14 - Clinical course and cost of care in ulcerative colitis: Markov chain analysis of a European prospective population-based cohort

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