in men and 110 (104 – 116) g/L in women. By week 12, haemoglobin, ferritin, SIBDQ, the WPAI, and both the mental and physical component scores of the SF-12 had improved significantly (all p values &amp;lt;0.0001; see Figure 1). Change in the physical score of SF-12 correlated positively with change in haemoglobin (r = 0.38, p&amp;lt;0.0001), while the change in WPAI correlated negatively with change in haemoglobin (r = -0.30, p=0.013). Conclusion Treatment with intravenous ferric derisomaltose in patients with iron deficiency anaemia and IBD was associated with significant improvements in haematological, work productivity, and quality of life parameters.

P833 Burden of steroid use in patients with moderate ulcerative colitis in Europe and the United States

Abstract Background Steroids are an effective short-term therapy option for induction of remission of ulcerative colitis (UC). However, long-term and frequent steroid use is common in clinical practice despite the risks of complications and adverse events.1 We aimed to describe disease burden in moderate UC patients (pts) based on their steroid use history. Methods Data were drawn from the Adelphi UC Disease Specific Programme™, a cross-sectional survey of gastroenterologists (GIs) and their pts in France, Germany, Italy, Spain, the UK and US from Jan 2020–Mar 2021. GIs reported patient demographics, clinical characteristics, treatments and healthcare resource utilization (HCRU). Pts reported quality of life (QoL) via the EQ-5D, short inflammatory bowel disease questionnaire (SIBDQ), and work productivity and activity impairment (WPAI) questionnaire. Pts had received 5-ASA or immunomodulator with no biologic or Janus kinase inhibitor in the 90 days following treatment initiation, had a history of physician-assessed moderate disease severity or a Mayo endoscopic subscore of 2, and no history of colectomy. Pts were categorized as: no steroids (NS; never received steroids), short term/intermittent (ST/I; currently receiving intermittent steroids or received steroids within the last two years for &amp;lt;90 days), or long term/escalated (LT/E; received steroids for ≥90 days within the last two years or had undergone steroid dose escalation within their current course). Analyses were descriptive. Results Overall, 217NS, 88 ST/I and 172 LT/E pts were analysed (Table 1). Median (interquartile range) total steroid use duration was 4.1 (1.6–22.3) months for ST/I and 14.9 (5.8–36.7) months for LT/E. NS (24.4%), ST/I (25.0%) and LT/E (26.2%) pts experienced abdominal pain; 0.5%, 4.6% and 5.2% had severe/extremely severe pain, respectively. Non-bloody diarrhoea was reported by 16.6%, 14.8%, 20.9% of pts, respectively. In the last 12 months, mean (standard deviation; SD) number of health care visits for NS, ST/I and LT/E was 6.1 (6.2), 7.3 (4.8), 8.0 (7.1); mean (SD) number of tests was 20.8 (17.2), 23.3 (15.7), 25.2 (18.2), respectively. NS, ST/I and LT/E patients reported mean EQ-5D scores (0.85, 0.81, 0.79), SIBDQ total scores (54.6, 49.7, 48.3) and overall work impairment (19.4, 23.1, 27.7). Key comorbidities experienced by ST/I and LT/E were hypertension, depression and diabetes (Figure 1). Conclusion Patients with long-term or escalated steroid use had high symptom burden, frequent comorbidities, high HCRU, and poor QoL. This highlights the need for alternative treatment approaches for moderate UC patients to avoid long-term steroid use. 1. Cross R.K. Inflamm Bowel Dis. 2017;23(10):1689–1701

P683 Economic impact of achieving mucosal healing on UC-related hospitalisations and work productivity in patients with moderately to severely active UC: A post-hoc analysis of risankizumab Phase 2b/3 trials

Abstract Background The value of endoscopic-histologic healing is incompletely understood, and definitions are variable. We assessed the clinical and economic value of achieving mucosal healing in patients with ulcerative colitis (UC) by evaluating the relationship of histologic-endoscopic mucosal improvement (HEMI) and subsequent UC-related hospitalisation and work productivity, and associated costs in the United States (US); United Kingdom (UK); and France, Germany, Italy, and Spain (EU4). Methods Data from the risankizumab (RZB) INSPIRE induction (NCT03398148) and COMMAND maintenance (NCT03398135) studies were analysed. The number of UC-related hospitalisations was compared in patients who achieved HEMI or no HEMI using a chi-square test. The mean percent changes in Work Productivity and Activity Impairment (WPAI)-UC domains from baseline to induction week 12 and maintenance week 52 were compared in patients who achieved HEMI or no HEMI using analysis of variance test. Hospitalisation and work productivity differences during induction and maintenance were converted to annualised costs based on average earnings and hospitalisation cost inputs from US, UK, and EU4. Results UC-related hospitalisations were significantly lower in patients who achieved HEMI at induction week 12 than those who did not (0% vs 2.9%, p≤0.05). A similar result was found at maintenance week 52, but the difference was not significant. In patients who achieved HEMI vs no HEMI, a greater mean change in activity impairment, impairment while working, and overall work impairment from baseline to induction week 12 was observed (p≤0.001). Improvements were sustained at maintenance week 52 for patients who achieved HEMI vs those who did not. Estimated annualised cost benefits from maintenance data for UC-related hospitalisations in patients who achieved HEMI was $490 in the US, £29 in the UK, and €28–€58 in EU4. Greater monetised benefits accrued from work productivity gains, where estimated annualised cost savings were $5,085 in the US, £3,507 in the UK, and €3,240–€4,456 in EU4. Conclusion These findings demonstrate that patients treated with RZB who achieved HEMI had fewer UC-related hospitalisations and greater improvement in work productivity and ability to perform daily activities than those who did not, which results in moderate direct cost savings and substantial indirect cost savings to healthcare systems in the US, UK, and EU4.

Work productivity and activity impairment in patients with narcolepsy type 1.

The aim of this study was to assess work productivity and activity impairments and to explore their association with excessive daytime sleepiness, body mass index (BMI), depression, and anxiety in patients with narcolepsy type 1. We carried out a cross-sectional study in which patients with narcolepsy type 1 and matched controls for sex, age, and education were assessed for occupational features, EDS (Epworth Sleepiness Scale), BMI, depression (Beck Depression Inventory), anxiety (State-Trait Anxiety Inventory), and Work Productivity and Activity Impairment (WPAI). Different statistical approaches were used to investigate differences between groups and correlations between WPAI scores and clinical features. The 127 patients with narcolepsy type 1 (mean age 38.2 ± 15.5, 91.3% taking drugs for narcolepsy) and 131 controls (mean age of 37.4 ± 14.3) included did not differ in terms of occupational features, except for hours worked/week (29.9 in patients vs. 34.9 in controls) and officially recognised disability (30.7% vs. 5.3%). Impairment in all WPAI scores was approximately three times greater in patients. Narcolepsy was associated with work time missed in 27.4% of patients, while 93.2% to 95.5% of them had some impairment while working or during daily activities (vs. 37.5-46.8% of controls). Correlations with WPAI scores were found for excessive daytime sleepiness only in patients, and for both depression and anxiety in patients and controls, with a stronger correlation for activity impairment in patients. These results suggest that, despite treatment, narcolepsy type 1 was associated with extensive impairment especially regarding job effectiveness and daily activities. Future studies should investigate risk factors and effects of interventions on these outcomes.

Disease burden and treatment satisfaction in patients with prurigo nodularis in Japan.

Prurigo nodularis (PN) is a chronic inflammatory skin disorder with a high disease burden. In this cross-sectional, web-based survey, Global Questions (GQ), the Numerical Rating Scales (NRS) for pruritus, burning sensation and sleep disturbance, the Short-Form-8 (SF-8) Health Survey, Dermatology Life Quality Index (DLQI), Patient Health Questionnaire 9 (PHQ-9), Work Productivity and Activity Impairment (WPAI), and Treatment Satisfaction Questionnaire for Medication-9 (TSQM-9) scores were used to assess the current disease burden and treatment satisfaction among patients with PN in Japan. In total, 97 patients were included (55.7% male, median age 51 years, median duration of PN 36 months). Based on GQ scores, 35.1% of patients had mild disease, 50.5% moderate, and 14.4% severe disease. Disease burden increased as the severity of PN increased, as indicated by worsening of pruritus NRS scores and quality of life (DLQI, PHQ-9, WPAI presenteeism, work productivity loss, and activity impairment scores). Patients with comorbid atopic dermatitis (AD) also had more intense pruritus than those without AD. Mean ± standard deviation TSQM-9 scores for effectiveness, convenience, and global satisfaction were 54.7 ± 18.1%, 62.4 ± 15.2%, and 57.4 ± 15.9%, respectively. TSQM-9 scores were lowest in patients receiving the most intensive guideline-directed treatment (i.e., topical corticosteroids + systemic oral corticosteroids or cyclosporine), highlighting an unmet need for more effective treatment options for patients with PN. In summary, Japanese patients with PN reported increased disease burden and reduced treatment satisfaction with increased disease severity, despite the use of guideline-recommended therapies.

Association of Health-Related Quality of Life and Work Productivity with Clinical Characteristics in Adults with Sickle Cell Disease

Introduction: Adults with sickle cell disease (SCD) suffer from periodic episodes of severe acute pain, chronic pain, fatigue, acute complications, end-organ damage and early mortality. We explored clinical characteristics associated with health-related quality of life (HRQoL) and work productivity and activity impairment (WPAI) in adults with SCD. Methods: Between January 2022 and June 2023, we recruited 87 adults aged ≥18 years with a diagnosis of SCD from four U.S. NASCC recognized SCD centers participating in the Globin Research Network for Data and Discovery ( GRNDaD) registry. We collected data on patient socio-demographics, fatigue, chronic pain, WPAI, and HRQoL measured by EQ-5D-5L and ASCQ-Me via patient survey. Medical history checklist (MHC) score sums 9 SCD complications and treatment history. Clinical charateristis on SCD subtype and baseline hemoglobin were obtained from the medical record. Clinical characteristics and self-reported MHC, chronic pain associated with HRQoL, and WPAI scores were assessed by Student T-tests or Pearson correlation. Results: Mean age was 38.0±13.4 (standard deviation) years, 58.6% of the sample was female, 64.3% had hemoglobin (Hb) SS disease, 73.6% reported chronic pain (experiencing pain on ≥3 days per week in the past 6 months). Mean EQ visual analogue scale (VAS) was 71.3 (lower than the U.S. 35-44 age mean of 81.8). Mean EQ index score was 0.73 (lower than the U.S. 35-44 age group population norm 0.85). Mean fatigue score was 52.1 (range 33.7-75.8) and was negatively correlated with HRQoL scores, indicating higher fatigue correlated with lower patient's self-rated health, including the EQ VAS (correlation coefficient r=-0.49, p&amp;lt;0.0001), EQ index score (r=-0.53, p&amp;lt;0.0001), and all domain of ASCQ-Me scores including pain (r=-0.52, p&amp;lt;0.0001), stiffness (r=-0.55, p&amp;lt;0.0001), sleep (r=-0.43, p&amp;lt;0.0001), emotion (r=-0.65, p&amp;lt;0.0001), and social functioning score (r=-0.64, p&amp;lt;0.0001). Fatigue score was correlated with pain episode frequency (r=0.29, p=&amp;lt;0.001, indicated more frequent pain episodes correlated with higher fatigue), and pain episode severity score (r=0.34, p=0.002). Fatigue score also correlated with overall activity impairment due to SCD (r=0.47, p&amp;lt;0.0001). MHC score was negatively correlated with EQ VAS (r=-0.32, p=0.003), EQ index score (r=-0.35, p=0.001), ASCQ-Me pain (r=-0.25, p=0.02), stiffness (r=-0.28, p=0.009), emotion (-0.23, p=0.03), social (r=-0.28, p=0.01), pain episode severity score (r=0.26, p=0.02) and fatigue score (r=0.35, p=0.0009). Hemoglobin was not correlated with HRQoL or fatigue scores. MHC score significantly correlated with overall activity impairment (r=0.22, p=0.04). As compared to patients who had MHC≤2, those with score&amp;gt;2 had significantly lower mean EQ-VAS, EQ index score, ASCQ-Me domain impacts in pain, stiffness, sleep, emotion, social funtioning, and pain episode severity, but higher fatigue score and greater absenteeism. Patients who reported chronic pain had significantly lower mean EQ VAS, EQ index score, ASCQ-Me domain impacts in pain, stiffness, sleep, emotion, social functioning, higher pain episode frequency, pain episode severity, and fatigue score, greater presenteeism score (impairment while working), overall work productivity loss and overall activity impairment than those without chronic pain. SCD subtype was not associated with HRQoL and fatigue scores. Conclusions: Hemoglobin and SCD subtype were not significantly associated with HRQoL and fatigue in this sample (possibly due to selection bias, where higher functioning patients were more likely to be selected for study participation). Fatigue in adults with SCD is moderately correlated with EQ-5D-5L scores, ASCQ-Me domains on pain, stiffness, sleep, emotion, and social functioning, as well as overall activity impairment, but weakly correlated with pain episode frequency and severity. MHC had weak correlation with EQ-5D-5L scores, ASCQ-Me domains on pain, stiffness, emotion, and social, and activity impairment. Individuals who had higher fatigue score, MHC score≥2, and reported chronic pain showed lower HRQoL and higher impairment of work productivity and activity. Future analyses will explore how multiplicity problems that SCD patients suffer impact HRQoL and work productivity and activity impairment in longitudinal data, which will identify the opportunity on intervention to improve patient care.

Title: The Impact of Recent Vaso-Occlusive Crisis on Health-Related Quality of Life in Adults with Sickle Cell Disease

Introduction: Sickle cell disease (SCD) is characterized by vaso-occlusive crises (VOCs) and a progressive clinical course, often leading to end organ damage and mortality. Individuals living with SCD with recurrent VOCs experience daily life disruptions due to recurrent pain crises, debilitating chronic pain and fatigue, which substantially impair health-related quality of life (HRQoL). The impact of a recent VOC on HRQoL has not been quantified. We investigated HRQoL impacts in adults with SCD who experienced a recent VOC (&amp;lt; 1 week) in comparison to overall adults with SCD with recurrent VOCs. Methods: A mixed-methods study was conducted to quantify the HRQoL, work impacts, and perceived health inequalities of individuals with SCD with recurrent VOCs. The study consisted of qualitative interviews and an online longitudinal survey administered at 3 timepoints (month 0, 3, and 6) in the US, UK, France, Germany, and Italy. Patient advocacy groups used multi-channel outreach to invite participants, who were required to meet the eligibility criteria and provide consent. Key eligibility criteria included recurrent VOCs defined as ≥ 2 VOCs/year in each of the 2 years prior to enrollment requiring a medical facility interaction and administration of pain medication or red blood cell transfusion. The survey included multiple patient-reported outcome (PROs) measures: the Functional Assessment of Cancer Therapy - Bone Marrow Transplant (FACT-BMT) inclusive of the FACT-General (FACT-G), EuroQol- 5 Dimension 5-Level (EQ-5D-5L), 11-point pain numerical rating scale (NRS), Adult Sickle Cell Quality of Life Measurement Information System (ASCQ-Me), and the Work Productivity and Activity Impairment (WPAI) questionnaire. In this post-hoc analysis study participants with a current or recent VOC (&amp;lt; 1 week ago) were identified based on ASCQ-Me responses (herein referred to as recent VOC). The HRQoL impact of a recent VOC was assessed by descriptively comparing PRO scores between those with a recent VOC and the overall population of adults with SCD with recurrent VOCs (herein referred to as overall population). Results: The survey was completed by 142 participants with SCD (≥ 18 years) with 139 providing time since last VOC living in the US (n=82) and UK, Germany, France, and Italy (n=57). Fifty-six (40.3%) reported a recent VOC and had a similar mean age (35.7 vs. 35.3 years) and hydroxyurea use in the past month (58.9% vs. 61.9%) compared with the overall population. A higher proportion of those with a recent VOC were unemployed or unable to work due to SCD (76.8% vs. 64.7%). The mean EQ-5D VAS (0-100 scale, 100=best health) among those with a recent VOC was 49.2 (SD: 14.2), which was 16.2% and 38.8% lower relative to the overall study population (58.7 [SD: 19.4]) and the US general population (80.4 [SD: 15.6]), respectively. The overall mean EQ-5D health utility US index score (0.59 [SD: 0.27]) was much lower than the US general population (0.85 [SD: 0.21]) and further reduced among those with a recent VOC by 0.11 (0.48 [SD: 0.25]). The FACT-G total mean score was 53.6 (SD: 14.3) (0-108 scale, 108=best HRQoL) among those with a recent VOC representing a clinically meaningful reduction compared with the overall population (62.5 [SD:18.1]); with all FACT-G domain scores negatively impacted by a recent VOC. Based on the WPAI, those employed with a recent VOC (n=15) reported a mean of 35.4% (SD: 35.8%) absenteeism and 62.5% (SD: 21.8%) presenteeism, which were higher than the overall study population (24.7% [SD: 27.1%] and 42.0% [SD: 27.8%)], respectively). In the past 12 months, those with a recent VOC had a greater mean number of emergency room visits (9.6 [SD: 12.6] vs 6.2 [SD: 8.8]), hospitalizations with overnight stays (6.0 [SD: 5.7] vs. 4.0 [SD: 4.5]), and days overnight in the hospital (21.8 days [SD: 32.9] vs. 14.7 [SD: 24.7]) compared to the overall population. Conclusions: Despite current treatments, nearly 40% of adults with SCD in the surveyed population experienced a recent VOC (&amp;lt; 1 week), which has significant negative impacts on HRQoL and functional status, including the ability to work. These results demonstrate the substantial humanistic burden of those living with SCD with recurrent VOCs and the additional impairment of a recent VOC. Novel treatments that reduce or eliminate VOCs may provide an opportunity to improve health inequalities, HRQoL, and address unmet needs in this patient population.

Real-World Treatment Outcomes of Paroxysmal Nocturnal Hemoglobinuria (PNH) Patients Treated with Pegcetacoplan and Complement Protein 5 Inhibitors (C5i)

Paroxysmal nocturnal hemoglobinuria (PNH) is a rare, potentially fatal disease characterized by complement-mediated hemolysis which clinically manifests with symptoms including fatigue, weakness and, in severe cases, thrombosis. Previous disease-modifying treatments solely comprised of complement protein 5 inhibitors (C5i) which effectively reduce intravascular hemolysis (IVH) in most patients with PNH. However, due to residual IVH and emerging extravascular hemolysis (EVH), complement protein 3 inhibitor (C3i), pegcetacoplan (PEG) has been recently approved to target the complement cascade further upstream, tackling both IVH and EVH. The aim of this study was to report real-world outcomes of PEG-treated and C5i-treated patients. Data were drawn from the Adelphi PNH Disease Specific Programme (DSP)™, a real-world, cross-sectional survey of physicians and their patients with PNH in France, Italy, Germany, Spain and the United States of America from January - November 2022. Patients were eligible for inclusion if they had received PEG for ≥1 month. Physicians recorded patient demographics, hemoglobin (Hb) levels, treatment administration and hospitalizations. The same patients were invited to self-report on symptomatology, fatigue via the Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) questionnaire, and impact on work and productivity via the Work Productivity and Activity Impairment (WPAI) questionnaire. Descriptive statistics were reported for patients receiving PEG from the DSP and from previously published data describing patients receiving C5i treatment (Panse, J et al. Eur J Haematol. 2022 Oct;109(4):351-363 1; Sicre de Fontbrune F et al. Hematology. 2022 Dec;27(1):1140-1151 2). Fourteen physicians reported data for 61 patients receiving PEG. Mean (standard deviation; SD) age was 37.1 (11.3) years and 59.0% of patients were male. Mean (SD) time since diagnosis was 3.7 (3.3) years and mean (SD) time receiving PEG was 5.9 (4.0) months. All patients received 1080 mg dose of PEG, with 98.3% of patients receiving this dose twice weekly. For PEG-treated patients mean (SD) Hb from the most recent result was 11.5 (1.6) g/dL and 34.4% of patients had Hb &amp;gt;12 g/dL. Published literature based on a real-world survey reported C5i-treated patients had a mean (SD) Hb of 10.2 (2.0) g/dL and 14.3% had Hb &amp;gt;12 g/dL 1. C5i-treated patients had mean (SD), 0.4 (1.0) emergency room (ER) visits during the 12-months prior to data collection 2. In the DSP sample, no patients required ER visits during the time they were receiving PEG. Thirty PEG-treated patients provided self-reported data with less reporting to experience shortness of breath (23.3% vs 46.5%), difficulty swallowing (10.0% vs 19.7%) and abdominal pain (16.7% vs 19.7%) at the time of survey than C5i-treated patients 1. At the time of survey 83.3% of PEG-treated patients reported fatigue (63.4% C5i patients in the literature 1). PEG-treated patients reported a mean (SD) FACIT-F score of 37.4 (8.6). C5i-treated patients reported 35.0 (13.7) 1. 73.5% of PEG-treated patients were employed, 2.5% reported absenteeism and 22.4% reported overall activity impairment. For previous literature regarding C5i patients this was 57.7%, 10.2% and 37.5%, respectively 1. We assessed previously published literature of C5i-treated patients and demonstrated favorable outcomes for PEG-treated patients across the endpoints assessed in this analysis. Patients receiving PEG reported higher Hb and FACIT-Fatigue scores than C5i-treated patients. More PEG-treated patients remained in paid employment and reported less impact on their daily activities than C5i-treated patients. Further research is required to explore the real-world effectiveness of PEG compared to other therapeutic options and understand how newer therapies can improve outcomes for patients with PNH.

A real world study of cough burden and quality of life of UK patients who have undergone evaluation for chronic cough

Objective Treatment options for adults with chronic cough (CC) are limited. This study reports on the health status and experiences of patients with recent healthcare evaluation for CC. Methods This prospective, UK, cross-sectional study surveyed adults with a CC evaluation within the previous 12 months. All were never smokers (or ex-smokers for ≥12 months). Subjects completed five validated patient-reported outcome measures: cough visual analogue scale (VAS), EuroQoL 5 dimension, 5 level (EQ-5D-5L), EQ-5D VAS, Leicester Cough Questionnaire (LCQ), and Work Productivity and Activity Impairment (WPAI) questionnaire. Results A total of 101 participants were recruited: 71% were female, mean age was 54.9 ± 15.2 years. Median (IQR) CC duration was 36 (11, 120) months. Mean self-reported CC severity (Cough-VAS) was 51.3 ± 22.9 over the previous 2 weeks and 62.9 ± 23.7 on the worst day of coughing. EQ-5D values were lower for CC patients than population norms. Subanalyses revealed that EQ-5D and LCQ scores were significantly impacted by CC duration and the number of healthcare providers (HCPs) visited. WPAI analysis showed a 27.6% work time impairment because of participants’ CC. The number of HCP attendances ranged from 1 to 10 (3.3 ± 2.8) before diagnosis was confirmed. Treatment was being prescribed to 87% of participants and comprised mainly steroids (nasal [19%] and inhaled [25%]), beta agonists (24%), and proton pump inhibitors (21%); 44% of patients were dissatisfied with treatment efficacy. Conclusion Real-world data from a nationally representative UK population show significant unmet needs associated with CC, including multiple healthcare visits and limited treatment effectiveness, resulting in inadequate cough control and impaired health status.

[Artículo traducido] Gravedad de la psoriasis, calidad de vida relacionada con la salud, productividad laboral y deterioro de la actividad en pacientes con psoriasis moderada a grave que reciben tratamiento sistémico: datos de la vida real de la práctica clínica en España

Background and objectiveThe treatment of psoriasis should not only focus on skin affectations but also weigh the parameters for health-related quality of life (HRQoL), thereby tackling the concept of cumulative life course impairment (CLCI) and treating the patient from a holistic perspective. The CRYSTAL study aimed to characterize psoriasis with real-word data from Spanish clinical practice in patients with moderate to severe disease who received continuous systemic treatment for at least 24 weeks by using the absolute Psoriasis Area and Severity Index (PASI) score and its correlation to HRQoL. Material and methodsThis was a non-interventional, cross-sectional study conducted in 30 centers in Spain, with 301 patients between the ages of 18 and 75 years. The study collected data regarding current treatment and absolute PASI and their relationship to HRQoL using the Dermatology Life Quality Index (DLQI), to activity impairment using the Work Productivity and Activity Impairment (WPAI) questionnaire, and to treatment satisfaction. ResultsThe mean (SD) age was 50.5 (12.5) years, with a duration of disease of 14 (14.1) years. The mean (SD) absolute PASI reported was 2.3 (3.5), with 28.7% of patients presenting with PASI from >1 to ≤3 and 22.6% with PASI>3. Higher PASI scores were associated with higher DLQI (p<0.001) and WPAI scores and lower levels of treatment satisfaction (p<0.001). ConclusionsThese data indicate that achieving lower absolute PASI values may correlate not only with better HRQoL but also with better work productivity and treatment satisfaction.