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Treatment satisfaction, preferences and perception gaps between patients and physicians in the ulcerative colitis CARES study: A real world-based study
Digestive and Liver Disease, Volume 48, Issue 6, June 2016, Pages 601 - 607
Ulcerative colitis (UC) is a life time disease and issues with therapy may impact on patient satisfaction and treatment preferences.
To assess disease and treatment perception gaps from patients’ and physicians’ perspectives in UC patients.
Adult patients with moderate-to-severe UC (Mayo score ≥6) naïve to biologic therapy were enrolled in a European, observational, cross-sectional, retrospective study. Treatment satisfaction was assessed by the TSQM questionnaire and treatment preferences and patient's knowledge with pre-defined questions. Physicians’ and patients’ perceptions were compared through the level of agreement.
256 patients from 11 European countries were included. 48.0% of patients were dissatisfied with their current treatment. Effectiveness, long lasting action, rapid start of action, and fewer side effects were the attributes more frequently considered important or very important by patients (96.9%, 89.1%, 83.8%, and 81.8%, respectively). 26.2% patients rated their overall disease knowledge as very knowledgeable. The agreement between patients’ and physicians on disease severity was good (kappa = 0.62).
Half patients with moderate-to-severe UC managed with conventional therapy, are dissatisfied with their treatments. Effectiveness, long lasting action and rapidity of action were the most frequently rated items in treatment preferences. There are major gaps between physicians and patients when evaluating disease burden.
Keywords: Inflammatory bowel disease, Unmet needs.
Ulcerative colitis (UC) is a chronic and disabling condition. The advent of biologics has changed the way to treat inflammatory bowel disease (IBD) refractory to standard medications. However, therapies used in clinical practice often result in failure or in unacceptable side effects. Approximately 50% of all patients with UC have ongoing disease activity and up to 10% of patients need to undergo a surgical procedure such a colectomy  and . While enriching our therapeutic armamentarium with new biologics such as vedolizumab or golimumab, the choice between different medications has emerged as a major issue in clinical practice. Route of administration, rapidity of action and safety profile, are key issues when discussing treatment preferences . Patients report that efficacy and durable control of symptoms as well as safety are more important to them than the nature of the treatment they receive .
However there may be some disease and treatment perception gaps between patients and physicians, possibly resulting in under treatment of UC patients .
In spite of the clearly demonstrated negative impact of UC, there are few studies addressing patients’ experiences and opinions of their disease, treatment satisfaction, or the concordance between patients’ and physicians’ perspectives, awareness and knowledge of UC  and . The UC-CARES study was designed to characterize the unmet needs of disease control and limitations of available therapies in UC considering both patients’ and physicians’ perspectives and including evaluation of patients’ treatment preferences and satisfaction.
2. Materials and methods
2.1. Study design
The UC-CARES study was an observational, multinational, multi-centre, retrospective chart review including cross-sectional collection of patient reported outcomes (PRO). The day of patient data inclusion was defined as index date with a maximum retrospective review period of 24 months.
The study was carried out in 11 European countries: Belgium, France, Germany, Greece, Italy, Spain, Sweden, Switzerland, The Netherlands, Turkey, and United Kingdom, under the International Conference of Harmonization (ICH) ethical standards, and was notified to or approved by the Ethics Committees of participating centres in accordance with regional and national regulations.
This paper has focused on PROs related to disease knowledge, patient treatment satisfaction, patient attitudes, sources of information, severity as perceived by patients and information on available treatments. Symptoms and disease severity as assessed by the physician are also described. Agreement between patient and physician assessments of severity has been evaluated. Moreover, patients were asked to indicate their level of agreement with statements related to UC and their physician. The protocol was amended after data collection had started to include specially designed questions on patient treatment preferences.
Investigators were physicians involved in the management and treatment of UC patients (gastroenterologists, internists or GPs). Patients that attended a routine office visit and met the study selection criteria were included consecutively. It was not a requirement that UC was the primary reason for the patients visit on the index date.
After giving written informed consent, patients completed a set of questionnaires. Patients’ demographic and clinical data were collected at the index date and retrospectively for a period of 12 months from the patient's medical charts.
2.2. Study population
Enrolled patients were ≥18 years and were diagnosed with moderate to severe UC (Mayo score ≥6) at index date or within the 12 months prior to the index date. Core study data from medical charts had to be available at least for the previous 12 months and patients had to be able to self-complete study questionnaires. Patients were excluded if they had ever received biologic therapies, if their UC-treatment medications had been changed within the 2 weeks prior to index date, and if they had a previous colectomy with or without ileo-anal J-pouch reconstruction. Pregnant or breast-feeding patients and those who had participated in any clinical trial during or 3 months before the retrospective observational period were excluded.
2.3. Study measures
2.3.1. Disease remission and control
Disease remission was defined as presence of total Mayo score ≤2, with no individual sub-score >1 . For patients with no endoscopy available, definition of remission considered the presence of partial Mayo score ≤2, with no individual sub-score >1.
Those patients in remission that had not received corticosteroids during the previous two months were defined as controlled.
2.3.2. Patient's reported treatment satisfaction and unmet needs
Treatment satisfaction was assessed using the Treatment Satisfaction Questionnaire for Medication (TSQM) . Only effectiveness-related items were included in this study for two reasons: because effectiveness of treatment was perceived as the key one for the study objectives and to avoid overloading patients with too many questionnaires.
Patients with unmet needs were defined as those who met all three of the following criteria: uncontrolled disease, self-perception of ‘moderate’ or ‘severe’ disease activity, and dissatisfaction with current treatments (dissatisfaction was defined as ‘TSQM global satisfaction score’ lower than the median values obtained for study patients).
In addition, a Kruskal–Wallis test and a Chi-square test were conducted to compare the global scores and the categories (i.e., no-dissatisfied versus dissatisfied), respectively, from the TSQM between countries.
2.3.3. Patient's reported treatment preferences
Treatment preferences were measured by asking the patients to score the following treatment-related attributes on a six point scale that ranged from ‘very important’ to ‘don’t know/no opinion’: effectiveness, fewer side effects, financial cost to you, mode of administration, dosing frequency (every two weeks, monthly, every two months), rapid start of action, long lasting action and setting (hospital or home treatment). Patients were also asked about their preferences with respect to colectomy versus three possible treatment options for biological therapy. The biological treatment options used for induction treatment, stated to have comparable effectiveness and safety, were as follows:
- - Intravenous, three administrations, hospital/specialist IV clinic, every eight weeks.
- - Subcutaneous, three administrations, hospital by nurse/home by patient, every two weeks.
- - Subcutaneous, two administrations, hospital by nurse/home by patient, every four weeks.
2.3.4. Disease awareness and knowledge
Patients were asked to complete a set of specially prepared questions to measure their disease knowledge. They could select from four possible responses, ranging from “very knowledgeable” to “no knowledge”, and the parameters evaluated were: overall knowledge; knowledge regarding possible progression of UC; and knowledge regarding possible complications of UC. Patients were also asked if they had or not participated in a patient support programme.
2.3.5. Patients’ perception of disease disruption
Patients were asked to complete a series of questions related to living with UC; there were four possible responses, ranging from ‘very’ to ‘not at all’ and questions related to overall disruption due to UC, disruption during remission and disruption during flare-ups.
Patients were also presented with a list of 14 statements related to their disease and the doctor treating their UC, and patients could indicate their level of agreement as ‘strongly agree’, ‘somewhat agree’, ‘somewhat disagree’ and ‘strongly disagree’.
In addition, patients were asked to select their five main fears related to UC from a list of 10 possibilities; the possibility causing most fear was numbered ‘1’ and the fifth most fear-causing possibility was numbered ‘5’.
2.3.6. Perception gaps between patients and physicians
126.96.36.199. Patient's perspective of physician's attitude
The involvement of patients on treatment decisions, attitude and information available regarding to UC treatment were asked to the patients through a battery of questions at index date. Moreover agreement of patients with stated questions related to the doctor who manages patient's UC was also reported.
188.8.131.52. Patient and physician-assessed disease severity
The level of agreement with doctor and assessment of UC disease were also reported.
2.4. Statistical analysis
All evaluable patients included in the study were considered for analysis. All analyses were primarily performed by descriptive statistical methods. Continuous variables were described in terms of number of patients with valid observations, mean, standard deviation (SD), median, percentile 25 and percentile 75. Categorical variables were described by frequencies and related percentages per class level as well as the number of patients with valid observations.
Treatment satisfaction was analyzed by disease control and according to the specific symptoms reported in Mayo score. Treatment preferences were also analyzed according to disease control. A α of 0.05 was applied in statistical tests. Continuous variables were assessed for normal distribution using the Kolmogorov–Smirnov statistical test. Following the normal distribution, the Student t-test was applied; when data was non-normal, Mann–Whitney U was applied. For categorical variables, according to the distribution of the variable in the response category, the Chi-square or the exact Fisher test was applied if necessary. A logistic regression model to define specific symptoms related with treatment dissatisfaction was constructed under a backward selection procedure using a p-value of 0.1. The degree of agreement between physicians and patients about the disease severity was analyzed using weighted kappa coefficient.
3.1. Participants’ characteristics
A total of 256 patients from 11 European countries were enrolled in the study. Of the initial sample, three patients had to be excluded from the final analysis because they did not meet the inclusion criteria. A total of 150 patients were included in accordance with the amended protocol.
The mean age (SD) of patients was 46.6 (16.3) years and 58.8% were male. Most study participants (62.6%) were in some form of employment. The mean time (SD) from diagnosis to inclusion was 9.6 (9.4) years and the mean time (SD) since the last flare was 8.3 (10.7) months. At enrollment 26.7% of the patients presented extra-intestinal manifestations. Full Mayo scores were calculated for 246 patients; of these, 25.6% had a Mayo score ≤2, 30.1% between 3 and 5, and 44.3% ≥6. The mean (SD) full Mayo score was 4.9 (3.0). Endoscopies used to calculate the Mayo score were performed at a mean (SD) of 3.7 (4.2) months before the enrolment visit. At the index date, 75.2% of participants were receiving aminosalicylates, 63.2% thiopurines and 23.6% received corticosteroids. Considering the per protocol definition of corticosteroid-free remission, only a minority of patients had their UC under control (12.8% vs. 87.2% non-controlled).
3.2. Patient's reported treatment satisfaction and unmet needs
Overall, 48.0% of patients were dissatisfied with their current treatment. Patients with non-controlled disease were more dissatisfied with treatment (51.4% vs. 25.0% of controlled disease [p = 0.007]). Patients with controlled UC reported higher scores in the effectiveness domain of the TSQM questionnaire (mean [SD] of 72.0 [21.7]) than non-controlled patients (59.2 [21.4]) (p = 0.0014). TSQM scores were stratified by type of medication being received with very similar scores obtained (60.6 [21.3], 60.3 [22.3] and 60.7 [20.4], respectively).
TSQM results according to the specific symptoms have shown that lower treatment satisfaction was associated with a higher number of daily stools (p < 0.0001), higher presence of rectal bleeding (p < 0.0001), and more severe disease activity reported in physician global score (p = 0.0002) (Table 1). In a multivariate logistic regression model, patient's dissatisfaction was significantly predicted by the presence of moderate to severe symptoms (OR = 2.04; 95%CI: 1.06–3.92) and having more stools than normal (1–2 more than normal OR = 2.87; 95%CI: 1.36–6.14, and 3–4 more than normal OR= 3.36; 95%CI: 1.55–7.30).
|Number of daily stools*|
|Normal number for this patients||67 (52.8%)||27 (23.1%)||94 (38.5%)|
|1–2 stools more than normal||27 (21.3%)||26 (22.2%)||53 (21.7%)|
|3–4 stools more than normal||21 (16.5%)||39 (33.3%)||60 (24.6%)|
|5 or more stools more than normal||12 (9.4%)||25 (21.4%)||37 (15.2%)|
|No blood seen||79 (62.2%)||40 (34.2%)||119 (48.8%)|
|Streaks of blood with stool less than half the time||29 (22.8%)||35 (29.9%)||64 (26.2%)|
|Obvious blood with stool most of the time||19 (15.0%)||40 (34.2%)||59 (24.2%)|
|Blood alone passes||0 (0.0%)||2 (1.7%)||2 (0.8%)|
|Physicians global score**|
|Normal, quiescent disease activity||48 (37.8%)||17 (14.5%)||65 (26.6%)|
|Mild disease activity||33 (26.0%)||29 (24.8%)||62 (25.4%)|
|Moderate disease activity||41 (32.3%)||62 (53.0%)||103 (42.2%)|
|Severe disease activity||5 (3.9%)||9 (7.7%)||14 (5.7%)|
* p < 0.0001.
** p = 0.0002.
a Dissatisfaction with current treatment was defined as TSQM global satisfaction score lower than the median values obtained for study patients.
Results show number of patients (%) for each item. There were some missing values in all the variables.
Furthermore, 25.4% of the whole sample had unmet needs.
An exploratory analysis was conducted to compare treatment satisfaction among the participant countries but none of the comparisons of the global scores and TSQM categories reached statistical significance (p > 0.05).
3.3. Patient's reported treatment preferences
Effectiveness, long lasting action, rapid start of action, and fewer side effects were the attributes of medication more frequently considered important or very important by patients (n = 150) (96.9%, 89.1%, 83.8%, and 81.8%, respectively). Other attributes such as route of administration, dosing frequency or setting were considered of no real importance or completely irrelevant (25.3%, 32.3% and 21.1% of patients, respectively). Financial costs to the patient were not a relevant issue (of no real importance or completely irrelevant [31%] and slightly important [27%]).
When an extra treatment to control UC was required, the most preferred posology was two subcutaneous administrations every four weeks which patients could self-inject (45.7%), followed by the posology based on three intravenous administrations every eight weeks in a hospital (36.4%) and the one based on two subcutaneous administrations every two weeks patients could self-inject (12.4%). Surgical removal of affected part of colon was only preferred by 5.4% of patients. No statistically significant differences were obtained in treatment preferences according to disease control.
3.4. Disease awareness and knowledge
Only 26.2% of responding patients rated their overall knowledge about their disease as very knowledgeable, lower percentages of patients reported being very knowledgeable with respect to possible progression of UC (21.3%) and possible complications of UC (20.5%). Only 8 patients (n = 244) were participating in a patient support programme.
Most used sources of information about the disease and therapy were physician and related staff (95.6%) followed by UC or healthcare websites (52.0%).
3.5. Patients’ perception of disease disruption
52.0% and 27.0% of patients perceived living with UC as somewhat or very disruptive, respectively. These percentages were lower when patients were asked about “disruption during remission periods” (29.9% and 11.1%, respectively) and higher when patients were asked about “disruption during flares” (35.0% and 57.3%). Furthermore, 57.3% of patients admitted to have always on their mind the time of experiencing a new flare-up and 35.0% thought on it multiple times a day.
Regarding some statements about UC experience and impact, 80.2% of patients were worried about the long-term health effects of having UC and 78.0% agreed that they had learnt to live with the life-disruptions caused by UC. Nearly 73% of patients agreed on they had accepted that they would have to live with UC for the rest of their lives and 72.0% agreed that UC made their lives more stressful (Fig. 1).
The factor that caused most fear in patients was the possibility of developing colon cancer, followed by colectomy or requiring some other surgery (mean [SD] of 1.90 [1.39], 2.29 [1.22] and 2.58 [1.31] points, respectively).
3.6. Perception gaps between patients and physicians
3.6.1. Patient's perspective of physician's attitude
Most patients reported that their doctor made the main decisions regarding treatment (48.1%) and that they trusted their doctor's treatment decisions (61.0%). One third of patients felt that they had an equal partnership with their doctor. Most patients (65.2%) scheduled regular visits however almost a third said that they do not plan to visit unless they have a flare-up. Regarding their knowledge about treatments, in general patients felt comfortable asking their doctor about new treatment options (88.2%) and considered themselves informed about treatments availability (76.6%) (Table 2).
|Study sample (n = 253)|
|When do you typically see the physician who primarily treats your UC?|
|I schedule regular visits||161 (65.2%)|
|Only when I’m not feeling well or have a flare-up||70 (28.3%)|
|I try to stay away from the doctor's office and avoid it until a flare-up results in serious consequences||15 (6.1%)|
|I never see a doctor||1 (0.4%)|
|How involved are you in decisions about treating your UC?|
|My doctor makes most decisions regarding treatment||117 (48.1%)|
|I have an equal partnership with my doctor, where we make decisions together||81 (33.3%)|
|My doctor advises me and helps me understand my options so I can make the best decisions on my own behalf||45 (18.5%)|
|Patient involvement in specific treatment decisions|
|I trust my doctor to make whatever treatment decisions are needed||150 (61.0%)|
|I prefer an equal partnership with my doctor, where we make decisions together||86 (35.0%)|
|I prefer to make most of my own treatment decisions||10 (4.1%)|
|How comfortable are you taking the initiative to ask your doctor about new medications and treatment options?|
|Very comfortable||132 (53.4%)|
|Somewhat comfortable||86 (34.8%)|
|Not very comfortable||24 (9.7%)|
|Not at all comfortable||5 (2.0%)|
|How informed do you feel about the different medications available to treat UC?|
|Very informed||55 (22.2%)|
|Somewhat informed||135 (54.4%)|
|Not very informed||50 (20.2%)|
|Not at all informed||8 (3.2%)|
|How often to you seek out information about UC and/or various treatment options that are available?|
There were some missing values in all the variables. UC: ulcerative colitis.
Patient's perspectives of the attending physician and relationship patient–physician were also studied. Most patients (82.8%) agreed that their doctor cares about how UC affects their lives and they had tailored treatments to their needs and preferences (84.5%). On the contrary 77.5% of patients believe their doctor does not understand difficulties related to living with UC (Fig. 2).
3.6.2. Patient and physician-assessed disease severity
The degree of agreement between patients’ and doctors about the disease severity was good (Table 3). According to their own perception of UC severity, 20.6% of patients rated their disease as mild UC, 59.5% as moderate, and 19.8% as severe. Disease assessment by doctor was rated as mild-moderate in 17.2% of patients, as moderate-severe in 51.2% of patients and as severe in 18.9% of patients (Table 4).
|Disease severity assessed by patient||Weighted kappa|
|Disease severity assessed by physician|
|Mild||30 (68.2%)||11 (8.7%)||0 (0.0%)||0.6239|
|Moderate||14 (31.8%)||98 (77.8%)||10 (24.4%)|
|Severe||0 (0.0%)||17 (13.5%)||31 (75.6%)|
|Study sample (n = 253)|
|Number of visits to inflammatory bowel disease specialist in the past 12 months|
|Mean (SD)||4.42 (3.68)|
|Median (P25; P75)||3.0 (2.0; 5.0)|
|UC severity described by doctor|
|Mild – moderate||1 (0.4%)|
|Moderate – severe||2 (0.8%)|
|Not sure||31 (12.7%)|
|UC severity described by patient|
|Statement that best describe how effectively your disease has been controlled over the past 12 months|
|My symptoms were completely or mostly under control||55 (22.6%)|
|My symptoms were present but did not interfere with my life||50 (20.6%)|
|My symptoms caused some disruption to my activities, but my quality of life was okay||81 (33.3%)|
|My symptoms negatively affects my life on a regular basis||57 (23.5%)|
|Statement that best describes what remission means for patient|
|Experiencing no symptoms, feeling similar to how I did before I developed the disease||137 (56.1%)|
|Living with some symptoms, but managing life without interruption||100 (41.0%)|
|Living with symptoms and interruptions to daily life, but with less severity, pain and bleeding as during a flare-up||7 (2.9%)|
UC: ulcerative colitis; SD: standard deviation; P25: percentile 25; P75: percentile 75.
The purpose of this study was to assess UC patients’ perceptions and knowledge regarding clinical, therapeutic and management aspects of their disease.
The study results have highlighted that UC patients are in general dissatisfied with their treatment, especially those patients with non-controlled disease; lower treatment satisfaction was associated with disease activity. Surprisingly few patients rated their overall knowledge about the disease as very knowledgeable. The UC has a high impact in patients’ life in terms of fears and stress and most of the patients did not have many involvement and relied on their treating physician. Timely and highly individualized treatment based on disease extent and severity may achieve the realistic goal of inducing and maintaining corticosteroid-free remission and mucosal healing .
None of the comparisons performed of the global scores and the categories of treatment satisfaction reached statistical significance, however, this could be due to the small sample size.
Our study shows that aminosalicylates are the most commonly prescribed drugs. Few studies have been conducted on patients’ satisfaction  and . A study based on a large Crohn's and Colitis Foundation of America internet-based cohort which included 3945 colitis patients  and  has also demonstrated that aminosalicylates were the most commonly used drugs, followed by immunomodulators and corticosteroids. However in that study 17.3% patients were using biologics, a treatment which was not allowed by our study protocol. Our results show that around 50% patients were dissatisfied with the effectiveness of their treatment, even more if they have uncontrolled disease. In fact, features of non-controlled disease were associated with lower TSQM scores. These results are consistent with those published from a study on the experiences and management of UC based on an international survey including European countries and Canada . Results from Spanish patients showed that in spite of the high reported adherence to 5-ASA (91%) patients’ satisfaction with treatment was quite low (42% reported being ‘not very’ or ‘not at all’ satisfied) . A previous German study  showed a lower percentage of dissatisfaction (30% of the UC-patients described their treatment as ‘moderate’ or ‘bad’). Nevertheless this study had a much smaller sample and most patients had mild disease.
The most valuable attributes of medication for patients were effectiveness, long-lasting and rapid-onset action, and safety and tolerability. Surprisingly costs to the patient, mode of administration and dosage were of lower importance. Interestingly these observations are consistent with previous studies including patients from countries other than Spain  and  suggesting some stable needs regardless of culture, healthcare system or drugs policies. It is expectable that patients rate high those attributes they consider most related to symptom relief, taking into account the disruption they cause in their lives. Consistently, minimal side effects are highly rated as well.
It is known that UC is disruptive and patients are worried about the short-term possibility of flare-ups and embarrassing symptoms and the long-term risks of colectomy and colon cancer. It has been shown that the subjective view of health is influenced not only by physical symptoms, but also by the level of worries and concerns about the disease  and . In this regard, what happens during physician office visits matters to patients’ perception of their health.
This study has shown that UC patients in the investigated countries visit their physicians regularly and are happy to discuss treatment options. However most patients’ treatment decisions are made by their physicians. Based in our study, we suggest that physicians could include their patients more in treatment decisions, especially taking into account that patients are afraid of long-term risks and prefer effective, safe treatments to those that might be easier to administer or are cheaper. Evidence from several other studies , , and  show an increasing patient's preference for new models of follow-up, as self-management and ‘virtual’ or distance care. In our study not many patients considered themselves to be very knowledgeable about their UC and participation in UC patient support programmes was uncommon. The most important source of information was their doctor, though the Internet emerges as a second source of disease information for patients. Grey et al. obtained very similar results; nevertheless the most trusted information sources were gastroenterologists and family physicians .
Regarding the agreement between patient- and physician-perception of disease, physicians seem to care truly about the impact of disease on patients’ life but according to patients do not really understand how the daily life with UC is. Schreiber et al. addressed specifically the gaps between patients and physicians perceptions within a multinational survey . Thus, disease severity estimated by physicians was in higher percentage ‘mild’ than self-reported by patients, physicians estimated fewer flares than reported by patients and a higher percentage of patients than estimated by physicians had reduced quality of life due to UC.
One major limitation of our study is that PROs were recorded in a cross-sectional way, during the index day. These kinds of outcomes are subjective and highly sensitive to several personal and environmental factors. The reason for the patient to visit the physician, or some emotional aspect such as individual expectations about the treatment or the disease clinical course, are likely to change over time, thus influencing the outcomes reported. The fact that only moderate-severe patients were included could have resulted in overestimation of some variables such as satisfaction with treatment. Also to mention that patient preferences for therapy were only studied in part of the patients.
In conclusion, in this study cohort of patients, naïve to biological therapies, with moderate to severe UC, half of the patients were dissatisfied with their current treatment and, despite the impact on their lives, patients do not appear to have enough knowledge about several aspects of the disease. Improving communication between physician and patient in order for patients to feel more involved in their own clinical management should thus be a priority for UC care.
Conflict of interest
Dr. Peyrin-Biroulet: Consulting fees from Merck, Abbott, Janssen, Genentech, Mitsubishi, Ferring, Norgine, Tillots, Vifor, Shire, Therakos, Pharmacosmos, Pilège, BMS, UCB-pharma, Hospira, Celltrion, Takeda, Biogaran, Boerhinger-Ingelheim, Lilly, Pfizer. Lecture fees from Merck, Abbott, Takeda, Janssen, Ferring, Norgine, Tillots, Vifor, Therakos, HAC-pharma.
Dr. Van Assche: Research support to the university of Leuven Abbvie MSD, Consulting Fee to the University of Leuven Abbvie, MSD, Ferring, UCB, Takeda. Speaker's fee Abbvie, Ferring, MSD, Janssen.
Dr. Sturm: received support for talks or consultancy fee within the last 5 years from Abbvie, ArdeyPharm, Bayer-Schering, Dr. Falk Pharma, Ferring, MSD, Takeda.
Dr. Gisbert has served as a speaker, a consultant and advisory member for, or has received research funding from MSD, Abbvie, Hospira, Kern Pharma, Takeda, Janssen, Pfizer, Ferring, Faes Farma, Shire Pharmaceuticals, Dr. Falk Pharma, Chiesi, Casen Fleet, Gebro Pharma, Otsuka Pharmaceutical, Vifor Pharma.
Dr. Gaya: advisory fees and speaker honararia for AbbVie, Warner Chilcott, Ferring, Vifor pharma, Takeda, MSD.
Dr. Bokemeyer: consulting fees from Abbvie, MSD, Shire, Ferring, UCB, Hospira, Takeda, Movetis. Speaking and Teaching: Abbvie, Ferring, MSD, Merckle, Falk, HLR, UCB. Grant/Research: Abbvie, Ferring, UCB.
Dr. Mantzaris: consultant for Merck Sharpe and Dohme, Danon, and OMEGA Pharma; as advisory board member for AbbVie, Abbott laboratories, Merck Sharp and Dohme, UCB-Pharma, Pharmacosmos, and Takeda; as speaker for AbbVie, Merck Sharpe and Dohme, Ferring International, Falk Pharma, Angelini, and OMEGA Pharma. Research support from AstraZeneca, AbbVie, Merck Sharpe and Dohme, Menarini, and Genesis.
Dr. Armuzzi: consultant for Abbvie, Hospira, Lilly, MSD, Mundipharma, Pfizer, Sofar, Takeda; lecture fee for Abbvie, Astra-Zeneca, Chiesi, Ferring, Hospira, MSD, Otsuka, Takeda, Zambon; research grant for MSD.
Dr. Sebastian: advisory fees and speaker honararia for AbbVie, Warner Chilcott, Ferring and Vifor pharma.
Dr. Lara, Mark Lynam and Sònia Rojas-Farreras are employees of IMS Health, which was funded by Merck & Co. Inc. to conduct the design, management and statistical analyses of the data as well as to prepare the study report.
Dr. Fan, Dr. Ding, Dr. Kachroo and Christopher Black are employees of Merck.
The study has been sponsored by Merck & Co.
To Peyrin-Biroulet, Van Assche, Sturm, Gisbert, Gaya, Bokemeyer, Mantzaris, Armuzzi and Sebastian for their contribution on the conception and design of the study, acquisition of data, revising the manuscript critically for important intellectual content and final approval of it.
To Lara, Lynam and, Rojas-Farreras for their contribution on the conception and design of the study, analysis and interpretation of data and drafting the manuscript.
To Fan, Ding, Black and Kachroo for the contribution on the conception and design of the study, interpretation of the data, revising the manuscript critically for important intellectual content and final approval of it.
To Shuvayu Sen from Merck for his help and guidance during initial planning stage of the study.
Moreover, the authors of this manuscript are grateful to all the centres and the clinicians for their contributions on the inclusion of patients and data collection.
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a Department of Hepato-Gastroenterology and Inserm U954, University Hospital of Nancy, Lorraine University, Vandoeuvre-lès-Nancy, France
b Division of Gastroenterology, University Hospitals Leuven, Leuven Belgium
c Department of Gastroenterology, DRK Kliniken Berlin I Westend, Berlin, Germany
d Gastroenterology Unit, Hospital Universitario de La Princesa, Instituto de Investigación Sanitaria Princesa (IIS-IP) and Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBEREHD), Madrid, Spain
e Gastroenterology Unit, Glasgow Royal Infirmary, Glasgow, United Kingdom
f Gastroenterology Practice, Minden, Germany
g Department of Gastroenterology, Evangelismos Hospital, Athens, Greece
h IBD Unit, Complesso Integrato Columbus, Catholic University, Rome, Italy
i Gastroenterology and IBD Unit, Hull and East Yorkshire Hospitals NHS Trust, Hull, United Kingdom
j IMS Health, Real World Evidence Solutions, Spain
k Merck & Co., Inc., Kenilworth, NJ, United States
⁎ Corresponding author. Tel.: +33 3 83 15 36 61; fax: +33 3 83 15 36 61.
© 2016 Editrice Gastroenterologica Italiana S.r.l., Published by Elsevier B.V.