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Cost analysis in a prospective European population-based inception cohort : is there a cost-saving effect of biological therapy?

Background The role of environmental factors in development of inflammatory bowel disease (IBD) remains uncertain. The aim of the present study was to assess a number of formerly suggested environmental factors in a case-control study of an unselected and recently diagnosed group of patients with IBD and a control group of orthopaedic patients. Methods A total of 123 patients diagnosed with Crohn's disease (CD) and 144 with ulcerative colitis (UC) in Copenhagen (2003–2004) were matched 1:1 on age and gender to 267 orthopaedic controls. Participants received a questionnaire with 87 questions concerning environmental factors prior to IBD/orthopaedic admission. Odds ratios (OR) were calculated by logistic regression. Results Being breastfed > 6 months (OR, 0.50; 95% CI, 0.23–1.11) and undergoing tonsillectomy (OR, 0.49; 95% CI, 0.31–0.78) decreased the odds for IBD, whereas appendectomy decreased the odds for UC only (OR, 0.29; 95% CI, 0.12–0.71). Vaccination against pertussis (OR, 2.08; 95% CI, 1.07–4.03) and polio (OR, 2.38; 95% CI, 1.04–5.43) increased the odds for IBD, whereas measles infection increased the odds for UC (OR, 3.50; 95% CI, 1.15–10.6). Low consumption of fibres and high consumption of sugar were significantly associated with development of CD and UC. Smoking increased the risk for CD and protected against UC. Conclusion Among Danish patients with CD and UC belonging to an unselected cohort, disease occurrence was found to be associated both with well-known factors such as smoking and appendectomy, and with more debated factors including breastfeeding, tonsillectomy, childhood vaccinations, childhood infections, and dietary intake of fibres and sugar.

Disease course during the first five years following diagnosis in a prospective European population-based inception cohort - the ECCO-EpiCom cohort

Change in Crohn's disease behavior in a prospective European population-based inception cohort - the ECCO-EpiCom cohort

Frequency of anaemia and anaemia subtypes in east-west European inception cohort : an ECCO-EpiCom cohort study

The risk of proximal disease extension in patients with limited ulcerative colitis in a prospective European population-based inception cohort - the ECCO-EpiCom cohort

The cost of investigations and medical treatment including biological therapy in a European inception cohort from the biological era : An ECCO-EpiCom study

in all study groups (105.8% vs 114.3% RDA in normal controls; 88.7% vs 109.2% RDA in diseased controls, 100.4% vs 87.6% RDA in IBD. Conclusions: In this study IBD patients had a significantly lower Ca intake than healthy controls. In accordance to previous studies, gender and age, more than diagnosis, are relevant factors in determining inadequate Ca intake. The trend is more marked in IBD, especially in postmenopausal women. Selfreported lactose intolerance, leading to dietary restrictions, is the single major determinant of low Ca intake in all pts groups, irrespective to diagnosis, age and gender. Inadequate Ca intake is observed in about one third of IBD pts and represents an easily reversible risk factor for osteoporosis. The observation that celiac patients on low gluten diet have a Ca intake well over RDA, further supports the need for tailored nutrition advice also in ulcerative colitis and Crohn’s disease.

s of the 4th Congress of ECCO the European Crohn’s and Colitis Organisation S9 were randomized to receive maintenance therapy with CZP 400mg sc q2w or q4w through Week 24. Clinical response was defined as 100-point decrease from baseline in CDAI and remission as a CDAI score of 150 points. Results: At week 6, 62.0% (334/539) of patients who received open-label induction therapy with CZP were in clinical response. Of these responders, 329 entered the double-blind maintenance trial and were thus included in the modified intent-to-treat population (CZP q2w, n = 161; CZP q4w, n = 168). Clinical response and remission rates at Week 26 are shown in the table. There was no significant difference between q2w or q4w CZP dosing regimens with respect to response (CDAI decrease of 100 or 70 points from baseline [P = 0.55 and P = 0.74, respectively] or remission rates [P = 0.81]). No new safety signals were observed. Week 26 CZP, % patients q2w (n = 161) q4w (n = 168) CDAI 100 point decrease 36.6 39.9 CDAI 70 point decrease 41.0 42.9 CDAI 150 points 30.4 29.2 Conclusions: Sixty-two percent of patients with moderateto-severe CD who had previously responded to IFX and lost response or developed hypersensitivity responded to open-label induction therapy with CZP. Among patients who responded to induction therapy with CZP, continuing therapy with CZP 400mg q4w is as effective as CZP 400mg q2w for maintenance of response and remission at Week 26. 14 Clinical course and cost of care in ulcerative colitis: Markov chain analysis of a European prospective population-based cohort S. Odes1 *, H. Vardi2, M. Friger2, P. Munkholm3, D. Esser4, M. Elkjaer3, H. Waters5, E. Langholz6. 1Gastroenterology Department, Soroka Medical Center and Ben Gurion University of the Negev, Beer Sheva, Israel, 2Epidemiology Department, Ben Gurion University of the Negev, Beer Sheva, Israel, 3Gastroenterology Department, Herlev Hospital and University of Copenhagen, Copenhagen, Denmark, 4Centocor BV, Leiden, Netherlands, 5Centocor Ortho Biotech Services, Malvern, PA, USA, 6Gastroenterology Department, Gentofte Hospital and University of Copenhagen, Copenhagen, Denmark Introduction: Predicting the clinical and economic outcome is difficult in ulcerative colitis, with its recurring-remitting course over many years, competing risk factors and multiple possible consequences. The Markov chain, a stochastic process with the Markov assumption, is an increasingly used approach in outcomes-analysis in complex disease. Methods: The European Collaborative Study of Inflammatory Bowel Disease (EC-IBD) Group incepted European and Israeli patients prospectively at diagnosis of ulcerative colitis from 1991 to 1993. Patients having more than 5 years unbroken tracking from diagnosis within a 10-year time horizon were grouped into clinical transition states by: (1) medical and surgical therapies recorded in continuous quarter-year cycles, (2) presence of flare-years in a minority ( 50%) of the follow-up years (hereafter called “minority flare-years” patients or “majority flare-years” patients respectively). Clinical course transition states (graded by treatment) were calculated by a Markov model (SPSS 16, STATA 10.1). The 5 transition states were defined as follows: “remission” (symptomatic treatment), “mild-moderate” (local corticosteroids, budesonide, mesalazine, antibiotics), “severe” (systemic steroids, immunosuppression, biologics), surgery (abdominal and pouch surgery), and death (from ulcerative colitis). Healthcare costs per patient per cycle were matched to the transition states. Results: 705 patients had 39208 cycles. In 644 cases with minority flare-years, the probability (expressed per cycle) of worsening (to a more severe state or surgery or death) of the “remission state” was 0.0811, of “mild-moderate state” 0.0763, of “severe state” 0.2664. In 61 cases with majority flare-years, the probability of worsening of the “remission state” was 0.2980, of “mild-moderate state” 0.1432, of “severe state” 0.2733. Minority flare-year patients in the initial “surgery state” had probabilities of 0.3291 for subsequent mild disease and 0.3924 for severe disease (pouchitis), and 0.0506 for pouch removal; majority flare-year patients had probabilities 0.3750 for mild or severe disease (pouchitis). The subsequent “surgery state” in the minority flare-years group acquired cases mostly from “surgery” (patients postcolectomy requiring pouch removal, probability 0.0506), and in the majority flare-years group from “severe” disease (patients requiring colectomy, probability 0.0104). Mean healthcare costs (euros/patient-cycle) were as follows: remission 93, mildmoderate 267, severe 939, surgery 8623, death 655. Surgery accounted for 72% of costs in year 1, and 83% in follow-up year 10. Conclusions: Severe ulcerative colitis has an inferior prognosis and high healthcare costs, with surgery accounting for the greatest expense. There is a considerable probability of pouchitis after surgery. Medical treatments must aim therefore to maintain patients in remission and avoid the need for surgical operations. 15 Laparoscopic-assisted versus open ileocolic resection for Crohn’s disease: long term results of a prospective randomized trial E.J. Eshuis1 *, J.F.M. Slors1, M.A. Cuesta2, R.E.G. Pierik3, P.C.F. Stokkers1, M.A.G. Sprangers1, W.A. Bemelman1. 1Academic Medical Center, Amsterdam, Netherlands, 2Free University Medical Center, Amsterdam, Netherlands, 3Isala Clinics, Zwolle, Netherlands Aim: Four meta-analyses exist evaluating the short term results of laparoscopic versus open ileocolic resection for Crohn’s disease. Little is known about the long term results of both procedures with respect to surgical recurrence rate, overall reoperation rate, incidence of incisional hernia, adhesive small bowel obstruction, quality of life (QOL) and Body Image (BI) and cosmesis. The objective of this study is to determine the long term results of a randomized multicenter study comparing laparoscopic with open ileocolic resection for Crohn’s disease. Materials and Methods: Sixty patients who participated in this trial were prospectively followed in the outpatient clinic. Patients had an ileocolic resection between 1999 and 2003. Primary outcome parameters were overall reoperation and readmission rate and re-resection rate for recurrent Crohn’s disease. Secondary outcomes were QOL, BI and cosmesis. Results: Five patients, 1 from the laparoscopic group and 4 from the open group were lost to follow up. The groups were comparable for characteristics as sex, age, and maintenance therapy. Mean follow-up was 6.8 years. Overall, 16/29 (55%) and 16/26 (62%) patients remained relapse-free after the ileocolic resection in the laparoscopic and open group respectively (p =NS). Resection of recurrent Crohn’s disease occurred in 2/29 (7%) and 3/26 (12%) patients ( p =NS). Two reoperations for incisional hernia were done in the open group (2/26 [8%]) vs. nil in the laparoscopic group. Reoperation for adhesive small bowel obstruction was done twice in the open group (2/26 [8%]) vs. nil in the laparoscopic group. Overall reoperation rate was 2/29 (7%) versus 7/26 (27%) by gest on Sptem er 4, 2016 http://eccoxfordjournals.org/ D ow nladed from

Background: In the Danish Crohn Colitis Database during the treatment era of 5-Aminosalicylic acid (5-ASA), steroids and surgery, it has been revealed that 8 years from diagnosis 44% of Crohn’s disease (CD) patients were characterized with a mild disease course, 20% with an aggressive (relapse every year) and 36% with a moderate disease course (relapse every other year). Aim: The outcome of the first treatment course with 5-ASA monotherapy (1.5 4.8 g/day) was retrospectively studied in a consecutive cohort of 345 patients with CD diagnosed 1952 2007. The immediate and long-term outcome of 5-ASA treament was described. Methods: A phenotyped model was used to assess treatment response: Immediate outcome (30 days after the start of 5-ASA) was defined as Complete response: Total regression of symptoms. Partial response: Improvement of symptoms. No response: No regression of symptoms with a need to shift from 5-ASA to an immunomodulator or surgery. Longterm outcome (irrespective of the length of the treatment) was defined as: Prolonged response: Still in complete/partial remission 1 year after induction of remission (either maintained on or after cessation of 5-ASA). 5-ASA dependency: Relapse on stable/reduced dose of 5-ASA requiring dose increase to regain remission or relapse within 1 year after 5-ASA cessation regaining complete/partial response after 5-ASA reintroduction. Results: One hundred sixty-five (48%) out of 345 patients had monotherapy with 5ASA. In 50% of them 5-ASA was initiated within one year of diagnosis with a range 0 49 years. Complete or partial response was obtained in 75% and no response in 25% of patients within 30 days of treatment. Among initial responders (complete/partial response), prolonged 5-ASA response was obtained in 47% (59) of patients, 5-ASA dependency in 31% (38) and 18% (22) of patients lost initial response to 5-ASA and had to shift to surgery (73%) or immunomodulator (27%). Five patients (4%) were not assessed in long-term outcome due to short treatment couse. Female gender was associated with higher probability to develop prolonged response or 5-ASA dependency (OR 2.68, 95%CI: 1.06 6.77, p = 0.03). The median duration (range) of 5-ASA course was 34 months (1 304) in prolonged responders, 63 (6 336) in 5-ASA dependent and 5 (2 10) in non-responders. Conclusion: Patients with CD may profit from 5-ASA treatment. Seventy-eight percent of initial responders obtained long-term benefit with 31% becoming 5-ASA dependent, resulting in 5 up to 28 years of remission on 5-ASA in 50% of them. Prospective studies are warranted to assess the role of 5-ASA in CD.