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sfrom the electronic records. Chart review included disease variables and a Harvey-BradshawIndex (HBI) score was calculated when possible for each visit. Response was defined as anydecrease in: HBI score, patient symptoms or objective assessment of inflammation. Remissionwas defined by evidence of inactive disease on imaging or histology, no steroid therapy atassessment, an HBI of less than 5, or physician assessment of clinical remission if HBI notavailable. Results: Fifty-six patients (35 women, 63%; mean age when starting therapy, 36.3years) were switched from standard dosing after a median time of 6 months (range, 2-29).Twenty-six patients had active inflammatory disease and 30 fistulizing disease. The majorityhad ileocolonic disease. Thirty-four patients had previously failed two anti-TNFs, 19 hadfailed one anti-TNF and 3 had no previous anti-TNF treatment. Sixteen patients (29%)achieved clinical remission, with a median time to remission from dose splitting of 8 months(range, 3-14). Another 27 patients (48%) had a response but did not achieve remission,with a median time to response of 3 months since dose modification (range, 1-21). Thirty-four percent of patients on split-dose modification required steroids for rescue therapy aftera median time of 1 month (range, 0-13) after dose splitting. Twelve patients initially treatedwith split dosing (7 women; mean age when starting therapy, 37.4 years) were also evaluated;one achieved remission after a time of two months, and another 7 met the definition forresponse at a median time of four months. Conclusion: CZP induced a clinical remissionin 29% of CD patients with split-dose modification after experiencing recurrent activesymptoms. In addition, 48% of patients recaptured or gained clinical response with thisdosing strategy. Although limited by small sample size, the strategy of initiating split dosingappears to be an effective one. Flexible dosing regimens rather than dose escalation per sewarrants further investigation for patients with active CD.

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Reduced Length of Hospitalisation and Treatment Costs With InfliximabVersus Ciclosporin in Patients With Severe Ulcerative ColitisM. Lowenberg, Nicolette W. Duijvis, Cyriel Ponsioen, Gijs R. van den Brink, Willem A.Bemelman, Paul Fockens, Geert R. D'Haens

BACKGROUND: Efficacy and safety of treatment with ciclosporin or infliximab are compara-ble in patients with severe ulcerative colitis (UC) ( Laharie D et al, Lancet, 2012). Reductionof duration of hospital stay has important impact on treatment costs. AIM: To analyseduration of hospital stay and costs in patients admitted for severe UC receiving treatmentwith ciclosporin or infliximab. METHODS: We carried out a retrospective analysis of patientswith steroid-refractory UC treated with intravenous ciclosporin or infliximab. Adult andpaediatric patients were included who were Naïve to either therapy and admitted betweenMarch 2004 and August 2012 at a single tertiary referral centre. Information was retrievedfrom patient records. Length of hospital stay from initiation of rescue therapy to time ofdischarge was analyzed. Hospital costs for both treatment groups were analyzed. RESULTS:A total of 42 patients (mean age 35 years; 43% female) were included in the analysis, with26 (range 17-56 years) in the ciclosporin and 16 (range 16-69 years) in the infliximabgroup. Patient characteristic showed no statistically significant difference between the twogroups: median duration of disease 7 versus 6 years, smoking 23% vs. 31%, thiopurine use46% vs. 69% and proportion of patients with pancolitis 90% vs. 69% in the ciclosporinand infliximab group, respectively. The median length of hospital stay after initiation oftherapy was 10,3 days in ciclosporin treated patients (range 6-19 days) vs. 4,5 days in theinfliximab group (range 2-8 days) (P,0.0001). Hospital costs without drug costs weresignificantly greater for ciclosporin than for infliximab treated patients (average costs perpatient: 5750 and 2588 euro in the ciclosporin and infliximab group, respectively(P,0.0001)). Total treatment costs per patient (including drug costs) averaged to 6041 vs.4853 euro for ciclosporin and infliximab treated patients, respectively. There was no signifi-cant difference in colectomy rates in the years following rescue therapy between the twogroups (42,3% and 43,8% for ciclosporine and infliximab, respectively). CONCLUSIONS:Length of hospital stay and hospital costs have been reduced significantly since the introduc-tion of infliximab as rescue therapy for severe UC instead of ciclosporin.

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Analysis of a US Patient Claims Database to Assess Appropriate Initial Dosingin Patients Newly Prescribed Certolizumab Pegol for Crohn's DiseaseSunanda V. Kane, Sunni Jenkins, Srihari Jaganathan, Fred M. Cox, David A. Schwartz

BACKGROUND Certolizumab pegol (CZP) is a PEGylated Fc-free human monoclonal anti-body fragment that targets tumor necrosis factor-α (TNF) and has proven efficacy in treatingadults with moderate to severe Crohn's disease (CD).[1] The FDA-approved loading dosefor CZP is 400 mg at Wks 0, 2, and 4. If a patient responds, the FDA-approved maintenance

S-428AGA Abstracts

dose is 400 mg every 4 wks. The aim of this analysis is to evaluate the level and clinicalimpact of adherence to the FDA-approved loading dose among patients newly prescribedCZP. METHODS OptumInsight's Clinformatics Data Mart, an administrative health claimsdatabase, was used for analysis. US patients were identified that had a diagnosis of CD andwere prescribed CZP from January 2009 to May 2011. Patients were eligible for inclusionin the analysis if they were aged ≥18 yrs, had not received anti-TNF therapy in the 6 monthsprior to first anti-TNF, and had 12-months' continuous enrollment in the database. Patientsthat received 3 loading doses of CZP 400 mg at Wks 0, 2, and 4 (28 days) were given a7-day grace period to account for any minor delays in prescription pick-up. A total of 35days was allowed for patients to receive these initial 3 doses of CZP. At 1 year, rates ofpersistency on CZP, corticosteroid (CS) avoidance, and surgery were evaluated to identifyif there were clinical implications for patients who received the approved loading dose vsthose who did not. RESULTS A total of 271 patients met the eligibility requirements. Ofthese patients, 169 (62%) received the FDA-approved loading dose when they were initiatedon CZP. At 1 year, patients who received the FDA-approved loading dose showed increasedpersistence on CZP over those who did not receive the loading dose (63% vs 45%, respec-tively) (Figure). Rates of CS avoidance were 58% vs 48% (p=0.224) for patients who receivedthe approved loading dose vs those who did not. In addition, 7% of patients who receivedthe appropriate loading dose had a surgical intervention for CD at 1 year compared with9% of those who did not (p=0.7355). CONCLUSIONS Approximately two thirds of CDpatients within the database who were initiated on CZP received the FDA-approved loadingdose. Patients with documented receipt of the initial loading dose had increased persistencyon CZP at 1 year, compared with those who did not, as well as fewer steroid prescriptionsand a slightly lower incidence of surgery at 1 year. A limitation of this database is the lownumber of patients with data available, and patients who may have received a sample asone of their 3 loading doses could not be accounted for. Further analysis is underway toevaluate larger patient populations and the clinical implications of nonadherence to theloading dose at time points beyond 1 year. REFERENCE 1. Sandborn WJ, et al. N Engl JMed 2007;357:228-38.

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Comparative Long-Term Outcomes of Tacrolimus, Cyclosporine and Infliximabfor Steroid-Refractory Ulcerative Colitis - Week 52 Results Swiss IBD CohortStudyMarijana Protic, Pascal Frei, Zoran A. Radojicic, Alain Schoepfer, Pascal Juillerat,Christian Mottet, Gerhard Rogler, Christoph Beglinger, Frank Seibold

BACKGROUND: Cyclosporine (CsA), Tacrolimus (Tcl) and Infliximab (IFX) are establishedrescue therapies in steroid-refractory ulcerative colitis (UC). Follow-up studies have shownincreasing risk of colectomy with time in those treated with CsA and favorable long termresponse to IFX. Long term comparative analyses for the three drugs are missing. METHOD:Response to treatment in patients with steroid-refractory moderate to severe UC was retro-spectively studied in three cohorts of patients: Cohort A (n=32) treated with oral Tcl (initially0.05mg/Kg twice daily, aiming for serum trough levels of 7-12ng/mL); Cohort B (n=28)treated with intravenous CsA 2mg/kg/daily and then oral CsA 5mg/kg/daily; Cohort C. (n=63) treated with IFX (5mg/kg intravenously at week 0, 2, 6 and then every 8 weeks). Aftersuccessful rescue therapy with Tcl or CsA, thiopurine maintenance therapy or maintenancetherapy with Tcl (in Tcl pre-treated patients) was introduced. The endpoints were evaluationof steroid free remission rate (on the basis of modified Truelove-Witts severity index(MTWSI)) and colectomy frequencies at week 52. RESULTS: After 1 year, 22% (7/32) ofpatients on Tcl remained in steroid free remission (MTWSI score ≤4) compared to 11% (3/28) on CsA and 49% (31/63) of patients on IFX (Tcl& CsA vs IFX P= 0.0001). Overallresponse rates (decrease of MTWSI score of more than 4 points) at week 52 were 47% (15/32) on Tcl, compared to 28.6% (8/28) in CsA group and 68% (43/63) given IFX (P=0.005).Subgroup analysis showed the highest steroid free remission rate in those with moderatedisease treated with IFX: 31 % (4/13) in Tcl group compared to 0% (0/4) in CsA groupand 60% (12/30) in IFX group (P=0.031). Patients with severe colitis showed higher remissionrate in IFX group as well: 16% (3/19) on Tcl compared to 12.5% (3/24) on CsA and 40%(8/16) on IFX (P= 0.039). Cumulative colectomy rate after 1 year, were significantly lowerin IFX group: 3.2% (2/63) on IFX versus 12.5% (4/32) on Tcl (Tcl vs IFX P=0.038; HR5.72; CI 1.11- 29.60) versus 28.6% (8/28) on CsA (CsA vs IFX P= 0.001; HR 12.75, CI2.65-59.60) (Fig 1.). Regardless of colectomy, an important number of patients was with-drawn from the rescue treatment after a year, due to primary resistance, loss of responseor adverse events: in Tcl group 34 % (11/32), in CsA group 39% (11/28) and in IFX group25% (13/63) (P= 0.37). CONCLUSION: After one year of follow up, patients with moderateto severe steroid refractory ulcerative colitis treated with IFX were more likely to have steroidfree remission than those receiving CsA or Tcl. Better outcome in IFX group was alsodemonstrated with significantly lower colectomy frequency after 12 months of follow up.