Long-term symptomatic, clinical response/remission, endoscopic, and histologic data from an open-label study of patients with moderately-to-severely active ulcerative colitis demonstrate that 3-year continuous treatment with mirikizumab maintained clinical remission in most induction clinical responders, regardless of previous biologic failure status.

Background:Improvement in bowel urgency (BU) was associated with better clinical outcomes in phase 3 LUCENT-1 (induction) and LUCENT-2 (maintenance) studies in moderately-to-severely active ulcerative colitis (UC). We assessed association of BU with quality-of-life (QoL) outcomes. Methods:LUCENT-1: 1162 patients randomized 3:1 to intravenous mirikizumab 300 mg or placebo every 4 weeks (Q4W) for 12 weeks. LUCENT-2: 544 mirikizumab induction responders re-randomized 2:1 to subcutaneous mirikizumab 200 mg or placebo Q4W through Week (W) 40 (W52 of continuous treatment). Patients reported BU severity in the past 24 hours using a validated Urgency Numeric Rating Scale (NRS). In patients with baseline Urgency NRS ≥3, the association between BU Clinically Meaningful Improvement (CMI; ≥3-point decrease) and remission (score 0 or 1) with patient-reported outcomes was assessed at W12 and W52. Results:A significantly greater proportion of patients with versus without BU Remission achieved IBDQ remission (W12: 87.3% vs 42.7%, P < .0001; W52: 91.4% vs 45.5%, p < .0001). Similarly, BU Remission was associated with more patients achieving CMI in SF-36 Physical Component Summary (W12: 69.0% vs 44.4%, P < .0001; W52: 77.5% vs 42.1%, P < .0001) and Mental Component Summary (W12: 53.5% vs 41.0%, P = .0019; W52: 62.0% vs 38.3%, P < .0001) scores. At W12 and W52, patients with BU CMI or Remission showed significant improvements in EQ-5D-5L and Work Productivity and Activity Impairment:UC scores. Significant improvements were also seen in fatigue, abdominal pain, and nocturnal stool. Conclusions:In patients with moderately-to-severely active UC, improvement in BU was associated with improved QoL in phase 3 LUCENT-1 and LUCENT-2 studies. Clinical Studies:LUCENT-1: NCT03518086; LUCENT-2: NCT03524092.

BACKGROUND:Efficacy and safety of mirikizumab, a p19-targeted anti-interleukin-23 monoclonal antibody, for moderately to severely active ulcerative colitis was demonstrated previously. We evaluated clinical response, baseline characteristics, and clinical status in patients not responding by 12 weeks (W) of induction who then received extended induction treatment. METHOD:Patients unresponsive to 300 mg of intravenous (IV) mirikizumab every 4 weeks by W12 received 3 additional 300 mg IV doses every 4 weeks. Week-4 responders received 200 mg mirikizumab every 4 weeks subcutaneously until W52. Patients responding by W12 but subsequently losing response received rescue therapy with 300 mg IV for 3 doses every 4 weeks. Logistic regression modelling was performed for patients not achieving W12 clinical response to assess baseline characteristics and W12 efficacy parameters and potential prognostic factors of clinical response at W24. RESULTS:Of patients not achieving clinical response during induction, 53.7% achieved response following extended induction. After 52W, 72.2%, 43.1%, and 36.1% of patients achieved clinical response, endoscopic, and clinical remission, respectively. Of induction responders who subsequently lost response, 63.2% and 36.8% achieved symptomatic response and remission, respectively, after receiving rescue therapy No prior biologic or tofacitinib treatment, no immunomodulators at baseline, age older than 40 years, and W12 modified Mayo Score improvement were positively associated with a response to extended induction. The safety profile was similar to initial induction, with 38.3% treatment emergent adverse events, mostly mild. CONCLUSION:With "extended induction," total of 80.3% mirikizumab-treated patients achieved clinical response by W24. Potential prognostic factors determining response include disease severity, disease phenotype, C-reactive protein, and previous biologic therapy.

Introduction: Bowel urgency (BU) is a common symptom reported by patients with ulcerative colitis (UC) and Crohn’s disease (CD) and has been shown to negatively impact patients’ emotional, psychological, and social functioning. The current study was designed to provide insight into real-world experiences and perspectives around the management of UC and CD by healthcare professionals (HCPs), including how they assess BU in clinical practice. Methods: This was a cross-sectional, web-based survey among HCPs who manage patients with UC and CD in the United States. The sample included 100 gastroenterologists (GIs); 154 family or internal medicine or primary care physicians (FM/IM/PCPs); 101 physician assistants (PAs); and 104 nurse practitioners (NPs) recruited through a national HCP panel. Data were collected from November 21, 2022, through December 6, 2022. The survey included a question about how HCPs currently assess BU in practice; a description of the Urgency Numeric Rating Scale (UNRS), a validated 11-point scale where 0 = no urgency and 10 = worst possible urgency; and an assessment of HCPs’ willingness to use the UNRS in clinical practice. Results: Among 459 HCP participants (Table 1), 51% reported that they ask patients a yes/no question to assess BU, 23% use the UNRS, 14% use a different measure, and 12% do not use any measure. Current use of the UNRS was higher among PAs (29%) and FM/IM/PCPs (27%) than NPs (19%) and GIs (14%) (Figure 1). Among those who indicated that they use a different measure (n = 66), 46% use the UC Patient-Reported Outcomes Signs and Symptoms (UC-PRO/SS), 39% use the Symptoms and Impacts Questionnaire for CD or UC (SIQ-CD or SIQ-UC), and 26% use the Simple Clinical Colitis Activity Index (SCCAI). On a 5-point scale, of those not using the UNRS (n = 354), 89% were somewhat, very, or extremely willing to use it (Figure 1). There were differences by specialty. Conclusion: Given the negative impact of BU on patients’ quality of life, it is important for HCPs to fully assess BU when managing patients with UC and CD. The UNRS is a single-item question that offers HCPs a better understanding of the current severity of a patient’s BU rather than asking a dichotomous yes/no question and takes less time for a patient to answer than other measures. The UNRS is a scale that is a more useful tool to assess the severity of BU in clinical practice. Efforts to inform HCPs of this new measure, especially GIs, can help them better manage patients with UC and CD. Table 1. - HCP Characteristics Type of Healthcare Provider Overall (N = 459) GIs (n = 100) FM/IM/PCPs (n = 154) PAs (n = 101) NPs (n = 104) Primary medical specialty Gastroenterology 173 (37.7%) 100 (100.0%) 0 37 (36.6%) 36 (34.6%) Internal medicine 59 (12.9%) 0 20 (13.0%) 20 (19.8%) 19 (18.3%) Primary care/family care 227 (49.5%) 0 134 (87.0%) 44 (43.6%) 49 (47.1%) Type of primary work environment Private practice, solo 56 (12.2%) 9 (9.0%) 22 (14.3%) 15 (14.9%) 10 (9.6%) Private practice, group 228 (49.7%) 54 (54.0%) 79 (51.3%) 49 (48.5%) 46 (44.2%) Managed care or HMO practice 12 (2.6%) 0 7 (4.5%) 2 (2.0%) 3 (2.9%) Hospital, inpatient service 28 (6.1%) 4 (4.0%) 6 (3.9%) 8 (7.9%) 10 (9.6%) Outpatient clinic (e.g., ambulatory care center, urgent care center) 78 (17.0%) 7 (7.0%) 32 (20.8%) 20 (19.8%) 19 (18.3%) Academic medical center 55 (12.0%) 25 (25.0%) 7 (4.5%) 7 (6.9%) 16 (15.4%) Other (e.g., research, administration) 2 (0.4%) 1 (1.0%) 1 (0.6%) 0 0 Description of primary work location Rural 57 (12.4%) 2 (2.0%) 21 (13.6%) 20 (19.8%) 14 (13.5%) Suburban 233 (50.8%) 50 (50.0%) 87 (56.5%) 46 (45.5%) 50 (48.1%) Urban 169 (36.8%) 48 (48.0%) 46 (29.9%) 35 (34.7%) 40 (38.5%) Figure 1.: Current use of the UNRS.

Introduction: In patients with Crohn’s disease (CD), clinical trials often focus on disease activity measures such as abdominal pain and stool frequency. Patients with CD frequently experience bowel urgency (BU), yet less is known about the prevalence of BU and its association with quality of life (QoL) in real-world CD populations. Methods: In this cross-sectional study from the nationwide inflammatory bowel disease (IBD) Partners cohort, BU was measured utilizing the validated 11-point Urgency Numeric Rating Scale (NRS)1. This was categorized into “no or minimal” BU (Urgency NRS=0-1) vs. BU (Urgency NRS=2-10). Remission was measured utilizing the Short CD Activity Index (sCDAI). QoL measures included Patient Reported Outcome Measurement Information System (PROMIS) measures of depression, anxiety, pain interference, sleep disturbance, fatigue, and social satisfaction via T-scores. Bivariate analyses were utilized to compare categorical variables by urgency. Correlations were performed utilizing Pearson and Spearman rank as appropriate. Results: Among 1533 patients with CD, 58% reported BU. Rates of BU were higher among patients with active disease as compared to those with remission (87% vs. 48%, P< 0.001). Other factors significantly associated with BU included higher body mass index (BMI), longer disease duration, prior hospitalization, prior surgery, and corticosteroid use (P< 0.05 for all) (Table 1). Patients with BU had significantly higher rates of depression (25% vs. 13%, P< 0.001), anxiety (39% vs. 21%, P< 0.001), pain (38% vs. 14%, P< 0.001), sleep disturbance (27% vs. 14%, P< 0.001), fatigue (47% vs. 24%, P< 0.001) and worse social satisfaction (46% vs. 23%, P< 0.001; Figure 1). In a sub-analysis of those in remission, BU continued to be significantly associated with anxiety, pain, fatigue, and worse social satisfaction (p≤0.001 for all). BU was moderately correlated with disease activity (r=0.52) and weakly correlated with PROMIS measures (r=0.23-0.34). Conclusion: Bowel urgency is common in this real-world Crohn’s disease population, with profound effects on important quality of life measures. Factors associated with more severe disease, such as prior surgery, hospitalization and longer disease duration are also associated with bowel urgency in Crohn’s disease. Bowel urgency is moderately associated with disease activity.Figure 1.: Associations between bowel urgency and PROMIS measures in the CD population. N, Total number of patients; n, number of patients in the subgroups; PROMIS, Patient-Reported Outcome Measurement Information System; CD, Crohn’s Disease. PROS measured by PROMIS T-scores, dichotomized at ≥55 or ≤45 for each measure as appropriate. Bowel urgency was measured via 11 point validated scale, 0-1=No or minimal bowel urgency, 2-10= bowel urgency. P-value was measured by chi-square test. Table 1. - Characteristics of the Crohn’s Disease Population by Presence of Bowel Urgency Characteristic No or minimal bowel urgency (0-1)a N=650 Bowel urgency (2-10)N=883 P-valueb Age (years), mean (SD) 53.4 (16.1) 54.1 (15.5) 0.320 Female, n (%) 452 (70) 632 (73) 0.290 Education (>high school), n (%) 601 (92) 789 (89) 0.039 Race (%) Caucasian 592 (91) 789 (89) 0.196 African American 11 (2) 10 (1) Other 47 (7) 84 (10) Current smoking (yes), n (%) 11 (2) 29 (3) 0.053 BMI, mean (SD) 25.3 (4.9) 26.8 (6.3) < 0.001 Disease duration (years), mean (SD) 23.7 (13.7) 25.7 (14.1) 0.003 Ever GI surgery (yes), n (%) 311 (48) 540 (61) < 0.001 Ever GI hospitalization (yes), n (%) 417 (64) 649 (73) < 0.001 Number hospitalizations, mean (SD) 3.1 (2.3) 3.9 (2.6) < 0.001 Current medications, n (%) Anti-TNFs 246 (38) 311 (35) 0.258 Vedolizumab 64 (10) 98 (11) 0.450 Ustekinumab/Risankizumab 108 (17) 168 (19) 0.242 Tofacitinib/Upadacitinib 2 (0) 3 (0) 0.918 Immunomodulatorsc 118 (18) 152 (17) 0.601 Corticosteroids 24 (4) 80 (9) < 0.001 5-ASA 98 (15) 136 (15) 0.894 Remission (yes), n (%) 599 (92) 544 (62) < 0.001 ASA, aminosalicylic acid; GI, gastrointestinal; N, total number of patients; TNF, tumor necrosis factor.aUrgency was measured using 11-point validated Urgency NRS, 0-1=No or minimal bowel urgency, 2-10=bowel urgency; bChi-square test was used to compare minimal urgency vs urgency for each of the variables; cImmunomodulators included thiopurine or methotrexate. Reference 1 Dubinsky MC, et al. J Patient Rep Outcomes.6, 114 (2022).

Bowel urgency (BU) is an important symptom of Crohn’s disease (CD), however there is no patient-reported outcome (PRO) scale validated in this population to assess BU severity. Here we evaluated the content validity and psychometric properties of the Urgency Numeric Rating Scale (NRS). Qualitative interviews were conducted with moderate-to-severe CD participants to confirm importance and relevance of BU in this population, cognitively debrief the Urgency NRS, and explore score interpretation and CD remission. A quantitative web survey study was conducted to explore the measurement properties of the urgency NRS. Qualitative Interview: 34 of 35 participants reported BU. It was most bothersome for 44

Introduction: Bowel urgency (BU), the sudden need for a bowel movement, affects over 80% of patients with ulcerative colitis (UC).1 However, real-world evidence examining the impact of different advanced therapies on BU in patients with UC is limited. We aimed to assess the prevalence of BU among patients with UC treated with advanced therapies. Methods: This retrospective longitudinal study utilized data from the Study of a Prospective Adult Research Cohort with Inflammatory Bowel Disease (SPARC IBD) registry in the US from November 2016 to March 2022. Patients were required to be on advanced therapy at the time of enrollment and remain on the same advanced therapy for at least 6 or 12 months. Advanced therapies included TNFi (adalimumab, infliximab, and golimumab) and non-TNFi (ustekinumab, vedolizumab, and tofacitinib). Patient-reported outcomes, including BU questionnaire, were collected quarterly on a scale ranging from 0 (none) to 4 (severe). BU categories of mild, moderate, moderately severe, and severe were combined to form the group of patients who experienced BU. The proportion of patients who experienced BU at enrollment, 6-, and 12-month visits was summarized by advanced therapy class (TNFi vs non-TNFi) and by individual therapies using descriptive statistics. Results: Of 203 patients (54.1% females; mean age: 42.4 years) included in this study, 108 received TNFi and 95 received non-TNFi at enrollment. BU was reported by 56.5% of TNFi patients and 68.4% of non-TNFi patients at enrollment. Despite treatment with advanced therapy for 12 months, >50% of patients continued to experience BU in the TNFi (53.2%) and non-TNFi (64.3%) groups (Table 1).Compared to enrollment visit, the proportion of patients who reported BU at 12-month visit was comparable with TNFi therapy (56.5% vs 53.2%) and with vedolizumab (65.1% vs 67.5%; Figure 1). Conclusion: Patients with UC continue to experience bowel urgency despite treatment with advanced therapies for 1 year. Given that patients with UC perceive bowel urgency as the most relevant symptom2, better treatment options are needed. References: 1. Nóbrega VG et al., Arq Gastroenterol. 2018;55(3):290-295. 2. Dubinsky MC et al. CC360, 2022;5(1):otac044.Figure 1.: Proportion of patients reporting bowel urgency while receiving advanced therapy. * Data from patients who were receiving ustekinumab or tofacitinib for UC are not shown due to the small sample size. TNFi: Tumor necrosis factor inhibitors (adalimumab, golimumab, and infliximab); Non-TNFi: Non-Tumor necrosis factor inhibitors (ustekinumab, vedolizumab, and tofacitinib). Table 1. - Effectiveness of TNFi and non-TNFi on bowel urgency among patients with UC Cohort TNFi Non-TNFi All Enrollment N=108 N=95 N=203 No urgency, n (%) 47 (43.5) 30 (31.6) 77 (37.9) Urgency, n (%) 61 (56.5) 65 (68.4) 126 (62.1) 6 months N=80 N=74 N=154 No urgency, n (%) 35 (43.8) 25 (33.8) 60 (39.0) Urgency, n (%) 45 (56.3) 49 (66.2) 94 (61.0) 12 months N=77 N=56 N=133 No urgency, n (%) 36 (46.8) 20 (35.7) 56 (42.1) Urgency, n (%) 41 (53.2) 36 (64.3) 77 (57.9) N=total number of patients; n = Number of patients with non-missing observations; TNFi: Tumor necrosis factor inhibitors (adalimumab, golimumab, and infliximab); Non-TNFi: Non-Tumor necrosis factor inhibitors (ustekinumab, vedolizumab, and tofacitinib).No data imputation for missing data was performed in this study.

Introduction: The Urgency Numeric Rating Scale (UNRS) is a single-item patient-reported outcome (PRO) measure assessing bowel urgency (BU) severity in ulcerative colitis (UC) patients. The UNRS has documented evidence of content validity and psychometric performance, including reliability and validity. The original UNRS with a 24-hour recall period was used to evaluate mirikizumab treatment benefits in patients with moderately to severely active UC in the Phase 3 LUCENT trials. The aim of the present work was to evaluate new recall periods to facilitate the introduction of the UNRS into clinical practice. Methods: Qualitative interviews with 10 adults diagnosed with moderate-severe UC evaluated interpretation and relevancy of 2 recall periods for the UNRS (the past 3 days and the past 7 days; 7-day recall UNRS shown in Figure 1). Interpretations were analyzed against a priori definitions created by developers to determine if recall periods were interpreted as intended, along with participant responses of which recall period was more relevant to their BU experience. Interviews were audio-recorded, transcribed, and coded thematically using qualitative analytic software. Results: Mean sample age was 53.1 years; 50% were female. UC severity was equally split between moderate and severe patients. Eight participants interpreted the 7-day recall period (n=8/10 80%) as intended (n=1 did not interpret as intended, n=1 did not provide sufficient information). Similarly, 8 participants interpreted the 3-day recall period (n=8/8, 100%) as intended (n=2 were not asked). Six participants (n=6/10, 60%) reported that the 7-day recall period was more relevant to their experience of BU and 2 participants (n=2/10, 20%) reported that the 3-day recall period was more relevant. One participant (n=1/10, 10%) reported that both the 7-day and 3-day recall periods were relevant. One (n=1/10, 10%) reported that neither 7- nor 3-day recall periods were relevant to their experience, but suggested providing a time range for the recall period (i.e., the past 2-3 or 4-7 days). Conclusion: Findings suggest that both 3-day and 7-day recall periods to evaluate BU are appropriately understood by patients with moderate-severe UC. These results expand on existing UNRS literature and suggest that the UNRS with a 3- or 7-day recall period may be introduced into clinical practice.Figure 1.: Urgency NRS with 7-day recall period.

Introduction: Numerous biologics and small molecules are approved for the treatment of moderately to severely active ulcerative colitis (UC). Current clinical practice guidelines suggest switching to a new mechanism of action (MOA) after failing on a tumor necrosis factor inhibitor (TNFi) rather than switching to another TNFi. There is little real-world evidence regarding treatment outcomes in pts with UC receiving another TNFi after failing an initial TNFi (TNFi cyclers) and those who received advanced therapy (AT) with another MOA (MOA switchers). Methods: This retrospective cohort study identified adult patients (pts) in the IQVIA PharMetrics® Plus database who were diagnosed with UC and switched to a second AT after initial treatment with a TNFi between 01 Jan 2015 and 31 May 2021. Pts had ≥12 months of pre-index and 24 months of post-index continuous enrollment in a health plan and no evidence of other autoimmune diseases. Pts were grouped into cohorts of TNFi cyclers or MOA switchers. Treatment persistence and augmentation were assessed from the start of the second AT until the end of follow-up. Discontinuation was defined as a gap ≥2 times the days’ supply of the second AT or starting a new AT. Augmentation was defined as treatment with non-advanced therapies while on the second AT. Descriptive statistics of outcomes were reported, and Kaplan-Meier method was used to report the time to treatment discontinuation. Results: Of 1031 pts included in the study, 313 (30.4%) were TNFi cyclers and 718 (69.6%) were MOA switchers (vedolizumab: 78.4%; tofacitinib: 11.1%; ustekinumab: 10.4%). Persistence rates at both 12- and 24-months after second line initiation were higher in MOA switchers than TNFi cyclers (12-month rates: 74.7% vs. 58.2%; 24-month rates: 63.0% vs. 44.1%). The median (95% confidence interval) times to treatment discontinuation were 44.0 (36.2-50.6) vs. 18.5 (14.2-26.2) months in MOA switchers vs. TNFi cyclers, respectively (Figure 1). Furthermore, augmentation was less common in MOA switchers than TNFi cyclers (83.1% vs. 91.4%). Conclusion: Among pts who failed a TNFi, those who received a different MOA had a numerically lower rate of treatment augmentation and higher treatment persistence than those who received another TNFi. These results suggest that switching to a new MOA may be a more effective treatment strategy than cycling to another TNFi after initial TNFi failure in pts with moderately to severely active ulcerative colitis.Figure 1.: Kaplan-Meier curves of the probability of treatment persistence in TNFi-experienced ulcerative colitis pts, stratified by TNFi cyclers and MOA switchers. Legend: TNFi, Tumor Necrosis Factor inhibitor. MOA switchers, pts who had first-line treatment with a TNFi and second-line treatment with a different mechanism of action. TNFi Cyclers, pts who had first-line treatment with a TNFi and second-line treatment with a different TNFi. Persistence is defined as the presence of a gap of more than 2 times the dose frequency of respective advanced therapy or switching to different advanced therapy.

Introduction: Mirikizumab (miri), a p19-directed IL-23 antibody, was efficacious in inducing clinical remission at Week (W)12 (LUCENT-1) and maintaining clinical remission at W52 (LUCENT-2) in patients with moderately to severely active ulcerative colitis (UC). We present results from the ongoing open-label LUCENT-3 study evaluating efficacy and safety of miri in patients who received extended induction therapy. Methods: We investigated patients who at W12 of LUCENT-1 had not responded to initial induction with miri but then received extended induction treatment of 3 doses of 300 mg IV miri, and subsequently responded at W24 (LUCENT-2). These delayed responders entered LUCENT-3 at W40, receiving 200 mg miri Q4W SC. Following 104W of miri treatment, we report clinical response and remission, corticosteroid-free (CSF) remission, endoscopic remission, histologic-endoscopic mucosal improvement (HEMI) and histologic-endoscopic mucosal remission (HEMR), symptomatic remission, bowel urgency (BU) clinical meaningful improvement (CMI) and remission scores, and induction baseline biologic failure status. Week numbers are shown as cumulative, i.e., W12 of LUCENT-2 is defined as W24 overall. Discontinuations or missing data were handled using non-responder imputation. All data were summarized as descriptive. Biologic Failed was defined as prior inadequate response, loss of response, or intolerance to biologic therapy or tofacitinib; otherwise, patients were categorized as Not Biologic Failed. Safety data were assessed. Results: Among delayed responders (N=81) with clinical response at W52, 67.9% were still in clinical response at W104. Remission rates were: 34.6% clinical, 32.1% CSF, 45.7% endoscopic, 33.3% HEMR, 63.0% symptomatic, and 45.7% BU. Patients achieving HEMI and BU CMI were 40.7% and 59.7%, respectively. Biologic Failed/Not Failed subgroup data were similar (Figure 1). Severe TEAEs were reported in 3.3% of patients (LUCENT-3 safety population, N=123); 4.9% had serious AEs, and 4.1% discontinued treatment due to an AE. Most common TEAEs (≥4%) were COVID-19 (13.8%), UC (13.0%), diarrhea, headache and pyrexia (both 4.9%), nasopharyngitis, and upper respiratory tract infections (both 4.1%). One reported death was unrelated to miri treatment. Conclusion: Extended induction of miri sustained efficacy and safety over 104 wks for patients with moderately to severely active UC and refractory to initial induction. There were no new safety concerns (see Table 1).Figure 1.: Efficacy endpoint response rates for all patients and by biologic failure status. Table 1. - Patient Demographics and Disease Summaries* of Mirikizumab Induction Delayed Responders at Week 24 (N=102**) Age, mean years (SD) 45.9 (13.5) Male, n (%) 58 (56.9) Disease duration, mean years (SD) 7.5 (7.2) Disease location, n (%) Left-sided colitis 60 (58.8) Pancolitis 42 (41.2) Modified Mayo Score, n (%) Mild [1-3] 1 (1.0%) Moderate [4-6] 40 (39.2) Severe [7-9] 61 (59.8) Mayo endoscopic subscore: severe disease (3), n (%) 76 (74.5) Bowel urgency severity (UNRS) Mean (SD) 6.3 (2.1) UNRS≥3, n (%) 97 (95.1) Faecal calprotectin, µg/g, median (Q1, Q3) 1538.5 (572.0, 4165.0) C-reactive protein (CRP), mg/L, median (Q1, Q3) 4.8 (2.2, 12.0) IBDQ total score, median (Q1, Q3) 126.0 (103.0, 152.0) Prior UC therapy, n (%) Prior biologic or tofacitinib failure 43 (42.2) Number of failed biologics or tofacitinib 0 59 (57.8) 1 17 (16.7) 2,3 26 (25.5) Prior vedolizumab failure 19 (18.6) Prior tofacitinib failure 4 (3.9) Baseline UC therapy, n (%) Corticosteroids 42 (41.2) Immunomodulators 27 (26.5) Aminosalicylates 83 (81.4) *At baseline of induction of LUCENT-1.**The modified intent-to-treat population in LUCENT-3.Abbreviations: IBDQ=Inflammatory Bowel Disease Questionnaire; N=number of patients; Q=quartile; SD=standard deviation; UNRS=Urgency Numeric Rating Scale.

The American Journal of Gastroenterology 114(7):p 1020-1021, July 2019. | DOI: 10.14309/ajg.0000000000000243

1Philadelphia Gastroenterology Consultants, LTD, Philadelphia, PA, USA. 2James E. Beasley School of Law, Temple University, Philadelphia, PA, USA. 3Department of Medicine, Jeanes Hospital, Temple University Health System, Philadelphia, PA, USA. 4Augusta Health and Augusta Care Partners ACO, Fishersville, VA, USA. Correspondence: R.E.M. (email: [email protected]) Received 16 January 2018; accepted 30 April 2018; Published online 14 June 2018

1Philadelphia Gastroenterology Consultants, Temple University School of Medicine, Philadelphia, Pennsylvania, USA 2James E. Beasley School of Law, Temple University, Philadelphia, Pennsylvania, USA 3Department of Medicine, Jeanes Hospital, Temple Health, Philadelphia, Pennsylvania, USA 4Blair Gastroenterology Associates, UPMC Altoona, Altoona, Pennsylvania, USA Correspondence: Richard E Moses, DO, JD, FCLM, 700 Cottman Ave, Building B, Suite 201, Philadelphia, Pennsylvania 19111, USA. E-mail: [email protected] Guarantor of the article: Richard E. Moses, DO, JD, FCLM. Specific author contributions: jointly planned the article and contributed to the research and analysis: Richard E. Moses and Ralph D. McKibbin; drafted the initial manuscript and made the suggested peer reviewed revisions: Richard E. Moses; approved the final draft submitted: Richard E. Moses and Ralph D. McKibbin. Financial support: None. Potential competing interests: None.

1Philadelphia Gastroenterology Consultants, Philadelphia, Pennsylvania, USA 2Temple University School of Medicine, Philadelphia, Pennsylvania, USA 3James E. Beasley School of Law, Temple University, Philadelphia, Pennsylvania, USA 4Department of Medicine, Jeanes Hospital, Temple Health, Philadelphia, Pennsylvania, USA 5Blair Gastroenterology Associates, Altoona, Pennsylvania, USA 6UPMC Altoona, Altoona, Pennsylvania, USA Correspondence: Richard E. Moses, DO, JD, FCLM, 700 Cottman Avenue, Bldg B, Suite 201, Philadelphia 19111, USA. E-mail: [email protected] Guarantor of article: Richard E. Moses, DO, JD, FCLM. Specific author contributions: Moses and McKibbin jointly planned the articles and contributed to the research and analysis. Moses drafted the initial manuscript and made the suggested peer reviewed revisions. Both authors approved the final draft submitted. Financial support: None. Potential competing interests: None.

Wilson, Louis J MD, FACG1; Yepuri, Jay N MD, MS2; Moses, Richard E DO, JD3,4 Author Information