Total Inflammatory Bowel Disease Questionnaire Research Articles

Impact of Kono-S anastomosis on quality of life after ileocolic resection in Crohn's disease: an analysis from the SuPREMe-CD trial.

Crohn's disease has debilitating effects on patients' quality of life. Currently, there are limited data on the effect of anastomotic configuration on health-related quality of life after ileocaecal resection for Crohn's disease. This study aimed to assess the impact of Kono-S anastomosis on quality of life after ileocolic resection, compared to the conventional side-to-side anastomosis. Patients with primary or recurrent Crohn's disease participating in the ongoing SuPREMe-CD trial were interviewed about quality of life using the Inflammatory Bowel Disease Questionnaire (IBDQ). The primary endpoint was disease-specific quality of life, assessed with IBDQ. Secondary outcomes were quality of life related to bowel symptoms, systemic symptoms, social function and emotional function. Of the 94 patients included, 51 (54%) received the conventional side-to-side anastomosis and 43 (46%) the Kono-S anastomosis. Demographics were comparable between the two groups. The IBDQ was assessed at a mean follow-up of 54.0 ± 18.7 months from surgical intervention. The mean total IBDQ score was 155.1 ± 28.07 in the conventional group and 163.8 ± 25.23 in the Kono-S group (P = 0.11). When considering bowel symptoms and social function, mean scores were 50.7 and 23.5 in the conventional group, and 56.3 and 26.5 in the Kono-S group (P = 0.002 and P = 0.02, respectively). Kono-S anastomosis was independently associated with improved quality of life regarding bowel symptoms (P = 0.006) and social function (P = 0.03) after correcting for other confounding factors on linear regression analysis. Compared to conventional side-to-side anastomosis, patients with Kono-S anastomosis presented significantly better bowel symptoms and social function scores at 54 months after surgery.

Structured Reporting of Computed Tomography Enterography in Crohn's Disease.

To compare the integrity, clarity, conciseness, etc., of the structured report (SR) versus free-text report (FTR) for computed tomography enterography of Crohn's disease (CD). FTRs and SRs were generated for 30 patients with CD. The integrity, clarity, conciseness etc., of SRs versus FTRs, were compared. In this study, an evidence-based medicine practice model was utilized on 92 CD patients based on SR in order to evaluate its clinical value. Then, the life quality of the patients in two groups was evaluated before and after three months of intervention using an Inflammatory Bowel Disease Questionnaire (IBDQ). SRs received higher ratings for satisfaction with integrity (median rating 4.27 vs. 3.75, P=0.008), clarity (median rating 4.20 vs. 3.43, P=0.003), conciseness (median rating 4.23 vs. 3.20, P=0.003), the possibility of contacting a radiologist to interpret (median rating 4.17 vs. 3.20, P<0.001), and overall clinical impact (median rating 4.23 vs. 3.27, P<0.001) than FTRs. Besides, research group had higher score of IBDQ intestinal symptom dimension (median score 61.13 vs. 58.02, P=0.003), IBDQ systemic symptom dimension (median score 24.48 vs. 20.67, P<0.001), IBDQ emotional capacity dimension (median score 65.65 vs. 61.74, P<0.001), IBDQ social ability dimension (median score 26.80 vs. 22.37, P<0.001), and total IBDQ score (median score 178.07 vs. 162.80, P<0.001) than control group. The SR of CTE in CD patients was conducive to improving the quality and readability of the report, and CD patients' life quality could significantly improve after the intervention of an evidence-based medicine model based on SR.

Golimumab improves health-related quality of life of patients with moderate-to-severe ulcerative colitis: Results of the go-care study

BackgroundIn recent years, improvement of Health-Related Quality of Life (HRQoL) in Ulcerative colitis (UC) has become a relevant measure for treatment efficacy. MethodsWe report results from a multicenter prospective study in Italy investigating HRQoL in adult patients with UC treated with golimumab (GLM). Patients who had shown clinical response after a 6-week induction phase (w0), were followed for an additional 48 weeks (w48) (total 54-week treatment). ResultsOf the 159 patients enrolled 90 completed the study. Compared to values at the beginning of treatment (n = 137), significant improvements were observed for mean total Inflammatory Bowel Disease Questionnaire (IBDQ) scores at w0 (168.5) and w48 (181.7). Patients with baseline PMS above the median tended to have greater improvements in IBDQ at w0 (OR 2.037, p = 0.033) and w48 (OR 3.292, p = 0.027). Compared to beginning of GLM treatment, the mean Full Mayo Score (FMS) decreased by 5.9 points at w48, while mean Partial Mayo Score (PMS) decreased by 3.9 points at w0 and by 4.9 points at w48. ConclusionsGLM improved HRQoL, disease activity and inflammatory biomarkers in UC patients with moderate-to-severely active disease. The greater the burden of disease activity at baseline, the greater the improvement of HRQoL after 24 and 48 weeks of treatment.

A31 MIRIKIZUMAB IMPROVES QUALITY OF LIFE IN MODERATELY-TO-SEVERELY ACTIVE UC: IMPROVEMENT IN IBDQ SCORES IN PARTICIPANTS OF LUCENT-1 AND LUCENT-2 RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED PHASE 3 TRIALS

A31 MIRIKIZUMAB IMPROVES QUALITY OF LIFE IN MODERATELY-TO-SEVERELY ACTIVE UC: IMPROVEMENT IN IBDQ SCORES IN PARTICIPANTS OF LUCENT-1 AND LUCENT-2 RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED PHASE 3 TRIALS

P546 Comparative efficacy and safety of upadacitinib versus ustekinumab as induction therapy in patients with moderately to severely active ulcerative colitis: A matching-adjusted indirect comparison

Abstract Background Upadacitinib (UPA), an oral Janus kinase inhibitor, and ustekinumab (UST), a parenteral IL-12/23 inhibitor, are approved therapies for patients (pts) with moderately to severely active Ulcerative Colitis (UC). In the absence of head-to-head data, we conducted a placebo (PBO)-anchored matching-adjusted indirect comparison (MAIC) to compare efficacy and safety of UPA vs UST during induction. Methods Pts received UPA 45 mg oral, once daily for 8 weeks or PBO in the phase 3 studies U-ACHIEVE (NCT02819635) and U-ACCOMPLISH (NCT03653026), and UST 6 mg/kg IV at week 0 with 8-week follow up or PBO in the phase 3 study UNIFI (NCT02407236). Efficacy outcomes were stratified by previous biologic exposure (ie, no prior exposure [bio-naïve] or inadequate response, loss of response, or intolerance to biologics [bio-failed]). Baseline characteristics for age, gender, extent and duration of disease, total Inflammatory Bowel Disease Questionnaire score, total Mayo score, high-sensitivity CRP, faecal calprotectin levels, weight, and UC medication use from the UPA trials were weighted to match the UNIFI trial. Efficacy outcomes at Week 8 were clinical remission per full Mayo score (FMS; FMS ≤2 with no subscore &amp;gt;1), clinical response (decrease in FMS ≥3 points and ≥30%, plus a decrease in rectal bleeding score [RBS] of ≥1 or an absolute RBS of 0 or 1), endoscopic improvement (endoscopic subscore 0 or 1), and histologic-endoscopic mucosal improvement (HEMI). Safety outcomes evaluated in the overall population were adverse events (AEs) and serious AEs (SAEs), comprising the only safety assessments consistently collected across trials. Numbers needed to treat/harm (NNT/NNH) were calculated as the inverse of the difference in proportions achieving efficacy/safety outcomes between UPA and UST. Results The MAIC included 824 UPA and 625 UST pts with efficacy data and 839 UPA and 639 UST pts with safety data. A greater proportion of pts receiving UPA vs UST in bio-naïve and bio-failed groups achieved clinical remission, endoscopic improvement, and HEMI after weighting (p≤0.01, Table 1) with NNTs &amp;lt;10. In bio-naïve pts, differences in the proportion of pts with clinical remission, clinical response, endoscopic improvement, and HEMI for UPA vs UST were 0.172, 0.146, 0.312, and 0.255, respectively, and 0.105, 0.235, 0.135, and 0.118 for bio-failed pts. AEs and SAEs were not statistically different between UPA and UST. Conclusion During induction, greater efficacy with similar safety was observed with UPA vs UST for pts with moderately to severely active UC based on MAIC. Potential bias due to unobserved confounders may exist with MAIC methodology. Further analyses to assess longer-term outcomes are warranted.

P465 Health-related quality of life from the Inflammatory Bowel Disease Questionnaire in patients with ulcerative colitis treated with etrasimod in the phase 3 ELEVATE UC 52 and ELEVATE UC 12 trials

Abstract Background Etrasimod is an investigational, once-daily, oral, selective sphingosine 1-phosphate receptor 1,4,5 modulator (S1P1,4,5) in development for the treatment of moderately to severely active ulcerative colitis (UC). ELEVATE UC 52 and ELEVATE UC 12 were two phase 3 studies that demonstrated efficacy and safety of etrasimod in patients with UC in which several patient-reported outcomes were collected. Health-related quality of life (HRQoL) was assessed in a post hoc analysis of the ELEVATE programme with the validated Inflammatory Bowel Disease Questionnaire (IBDQ).1 Methods In ELEVATE UC 52 (NCT03945188) and ELEVATE UC 12 (NCT03996369), patients (16-80 years) with moderately to severely active UC were randomised 2:1 to once-daily etrasimod 2 mg or placebo (PBO). Patients in the full analysis set with modified Mayo Scores 5-9 with a completed 32-item IBDQ questionnaire at baseline, week 12 (both trials) and week 52 (ELEVATE UC 52 only) were included in this analysis. Least squares mean (LSM) change from baseline for IBDQ total score and IBDQ domain scores were compared between etrasimod and PBO arms in both trials at each time point (data as observed), along with the proportion of patients who achieved IBDQ remission (IBDQ total score ≥170; nonresponder imputation). Results At baseline, a total of 237 and 191 etrasimod-treated patients and 112 and 96 PBO-treated patients completed the IBDQ for ELEVATE UC 52 and ELEVATE UC 12, respectively. LSM change from baseline in IBDQ total scores for etrasimod vs PBO were 42.8 vs 27.4 (difference [95% CI] 15.4 [6.5, 24.4]; P&amp;lt;0.001) and 55.8 vs 38.1 (difference [95% CI] 17.7 [6.6, 28.6]; P=0.002) at week 12 and week 52, respectively, in ELEVATE UC 52, and 47.5 vs 30.2 (difference [95% CI] 17.3 [8.5, 26.2]; P&amp;lt;0.001) at week 12 in ELEVATE UC 12 (Figure 1A). A greater proportion of etrasimod-treated patients achieved IBDQ remission at week 12 in both trials and week 52 in ELEVATE UC 52 (Figure 1B). Etrasimod-treated patients demonstrated significant improvements from baseline vs PBO in all 4 IBDQ domains in both trials (Figure 2). Across all IBDQ domains, improvements were seen at 12 weeks and the LSM change from baseline was greatest among etrasimod-treated patients at all time points. Conclusion Patients treated with etrasimod demonstrated greater improvement from baseline in total and all 4 domain scores of the IBDQ at the end of the 12-week induction phase and 52-week maintenance phase in comparison with PBO. These findings demonstrate the benefits of etrasimod on disease-specific HRQoL and support the clinical findings from the ELEVATE programme. Reference: 1. Chen XL, et al. Health Qual Life Outcomes. 2017;15:1-13.

S735 Mirikizumab Improves Quality of Life in Moderately-to-Severely Active UC: Improvement in IBDQ Scores in Participants of LUCENT-1 and LUCENT-2 Randomized, Double-Blind, Placebo-Controlled Phase 3 Trials

Introduction: The Inflammatory Bowel Disease Questionnaire (IBDQ) is a measure of health-related quality of life (QoL). This analysis evaluated effect of mirikizumab (miri) vs placebo (PBO) on IBDQ scores in patients (pts) with moderately-to-severely active ulcerative colitis (UC) who had failed prior conventional or biologic therapy in a Phase 3, double-blind, 12-week (W) induction study (LUCENT-1) followed by a 40W maintenance study (LUCENT-2) for a total of 52W continuous therapy. Methods: Pts (N=1162) in LUCENT-1 were randomized 3:1 to receive 300mg miri or PBO intravenously once every four weeks (Q4W). 544 pts who achieved Modified Mayo Score Clinical Response to miri by W12 of induction were rerandomized 2:1 in LUCENT-2 to subcutaneous miri 200mg or PBO Q4W in maintenance period. Randomization was stratified by previous biologic therapy failure, baseline corticosteroid use, and region. LUCENT-1 stratification included baseline (BL) disease activity, and LUCENT-2 included LUCENT-1 clinical remission status. The least squares mean change from BL in IBDQ scores at W12 of induction and W40 of maintenance was determined using analysis of covariance models. BL was W0 of therapy and stratification factors and BL scores were used as covariates. The Minimal Clinically Important Difference (MCID) was defined as an improvement of ≥16 points in total IBDQ score (IBDQ response) and IBDQ remission as a total score ≥170 points. IBDQ response and remission were calculated using non-responder imputations. Treatments were compared using the common risk difference (risk diff). Results: Miri treatment resulted in significantly greater improvement from BL in IBDQ total and domain scores vs PBO at both W12 of induction and W40 of maintenance (52W treatment) (Table). The proportions of pts who achieved an IBDQ response was significantly greater for miri treated pts vs PBO at W12 (risk diff =17.1[95%CI:10.7, 23.5]) and W40 (29.5 [21.0, 37.9]). Significantly greater proportions of pts receiving miri achieved IBDQ remission at W12 (18.1 [11.8, 24.4]) and W40 (28.5 [20.1, 37.0]) vs PBO (all evaluations and timepoints: p< 0.001). Conclusion: Pts reported significantly greater improvements in IBDQ scores at induction and maintenance with miri compared to PBO. Over 75% of pts achieved a clinically meaningful improvement in QoL, as measured by IBDQ response, at the end of the 52 weeks of miri treatment. Table 1. - LUCENT-1 and LUCENT-2 Trials Change from Baseline in the Inflammatory Bowel Disease Questionnaire IBDQ Total Score 1 IBDQ Response 2 Score Improvement ≥16 IBDQ Remission 2 IBDQ Total Score ≥170 LSM Change from BL (SE) LSM Diff (SE) n (%) Risk Diff (95% CI) n (%) Risk Diff (95% CI) LUCENT-1 Week 12 of Induction PBO IV Q4W (N=294) 25.21 (1.80) 164 (55.8) 117 (39.8) Miri 300 mg IV Q4W (N=868) 38.42 (1.11) 13.21 (2.01)* 631 (72.7) 17.1 (10.7, 23.5)* 499 (57.5) 18.1 (11.8, 24.4)* LUCENT-2 Week 40 of Maintenance (52 Weeks of Continuous Therapy) of Miri Induction Responders PBO SC (N=179) 24.51 (2.77) 88 (49.2) 77 (43.0) Miri 200 mg SC (N=365) 49.75 (2.10) 25.24 (3.09)* 289 (79.2) 29.5 (21.0, 37.9)* 264 (72.3) 28.5 (20.1, 37.0)* Abbreviations: BL=baseline; CI=confidence interval; Diff=difference; IBDQ=Inflammatory Bowel Disease Questionnaire; IV=intravenous; LSM=least squares mean; Miri=mirikizumab; n=number of patients in the specified category; N=number of patients in the analysis population; PBO=placebo; Q4W=every 4 weeks; Risk Diff=common risk difference; SC=subcutaneous; SE=standard error.1Inflammatory Bowel Disease Questionnaire domains and total scores were evaluated by analysis of covariance with modified baseline observation carried forward and adjustment for covariates.2Inflammatory Bowel Disease Questionnaire-based measurements for clinical response and remission were analyzed using non-responder imputation. The common risk difference was the stratification-adjusted difference in the proportion of participants receiving mirikizumab minus the proportion of participants receiving placebo.*p< 0.001.

S857 Patient-Reported Outcomes of Response and Remission Following Guselkumab Induction Treatment as Measured by the Inflammatory Bowel Disease Questionnaire: Results Through Week 12 of the Phase 2 GALAXI 1 Study

Introduction: GALAXI 1 is a phase 2, double-blind, placebo-controlled study of guselkumab (GUS), an IL-23 antagonist, for the treatment of patients (pts) with moderately to severely active Crohn’s disease (CD) who had inadequate response or intolerance to conventional therapies (corticosteroid, immunosuppressant) and/or biologics (TNF antagonist, vedolizumab). Patient-reported outcomes from the Inflammatory Bowel Disease Questionnaire (IBDQ) through Week (Wk) 12 following GUS induction are reported here for the interim analysis population. Methods: Pts with moderate to severe CD (CDAI score 220-450) were randomized 1:1:1:1:1 to GUS 200, 600, or 1200mg IV at Wks 0, 4, 8; ustekinumab (UST) ∼6mg/kg IV at Wk 0 and 90mg SC at Wk 8; or placebo (PBO) IV. The IBDQ is a 32-item questionnaire with 4 dimensions: bowel symptoms, emotional function, systemic symptoms, and social function. IBDQ scores range from 32 to 224 with higher scores indicating better quality of life. IBDQ scores were evaluated at Wk 8 and Wk 12 for change from baseline, IBDQ response (defined as ≥16-point improvement from baseline), and IBDQ remission (defined as IBDQ score ≥170) for the GUS combined and PBO treatment groups. UST was a reference arm. Results: Two hundred fifty pts were evaluated; approximately 50% failed previous biologic therapy. Baseline demographics and disease characteristics were generally similar across treatment groups. However, some differences were observed between the groups, the most notable of which included a slightly lower disease duration in the GUS 1200mg IV group (6.2 yrs) compared with the GUS 200mg IV group (11.7 yrs), and a lower mean baseline IBDQ total score in the PBO group (117.3) compared with the GUS combined and UST groups. IBDQ scores change from baseline at Wk 8 and Wk 12 are presented in Table 1. Mean change from baseline in total IBDQ and each of the 4 IBDQ domains was greater among pts in the combined GUS group compared with the PBO group. The proportion of pts who achieved IBDQ response at Wk 8 and Wk 12 was higher in the combined GUS treatment group compared with PBO (Figure 1). A similar trend was seen for IBDQ remission. Conclusion: In pts with moderately to severely active CD, pts treated with GUS (combined) induction therapy reported greater improvement in IBDQ scores compared with PBO as early as Wk 8. A higher proportion of pts treated with GUS compared with PBO achieved IBDQ response and remission at Wks 8 and 12, and this treatment benefit (as delta) increased from Wk 8 to Wk 12.Table 1.: Change from baseline in IBDQ total and domain scores, at Week 8 and Week 12.Figure 1.: IBDQ Response and IBDQ Remission at Week 8 and Week 12.

Effect of Originator Infliximab Treatment on Disease-Related Hospitalizations, Work Productivity and Activity Impairment, and Health Resource Utilization in Patients with Crohn’s Disease in a Real-Life Setting: Results of a Prospective Multicenter Study in Germany

Introduction: Infliximab (IFX) therapy is efficacious for inducing and maintaining symptomatic remission in patients with Crohn’s disease (CD), but whether this benefit results in reduced hospitalization rates and therefore may improve patients’ quality of life in an economically sensible way is conflicting so far. Methods: We conducted a noninterventional, multicenter, open-label, prospective study to evaluate the effect of originator IFX treatment on patient-reported outcomes and disease-related hospitalizations in adult CD patients in Germany treated for the first time with IFX according to label. Results: Two hundred and ninety-four patients were included in the study. We observed a statistically significant reduction in the number of CD-related hospitalizations from the year before baseline (mean 1.00 per patient, SD ± 0.93) to the mean value of the 1st (0.62, SD ± 0.95) and 2nd year (0.32, SD ± 0.75) of the observation period (p < 0.0001). After 3 months of IFX therapy, work productivity and activity increased by an average of 12.6 and 17.1%, respectively. Patient’s clinical outcome was markedly improved as the total CD activity index (CDAI) sum score continuously decreased from baseline to month 24 and the mean score of the total inflammatory bowel disease questionnaire (IBDQ) changed substantially from 141 at baseline to 172 after 24 months of IFX treatment. Additionally, the number of work incapacity days declined. Recently, no new safety issues of IFX have been identified. Conclusion: In this large, prospective, multicenter study on disease-related hospitalization rates, work productivity, capacity for daily activities, and HRQoL in patients with CD, IFX significantly reduces their hospitalization rates and improves work productivity, daily activity, and quality of life over 24 months.

S0682 Absence of Bowel Urgency Is Associated With Significantly Improved Inflammatory Bowel Disease Related Quality of Life in a Phase 2 Trial of Mirikizumab in Patients With Ulcerative Colitis

INTRODUCTION: Mirikizumab (miri), a humanized monoclonal antibody directed against the p19 subunit of IL-23, demonstrated efficacy and was well-tolerated in a phase 2 randomized clinical trial in patients with ulcerative colitis (UC). Bowel urgency is one of the most bothersome symptoms experienced by patients with UC and is closely tied to health-related quality of life (QoL). Here we show the relationship between patient-reported urgency and Inflammatory Bowel Disease Questionnaire (IBDQ) scores. METHODS: Patients (N = 247) were randomized 1:1:1:1 to receive intravenous placebo, miri 50 mg or 200 mg with possibility of exposure-based dose increases, or fixed miri 600 mg every 4 weeks. Patients who achieved clinical response at Week 12 (decrease in 9-point Mayo score ≥2 points and ≥35% from baseline [BL], and either a decrease in rectal bleeding [RB] subscore ≥1 or RB subscore of 0 or 1; n = 106) were re-randomized 1:1 to double-blind maintenance treatment with miri 200 mg subcutaneously every 4 or 12 weeks and were treated through Week 52. Absence of urgency at Weeks 12 and 52 was defined as having no urgency for the three consecutive days prior to each scheduled visit, regardless of urgency status at BL. Patients lacking urgency data were imputed as having experienced urgency at that visit. The mean change from BL (Week 0) in IBDQ scores between patients with absence or presence of urgency at Weeks 12 and 52 was determined using analysis of covariance models. RESULTS: As previously reported, miri significantly reduced urgency over 52 weeks of treatment (1). In this analysis, total IBDQ score was significantly higher in patients with absence of urgency compared to those with presence of urgency at weeks 12 and 52. [LSM (SE)]: Week 12, 179.2 (3.6) absence, 150.5 (3.2) presence, P < 0.0001; Week 52, 186.0 (3.91) absence, 163.1 (4.35) presence, P < 0.0001. A similar pattern was observed for the 4 IBDQ subscores and corresponded to percent changes from BL (% ΔBL) that were more than two times greater in patients with absence of urgency compared to patients with presence of urgency (Table 1). CONCLUSION: In patients with absence of urgency at Weeks 12 and 52, Qol as measured by IBDQ was significantly improved compared to those with urgency. Our data demonstrate the significant negative impact of urgency on QoL in patients with UC.Table 1

2913 Health-Related Quality of Life in Patients With Inflammatory Bowel Disease at the University Hospital of the West Indies

INTRODUCTION: Inflammatory bowel disease (IBD) is a chronic condition that can significantly affect health-related quality of life (HRQoL). The aim of this study is to determine the HRQoL of patients with IBD seen at the Gastroenterology clinic at the University Hospital of the West Indies (UHWI). METHODS: A cross sectional study was conducted, which included seventy patients with IBD (CD 25, UC 44 and one patient with Indeterminate colitis). Data analyses were restricted to 69 patients who had CD or UC. All the patients completed the validated Inflammatory Bowel Disease Questionnaire (IBDQ) and a questionnaire with demographic data. Disease activity was measured using Crohn's Disease Activity Index (CDAI) for CD and Truelove and Witts severity index for UC. Data analysis was conducted using Stata 14 statistical software. RESULTS: Mean age was 44.3 ± 16.2 years, 56.5% females, mean disease duration 12.0 ± 11.0 years and mean age at diagnosis of IBD was 31.5 ± 13.4 years. Patients with CD had more frequent hospital admissions (3.9 ± 3.7 vs 0.9 ± 1.8; P value 0.001) and surgeries (0.75 ± 0.8 vs 0.1 ± 0.4; P value 0.001) compared to those with UC. The mean total IBDQ score was 179.6 ± 34.4 (CD was 175.0 ± 37.1 and 182.1 ± 33.0 for patients with UC). Patients with higher IBDQ scores were more likely to be male gender (OR 1.93, 95% CI 0.69–5.39, P value 0.207), married (OR 2.25, 95% CI 0.60-7.31, P value 0.177), educated to secondary school level (OR 2.05, 95% CI 0.46-9.06, P value 0.343), employed in the private sector (OR 3.00, 95% CI 0.83-10.90, P value 0.095) and on no medications (OR 3.24, 95% CI 0.27–0.80, P value 0.006). Higher IBDQ score was associated with fewer hospital admissions (OR 0.90, 95% CI 0.73-1.10, P value 0.287). The best score was seen in the systemic domain. The lowest score was seen in emotional domain for both diseases. Overall male patients had a better score for all domains. CONCLUSION: The HRQoL for patients with IBD at the UHWI was comparable to those in other studies. Patients with UC and male gender appeared to have better quality of life, but comparisons were limited by small sample size.

690 Ustekinumab Maintained Clinically Meaningful Improvement in Health-Related Quality of Life in Patients With Moderate to Severe Crohn's Disease: Results From the IM-UNITI Long-Term Extension

INTRODUCTION: The IM-UNITI study evaluated the safety and efficacy of subcutaneous (SC) ustekinumab (UST) maintenance therapy in patients with moderately to severely active Crohn's disease (CD) who completed induction treatment with UST. Previously, we reported the effects of UST on health-related quality of life (HRQoL) through Wk44. Here, we evaluated HRQoL through Wk140 in patients who entered the long-term extension of the IM-UNITI study. METHODS: Patients who completed the safety and efficacy evaluation at Wk 44 of the maintenance study were eligible to continue their regimen in the extension study (placebo [PBO], UST 90 mg q12w, or UST 90 mg q8w). All patients who were treated in the extension study were included in this analysis of Inflammatory Bowel Disease Questionnaire (IBDQ) and SF-36 data according to the treatment they received during the extension study. The IBDQ is a 32-item questionnaire with 4 dimensions: bowel symptoms, systemic symptoms, emotional function, and social function. The total score ranges from 32 to 224, higher scores indicate better quality of life, and a change ≥16 points was defined as clinically meaningful. For SF-36, a change ≥5 points was defined as clinically meaningful. RESULTS: For patients who entered the extension, mean total IBDQ scores and SF-36 scores at maintenance baseline were comparable across treatment groups (Table 1). Patients who received UST maintained the improvement in IBDQ and SF-36 that was achieved by maintenance baseline through Wk140, and those who received PBO generally worsened. Through Wk 140, 26.5% of patients receiving PBO, 61.5% of patients receiving UST 90 mg q12w, and 59.3% of patients receiving UST 90 mg q8w had ≥16-point improvements from induction baseline in IBDQ score. In addition, 10.9%, 51.6%, and 54.2%, respectively, had ≥5-point improvements in SF-36 physical component summary scores, and 8.7%, 43.8%, and 43.7%, respectively, had ≥5-point improvements in SF-36 mental component summary scores during the same period. CONCLUSION: In patients who entered the long-term extension of the IM-UNITI study, those who received SC UST maintenance generally maintained improvements in IBDQ and SF-36 scores that were achieved through IV induction, and those who received PBO gradually lost these improvements.

Unmet Psychosocial Needs of Patients with Newly Diagnosed Ulcerative Colitis: Results from the Nationwide Prospective Cohort Study in Korea.

Background/AimsLimited data are available regarding psychosocial distress at the time of diagnosis of ulcerative colitis (UC). We investigated the psychosocial burden and factors related to poor health-related quality of life (HRQL) among patients newly diagnosed with moderate-to-severe UC who were affiliated with the nationwide prospective cohort study.MethodsWithin the first 4 weeks of UC diagnosis, all patients were assessed using the Hospital Anxiety and Depression Scale (HADS), Work Productivity and Activity Impairment questionnaire, Inflammatory Bowel Disease Questionnaire (IBDQ), and 12-Item Short Form (SF-12) health survey. A multiple linear regression model was used to identify factors associated with HRQL.ResultsBetween August 2014 and February 2017, 355 patients completed questionnaires. Significant mood disorders requiring psychological interventions, defined by a HADS score ≥11, were identified in 16.7% (anxiety) and 20.6% (depression) of patients. Patients with severe disease were more likely to have presenteeism, loss of work productivity, and activity loss than those with moderate disease (all p<0.05). Significant mood disorders had the strongest negative relationship with total IBDQ score, which indicates disease-specific HRQL (β coefficient: –22.1 for depression and –40.0 for anxiety, p<0.001). The scores of all SF-12 dimensions, which indicate general HRQL, were remarkably decreased in the study population compared indirectly with previously reported scores in the general population. The Mayo score, C-reactive protein level, and white blood cell count showed significant negative associations with the IBDQ score (p<0.05).ConclusionsPsychosocial screening and timely interventions should be incorporated into the initial care of patients newly diagnosed with UC.

Su1932 - Maintenance of Quality of Life Improvement in a Phase 3 Study of Tofacitinib for Patients with Moderately to Severely Active Ulcerative Colitis

Introduction Tofacitinib is an oral, small molecule Janus kinase inhibitor that is being investigated for ulcerative colitis (UC). Tofacitinib 10 mg twice daily (BID) improved quality of life (QoL) in the Phase 3 OCTAVE Induction 1 and 2 studies of patients (pts) with moderate to severe UC.1 Method OCTAVE Sustain (NCT01458574) was a Phase 3, 52 week, randomised, double-blind, placebo (Pbo)-controlled study in pts completing OCTAVE Induction 1 or 2 with clinical response (≥3 points and ≥30% decrease from baseline (BL) Mayo score plus decrease in rectal bleeding subscore (RBSS) of ≥1 or RBSS ≤1). Pts were re-randomised (1:1:1) to Pbo, tofacitinib 5 or 10 mg BID. QoL was assessed at Weeks 24 and 52 using the 32-item Inflammatory Bowel Disease Questionnaire (IBDQ) and the Short Form-36 (SF-36v2, 1 week recall; 8 domain scores and Physical/Mental Component Summaries [PCS and MCS]). Clinically relevant endpoints including IBDQ Remission (IBDQ Score ≥170) and Response (≥16 point improvement from induction BL IBDQ Score) were compared by Cochran-Mantel-Haenszel chi-square test. Continuous endpoints were analysed using a linear mixed-effects model. Results OCTAVE Sustain randomised 593pts (Pbo: n=198; 5 mg BID: n=198; 10 mg BID: n=197). At Sustain BL, mean IBDQ total score ranged from 166.7–167.7, and mean SF-36 PCS and MCS ranged from 49.3–50.5 and 47.8–49.0, respectively, across groups. There was minimal change from BL at Week 24 and 52 in the total IBDQ scores in the tofacitinib groups, while there was a worsening (decrease) in the Pbo group. Both the tofacitinib 5 and 10 mg BID groups showed significant difference in change from Sustain BL in total IBDQ scores at Weeks 24 and 52 compared to Pbo (all p Conclusion For pts with moderate to severe UC and clinical response to induction therapy, significant and clinically meaningful improvements in QoL (IBDQ; SF-36) were maintained with tofacitinib 5 and 10 mg BID vs Pbo through 52 weeks maintenance therapy. References . Panes J, et al. J Crohns Colitis2016; 10: S283. Disclosure of Interest J Panes Conflict with: AbbVie and MSD, Conflict with: AbbVie, Boehringer Ingelheim, Genentech-Roche, Janssen, Pfizer Inc, Takeda, and TiGenix, Conflict with: AbbVie, Janssen, MSD, and Pfizer Inc, D Rubin Conflict with: AbbVie, Genentech, Janssen, Takeda, and UCB, Conflict with: AbbVie, Amgen, Janssen, Pfizer Inc, Takeda, and UCB, S Vermeire Conflict with: Centocor, AbbVie, Takeda and Merck, Conflict with: Takeda, Roche/Genentech, Merck, Centocor, AbbVie, UCB, Pfizer, Ferring, Second Genome and Galapagos, Conflict with: Merck, AbbVie, Takeda, Pfizer, Ferring, Falk and Centocor, J Lindsay Conflict with: MSD, Hospira (Pfizer Inc), Shire and Takeda, Conflict with: AbbVie, Celgene, Ferring, Janssen, Merck, Robarts Clinical Trials, Shire, Pfizer Inc and Takeda, Conflict with: AbbVie, Allergan, Ferring, Janssen, MSD, Shire and Takeda, Conflict with: Advisory Board: AbbVie, Atlantic Healthcare, Ferring, Hospira, Janssen, MSD, NAP, Shire, Pfizer, Takeda and Vifor, B Sands Conflict with: AbbVie, Celgene, GlaxoSmithKline, Janssen R and D, Pfizer Inc, Prometheus Laboratories and Takeda, Conflict with: AbbVie, Akros Pharma, Amgen, AstraZeneca, Boehringer Ingelheim, Celgene, Forest Research Institute, Lilly, MedImmune, Puretech Ventures, LLC, Receptos, Salix, Shire, Takeda, Topivert Pharma, Vedanta Biosciences, Bristol-Myers Squibb, Janssen R and D, Luitpold Pharmaceuticals, Pfizer Inc, Prometheus Laboratories, Synergy Pharmaceuticals, Takeda, Theravance Biopharma and Tigenix, C Su Conflict with: Pfizer Inc, Conflict with: Pfizer Inc, G Friedman Conflict with: Pfizer Inc, Conflict with: Pfizer Inc, H Zhang Conflict with: Pfizer Inc, Conflict with: Pfizer Inc, C Kayhan Conflict with: Pfizer Inc, Conflict with: Pfizer Inc, A Manuchehri Conflict with: Pfizer Inc, Conflict with: Pfizer Ltd, P Healey Conflict with: Pfizer Inc, Conflict with: Pfizer Inc

DOP075 Tofacitinib in active ulcerative colitis: Analysis of efficacy based on patient-reported outcomes

Background: Tofacitinib, a novel oral Janus kinase inhibitor being investigated as a targeted immunomodulator, demonstrated dose-dependent efficacy for induction of clinical response and remission in patients with active ulcerative colitis (UC) in a Phase 2 randomised controlled trial (Clinicaltrials.gov NCT00787202; Pfizer Inc A3921063). Reported here is the effect of tofacitinib on patient-reported outcomes (PROs), including aspects of health-related quality of life (HRQoL) and patient preference for study medication, in the same patient population. Methods: Patients ( 18 years of age, n = 194) with active UC (total of full Mayo score 6 12 points and moderately-toseverely active disease on sigmoidoscopy) were randomised in a 2:2:2:3:3 ratio to receive twice daily (BID) oral tofacitinib 0.5mg (n = 31), 3mg (n = 33), 10mg (n = 33) or 15mg (n = 49) or placebo (n = 48) for 8 weeks. PROs included the Inflammatory Bowel Disease Questionnaire (IBDQ) and the Inflammatory Bowel Disease Patient-Reported Treatment Impact (IBD PRTI) questionnaire. Relationships were assessed with Pearson correlation coefficients, logistic regression for binary outcomes and linear regression for continuous outcomes. Results: At Week 8 mean IBDQ total scores improved relative to baseline across all 5 treatment groups (baseline range 123.2 134.5; Week 8 range 149.6 175.4); improvement was significantly greater for tofacitinib 15mg BID vs. placebo (mean ± std dev: 50.7±35.6 vs. 27.8±29.8, P= 0.001). At Week 8 patients receiving tofacitinib 15mg BID had an odds ratio of 4.18 (95%CI: 1.75 10.02; P< 0.001) to achieve an IBDQ response ( 16-point improvement) and an odds ratio of 5.23 (95%CI, 2.14 12.75; P< 0.001) to achieve IBDQ remission (total IBDQ score of 170) relative to placebo-treated patients. At Week 8, IBDQ total score significantly correlated with the full Mayo score (r = 0.62, P< 0.0001) and Mayo endoscopy subscore (r = 0.46, P< 0.0001). For the three PRTI questions (satisfaction, preference, willingness), at Week 8 the majority of patients receiving tofacitinib 15mg BID reported being “satisfied” or “extremely satisfied” with the drug received, definite preference for the study drug, and definite willingness to use the study drug again. Patients achieving endoscopic remission (Mayo endoscopy score of 0) had significantly more favourable (P< 0.05) IBDQ scores and PRTI scores than those not achieving endoscopic remission. Conclusions: Short-term treatment with oral tofacitinib was associated in patients with moderately-to-severely active UC with dose-dependent improvement of HRQoL and in patient preference for the study medication. The results complement reported efficacy and safety data from the same trial.

Restorative proctocolectomy in patients with ulcerative colitis: a cross‐sectional Danish population study on function and quality of life

The study evaluated function and quality of life (QoL) in all patients having restorative proctocolectomy (RPC) in Denmark for ulcerative colitis (UC) from 1980 to 2010. Inclusion of all patients in one country has never previously been achieved. All patients who had had a RPC in Denmark, from the first case in 1980 to the last case in 2010, were studied. A cross-sectional questionnaire survey was performed, and function and QoL were assessed using a standardized questionnaire - the Short-Form 36 (SF36) - and the inflammatory bowel disease questionnaire (IBDQ). The median duration of follow up was 11 (range, 1-30) years. Apart from deaths, pouch failures and research protection, data on function and QoL were obtained from 1047 (85%) of 1229 patients who had a functioning pouch at the time of the investigation. More female patients than male patients experienced urgency (56% vs 44%, P = 0.0021). The median number of bowel movements per 24 h was 7 (range, 1-23) in female patients and 6 (range, 1-20) in male patients (P < 0.001). Pad usage was more frequent among female patients than among male patients (62% vs 38%, P < 0.001). A higher incidence of major incontinence (P = 0.009) and use of pads (P = 0.01) was found among patients who had been operated on 21-30 years previously compared with those operated on 11-20 years previously. The prevalence of urgency was higher in patients who received surgery 0-10 years previously compared with 11-20 years previously (P = 0.009). The total IBDQ score was higher in male patients than in female patients (P < 0.001). Male patients scored higher in five of eight SF36 domains (P < 0.001). Female patients had more urgency, a higher frequency of defaecation and higher pad usage. This was associated with a reduced QoL. Nevertheless, RPC resulted in good function and a high degree of satisfaction in most patients.

PTU-186 12 Month outcome and Patient Satisfaction with Structured Gastroenterological Evaluation for Chronic Gastrointestinal Symptoms following Pelvic Radiotherapy

IntroductionSeventeen thousand patients are treated with radical pelvic radiotherapy annually in the UK.50% develop chronic GI symptoms. The structured approach to management used in this service evaluation has been shown...

The Short Health Scale: A valid and reliable measure of health related quality of life in English speaking inflammatory bowel disease patients

BackgroundHealth related quality of life in inflammatory bowel disease is influenced both by disease activity as well as by the psychosocial characteristics of the individual patient. The Short Health Scale (SHS) is a four-part visual analogue scale questionnaire using open-ended questions that are designed to assess the impact of inflammatory bowel disease on a health related quality of life. The four dimensions include bowel symptoms, activities of daily life, worry and general wellbeing. It has previously been validated in Swedish and Norwegian speaking patients. AimTo evaluate the SHS in an English speaking inflammatory bowel disease population. MethodsFour hundred and ninety Crohn's disease and ulcerative colitis patients completed the SHS. Individual SHS items were correlated with Inflammatory Bowel Disease Questionnaire (IBDQ) dimensions and with disease activity to assess validity. Test–retest reliability was assessed in 38 patients who completed the Short Health Scale two weeks apart. ResultsAll four items correlated with corresponding IBDQ dimensions with correlation coefficients ranging from −0.66 to −0.74 (all p values<0.001). In addition, total SHS scores correlated with total IBDQ scores in both Crohn's disease (−0.836) and ulcerative colitis (0.797). There was a stepwise increase in Short Health Scale scores with increasing disease activity (all p values<0.001). Reliability was confirmed with test–retest correlations ranging from 0.70 to 0.89 (all p values<0.005). ConclusionsThe Short Health Scale is a valid and reliable measure of health related quality of life in English speaking inflammatory bowel disease patients.

The Potential Role of a Self-Management Intervention for Ulcerative Colitis

Inflammatory bowel diseases (IBD) are chronic inflammatory illnesses marked by unpredictable disease flares, which occur spontaneously and/or in response to external triggers, especially personal health behaviors. Behavioral triggers of flare may be responsive to disease self-management programs. We report on interim findings of a randomized controlled trial of gut-directed hypnotherapy (HYP, n = 19) versus active attention control (CON, n = 17) for quiescent ulcerative colitis (UC). To date, 43 participants have enrolled; after 5 discontinuations (1 in HYP) and 2 exclusions due to excessive missing data, 36 were included in this preliminary analysis. Aim 1 was to determine the feasibility and acceptability of HYP in UC. This was achieved, demonstrated by a reasonable recruitment rate at our outpatient tertiary care clinic (20%), high retention rate (88% total), and our representative IBD sample, which is reflected by an equal distribution of gender, an age range between 21 and 69, recruitment of ethnic minorities (∽20%), and disease duration ranging from 1.5 to 35 years. Aim 2 was to estimate effect sizes on key clinical outcomes for use in future trials. Effect sizes (group × time at 20 weeks) were small to medium for IBD self-efficacy (.34), Inflammatory Bowel Disease Questionnaire (IBDQ) total score (.41), IBDQ bowel (.50), and systemic health (.48). Between-group effects were observed for the IBDQ bowel health subscale (HYP > CON; p = .05) at 20 weeks and the Short Form 12 Health Survey Version 2 (SF-12v2) physical component (HYP > CON; p < .05) at posttreatment and 20 weeks. This study supports future clinical trials testing gut-directed HYP as a relapse prevention tool for IBD.

Impact of demographic factors, medication and symptoms on disease-specific quality of life in inflammatory bowel disease

To investigate the relation of demographic factors, medication and symptoms to health-related quality of life in patients with inflammatory bowel disease, and to identify patients in need of special support. A questionnaire packet comprising the Inflammatory Bowel Disease Questionnaire (IBDQ) and the European Federation of Crohn's and Colitis Associations' (EFCCA) Survey Questionnaire was sent to 3,852 adult members of the Crohn and Colitis Association of Finland. IBDQ was used for measuring health-related quality of life (HRQoL), and the EFCCA questionnaire gave information about demographics, symptoms and medication. Altogether 2,386 questionnaires (62%) were available for analysis. Patients reporting symptoms affecting leisure activities or work had significantly lower total IBDQ scores (indicating worse HRQoL) than patients with less disturbing symptoms. Satisfaction with current therapy, female gender and age affected the scores. Subjects who had undergone surgery scored lower than those who had not. Patients currently receiving corticosteroids and newly diagnosed patients had lower scores than other patients. In everyday practice, paying attention to and reducing patients' symptoms and their impact on daily life is important when aiming at improving HRQoL. Special attention should be given to patients who have undergone surgery, and to newly diagnosed patients.