Corticosteroid-free Remission Rates Research Articles

One-year Safety and Effectiveness of Ustekinumab in Patients With Crohn's Disease: The K-STAR Study.

This study investigated the safety and effectiveness of ustekinumab (UST) in Korean patients with Crohn's disease (CD). Adult patients with CD treated with UST were prospectively enrolled in the K-STAR (Post-MarKeting Surveillance for Crohn's Disease patients treated with STelARa) study between April 2018 and April 2022. Both the clinical effectiveness and adverse effects of UST therapy were analyzed. Missing data were handled using nonresponder imputation (ClinicalTrials.gov Identifier: NCT03942120). Of the 464 patients enrolled from 44 hospitals across Korea, 457 and 428 patients (Crohn's disease activity index ≥150) were included in the safety analysis and effectiveness analysis sets, respectively. At weeks 16 to 20 after initiating UST, clinical response, clinical remission, and corticosteroid-free remission rates were 75.0% (321 of 428), 64.0% (274 of 428), and 61.9% (265 of 428), respectively. At week 52 to 66, clinical response, clinical remission, and corticosteroid-free remission rates were 62.4% (267 of 428), 52.6% (225 of 428), and 50.0% (214 of 428), respectively. Combined effectiveness (clinical response + biochemical response) was achieved in 40.0% (171 of 428) and 41.6% (178 of 428) at week 16 to 20 and week 52 to 66, respectively. Biologic-naïve patients exhibited significantly higher rates of combined effectiveness than biologic-experienced patients (50.3% vs 30.7% at week 16-20, P < .001; 47.7% vs 36.0% at week 52-66, P = .014). No additional benefits were observed with the concomitant use of immunomodulators. Ileal location was independently associated with a higher probability of clinical remission compared with colonic or ileocolonic location at week 52 to 66. Adverse and serious adverse events were observed in 28.2% (129 of 457) and 12.7% (58 of 457), respectively, with no new safety signal associated with UST treatment. Ustekinumab was well-tolerated, effective, and safe as induction and maintenance therapy for CD in Korea.

Infantile and Very Early Onset Inflammatory Bowel Disease: A Multicenter Study.

This study described disease characteristics and long-term outcomes in patients diagnosed with very early onset inflammatory bowel disease (VEOIBD) (diagnosed before 6 years of age) and infantile-IBD (before 2 years). Cases from 21 centers worldwide diagnosed with VEOIBD (2008-2018), with minimum 2 years of follow-up, were retrospectively reviewed. The cohort included 243 patients (52% males, median follow-up of 5.8 [range 2-18] years, including 69 [28%]) with infantile-IBD. IBD subtypes included Crohn's disease (CD), ulcerative colitis (UC), or IBD-unclassified (IBDU) in 30%, 59%, and 11%, respectively. Among patients with CD, 94% had colonic involvement, and among patients with UC/IBDU, 75% had pancolitis. Patients with infantile-IBD presented with higher rates of IBDU, lower hemoglobin and albumin levels, and higher C-reactive protein, and had lower response rates to first-induction therapy and corticosteroids therapy (P < .05 for all). Colectomy and diversion surgeries were performed in 11% and 4%, respectively, with no significant differences between age groups. Corticosteroid-free remission rates were 74% and 78% after 3 and 5 years, respectively, and 86% at end of follow-up. Genetic testing was performed in 96 (40%) patients. Among tested population, 15 (16%) were identified with monogenic disease. This group demonstrated lower response rates to induction therapies, higher rates of surgical intervention, and higher rates of major infections (P < .05 for all). Patients with VEOIBD, including infantile-IBD, exhibit low rate of complications and surgical interventions at the long term. Patients with monogenic IBD are at risk for more severe disease course.

DOP55 Long-term outcomes after histologic-endoscopic mucosal healing: Results from the UNIFI study in Ulcerative Colitis

Abstract Background In the UNIFI study of ustekinumab (UST) in ulcerative colitis (UC), patients who achieved histo-endoscopic mucosal healing (HEMH; ie, both histologic and endoscopic improvement of mucosa) after induction had higher clinical remission and corticosteroid-free clinical remission rates through 1 year than those who achieved either histologic or endoscopic improvement alone.1 Here, we report the effect of achieving HEMH after induction on long-term symptomatic outcomes through 3 years. Methods Patients who were in clinical response after 8 wks of IV induction with UST 130mg or ~6mg/kg (wk 8 responders) were randomized to maintenance treatment with SC UST 90mg q12w or q8w on entry into maintenance. Those who were not in clinical response to the initial UST dose at wk8 but achieved response at wk16 after receiving a single SC dose of UST 90mg at wk8 (wk16 responders) entered maintenance receiving SC 90mg q8w. After 44 wks of maintenance treatment, patients were given the option to continue in the long-term extension. HEMH was defined as achieving both endoscopic improvement (Mayo endoscopy subscore ≤1) and histologic improvement (neutrophil infiltration in &amp;lt;5% of crypts, no crypt destruction, and no erosions, ulcerations, or granulation tissue; based on the Geboes score). Patients with insufficient data for histologic evaluation at the end of induction were excluded. Symptomatic remission was defined as a Mayo stool frequency subscore of 0 or 1 and a Mayo rectal bleeding subscore of 0. Results Of the 438 patients who were wk8 or wk16 responders to UST induction and received UST maintenance, 116 (26.5%) achieved HEMH after induction, 30 (6.8%) achieved endoscopic improvement without histologic improvement (EI), and 106 (24.2%) achieved histologic improvement without endoscopic improvement (HI). Patients who achieved HEMH after induction had higher symptomatic remission and corticosteroid-free symptomatic remission rates at wks92 and 152 than those with EI or HI; the differences were statistically significantly greater at wk152, while they were only numerically greater at wk92 (Table). The differences were primarily driven by patients with HEMH after induction being more likely to maintain symptomatic remission between wks92 and 152, than those with EI or HI alone. Symptomatic remission and corticosteroid-free remission rates decreased between wks92 and 152 in patients with EI or HI only. Conclusion Patients with UC who achieved HEMH after induction with UST were more likely to maintain symptomatic remission and corticosteroid-free symptomatic remission between 2 and 3 years of maintenance treatment than those who achieved EI or HI alone. Reference 1. K Li, et al. Poster 1008. Presented at UEGW 2019. October 22, 2019. Barcelona, Spain.

P426 Association Between vedolizumab therapy outcome and Pre-treatment DUBLIN Score &amp; CRP-Albumin Ratio in Ulcerative Colitis

Abstract Background The DUBLIN score is a measure of ulcerative colitis (UC) inflammatory burden and is associated with clinical outcomes. A high CRP/albumin ratio (CAR) is associated with disease severity in IBD. The aim of our study was to evaluate if there was an association between vedolizumab therapy outcome and pre-treatment DUBLIN score and CAR in UC. Methods 35 patients with UC initiating vedolizumab with available pre-treatment DUBLIN score and CAR data were identified. Baseline characteristics, biochemistry and endoscopic findings were defined by retrospective review. A previously validated DUBLIN score threshold of ≥3 and CAR threshold &amp;gt;0.6 were utilised to categorise patients with high inflammatory burden. Clinical response at, 3-months and corticosteroid-free remission at, 6-months were recorded. The association between, 3-month clinical response and, 6-month remission rates &amp; pre-treatment DUBLIN score and CAR ratio were evaluated. P values &amp;lt;0.05 were considered significant. Results Baseline characteristics of the study cohort: age [median, range], 53 [19 -87] years;, 60% male; disease duration [median, range], 11 [2–41] years. A pre-treatment DUBLIN score ≥3 and CAR &amp;gt;0.6 were observed in, 65% and, 51% of patients respectively., 3-month clinical response and, 6-month corticosteroid-free remission rates were observed in, 79% and, 67% of the cohort respectively. There was no significant difference between rates of, 3-month clinical response and, 6-month corticosteroid-free remission comparing high and low pretreatment DUBLIN score and CAR groups, p=0.59 and p=0.16 respectively. Conclusion Vedolizumab was an effective therapy in patients with a significant inflammatory burden assessed by DUBLIN score and CAR. Pre-treatment DUBLIN score and CAR were not associated with therapy outcome.

P452 Tofacitinib Effectiveness and Safety as Therapy for Ulcerative Colitis

Abstract Background Tofacitinib is an oral small molecule directed against the JAK/STAT pathway. It is the first JAK inhibitor approved for the treatment of ulcerative colitis (UC) and is licenced for use in moderate to severely active disease. This study aims to evaluate tofacitinib effectiveness and safety in real-world clinical practice for moderate-to-severely active UC. Methods Consecutive patients receiving Tofacitinib for UC in four Irish tertiary referral centres were identified. Baseline clinical data and information on therapy outcomes were collected by retrospective review of electronic patient records. Patients included in the study cohort were older than 18 years of age, had a confirmed diagnosis of UC, had received at least one induction dose of tofacitinib, and had available clinical follow-up. The primary study endpoint was 6-month corticosteroid-free remission rate. Secondary endpoints included 3-month clinical response, inflammatory biomarkers responses to tofacitinib therapy, rates of tofacitinib discontinuation, and side effects. Continuous variables are presented as median [range]. P values &amp;lt; 0.05 were considered significant in all analyses. Results Fifty-three UC patients were included; age 40.4 [33.3 – 53.9] years, 66% male, disease duration 5.7 [2.6–10.9] years; follow-up 8.7 [6.4–14.1] months. 43%, 40% and 17% of patients had extensive, left-sided disease and proctitis respectively. At baseline, clinical Mayo subscore was 7 [5–8], CRP 4.0 [1.0–16.7] mg/L and faecal calprotectin 914 [444.0–1000] mcg/g. The 3-month clinical response and 6-month corticosteroid-free remission rates were 69% and 43%, respectively. Following tofacitinib therapy, compared with baseline values, a significant reduction in 3-month clinical Mayo score, 3-month CRP, and post-induction faecal calprotectin was observed, p &amp;lt;0.03 for all comparisons. 36% of patients (n=19) discontinued tofacitinib during study follow-up (time to Tofacitinib discontinuation 1.9 [0.5–18.9] months). Side effects occurred in 26% percent of patients with the majority minor and self-limiting. No cardiovascular or venous thromboembolic events were observed and no hospitalisations occurred due to therapy-related side effects Conclusion These data are in concordance with prior studies of tofacitinib effectiveness and safety in real world practice. They demonstrate that, in a cohort of UC patients with significant prior therapy exposure, tofacitinib is an effective therapy with an acceptable safety profile.

Safety and effectiveness of adalimumab in the treatment of ulcerative colitis: results from a large-scale, prospective, multicenter, observational study.

Background/AimsAdalimumab has been shown to induce and maintain clinical remission in patients with moderate to severe ulcerative colitis (UC). However, no large-scale population-based studies have been performed in Japan. This study was conducted to evaluate the safety and effectiveness of adalimumab in clinical practice in Japanese patients with UC.MethodsIn this 52-week, prospective, multicenter, single-cohort, noninterventional, observational, postmarketing surveillance study, patients with moderate to severe UC received an initial subcutaneous injection of adalimumab 160 mg, followed by 80 mg at 2 weeks, and then 40 mg every other week. Safety assessments were the incidence of adverse drug reactions (ADRs) and serious ADRs. Effectiveness assessments were clinical remission, corticosteroid-free remission, mucosal healing, and change in C-reactive protein (CRP) levels from baseline.ResultsOf 1,593 registered patients, 1,523 (male, 57.6%; mean age, 41.8 years) and 1,241 patients were included in the safety and effectiveness populations, respectively. ADRs were reported in 18.1% and serious ADRs in 4.9% of patients. Clinical remission was achieved in 49.7% of patients at week 4, increasing to 74.4% at week 52. Corticosteroid-free remission rates increased over time, from 10.4% at week 4 to 53.1% at week 52. More than 60% of patients demonstrated mucosal healing at weeks 24 and 52. Mean CRP levels (mg/dL) decreased from 1.2 at baseline to 0.6 at week 4 and 0.3 at week 52.ConclusionsThis large real-world study confirmed the safety and effectiveness of adalimumab in patients with UC in Japan. No new safety concerns were identified.

Experiences of using vedolizumab in the treatment of inflammatory bowel disease in the East Midlands UK – a retrospective observational study

Purpose Clinical trials have demonstrated efficacy of vedolizumab in ulcerative colitis (UC) and Crohn’s disease (CD). Further real-world data is needed to inform clinical practice. The primary outcome was to assess corticosteroid-free and clinical remission after vedolizumab initiation. Secondary outcomes included effect on disease activity scores, biochemical markers, concomitant drug use, endoscopic remission, surgical intervention, hospital admissions and adverse events. Materials and methods A multi-centre retrospective observational study was conducted with patients initiated on vedolizumab across seven UK hospitals 1/11/14-30/11/16. Clinical disease activity was assessed using the partial Mayo Scores (pMS) and Harvey Bradshaw Index (HBI). Clinical remission was defined as HBI ≤4 or pMS <2 with a combined stool frequency and rectal bleeding sub score of ≤1. Clinical response was defined as ≥2-point decrease from baseline in pMS and ≥3-point decrease from baseline in HBI. Results One hundred ninety-two patients were included in the final analysis. 45% of UC and 10% of CD patients were anti-TNF naive. Over the observation period corticosteroid-free remission rates for UC and CD were 46% and 45%, while clinical remission rates were 52% and 44%, respectively. Time to corticosteroid free remission for UC and CD was 17.6 [IQR: 8.7–29.6] and 14.1 [QR: 6.0–21.7] weeks, respectively. Time to clinical response for UC was 9.4 [IQR: 5.7–15.4] and CD was 9.5 [IQR: 6.1–18.2] weeks. There was a substantial decrease in the concomitant use of immunomodulators and a similar decrease in concomitant corticosteroid use over the study period. Conclusions Results in this predominately anti-TNF experienced population mirror other published real-world data, demonstrating good clinical effectiveness and a comparable safety profile.

Golimumab effectiveness and safety in clinical practice for moderately active ulcerative colitis.

Golimumab (GLB) is an antitumour necrosis factor-α (anti-TNF) therapy that has shown efficacy as induction and maintenance therapy for ulcerative colitis (UC). We aimed to describe the outcome of GLB therapy for UC in a real-world clinical practice. Consecutive patients receiving GLB for UC in six Irish Academic Medical Centres were identified. The primary study endpoint was the 6-month corticosteroid-free remission rate. The secondary endpoints included the 3-month clinical response, time free of GLB discontinuation and adverse events. Seventy-two patients were identified [57% men; median (range) age of 41.4 years (20.3-76.8); disease duration 6.6 years (0-29.9); follow-up 8.7 months (0.4-39.2)]. Sixty-four percent of patients were anti-TNF naive. The 3-month clinical response and the 6-month corticosteroid-free remission rates were 55 and 39%, respectively. Forty-four percent of patients discontinued GLB during the follow-up, median (95% confidence interval) time to GLB discontinuation 18.7 months (9.2-28.1). A C-reactive protein more than 5 mg/l at baseline was associated with failure to achieve 6-month corticosteroid-free remission and a shorter time to GLB discontinuation, odds ratio 0.2 (0.1-0.7), P=0.008, and hazard ratio (95% confidence interval) 2.8 (1.3-5.7), P=0.007, respectively. Adverse events occurred in 7% of patients (n=5), all of which were minor and self-limiting. These real-world clinical data suggest that GLB is an effective and safe therapy for a UC cohort with significant previous anti-TNF exposure. An elevated baseline C-reactive protein, likely reflective of increased inflammatory burden, is associated with a reduced likelihood of a successful outcome of GLB therapy.

Accelerated Clearance of Infliximab is Associated With Treatment Failure in Patients With Corticosteroid-Refractory Acute Ulcerative Colitis.

A significant proportion of patients with corticosteroid-refractory acute ulcerative colitis [UC] fail therapy. We aimed to assess the pharmacokinetics [PK] of infliximab [IFX] in patients with corticosteroid-refractory acute UC and determine the association between induction IFX PK and short- and long-term therapy outcome. A population PK model was developed using data from 51 patients with UC [n = 42] and Crohn's disease [n = 9]. A subset of patients [n = 36] with acute corticosteroid-refractory UC (median Mayo score 11 [range 8-12]; 33 of 36 hospitalized; median corticosteroid dose at study entry 50mg prednisolone equivalent IV/oral) commencing IFX were studied to assess further correlations between PK from the first induction dose and therapy outcomes. Serial induction drug levels from the 36 UC patients were collected, facilitating population-based PK analysis. IFX and antibodies-to-infliximab [ATIs] concentrations were determined using AnsrTM IFX assay [Prometheus Inc.]. The Week 14 clinical response and Week 54 corticosteroid-free remission rates were 78% [28/36] and 53% [19/36], respectively. The estimated effective IFX half-life [T1/2] (median [range]) and clearance (median [range]) were 8.42 [3.94-22.03] days and 0.50 [0.19-1.41] L/day respectively. Longer induction IFX T1/2 and lower clearance were associated with the Week 14 clinical response [p = 0.005] and the Week 54 corticosteroid-free remission rates [p = 0.007]. Accelerated IFX clearance occurs in corticosteroid-refractory acute UC and is associated with therapy failure. These data support the use of accelerated IFX induction regimens in patients with corticosteroid-refractory acute UC failing conventional dosing regimens.

Changes in Patient-Reported Outcomes With Vedolizumab Therapy in Patients With Inflammatory Bowel Diseases (IBD)

Introduction: Patient-reported outcomes (PROs) are important measures to assess response in patients with IBD. Vedolizumab (VDZ) is a gut-selective monoclonal antibody that specifically binds α 4β7 integrin and blocks gut lymphocyte trafficking, and is approved for use in moderate to severe Crohn's disease (CD) and ulcerative colitis (UC) patients who are naïve or have previously been exposed to tumor necrosis factor antagonists (anti-TNFs). Less is known about the real-world experience of patients on VDZ for changes in PROs. Methods: We performed a prospective cohort study investigating changes in PROs within the CCFA Partners cohort. All patients with CD or UC initiating VDZ from 2014 to present who had at least 6 months of follow-up were included. We stratified by biologic anti-TNF naïve (BN) or biologic anti-TNF exposed (BE) status. Outcomes included the short inflammatory bowel diseases questionnaire (SIBDQ); PRO measurement information system (PROMIS) assessing anxiety, depression, fatigue, social satisfaction, sleep disturbance, and pain interference; and the short CD activity index (sCDAI) as a measure of clinical remission. Bivariate analyses were performed to describe differences by BN or BE status; PRO changes were analyzed. Results: VDZ was initiated in 348 patients with CD and 169 with UC. The majority of CD (54%) and UC patients (65%) were managed in private practice settings (Table 1). A total of 20 (6%) CD patients and 32 (19%) UC patients were BN. CD patients who were BE had higher rates of prior surgery (67%) than BN patients (37%, p=0.01); BE UC patients had higher rates of prior hospitalization (72%) than BN patients (28%, p < 0.01). In the overall IBD population, corticosteroid-free remission (CSFR) rates as defined by sCDAI at 6-12 months improved from 20% to 45% in BN patients (difference 25%, p=0.03) vs improvement of 24% to 30% in BE patients (difference 6%, p=0.13). BN patients experienced greater improvements in PROs than BE patients, with significant improvement in social satisfaction (p=0.03) (Table 2). Multiple PRO domains met minimally clinically important differences at follow-up for BN patients.Table: No Caption availableTable: No Caption availableConclusion: VDZ was predominantly used in individuals with prior BE in this real-world cohort. CSFR rates and social satisfaction were significantly improved in BN patients after VDZ. Trends toward minimally clinically important differences in multiple additional PRO domains were also noted in BN patients.

P403 Golimumab therapy for ulcerative colitis – an Irish multicentre experience

Background: Golimumab (GLB) is a subcutaneous anti-tumour necrosis factor alpha (anti-TNF) therapy. Randomised controlled trials have demonstrated GLB efficacy in the induction and maintenance of remission in ulcerative colitis (UC). Data are few on the outcome of GLB therapy for UC in routine clinical practice. Aims: To describe the outcome of GLB therapy for UC in routine clinical practice in Ireland. Methods: Patients receiving GLB as therapy for UC were identified (n=77) from six Irish Medical centers. Only ambulatory outpatients, with 6 months of follow up post GLB initiation were included (n=69). Baseline clinical, demographic and laboratory data were collected. The primary endpoints were factors associated with durability of GLB response measured by time to drug discontinuation; 3-month clinical response; and 6-month corticosteroid free remission rates. Clinical response was defined as a decrease from baseline in partial Mayo score of at least 3 points and ongoing receipt of GLB. Clinical remission was defined as a partial Mayo score of less than or equal to 2 and continuing receipt of GLB. Secondary endpoints included rates of dose optimisation, dose intervention strategy and adverse events. Raw p values are reported with p values <0.006 (Bonferroni correction) considered significant Results: The study cohort comprised n=69 UC patients. Baseline characteristics were as follows (continuous variables, median [range]): Age 41.4 years [20.3–76.8]; 55% male; disease duration 6.5 years [0–29.9]; clinical Mayo subscore 6 [0–9]; proctitis, left-sided and extensive colitis in 8%, 54% and 38% respectively; baseline CRP 4.4 mg/L [0.2–134.6]; baseline albumin 42 g/L (16–51). Proportions on concomitant medications at GLB initiation were as follows: 5-aminosalicylate therapy 78%, concomitant immunomodulator 45%, systemic corticosteroids 40% (prednisolone dose, 35mg [5–40]). 36% of subjects were anti-TNF naive. Proportions receiving 50mg and 100mg 4-weekly maintenance regimes were 44% and 56% respectively. 3-month clinical response and 6-month corticosteroid free clinical remission rates were 42% and 42% respectively. 41% of patients required GLB dose optimisation (median [95% CI] time to dose optimisation: 6.5 months [1.4–11.6]); 44% dose increase and 56% interval shortening. Baseline CRP of ≥5mg/L is associated with a shorter time to GLB discontinuation, hazard ratio 3.1 (95% CI 1.4–6.7], p=0.005. Significant adverse events occurred in 3% of patients. Conclusions: These real world clinical data demonstrate GLB is an effective and safe induction and maintenance agent for UC. GLB dose optimisation is frequently required. A high baseline CRP, likely reflective of increased inflammatory burden, is associated with a less durable GLB response.

Efficacy of early immunomodulator therapy on the outcomes of Crohn's disease.

BackgroundThe natural course of Crohn’s disease (CD), with continuing relapses and remissions, leads to irreversible intestinal damage. Early adoption of immunomodulator therapy has been proposed in order to address this; however, it is still uncertain whether early immunomodulator therapy could affect the natural course of the disease in real practice. We evaluated the efficacy of such therapy on the prognosis of newly diagnosed patients with CD.MethodsThis retrospective study included 168 patients who were newly diagnosed with CD and who started treatment at Severance Hospital, Seoul, Korea between January 2006 and March 2013. The short- and long-term outcomes were compared between patients treated with early immunomodulator therapy and those treated with conventional therapy.ResultsA Kaplan-Meier analysis identified that administration of immunomodulators within 6 months after diagnosis of CD was superior to conventional therapy in terms of clinical remission and corticosteroid-free remission rates (P=0.043 and P=0.035). However, P=0.827). Patients with a baseline elevated CRP level were more likely to relapse (P<0.005). Drug-related adverse events were more frequent in the early immunomodulator therapy group than in the conventional therapy group P=0.029).ConclusionsEarly immunomodulator therapy was more effective than conventional therapy in inducing remission, but not in preventing relapse. Baseline high CRP level was a significant indicator of relapse.

Reductions in Corticosteroid Use in Patients with Ulcerative Colitis or Crohnʼs Disease Treated with Vedolizumab

Purpose: Long-term corticosteroid use in ulcerative colitis (UC) and Crohn's disease (CD) leads to adverse effects/dependence. The effect of vedolizumab (VDZ), an anti-α4β7 integrin antibody, on corticosteroid reduction has been studied in UC and CD patients (pts). Methods: In two phase 3 studies (GEMINI I [UC] and II [CD]), pts received placebo (PB) or VDZ 300 mg intravenously during induction (weeks 0 and 2) and maintenance (weeks 6-52, every 8 or 4 weeks [Q8W/Q4W]). Pts on corticosteroids at week 0 with a clinical response at week 6 began corticosteroid tapering at week 6. Week 52 corticosteroid-free remission rates (prespecified) and associations between week 6 end points and week 52 corticosteroid-free remission (post hoc) were assessed. Results: In the UC trial, VDZ Q8W and Q4W led to significantly greater week 52 corticosteroid-free remission rates and decreased corticosteroid use for up to 180 d than did PB. Of pts in week 6 remission, significantly more in the VDZ Q4W group than the PB group had corticosteroid-free week 52 remission. In pts with week 6 mucosal healing, week 52 corticosteroid-free remission rates were significantly higher with VDZ Q8W and Q4W than PB. In the CD trial, VDZ also led to significantly greater week 52 corticosteroid-free remission rates (Q8W, Q4W) and decreased corticosteroid use for up to 180 d (Q8W) than did PB. In CD pts in week 6 clinical remission, no significant differences from PB in VDZ week 52 corticosteroid-free remission rates were seen. Conclusion: VDZ treatment led to corticosteroid-free remission in UC and CD patients. Future studies are needed to confirm whether 6-week clinical remissions and/or mucosal healing are predictive of 52-week steroid-free remissions. This research was funded by Millennium Pharmaceuticals, Inc., a Takeda Company, Cambridge, MA. Disclosure - B. Sands - Financial support for research from: Takeda Pharmaceuticals, Abbott Immunology, Janssen Biotech, Celgene, Pfizer, UCB, GlaxoSmithKline, Prometheus Laboratories, Lecture fee(s) from: Mechanisms in Medicine, Creative Educational Concepts, Curatio CME, IMEDEX, Consultancy for: Takeda Pharmaceuticals, Abbott Immunology, Amgen, Astellas Pharmaceutical Global Development, Avaxia Biologics, Axcan Pharmaceuticals, Biogen Idec, Bristol-Myers Squibb, Janssen Biotech, Chandler Chicco Agency, Cornerstones, Emmi Solutions, Elan Pharmaceuticals, Merrimack Pharmaceuticals, Pfizer, Prometheus Laboratories, Kyowa Hakko Kirin Pharma Inc, Vertex Pharmaceuticals, Strategic Consultants International, Dyax, GlaxoSmithKline, Puretech Ventures, Novartis, Baxter Healthcare Corporation, Dainippon Sumitomo Pharm Co, Immune Pharmaceuticals Corporation, Teva Pharmaceuticals, Shareholder of: Avaxia Biologics; S. Hanauer - Financial support for research from: Millennium Pharmaceuticals, Consultancy for: Takeda Pharmaceuticals, Millennium Pharmaceuticals; J.-F. Colombel - Financial support for research from: Ferring, MSD, Abbott Laboratories, Lecture fee(s) from: Abbott Laboratories, Centocor, Ferring, Given Imaging, Shire, MSD, UCB Pharmaceuticals, Tillotts, Consultancy for: Takeda Pharmaceuticals, Abbott Laboratories, Amgen, Biogen Idec Inc, Boehringer-Ingelheim, Bristol-Myers Squibb, Cellerix SL, Chemocentryx Inc, Centocor, Cosmo Technologies, Elan Pharmaceuticals, Genentech, Giuliani, Given Imaging, GlaxoSmithKline, Hospira, Immune Pharmaceuticals, MSD, Neovacs, Ocera Therapeutics, Pfizer, Prometheus, Shire Pharmaceuticals, Synta Pharmaceuticals, Teva Pharmaceuticals, Therakos, UCB Pharmaceuticals, TXCell, Wyeth, Shareholder of: Intestinal Biotech Development, Other: Takeda Pharmaceuticals, Schering-Plough; S. Danese - Lecture fee(s) from: Vifor Pharma, MSD, Consultancy for: Ferring, Takeda Pharmaceuticals, Abbott, MSD, Vifor Pharma, Novo Nordisk, AstraZeneca, UCB, Pfizer; M. Abreu - Consultancy for: Abbott Laboratories, Bristol-Myers Squibb, Hospira, Merck, Pfizer, Sanofi-Aventis, UCB; V. Ahuja - None Declared; T. Ponich - None Declared; I. Hilmi - None Declared; S. Sankoh - Employee: Millennium Pharmaceuticals; M. Smyth - Shareholder of: Takeda Global Research & Development Centre, Employee: Takeda Global Research & Development Centre, B. Abhyankar - Shareholder of: Takeda Global Research & Development Centre, Employee: Takeda Global Research & Development Centre; I. Fox - Shareholder of: Millennium Pharmaceuticals, Employee: Millennium Pharmaceuticals; B. Feagan - Financial support for research from: Takeda Pharmaceuticals, Lecture fee(s) from: Johnson and Johnson, Abbott Laboratories, UCB, Shire, Consultancy for: Takeda Pharmaceuticals, Johnson and Johnson, Centocor, Elan/Biogen, Bristol-Myers Squibb, Celgene, CombinatoRx, UCB Pharma, Napo Pharma, Abbott Laboratories, Procter and Gamble, Berlex, Ore Pharmaceuticals, Cerimon Pharma, Genentech, Tillotts, Unity Pharmaceuticals, Albireo Pharma, Salix Pharma, Novo Nordisk, GSK, Astra Zeneca, Serono, Given Imaging Inc, Actogenix, Prometheus Therapeutics and Diagnostics, Athersys, Axcan, Gilead, Nektar, Pfizer, Shire, Wyeth, Zealand Pharma, Zyngenia, GICare Pharma, Sigmoid Pharma. This research was supported by an industry grant from Millennium Pharmaceuticals, Inc, a Takeda Company.Table