Abstract Background Acute Severe Ulcerative Colitis (ASUC) is a medical emergency, with limited therapeutic options available for medical management. Tofacitinib and Upadacitinib are novel Janus Kinase inhibitors (JAKi), with proven efficacy for ulcerative colitis (UC). This study aimed to examine the outcomes of patients treated with JAKi for ASUC in a real-world population. Methods A retrospective multi-centre study was conducted including patients (≥18 years) with ASUC commenced on Tofacitinib or Upadacitinib from April 2021 to April 2024. ASUC was defined according to Truelove and Witt’s criteria. Demographic and clinical data were recorded at admission, JAK induction, discharge, week 8, week 16 and 1 year post-induction. The primary outcome was need for colectomy. We further evaluated adverse events and drug-specific response. Results A total of 124 patients were included from 11 Australian Inflammatory Bowel Disease (IBD) centers. Tofacitinib was used in 49%, while Upadacitnib was used in the remainder. 58% of patients received JAKi as first line salvage therapy, while the remainder received JAKi sequentially after failure of first line infliximab therapy. The rate of colectomy during admission was 17% and 40% by 1 year. There was no significant difference between rate of colectomy during index admission (p=0.38), or 1 year post induction (p=0.24) between Tofacitinib and Upadacitinib. There was a significantly increased risk of inpatient colectomy for those receiving sequential salvage compared to initial JAKi salvage (p=<0.01). However, there was no significant difference in the rate of colectomy in either cohort up to 1 year post induction (p=0.19). Clinical response was observed in 45% of patients by day 3 of induction and 65% by day 7. Clinical remission rates were 40% by week 8 and 65% by week 16. Biochemical remission was achieved in 51% by week 16. Mucosal healing was achieved in 47% of patients who underwent repeat endoscopy within 16 weeks of induction. Adverse events occurred in 16% of patients, all of which were minor and did not require hospitalisation. The most common events noted were acne (7%) and nasopharyngitis (6%). Conclusion Jaki demonstrate effectiveness and safety for the management of ASUC. There was no significant difference in the inpatient colectomy rate between Tofacitinib and Upadacitinib. There was a significantly higher rate of inpatient colectomy for patients requiring sequential salvage therapy, but no significance when patients were followed up to 1 year. There is variability in prescribing practice between dosage of Tofacitinib and Upadacitinib, duration and dosage of corticosteroid wean, and the use of prophylactic PJP and VTE prophylaxis.

Abstract Background The treatment paradigm for Acute Severe Ulcerative Colitis (ASUC) continues to evolve in the era of biologics and small molecules, with corticosteroids forming the initial foundation of treatment. A significant proportion of patients fail to improve on corticosteroid therapy alone1 and are at subsequent risk of colectomy, requiring treatment escalation. We applied the recently developed ADMIT-ASC2 model to an Australian cohort of ASUC patients to further validate its role in predicting steroid failure. Methods 158 admissions (147 patients) that met the modified Truelove and Witts’ criteria for ASUC between 2016-2023 at a Western Australian tertiary hospital were retrospectively analysed. The previously described ADMIT-ASC model was applied to our cohort: CRP ≥100mg/L (1 point), albumin ≤25g/L (1 point), UCEIS ≥4 (1 point) or ≥7 (2 points). Baseline patient data including demographic, disease characteristics, and prior treatment information were collected. Steroid-failure was defined as requiring a lack of clinical improvement (defined by the Oxford Criteria) necessitating medical rescue therapy or surgery. Results In our cohort, 158 admissions for ASUC were analysed and 46 (29%) patients were new diagnoses of ulcerative colitis at the time of admission. Of those, 99 patients (62.7%) received medical rescue therapy (95% infliximab, 4% tofacitinib, 1% cyclosporine). Twenty-two (13.9%) patients underwent a colectomy within 30 days and an additional 12 (7.6%) required colectomy within 12 months of discharge. The ADMIT-ASC score was applied to our cohort. A score of ≥3 yielded a 94.1% positive predictive value for steroid failure (OR 9.56). A score of 0 predicted steroid response in 100% of the cohort. The baseline characteristics of the steroid responsive and non-steroid responsive groups are shown in Table 1. Conclusion The ADMIT-ASC score provides a simple scoring system available from initial endoscopic and biochemical evaluation. Increased utilisation of this validated tool potentially allows for day 1 prediction of patients at high risk of steroid failure to prompt earlier treatment escalation to advanced therapies. References [1]Adams, A., Gupta, V., Mohsen, W., Chapman, T. P., Subhaharan, D., Ramaswamy, P. K., ... & Satsangi, J. (2023). Early management of acute severe UC in the biologics era: development and international validation of a prognostic clinical index to predict steroid response. Gut, 72(3), 433-442.Chicago [2]Ho, G. T., Mowat, C., Goddard, C. J. R., Fennell, J. M., Shah, N. B., Prescott, R. J., & Satsangi, J. (2004). Predicting the outcome of severe ulcerative colitis: development of a novel risk score to aid early selection of patients for second-line medical therapy or surgery. Alimentary pharmacology & therapeutics, 19(10), 1079-1087.

Abstract Background Upadacitinib (UPA), an oral Janus kinase inhibitor approved for the treatment of moderately to severely active Crohn’s disease (CD), has demonstrated the ability to provide rapid symptom relief within the first week of induction treatment in patients with CD.1 As symptomatic remission is critical for patients, this phase 3 post hoc analysis evaluated the impact of UPA on patient-reported outcomes (PROs) of abdominal pain score (APS) and stool frequency (SF) over the full induction and maintenance time periods. Methods Data were pooled from the U-EXCEL (NCT03345849) and U-EXCEED (NCT03345836) induction studies evaluating patients with moderately to severely active CD with an average daily APS ≥ 2 and/or SF ≥ 4 and received UPA 45 mg (UPA45) once daily (QD) or PBO for 12 weeks. Patients who achieved clinical response to 12 weeks of UPA45 induction were re-randomised in a maintenance study (U-ENDURE, NCT03345823) to receive UPA 15 mg (UPA15) QD, UPA 30 mg (UPA30) QD, or PBO for 52 weeks. APS and SF were recorded in a daily diary and evaluated over time. Results The average daily APS (mean: PBO 1.9, UPA45 1.9) and SF (mean: PBO 5.6, UPA45 5.4), were similar between the treatment groups at induction baseline (BL). Of patients reporting BL APS ≥ 1 (PBO 91.6%, UPA45 92.4%) or BL SF ≥ 2.8 (PBO 85.6%, UPA45 85.2%), higher proportions of patients receiving UPA vs PBO achieved APS = 0 or SF ≤ 1, or complete resolution of symptoms (APS = 0 and SF ≤ 1) at week 12 of induction, as well as at week 52 of maintenance (all P ≤ .001; Figure 1A). During induction, the mean change from BL in APS and SF was improved with UPA45 vs PBO starting at week 2 through to week 12 (all P < .001; Figure 1B-C). Throughout the 52-week maintenance period, a higher proportion of patients receiving UPA15 or UPA30 achieved APS ≤ 1 or SF ≤2.8 vs PBO (Figure 1B-C). Patients treated with UPA30 demonstrated a numerically higher rate of symptomatic response vs UPA15. In patients who met the Crohn's Disease Activity Index (CDAI) criteria per US labeling (CDAI ≥ 220 at induction BL; clinical response [CR-100] at week 12 with UPA45),2 comparable symptom improvements were observed over time compared to the overall study population. Conclusion Patients with moderately to severely active CD demonstrated improvements in APS and SF as early as 2 weeks after UPA induction treatment. A greater proportion of patients achieved PRO-defined remission within 12 weeks of UPA induction treatment compared with PBO, which were sustained through week 52 of UPA maintenance treatment. References: 1. Colombel, J. F. et al. J. Crohn’s Colitis. 2023;17;i102–3 2. AbbVie Inc. RINVOQ® (upadacitinib) [Package Insert]. N. Chicago, Ill.: AbbVie Inc., 2023

Abstract Background Ustekinumab (UST) is a monoclonal antibody targeting IL-12 and IL-23 through their shared p40 subunit. This study aimed to determine the clinical outcomes after UST treatment in Crohn’s disease (CD) patients in a real-world setting, and to investigate the association of clinical outcomes with IL-12, IL-23 and UST levels. Methods A multi-centre prospective observational cohort study of UST for moderate to severe CD was conducted. Patients were recruited from 19 Australian centres between Sep 2019 and Apr 2022. Clinical assessments were performed at baseline study visit (SV) 1 and post-induction (SV2). Patients were assessed every 6 months during maintenance therapy to 18 months (SV4). Clinical response and remission rates were determined using PRO2 definitions (STRIDE II guidelines). Logistic regression analyses were performed to identify predictors of clinical response and remission. UST levels were measured post induction and interleukin levels including IL12p40 and IL-23p19 were measured at SV1 and SV2 using ProQuantum ELISA assays. Results A total of 198 patients were recruited: median age 40.7 years, 54.3% male, median duration of disease 90.5 months, 12.8% active smokers, and 49.7% on concomitant immunomodulatory therapy. The majority (58.4%) were biologic-naïve and 82 patients were previously exposed to biologics (51.9%; IFX n=42, ADA n=50, VDZ n=9). Clinical response was achieved in 137 patients (75.7%), and remission in 84 (46.4%) with higher rates of response (85.2% vs 61.6%, p=0.001) and remission (54.6% vs 34.2%, p=0.006) in biologic naïve patients compared to biologic-exposed. For the 114 patients with 18 months (SV4) of follow-up, durable clinical response was maintained in 66.8% and remission in 50.0%. Dose escalation (90mg 4 weekly) was administered to 13 patients (6.6%) during induction, 48 (42.1%) in maintenance, and 15 patients (13.2%) received IV re-induction during maintenance. There was a significant reduction in IL-12 and IL-23 levels from SV1 to SV2 in responders (p=0.0001), but no significant reduction in non-responders (Figure 1). Clinical response at SV4 (n=101) was associated with higher post-induction UST levels (p=0.03) (Table 1). The combination of IL-12. IL-23 and UST level at SV2 predicted long-term response at SV4 (Sn 73%, Sp 71%, AUROC 0.765), but not at SV2 (Figure 2). Conclusion This large real-world study confirms that UST is most effective in bio-naïve CD patients with significantly higher response and remission rates than bio-experienced patients. The combination of post-induction IL-12, IL-23, and UST levels was associated with response at 18 months and could represent a novel predictor of long-term clinical outcomes.

Abstract Background Gastrointestinal ultrasound (GIUS) can accurately assess disease activity in atients with ulcerative colitis (UC). The aim of this study was to determine the accuracy of GIUS in predicting IV corticosteroid (CS) failure in patients with Acute Severe Ulcerative Colitis (ASUC) and the requirement for rescue therapy. Methods We conducted a multi-centre prospective observational cohort study of adult ASUC admitted to hospital between November 2019 to July 2022. GIUS was performed at six time points for each patient: at hospital admission (SV1), day 3 (SV2), at discharge (SV3), and thereafter during outpatient review in the 10 months of follow-up. Medical rescue therapy was given at the discretion of treating physician according to best clinical practice. Results A total of 32 consecutive patients with ASUC were recruited with a median follow-up duration of 8.9 months: median age 32 years, 38% male and median duration of disease 19 months. Seven patients had newly diagnosed UC and six patients (19%) were biologic experienced. Sixteen patients (50%) were CS responders and the remainder required medical rescue therapy; two patients required colectomy. The median time to rescue therapy and colectomy was 3.5 and 11 days from admission, respectively. At SV1, the median BWT of the worst affected segment was similar between CS responders and non-responders (5.50mm vs 5.85mm, p=0.66), however at SV2, responders had a significantly lower BWT (3.85mm vs 5.05mm, p=0.02). CS responders demonstrated a significant reduction in width of the muscularis propria (p=0.02) and submucosal (p=0.006) layer, but not the mucosal (p=0.61) layer (Figure 1). CS non-responders had a smaller absolute and relative reduction in median BWT at SV2. Receiver operating characteristic curve analysis showed that an absolute reduction of <1.40mm (Sn 63%, Sp 75%, AUROC 0.76) or a relative BWT reduction of <20% (Sn 81%, Sp 75%, AUROC 0.78) predicted CS non-response and need for rescue therapy well. A reduction in BWT and the absence of doppler activity at SV2 further enhanced the predictive capability of GIUS (Sn 81.3%, Sp 87.5%, AUROC 0.91) (Figure 2). Conclusion This study demonstrates the predictive utility of early GIUS in the management of ASUC. A reduction in absolute BWT of <1.40mm or relative BWT of <20% at 36-48 hours of admission identifies CS non-responders with good sensitivity and specificity. BWT reduction at SV2 in responders was driven mainly by decreased muscularis propria and submucosal thickness. Accuracy is further augmented when reduction in BWT and resolution of doppler signal are combined. This study suggests GIUS may allow clinicians to expedite initiation of rescue therapy for patients requiring salvage treatment.

Abstract Background Switching patients with inflammatory bowel disease (IBD) from originator to biosimilar infliximab has been demonstrated to be non-inferior to continuing originator infliximab by several studies. However, data comparing treatment outcomes beyond 12-months across switch and non-switch cohorts specific to IBD patients remains comparatively underreported. Here we report long-term (>48 weeks) treatment outcomes of the SAME study, a large-scale parallel cohort study of Australian IBD patients who underwent non-medical switching from originator to biosimilar (CT-P13) (n=204) or continued originator infliximab (n=141). Methods The SAME study was a multi-centre, prospective parallel cohort non-inferiority study across seven Australian hospitals over 48 weeks undertaken between May 2017 to October 2019. The data that we present here is the long-term extension study, obtained retrospectively, which sought to compare long-term infliximab persistence beyond 48 weeks across switch and non-switch cohorts. This study included five of the original seven sites, three of which switched from originator to biosimilar infliximab. The primary outcome was infliximab persistence, defined as the proportion of originator or biosimilar infliximab treated patients from the original cohort at last follow up. Secondary outcomes included disease worsening requiring infliximab dose escalation or discontinuation, rates of adverse events, and development of antibodies to infliximab (>10ng/mL). Results Data from 263 (90 Ulcerative colitis and 173 Crohn’s disease) of 345 (76%) patients enrolled in the original SAME study were included with median follow up of 54.2 months (IQR 46.1-59.3). At last follow-up, 103 (65.5%) and 68 (64.2%) patients across the switch and non-switch cohorts (p = 0.8) remained on infliximab. There were no differences in the proportions that discontinued infliximab due to clinical or biochemical worsening of disease (21.7 v 23.6%, p = 0.72); required infliximab dose escalation (35.2 v 32.4%, p=0.8); developed antibodies to infliximab (5.3 vs 11.3%, p = 0.09) or experienced drug related adverse events (7.8 vs 8.3%, p = 0.8) between switch and non-switch cohorts, at last follow-up. Conclusion Long-term infliximab persistence was similar between switch and non-switch cohorts after a median of 54 months. This study represent one of the longest ‘real-world’ comparisons between switch and non-switch cohorts specific to IBD, and should provide reassurance to clinicians and patients alike.

Abstract Background Higher anti-tumour necrosis factor-α (TNF) drug levels are associated with improved clinical fistula healing and closure in perianal fistulising Crohn’s disease (pfCD). It is hypothesised that higher drug levels will lead to improved healing on magnetic resonance imaging (MRI); but this is yet to be established. This study evaluated the association between anti-TNF drug levels and radiological outcomes in pfCD. Methods A multi-centre retrospective study (FISCAL), across 10 ANZ Inflammatory Bowel Disease Consortium sites. Patients with pfCD on stable maintenance dosing of infliximab or adalimumab, with drug levels within 6-months of a pelvic MRI from 2010 to 2020 were included. Patients receiving perianal fistula surgery between drug level and MRI were excluded. MRI disease activity was scored using the Van Assche Index (VAI), with an inflammatory sub-score (VAIinfl) derived from the VAI indices: hyperintensity on T2-weighted images, collections >3mm diameter, and rectal wall involvement. Primary endpoint was radiological healing (VAIinfl≤6). Secondary endpoint was radiological remission (VAIinfl=0). Drug level tertiles were correlated to changes in VAIinfl scores. ROC analyses were used to identify optimal target drug levels. Results Of 193 patients (infliximab, n=117; adalimumab, n=76), radiological healing was achieved in 47.0 and 44.7% and radiological remission in 17.1 and 15.8% of patients receiving infliximab and adalimumab, respectively. Patients with radiological healing had higher median drug levels compared to those with radiologically active disease (infliximab 6.0 vs 3.9µg/mL, P=0.03; adalimumab 9.1 vs 6.2µg/mL, P=0.02). Patients with radiological remission had higher median drug levels compared to those with radiologically active disease (infliximab 7.4 vs 3.9µg/mL, P<0.01; adalimumab 9.8 vs 6.2µg/mL, P=0.07). There was a significant incremental reduction in median VAIinfl with higher anti-TNF drug level tertiles, shown in Figure 1. By ROC analyses, the optimal trough infliximab levels for radiological healing and remission were 4.0µg/mL (sensitivity 69.1%, specificity 45.2%, AUC 0.62, P=0.03) and 6.5µg/mL (sensitivity 60.0%, specificity 72.2%, AUC 0.67, P=0.02), respectively. The optimal adalimumab levels for radiological healing and remission were 7.2µg/mL (sensitivity 67.6%, specificity 59.5%, AUC 0.65, P=0.03) and 9.7µg/mL (sensitivity 58.0%, specificity 70.0%, AUC 0.62, P=0.20), respectively. Conclusion In the largest study of its kind, higher anti-TNF drug levels were associated with improved MRI parameters as per the VAI in patients with pfCD; with an incremental improvement in MRI outcomes at higher anti-TNF drug level tertiles for both infliximab and adalimumab. Replication in prospective studies are awaited.

Abstract Background A high body mass index (BMI) is known to adversely affect anti-TNFα trough levels and secondary loss of response (SLOR); however, the literature is scarce in defining what aspect of body mass determine these outcomes. We hypothesise that a large visceral fat area is associated with a lower anti-TNFα level and a higher rate of SLOR. Our aim was to determine the impact of fat and muscle compartment areas on these outcomes. Methods Crohn’s disease (CD) patients who were prescribed standard doses of an anti-TNFα agent [5 mg/kg, 8 weekly infliximab (IFX) or 40 mg EOW of adalimumab (ADA)] from 1 February 2015 to 30 June 2018 were examined retrospectively. Primary responders with a minimum therapy duration of 12 weeks, at least 12 months of follow-up and a trough level within 6 months of a CT or MRI, were eligible for inclusion. The primary outcome was the trough level and the secondary outcome was time to SLOR, defined as a need to dose escalate, change out of class, requiring ≥3 courses of corticosteroids in a 12-month period, or surgery. Patients were followed until they met a SLOR or the census date of 30 June 2019. Visceral fat area (VFA), subcutaneous fat area (SFA) and skeletal muscle area (SMA) were measured on the CT/MRI at the L3 vertebral level in cm2 by a radiologist blinded to the clinical outcome and corrected for patient height (cm2/m2). Results Of 813 patients prescribed an anti-TNFα agent in the study period, data from 69 eligible CD patients were included for analysis. The median age was 43.5 ± 16.2 years, and 42 (60.9%) were males. Forty-four (63.8%) and 25 (36.2%) patients were treated with IFX and ADA respectively. The mean BMI was 26.9 ± 5.2. Univariate analysis of infliximab trough levels found that total fat area, VFA, visceral fat index [VFI (VFA/height in m2)] and VFA/SMA ratio were inversely correlated with anti-TNFα trough level (p < 0.05). No association was found between ADA trough level and muscle/fat areas. After multivariate adjustment for CRP, albumin, presence of antibodies, concurrent immunomodulator use and gender, IFX levels were inversely associated with VFA [-0.021 (−0.038, −0.003) p = 0.025], VFI [−0.066 (−0.119, −0.013) p = 0.016] and VFA/SMA [−3.805 (−7.132, −0.477) p = 0.026] but not BMI [−0.232 (−0.520, 0.055) p = 0.11). No association was found for ADA trough levels. Kaplan–Meir analyses showed a trend towards a shorter time to SLOR with an increasing tertile of VFI in both IFX and ADA treated patients. Conclusion Visceral fat area corrected for height (VFI) is a better determinant of anti-TNFα trough levels and SLOR than BMI.

Stricturing Crohn’s disease (CD) is associated with significant morbidity and high rates of surgery with anastomotic strictures commonly occurring after surgery. Endoscopic balloon dilatation (EBD) may avoid or delay operative management of strictures. A retrospective audit of CD patients undergoing EBD was conducted at 11 hospitals across Australia and New Zealand. Local, prospectively maintained patient databases and procedure records were used to identify cases from June 1999 to October 2018. A stricture was defined as a narrow segment of intestine unable to be traversed with a colonoscope. Stricture length (long ≥4 cm, short <4 cm), location (ileal, ileocolonic, colonic, anorectal) and type (anastomotic vs. de novo) were collected from endoscopy reports. Dates of surgeries and follow-up were obtained from medical records. Technical success was defined as the ability to traverse the stricture following dilatation. Baseline smoking status, Montreal phenotype and medications for CD were also documented. A total of 236 patients with stricturing CD were identified (120 male, median age 48 [IQR: 10], 29% ileal, 12% colonic, 59% ileocolonic). A total of 620 dilatation procedures (303 for anastomotic strictures, 312 for de novo strictures, 5 unknown) were performed (median 2 per patient) with 428 (69%) on short strictures, 109 (18%) on long strictures, and 83 (13%) of unknown length. Balloon dilation diameter was 8 mm–20 mm (median 15 mm). Technical success was achieved in 433 (84%) of dilatations, and was significantly higher for short vs. long strictures (93% vs. 66%, p < 0.001). Technical success was lower in ileal strictures (72%) than colonic or ileocolonic strictures (89% and 85%, respectively, p = 0.002). End-to-end anastomosis had a numerically higher success rate (85% vs. 75%, p = 0.19). During the median follow-up time from first EBD to last review or surgery (50 months, [IQR: 30]), 55 patients (23%) required surgery for stricturing CD post-dilatation. The median time to surgery following the last dilatation was 8 months (range 0–90 months). Complications of EBD included 3 cases of perforation and two cases of aspiration. There was no major bleeding or procedure-related mortality identified. In one of the largest analyses of EBD for CD strictures, EBD is found to be a safe procedure with a high technical success rate overall. The highest success was observed in strictures less than 4 cm in length and non-ileal in location. EBD may be an effective strategy for avoiding surgery in stricturing Crohn’s disease and post-operative anastomotic strictures.

BackgroundEarly postoperative endoscopic recurrence (EPER)within the first year after a Crohn's disease (CD) resection can be as high as 90%. Established risk factors include smoking, previous resections, perforating disease, extent of resection and the presence of myenteric plexitis. Equivocal data exist, however, on the impact that the type of surgical anastomosis or the early use of medical prophylaxis has on the incidence of EPER. Our primary aim was to evaluate whether the type of anastomosis and the early use of biologic/immunosuppressant modified the risk of developing EPER.

In GEMINI 1, UC response to vedolizumab (VDZ) was 47% at Week 6 and 42% by Week 52. Our aim was to assess real-life outcomes for VDZ in UC. Data collected at 12 Australian (Aus), 1 UK and 2 Hong Kong (HK) centres, assessed response to VDZ at 3, 6, and 12 months using the Mayo Clinic Score (MCS, Aus/HK) or SCCAI and UCEIS (UK). Two hundred and ninety-three patients (53% male, median age 38 years, 196 Aus, 93 UK, 4 HK) were assessed with similar age, disease location and duration allowing combining of data. Median MCS pre VDZ was 8 (range 2–12, n = 152) and Mayo endoscopy subscore 2 of 3 (Aus, HK). Median SCCAI was 8 (range 0–13, n = 87) and UCEIS 5 of 8 (UK). VDZ was the first biological agent in 170 of 293 (58%), prior anti-TNF use occurred in 123 [reason for switching: primary non-response (PNR) n = 46, loss of response (LOR) n = 62, side-effects (SE) n = 15; two patients with side-effects were in remission and not included for analysis]. At VDZ start, 61% taking steroids and 56% immunomodulation (IM). Response rates at 3 months: 220 of 279 (79%) overall responded, TNF-naïve 134 of 163 (82%), TNF-exposed 86 of 116 (74% p = NS). Remission rates at 3 months: 155 of 279 (55%) in clinical remission, TNF-naïve 110 of 163 (67%), TNF-exposed 45 of 116 (39%, p = 0.01). 60 of 132 (45%) patients in remission were on IM and 49 of 101 (49%) if not (NS). Six months: Overall 144 of 235 (61%) in clinical remission, TNF-naïve 97 of 131 (74%), TNF-exposed 47 of 104 (45%, p = 0.03), and 60 of 124 (48%) in endoscopic remission (MES = 0 or 1). Steroids were ceased in 61 of 136 (45%) if in remission and 23 of 85 (27%) if not (p = 0.08). 39% (49 of 125) patients in remission were on IM and 29% (24 of 82) if not (NS). 12 months: Overall 117 of 196 (60%) were in remission, TNF-naïve 72 of 106 (68%), TNF-exposed 45 of 90 (50%, NS). No significant difference in remission rates seen between PNR, LOR, or anti-TNF naïve patients. Steroids ceased in 55 of 110 (50%) if in remission and 6 of 80 (8%) if not (p < 0.001). Thirty-seven of 104 (36%) patients in remission were on IM and 13 of 78 (17%, p = 0.03) if not. Those in remission at 3 and 6 months, 90% (74 of 82) and 92% (96 of 104), respectively maintained remission. Smoking status did not affect response to VDZ. Colectomy occurred in 33 of 293 (11%). Adverse events occurred in 20 of 293 (7%); 2 were serious (Klebsiella sepsis and hemophagocytic syndrome). VDZ induced remission in 55% at 3 months and 61% at 6 months with >90% maintaining remission at 12 months. VDZ use continued for 12 months in 71% (139 of 196) with 61% in remission. Steroids were withdrawn in 50% patients in remission at 12 months. IMs might increase remission rates at 12 months. VDZ was initially more effective in anti-TNF naïve patients but differences were lost at 12 months suggesting patience may be needed in anti-TNF-exposed patients.