Health-related quality of life, work productivity, and persisting challenges in treated ulcerative colitis patients: a Japanese National Health and Wellness Survey

Sakiko Hiraoka; Zhezhou Huang; Fei Qin; Fatima Megala Nathan Arokianathan; Kiran Davé; Shweta Shah; Hyunchung Kim

doi:10.5217/ir.2024.00104

Articles

Page Path: HOME > Intest Res > Ahead-of print articles > Article

Original Article Health-related quality of life, work productivity, and persisting challenges in treated ulcerative colitis patients: a Japanese National Health and Wellness Survey: Sakiko Hiraoka¹, Zhezhou Huang², Fei Qin², Fatima Megala Nathan Arokianathan^3,, Kiran Davé⁴, Shweta Shah⁵, Hyunchung Kim⁶; DOI: https://doi.org/10.5217/ir.2024.00104
Published online: January 2, 2025

¹Department of Gastroenterology, Okayama University, Okayama, Japan

²Cerner Enviza, Shanghai, China

³Oracle Life Sciences, Singapore

⁴Bristol Myers Squibb, Uxbridge, UK

⁵Bristol Myers Squibb, Princeton, NJ, USA

⁶Bristol Myers Squibb, Tokyo, Japan

Correspondence to Fatima Megala Nathan Arokianathan, Oracle Life Sciences, Oracle Corporation Singapore Pte. Ltd., Fusionopolis Galaxis Level 12, 1 Fusionopolis Place, (S) 138522, Singapore. E-mail: megala.nathan.arokianathan@oracle.com

• Received: July 2, 2024 • Revised: October 9, 2024 • Accepted: October 23, 2024

This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/4.0/) which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.

300 Views
34 Download

Full Article

Download PDF

Abstract
INTRODUCTION
METHODS
RESULTS
DISCUSSION
NOTES
Supplementary Material
REFERENCES

Abstract

Background/Aims
Despite available treatments for ulcerative colitis (UC), unmet needs persist among patients in Japan. This study explored the health-related quality of life (HRQoL), work productivity and activity impairment (WPAI), indirect cost, and unmet needs among treated UC patients in Japan.
Methods
This cross-sectional, observational study utilized data from the online 2017, 2019, and 2021 Japan National Health and Wellness Survey. Respondents were aged ≥ 18 years and had undergone or were on UC treatment (5-aminosalicylic acid, steroids, immunomodulators/immunosuppressants, biologics/Janus kinase inhibitors [JAKi]). Demographic, general health, and clinical characteristics, medication adherence, HRQoL, WPAI, and indirect cost were collected and analyzed.
Results
Among 293 treated UC patients, 83.6% were non-biologic/JAKi users, 29.0% had UC ≥ 15 years, 34.8% had moderate-to-severe disease severity, 55.3% experienced ≥ 1 persisting UC symptom, and 91.5% reported UC as bothersome to an extent. Patients reported EuroQoL visual analog scale score of 68.1 and ≥ 35% reported anxiety and depression. Mean work productivity loss was 29.3%, resulting in an annual mean indirect loss of 1.1 million JPY (45.3 thousand USD) per person. Higher WPAI (impairment) was associated with being male, moderate-to-severe disease severity, and low treatment adherence (P<0.05). Biologics/JAKi users had higher work impairment, and IM/IS users had higher activity impairment than 5-aminosalicylic acid users (P<0.05).
Conclusions
Despite treatment, Japanese UC patients experienced high disease burden and persistent disease-related challenges. Overall HRQoL were lower than the mean healthy population and work productivity impairment led to high indirect costs. The findings suggest the importance of new interventions for optimizing UC outcomes.
Keywords: Quality of life; Presenteeism; Absenteeism; Ulcerative colitis; Japan

INTRODUCTION

Ulcerative colitis (UC) is a chronic idiopathic inflammatory bowel disease (IBD) characterized by superficial mucosal inflammation and ulcers on the inner lining of the colon [1]. The global prevalence varies, with the highest rates observed in developed countries. In North America and Europe, the prevalence of UC has been reported as approximately 200–500 cases per 100,000 individuals [2]. In Japan, despite UC being designated as an intractable disease, the annual prevalence in 2014 showed a 10-fold increase in 10 years, while the incidence rate rose from 0.6 per 100,000 person-years in 2010 to 12.7 per 100,000 person-years in 2019, representing a more than 10-fold increase in 9 years [3].

Current treatment guidelines in Japan include early remission and recurrence prevention. As the most common treatment for remission induction therapy, 5-aminosalicylic acid (5-ASA) is prescribed for UC patients with mild-to-moderate severity. When inadequate response or intolerance to standard 5-ASA treatment occurs, steroids such as budesonide and prednisone are recommended to induce remission, while carotegrast methyl may be prescribed for moderate severity UC patients [4-7]. In steroid-refractory or steroid-dependent UC patients, the use of treatments such as immunomodulators/immunosuppressants (IMs/ISs) and biologic drugs have increased in recent years [8,9]. However, despite the availability of these different treatment types, unmet needs persist with limited Japanese studies reporting the impact of treatment types on patients work productivity and activity impairment (WPAI) and health-related quality of life (HRQoL) [10-12]. While the use of 5-ASA is effective in induction of remission of moderate UC, remission appears dose-dependent and required a prolonged duration of treatment compared to steroids [13]. For steroids and certain biologicals (e.g., adalimumab and golimumab), prolonged use was associated with an increased risk of adverse effects, centered along increased risk of infections [14-16].

The impact of UC on mental and emotional health issues stems from the disease outcomes, including abdominal pain and diarrhea during the disease’s active phase, disrupting a patient’s HRQoL [17]. While bowel urgency and incontinence are the 2 key elements of patient burden in UC, a study among the Japanese patient population revealed that both elements were underreported due to a potential discomfort in relaying the symptoms to healthcare professionals [18]. Moreover, studies have reported patients with moderate-to-severe UC having increased morbidity, poorer HRQoL, and severe impairment of social engagements [18,19]. Studies on UC have reported undesired outcomes impacting patients’ professional lives, with effects on increased absence and lack of confidence in the workplace [20]. Patients across Europe and Japan reported missing work due to worrying about the symptoms of UC rather than experiencing the actual symptoms [21,22]. Furthermore, studies have indicated that Japanese patients with IBD experienced greater mental strain. This increased burden is attributed to a “self-critical” mindset regarding their condition and a prevalent stigma against seeking counseling, unlike patients in other regions [22].

Although advanced treatments (e.g., ustekinumab and tofacitinib) have shown clinical benefits, the high costs have not always met the financial allocations of disease management and healthcare resources [23]. A study from the United States revealed that the annual mean cost of $1,077 (in US dollars) per patient, resulting in cost of illness of $22 million [24]. In Japan, a claims data study reported an annual medical cost of $1,457 per patient, with $249 million attributed towards total treatment cost [25].

A study reported the impact of UC on the indirect cost among Japanese patients surmounted to approximately 2 million Japanese Yen (¥), further emphasizing the disease burden in working individuals [26]. Hence, there remains a high unmet need for treatments, especially as the disease severity increases, increases on the healthcare burden and negative impact on society is observed as well.

While large epidemiological studies have been conducted across various regions in Asia, limited real-world evidence of the disease burden in Japanese UC patients remains [10,27,28]. Hence, the objective was to understand the disease burden and current unmet needs in UC patients treated with the standard of care and investigate how certain factors (e.g., treatment type, disease severity, and differences in working age groups) may impact the HRQoL and work productivity loss in treated UC patients utilizing data from the Japan National Health and Wellness Survey (NHWS). Additionally, the study aimed to quantify work productivity loss and indirect cost among employed patients with UC.

METHODS

1. Study Design

This was a retrospective, cross-sectional, observational study utilizing existing data from the Japan NHWS database of online survey responses conducted in 2017, 2019, and 2021. As an online-based questionnaire, it is self-administered to adults aged ≥ 18 years. A flowchart representing the study population is as detailed in Fig. 1. It consists of a base survey component used to assess demographics, disease experienced, and diagnosed, and measures such as HRQoL and WPAI [29], capturing vitality through the widely used 12/32-item Short Survey Instrument (SF-12/32) [30,31]. The survey is projected to reflect the general population using known population incidences for key characteristics. Eligible respondents are recruited through an existing, general purpose, internet-based consumer panel that is maintained by Lightspeed Research and its partnering companies [32]. The added uniqueness of the survey is the recruitment of panel members that are not strictly based on convenience but instead, such as in this study, an attempt was made to estimate the adult population distribution in Japan (e.g., age and sex). For example, in a study conducted in Japan, the sex was 52% versus 49% females in the adult population and in the panel respectively, accounting for clear similarities. Although the stratified sampling in the study did not account for additional factors (e.g., education), the NHWS sample in general, remains comparable to the population, with reference to the studied characteristics [33-35]. Furthermore, to substantiate, various peer-reviewed publications have previously compared the NHWS with other governmental sources [36-38]. The NHWS was reviewed by Pearl Institutional Review Board (Indianapolis, IN, USA; #17-KANT-150 [2017], #19-KANT-211 [2019], #21-KANT-256 [2021]) and granted exemption status. As patient identification in the database is anonymized, no personally identifiable information is included in the database and patients provided informed consent prior to participating.

2. Description of Participants

Respondents were aged ≥ 18 years, with self-reported UC and had undergone or were on treatment (5-ASA, steroids, IMs/ ISs, biologics/Janus kinase inhibitor [biologics/JAKi], or others [other unspecified UC medications]). Patients were grouped based on demographic, general health, and clinical characteristics. For exploratory analysis conducted, patients were further stratified into those who were employed and at the working age group (18–64 years) and grouped based on the above characteristics.

3. Study Variables

All variables of the study were determined based on self-reported information provided by the patients. Demographic variables included age, sex, employment status, marital status, education, and family income. Family income was dichotomized as either below or above ¥5,000,000. Specifically, the family income was reported in various categories, with the mean in 2017, 2019, and 2021 falling within the range of ¥5,000,000 to ¥5,999,999 (¥5,100,000 in 2017 and ¥5,140,000 in 2019 and 2021) [39]. Therefore, a cutoff value of ¥5,000,000 was adopted to classify family income. General health variables (e.g., body mass index, smoking status, alcohol use, exercise behavior, and Charlson Comorbidity Index [CCI]) and clinical characteristics (e.g., medication class, self-reported severity, and medication adherence) were assessed based on disease-specific questions for UC in the NHWS. Self-reported height and weight were used to calculate a standard body mass index (calculated as weight in kilograms divided by height in meters squared). The CCI represents a weighted sum of multiple comorbidities (e.g., human immunodeficiency virus/acquired-immunodeficiency disease syndrome, metastatic tumor, lymphoma), and higher total CCI scores indicate a greater burden from comorbidities [40]. Medication classes encompassed 5-ASA, steroids, IMs/ISs, biologics/JAKi, and others. Specific medication names categorized within the classes are as listed in Supplementary Table 1. Medication adherence was quantified as high (≥ 80%) or low (< 80%) based on the amount of prescribed UC medication that was consumed in the past 4 weeks. HRQoL was measured by SF-36 version 2 (SF-36v2) that provided summary mental component scores (MCS) and physical component scores (PCS). Health state utility visual analog scale (VAS) scores were obtained from the EuroQol-5-Dimension 5-Level Health Questionnaire (EQ-5D-5L) instrument, providing a generic measure of health. The WPAI questionnaire measured the impact of health on employment-related and general activities in the form of 4 metrics: absenteeism (the percentage of missed work time because of health in the past 7 days), presenteeism (the percentage of impairment experienced because of health while at work in the past 7 days), overall work impairment (an overall impairment estimate that is a combination of absenteeism and presenteeism), and activity impairment (the percentage of impairment in daily activities because of health in the past 7 days).

Depression was measured through the 9-item Patient Health Questionnaire (PHQ-9), taking into consideration patients experiences on emotional status, functionality, and concentrations in achieving tasks over a 2-week period. Responses ranged from “0” (not at all) to “3” (nearly every day). Items were scored on a continuous scale and converted to interval scores relating to none (0–4), mild-to-moderate (5–14), moderate (10–14), and severe (≥ 15) levels of depression. Anxiety was evaluated based on related feelings and the extent of severity using the 7-item Generalized Anxiety Disorder Survey (GAD-7) score. Responses ranged from “0” (not at all) to “3” (nearly every day). Items were scored on a continuous scale and converted to interval scores relating to minimal (0–4), mild-to-moderate (5–14), and severe (15–21) levels of anxiety.

Annual indirect cost of absenteeism, presenteeism, and indirect costs assessed by overall work productivity loss were calculated based on the WPAI results and publicly available age and sex stratified hourly wage rates in Japanese Yen for the years of 2017, 2019, and 2021 from the Japan Basic Survey on Wage Structure, using the human capital method [41-43]. Total weekly absenteeism costs, presenteeism costs, and indirect costs were estimated and annualized, while considering the inflation index of the respective years (2017 and 2019: 0.5%, 2021: –0.2%) [44].

4. Statistical Analysis

Descriptive statistics were applied to summarize the study measures. Continuous variables were characterized by sample size (n), mean, standard deviation (SD), standard error (SE), median, first and third quartiles (interquartile range), and/or range (minimum and maximum). Categorical variables were described using frequencies and percentages. The count of non-missing and missing data for each variable was also reported.

Bivariate analyses were performed to evaluate differences in outcomes by subgroups across various factors, including medication class, severity, age, sex, employment status, medication adherence, and diagnosis duration. Additional analyses for exploratory outcomes on WPAI and resulting annual indirect cost in those employed aged 18 to 64 years were performed. Outcomes, treated as continuous variables, were analyzed using t-tests or analysis of variance for normally distributed data and Kruskal-Wallis H tests for skewed data. For each outcome variable, group n, means, SD, and P-values were presented. Missing data were excluded from the analysis.

Generalized Linear Models (GLMs) were employed to evaluate the associations of outcomes with demographic, general health, and clinical factors. The choice of multivariable analysis was contingent on the distribution of the outcome variables. For normally distributed outcomes, such as HRQoL measures, GLMs with normal distributions and identity link functions were applied. For positively skewed variables like indirect costs, gamma link functions were utilized. Negative binomial link functions were used for skewed variables such as WPAI, PHQ-9, and GAD-7 scores, effectively correcting SEs and addressing under- or over-dispersion. Each health outcome was analyzed using a separate GLM, reporting coefficients, SEs, and P-values. Cases with missing data were excluded from the analyses, and the sample sizes for each analysis were documented. All statistical analyses were performed using SAS software (version 9.4, SAS Institute, Inc., Cary, NC, USA), and a 2-sided P<0.05 was considered statistically significant.

RESULTS

1. Treated UC Patient Characteristics and Disease Burden

This study included 293 treated UC patients of which more than half were male (55.6%) and aged 40-64 years (51.2%). About two-thirds of patients were employed (64.2%), 61.8% had a university degree or above and 47.4% earned an ≥ mean Japanese family income (¥5,000,000) (Table 1). The majority of UC patients were non-biologics/JAKi users (83.6%), with most reported as 5-ASA monotherapy users (67.2%) and 16.4% received either steroids or IMs/ISs. Patients self-reported having moderate-to-severe disease severity posttreatment (34.8%). Close to a third were living with UC for ≥ 15 years (29.0%) and more than half (55.3%) experienced ≥ 1 persisting UC symptom. Loose stool or diarrhea (28.7%), abdominal pain or cramping (19.5%), and tiredness or fatigue (18.1%) were commonly reported (Table 2).

Despite active treatment (5-ASA, steroids, IMs/ISs, and/or biologics/JAKi), 91.5% self-reported UC as bothersome, ranging from “somewhat” to “extremely” (Fig. 2A) and over a third (≥ 35%) experienced varying severity levels of depressive and/or anxiety-related symptoms (Fig. 2B). In terms of HRQoL, a mean ± SE of 68.1 ± 1.3 was reported for the EQ VAS score, while the mean scores for MCS and PCS measured by SF-36v2 were 46.3 ± 10.5 and 50.4 ± 7.2, respectively (Fig. 2C).

2. Overall WPAI and Indirect Cost Outcomes in Treated UC Patients

A total of 200 of the 293 treated UC patients reported some level of activity impairment. Of 188 employed patients, 21 patients who did not respond to the questionnaire were considered as missing values. Of the eligible 167 employed patients without missing values for overall work impairment, 54 (32.3%) patients reported no impairment, while 113 (67.7%) reported overall work impairment. Majority of employed patients reported absenteeism (mean ± SE: 5.7% ± 1.27%) and presenteeism (mean ± SE: 27.6% ± 2.06%), with 98.4% (167 patients) and 89.4% (168 patients), respectively. On mean, employed patients reported ≥ 40.0% work productivity loss in the 113 patients, resulting in a mean annual indirect cost per patient of ¥1.1 million ($10.2 thousand) (Fig. 3 and Supplementary Table 2).

Multivariate analysis conducted showed higher WPAI was associated with being male, single, having an mean family income < ¥5,000,000, being drinkers, experiencing moderate-to-severe disease severity, and having low medication adherence (P<0.05). Compared to 5-ASA users, patients on biologics/JAKi treatment reported higher overall work impairment (coefficient: 0.44, P<0.05). Higher activity impairment was associated with treated UC patients aged 18–39 years, unemployed individuals, and IM/IS users (P<0.05) (Table 3). Additionally, higher WPAI scores were observed across all metrics (P<0.05) (Supplementary Table 3) among patients with ≥ 1 persisting UC symptom compared to those without clinical symptoms.

Bivariate analyses conducted (Supplementary Table 4) were consistent with those from the multivariate regression models (e.g., age, sex, employment status, disease severity and medication adherence) (Table 3). Differences were observed in terms of medication class, where the highest overall work impairment (mean ±SD) was associated with IM/IS (42.3% ± 32.2%), followed by biologics/JAKi (40.5% ± 33.3%), and steroid (33.8% ± 30.3%) users (Supplementary Table 4). Exploratory outcomes for WPAI in those with employment and aged 18–64 years (n = 164) reported a mean ± SD overall work impairment of 30.3% ± 30.0%, with an annual indirect cost of ¥1.1 million. Detailed results are presented in Supplementary Table 5.

3. Overall HRQoL (EQ VAS and SF-36) Outcomes among Treated UC Patients

Multivariate analyses were conducted to examine the factors associated with HRQoL (EQ VAS score, MCS, and PCS scores measured by SF-36v2). Being male, aged 18-39 years, and single were associated with both lower EQ VAS and MCS scores (P<0.05). Additionally, lower educational level, being underweight, former smokers, physical inactivity, mild-to-moderate severity, and ≥ 15 years experiencing UC were associated with lower EQ VAS scores (P<0.05). Unemployment was associated with a lower MCS score, while current smokers were associated with lower PCS scores (P<0.05). Compared with patients treated with 5-ASA monotherapy, IM/IS users had lower EQ VAS and MCS scores, while steroid users had a lower PCS score (P<0.05) (Table 4). Additional analyses on the association between patients with ≥ 1 persisting UC symptom compared to those without clinical symptoms (Supplementary Table 3) revealed lower HRQoL scores (EQ VAS, MCS, and PCS; P<0.05).

Bivariate analyses conducted (Supplementary Table 6) were consistent with the multivariate regression models (e.g., disease severity, sex, and age) (Table 4). Differences were observed in medication class where the lowest EQ VAS score (59.4 ± 26.3) was observed for steroid users, and the lowest PCS (45.3 ± 11.3) scores were observed for IM/IS users (Supplementary Table 6).

DISCUSSION

This study investigated the disease burden and clinical outcomes of treated Japanese UC patients using data from the Japan NHWS database (2017, 2019, and 2021). The findings highlighted that despite active treatment, UC was bothersome to a certain degree, with more than half having reported moderate-to-severe disease severity. Additionally, patients reported impacted HRQoL and loss in work productivity, especially among the employed patients. This was further translated into a mean indirect cost of ¥1.1 million ($10.2 thousand) per patient annually, suggesting a potential financial burden, especially among the lower income patients (< ¥5.0 million, < $45.3 thousand). Our current finding is comparable to a previous study reporting a mean indirect cost of ¥1.6 million ¥ per IBD patient annually [26]. The findings, particularly those related to standard of care treatments, provided valuable insights into how the HRQoL and WPAI of UC patients varied based on currently available treatment, highlighting persisting unmet needs that would need to be addressed.

Multiple studies coincided with the current findings, highlighting the disease impact on the HRQoL among treated patients. The overall HRQoL scores reported in the current study were lower than the mean Japanese healthy population (EQ VAS: 68.1 vs. 77.8) [45], which reinforced the disease burden of UC reported in current and previous studies. This was additionally reflected by the lower MCS scores in UC patients observed in our study compared to the mean general healthy Japanese population (46.3 vs. 52.0) [26]. A previous study in Japan reported poorer HRQoL outcomes, including physical and social functional capabilities, emotional, and mental wellbeing among IBD patients compared to controls [26,46]. Furthermore, increased disease severity was associated with decreased quality of life, similarly reported in our study [10]. The current study, in conjunction with these findings, underscores that despite available UC treatments, there are unmet needs potentially in identifying and the availability of effective treatments based on symptom severity [47,48]. This echoed previous reports where UC patients experienced some form of depression or anxiety, especially with the active form or increased severity of UC [47]. Moreover, patients reported UC controlling their lives rather than them having control of the outcomes.

In the current findings, younger patients (aged 18–39 years) experienced poorer HRQoL. This could potentially be attributed to emotional challenges arising from the unpredictability of the disease, exacerbated by the need to manage symptoms alongside employment or educational responsibilities as observed in IBD patients [49,50]. This contrasts with the elderly or those who may have experienced the disease for a longer period, having established more effective management routines or having come to terms with their condition, thus reporting a higher quality of life [50]. Additionally, younger patients face societal stigma and may be perceived as incapable due to their age. Their HRQoL may be impacted by different life priorities and the potential lack of social support systems due to the self-imposed stigma [51,52]. These challenges highlight the need for more interventions to improve the quality of life among UC patients, especially in the younger population, which is generally when UC initially onsets. Hence, early intervention and optimal care to improve patient’s quality of life is warranted. This may include psychological adaptation and tailored healthcare that aligns with individual expectations of health and well-being [53,54]. The situation underscores the importance of developing better treatment options to meet the diverse needs of UC patients.

Our study reported that the majority of employed patients experienced WPAI despite treatment, similar to findings from the Japanese cohort of the UC Narrative Global Survey, that reported 80% of employed patients were impacted by UC due to the necessity of taking time off work for treatment or resulting disease symptoms, and close to a half failing to communicate their conditions to employers in fear of repercussions [55]. A previous report highlighted that close to half of the study population felt the negative impacts of IBD on their career path, advancement opportunities, and potential earnings, with more than a third having reported losing their job or resigning due to IBD [22]. Additionally, similar to our findings, it is noteworthy that work productivity impairment has been reported due to UC and its associated symptoms despite treatment, including among patients with mild severity [47]. This once again implicates the importance of innovative treatments that could target difficult-to-treat patients, providing an early and sustainable clinical remission, and underscores the importance of workplace accommodations and understanding from employers to lift the disease burden of UC patients. In addition, patients themselves should be proactive in allowing the society to understand about their disease and obtaining understanding from their employers.

The loss of work productivity has been inevitably associated with financial and societal costs [47]. Productivity impairment at the workplace due to UC was estimated at one-fifth of the mean household income (¥5.0 million, $45.3 thousand, indirect cost at ¥1.1 million) in the current study. This coincided with our study that reported higher WPAI among those with a lower mean household income. Despite available financial assistance for intractable disease, approximately ¥10.0–20.0 thousand per month of co-pay was estimated in Japanese UC patients, implying a higher work productivity impairment impacting the lower income group [56]. Previous studies reported annual indirect costs at approximately 1.5-fold higher for patients with IBD compared to controls [57], while another reported annual indirect costs amounting to ¥1.6 million [26]. Similar trends in recent years were reported in a U.S. and Europe study, with UC reported as being a burdensome disease and impacting the overall work productivity, resulting in higher indirect costs [58,59]. Previous studies have shown associations between increased symptom severity and reduced social support that predisposed increased stress, resulting in the impact on work productivity and financial difficulties [47,60]. However, there is lack of information pertaining to low socioeconomic impact on WPAI among Japanese UC patients and future studies would require further analysis to determine possible associations.

The current study findings reported poorer WPAI and HRQoL scores in patients with lower medication adherence. Many patients were on more than one UC medication, suggesting the potential need for combination therapy in achieving clinical response. Yet, the possibility of combinatory approaches hindering better adherence, preventing patients from receiving the optimal treatment outcomes have been reported [61]. Treatment adherence remains one of the important factors to be addressed among UC patients. Patients with reduced treatment adherence had twice the higher risk for relapse compared to patients with higher treatment adherence, potentially leading to a higher WPAI as a result of increased symptom severity and burden from changing medication [57]. The poor persistence to medication, reflective of suboptimal patient outcomes, could contribute to an increased burden on UC patients and the healthcare system.62,63 Furthermore, non-compliance to treatment are often multifactorial and may include reasons such as, avoidance of injections, medication load, adverse events, fear of adverse outcomes or immunosuppression and therefore requires addressing in order to improve treatment outcomes [46,64,65]. There is a need to investigate the impact of different interventions (e.g., frequency of taking medication, route of administration, number of oral treatments to obtain the necessary therapeutic dosage) leading to non-adherence [66] and introduction of new treatment that could improve adherence would be critical.

The strength of the current findings is that this is one of the very few real-world evidence-based studies assessing the unmet needs of UC treated Japanese patients from various aspects (e.g., employment status, medication types and adherence, and disease severity) and the impact on the HRQoL and WPAI based on the updated NHWS. The NHWS has been utilized in understanding the impact of a disease on individuals and financial and health resources [67-69]. Existing self-administered surveys, targeting large populations with various diseases are rare, therefore the results of the database are unique, and the current study included data that provided a good representation of the study population. This provides insights into how best to utilize available resources and select from potential emerging treatments, helping define treatment approaches for optimal benefits among Japanese UC patients. This is also one of the first studies conducted within the UC Japanese population measuring mean indirect cost due to high work productivity impairment. The recruited study population also reflected a good generalization as majority of UC patients were males, employed, and in their 40s [8] and potentially linked to the current demographic landscape of Japan [70]. The majority of patients in the study utilized conventional therapy, widely accepted by healthcare professionals, with 5-ASA monotherapy being the most prevalent treatment. This aligns with the recommendation of 5-ASA as the first-line therapy for mild-to-moderate UC as outlined in the Japanese IBD guidelines and is consistent with findings from other studies [4,71]. Hence, further supporting the generalizability of the study that is reflective of the current treatment among the Japanese UC patient population. However, this study has limitations. First, the current study results interpretation is constrained as the cross-sectional design restricts interpretations of a causal relationship between disease exposure and health outcomes. Secondly, as this was an online-based study, wherein only individuals with access and knowledge to the internet or better socioeconomic status were involved, it was not representative of the national population [72]. Furthermore, the small number of patients in certain groups may require careful consideration when interpreting the results. However, this was partially mitigated by the involvement of a clinical advisor to support the findings in such circumstances. Additionally, the self-reporting nature of this study presents with recall and self-presentation biases. Despite this, a consistent trend of results was observed, mitigating the self-reporting nature and standardized recruitment process. Moreover, the NHWS lacks an IBD-specific PRO index that limits the accuracy of disease quantification based on numerous activity indices. However, additional insights were obtained through specific UC questions (e.g., persisting UC symptoms, medication adherence and bothersome scale). Finally, it was possible that an increased likelihood of treated UC patients with significant declines in HRQoL responded to the survey, potentially leading to overrepresentation. However, the potential biasness was minimized by the employment of stratified random sampling within the survey population to ensure a true representation of the general adult Japanese population. Additionally, the findings obtained from the current study was consistent with multiple previous findings characterizing the patient-reported burden of UC in the Japanese population.

In summary, the current study highlights that despite currently available treatments a high disease burden and unmet needs affecting Japanese UC patients persist. The majority of patients reported the disease as bothersome with various persisting symptoms. The overall HRQoL scores were lower in comparison to the mean healthy Japanese population. A decrease in HRQoL was associated with patients experiencing moderate-to-severe disease severity and having the disease for ≥ 15 years, with > 30% experiencing anxiety or depression. The indirect cost due to work productivity impairment was high, amounting to approximately a fifth of the mean household income. Furthermore, the association between low treatment adherence and increased WPAI suggests the importance of new and early convenient treatments for optimizing UC outcomes. Additionally, workplace accommodations and understanding of employers and associates on UC could assist in improving work productivity among these patients.

NOTES

Funding Source

This study was supported in part by funding from Bristol Myers Squibb.

Conflict of Interest

This study was supported in part by funding from Bristol Myers Squibb.

Kim H, Davé K, and Shah S are employees of and shareholders in Bristol Myers Squibb. Huang Z and Qin F are employees of Cerner Enviza. Nathan Arokianathan FM is an employee of Oracle Life Sciences (formerly known as Cerner Enviza). Cerner Enviza was employed for the study. Hiraoka S is the clinical advisor of the study and received honorarium. Except for that, no potential conflict of interest relevant to this article was reported.

Data Availability Statement

The data that support the findings of this study are available from Cerner Enviza, but restrictions apply to the availability of these data, which were used under license for the current study, and so are not publicly available. Data are, however, available from the corresponding author, upon reasonable request and permission of Cerner Enviza.

Author Contributions

Conceptualization: Kim H, Huang Z. Data curation: Huang Z. Formal analysis: Kim H, Hiraoka S, Huang Z, Nathan Arokianathan FM, Davé K, Shah S. Validation: Qin F. Writing - original draft: Nathan Arokianathan FM. Writing - review and editing: all authors. Approval of final manuscript: all authors.

Supplementary Material

Supplementary materials are available at the Intestinal Research website (https://www.irjournal.org).

Supplementary Table 1.

List of Medications Categorized within Different Medication Classe

ir-2024-00104-Supplementary-Table-1.pdf

Supplementary Table 2.

WPAI and Annual Indirect Cost among Treated UC Patients

ir-2024-00104-Supplementary-Table-2.pdf

Supplementary Table 3.

Multivariate Analyses of WPAI and HRQoL among Treated UC Patients with ≥1 Persisting UC Symptoms

ir-2024-00104-Supplementary-Table-3.pdf

Supplementary Table 4.

Bivariate Analyses Comparisons of WPAI among Treated UC Patients by Subgroups

ir-2024-00104-Supplementary-Table-4.pdf

Supplementary Table 5.

WPAI and Annual Indirect Cost among Treated UC Patients Who Were Employed and Aged 18–64 Years

ir-2024-00104-Supplementary-Table-5.pdf

Supplementary Table 6.

Bivariate Analyses Comparisons of HRQoL among Treated UC Patients by Subgroups

ir-2024-00104-Supplementary-Table-6.pdf

Fig. 1.

Schematic of treated ulcerative colitis (UC) patients included in the study. A total of 30,001 participants were enrolled in the Japan National Health and Wellness Survey (NHWS) in 2017, 30,006 in 2019 and 30,015 in 2021. The cross-sectional survey conducted separately in 2017, 2019, and 2021 included participants who experienced UC, diagnosed by a physician, and currently using prescription medication. All other participants who did not fulfill the criteria were excluded from the study. The data from different people obtained at the time of each separate survey totaled to 293 UC patients on prescription medication.

Fig. 2.

Disease burden of ulcerative colitis (UC). (A) Patient-reported perception of UC based on bothersome levels. (B) Patient-reported depression measured by 9-item Patient Health Questionnaire (PHQ-9) and anxiety measured by 7-item Generalized Anxiety Disorder survey (GAD-7). (C) Patient-reported health-state utility measured by EuroQoL visual analog scale (EQ VAS) and health-related quality of life (HRQoL) measured by 32-Item Short Survey Instrument version 2–mental component score (MCS) and physical component score (PCS). Measurements were based on a scale of 0–100, with higher scores reflecting better health outcomes. Data are expressed as mean±standard error.

Fig. 3.

The mean work productivity and activity impairment (WPAI) and the indirect cost resulting from work productivity loss per patient/year. The sample sizes pertaining to absenteeism (n=168), presenteeism (n=185), and overall work impairment (n=167; n=54 reported 0% and n=113 reported >0%) relied on patients who provided responses to relevant questionnaires within the employed patient population. Indirect cost comprised of results of absenteeism and presenteeism costs. Data are expressed as mean±standard error. aJapanese Yen (¥1,000=$6.44).

Table 1.

Demographic and General Health Characteristics of Treated Ulcerative Colitis Patients

Variable	Subgroup	No. (%)
Demographic characteristics
Sex	Male	163 (55.6)
	Female	130 (44.4)
Age (yr)	18–39	86 (29.4)
	40–64	150 (51.2)
	≥ 65	57 (19.5)
Marital status	Married/Living with partner	172 (58.7)
	Single, never married/divorced/separated/widowed	120 (41.0)
	Unknown	1 (0.3)
Education level	High school degree or below	98 (33.5)
	University degree or above	181 (61.8)
	Unknown	14 (4.8)
Income level	≥ Japanese mean family income (¥5,000,000)^a	139 (47.4)
	< Japanese mean family income (¥5,000,000)^a	121 (41.3)
	Unknown	33 (11.3)
Employment status	Employed	188 (64.2)
	Unemployed	105 (35.8)
General health characteristics
Body mass index (kg/m²)	Underweight (< 18.5)	47 (16.0)
	Normal (18.5–24.9)	183 (62.5)
	Overweight or obese (≥ 25)	57 (19.5)
	Unknown	6 (2.1)
Smoking status	Non-smoker	169 (57.7)
	Former smoker	61 (20.8)
	Current smoker	63 (21.5)
Alcohol use	Drinker	165 (56.3)
	Non-drinker	128 (43.7)
Times of vigorous exercise in the past month	None	171 (58.4)
	1–11 times	76 (25.9)
	≥ 12 times	46 (15.7)
CCI, mean ± SD		0.37 ± 2.40

^a Japanese Yen (¥1,000=$6.44).

CCI, Charlson Comorbidity Index; SD, standard deviation.

Table 2.

Clinical Characteristics of Treated UC Patients

Variable	Subgroup	No. (%)
Medication class	5-ASA mono	197 (67.2)
	Steroid	34 (11.6)
	IM/IS	14 (4.8)
	Biologics/JAKi	30 (10.2)
	Other	18 (6.1)
Severity of UC^a	Mild	191 (65.2)
	Moderate	84 (28.7)
	Severe	18 (6.1)
Medication adherence^b	High (≥ 80%)	176 (60.1)
	Low (< 80%)	34 (11.6)
	Unknown	83 (28.3)
Time since diagnosis (yr)	< 5	83 (28.3)
	5–14	105 (35.8)
	≥ 15	85 (29.0)
	Unknown	20 (6.8)
Use of another medication prior to current medication	Yes	99 (33.8)
	No	194 (66.2)
Treatment type of those who reported “yes” to the prior medication use?^c	5-ASA mono	55 (55.6)
	Steroid	14 (14.1)
	IM/IS	7 (7.1)
	Biologics/JAKi	17 (17.2)
	Other	6 (6.1)
Current existing UC symptoms	≥ 1 persisting UC symptom	162 (55.3)
	Loose stool/diarrhea	84 (28.7)
	Abdominal pain/cramping	57 (19.5)
	Tired/fatigue	53 (18.1)
	Blood in stool	48 (16.4)
	Abdominal bloating	40 (13.7)
	Feel the need to have bowel movement	38 (13.0)
	soon after eating
	Frequent bowel movements	35 (11.9)
	Mucus in stool	34 (11.6)
	Constantly feel the need to pass stool	27 (9.2)
	Urgency of bowel movements	25 (8.5)
	Joint pain	20 (6.8)
	Weight loss	13 (4.4)
	Loss of appetite	11 (3.8)
	Nighttime bowel movements	11 (3.8)
	Other^d	26 (8.9)

^a The level of self-reported severity of condition when using medication.

^b The amount of prescribed UC medication taken in the past 4 weeks.

^c The denominator is the number of patients who answered “Yes” to the question “Use of another medication prior to current medication.”

^d Leg ulcers and rashes, flatulence, vomiting, eye pain/redness, mouth ulcers, nausea, and other than those listed.

UC, ulcerative colitis; 5-ASA mono, 5-aminosalicylic acid monotherapy; IM/IS, immunomodulator/immunosuppressant; JAKi, Janus kinase inhibitors.

Table 3.

Multivariate Analyses of WPAI among Treated UC Patients

Variable	Absenteeism % (n=168)^a			Presenteeism % (n=185)^a			Overall work impairment % (n=167)^a			Activity impairment % (n=293)
Variable	Coeff	SE	P-value	Coeff	SE	P-value	Coeff	SE	P-value	Coeff	SE	P-value
Demographic characteristics
Sex (ref. male)
Female	–1.0	0.2	< 0.05	–0.2	0.1	< 0.05	–0.3	0.1	< 0.05	–0.1	0.0	< 0.05
Age (ref. 18–39 yr)
40–64 yr	–1.7	0.2	< 0.05	–0.1	0.1	0.12	0.0	0.1	0.86	–0.1	0.0	< 0.05
≥ 65 yr	0.4	0.2	0.05	–0.2	0.1	< 0.05	–0.1	0.1	0.12	–0.3	0.1	< 0.05
Marital status (ref. married/living with a partner)
Single/never married/divorced/separated/widowed	0.9	0.3	< 0.05	0.2	0.1	< 0.05	0.3	0.1	< 0.05	0.2	0.0	< 0.05
Education level (ref. high school degree/below)
University degree or above	0.6	0.2	< 0.05	0.1	0.1	0.14	0.3	0.1	< 0.05	–0.1	0.0	< 0.05
Income level (ref. ≥ mean family income 5,000,000¥)^b
< Mean family income 5,000,000¥^b	1.1	0.2	< 0.05	0.4	0.1	< 0.05	0.6	0.1	< 0.05	0.1	0.0	< 0.05
Employment status (ref. not employed)
Employed										–0.2	0.0	< 0.05
General health characteristics
BMI (ref. underweight, BMI < 18.5 kg/m²)
Normal (BMI 18.5–24.9 kg/m²)	0.1	0.2	0.77	0.1	0.1	< 0.05	0.2	0.1	< 0.05	0.1	0.0	< 0.05
Overweight or obese (BMI ≥ 25.0 kg/m²)	0.3	0.3	0.21	–0.1	0.1	0.22	0.0	0.1	0.62	0.0	0.1	0.88
Smoking status (ref. non-smoker)
Former smoker	–0.2	0.3	0.33	0.3	0.1	< 0.05	0.1	0.1	0.15	0.1	0.0	0.05
Current smoker	–0.1	0.2	0.79	0.2	0.1	< 0.05	0.1	0.1	0.07	0.1	0.0	0.11
Alcohol use (ref. non-drinker)
Drinker	–0.2	0.2	0.36	0.4	0.1	< 0.05	0.3	0.1	< 0.05	0.5	0.0	< 0.05
Times of vigorous exercise in past month (ref. none)
1–11 times	–2.6	0.3	< 0.05	0.0	0.0	0.45	0.0	0.1	0.45	–0.3	0.0	< 0.05
≥ 12 times	–2.1	0.3	< 0.05	0.4	0.1	< 0.05	0.1	0.1	0.07	0.1	0.0	0.16
Charlson Comorbidity Index	0.1	0.0	< 0.05	0.0	0.0	< 0.05	0.1	0.0	< 0.05	–0.1	0.0	< 0.05
Clinical characteristics
Medication class (ref. 5-ASA mono)
Steroid	2.0	0.3	< 0.05	–0.3	0.1	< 0.05	–0.1	0.1	0.14	0.1	0.1	0.06
IM/IS	0.6	0.7	0.35	–0.4	0.1	< 0.05	–0.3	0.1	< 0.05	0.3	0.1	< 0.05
Biologics/JAKi	2.1	0.3	< 0.05	0.3	0.1	< 0.05	0.4	0.1	< 0.05	0.1	0.1	0.06
Other	–3.2	0.5	< 0.05	–1.1	0.1	< 0.05	–1.0	0.1	< 0.05	–0.7	0.1	< 0.05
Severity of UC (ref. mild)^c
Moderate	–0.3	0.2	0.17	0.6	0.0	< 0.05	0.5	0.0	< 0.05	0.7	0.0	< 0.05
Severe	2.6	0.5	< 0.05	0.8	0.1	< 0.05	0.8	0.1	< 0.05	0.4	0.1	< 0.05
Medication adherence (ref. low)^d
High	–2.5	0.2	< 0.05	–0.6	0.1	< 0.05	–0.7	0.1	< 0.05	–0.6	0.1	< 0.05
Duration of UC (ref. < 5 yr)
5–14 yr	–0.5	0.2	< 0.05	0.0	0.1	0.87	0.0	0.1	0.55	0.1	0.0	0.07
≥ 15 yr	2.7	0.3	< 0.05	–0.2	0.1	< 0.05	0.0	0.1	0.89	0.0	0.0	0.95

^a The sample sizes pertaining to absenteeism, presenteeism, and overall work impairment rely on respondents who provided responses to relevant questionnaires within the employed patient population.

^b Japanese Yen (¥1,000=$6.44).

^c The level of self-reported severity of condition when using medication.

^d The amount of prescribed UC medication taken in the past 4 weeks.

WPAI, work productivity and activity impairment; UC, ulcerative colitis; Coeff, coefficient; SE, standard error; BMI, body mass index; 5-ASA mono, 5-aminosalicylic acid monotherapy; IM/IS, immunomodulator/immunosuppressant; JAKi, Janus kinase inhibitors.

Table 4.

Multivariate Analyses of HRQoL among Treated UC Patients

Variable	EQ VAS (n = 293)			MCS (n = 293)			PCS (n = 293)
Variable	Coeff	SE	P-value	Coeff	SE	P-value	Coeff	SE	P-value
Demographic characteristics
Sex (ref. male)
Female	0.1	0.0	< 0.05	0.1	0.0	< 0.05	0.0	0.0	0.08
Age (ref. 18–39 yr)
40–64 yr	0.0	0.0	0.92	0.1	0.0	0.06	0.0	0.0	0.09
≥ 65 yr	0.1	0.0	< 0.05	0.2	0.1	< 0.05	0.0	0.0	0.59
Marital status (ref. married/living with a partner)
Single/never married/divorced/separated/widowed	–0.2	0.0	< 0.05	–0.1	0.0	< 0.05	0.0	0.0	0.85
Education level (ref. high school degree or below)
University degree or above	0.1	0.0	< 0.05	0.0	0.0	0.19	0.0	0.0	0.28
Income level (ref. ≥ mean family income, 5,000,000¥)^a
< Mean family income, 5,000,000¥^a	0.0	0.0	0.06	–0.1	0.0	0.18	0.0	0.0	0.12
Employment status (ref. not employed)
Employed	0.0	0.0	0.58	0.1	0.0	< 0.05	0.0	0.0	0.12
General health characteristics
BMI (ref. underweight BMI < 18.5 kg/m²)
Normal (BMI 18.5–24.9 kg/m²)	0.1	0.0	< 0.05	0.0	0.0	0.60	0.0	0.0	0.44
Overweight or obese (BMI ≥ 25.0 kg/m²)	0.0	0.0	0.46	0.0	0.1	0.74	0.0	0.0	0.60
Smoking status (ref. non-smoker)
Former smoker	–0.1	0.0	< 0.05	0.1	0.0	0.18	–0.1	0.0	0.05
Current smoker	0.0	0.0	0.32	0.0	0.0	0.64	–0.1	0.0	0.02
Alcohol use (ref. non-drinker)
Drinker	–0.1	0.0	0.17	–0.1	0.0	0.05	0.0	0.0	0.73
Times of vigorous exercise in past month (ref. none)
1–11 times	0.1	0.0	< 0.05	0.0	0.0	0.33	0.0	0.0	0.37
≥ 12 times	0.1	0.0	< 0.05	0.0	0.0	0.36	0.0	0.0	1.00
Charlson Comorbidity Index	0.0	0.0	0.88	0.0	0.0	0.05	0.0	0.0	0.21
Clinical characteristics
Medication class (ref. 5-ASA mono)
Steroid	0.0	0.0	0.19	0.0	0.1	0.71	–0.1	0.0	0.03
IM/IS	–0.1	0.0	< 0.05	–0.3	0.1	< 0.05	0.0	0.0	0.29
Biologics/JAKi	0.0	0.0	0.33	–0.1	0.1	0.20	0.0	0.0	0.75
Other	–0.1	0.0	0.06	0.0	0.1	0.98	0.0	0.0	0.94
Severity of UC (ref. mild)^b
Moderate	–0.1	0.0	< 0.05	0.0	0.0	0.32	–0.1	0.0	< 0.05
Severe	–0.2	0.1	< 0.05	0.0	0.1	0.74	0.0	0.0	0.50
Medication adherence (ref. low)^c
High	0.1	0.0	0.14	0.0	0.1	0.49	0.1	0.0	0.07
Duration of UC (ref. < 5 yr)
5–14 yr	0.0	0.0	0.45	0.0	0.0	0.49	0.0	0.0	0.18
≥ 15 yr	–0.1	0.0	< 0.05	–0.1	0.0	0.21	0.0	0.0	0.13

^a Japanese Yen (¥1,000=$6.44).

^b The level of self-reported severity of condition when using medication.

^c The amount of prescribed UC medication taken in the past 4 weeks.

HRQoL, health-related quality of life; UC, ulcerative colitis; EQ VAS, EuroQol visual analog scale; MCS, mental component score; PCS, physical component score; Coeff, coefficient; SE, standard error; BMI, body mass index; 5-ASA mono, 5-aminosalicylic acid monotherapy; IM/IS, immunomodulator/immunosuppressant; JAKi, Janus kinase inhibitors.

REFERENCES

1. Gajendran M, Loganathan P, Jimenez G, et al. A comprehensive review and update on ulcerative colitis. Dis Mon 2019;65:100851.Article PubMed
2. Ng SC, Shi HY, Hamidi N, et al. Worldwide incidence and prevalence of inflammatory bowel disease in the 21st century: a systematic review of population-based studies. Lancet 2017;390:2769–2778.Article PubMed
3. Puri AS. Epidemiology of ulcerative colitis in South Asia. Intest Res 2013;11:250–255.Article
4. Nakase H, Uchino M, Shinzaki S, et al. Evidence-based clinical practice guidelines for inflammatory bowel disease 2020. J Gastroenterol 2021;56:489–526.Article PubMed PMC PDF
5. Sandborn WJ, Bosworth B, Zakko S, et al. Budesonide foam induces remission in patients with mild to moderate ulcerative proctitis and ulcerative proctosigmoiditis. Gastroenterology 2015;148:740–750.e2.Article PubMed
6. Sugiura T, Andou A, Hosoi Y, Koyama T. Pharmacological and clinical data of oral alpha 4 integrin antagonist, carotegrast methyl, CAROGRA. Nihon Yakurigaku Zasshi 2023;158:203–210.PubMed
7. Department of Gastroenterology, Kyorin University School of Medicine. Diagnostic criteria and treatment guidelines for ulcerative colitis and Crohn’s disease [Internet]. c2024;[cited 2024 Oct 1]. http://www.ibdjapan.org/pdf/doc15.pdf.
8. Ferretti F, Cannatelli R, Monico MC, Maconi G, Ardizzone S. An update on current pharmacotherapeutic options for the treatment of ulcerative colitis. J Clin Med 2022;11:2302.Article PubMed PMC
9. Lasa JS, Olivera PA, Danese S, Peyrin-Biroulet L. Efficacy and safety of biologics and small molecule drugs for patients with moderate-to-severe ulcerative colitis: a systematic review and network meta-analysis. Lancet Gastroenterol Hepatol 2022;7:161–170.Article PubMed
10. Kuwabara H, Kato M, Yamabe K. The relationship between disease severity and health-related quality of life in patients with ulcerative colitis in Japan. Value Health 2019;22:S625.
11. Hagelund LM, Elkjær Stallknecht S, Jensen HH. Quality of life and patient preferences among Danish patients with ulcerative colitis: results from a survey study. Curr Med Res Opin 2020;36:771–779.Article PubMed
12. Nasr S, Dahmani W, Jaziri H, et al. Exploring work productivity loss in patients with inflammatory bowel disease. Future Sci OA 2023;9–FSO872.Article
13. Cai Z, Wang S, Li J. Treatment of inflammatory bowel disease: a comprehensive review. Front Med 2021;8:765474.Article
14. Nakamura S, Asano T, Tsuchiya H, et al. Real-world data for golimumab treatment in patients with ulcerative colitis in Japan: interim analysis in post-marketing surveillance. Intest Res 2022;20:329–341.Article PubMed PDF
15. Rider P, Carmi Y, Cohen I. Biologics for targeting inflammatory cytokines, clinical uses, and limitations. Int J Cell Biol 2016;2016:9259646.Article PubMed PMC PDF
16. Singh S, Facciorusso A, Dulai PS, Jairath V, Sandborn WJ. Comparative risk of serious infections with biologic and/or immunosuppressive therapy in patients with inflammatory bowel diseases: a systematic review and meta-analysis. Clin Gastroenterol Hepatol 2020;18:69–81.e3.Article PubMed
17. Healthline. Ulcerative colitis and diarrhea: symptoms, triggers and treatment [Internet]. c2022;[cited 2023 Dec 15]. https://www.healthline.com/health/ulcerative-colitis/ulcerative-colitis-and-diarrhea.
18. Hibi T, Ishibashi T, Ikenoue Y, Yoshihara R, Nihei A, Kobayashi T. Ulcerative colitis: disease burden, impact on daily life, and reluctance to consult medical professionals: results from a Japanese internet survey. Inflamm Intest Dis 2020;5:27–35.Article PubMed PMC PDF
19. Van Assche G, Peyrin-Biroulet L, Sturm A, et al. Burden of disease and patient-reported outcomes in patients with moderate to severe ulcerative colitis in the last 12 months: multicenter European cohort study. Dig Liver Dis 2016;48:592–600.Article PubMed
20. Dubinsky MC, Watanabe K, Molander P, et al. Ulcerative colitis narrative global survey findings: the impact of living with ulcerative colitis-patients’ and physicians’ view. Inflamm Bowel Dis 2021;27:1747–1755.Article PDF
21. Lönnfors S, Vermeire S, Greco M, Hommes D, Bell C, Avedano L. IBD and health-related quality of life: discovering the true impact. J Crohns Colitis 2014;8:1281–1286.Article PubMed
22. Ueno F, Nakayama Y, Hagiwara E, Kurimoto S, Hibi T. Impact of inflammatory bowel disease on Japanese patients’ quality of life: results of a patient questionnaire survey. J Gastroenterol 2017;52:555–567.Article PubMed PDF
23. Saruta M, Kawaguchi I, Ogawa Y, et al. Assessing the economics of biologic and small molecule therapies for the treatment of moderate to severe ulcerative colitis in Japan: a cost per responder analysis of upadacitinib. J Med Econ 2024;27:566–574.Article PubMed
24. Pakdin M, Zarei L, Bagheri Lankarani K, Ghahramani S. The cost of illness analysis of inflammatory bowel disease. BMC Gastroenterol 2023;23:21.Article PubMed PMC PDF
25. Yamabe K, Kuwabara H, Inoue S, Kobayashi M. Burden of ulcerative colitis in Japan. Value Health 2017;20–A497.Article
26. Yamabe K, Liebert R, Flores N, Pashos CL. Health-related quality of life outcomes and economic burden of inflammatory bowel disease in Japan. Clinicoecon Outcomes Res 2019;11:221–232.PubMed PMC
27. Park SH. Update on the epidemiology of inflammatory bowel disease in Asia: where are we now? Intest Res 2022;20:159–164.Article PubMed PMC PDF
28. Wei SC, Sollano J, Hui YT, et al. Epidemiology, burden of disease, and unmet needs in the treatment of ulcerative colitis in Asia. Expert Rev Gastroenterol Hepatol 2021;15:275–289.Article PubMed
29. Oracle. Patient-reported healthcare evidence [Internet]. c2024;[cited 2024 Dec 11]. https://www.oracle.com/a/ocom/docs/industries/life-sciences/factsheet-nhws-patient-reportedhealthcare-evidence.pdf.
30. Ware JE, Kosinski M, Keller SD. SF-12: how to score the SF-12 physical and mental health summary scales. Boston: Health Institute, New England Medical Center, 1998.
31. Turner-Bowker D, Hogue SJ. Short Form 12 Health Survey (SF-12). In: Michalos AC, ed. Encyclopedia of quality of life and well-being research. Dordrecht: Springer Netherlands, 2014:5954–5947.
32. Lightspeed. LIGHTSPEED Research [Internet]. c2024;[cited 2024 Feb 20]. https://www.lightspeedresearch.com.au/.
33. Fukuhara S, Bito S, Green J, Hsiao A, Kurokawa K. Translation, adaptation, and validation of the SF-36 Health Survey for use in Japan. J Clin Epidemiol 1998;51:1037–1044.Article PubMed
34. Liu GG, DiBonaventura Md, Yuan Y, et al. The burden of illness for patients with viral hepatitis C: evidence from a national survey in Japan. Value Health 2012;15(1 Suppl): S65–S71.Article PubMed
35. Sadosky AB, DiBonaventura M, Cappelleri JC, Ebata N, Fujii K. The association between lower back pain and health status, work productivity, and health care resource use in Japan. J Pain Res 2015;8:119–130.PubMed PMC
36. Quick S. International data base. POPIN Bull 1984;(6-7):21–50.
37. Gore M, Sadosky A, Stacey BR, Tai KS, Leslie D. The burden of chronic low back pain: clinical comorbidities, treatment patterns, and health care costs in usual care settings. Spine (Phila Pa 1976) 2012;37:E668–E677.PubMed
38. Sadosky AB, Taylor-Stokes G, Lobosco S, Pike J, Ross E. Relationship between self-reported low-back pain severity and other patient-reported outcomes: results from an observational study. J Spinal Disord Tech 2013;26:8–14.PubMed
39. Statistics Bureau of Japan. Results of total households [Internet]. c2024;[cited 2023 Dec 26]. https://www.stat.go.jp/english/data/sousetai/1.html.
40. Charlson ME, Pompei P, Ales KL, MacKenzie CR. A new method of classifying prognostic comorbidity in longitudinal studies: development and validation. J Chronic Dis 1987;40:373–383.Article PubMed
41. Ministry of Health; Labour and Welfare. Overview of the results of the 2021 basic survey on wage structure [Internet]. c2024;[cited 2024 Jan 12]. https://www.mhlw.go.jp/toukei/itiran/roudou/chingin/kouzou/z2021/index.html.
42. Ministry of Health; Labour and Welfare. Overview of the results of the 2017 basic survey on wage structure [Internet]. c2024;[cited 2024 Jan 12]. https://www.mhlw.go.jp/toukei/itiran/roudou/chingin/kouzou/z2017/index.html.
43. Ministry of Health; Labour and Welfare. Overview of the results of the 2019 basic survey on wage structure [Internet]. c2024;[cited 2024 Jan 12]. https://www.mhlw.go.jp/toukei/itiran/roudou/chingin/kouzou/z2019/index.html.
44. World Economics. Japan’s economy–world economic data handbook [Internet]. c2023;[cited 2023 May 27]. https://ecodb.net/country/JP/economy/.
45. Szende A, Janssen B, Cabases J. Self-reported population health: an international perspective based on EQ-5D. Dordrecht: Springer, 2014.
46. Matsumoto T, Imai K, Goda Y, et al. Questionnaire survey for inflammatory bowel disease patients in Japan; a web-based Japan, Crohn’s disease, ulcerative colitis, patients survey. Crohns Colitis 360 2023;5–otad069.Article PDF
47. Matsuoka K, Yamazaki H, Nagahori M, et al. Association of ulcerative colitis symptom severity and proctocolectomy with multidimensional patient-reported outcomes: a cross-sectional study. J Gastroenterol 2023;58:751–765.Article PubMed PMC PDF
48. Regueiro M, Hudesman DP. Using 5-ASA and steroids for UC treatment [Internet]. c2022;[cited 2023 Aug 25]. https://www.hcplive.com/view/using-5-asas-and-steroids-for-uctreatment.
49. Min Ho PY, Hu W, Lee YY, et al. Health-related quality of life of patients with inflammatory bowel disease in Singapore. Intest Res 2019;17:107–118.Article PubMed PDF
50. Velonias G, Conway G, Andrews E, et al. Older age- and health-related quality of life in inflammatory bowel diseases. Inflamm Bowel Dis 2017;23:283–288.Article PubMed
51. Dibley L, Williams E, Young P. When family don’t acknowledge: a hermeneutic study of the experience of kinship stigma in community-dwelling people with inflammatory bowel disease. Qual Health Res 2020;30:1196–1211.Article PubMed PDF
52. Mizuno H, Katashima M, Sakagami K, Fujimoto Y, Murauchi C, Seto N. Factors of self-care agency in patients with inflammatory bowel disease in Japan. Inflamm Intest Dis 2024;9:103–114.Article PubMed PMC PDF
53. Odufalu FD, Dubinsky MC, Peyrin-Biroulet L, et al. Health care disparities, social determinants of health, and emotional impacts in patients with ulcerative colitis: results from a global ulcerative colitis narrative patient survey. Inflamm Bowel Dis 2023;29:1681–1692.Article PubMed PMC PDF
54. Willian MK, D’Haens G, Yarlas A, Joshi AV. Changes in health-related quality of life and work-related outcomes for patients with mild-to-moderate ulcerative colitis receiving short-term and long-term treatment with multimatrix mesalamine: a prospective, open-label study. J Patient Rep Outcomes 2018;2:22.Article PubMed PMC PDF
55. Watanabe K, Gardiner S, Arai S. Notable gaps between patients’ and physicians’ perspectives on communication and disease management in Japan: multifaceted ad hoc analyses of the global Ulcerative Colitis Narrative Survey for further optimal care. Therap Adv Gastroenterol 2022;15:17562848221095372.Article PubMed PMC PDF
56. Japan Intractable Diseases Information Center. Guide to the medical expense subsidy system for patients with designated intractable diseases: rare disease information center [Internet]. c2024;[cited 2024 Feb 11]. https://www.nanbyou.or.jp/entry/5460#wariai.
57. Kawakami A, Tanaka M, Nishigaki M, et al. Relationship between non-adherence to aminosalicylate medication and the risk of clinical relapse among Japanese patients with ulcerative colitis in clinical remission: a prospective cohort study. J Gastroenterol 2013;48:1006–1015.Article PubMed PDF
58. Ding Z, Muser E, Izanec J, Lukanova R, Kershaw J, Roughley A. Work-related productivity loss and associated indirect costs in patients with Crohn’s disease or ulcerative colitis in the United States. Crohns Colitis 360 2022;4–otac023.Article PDF
59. Holko P, Kawalec P, Sajak-Szczerba M, Avedano L, Mossakowska M. Indirect costs of inflammatory bowel diseases: a comparison of patient-reported outcomes across 12 European countries. Inflamm Bowel Dis 2023;29:752–762.Article PubMed PDF
60. Kitahata S, Furukawa S, Miyake T, et al. Association between socioeconomic status and mucosal healing in Japanese patients with ulcerative colitis: a cross-sectional study. BMJ Open Gastroenterol 2022;9:e001000.Article PubMed PMC
61. Cross RK, Naegeli AN, Harrison RW, et al. Disease burden and patient-reported outcomes among ulcerative colitis patients according to therapy at enrollment into CorEvitas’ inflammatory bowel disease registry. Crohns Colitis 360 2022;4–otac007.Article PDF
62. Chan W, Chen A, Tiao D, Selinger C, Leong R. Medication adherence in inflammatory bowel disease. Intest Res 2017;15:434–445.Article PubMed PMC PDF
63. Hirth RA, Greer SL, Albert JM, Young EW, Piette JD. Out-of-pocket spending and medication adherence among dialysis patients in twelve countries. Health Aff (Millwood) 2008;27:89–102.Article PubMed
64. Denesh D, Carbonell J, Kane JS, Gracie D, Selinger CP. Patients with inflammatory bowel disease (IBD) prefer oral tablets over other modes of medicine administration. Expert Rev Gastroenterol Hepatol 2021;15:1091–1096.Article PubMed
65. Nakase H, Wagatsuma K, Nojima M, et al. Anxiety and behavioral changes in Japanese patients with inflammatory bowel disease due to COVID-19 pandemic: a national survey. J Gastroenterol 2023;58:205–216.Article PubMed PMC PDF
66. Yagisawa K, Kobayashi T, Ozaki R, et al. Randomized, crossover questionnaire survey of acceptabilities of controlled-release mesalazine tablets and granules in ulcerative colitis patients. Intest Res 2019;17:87–93.Article PubMed PDF
67. Shimodaira Y, Watanabe K, Iijima K. Clinical course of ulcerative colitis associated with an age at diagnosis: a recent Japanese database survey. Tohoku J Exp Med 2021;255:33–39.Article PubMed
68. Terauchi Y, Ozaki A, Zhao X, et al. Humanistic and economic burden of cardiovascular disease related comorbidities and hypoglycaemia among patients with type 2 diabetes in Japan. Diabetes Res Clin Pract 2019;149:115–125.Article PubMed
69. Kubo T, Tobe K, Okuyama K, et al. Disease burden and quality of life of patients with chronic cough in Japan: a population-based cross-sectional survey. BMJ Open Respir Res 2021;8:e000764.Article PubMed PMC
70. International Monetary Fund (IMF) eLibrary. Japan’s gender gap [Internet]. c2019;[cited 2023 Dec 18]. https://www.elibrary.imf.org/view/journals/022/0056/001/article-A009-en.xml.
71. Miyazaki C, Sakashita T, Jung W, Kato S. Real-world prescription pattern and healthcare cost among patients with ulcerative colitis in Japan: a retrospective claims data analysis. Adv Ther 2021;38:2229–2247.Article PubMed PMC PDF
72. Organization for Economic Cooperation and Development (OECD). Education at a Glance 2023: OECD indicators [Internet]. c2023;[cited 2024 Feb 16]. https://www.oecd-ilibrary.org/education/education-at-a-glance-2023_e13bef63-en.

Figure & Data

REFERENCES

Citations

Citations to this article as recorded by

PubReader
ePub Link

Cite

CITE: export Copy Download Format; Close

Download Citation

Download a citation file in RIS format that can be imported by all major citation management software, including EndNote, ProCite, RefWorks, and Reference Manager.

Format:

RIS — For EndNote, ProCite, RefWorks, and most other reference management software
BibTeX — For JabRef, BibDesk, and other BibTeX-specific software

Include:

Citation for the content below
Citation and abstract for the content below

Health-related quality of life, work productivity, and persisting challenges in treated ulcerative colitis patients: a Japanese National Health and Wellness Survey

DOI: https://doi.org/10.5217/ir.2024.00104

XML Download

Figure

Health-related quality of life, work productivity, and persisting challenges in treated ulcerative colitis patients: a Japanese National Health and Wellness Survey

Fig. 1. Schematic of treated ulcerative colitis (UC) patients included in the study. A total of 30,001 participants were enrolled in the Japan National Health and Wellness Survey (NHWS) in 2017, 30,006 in 2019 and 30,015 in 2021. The cross-sectional survey conducted separately in 2017, 2019, and 2021 included participants who experienced UC, diagnosed by a physician, and currently using prescription medication. All other participants who did not fulfill the criteria were excluded from the study. The data from different people obtained at the time of each separate survey totaled to 293 UC patients on prescription medication.

Fig. 2. Disease burden of ulcerative colitis (UC). (A) Patient-reported perception of UC based on bothersome levels. (B) Patient-reported depression measured by 9-item Patient Health Questionnaire (PHQ-9) and anxiety measured by 7-item Generalized Anxiety Disorder survey (GAD-7). (C) Patient-reported health-state utility measured by EuroQoL visual analog scale (EQ VAS) and health-related quality of life (HRQoL) measured by 32-Item Short Survey Instrument version 2–mental component score (MCS) and physical component score (PCS). Measurements were based on a scale of 0–100, with higher scores reflecting better health outcomes. Data are expressed as mean±standard error.

Fig. 3. The mean work productivity and activity impairment (WPAI) and the indirect cost resulting from work productivity loss per patient/year. The sample sizes pertaining to absenteeism (n=168), presenteeism (n=185), and overall work impairment (n=167; n=54 reported 0% and n=113 reported >0%) relied on patients who provided responses to relevant questionnaires within the employed patient population. Indirect cost comprised of results of absenteeism and presenteeism costs. Data are expressed as mean±standard error. aJapanese Yen (¥1,000=$6.44).

Fig. 1.

Fig. 2.

Fig. 3.

Health-related quality of life, work productivity, and persisting challenges in treated ulcerative colitis patients: a Japanese National Health and Wellness Survey

Variable	Subgroup	No. (%)
Demographic characteristics
Sex	Male	163 (55.6)
	Female	130 (44.4)
Age (yr)	18–39	86 (29.4)
	40–64	150 (51.2)
	≥ 65	57 (19.5)
Marital status	Married/Living with partner	172 (58.7)
	Single, never married/divorced/separated/widowed	120 (41.0)
	Unknown	1 (0.3)
Education level	High school degree or below	98 (33.5)
	University degree or above	181 (61.8)
	Unknown	14 (4.8)
Income level	≥ Japanese mean family income (¥5,000,000)^a	139 (47.4)
	< Japanese mean family income (¥5,000,000)^a	121 (41.3)
	Unknown	33 (11.3)
Employment status	Employed	188 (64.2)
	Unemployed	105 (35.8)
General health characteristics
Body mass index (kg/m²)	Underweight (< 18.5)	47 (16.0)
	Normal (18.5–24.9)	183 (62.5)
	Overweight or obese (≥ 25)	57 (19.5)
	Unknown	6 (2.1)
Smoking status	Non-smoker	169 (57.7)
	Former smoker	61 (20.8)
	Current smoker	63 (21.5)
Alcohol use	Drinker	165 (56.3)
	Non-drinker	128 (43.7)
Times of vigorous exercise in the past month	None	171 (58.4)
	1–11 times	76 (25.9)
	≥ 12 times	46 (15.7)
CCI, mean ± SD		0.37 ± 2.40

Variable	Subgroup	No. (%)
Medication class	5-ASA mono	197 (67.2)
	Steroid	34 (11.6)
	IM/IS	14 (4.8)
	Biologics/JAKi	30 (10.2)
	Other	18 (6.1)
Severity of UC^a	Mild	191 (65.2)
	Moderate	84 (28.7)
	Severe	18 (6.1)
Medication adherence^b	High (≥ 80%)	176 (60.1)
	Low (< 80%)	34 (11.6)
	Unknown	83 (28.3)
Time since diagnosis (yr)	< 5	83 (28.3)
	5–14	105 (35.8)
	≥ 15	85 (29.0)
	Unknown	20 (6.8)
Use of another medication prior to current medication	Yes	99 (33.8)
	No	194 (66.2)
Treatment type of those who reported “yes” to the prior medication use?^c	5-ASA mono	55 (55.6)
	Steroid	14 (14.1)
	IM/IS	7 (7.1)
	Biologics/JAKi	17 (17.2)
	Other	6 (6.1)
Current existing UC symptoms	≥ 1 persisting UC symptom	162 (55.3)
	Loose stool/diarrhea	84 (28.7)
	Abdominal pain/cramping	57 (19.5)
	Tired/fatigue	53 (18.1)
	Blood in stool	48 (16.4)
	Abdominal bloating	40 (13.7)
	Feel the need to have bowel movement	38 (13.0)
	soon after eating
	Frequent bowel movements	35 (11.9)
	Mucus in stool	34 (11.6)
	Constantly feel the need to pass stool	27 (9.2)
	Urgency of bowel movements	25 (8.5)
	Joint pain	20 (6.8)
	Weight loss	13 (4.4)
	Loss of appetite	11 (3.8)
	Nighttime bowel movements	11 (3.8)
	Other^d	26 (8.9)

Variable	Absenteeism % (n=168)^a			Presenteeism % (n=185)^a			Overall work impairment % (n=167)^a			Activity impairment % (n=293)
Variable	Coeff	SE	P-value	Coeff	SE	P-value	Coeff	SE	P-value	Coeff	SE	P-value
Demographic characteristics
Sex (ref. male)
Female	–1.0	0.2	< 0.05	–0.2	0.1	< 0.05	–0.3	0.1	< 0.05	–0.1	0.0	< 0.05
Age (ref. 18–39 yr)
40–64 yr	–1.7	0.2	< 0.05	–0.1	0.1	0.12	0.0	0.1	0.86	–0.1	0.0	< 0.05
≥ 65 yr	0.4	0.2	0.05	–0.2	0.1	< 0.05	–0.1	0.1	0.12	–0.3	0.1	< 0.05
Marital status (ref. married/living with a partner)
Single/never married/divorced/separated/widowed	0.9	0.3	< 0.05	0.2	0.1	< 0.05	0.3	0.1	< 0.05	0.2	0.0	< 0.05
Education level (ref. high school degree/below)
University degree or above	0.6	0.2	< 0.05	0.1	0.1	0.14	0.3	0.1	< 0.05	–0.1	0.0	< 0.05
Income level (ref. ≥ mean family income 5,000,000¥)^b
< Mean family income 5,000,000¥^b	1.1	0.2	< 0.05	0.4	0.1	< 0.05	0.6	0.1	< 0.05	0.1	0.0	< 0.05
Employment status (ref. not employed)
Employed										–0.2	0.0	< 0.05
General health characteristics
BMI (ref. underweight, BMI < 18.5 kg/m²)
Normal (BMI 18.5–24.9 kg/m²)	0.1	0.2	0.77	0.1	0.1	< 0.05	0.2	0.1	< 0.05	0.1	0.0	< 0.05
Overweight or obese (BMI ≥ 25.0 kg/m²)	0.3	0.3	0.21	–0.1	0.1	0.22	0.0	0.1	0.62	0.0	0.1	0.88
Smoking status (ref. non-smoker)
Former smoker	–0.2	0.3	0.33	0.3	0.1	< 0.05	0.1	0.1	0.15	0.1	0.0	0.05
Current smoker	–0.1	0.2	0.79	0.2	0.1	< 0.05	0.1	0.1	0.07	0.1	0.0	0.11
Alcohol use (ref. non-drinker)
Drinker	–0.2	0.2	0.36	0.4	0.1	< 0.05	0.3	0.1	< 0.05	0.5	0.0	< 0.05
Times of vigorous exercise in past month (ref. none)
1–11 times	–2.6	0.3	< 0.05	0.0	0.0	0.45	0.0	0.1	0.45	–0.3	0.0	< 0.05
≥ 12 times	–2.1	0.3	< 0.05	0.4	0.1	< 0.05	0.1	0.1	0.07	0.1	0.0	0.16
Charlson Comorbidity Index	0.1	0.0	< 0.05	0.0	0.0	< 0.05	0.1	0.0	< 0.05	–0.1	0.0	< 0.05
Clinical characteristics
Medication class (ref. 5-ASA mono)
Steroid	2.0	0.3	< 0.05	–0.3	0.1	< 0.05	–0.1	0.1	0.14	0.1	0.1	0.06
IM/IS	0.6	0.7	0.35	–0.4	0.1	< 0.05	–0.3	0.1	< 0.05	0.3	0.1	< 0.05
Biologics/JAKi	2.1	0.3	< 0.05	0.3	0.1	< 0.05	0.4	0.1	< 0.05	0.1	0.1	0.06
Other	–3.2	0.5	< 0.05	–1.1	0.1	< 0.05	–1.0	0.1	< 0.05	–0.7	0.1	< 0.05
Severity of UC (ref. mild)^c
Moderate	–0.3	0.2	0.17	0.6	0.0	< 0.05	0.5	0.0	< 0.05	0.7	0.0	< 0.05
Severe	2.6	0.5	< 0.05	0.8	0.1	< 0.05	0.8	0.1	< 0.05	0.4	0.1	< 0.05
Medication adherence (ref. low)^d
High	–2.5	0.2	< 0.05	–0.6	0.1	< 0.05	–0.7	0.1	< 0.05	–0.6	0.1	< 0.05
Duration of UC (ref. < 5 yr)
5–14 yr	–0.5	0.2	< 0.05	0.0	0.1	0.87	0.0	0.1	0.55	0.1	0.0	0.07
≥ 15 yr	2.7	0.3	< 0.05	–0.2	0.1	< 0.05	0.0	0.1	0.89	0.0	0.0	0.95

Variable	EQ VAS (n = 293)			MCS (n = 293)			PCS (n = 293)
Variable	Coeff	SE	P-value	Coeff	SE	P-value	Coeff	SE	P-value
Demographic characteristics
Sex (ref. male)
Female	0.1	0.0	< 0.05	0.1	0.0	< 0.05	0.0	0.0	0.08
Age (ref. 18–39 yr)
40–64 yr	0.0	0.0	0.92	0.1	0.0	0.06	0.0	0.0	0.09
≥ 65 yr	0.1	0.0	< 0.05	0.2	0.1	< 0.05	0.0	0.0	0.59
Marital status (ref. married/living with a partner)
Single/never married/divorced/separated/widowed	–0.2	0.0	< 0.05	–0.1	0.0	< 0.05	0.0	0.0	0.85
Education level (ref. high school degree or below)
University degree or above	0.1	0.0	< 0.05	0.0	0.0	0.19	0.0	0.0	0.28
Income level (ref. ≥ mean family income, 5,000,000¥)^a
< Mean family income, 5,000,000¥^a	0.0	0.0	0.06	–0.1	0.0	0.18	0.0	0.0	0.12
Employment status (ref. not employed)
Employed	0.0	0.0	0.58	0.1	0.0	< 0.05	0.0	0.0	0.12
General health characteristics
BMI (ref. underweight BMI < 18.5 kg/m²)
Normal (BMI 18.5–24.9 kg/m²)	0.1	0.0	< 0.05	0.0	0.0	0.60	0.0	0.0	0.44
Overweight or obese (BMI ≥ 25.0 kg/m²)	0.0	0.0	0.46	0.0	0.1	0.74	0.0	0.0	0.60
Smoking status (ref. non-smoker)
Former smoker	–0.1	0.0	< 0.05	0.1	0.0	0.18	–0.1	0.0	0.05
Current smoker	0.0	0.0	0.32	0.0	0.0	0.64	–0.1	0.0	0.02
Alcohol use (ref. non-drinker)
Drinker	–0.1	0.0	0.17	–0.1	0.0	0.05	0.0	0.0	0.73
Times of vigorous exercise in past month (ref. none)
1–11 times	0.1	0.0	< 0.05	0.0	0.0	0.33	0.0	0.0	0.37
≥ 12 times	0.1	0.0	< 0.05	0.0	0.0	0.36	0.0	0.0	1.00
Charlson Comorbidity Index	0.0	0.0	0.88	0.0	0.0	0.05	0.0	0.0	0.21
Clinical characteristics
Medication class (ref. 5-ASA mono)
Steroid	0.0	0.0	0.19	0.0	0.1	0.71	–0.1	0.0	0.03
IM/IS	–0.1	0.0	< 0.05	–0.3	0.1	< 0.05	0.0	0.0	0.29
Biologics/JAKi	0.0	0.0	0.33	–0.1	0.1	0.20	0.0	0.0	0.75
Other	–0.1	0.0	0.06	0.0	0.1	0.98	0.0	0.0	0.94
Severity of UC (ref. mild)^b
Moderate	–0.1	0.0	< 0.05	0.0	0.0	0.32	–0.1	0.0	< 0.05
Severe	–0.2	0.1	< 0.05	0.0	0.1	0.74	0.0	0.0	0.50
Medication adherence (ref. low)^c
High	0.1	0.0	0.14	0.0	0.1	0.49	0.1	0.0	0.07
Duration of UC (ref. < 5 yr)
5–14 yr	0.0	0.0	0.45	0.0	0.0	0.49	0.0	0.0	0.18
≥ 15 yr	–0.1	0.0	< 0.05	–0.1	0.0	0.21	0.0	0.0	0.13

Table 1. Demographic and General Health Characteristics of Treated Ulcerative Colitis Patients

Japanese Yen (¥1,000=$6.44).

CCI, Charlson Comorbidity Index; SD, standard deviation.

Table 2. Clinical Characteristics of Treated UC Patients

The level of self-reported severity of condition when using medication.

The amount of prescribed UC medication taken in the past 4 weeks.

The denominator is the number of patients who answered “Yes” to the question “Use of another medication prior to current medication.”

Leg ulcers and rashes, flatulence, vomiting, eye pain/redness, mouth ulcers, nausea, and other than those listed.

UC, ulcerative colitis; 5-ASA mono, 5-aminosalicylic acid monotherapy; IM/IS, immunomodulator/immunosuppressant; JAKi, Janus kinase inhibitors.

Table 3. Multivariate Analyses of WPAI among Treated UC Patients

The sample sizes pertaining to absenteeism, presenteeism, and overall work impairment rely on respondents who provided responses to relevant questionnaires within the employed patient population.

Japanese Yen (¥1,000=$6.44).

The level of self-reported severity of condition when using medication.

The amount of prescribed UC medication taken in the past 4 weeks.

Table 4. Multivariate Analyses of HRQoL among Treated UC Patients

Japanese Yen (¥1,000=$6.44).

The level of self-reported severity of condition when using medication.

The amount of prescribed UC medication taken in the past 4 weeks.