https://orcid.org/0000-0002-8379-4381
Abstract
Objective
Vedolizumab is an antibody targeting α4β7 integrin used in the treatment of ulcerative colitis (UC). Patients are commonly prescribed higher-than-standard doses if treatment response is inadequate, but little is known about the drivers and impact of increased dosing. Our objective was to use real-world data to describe vedolizumab dosages in current clinical practice, patient characteristics, physicians’ reasons for prescribing vedolizumab, and physician treatment satisfaction.
Methods
Data were derived from the Adelphi Real World UC vedolizumab Chart Review, a cross-sectional survey of gastroenterologists and their UC patients, conducted in France, Germany, Italy, Spain, and the United Kingdom between December 2022 and March 2023. Gastroenterologists provided data on patient demographics, clinical characteristics, treatment and vedolizumab dosage history, reasons for dose choice, and treatment satisfaction.
Results
Data were returned on 448 patients by 112 gastroenterologists. Overall, 83.5% of patients were on a standard vedolizumab dose and 10.3% were on a higher-than-standard dose. The worsening of symptoms was the most cited reason for higher doses. Most reported symptoms at survey were fatigue, abdominal distention or pain, diarrhea, and bowel urgency, with the latter particularly in higher-than-standard dose patients. Patients on higher-than-standard dose had high rates of mild (37.0%) or moderate (26.1%) disease, and low rates of remission (33.8%). Physicians were dissatisfied with treatment control for 2.7% of standard and 26.1% of higher-than-standard dose patients.
Conclusions
Over 10% of patients were receiving a higher-than-standard dose of vedolizumab, but despite this were found to have suboptimal clinical outcomes and low physician satisfaction.
Introduction
Inflammatory bowel disease (IBD) is characterized by autoimmune-mediated chronic inflammation of the intestinal tractCitation1. Ulcerative colitis (UC) is a subtype of IBD which mainly affects the large colon and has a prevalence of 0.3–0.5% in Europe and the United States of America (US)Citation2. Patients with UC suffer from periodic exacerbations of symptoms, known as flare ups, which are interspersed by periods of low symptom burden, known as remissionCitation3. Symptoms include diarrhea (both with and without the presence of blood), abdominal pain, bowel urgency, and rectal bleedingCitation3.
Current treatments aimed at achieving remission in UC include conventional therapeutics such as aminosalicylates (5-ASAs), corticosteroids, immunosuppressants, and advanced therapeutics such as biologics, Janus kinase inhibitors, and sphingosine-1-phosphate receptor modulatorsCitation4,Citation5. The most common biologics are antibodies that target tumor necrosis factor α (TNFα), such as infliximab, adalimumab, and golimumab. However, up to 30% of patients do not respond to anti-TNFα treatment, and of those who do, up to 40% may eventually lose response to treatmentCitation6.
Other biologic options include vedolizumab, which inhibits the trafficking of lymphocytes into the gut through binding to the adhesion molecule α4β7 integrin, thereby reducing local inflammationCitation7. Vedolizumab gained approval in the USCitation8 and EuropeCitation9 in 2014 and is recommended for moderately-to-severely active UC that is refractory to either conventional therapy or TNFα antagonist treatmentCitation10,Citation11. A meta-analysis of studies from the US and Europe has shown vedolizumab was effective in improving long-term clinical responses and remission in moderate-to-severe UC patientsCitation12.
In cases of non-response to biologic treatments, dose escalation is sometimes used to attempt to recapture the patient response. The reported rates of dose escalation vary significantly, ranging from 5 to 71% of patients on anti-TNF biologicsCitation13–15, and vedolizumab dose escalations reported in up to 60% of patients with IBDCitation16. Although some success has been reported with dose escalation in anti-TNF treatmentCitation17, little research has been conducted into the impact of escalated doses of many advanced therapies, including vedolizumab, on patients in real-world practice. Additionally, although there are recommended guideline doses for the prescription of advanced therapy for UC, little is known regarding the adherence of physicians to these guidelines and the driving reasons for prescribing escalated doses.
Therefore, the aim of this study was to use real-world data to describe vedolizumab dosages in current clinical practice, as well as the clinical outcomes, reasons for dose choice, physician treatment satisfaction, and healthcare resource utilization among patients receiving standard and higher-than-standard maintenance doses.
Methods
Data source
Data were derived from the Adelphi Real World UC vedolizumab Chart Review, a cross-sectional survey of gastroenterologists treating UC patients, with elements of retrospective data collection. Data were collected in France, Germany, Italy, Spain, and the United Kingdom (UK) between December 2022 and March 2023.
To be eligible, gastroenterologists were required to be personally responsible for the management and systemic treatment decisions for a minimum of four patients with UC per month and have consulted a minimum of two patients with UC being treated with vedolizumab per month. Target physicians were identified by the local fieldwork team from public lists. Respondents who met the eligibility criteria were subsequently invited to participate in the full program and participation was solely dependent on the physician’s willingness to take part. Physicians were compensated for their participation according to fair rates consistent with the time involved. Patients over 18 years of age with a physician-confirmed diagnosis of UC, who were in the maintenance phase of their prescribed vedolizumab treatment and were not enrolled in any clinical trial, were eligible for inclusion in the study.
Physicians were instructed to complete patient record forms for the next 2–6 consecutively consulting eligible patients. Each record form included details regarding patients’ demographic and clinical characteristics, treatment history including full details of vedolizumab dosing (induction and maintenance), reasons for their dose choices, and physician satisfaction with the current treatment.
Outcomes
The primary outcomes of interest were the description of vedolizumab dosing in current clinical practice, and the clinical outcomes, reasons for dose choice, physician satisfaction, and healthcare resource utilization among patients receiving standard and higher-than-standard maintenance doses of vedolizumab. Secondary outcomes of interest were the pattern of routes of administration of vedolizumab and switching therein, and the prevalence of corticosteroid use in patients prescribed vedolizumab.
Patient groups by vedolizumab dose
Patient groups were defined based on vedolizumab maintenance dosing. For patients receiving intravenous (IV) treatment, 300 mg every eight weeks was considered the standard dose. For patients receiving subcutaneous (SC) treatment, 108 mg every two weeks was considered the standard doseCitation18. For both routes of administration, more frequent administration was considered higher-than-standard dose, less frequent administration was considered lower-than-standard. Patients’ induction dose schedule was also recorded. The recommended induction schedule for vedolizumab is 300 mg IV at zero, two and six weeks of treatment; in order to record real-world practice, physicians were asked to report their employed induction dosing schedule, even if it deviated from the recommended regime.
Clinical characteristics
Physicians reported on patients’ concomitant conditions and symptoms, disease activity by Mayo score, and remission status based on symptoms and endoscopy where available. Clinical remission was defined as the reduction or absence of symptoms based on physicians’ clinical judgment. Endoscopic remission was based on physicians’ judgement according to the following criteria: “absence of inflammation confirmed by scoping (e.g. no erosions or ulcers)”.
Statistical analysis
Data were analyzed descriptively. Numeric variables were described using mean and standard deviation (SD), and median and interquartile range (IQR) for non-normally distributed variables. Categorical variables were described using n and the percentage of the total. All analyses were performed using Stata 17.0 (StataCorp LP, College Station, TX, USA).
Ethics
Using a check box, physicians 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 physicians and patients could not be identified directly; all data were aggregated and de-identified before receipt.
The data collection was conducted in accordance with relevant market research and privacy regulations (EphMRA)Citation19 and performed in accordance with the principles stated in the Declaration of Helsinki. The ethical exemption was sought from the Pearl Institutional Review Board (protocol number 22-ADRW-174).
Results
This study included data on 448 patients (France: 92, Germany: 76, Italy: 97, Spain 98: UK: 85) who were in the maintenance phase of their vedolizumab treatment, reported by 112 physicians, out of 660 initially contacted physicians.
Vedolizumab dosing patterns
Overall, 77.4% of patients followed the recommended dosing schedule for vedolizumab induction, receiving 300 mg IV at weeks zero, two, and six. This dosing schedule was most common among patients in France (81.4%) and least common in Spain (75.8%; ). There was variation across patients in the number of doses received and time intervals between doses, with a further 10.7% of patients receiving the recommended three infusions during their vedolizumab induction, but at weeks other than zero, two, and six. The remaining 2.1%, 6.5%, 3.0%, and 0.2% of patients received one, two, four, and five 300 mg doses, respectively. One patient (0.2%) was reported to have received 300 mg IV at weeks zero, two, and six, followed by 108 mg SC at week eight.
Table 1. Vedolizumab dosing patterns by country.
At the time of the survey, 83.5% of patients were on a standard maintenance dose of vedolizumab, 10.3% on a higher-than-standard dose and 6.3% on a lower-than-standard dose (). Higher-than-standard doses were most common in Italy (18.6%) and least common in Germany (3.9%). Standard and higher-than-standard doses were more commonly administered IV, whereas SC administration was more commonly used for lower-than-standard dosing. The most reported higher-than-standard dose was 300 mg Q4/week (wk) IV, in 5.4% of patients (range: 1.3% in Germany to 10.3% in Italy). Less common higher-than-standard doses were 300 mg Q5/wk IV, 300 mg Q6/wk IV, 300 mg Q7/wk IV, and 108 mg Q1/wk SC, at 0.2%, 4.2%, 0.2%, and 0.2% of patients, respectively. The most frequently reported lower-than-standard dose was 108 mg Q8/wk SC, in 4.2% of patients. Other reported lower-than-standard doses were 108 mg Q4/wk SC, 108 mg Q6/wk SC, 108 mg Q9/wk, and 300 mg Q12/wk IV, in 1.1%, 0.4%, 0.2%, and 0.2% of patients, respectively. The mean time between IV doses was 7.6 ± 1.2 weeks (range 7.4 ± 1.4 in Italy and Spain to 7.8 ± 0.8 weeks in Germany), for SC doses this was 3.0 ± 2.2 weeks (range 2.2 ± 1.1 in the UK to 4.4 ± 3.1 in Italy).
Patients had been on their current dose regime for a median [IQR] of 37.0 [15.6–66.5] weeks (range 29.4 [13.9–46.4] in Germany to 49.3 [31.6–105.3] in Spain) and had been in the maintenance phase of their treatments for a median of 40.0 [19.3–77.3] weeks (range 30.8 [15.0–46.4] in Germany to 50.2 [36.4–113.6] in Spain). Most patients (90.2%, range 85.5% in the UK to 96.1% in Germany) did not have a change to their treatment regime since the start of their maintenance phase. The most common change was altering the route of administration from IV to SC (4.8% of patients).
Reasons for dose choice
The most reported reason for prescribing a standard dose was the improvement of symptoms (36.9%; ). Other commonly cited reasons for prescribing standard dose were patient had achieved remission (34.5%) and to control the patient’s flares (28.1%). In contrast, the worsening of symptoms was the most common reason for choosing a higher-than-standard dose (30.4%), with other common motivations being a lack of improvement in symptoms (19.6%) and non-clinical factors including following local protocols and guidelines (19.6%).
Table 2. Physician reason for current vedolizumab dose choice.
Patient demographics
lists the demographic, clinical, and healthcare resource utilization data for patients split by vedolizumab maintenance dose. Data delineated by country can be found in supplementary table S2. Data for patients on a lower-than-standard dose (6.3% of patients) are not shown due to insufficient sample size. The mean age for patients on a standard dose was 44.5 ± 14.7 years, in the higher-than-standard dose group this was 48.7 ± 16.4 years. Overall, patients had normal mean BMI (24.1 ± 3.2 kg/m2), 54.1% were male, and the majority were white (92.5%) and employed full-time (62.8%). Median (IQR) time since diagnosis was 3.9 (1.9–7.7) years overall, 3.9 (1.9–7.7) for the standard dosing group and 4.0 (2.2–8.3) years for those on a higher-than-standard dose. Overall, standard dose patients had been in the maintenance phase of their treatment for a median (IQR) of 41.9 (21.6–80.9) weeks and on their current maintenance dose for 39.7 (18.3–72.3) weeks. For higher-than-standard dose patients, this was 38.0 (16.7–112.3) weeks and 22.4 (6.6–62.9) weeks, respectively.
Table 3. Patient demographics and clinical characteristics.
Clinical characteristics
The most reported concomitant conditions were anxiety, anemia, depression, diabetes without chronic complications, and metabolic syndrome (). Anxiety was the most reported concomitant condition in the standard dosing group, at 14.2%. In the higher-than-standard dosing group, anemia (37.0%) was the most reported, followed by anxiety (32.6%).
Overall, most patients were in disease remission at the time of the survey (66.7%). However, only 34.8% of patients on a higher dose were in remission, whereas 70.6% of those on the standard dose were. Patients on a higher dose had high rates of mild or moderate disease at the time of the survey, at 37.0% and 26.1% respectively. Patients on higher-than-standard doses frequently reported fatigue (37.0%), abdominal pain (23.9%), non-bloody diarrhea (21.7%), and bowel urgency (19.6%), these were reported by 27.6%, 17.7%, and 11.5% of standard dose patients, respectively.
Clinical disease remission, defined as the reduction or absence of symptoms, was reported by 89.5% of standard-dose patients, but only by 67.4% of those on a higher-than-standard dose. Median (IQR) time in clinical remission was 10.7 (4.9–21.8) months for the standard dose group and 9.1 (2.6–18.1) months for those on higher-than-standard doses. Of patients with known data, endoscopic disease remission – defined as the absence of inflammation confirmed by endoscopy – was reported for 76.3% of standard-dose patients and 37.8% of those on higher-than-standard doses. The median (IQR) time in endoscopic remission was 10.8 (4.3–19.3) months for standard-dose patients and 12.6 (3.9–36.9) months for higher-than-standard dose patients.
Few patients were receiving corticosteroids at the time of the survey (4.3–10.9%), however, most of both the standard and the higher-than-standard dose patients (91.0% and 95.4%, respectively) had received corticosteroids during the course of their disease. During their current vedolizumab treatment, 51.0% of standard-dose patients and 55.3% of higher-than-standard-dose patients had received corticosteroids. At the time of the survey, 9.4% of standard-dose patients and 13.0% of higher-than-standard-dose patients were receiving an immunomodulator.
While 58.6% of standard-dose patients had not received any other advanced therapies prior to vedolizumab, 8.6% had received two or more advanced therapies previously. In the higher-than-standard dose group, 54.4% of patients received vedolizumab as their first advanced therapy, while 15.2% had received two or more advanced therapies previously.
Healthcare resource utilization
In the 12 months prior to the survey, patients had a mean number of 6.6 ± 4.9 healthcare professional consultations, with standard-dose patients having 6.4 ± 4.8 consultations and higher-than-standard dose patients reporting 7.9 ± 5.8 consultations (). The mean total number of tests in the last 12 months was 33.4 ± 19.7 for standard dose patients and 44.0 ± 31.2 for those on higher-than-standard dose. The majority of these were blood tests (25.1 ± 16.8 and 34.3 ± 28.1 for standard and higher-than-standard doses, respectively); biopsies, endoscopies, imaging tests, or stool tests were reported at lower levels (range: 0.6–2.7 per year) in both groups. Patients required a mean of 0.2 ± 0.5 hospitalizations in the 12 months prior to the survey (standard dose: 0.1 ± 0.5, higher-than-standard dose: 0.3 ± 0.7), although at least three-quarters of patients in both groups had not been hospitalized during this time period.
Physician satisfaction
The satisfaction of reporting physicians with the current vedolizumab treatment is listed in ; data split out by country are reported in Supplementary Table S3. For most standard dose patients (76.2%), physicians were satisfied with the treatment and believed they had achieved the best possible disease control. In contrast, physicians reported they were satisfied and believed they had achieved the best possible disease control for only 43.5% of those on higher-than-standard doses. Physicians reported being not satisfied with the treatment and believed better control was possible for 17.4% of higher-than-standard dose patients, but for only 2.4% of standard dose patients.
Table 4. Physician satisfaction with current treatment regime.
Discussion
Vedolizumab is indicated for moderately-to-severely active UC that is refractory to either conventional therapy or TNFα antagonist. Dose escalation of vedolizumab may be utilized by physicians to achieve or recapture response in difficult-to-treat patients. This study has, for the first time, described the real-world demographic and clinical characteristics for UC patients on standard and higher-than-standard doses of vedolizumab, and shows that despite receiving high doses of vedolizumab, some patients continue to have poor disease outcomes.
We found that although most patients followed the recommended induction schedule for vedolizumab, there was a significant proportion of patients who received a variety of alternative and off-label schedules. This may be due to a physician-perceived lack of response, leading to extended induction periods, or non-clinical factors such as patients missing appointments for dosing.
The frequency of switching to a higher maintenance dose of vedolizumab in our cohort was lower than previously reported in UCCitation14,Citation20–22 or IBD in generalCitation23. This suggests that patients in our cohort who did not achieve the desired response to treatment in the induction phase were immediately prescribed a higher-than-standard maintenance dose, rather than switching to a higher-than-standard dose at a later point during their maintenance phase. This is supported by our finding that the median time on the current dose was similar to the time on maintenance therapy for patients on a higher-than-standard dose, indicating most patients were indeed put on a higher-than-standard dose immediately after induction. Following induction, vedolizumab takes longer to exhibit therapeutic effect compared to anti-TNF treatments, which physicians may be more familiar withCitation21. Therefore, this lack of evident therapeutic effect may contribute to physicians opting to increase the dose immediately following induction. This pattern was also seen in a trial investigating the use of vedolizumab in TNFα antagonist-refractory patients with Crohn’s diseaseCitation24.
The proportion of patients in our cohort on higher-than-standard doses was low compared to previous European studies, which showed 47.1%–60.0% of patients were on higher-than-standard dose after one yearCitation16,Citation22 and 52.1% of patients after three years of treatmentCitation25. However, as these studies took place shortly after vedolizumab approval, our study may be more reflective of current clinical practice and the use of vedolizumab treatment since its approval in 2014.
Even though guidelines for vedolizumab use are identical across all countries in this study, significant differences in both induction schedules and the prescription rates of higher-than-standard doses were reported. Italian physicians prescribed higher-than-standard doses more than four times as frequently than German physicians. This may be due to non-clinical factors such as local guidance or coverage, given this was frequently reported by Italian physicians as a reason for prescribing a higher-than-standard dose.
Patients who received a lower-than-standard dose more frequently did so subcutaneously rather than through IV, and the mean time between SC doses was longer than the recommended two weeks. This may reflect a lack of treatment adherence for self-administered SC injection. Alternatively, it may be that lower-than-standard doses are prescribed to those who have better disease control and have a lower clinical need to receive higher-than-standard doses, compared to patients who receive IV vedolizumab. A switch from IV to SC was also the most common change to patients’ treatment regime. A previous study has suggested that clinical efficacy is maintained after a switch from IV to SC administrationCitation26.
Patients on higher-than-standard doses were reported to have high levels of concomitant disease and were often not in disease remission. Patients without clinical symptomatic remission were also found to have high symptom load, most commonly experiencing fatigue, abdominal pain, and bowel urgency, which has previously shown to place a considerable burden on patient health-related quality of lifeCitation27. This suggests that these patients had more severe or difficult-to-control disease, requiring higher-than-standard doses. Dose escalation of vedolizumab has been reported to result in clinical response in 42–75% of UC patientsCitation28. This is comparable with the 37.8% and 67.4% of patients in our survey who were on a higher-than-standard dose and were reported to be in endoscopic or clinical remission, respectively.
However, the fact that patients continue to report sub-optimal disease outcomes indicates even higher-than-standard doses are inadequate in at least some patients. In previous analyses of vedolizumab treatment in UC, prior exposure to other biological treatments has been associated with a lower likelihood of being in remissionCitation29,Citation30. This may contribute to the sub-optimal outcomes in the higher-than-standard dose population in our cohort, given a significant proportion of the cohort had already received one or more previous lines of advanced treatment prior to vedolizumab.
Rates of endoscopic remission in our study were comparable to previous studies on vedolizumab in UC, which reported endoscopic remission in 26.6%–43.1% of patientsCitation31,Citation32. Even though in most cases patients on higher-than-standard doses do not reach endoscopic remission, those that do remain in remission for long durations. This may indicate that for patients receiving higher-than-standard doses who reach endoscopic remission, vedolizumab is efficient at maintaining remission for long periods of time.
Physicians were overwhelmingly satisfied with the treatment regime for their standard dose patients, which agrees with previous reports on physician satisfaction with treatments in UC patient populationsCitation33,Citation34. However, physicians were dissatisfied with the treatment for a significant proportion of their higher-than-standard dose patients. This suggests a subset of patients with continued lack of response to treatment, even at the higher dosage, and may reflect the fact that higher doses are more commonly used in the most difficult-to-treat patients.
This lack of response is also suggested by physician-reported reasons for prescribing a higher-than-standard dose, which were worsening or a lack of improvement in symptoms. This is in agreement with prescribing guidelines, which recommend an increase of dosing frequency to 300 mg IV every four weeks when a decrease or loss of response is observedCitation18. In contrast, several of the reasons given for prescribing a standard dose, such as improvement of symptoms, remission achieved, and mucosal healing suggest this dose is largely used in patients with well-controlled disease.
Our real-world data describing the clinical characteristics of UC patients on higher-than-standard doses of vedolizumab show that even at high levels of treatment, patients continue to have sub-optimal clinical outcomes. This suggests that there is a subgroup of patients currently treated with vedolizumab that do not have favorable responses to their treatment, regardless of the dose. This, coupled with the low physician satisfaction with treatment of those on higher-than-standard doses makes it likely that physicians will be exploring alternative treatments.
However, there are currently limited treatment options for those that do not respond to vedolizumab. Treatment with vedolizumab indicates the patient was already refractory to anti-TNF treatment or conventional systemic treatment. Other treatment options for those refractory to anti-TNF treatments are interleukin-12/23 inhibitors, sphingosine-1-phosphate modulators and Janus kinase inhibitors. However, these treatments may also not be efficacious in this patient group. Janus kinase inhibitors in particular are less efficacious in anti-TNF-exposed patientsCitation4 and carry significant safety risksCitation35.
Development of treatments with new mechanisms of action, including those selective Janus kinase inhibitors, anti-interleukin treatments, other adhesion molecule targeting biologics and toll-like receptor 9 antagonists is currently ongoingCitation36. These developments may provide further treatment options for UC patients and will necessitate continued monitoring of real-world prescribing habits as these treatments reach the clinic. Taken together, our data show a significant unmet clinical need in UC patients on higher-than-standard doses on vedolizumab and points to a need for more efficacious medication for these difficult cases.
Limitations and strengths
Being in the maintenance phase of vedolizumab treatment was one of the inclusion criteria for the study, therefore response rates may be biased, as those with an early lack of response are less likely to be included in the study.
Participating patients may not reflect the general UC population receiving vedolizumab since the survey only included patients who were consulting with their physician. This means that patients who consult more frequently have a higher likelihood of being included.
The survey is based on a pseudo-random sample of physicians and patients. While minimal inclusion criteria governed the selection of participating physicians, participation was influenced by their willingness to complete the survey. A response bias may be present due to the fact that 112 out of 660 initially contacted physicians took part. This may have biased our sample towards physicians with a greater willingness to take part in research, who may have different prescribing behavior.
To minimize patient selection bias, physicians were asked to provide data for a consecutive series of eligible patients. Patient eligibility was based on the judgement of the respondent physician and not on a formalized diagnostic checklist, however, it is representative of the physician’s real-world classification of their patients.
Recall bias, a common limitation of surveys, might also have affected the responses of both physicians and patients. However, physicians did have the ability to refer to the patients’ records while completing the survey, thus minimizing the possibility of recall bias.
Data reported are based on the responses of physicians, without independent verification of patient clinical records. Therefore, the possibility of erroneous reporting exists.
The number of HCP visits may be confounded by physicians including visits for vedolizumab infusion in their counts. The questionnaire used did not address this specifically, therefore it cannot be said with certainty whether the physicians accounted for IV infusions when answering this particular question.
The strengths of this study include a large sample size recruited from multiple centers in multiple European countries, surveyed to a greater level of detail than any previous study into dose escalation.
Conclusions
Both induction and maintenance schedules of vedolizumab for UC vary significantly in real-world practice, including some that are off label. Over 10% of patients were receiving a higher-than-standard maintenance dose of vedolizumab, and despite this, were found to have sub-optimal clinical outcomes including low rates of remission, high disease burden, and high symptom load, as well as low physician satisfaction. Physicians’ reasons for prescribing higher-than-standard doses suggested these are mostly used for difficult-to-treat patients, however, the findings of this study indicate a need for alternative therapeutic options to achieve optimal treatment response for such patients.
Transparency
Author contributions
All authors (1) were involved in conception or design, or analysis and interpretation of data; (2) were involved in drafting and revising the article; (3) reviewed and agreed on the final version to be published; and (4) agreed to take responsibility and be held accountable for the contents of the article, including resolving any questions raised about the accuracy or integrity of the published work.
Supplemental Material
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Download MS Word (28.2 KB)Acknowledgements
Medical writing support under the guidance of the authors was provided by Niels Haan of Adelphi Real World, in accordance with Good Publication Practice (GPP3) guidelines.
Declaration of funding
Data collection was undertaken by Adelphi Real World as part of an independent survey, entitled the Adelphi Real World UC vedolizumab Chart Review. The Adelphi Real World UC vedolizumab Chart Review is a wholly owned Adelphi product. Eli Lilly and Company subscribed to this survey and did not influence the original survey through contribution to the design of questionnaires or data collection. Publication of study results was not contingent on the subscriber’s approval or censorship of the manuscript.
Declaration of financial/other relationships
PS, IR, SH and THG are employees of Eli Lilly and Company and may hold stock or stock options.
HK, EQ, NH, and VP are employees of Adelphi Real World.
JPG has served as a speaker, a consultant and advisory member for or has received research funding from MSD, Abbvie, Hospira, Pfizer, Kern Pharma, Biogen, Takeda, Janssen, Roche, Sandoz, Celgene, Ferring, Faes Farma, Shire Pharmaceuticals, Dr. Falk Pharma, Tillotts Pharma, Chiesi, Casen Fleet, Gebro Pharma, Otsuka Pharmaceutical, Vifor Pharma.
A reviewer on this manuscript has disclosed that they sit or have sat on the advisory board for and/or received lecture grants from AbbVie, Biogen, MSD, Galapagos, Ferring, Janssen, Pfizer, Takeda. Peer reviewers on this manuscript have received an honorarium from CMRO for their review work but have no other relevant financial relationships to disclose.
Data availability statement
All data, i.e. methodology, materials, data, and data analysis, that support the findings of this survey are the intellectual property of Adelphi Real World. All requests for access should be addressed directly to Hannah Knight at [email protected]. Hannah Knight is an employee of Adelphi Real World.
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