Introduction

Within Inflammatory bowel disease (IBD), cost-utility of telemedicine have only been evaluated in few short-term studies compared to standard care. Constant Care (CC) is a telemonitoring web app which has been implemented in North Zealand Hospital in Denmark since 2015. The aim of this study was to assess long-term cost effectiveness of remote telemedicine services (eCare) compared to standard care (sCare) for IBD patients during five years.

Aims & Methods

A retrospective register-based study was carried out among patients with ulcerative colitis (UC) and Crohn’s disease (CD) continuously included in the telemedicine service CC in 2015-2020. Direct and indirect healthcare costs over a 5-year period were obtained from Danish registers and compared to a control group of IBD patients from all five regions in Denmark. Patients were matched 1:5 on year of birth, gender, education, income, disease, use of any biologics, duration of disease and Charlson Comorbidity index. These patients were divided into cohort 1: not recieving biologics and cohort 2: receiving biologics, on which direct and indirect costs were estimated on yearly basis from two years before inclusion in CC (the index year) and five years after using a linear regression model.

Results

A total of 572 IBD patients were included in the study and followed up in 5 years. In cohort 1 (62%), average total direct costs and total earnings were 14,703€ and 310,877€ in eCare compared to 17,119€ and 290,916€ in sCare.While in cohort 2, average total direct costs and total earnings were 76,366€ and 225,769€ compared to 31,456€ and 214,952€ in sCare. Analysis of PROs data of patients in CC through 5 years showed increasing QoL and was higher in cohort 1 than in cohort 2. While disease activity in CD patients, i.e. HBI was shown to be increasing after year 3 and 4 in cohort 1 and 2, respectively. Cohort 1 in CC were more adherent to medication compared to cohort 2.

Conclusion

Telehealth is cost-effective approach for patients not receiving biologics compared to sCare. However, biologics remain more expensive for patients in eCare. Remote tight control in terms of PRO measures in eCare improves quality of life and adherence to medication and possibly prolong time to relapse.

Disclosure

P. Munkholm has received consulting or lecture fees from AbbVie, Calpro A/S, Ferring Pharmaceuticals, Jansen-Cilag, Celgene, Takeda, Tillotts Pharma, Merck Sharp & Dohme, Pfizer, and research funds from Coloplast, Ferring Pharmaceuticals, Jansen-Cilag, Merck Sharp and Dohme, Pharmaforce, Svar A/S, Takeda, Tillotts Pharma, Novo Nordic.
J. Burisch reports personal fees from AbbVie, grants and personal fees from Janssen-Cilag, personal fees from Celgene, grants and personal fees from MSD, personal fees from Pfizer, grants and personal fees from Takeda, grants and personal fees from Tillots Pharma, personal fees from Samsung Bioepis, grants and personal fees from Bristol Myers Squibb, grants from Novo Nordisk, personal fees from Pharmacosmos, personal fees from Ferring, personal fees from Galapagos, outside the submitted work.
M. Al-sheikh, C. Peters-Lehm, M. Bennedsen, and R. Naimi have no conflict of interest.
J. Olsen, M. Spanggaard, P. Egedesø are employees of EY, a paid vendor to Calpro AS.

Introduction

Multiple studies have evaluated the efficacy and safety of subcutaneous vedolizumab in inflammatory bowel diseases (IBDs). Combined with home-monitoring, subcutaneous vedolizumab has the potential to promote effective and personalized management, enables self-administration and optimize use of medical resources. Our study aimed to assess the impact of home monitoring based on patient reported outcomes (PROs) and home test fecal calprotectin in patients with IBD treated with subcutaneous vedolizumab.

Aims & Methods

This was an observational study of 43 IBD patients diagnosed with Ulcerative colitis (UC) or Crohn’s Disease (CD) at North Zealand Hospital in Denmark (NOH). Patients were switched from intravenous to subcutaneous vedolizumab in 2020-2022 and followed for two years via home-monitoring web app IBD Constant Care (CC). Data retrieved from www.ibd.constant-care.com included clinical disease activity scores (Simple Clinical Colitis Activity Index (SCCAI) for UC and Harvey-Bradshaw Index (HBI) for CD), medicine adherence score (MARS), quality of life (QoL), disability (WEB-DI), Fatigue (FACIT-F), and fecal calprotectin levels (using a home testing kit, Calpro smart APP subsequently results transferred to patients file in EPIC). Data including patient descriptions, drug frequency (Q) in weeks, adverse events (AE), severe AE, IBD-related hospital admissions, surgeries and death were obtained from patient journals (EPIC system).

Results

After the exclusion of two patients (one for not starting SC vedolizumab and shifting from IV vedolizumab to another biologic due to primary non-response, and another for lacking a recorded date of consent), forty-one patients, CD (n=21) and UC (n=20) were switched from intravenous to subcutaneous vedolizumab. Treatment was evaluated at baseline, after one and two years. Our study found high adherence to PROs submissions in CC, with only 10% of patients with UC failing to complete them after the two-year period. Only 21 (51%) patients were maintained on subcutaneous vedolizumab after 2 years with tendency to shortened treatment interval compared to baseline and year 1. The proportion of patients achieving remission and low disease activity after 2 years were 70% in UC and 77.8% in CD. 94,1% (n=16) of patients reported improved QoL after 2 years. The most frequent adverse event was reaction at injection site and was reported by 16 (39%) patients, upon which 11 (69%) patients stopped the treatment. 4 (10%) patients undergone IBD-related surgery.

Conclusion

Home monitoring using CC has the potential to transform IBD care by delivering continuous, long-term data on patient reported outcomes. Subcutaneous vedolizumab as maintenance treatment in active, moderate to severe IBD proved to be feasible to monitor by telemedicine and effective for both UC and CD in terms of improving disease activity and quality of life with high rate of adherence to medication. However, local adverse events could lead to treatment discontinuation.

Disclosure

Marwah Al-Sheikh; none.
Zarah Thomsen; none.
Mette Bennedsen; none.
Gasper Letnar; none.
Petra Weimers; is a full-time employee and stock owner of Novo Nordisk.
Dorit Vedel Ankersen; none.
Charlotte Teglgaard Peters-Lehm; none.
Johan Burisch; Dr. Burisch reports grants from AbbVie, Janssen-Cilag, MSD, Takeda, Tillots Pharma, Bristol Myers Squibb, and Novo Nordisk Foundation; personal fees from AbbVie, Janssen-Cilag, Celgene, MSD, Pfizer, Takeda, Tillots Pharma, Bristol Myers Squibb, Samsung Bioepis, Pharmacosmos, Ferring, Galapagos, Eli Lilly, Dr Falk Pharma, Celltrion and Orion Pharma.
Pia Munkholm; Dr. Munkholm reports grants from AbbVie, Coloplast, Ferring, Janssen-Cilag, Dr. Falk, MSD, Takeda, Tillots Pharma, Bristol Myers Squibb, Pfizer(Pharmacia) and Pharmacosmos;
personal fees from AbbVie, Janssen-Cilag, Celgene, MSD, Pfizer, Takeda, Tillots Pharma, Bristol Myers Squibb, Pharmacosmos, Ferring, Galapagos, Eli Lilly, Dr Falk Pharma, Celltrion.

Introduction

Patient-reported outcomes (PROs) are pivotal in assessing treatment efficacy, delivering patient-centered care, and estimating the burden for inflammatory bowel diseases (IBD), including ulcerative colitis (UC) and Crohn’s disease (CD).

Aims & Methods

We aimed to investigate PROs at IBD diagnosis, including associated factors.
Since May 1^st, 2021, all adult and pediatric patients with incident IBD within a catchment area encompassing 20% of the Danish population were enrolled in the prospective population-based Copenhagen IBD Inception Cohort.¹ Upon diagnosis, all adult patients diagnosed between May 2021 and May 2023 were asked to report PROs including Short inflammatory Bowel Disease Questionnaires (SIBDQ), IBD-Disability Index (IBD-DI), and Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F). Symptoms were evaluated using Memorial Symptom Assessment Scale, IBD Symptom Inventory, and Mayo Assessment of Functional Gastrointestinal Disease. Multivariable logistical analysis adjusting for gender, age, and disease phenotype was conducted (adjusted odds ratio, aOR (95% confidence interval)).

Results

The population consisted of 203 and 116 patients with UC and CD (66% and 58% of the original cohort), respectively, who completed the PROs questionnaires within a median of 1.2 (IQR 0.3–3.0) months from diagnosis. The only baseline difference between participants and non-participants was a higher proportion of females with UC in the former group (60% vs. 44%, p<0.01).
In total, 160 (79%) and 99 (85%, p=0.18) patients with UC and CD, respectively, reported moderate to severe affection of at least one PRO, while 44% and 64% (p<0.01), respectively, reported moderate to severe affection of at least two PROs.
Specifically, a higher proportion of patients with CD reported moderately to severely impaired quality of life (QoL) (96 (82.8%)) compared to UC (141 (69.5%), p<0.01). Of those, 33 (82.5%) and 41 (56.9%), respectively, reported simultaneously moderate to severe fatigue and disability (p=0.48), while 19 (19.8%) and 27 (19.1%, p=0.90), respectively, reported moderate to severe QoL and fatigue but not disability. In addition, among 71 (35.0%) and 52 (44.8%) with UC and CD, respectively, reporting moderate to severe fatigue (p=0.08), all but three patients with UC had moderate to severe QoL, while 57.6% and 63.5%, respectively, reported moderate to severe disability. Accordingly, FACIT-F correlated strongly with SIBDQ in both UC (Pearson correlation coefficient (PCC) 0.76 (0.70-0.82) and CD (PCC 0.84 (0.78-0.89).
The most frequent symptoms of UC were bloody stool (88%), lack of energy (82%), and abdominal pain (78%), whereas those of CD were lack of energy (86%, p=0.36) and abdominal pain (84%, p=0.17). These symptoms as well as bowel urgency (46% vs. 43%, p=0.60) were equally common in UC and CD, while bloody stool was less frequent in CD (54%, p<0.01). Finally, bowel urgency was linked to moderate to severe disability in UC (aOR=4.01 (1.11;14.51)), but not QoL or fatigue, which was confirmed in sensitivity analysis of proctitis.

Conclusion

Our prospective population-based inception cohort study highlights a considerable burden of UC and CD at the time of diagnosis, with moderate to severe impairment of PROs in most patients. In addition, we observed a clustering of impaired PROs in half of the patients, underscoring the interconnectedness of PRO metrics and symptoms. These findings emphasize the importance of tight monitoring of PROs and symptoms in clinical practice, allowing timely interventions.

References

1. Attauabi M, Madsen GR, Bendtsen F, et al. Influence of Genetics, Immunity and the Microbiome on the Prognosis of Inflammatory Bowel Disease (IBD Prognosis Study): the protocol for a Copenhagen IBD Inception Cohort Study. BMJ Open. 2022;12(6):e055779. doi:10.1136/bmjopen-2021-055779

Disclosure

Mohamed Attauabi: None
Gorm Roager Madsen: Personal fees from Tillotts
Flemming Bendtsen: Tillotts, Ferring
Jakob Benedict Seidelin: has received research grants from Takeda, Janssen, the Danish Research Council, and the Capital Region Denmark, and is national coordinator of studies from AbbVie, Arena Pharmaceuticals, Ely Lilly, and Boehringer Ingelheim.
Johan Burisch: reports grants and personal fees from AbbVie, grants and personal fees from Janssen-Cilag, personal fees from Celgene, grants and personal fees from MSD, personal fees from Pfizer, grants and personal fees from Takeda, grants and personal fees from Tillots Pharma, personal fees from Samsung Bioepis, grants and personal fees from Bristol Myers Squibb, grants from Novo Nordisk, personal fees from Pharmacosmos, personal fees from Ferring, personal fees from Galapagos, outside the submitted work.

Introduction

The Epi-IBD cohort is a prospective European population-based cohort of 1,390 patients diagnosed with inflammatory bowel disease (IBD) in 2010 and 2011 according to Copenhagen criteria. Of these, 482 were diagnosed with Crohn’s Disease (CD), 817 with ulcerative colitis (UC) and 91 with IBD unclassified (IBDU). The Epi-IBD cohort was established to examine differences in incidence, treatment strategies, disease course and prognosis among IBD patients in Eastern and Western Europe.

Aims & Methods

This study aims to describe the use of biological therapy as well as the treatment prior to biological therapy. IBD patients were followed prospectively from the time of diagnosis until the 31^st December 2020, death, emigration or loss of follow-up. Clinical data on surgery, hospitalizations, and medical treatment, were captured throughout the follow-up period and entered into a validated web-database, www.epi-ibd.org.

Results

During a median follow-up period of 10.7 (interquartile range (IQR), 10.0-11.4) years, 34% (N=165/482) of CD and 15% (N=122/817) of UC patients were started on biological therapy. Biological therapy was initiated within the first year after diagnosis in 16.8% (N=81/482) of all CD and 3.8% (N=31/817) of all UC patients. In median biological therapy was started at 1.0 year (IQR, 0.3-3.1) and 2.7 years (IQR, 1.6-4.0) after CD and UC diagnosis, respectively. First-line biological therapy was infliximab in 74% (N=213/287) and adalimumab in 22% (N=64/287) of the patients. The remaing (N=10/287) received either Golimumab, Vedolizumab, Ustekinumab or were part of a trial/unknown. The sequences of biological therapies are displayed in Sankey diagrams, Figures 1 and 2. Herein illustrated is that 34% (N=56/165) CD and 34% (N=41/122) UC received at least two different biological drugs. Immunomodulators were initiated simultaneously to the first biological therapy in 19% (N=31/165) of CD patients and in 9% (N=11/122) of UC patients. Overall 63% (N=104/165) CD and 51% (N=62/122) UC patients were receiving concomittant immunomodulators with the first biological therapy.
The sequences of therapy leading up to biological therapy are displayed in Sankey diagrams, Figures 3 and 4. Herein illustrated is that the most common sequence of treatment before the first biological therapy for CD was 1) Steroids, 2) Immunomodulators (21%, N=34/165), and for UC was 1) 5-aminosalicylic-acid (5ASA), 2) Steroids, 3) Immunomodulators (39%, N=48/122). Prior to the first biological therapy one, two and three or more courses of systemic steroid were used in 41%, 28% and 17% (N=67, 47 and 28) of CD patients and 43%, 24% and 26% (N=52, 29 and 32) of UC patients. In 14% (N=23/165) and 7% (N=9/122) of CD and UC patients, systemic steroids were not used prior to first biological therapy. In patients having immunomodulators prior to biological therapy, these were administered for a median of 0.5 (IQR, 0.1-1.9) years and 1.1 (IQR, 0.2-3,2) years in CD and UC, respectively. For 5ASA this was 0.8 (IQR, 0.2-1.5) years for CD and 2.2 (IQR, 0.8-4.3) years for UC.

Conclusion

In this multicenter European population-based cohort, different prescribing patterns for biologics emerge: 34% of CD and 15% of UC patients received biologics within 10 years after diagnosis. Infliximab was the most common first-line biological therapy. Only about half of the patients received concomitant immunomodulators. Prior to the first biological therapy, most patients were exposed to systemic steroids and many to repeated courses.

Introduction

In Inflammatory Bowel Disease (IBD), histological assessment of colonic biopsies may detect areas “indefinite for dysplasia” (IND). This definition is used when a definite distinction between non-neoplastic changes and neoplasia is not possible(1). The role of this finding in predicting the endoscopic and histological findings in IBD colitis is currently undefined.

Aims & Methods

Primary aim was to evaluate the outcome of IBD patients(pts) with an initial histological finding of areas IND in random colonic biopsies, followed up for ≥ 3 years. At this purpose, all IBD pts showing areas IND in colonic biopsies taken from March 2018 to March 2022, subsequently followed up for ≥3 years including ≥ 1 control colonoscopy were retrospectively enrolled. All pts were in regular follow up at our referral IBD Unit and underwent colonoscopy with histological assessment in the same center.

Results

The study population included 99 pts with IBD colitis and histological aspects IND detected in random colonic biopsies in 79(79.8%) pts and in target biopsies in 20(20.2%) pts. In the 79 pts, areas IND were detected in random biopsies taken from: rectum in 62(78%), left colon in 29(36%), transverse colon in 6(7.5%), right colon in 5(6.3%), >1 area in 18(22.3%) pts. In the 20 pts with areas IND on target biopsies, these were taken from stenosis (5 pts), polyps (9 pts), lateral spreading tumors (2 pts), flat elevated mucosa (4 pts). For the aim of the study, only the 79 IBD pts (37 females, 46.8%) showing in random colonic biopsies areas IND were considered. These 79 IBD pts (69 UC, 9 CD, 1 unclassified colitis) showed median age of 51 [18-79], long-standing IBD in 54(68.4%), family history of CRC in 11(13.9%), concomitant primary sclerosing cholangitis in 1(1.3%) pt. Random biopsies were taken from colonic mucosa proximal to ulcerations in 54(68.4%) pts, erosions in 19(24%) pts and to mild inflammation in 6(7.6%) pts. The second colonoscopy was performed after a median of 11[1-42] months. In the 79 pts with a first evidence of areas IND on random biopsies, the second colonoscopy detected: dysplasia in 10(12.6%) pts (high grade, HGD in 2[2.5%], low grade dysplasia, LGD in 8[10.1%]pts), areas IND in 12(15.2%) pts, no dysplasia (HGD, LGD or IND) in 38(48.1%) pts, while in the remaining 16(20.3%) pts no reliable histology was available. LGD at second colonoscopy was detected in random biopsies (4pts) or in target biopsies (4pts). Differently, in both pts with HGD it was detected in target biopsies, including one focal area of adenocarcinoma (CRC) in 1(1.3%) pt. Areas IND confirmed at second colonoscopy were detected in the same colonic segment in 11(13.9%) pts and in a different segment in 1(1.3%) pt. After the second colonoscopy, 4 out of the 79 IBD pts required IBD-related colonic surgery, and histology of the surgical specimen detected LGD in 1 pt, CRC in 1 pt and areas IND in 2 pts. During the study period (median 27[2-75] months) 51 out of the 79(64.5%) IBD pts repeated a third colonoscopy detecting: areas IND in 4(7.8%), LGD in 6(11.8%), HGD in 1(2%) pts and no CRC.

Conclusion

Patients with IBD colitis showing areas indefinite for dysplasia deserve careful endoscopic surveillance as dysplasia and CRC may be detected at subsequent colonoscopies.

References

1. Feakins R, Borralho Nunes P, Driessen A, Gordon IO, Zidar N, Baldin P, Christensen B, Danese S, Herlihy N, Iacucci M, Loughrey MB, Magro F, Mookhoek A, Svrcek M, Rosini F. Definitions of Histological Abnormalities in Inflammatory Bowel Disease: an ECCO Position Paper. J Crohns Colitis. 2024 Feb 26;18(2):175-191.

Introduction

Inflammatory bowel diseases (IBD), encompassing ulcerative colitis (UC) and Crohn’s disease (CD), are associated with an increased risk of metabolic bone diseases (MBD), primarily osteopenia and osteoporosis; however, the risk at IBD diagnosis is currently unknown.

Aims & Methods

The aim of the current study was to evaluate a screening strategy for MBD in which all patients with newly diagnosed IBD are offered a Dual-energy X-ray absorptiometry (DXA) scan. Secondly, we aimed to identify risk factors for development of MBD.
All adult patients with newly diagnosed IBD within a catchment area corresponding to ~20% of the Danish population have since May 2021 been enrolled in an ongoing prospective population-based inception cohort, IBD Prognosis Study. Herein, all participants were, as part of the initial work-up, invited to a DXA scan at IBD diagnosis. A T-score< −2.5 standard deviations (SD) was diagnostic for osteoporosis, while a T-score between –1 and –2.5 defined osteopenia. Multivariate analyses adjusted findings for age, gender, and medication differences.

Results

As of April 15^th, 2023, a total of 316 newly diagnosed patients with IBD (UC: 178, CD: 117, IBD unclassified (IBDU): 21) received a DXA scan within 90 days (interquartile range (IQR) 51-139 days). Baseline characteristics of the population were similar to those previously described for newly diagnosed IBD.
In total, 48 (27.0%, females (F): 26.3%, males (M): 27.7%) and 17 (9.6%, F: 13.7%, M: 4.8%) patients with UC were found to have osteopenia and osteoporosis, respectively. The corresponding numbers for CD were 23 (19.7%, F: 15.3%, M: 24.1%) and nine (7.7%, F: 6.8%, M: 8.6%).
Subgroup analysis showed a high occurrence of osteopenia in both UC and CD regardless of age group (Table 1). Further, no difference between UC and CD was observed in terms of the risk of osteopenia (adjusted odds ratio (aOR)=1.86 (95% confidence interval (CI) 0.99-3.60) or osteoporosis (OR=1.42 (95% CI 0.53-4.08)).
Further, low albumin level (<36 g/L) was the only factor associated with the risk of osteopenia in patients with UC (aOR=2.57 (95% CI 1.05-6.53). In patients with CD, no risk factors were identified for development of osteopenia, although a trend was seen with high age (aOR=4.28 (95% CI 0.99-20.23). However, the risk of osteoporosis was independently associated with age higher than 65 years in both UC (aOR=13.4 (95% CI 3.78-51.36)) and CD (aOR=6.39 (95% CI 1.09-35.47)), while female gender was not relevant (UC: aOR=2.63 (95% CI 0.75-10.98), CD: (aOR=0.47 (95% CI 0.08-2.20)).
Finally, in both UC and CD, the risk of these MBD was not associated with IBD phenotype, medications, or patient-reported or endoscopic severity.

Table 2: Prevalence of osteopenia and osteoporosis in different age groups in patients with newly diagnoses patients with inflammatory bowel diseases

Conclusion

To our knowledge, the current study is the first evaluation of DXA scans as a screening tool for patients with newly diagnosed IBD in a population-based setting. We found a high incidence of osteopenia affecting every fourth patient at IBD diagnosis. These findings are concerning given the high risk of repeated need for systemic steroids in this patient population.

Disclosure

Mohamed Attauabi: None
Gorm Roager Madsen: None
Flemming Bendtsen: Tillotts, Ferring
Klaus Theede: Ferring, Janssen, Takeda, Pfizer and Tillotts
Jakob Benedict Seidelin: has received research grants from Takeda, Janssen, the Danish Research Council, and the Capital Region Denmark, and is national coordinator of studies from AbbVie, Arena Pharmaceuticals, Ely Lilly, and Boehringer Ingelheim.
Johan Burisch: reports grants and personal fees from AbbVie, grants and personal fees from Janssen-Cilag, personal fees from Celgene, grants and personal fees from MSD, personal fees from Pfizer, grants and personal fees from Takeda, grants and personal fees from Tillots Pharma, personal fees from Samsung Bioepis, grants and personal fees from Bristol Myers Squibb, grants from Novo Nordisk, personal fees from Pharmacosmos, personal fees from Ferring, personal fees from Galapagos, outside the submitted work.

Introduction

Proper and timely risk stratification of inflammatory bowel diseases (IBD), including ulcerative colitis (UC) and Crohn’s disease (CD), is essential to tailor personalized treatment.

Aims & Methods

The aims of the current study were to report the early disease course of newly diagnosed UC and CD and identify risk factors for a severe disease course. Patients were identified from an ongoing prospective population-based inception cohort at Hvidovre University Hospital and Herlev University Hospital, IBD Prognosis Study, which includes all patients with newly diagnosed IBD since May 2021 and forth within a catchment population of 1.050.000 (~20% of the Danish population). We defined severe disease course as the need for surgery or initiation of biological therapies within six months of diagnosis. A Cox proportional hazard model with Bonferroni correction adjusting for multiple comparisons was constructed to identify predictors hereof.

Results

As of April 15^th, 2023, the cohort comprised 501 patients, including 287 with UC,180 with CD, and 34 with IBD unclassified (IBDU). The mean age (interquartile range (IQR)) at diagnosis was 39 years (27-56), 36 (25-54), and 36 (27-52), respectively. The cumulative risk of a severe disease course within six months after the onset of UC, CD and IBDU was 3.8% (95% confidence interval 1.9-6.8), 13.9% (95% CI 9.2-19.8) and 11.4% (95%CI 3.2-26.7).
In a Cox multivariable regression model adjusting for age and gender, a severe initial disease course for UC was predicted by extensive disease distribution, severe disease endoscopically at diagnosis, and affected biochemical inflammation parameters (Table 1). In patients with CD, perianal disease but no other phenotypic characteristics were predictive for the initial course. However, in a sensitivity analysis of luminal CD, stricturing phenotype at diagnosis (adjusted hazard ratio (aHR) = 4.6 (95% confidence interval (CI) 1.5-13.6), the platelet count (HR= 1.3 (95% CI 1.2-10.6), and CRP > 10 mg/L (aHR= 14.2 (95% CI 1.9-108.5) were independently associated with a severe initial course, while initial use of systemic steroids was associated with a reduced risk. In patients with IBDU, only low hemoglobin was predictive for an initial severe disease course.

Table 1: Predictors of early severe disease course in newly diagnosed IBD in multivariate Cox proportional hazard model with Bonferroni correction (hazard ratio (95% confidence interval))

Conclusion

In this population-based study, we found 4%, 14%, and 11% of patients with newly diagnosed UC, CD, and IBDU, respectively, to experience an early severe disease course. Furthermore, systemic inflammation was predictive for a severe initial course in UC. In CD, perianal disease or stricturing disease phenotypes identify the subgroup of patients at high risk of early severe disease course.

Disclosure

Mohamed Attauabi: None
Gorm Roager Madsen: None
Flemming Bendtsen: Tillotts, Ferring
Klaus Theede: Ferring, Janssen, Takeda, Pfizer, and Tillotts
Jakob Benedict Seidelin: has received research grants from Takeda and Janssen and is national coordinator of studies from AbbVie, Arena Pharmaceuticals, Ely Lilly, and Boehringer Ingelheim. None of these pertain to the research submitted here.
Johan Burisch: reports grants and personal fees from AbbVie, grants and personal fees from Janssen-Cilag, personal fees from Celgene, grants and personal fees from MSD, personal fees from Pfizer, grants and personal fees from Takeda, grants and personal fees from Tillots Pharma, personal fees from Samsung Bioepis, grants, and personal fees from Bristol Myers Squibb, grants from Novo Nordisk, personal fees from Pharmacosmos, personal fees from Ferring, personal fees from Galapagos, outside the submitted work.