Unmet needs in adult patients with ulcerative colitis in Spain: a real-world Adelphi Disease Specific Programme study

Abstract

Background:

Ulcerative colitis (UC) is an inflammatory bowel disease (IBD) characterized by chronic inflammation of the colonic mucosal lining.

Objectives:

This study aimed to examine unmet needs among patients with UC in Spain.

Design:

Data were analyzed from the Adelphi Real World IBD Disease Specific Programme™, a cross-sectional survey of physicians and patients with IBD in Spain between October 2020 and March 2021.

Methods:

Physicians reported patient clinical characteristics, disease severity, treatment patterns and satisfaction, symptoms, and flare and remission status. Patients were then invited to voluntarily self-complete a form reporting health-related quality of life (HRQoL) and work productivity/activity impairment. Analyses were descriptive.

Results:

Overall, 57 physicians reported data for 410 patients with UC presenting a high disease severity profile. The mean (standard deviation) patient age was 45 (15) years, with 88% presenting with moderate-to-severe UC at diagnosis. In the survey, 75% and 63% of patients were treated with conventional therapy and biologics, respectively. After treatment initiation, patients had lower disease severity, but 29% of patients had moderate-to-severe disease despite receiving biologics or Janus kinase inhibitors. Overall, 81% of patients and 86% of physicians were satisfied with treatment. Among patients classified as having moderate-to-severe UC, commonly reported symptoms included abdominal pain (41%), bowel urgency (37%), and bloody diarrhea (37%). The mean number of flares experienced in the past year was 1.7, lasting on average >30 days. Consequently, the HRQoL of these patients was impaired.

Conclusion:

While disease severity appeared to be lower after the initiation of current treatment, and despite the high prevalence of treatment satisfaction, almost a third of patients remained classified as moderate-to-severe, experiencing symptoms, flares, and impaired HRQoL. Therefore, there is a need for new therapeutic alternatives to target patient unmet needs.

Plain language summary

Unmet Needs in Adults with Ulcerative Colitis in Spain: Findings from a Real-World Study

Ulcerative colitis (UC) is a disease that causes the large intestines to become inflamed. People with UC experience periods of time with mild or no symptoms, followed by periods where their symptoms return and are more severe. This greatly impacts their quality of life and day-to-day activities. We aimed to describe the experiences of people living with UC in Spain. We surveyed 57 doctors and 116 people with UC between October 2020 and March 2021. We found that people with UC have lower disease severity after treatment initiation and that most of them are satisfied with their treatment. Still, they experience a high burden related to their UC symptoms, which impacts their quality of life. There is a need for better treatment that will help reduce this burden and for doctors treating patients with UC to include their patients’ perspectives in treatment decisions.

Keywords

disease activity disease severity health-related quality of life treatment patterns ulcerative colitis

Introduction

Ulcerative colitis (UC) is an inflammatory bowel disease (IBD) characterized by chronic superficial inflammation of the gastrointestinal tract, specifically the mucosal lining of the colonic tissue.¹ The disease typically follows a pattern of recurring episodes of mucosal inflammation marked by a return of symptoms, or flare-up periods, followed by periods of improvement, or remission.^2,3 Patients with UC typically exhibit bloody diarrhea with or without mucus, bowel urgency (the sudden and immediate need to have a bowel movement), tenesmus, and abdominal pain relieved by defecation.^4,5 UC is a progressive disease; if left untreated or under-treated, it can lead to complications, such as strictures of the colon, fibrosis, and an increased risk of colorectal cancer.^6,7

In Spain, a UC incidence of 8.1 per 100,000 person-years⁸ and a UC prevalence of 0.39%⁹ have been estimated. This prevalence continues to rise, due to the early age of onset and low mortality rates associated with the disease.^1,10,11

UC onset typically occurs during the second or third decade of life, affecting men and women equally⁸; a period when people are at their most socially and economically productive.⁴ Health-related quality of life (HRQoL) is considerably reduced in patients with UC, impacting several aspects of their life including emotional, psychological, social, and physical functioning, and work and academic life.¹² Moreover, UC has been shown to create substantial barriers to physical activity, often resulting in patients exhibiting low levels of engagement in such activities.¹³ The ultimate disease management goal is to maintain health,¹⁴ achieve clinical improvement, and biomarker normalization, followed by sustained remission and endoscopic recovery to prevent long-term disability.¹⁵ National and international treatment guidelines recommend treatment strategies for induction and maintenance that are generally based on the severity, distribution, and pattern of disease (i.e., relapse frequency, disease course, response to previous medications, adverse events, and extraintestinal manifestations).² In Spain, the Spanish Working Group on Crohn’s Disease and Ulcerative Colitis (GETECCU) treatment guidelines^16,17 recommend a treatment strategy focused not only on symptom control and HRQoL improvement but also on good control of inflammation.

Over 40,000 patients are estimated to be treated in Spain for UC,¹⁸ and their medical management has become increasingly complex as new therapeutic options have become available. Despite the evolution of pharmacological treatments, recent studies suggest that most patients do not achieve remission,¹⁹ contributing to an increased disease burden, a negative impact on quality of life, and higher utilization of healthcare resources.²⁰

A systematic literature review including 38 Spanish studies on IBD showed that patients with UC have a worse HRQoL compared to the general population.²⁰ Many patients with UC, even those in remission, suffer from depression and anxiety,^20,21 and often report feelings of embarrassment, worry, frustration, and fear caused by their disease.²²

Therefore, there is a need to understand the extent of this disease burden, utilizing real-world data to identify and evaluate remaining unmet needs among UC patients. The objective of the present study was to describe patient demographics, clinical outcomes, treatment patterns, symptoms, flare and remission status, HRQoL, and work productivity and activity impairment in Spanish patients with UC.

Materials and methods

Data source

This analysis utilized data sourced from the Adelphi Real World IBD (Wave VII) Disease Specific Programme (DSP)™ conducted in Spain from October 2020 to March 2021. DSPs are cross-sectional surveys, with elements of retrospective data collection, of physicians and patients conducted in real-world clinical settings. The methodology has been previously described,^23,24 validated,²⁵ and demonstrated to be representative and consistent over time.²⁶

Physicians completed both a physician survey (PS) and a patient record form (PRF) for up to 10 consecutively consulting patients. Each patient for whom the physician completed a PRF was then invited to fill out a patient self-completion (PSC) form. PRF data were matched with the corresponding PSC forms, when available. Physician and patient questionnaires were completed simultaneously but independently, to minimize potential bias or alignment in responses. The DSP is based on a pseudo-random sample of physicians or patients.

Participants and setting

This analysis included data from physicians specializing in IBD treatment. Patients were eligible for inclusion if they were ⩾18 years old, not participating in a clinical trial, and had a physician-confirmed diagnosis of UC. Eligible patients had to meet one of the following criteria: disease ever classified as moderate-to-severe in the opinion of the treating physician, currently/ever receiving a corticosteroid/immunomodulator (IM)/biologic/Janus kinase (JAK) inhibitor, or ever had a Mayo score >4 (full, partial, modified, or symptom Mayo score).

Study outcomes

The main objective of this study was to describe patient sociodemographic, clinical, treatment-related, and disease-related characteristics. In addition, the study aimed to analyze HRQoL and work productivity and activity impairment.

Patients were classified as having mild-to-moderate or moderate-to-severe UC based on physicians’ assessments at diagnosis and prior to the initiation of the current treatment at the time of the survey. Data such as patient demographics (age, sex, ethnicity, body mass index, employment status), clinical characteristics (type of UC, extraintestinal manifestations, comorbidities), treatment patterns (type of treatment, previous treatment lines), treatment satisfaction, and symptoms (type, difficulty to treat, impact on patients) of the UC study population were collected. Additional variables were collected specifically for patients with moderate-to-severe UC, including flare and remission status, HRQoL, and work productivity and activity impairment (Supplementary Figure 1). Instruments used for data collection included the Short Inflammatory Bowel Disease questionnaire (SIBDQ), the European Quality of Life with 5 Dimensions questionnaire (EQ-5D), and the UC-specific Work Productivity and Activity Impairment questionnaire (WPAI:UC).

The SIBDQ measures overall HRQoL in the past 2 weeks across 10 items on a 7-point scale (where 1 = worst imaginable, 7 = best imaginable HRQoL). Total scores range from 10 (poor HRQoL) to 70 (optimal HRQoL). The EQ-5D is a standardized measure of HRQoL across five domains: mobility, self-care, anxiety/depression, pain/discomfort, and ability to perform usual activities. EQ-5D index scores range from 1 (full health) to 0 (a health state equivalent to death). The EQ Visual Analog Scale (VAS) records patients’ self-reported health on a scale from 1 (worst imaginable health) to 100 (best imaginable health). The WPAI:UC records the impact of UC on general health problems in the past 7 days. The WPAI measures percentage of impairment across four domains: work time missed (absenteeism), impairment at work (presenteeism), overall work impairment, and overall activity impairment.

Data were gathered using the different questionnaires available for the study. The PS contained information related to difficult-to-treat symptoms. The PRF included physician-reported data on patient demographics, clinical outcomes, treatment patterns, treatment satisfaction, symptoms, and flare and remission status. The PSC form included self-reported data on symptoms and treatments, their impact on patients’ lives, and patient-reported outcome measures.

Statistical analysis

Data were analyzed descriptively. Continuous variables were characterized by presenting their mean and standard deviation (SD), and skewed data by their median and interquartile range, while categorical variables were conveyed as percentages in their respective categories. Data analysis was performed using Unicom Intelligence Reporter 7.5.11. Missing data were not imputed; therefore, the base could vary from variable to variable and is reported separately where appropriate.

Ethics

Using a check box, patients provided informed consent for the use of their anonymized and aggregated data for research and publication in scientific journals. Data were collected in such a way that patients and physicians could not be identified directly; all data were aggregated and de-identified before receipt. This research also obtained ethics approval from the Western Institutional Review Board (Study protocol number 1-1249119-1).

Results

Demographics and clinical characteristics of the UC study population

Overall, 57 gastroenterologists completed PRFs for a total of 410 patients with UC, of whom 116 patients completed a PSC form. The mean (SD) age of all included patients was 45 (15) years, and 50% were female. Most were White (96%) and 64% were employed or in education (Table 1).

Table 1.

Patient demographics and clinical characteristics of adults with UC.

Demographic data (n = 410)
Mean (SD) age, years	44.6 (15.0)
Sex, %
Female	50
Ethnicity, %
White	96
Hispanic/Latino	3
Other	1
BMI kg/m², %
<18.5 Underweight	3
18.5–24.9 Normal	61
25–29.9 Overweight	31
>30 Obese	5
Employment status, %
Full-time	46
Part-time	9
Student	9
Retired	13
Unemployed	6
Homemaker	8
Don’t know	6
Disease severity and type	At diagnosis (n = 408)	At the time of the survey (n = 410)
Mild, n (%)	48 (12)	304 (75)
Ulcerative proctitis (E1),^a %	29	15
Proctosigmoiditis (E2),^a %	29	25
Left-sided colitis (E2),^a %	19	20
Pan-ulcerative (total) colitis (E3),^a %	23	37
Don’t know, %	0	3
Moderate, n (%)	277 (68)	90 (22)
Ulcerative proctitis (E1), %	13	11
Proctosigmoiditis (E2), %	28	20
Disease severity and type	At diagnosis (n = 408)	At the time of the survey (n = 410)
Left-sided colitis (E2), %	27	27
Pan-ulcerative (total) colitis (E3), %	31	41
Don’t know, %	1	1
Severe, n (%)	83 (20)	14 (3)
Ulcerative proctitis (E1), %	9	0
Proctosigmoiditis (E2), %	7	22
Left-sided colitis (E2), %	13	14
Pan-ulcerative (total) colitis (E3), %	70	64
Don’t know, %	1	0
Extraintestinal manifestations (n = 410)
Any extraintestinal manifestation, %	19
Involvement at the time of survey (n = 79)
Musculoskeletal system, %	56
Dermatologic and oral systems, %	28
Hepatopancreatobiliary system, %	13
Other, %	9
Ocular system, %	8
Metabolic system, %	4
Renal system, %	0
Comorbidities (n = 410)
Any comorbidity, %	54
AI comorbidities, %	22
Non-AI comorbidities, %	47
Both AI and non-AI comorbidities, %	15
No comorbidities, %	46
Top autoimmune comorbidities, %
Psoriasis	7
Axial spondylarthritis	4
Atopic dermatitis	4
Rheumatoid arthritis	3
Psoriatic arthritis	2
Celiac disease	2
Comorbidities (n = 410)
Alopecia areata	1
Sjögren’s syndrome	1
Top non-AI comorbidities, %
Anxiety	18
Hypertension	15
Depression	10
Diabetes without chronic complications	10
Mild liver disease	6
Osteoarthritis	5
Lactose intolerance	3
Any malignancy, including leukemia and lymphoma	3
Congestive heart failure	2
Renal disease	2

Based on Montreal classification criteria.²⁷

AI, autoimmune; BMI, body mass index; SD, standard deviation; UC, ulcerative colitis.

At the time of diagnosis, disease severity was reported for 408 patients as mild (12%; n = 48), moderate (68%; n = 277), and severe (20%; n = 83). At the time of diagnosis, pan-ulcerative (total) colitis (equivalent to Montreal classification E3)²⁷ was the most commonly observed disease type, especially in patients with severe UC (70%), followed by proctosigmoiditis and ulcerative proctitis (equivalent to Montreal classification E2 and E1, respectively),²⁷ which was most frequently observed in patients with mild UC (29%; Table 1).

Extraintestinal manifestations affected 19% of patients with UC, with musculoskeletal issues being observed in over half of these patients (56%; Table 1). Comorbidities were present in 54% of patients (non-autoimmune, autoimmune, or both).

Treatment patterns and satisfaction with treatment of the UC study population

In the sample of 410 patients, at the time of the survey, conventional therapy was used in 75% of patients, with 5-aminosalicylate (5-ASA) being the most common (66%) treatment, followed by IM (31%), and corticosteroids (13%). Biologic treatments were used by 63% of patients, and 4% of patients were receiving JAK inhibitors at the time of the survey (Figure 1(a)).

Figure 1.

(a) Treatment types at the time of survey (n = 410). (b) Lines of treatment ever received for UC.

Among 325 patients for whom a full treatment history was available, at the first treatment line, 31% of patients received 5-ASA monotherapy or combination therapy that included steroids (31%, n = 101), while biologics were used in 18% (n = 59) of patients (Figure 1(b)). Overall, 71% of patients (n = 232) received second-line therapy, 38% (n = 122) third-line therapy, and 17% (n = 55) fourth-line therapy. The use of biologics was 47% of patients (n = 109) at the second line, 64% (n = 78) at the third line, and 76% (n = 42) at the fourth line. JAK inhibitors were used as second-line, third-line, and fourth-line treatment in 2% (n = 5), 2% (n = 2), and 9% (n = 5) of patients, respectively.

Patients who received biologics (n = 272) or JAK inhibitors (n = 30) experienced predominantly moderate-to-severe UC (93% and 51%, respectively) before the initiation of their current treatment. Mild UC was recorded in 71% and 61% of these patients receiving biologics and JAK inhibitors, respectively, at the time of the survey. Nevertheless, 29% (n = 74) still presented with moderate-to-severe disease at the time of the survey.

Of the 410 UC patients included in the study, physicians were satisfied and believed this was the best control that could be achieved for 51% of patients. Physicians were satisfied with the current treatment but believed better control could be achieved for 35% of their patients, while they were not satisfied with the current treatment for 14% of their patients.

Moreover, 62% out of 115 patients with known treatment satisfaction data were satisfied with their current treatment and believed that this was the best control that could be achieved. In addition, 19% of patients were satisfied with current treatments but believed better control could be achieved, and 19% were not satisfied.

Symptoms of the UC study population and patients with moderate-to-severe UC

Data on symptoms were available for 408 patients. At the time of the survey, 62% of patients experienced UC symptoms. Among patients classified with moderate-to-severe UC because of those symptoms (n = 104, 25%), the most commonly reported were abdominal pain (40%), bowel movement urgency (38%), and bloody diarrhea (38%; Figure 2).

Figure 2.

Current symptoms according to disease severity at the time of survey.

Bowel movement urgency was identified by physicians as the most difficult-to-treat symptom (43%), followed by fatigue or tiredness (38%) and bloody diarrhea (29%). Out of the 99 patients from whom matched PRF and PSC form data were available, approximately one-third (31%) of patients considered bowel movement urgency to be the most bothersome symptom and believed that fatigue and tiredness affected them greatly (29%). Other symptoms that patients felt impacted their lives included bloody diarrhea (28%), abdominal distension (22%), and flatulence (22%).

Flare and remission status of patients with moderate-to-severe UC

In accordance with disease severity, over 50% of patients with moderate-to-severe UC were experiencing a flare at the time of the survey, and 24% had experienced a flare within the past year. The mean number of flares experienced over the 12 months prior to data collection by patients with moderate-to-severe UC (n = 79) was 1.7. The mean duration of the last flare for patients with moderate-to-severe UC with a known number of flares and not diagnosed at the time of the survey (n = 61) was 31.8 days. Moreover, 12% of patients with moderate-to-severe UC who had ever flared (n = 85) experienced a severe flare. Consequently, almost two-thirds of patients (65%) within the study, who at some point had been classified as having moderate-to-severe UC, had received corticosteroids/IMs/biologics/JAK inhibitors or had a Mayo score >4, were not in remission at the time of the survey, and only 2% had achieved clinical and symptomatic remission and full mucosal healing (histologic remission) according to their physician.

Quality of life and work productivity and activity impairment of patients with moderate-to-severe UC

In all, 35 patients with moderate-to-severe UC at the time of the survey reported SIBDQ data. These patients scored a mean of 44.0 on the SIBDQ for overall HRQoL (Figure 3(a)). A total of 35 and 36 moderate-to-severe patients provided EQ-5D and EQ-VAS scores, respectively. The mean EQ-5D index value was 0.83 and the mean EQ-VAS was 65.5. Moreover, although most patients reported having no problems with mobility, self-care, or usual activities, over a third reported experiencing pain/discomfort and anxiety/depression (Figure 3(b)). According to the WPAI questionnaire, patients with moderate-to-severe UC demonstrated absenteeism, presenteeism, lost productivity, and activity impairment (Figure 3(c)). Notably, patients with moderate-to-severe UC reported 41% activity impairment, compared to 16% impairment reported by patients with mild UC.

Figure 3.

Patient-reported outcomes in patients with moderate-to-severe UC at the time of the survey. (a) SIBDQ. (b) EQ-5D. (c) WPAI:UC.

Discussion

The present study adds to our understanding of the demographic and clinical characteristics—including symptoms, flares and remission status—treatment patterns and satisfaction, and HRQoL of Spanish patients with UC with more advanced disease, given the specific inclusion criteria applied to this study. Exploring disease severity in this study population revealed that at the time of diagnosis, 9 out of 10 patients were categorized as having moderate-to-severe UC, which was reduced to one in four following treatment. However, despite the evident improvement in severity, a considerable proportion of patients continued to experience symptom burden and impaired HRQoL.

In our study, conventional therapy was used across treatment lines at the time of the survey by 75% of patients, with 5-ASA being the most commonly used treatment (66%). This treatment choice of 5-ASA, a guideline-directed strategy, is consistent with other Spanish research that reports 65% of patients were treated with conventional therapy.¹⁵ Biological treatments were received by 63% of patients, which was higher than the 15% described in a large-scale Spanish epidemiology study published in 2021. Moreover, the use of topical or systemic steroids was lower in our population (13%) compared to the large-scale Spanish epidemiology study published in 2021 (34%), perhaps as a consequence of differing criteria used to classify patients as corticosteroid users.⁸

Interestingly, physicians were satisfied with current treatments in 86% of their patients, while 81% of patients expressed satisfaction. However, almost one-fifth of patients believed that better control could be achieved, and physicians believed better control could be achieved for 35% of their patients. These findings contrast with those of the CARES study, where almost half of patients with UC treated with conventional therapy were dissatisfied with their treatment.²⁸

The impact of symptoms on patients’ lives in UC is a significant concern. The high frequency of abdominal pain recorded by patients in this analysis aligns with findings by Coates et al., who reported that over half of patients with UC can experience abdominal pain.²⁹ Patients and physicians in this analysis agreed that bowel movement urgency had the largest significant impact. Bowel urgency is the most widely reported and debilitating symptom for patients with UC.³⁰ While its prevalence correlates with disease activity, it is present in both remission and disease flare states, and despite being a crucial symptom, it is not commonly integrated into clinical assessment indices or clinical trial endpoints.³⁰ Moreover, although patients may report bowel urgency to be one of their most commonly experienced symptoms of UC, physicians do not consider this to be one of the symptoms most reported by their patients.³¹ In addition, bowel urgency and fatigue/tiredness were considered the most challenging symptoms to treat effectively. The challenges in treating fatigue in patients with IBD have been documented in a Cochrane review.³²

While initiating treatment did decrease the severity of the disease, patients continued to experience symptoms and flares. In fact, at the time of the survey, more than half of patients were not in remission, being considered as having moderate-to-severe disease. Similarly, in a survey of GETECCU members, severe flares were reported in one-third of Spanish patients with UC.¹⁶ Despite various treatment options, remission is known to elude 30%–60% of patients with UC.⁵ These findings underscore the ongoing unmet need for more effective treatments and strategies to achieve sustained remission. Moving forward, personalized treatment approaches and earlier interventions may be crucial in improving long-term outcomes for patients with UC.

Patients with moderate-to-severe UC in our study reported poor HRQoL scores, with the disease affecting their physical and emotional well-being and their personal and work life, as well as their overall health state. In line with our findings, a high disease burden has been previously observed in Spanish patients with UC, negatively affecting their HRQoL.²⁰

Other Spanish observational studies have found that over three-quarters of patients have reported that their UC prevents them from leading a normal life,¹⁵ and almost half of patients have reported that their UC has influenced the kind of job they perform, with 15% having lost a job due to their UC.³³ Our data support those of these studies, revealing that a significant proportion of patients with moderate-to-severe UC experience substantial impairments in their daily activities, as evidenced by the 41% activity impairment reported in the SIBDQ. These findings are corroborated by our EQ-5D, EQ-VAS, and WPAI scores, further highlighting the substantial impact of UC on patient well-being and underlining the necessity for holistic management strategies that address not only the clinical but also the psychosocial dimensions of UC.

The current study had some limitations that should be considered when interpreting its findings. We aimed to minimize selection bias by recruiting consecutive patients; however, the method lacked formal source data verification. Severity diagnosis at the time of the survey relied on the physician’s judgment rather than a standardized diagnostic checklist. Consequently, patients who were classified as having moderate-to-severe UC could preset diverse characteristics, which could elucidate remission outcomes. It should be noted that the study inclusion criteria selected for patients with moderate-to-severe disease, with participation being totally voluntary, therefore, these findings may not be representative of the wider population of patients with UC in Spain. This also translated into a considerable difference in the number of physicians who completed PRFs (n = 410) and patients who completed PSC forms (n = 115). However, there is great value in having linked physician and patient-reported data, as it provides a more comprehensive understanding of the disease from both clinical and patient perspectives. Moreover, many answers to the survey questions were subjected to physicians’ criteria and assessment, but probably align with those of routine clinical practice.

Conclusion

This real-world study provides valuable insights into the unmet needs and treatment experiences of patients with UC in Spain. Despite the initiation of conventional and advanced therapies and high treatment satisfaction rates, patients continued to experience moderate-to-severe disease activity and HRQoL impairment. These findings highlight the necessity of better symptom and flare control, and higher remission achievement, and underscore the need for new therapeutic alternatives, perhaps with novel mechanisms of action, to target current unmet needs.

Supplemental Material

sj-docx-1-tag-10.1177_17562848251325190 – Supplemental material for Unmet needs in adult patients with ulcerative colitis in Spain: a real-world Adelphi Disease Specific Programme study

Supplemental material, sj-docx-1-tag-10.1177_17562848251325190 for Unmet needs in adult patients with ulcerative colitis in Spain: a real-world Adelphi Disease Specific Programme study by Ignacio Marín-Jiménez, Itxaso Aguirregabiria, Silvia Díaz-Cerezo, Sebastián Moyano, Hugo Gabilondo, Hannah Knight, Niamh Harvey, Theresa Hunter Gibble and Pilar Nos in Therapeutic Advances in Gastroenterology

Footnotes

Acknowledgements

The sponsors acknowledge the participation of all volunteers and the study site personnel involved in the original research. Use of the SIBDQ, authored by Dr. Jan Irvine et al., was made under license from McMaster University, Hamilton, Canada. Medical writing support was provided by Sarah Birch and Clare Konning (Rx Communications, Mold, UK), funded by Eli Lilly and Company.

Declarations

Supplemental material

Supplemental material for this article is available online.

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