bluuebunny/crossref_metadata_2025_split huggingface dataset:
P423 Treatment escalation and associated cost in German Ulcerative Colitis patients treated with advanced therapies
Authors: Picker N , Patel H , Wilke T , Rosin L , Bokemeyer B 
Published: May 2021

Abstract

Background
Advanced therapies used in moderate-to-severe Ulcerative Colitis (UC) may show a secondary loss of response (LOR) over time, requiring patients to undergo dose escalation or switching. Our study aimed to investigate the frequency of dose escalation in real-world practice and evaluated the associated cost.

Methods
Using German claims data (AOK PLUS) including prescription data, we identified UC patients by either at least two confirmed outpatient diagnoses or one primary inpatient diagnosis (ICD-10 K51). Analyzed patients initiated an advanced therapy (anti-TNF, vedolizumab, tofacitinib) between 01/01/2015-30/06/2019.
Therapy escalation was defined as dose increase exceeding the recommended maintenance dose according to product labels by more than 150%. Time to first escalation was analyzed using a Kaplan-Meier estimation. The observation ended with the discontinuation of index therapy + 90 days, or loss to follow-up, whatever occurred first. End of therapy was determined in case of a supply gap of &gt;60 days or switch of the advanced therapy. Patients with a follow-up &lt; 6 months were excluded.Direct UC-related resource use and costs accounting for hospitalizations, outpatient treatment, drug costs according to pharmacy sales prices were reported per patient-year (PY).

Results
Among 574 UC patients who initiated an advanced therapy, 328 patients (median age: 37 years; female: 52.1%; biologic-naïve: 85.4%) with sufficient follow-up time (median: 12.2 months) were identified.
Out of these, 59 patients (19%) were dose-escalated within the first year, whereas 73 patients (22%; anti-TNF: 61; vedolizumab: 12) were found to experience a therapy escalation during the whole follow-up time (average daily dose during maintenance therapy: adalimumab: 5.3 mg, infliximab: 14.6 mg, golimumab: 3.7 mg, vedolizumab: 11.1 mg, tofacitinib: n/a). Total observed direct cost related to UC amounted to €39,514/PY (95%-CI: 37,469-41,558), with €37,369/PY (34,852-39,885; Figure 1) caused by UC-related medication (95%). In comparison, UC-related total direct costs and drug costs for patients without any observable escalation were much lower (€30,425/PY [29,672-31,178]; p-value &lt;0.001 and €28,066/PY [27,230-28,902]; p-value &lt;0.001). Frequency of hospitalizations due to UC (0.3 [0.2-0.5] vs. 0.4 [0.3-0.5]; p-value: 0.947) and gastroenterologist visits (2.1 [1.6-2.6] vs. 2.3 [2.1-2.5]; p-value: 0.361) were similar among both groups.

Conclusion
Nearly one-fifth of observed patients required therapy escalation in the first year, most likely due to secondary LOR. This results in higher UC-related costs. Payers should consider rates and costs of dose escalations when evaluating the cost-effectiveness of advanced therapies.
P524 Endoscopic dilations of intestinal stenosis in Crohn’s disease
Authors: Badre W , Bahlaoui O , El Rhaoussi F Z , Tahiri M , Haddad F , Hliwa W 
Published: May 2021

Abstract

Background
The occurrence of intestinal stenosis is a common and potentially serious complication of Crohn’s disease (CD). These strictures represent 20% of the surgical indications in CD. Endoscopic dilation is an alternative to surgery for endoscopically accessible stenosis. The aim of this study is to evaluate the effectiveness of endoscopic balloon dilation (EBD) in CD intestinal stenosis.

Methods
This retrospective, descriptive study realized between January 2015 and October 2020, included CD patients diagnosed at least 6 months before and complicated with symptomatic intestinal stenosis (abdominal pain, bloating, nausea and vomiting). Anorectal strictures were excluded. All patients had a cross-sectional imaging before intestinal dilation to determine the characteristics of the stenosis and exclude abscess and fistula tract near the stenosis which constitute a contraindication of EBD. All patients underwent an EBD during a colonoscopy under sedation by propofol. The short-term success of EBD has been established on both technical (passage of the endoscope across the site of stenosis after dilation) and clinical level (relief of intestinal obstructive symptoms). The long-term efficacy was defined by no need for surgery within 6 months after dilation.

Results
Twelve patients (6 males and 6 females), with an average age of 32 years +/-7.7, were included. The average interval between onset of CD and the onset of intestinal stricture was 8 years. Eight patients had a history of bowel resection. The stenosis was located at the terminal ileum or ileocaecal valve in 4 cases, ileocolic anastomosis in 8 cases. The stenosis was ulcerated in 9 cases, inflammatory in 5 cases and polypoid in 3 cases. All patients were on medical treatment corticosteroids, Azathioprine and / or Anti TNF. We performed 18 EBD, divided into several sessions depending on the degree of stenosis (1 EBD, 2 EBD and 3 EBD in respectively 11, 3 and 2 patients). Two patients required surgery for persisting symptoms.
Technical success was obtained in 11 patients (92% of cases). Clinical success, defined by a disappearance of clinical symptoms with an HBI score of less than 4, was obtained in 9 patients (75% of cases). The mean follow-up after dilation was 23 months (range from 8 to 42 months). No major complications were observed in this study.

Conclusion
EBD is an effective therapeutic technique relatively safe for intestinal CD stenosis, allowing to delay or better, to avoid surgical treatment when the stenosis is well selected (stenosis&lt;4cm, single, anastomotic, non-angled, and without adjacent abscess or fistula).
P537 Anemia in Crohn’s Disease: Response to treatment and risk of recurrence
Authors: Gharbi G , Bibani N , Sabbah M , Nawel B , Trad D , Ouakaa A , Elloumi H , Gargouri D 
Published: May 2021

Abstract

Background
Anemia is common in Crohn’s Disease (CD). Iron deficiency and inflammation are the most common etiologies.
The aim of our study is to assess the response of patients with CD to anemia treatment , as well as the predisposing factors for recurrence after treatment.

Methods
This is a retrospective study including patients with CD complicated by anemia, treated in the gastroenterology department between January 2015 and December 2019.
Iron deficiency anemia is defined by a ferritin level &lt;50 ng /ml, it is inflammatory if the CRP level is high with a ferritin level which exceeds 100 ng/ml and mixed if this later ranges between 50 and 100 ng/ml.

Results
Fifty-four patients were included with a M / F sex ratio of 1.3. The mean age was 40.5 years old with a mean age at diagnosis of CD of 29 years old. Patients had ileal or ileocolic involvement in 82.2% of cases and pure colonic involvement in 16.7%. The main symptoms of anemia were asthenia (64.8%) and mucocutaneous pallor (42.6%).
Severe anemia was noted in 64.8% of patients. The factors statistically associated with severe anemia were: the number of relapses before the diagnosis of anemia (p= 0.012), an active disease (p = 00.024) assessed by the CDAI score, the presence of a deficiency syndrome, in particular hypocholesterolemia (p= 0.007) and hypocalcemia (p= 0.006).
The anemia was inflammatory in 44.4% of patients, iron deficiency in 31.7%, mixed in 20.4% and vitamin B12 deficiency in 16.7% of them.
Treatment of anemia depending on the etiology was effective in 72% of patients. The response was partial in 24% of cases. Only 4% of patients did not respond to treatment.
The predictive factors of a poor response to anemia treatment were: the disease duration (p= 0.05), an active disease at the time of diagnosis of anemia (p= 0.025) and an extended ileal resection (p= 0.005).
Patients with inflammatory anemia responded better to treatment (p= 0.006).
A longer duration of iron suplementation (p = 0.02), as well as the route of administration (IV) (p= 0.014) were correlated with a better response to therapy in case of iron deficiency anemia.
Recurrence of anemia was observed in 84.3% of patients with a mean time after anemia correction of 11.5 months.
Serum ferritin levels &lt;20 ng/ml during follow-up was the main risk factor for recurrence of anemia (p= 0.01).

Conclusion
Even after treatment, recurrence of anemia is common especially in patients followed for CD with ileal involvement. A clinical-biological remission, a sufficient duration of iron treatment and the control of the response to treatment by the dosage of the ferritin level even after the correction of the anemia is necessary in order to avoid this recurrence and thus ensure a better quality of life .
P548 Drug Survival in Patients with Inflammatory Bowel disease: An observational study
Authors: Kubesch A , Grimm L , Stratmann K , Knabe M , Filmann N , Sprinzl K , Hausmann J , Blumenstein I 
Published: May 2021

Abstract

Background
Although the therapeutic array has significantly widened, over the past decades predicting treatment persistence in IBD patients is still a challenge. In this study we collected longitudinal data to determine drug survival on the medications currently available for IBD.

Methods
Patients treated in the IBD outpatient clinic of the Goethe University Hospital were retrospectively analyzed. Laboratory parameters and data on treatment adherence were collected via the electronic patient file. We investigated how many patients continued on the respective substances after the induction period and after the 1-year mark.

Results
A total of 601 patients were included. 321 patients were female (53.4), 280 patients were male (46.6). The median age was 43 (range 19–86). The median disease duration was 14 years (range 1–52). 320 patients (53.2) suffered from CD and 281 (46,8) patients suffered from UC.
95 patients were treated with Infliximab (IFX) with a median duration of 912 days (20–5273). 91 patients (96.8) were still on IFX after the induction period. 73 patients (76.8) patients reached the 1-year mark. At the endpoint of this investigation, 39 patients (41.9) were still on IFX. 172 patients were started on Adalimumab (ADA) with a median of 1054 (48–4458) days on the medication. Of this collective, 172 (100%) patients continued on ADA after the end of the induction period. 136 patients (79.1) reached the 1-year mark. At the endpoint of this investigation, 90 patients (52.3) were still on ADA. Of the entire cohort, 124 patients were treated with Vedolizumab (VDZ) with a median of 745.50 (0-2204) days on the medication. After the induction period for this medication, 123 patients (99.2%) were still on VDZ. 89 patients (71.8%) achieved the 1-year mark. At the endpoint of this investigation, 82 patients (66.1%) were still on VDZ. Lastly, 66 patients were treated with Ustekinumab (UST) with a median duration of 720 days (50–1777). 64 patients (98.5%) achieved clinical remission. 48 patients (72.7%) achieved the 1-year mark. At the endpoint of this investigation, 54 patients (83.1%) were still on UST. As we provided longitudinal data some patients have been exposed to several medications which in part explains the lower patient numbers in the more recently approved drugs.

Conclusion
Conclusion: The majority of patients were still on the medication after the respective induction in all treatment groups. 1-year treatment persistence was higher for and ADA in comparison to VDZ and UST. Our study provides further evidence on drug survival in IBD and may aid in advising patients in this matter.
P562 Web-based questionnaire survey about self-management for patients with Inflammatory Bowel Disease in Japan
Authors: Nagahori M , Imai T , Tairaka A 
Published: May 2021

Abstract

Background
The importance of self-management (SMN) has been widely recognized in chronic diseases but the concept remains complex and its evaluation diverse. There is a limited number of studies evaluating SMN in Inflammatory Bowel Diseases (IBD), and notably in Japan. We have therefore explored the actual utilization of SMN in IBD, the type of supports needed by the IBD patients, and the phenotypic differences between patients with and without SMN.

Methods
We conducted a web-based survey considering SMN components as diet, treatment, symptoms/physical conditions, stress, financial worries, and support services from February to March 2020. Subjects were recruited from the Japanese IBD patients’ panel and solicited by email for participation. SMN patients were defined as those responding positively to 3 questions about (1) habit of checking nutrition labelling (2) adjustment of their diet (3) modification of their daily life behavior according to the health conditions. Factors associated with the SMN utilization were also analysed by logistic regression analysis.

Results
Among 371 evaluable patients [Ulcerative Colitis (UC): n=210, Crohn’s Disease (CD): n=161, mean age=42 years, mean disease duration=10.2 years], 59.6% composed the SMN group (UC: 54.3% CD: 66.5%). 87.9% responded “able to live well with IBD” (UC: 90.5% CD: 84.5%, SMN: 92.3% vs non-SMN: 81.3% p=0.002), and 74.4% responded “checking nutrition labelling when buying food” (UC: 67.1% CD: 83.9%) but only 18.3% kept a regular record of diet (UC: 16.7% CD: 20.5%, SMN: 24.9% non-SMN: 8.7%) and 26.1% for symptoms record (UC: 29.5% CD:21.7%, SMN: 29.9% non-SMN: 20.7%). Doctors and families were the most consulted partners for lifestyle, symptoms and treatment by all patients, while CD patients, compared to UC ones, privileged nurses and other IBD patients. As between patients treated or not with biologics and janus kinase inhibitor (Bio/JAKi), there were more items demonstrating significant differences such as the utilization of SMN in UC than in CD. Patients with Bio/JAKi significantly responded more often to be “satisfied with their current treatment”. Meanwhile, patients with hospitalization or surgery histories as well as UC patients with Bio/JAKi showed higher proportions of SMN utilization. “Having 3 or more kinds of people to consult about lifestyle” in UC and “History of hospitalization” in CD were the most influential factors of SMN utilization. Financial/Employment aspects (77.4%) was the most desired support for all patients.

Conclusion
This is the first survey to reveal the actual utilization of SMN and its possible benefits in IBD patients in Japan. Our results suggested that SMN contributes to a better living with IBD for Japanese IBD patients.
P582 Insights on the sphingolipid profile in patients with short bowel syndrome and consecutive intestinal failure
Authors: Kubesch A , Knauer F , Thomas D , Jakobi K , Filmann N , Zeuzem S , Pfeilschifter J , Grammatikos G , Blumenstein I 
Published: May 2021

Abstract

Background
Short bowel syndrome (SBS) is a rare condition, and providing care for these patients can be challenging. Investigating the serologic sphingolipid profile has enhanced the understanding of various pathophysiologic conditions. However, data on the serologic sphingolipid profile in patients with SBS are –to date- not available.

Methods
Serum probes from patients with SBS treated in the outpatient clinic of the Department of Gastroenterology and Hepatology of the University Hospital Frankfurt were included and analyzed retrospectively. Serologic sphingolipid (SL) and especially ceramide (Cer) levels were assessed by LC-MS/MS and correlated with clinical and laboratory chemical parameters.

Results
A total of 37 (16 male) patients with SBS were included, 11 with Crohn’s disease (CD) (29.73%). Patients’ median age was 62 (24–88), with a median weight of 59 kilograms (42–75). Patients with less than 100 centimeters of small intestine had significantly higher creatinine and lower total protein levels, whereas the serologic SL-profile was not significantly affected. Furthermore, Sphingosine-1-Phosphate (S1P) and C18-Cer were increased in patients with SBS with CD as the underlying etiology. No significant differences in the sphingolipidomic profile were observed between patients on total parenteral nutrition than patients with oral and parenteral nutrition and patients with associated elevation of the liver enzymes.

Conclusion
Conclusion: Our study provides first insights into the serologic SL profile of patients with SBS. We showed that patients with CD present with an altered SL profile compared to other aetiologies, while the occurrence of liver disease in this single-center cohort does not appear to affect the serologic SL profile in respective patients.
P592 Costs savings associated with ferric maltol and the reduced use of intravenous iron based on real world data
Authors: Howaldt S , Becker C K , Becker J A , Poinas A C 
Published: May 2021

Abstract

Background
Intravenous (IV) iron is frequently used in patients with iron deficiency (ID) when conventional oral ferrous products are ineffective or cannot be used (e.g. due to poor tolerability). Oral ferric maltol is a new iron ferric product registered in Europe and US. The aim of this study was to quantify the use of IV iron before and after the introduction of the new oral ferric maltol in real world settings and extrapolate the overall costs involved.

Methods
Data were collected from a single centre German clinical practice, MVZ für Immunologie, in inflammatory bowel disease (IBD) patients treated with iron therapy for ID with or without anaemia between 2013 and 2019 through the systematic CEDUR IBD registry and local medical records. The first cohort was formed of patients treated between 2013 and 2015, receiving only IV iron as ferric carboxymaltose (FCM). The second cohort was formed of patients treated between 2017 and 2019, receiving either oral ferric maltol only or ferric maltol in combination with FCM. Costs involved in each cohort were extrapolated using a societal perspective.

Results
Following the introduction of oral ferric maltol, the actual total number of FCM infusions observed was 138, showing a decrease of 70% compared to the first cohort in which oral ferric maltol was not available. This decreased number of infusions between the two cohorts was associated with total costs-savings of €56,933. In the first cohort, the administration costs were €44,536, the drug acquisition costs were €59,536 and the productivity loss were €30,944. In the second cohort, the administration costs were €13,597 the drug acquisition costs were €55,028 and the productivity loss were €9,447. A secondary scenario strictly applying the doses taken from respective SmPCs was tested and resulted in greater costs-savings.
Noteworthy, the mean (SD) haemoglobin (Hb) level at baseline in the first cohort was lower with 11.5g/dl (1.19) vs. 12.2g/dl (1.18) in the second cohort. Three to six months after the treatment had been stopped, the mean (SD) Hb level was 13g/dl in both the first and second cohort with a SD of 1.31 and 1.37 respectively, showing that Hb levels were maintained in both cohorts.

Conclusion
The introduction of the new oral ferric maltol resulted in a decrease of 70% in terms of number of FCM infusions which was associated with costs-savings of €56,933 in terms of administration, drug acquisition and productivity loss costs. Considering that Hb levels were maintained in both cohorts, these results indicate that ID patients with or without anaemia previously treated with IV iron can also be managed effectively with oral ferric maltol resulting in overall societal cost-savings.
P600 Real-world clinical characteristics and therapeutic strategies in patients with moderate-to-severe Inflammatory Bowel Disease in Argentina: Data from the RISE AR study
Authors: Lasa J S , Sambuelli A , Zubiaurre I , Correa G J , Lubrano P , Balderramo D C , Ruffinengo O , Brion L , Leonardi D B , El-Hakeh J , Guimaraens P N , Olivera Sendra P 
Published: May 2021

Abstract

Background
Evidence on the adoption of different pharmacologic strategies in inflammatory bowel disease (IBD) in the real-world setting in Latin America is scarce. Herein, we describe the clinical characteristics and therapeutic strategies of IBD patients (pts) in Argentina.

Methods
RISE AR (NCT03488030) was a multicentre, non-interventional study with a cross-sectional evaluation and a 3-year retrospective data collection period conducted in Argentina (12/2018-05/2019) to assess the use of IBD treatments. Adult pts (≥18 years old) with a previous diagnosis of moderate-to-severe ulcerative colitis (UC) or Crohn′s disease (CD) based on clinical, endoscopic or imaging criteria at least 6 months prior to enrolment, were included.

Results
Overall, 101 CD and 145 UC pts were included. Median (range) age (years) at enrolment was 39.5 (18.2–74.0) for CD (51.2% female) and 41.9 (18.0–80.4) for UC (55.2% female); median (range) disease duration (years) was 7.4 (0.6–36.9) for CD and 5 (0.7–33.8) for UC. At enrolment, 51.5% of CD pts had colonic involvement, 32.7% ileocolonic, 8.9% ileal, 1% isolated upper tract and 5.9% had combined L4/other. In UC, 46.2% had extensive colitis, 44.7% left-sided colitis and proctitis 9.1%. 51.6% of CD pts had non-inflammatory behaviour (37.7% stricturing; 13.9% penetrating), and 34% had perianal disease (13.9% as B1p), resulting in a total of 65.5% pts with complicated disease. Only 9.3% of CD (Harvey Bradshaw Index ≥8) and 7.7% of UC (partial Mayo Score ≥5) pts showed moderate-to-severe disease activity at enrolment. In CD, 70.3% of pts were receiving a biologic agent vs. 29.7% of UC pts. Immunosuppressant (IMM) use was similar between groups (CD 39.6%, UC 40.0%); nearly one-third of the pts on a biologic were receiving concomitant IMM (CD 33.8%, UC 34.9%). Aminosalicylates (5-ASA) were used for most UC pts (89.0%) vs. 47.5% of CD pts, mainly in those with L2 disease. 5-ASA monotherapy was prescribed in 32.1% of UC vs. 5.3% of CD pts, but were also used with IMM (UC 25%, CD 11%), biologics (UC 15%, CD 11.6%) or all three therapies combined (UC 6.4%, CD 17.9%). Corticosteroids (CS) were the least prescribed therapy (CD 7.9%, UC 13.8%).
IBD treatments ever prescribed during the retrospective period were (CD, UC): biologics: 79.2%, 33.8%; IMM: 65.3%, 58.6%; 5-ASA: 62.4%, 97.9%; CS: 55.4%, 69.7%.

Conclusion
In this cohort of IBD patients, biologics use was high, especially among CD patients, in line with disease behaviour, and possibly by their increased availability in these reference centres. This study also highlights country-specific clinical features such as the low proportion of CD pts and the high prevalence of colonic involvement in CD.