Harvey-Bradshaw Index Research Articles

Clinical efficacy and its influencing factors of ustekinumab in the treatment of patients with Crohn's disease

To analyze the clinical efficacy and its influencing factors of ustekinumab (UST) in the treatment of patients with Crohn's disease (CD). From January 2021 to January 2024, CD patients who received UST treatment were retrospectively collected from the Second Affiliated Hospital of Wenzhou Medical University. Harvey-Bradshaw index were applied to assess clinical activity of CD patients, C-reactive protein was used to evaluate biochemical remission rate, and simplified Crohn's disease endoscopy score was used to evaluate the degree of intestinal inflammation. Logistic regression model was used to analyze the influencing factors for the clinical response rate at week 8, as well as the clinical remission rate and endoscopic remission rate at week 32. A total of 138 CD patients were included, including 93 males and 45 females. The age of diagnosis [M (Q1, Q3)] was 24 (19, 32) years old. At week 8, the clinical response rate and biochemical remission rate was 58.0% and 49.3%, respectively. Multivariate logistic regression model analysis showed that disease behavior (stenosis or penetration) was the risk factor of the clinical response rate at week 8 (OR=0.46, 95%CI: 0.23-0.95). The clinical remission rate and endoscopic remission rate at week 32 were 56.5% and 37.7%, respectively. Multivariate logistic regression model analysis showed that disease behavior (stenosis or penetration) was the risk factor of the clinical remission rates (OR=0.18, 95%CI: 0.08-0.42) and endoscopic remission rates (OR=0.25, 95%CI: 0.11-0.55) at week 32. Failure to achieve clinical response at week 8 was the risk factor of the clinical remission rates (OR=0.21, 95%CI: 0.09-0.52) and endoscopic remission rates (OR=0.19, 95%CI: 0.07-0.50) at week 32. UST treatment has good clinical efficacy in CD patients. CD patients with intestinal stenosis or penetrating lesions can decrease the efficacy of UST treatment. Failure to achieve clinical response at week 8 can decrease the efficacy at week 32.

Quality of life of inflammatory bowel diseases patients in france with EQ-5D-5L: the QALY-MICI study.

This study aimed to document utility values and the Visual Analog Scale (VAS) with the 5-level version of the EQ-5D questionnaire in a large sample of patients with inflammatory bowel disease (IBD), including Crohn's disease (CD) and ulcerative colitis (UC). QALY-MICI was a cross-sectional survey across three sources in France. Data were collected between 2019 and 2022 for patients 18 and over. The EQ-5D-5L, the EQ-VAS, the Short Inflammatory Bowel Disease Questionnaire (SIBDQ), the Harvey-Bradshaw Index (HBI) for CD, and the Walmsley Index for UC (SCCAI) were collected. A total of 2,841 patients aged over 18 were recruited (1785 with CD, 1056 with UC). The mean age was 40.2 (SD 14.3). The time since diagnosis was 6 years and over for 61.9% of patients. The most impacted dimensions were usual activities, anxiety/ depression, and pain/ discomfort. The mean utility value was 0.863 (SD 0.172) versus 0.905 (SD 0.158) in the French population (p = 0.007). The mean VAS value was 68 (SD 19.2) versus 73.4 (SD 22.2) in the general population (p = 0.016). Utility values and VAS were similar for CD and UC and higher for men. There was a strong positive correlation between utility values, the VAS, and the SIBDQ score, and a negative correlation between the HBI and the SCCAI. The SIBDQ score and disease activity were the main predictors of utility and VAS. The QALY-MICI is, to our knowledge, the first study documenting utility values and VAS using the EQ-5D-5L questionnaire on a large sample, with a comparison to the general population.

Long-term Effectiveness and Safety of Risankizumab in Patients with Crohn’s Disease from a Large Tertiary Center

Background and AimsRisankizumab is a selective IL23 inhibitor approved for the treatment of Crohn’s disease (CD). We report a large long-term real-world experience with risankizumab in CD. MethodsWe performed a prospective monitoring of clinical outcomes in patients in our center who started treatment with risankizumab. Patients with active luminal disease who had at least 12 weeks of follow-up were included in the effectiveness analysis. Harvey-Bradshaw Index (HBI) as well as C-reactive protein (CRP) and fecal calprotectin (FCP) were used to monitor disease activity. Primary outcomes were clinical remission and steroid-free clinical remission rates at weeks 12, 26, and 52. Univariate analysis followed by a multivariate analysis using a logistic regression model was performed to identify predictors of steroid-free clinical remission at one year. All patients who started treatment with risankizumab for any indication were included in the safety analysis. Results134 patients were included in the effectiveness analysis. 70 (52%) were ustekinumab-experienced. Clinical remission rates were 69%, 64%, and 54% at weeks 12, 26, and 52, respectively. Steroid-free clinical remission rates at 12, 26, and 52 weeks were 58%, 58%, and 50% respectively. Remission rates in ustekinumab-experienced patients were not statistically lower compared to naïve patients, and in a multivariate analysis, prior ustekinumab treatment was not associated with lower odds of achieving steroid-free clinical remission at one year. Adverse effects were assessed in 243 patients and were consistent with previous literature. ConclusionsThis large real-world experience with risankizumab with long-term follow-up demonstrates effectiveness and safety in patients with CD; there was comparable effectiveness in ustekinumab-naïve and ustekinumab-experienced patients.

Extracorporeal Photopheresis with 5-Aminolevulinic Acid in Crohn's Disease-A First-in-Human Phase I/II Study.

Background/Objectives: With the increasing prevalence of Crohn's disease (CD), treatment options for patients who fail conventional and advanced therapy are highly needed. Therefore, we explored the safety and efficacy of extracorporeal photopheresis (ECP) using 5-aminolevulinic acid (ALA) and blue light (405 nm). Methods: Patients with active CD who failed or were intolerant to biological therapy were eligible. Mononuclear cells (90 mL) were collected from each patient using a Spectra Optia® apheresis system and diluted with 100 mL of 0.9% sodium chloride in a collection bag. The cells were incubated with ALA at a concentration of 3 millimolar (mM) for 60 min ex vivo and illumination with an LED blue light (405 nm) source (BLUE-PIT®) before reinfusion to the patient. Recording of vital signs and adverse events were regularly performed. At week 13, we assessed the patients with colonoscopy, the Harvey Bradshaw Index (HBI), the Inflammatory Bowel disease Health Related Quality of Life Questionnaire, and the measurement of serum C-reactive protein and fecal calprotectin (FC) levels. Biopsies of the intestines were taken for immunohistochemistry. Results: Seven patients were included. Four patients completed the treatments, with a total of 24 treatments. Three of the four patients achieved a favorable response, including a lower HBI, lower FC levels, and/or endoscopic improvement. No significant adverse events were observed. The remaining three patients received only one, three, or five treatments due to technical difficulties, medical reasons, or the withdrawal of informed consent. Conclusions: ALA-based ECP appears safe and seems to give some clinical improvement for the patients with active CD who failed to respond to conventional and advanced therapies.

Subcutaneous infliximab in Crohn’s disease patients with previous immunogenic failure of intravenous infliximab

PurposeImmunogenicity is a major reason for secondary loss of response to infliximab (IFX). Recent work suggested potentially lower immunogenicity of subcutaneous (SC) compared to intravenous (IV) IFX. However, it is unknown whether re-exposure to IFX SC after secondary loss of response and immunogenicity to its intravenous formulation is safe and effective.MethodsIn a retrospective cohort study conducted at two medical centers, patients with clinically (Harvey-Bradshaw Index ≥ 5) and/or biochemically (fecal calprotectin > 250 µg/g) active Crohn’s disease (CD) and previous immunogenic failure of IFX IV underwent exposure to IFX SC. Harvey-Bradshaw Index, fecal calprotectin, IFX serum concentration, and anti-drug antibodies were assessed until month 12.ResultsTwenty CD patients were included. The majority of patients (90%) had previous treatment with three or more biologics. Fifteen (75%) and ten (50%) of 20 patients continued IFX SC treatment until months 6 and 12, respectively. No immediate hypersensitivity reactions were observed. Two patients discontinued IFX SC treatment because of delayed hypersensitivity at week 2 and week 4. IFX serum concentrations increased from baseline to month 12, while anti-drug antibody levels decreased. Combined clinical and biochemical remission at month 12 was observed in seven of 20 patients (35%).ConclusionSubcutaneous infliximab treatment of Crohn’s disease patients with previous immunogenic failure of intravenous infliximab was well tolerated and effective in a cohort of patients with refractory Crohn’s disease.

Optimizing outcomes with maintenance IV UST in highly bio-exposed patients with IBD. Efficacy and adjusted regimen in real world

Background and aimsUstekinumab is an effective treatment for inflammatory bowel diseases. However, some patients do not respond to conventional doses. The aim of the study was to evaluate the effectiveness of intravenous maintenance ustekinumab in patients with secondary failure. MethodsSingle-center, retrospective study in adult patients with intravenous maintenance ustekinumab. The reduction of biochemical activity markers, ustekinumab trough levels and clinical indices of activity were evaluated. Biological remission was defined as the percentage decrease fecal calprotectin ≥80% and/or final fecal calprotectin ≤250 and C reactive protein <5mg/L. ResultsThirty-one patients were included: Crohn's disease 77.4%. All included patients were bio-exposed and 61.3% had carried ≥2 biologics.Pre-intravenous maintenance mean Harvey–Bradshaw Index was 6.5±4.38 vs 5±3.1 at week 8 (p=0.024) vs 4.1±3.1 at week 24 (p=0.019). The median ustekinumab trough level pre-intravenous maintenance was 1.40μg/ml [IQR 2.3] vs 5.35μg/ml [IQR 4.1] at week 8 (p<0.001) vs 4.8μg/ml [IQR 3.9] at week 24 (p<0.001). The pre-intravenous maintenance median fecal calprotectin was 809μg/g [IQR: 2256] vs 423μg/g [IQR: 999] at week 8 (p=0.025) vs 333μg/g [508] (p=0.001) at week 24.At the end of follow-up 48% went into biological remission. The presence of perianal disease was associated with lower biological remission (70.6% vs 27.3%, p=0.025). Median intravenous ustekinumab maintenance time was 8.55 [IQR 23.9] months. In 83.9% of patients no serious infections or malignancy were documented. ConclusionsThe use of maintenance intravenous ustekinumab appears to be an effective and safe strategy that can be evaluated as a salvage treatment especially in highly bio-exposed patients.

Multicohort study testing the generalisability of the SASKit-ML stroke and PDAC prognostic model pipeline to other chronic diseases

ObjectivesTo validate and test the generalisability of the SASKit-ML pipeline, a prepublished feature selection and machine learning pipeline for the prediction of health deterioration after a stroke or pancreatic adenocarcinoma...

Monitoring the psychopathological profile of inflammatory bowel disease patients treated with biological agents: a pilot study.

Biological agents were found to alter the psychopathological profile of a small subgroup of patients treated for a variety of conditions, including inflammatory bowel disease (IBD) and psychiatric disorders. The association between the administration of biological agents and psychopathology needs to be further investigated. In this naturalistic prospective cohort study, patients with IBD were assigned to two treatment groups, i.e., a biological agent (which also included tofacitinib) or conventional therapy. Clinician-administered scales were used to assess psychosomatic symptoms (Hamilton Depression Rating Scale [Ham-D], Hamilton Anxiety Rating Scale [Ham-A], Young Mania Rating Scale [YMRS], and Brief Psychiatric Rating Scale [BPRS]) and disease activity (Mayo Score and Harvey-Bradshaw Index [HBI]) at baseline, after one, three, and six months of treatment. Each group was assessed for the course of their scores during the observation period at each assessment point. Patients on biological drugs who completed three months of treatment (N.=32) and six months of treatment (N.=20) scored significantly lower on the Mayo compared to baseline. Patients on conventional treatment obtained significant drops from baseline on the HBI after one and three months of treatment (N.=30) and also at the six-month endpoint (N.=11). Both groups showed no improvement or worsening on the psychiatric rating scales. In this study, we found no evidence of psychiatric symptom worsening, as some literature would suggest. Our data suggest that the use of biological agents in IBD is safe.

Short term effectiveness of ustekinumab versus vedolizumab in Crohn's disease after failure of anti-TNF agents: An observational comparative study design with a Bayesian analysis.

Crohn's disease (CD) is a debilitating gastrointestinal disease with complex etiology. Although effective, recipients of anti-tumor necrosis factor (TNF) agents may experience primary or secondary nonresponse, necessitating alternative treatments. This study is intended to compare the short-term effectiveness of ustekinumab and vedolizumab in treating CD after failure of multiple lines of anti-TNF therapy using real-world data. A retrospective study was conducted at a tertiary hospital in Dammam, Saudi Arabia, including adults (≥18 years old) with CD who did not respond to anti-TNF therapy. Primary endpoints were clinical improvement per the Harvey-Bradshaw Index (HBI) scores and remission at 12 weeks on an ordinal outcome scale. Secondary endpoints included clinical, biochemical, and endoscopic remission; clinical response; corticosteroid-free days; and cumulative steroid dose. Proportional odds and logistic regression Bayesian models were used to analyze outcomes, and the probability of treatment effectiveness was calculated from the posterior distribution. The study included 101 patients (ustekinumab, n = 71 and vedolizumab, n = 30) with a median age of 32 years (IQR: 26.0-38.0); 54.4% were male. At 12 weeks, the HBI endpoint showed an adjusted odds ratio (aOR) = 0.60 (95% confidence interval [CI]: 0.25-1.31), favoring ustekinumab, with a 75% probability of treatment effectiveness over vedolizumab. The clinical ordinal scale had an aOR = 0.61 (95% CI: 0.26-1.35) with a 73% probability of effectiveness for ustekinumab. Ustekinumab was also associated with favorable outcomes in secondary endpoints, reaching up to a 90% probability of effectiveness. In CD patients with anti-TNF failure, ustekinumab was more effective than vedolizumab in the short term. These real-world insights contribute to understanding CD management but require validation in larger prospective studies and randomized controlled trials.

Sexual dysfunction is prevalent in IBD but underserved: a need to expand specialised IBD care

ObjectiveSexual dysfunction is common in patients with inflammatory bowel disease (IBD). Data on IBD disease activity and IBD patients’ desire to seek specialist advice regarding sexual dysfunction are lacking. We...

Real-world clinical effectiveness of ustekinumab in the treatment of Crohn’s disease in the East Midlands UK

ObjectivesTo evaluate the effectiveness of ustekinumab in treating Crohn’s disease (CD) in a UK real-world setting.DesignThis was a multicentre, retrospective observational study of patients (aged ≥18 years) with CD or...

Long-Term Outcomes of Intravenous Ustekinumab Maintenance Treatment in Patients With Loss of Response to Subcutaneous Dosing.

Ustekinumab (UST) is commonly used to treat Crohn's disease and ulcerative colitis. However, some patients may experience diminishing response or require increased dosage. Intravenous (IV) UST maintenance is explored as a solution. We sought to evaluate IV UST maintenance effectiveness and safety in inflammatory bowel disease patients with partial or lost subcutaneous UST response. This was a multicenter retrospective study of inflammatory bowel disease patients on IV UST maintenance. Clinical response and remission at weeks 12 and 52, defined as Harvey-Bradshaw Index ≤4 for Crohn's disease or partial Mayo score ≤2 for ulcerative colitis. Objective markers reduction (fecal calprotectin, C-reactive protein), UST trough levels pre- and post-IV maintenance, and adverse events were assessed. A total of 59 patients were included. Clinical remission at weeks 12 and 52 achieved by 47.5% and 64.3% respectively. 96.6% continued IV UST at follow-up. UST serum levels quadrupled. No adverse events reported. IV UST maintenance effectively sustained remission in most patients at 52 weeks.

The impact of cognitive functions, psychological disorders, and coping strategies on quality of life and disease outcomes in patients with inflammatory bowel diseases: A cross-sectional study.

Quality of life (QoL) in patients with inflammatory bowel disease (IBD) is influenced by several factors, many of which may also impact cognitive function. However, the extent of the interaction among these factors, QoL, and disease outcomes in IBD patients remains unknown. We thus aim to characterize the relationships among psychological disorders, coping mechanisms, cognitive function, and the overall impact on QoL and disease outcomes in patients with IBD. This cross-sectional observational study was conducted at an academic care center. QoL was evaluated using the Short Inflammatory Bowel Disease Questionnaire (SIBDQ), and disease severity was evaluated using the Harvey-Bradshaw Index (HBI) for Crohn's disease (CD) and the Simple Clinical Colitis Activity Index (SCCAI) for ulcerative colitis (UC). We also used the Hospital Anxiety and Depression scale (HADS). Regression models were used to test the associations among QoL, number of hospitalizations, disease severity, cognitive functioning (working memory [WM] and reaction time), and coping strategies while controlling for anxiety and depressive symptoms, age, and sex. This study included 41 patients (24 patients with CD and 17 with UC) whose mean age was 28.2 (±8.4) years (23 males) and mean SIBDQ score was 51.5 (±10.0). Patients with more WM errors had lower QoL scores (P = .041), whereas patients with higher anxiety levels had lower QoL and more active UC (P = .008 and P = .016, respectively). The use of avoidant coping mechanisms was associated with a significantly higher number of hospitalizations (P = .038), and patients who adopted more emotion-focused coping strategies had a longer illness duration (P = .021). Finally, patients with higher education levels were found to use more active coping mechanisms than others. These results confirm the impact of cognitive, psychological, and coping factors on QoL and disease outcomes in patients with IBD; however, the mechanisms by which these factors interrelate remain unclear. Therapies aimed at improving both cognitive functions and psychological conditions may thus be effective at improving QoL and disease outcomes in IBD patients, and education may play a positive role in promoting the adoption of more effective coping strategies among IBD patients.

Impact of Clinical Pharmacists in the Inflammatory Bowel Disease Clinic.

Background: Limited evidence exists regarding pharmacist involvement and impact in inflammatory bowel disease (IBD) interdisciplinary clinic care models. The purpose is to describe pharmacist utilization in an interdisciplinary IBD clinic and evaluate clinical impact on patient quality of life. Methods: This was a retrospective cohort study comparing outcomes in patients with Crohn's disease initiated on therapy when the implementation of pharmacy services began (Early Phase) to the expansion of pharmacy services (Recent Phase). The primary outcome compared the proportion of patients referred to a pharmacist and those achieving a Harvey-Bradshaw Index (HBI) reduction of ≥3 points after therapy initiation. Results: 50 patients were included in the Early Phase and 43 patients in the Recent Phase. Utilization in pharmacy referrals increased from 48% (n = 24) in the Early Phase to 72% (n = 31) in the Recent Phase (P = 0.03). The proportion of patients achieving a HBI reduction of ≥3 points increased from 35% (n = 14) in the Early Phase to 51% (n = 18) in the Recent Phase (P = 0.23). Results also found a greater proportion of patients remaining steroid free in the Recent Phase compared to the Early Phase (50% vs 63%; P = 0.01) and C-reactive protein (CRP) improved significantly in the Recent Phase (-11) compared to (-3) in the Early Phase (P = 0.006). Conclusion: The utilization of pharmacists in an interdisciplinary IBD clinic increased and showed to impact patient care through improving symptom relief as seen by the achievement rate of the HBI score reduction, reducing steroid use after therapy initiation, and making clinically significant interventions.

Switching from Dose-Intensified intravenous to SubCutaneoUS infliximab in Inflammatory Bowel Disease (DISCUS-IBD): protocol for a multicentre randomised controlled trial

IntroductionA substantial proportion of patients with inflammatory bowel disease (IBD) on intravenous infliximab require dose intensification. Accessing additional intravenous infliximab is labour-intensive and expensive, depending on insurance and pharmaceutical reimbursement....

Targeted surgery combined with postoperative medical therapy for residual disease for severe and multifocal Crohn disease

BackgroundIn patients with multifocal intestinal Crohn disease requiring surgery for complication or uncontrolled disease, resection of all the lesions may lead to diarrhea and malnutrition. MethodsThis is a single-center retrospective review of all patients undergoing targeted surgery for multifocal Crohn disease with at least one residual Crohn disease location left behind. The primary endpoint was the rate of insufficient control of residual Crohn disease lesions requiring redo-surgery targeting these lesions. The rate of clinical remission defined by Harvey–Bradshaw index <4 was studied over time. ResultsFrom January 2012 to August 2022, among 320 patients undergoing surgery for intestinal Crohn disease, 30 met all criteria. Before surgery, patients had received a mean of 3 medical treatment lines; 83% (n = 25) had a clinically active Crohn disease (Harvey–Bradshaw index ≥4). Surgery consisted in ileocolonic (n = 14;47%), small bowel (n = 5;17%) or colonic resection (n = 12;40%) and strictureplasty (n = 4;13%). Operative mortality was nil. Overall postoperative and severe morbidity rates were 15 of 30 (50%) and 3 of 30. Residual lesions were in the small bowel (n = 15;50%), the colon (n = 16;53%), and/or the rectum (n = 16;53%). Twenty-five patients (83%) had postoperative medical therapy. Median follow-up was 65. Six patients (20%) required reoperation for insufficient control of residual lesions at index surgery after a mean of 98 ± 8 months. The clinical remission rate increased from 17% before surgery to 59% at 6–12 months and 71% at 24 months. ConclusionIn patients with multifocal Crohn disease, surgery targeted to severe and complicated lesions combined with postoperative medical treatment is a safe and effective strategy.

Relationship between Ustekinumab trough concentrations and clinical, biochemical and endoscopic outcomes in Crohn's disease: A multi-center nationwide retrospective study (TARGET STUDY).

Ustekinumab has been shown to be effective in inducing and maintain clinical and endoscopic remission in Crohn disease (CD). We aim to assess whether ustekinumab trough levels are associated with improved outcomes in CD in real-life. We recruited patients with CD who were treated with ustekinumab for at least 6 months from January 2017 to June 2023. Patients received ustekinumab 6 mg/kg intravenous induction followed by 90 mg every 4-, 8-, or 12-weeks during maintenance were included. We assessed clinical, biochemical, and endoscopic outcomes. Trough concentrations of ustekinumab that were taken from week 42 to week 52 were measured. Primary outcome was to evaluate the relationship between ustekinumab trough concentrations and clinical remission, biochemical normalization, and endoscopic remission. Logistic regression was conducted to assess outcomes. A total of 137 patients with CD, median age of 32 years and 83 (60.6%) males. The median serum levels of ustekinumab measured was 7.2 mcg/mL (interquartile range [IQR] 3.1-9.6). Using Spearman correlation analysis, a strong negative correlation was observed between ustekinumab drug levels and simple endoscopic score (SES-CD) (r = -0.464, P < .001). Additionally, ustekinumab drug levels demonstrated substantial negative correlations with disease severity measured by Harvey-Bradshaw index (HBI) score (r = -0.582, P < .001), C-Reactive Protein (CRP) levels (r = -0.598, P < .001) and fecal calprotectin (FC) levels (r = -0.529, P < .001). A multivariable analysis adjusted for age, sex and body mass index (BMI) showed a significant association between ustekinumab serum drug levels and predefined outcomes. Ustekinumab serum drug level above 4.5 mcg/mL was associated with 24% increase in the likelihood of having an SES-CD score <3 (OR 1.24, confidence interval [CI] 1.12-1.37, P value < .001), 44% more likely to achieve HBI score <5 (OR 1.44, CI 1.26-1.65, P value < .001), 52% higher likelihood of CRP more than 10 (OR 1.52, CI 1.31-1.77, P < .001), and 42% increased likelihood of FC more than 250 (OR 1.42, CI 1.24-1.62, P < .001). Ustekinumab trough concentrations above 4.5 mcg/mL were associated with clinical, biochemical and endoscopic remission in CD. Prospective data is warranted to confirm these findings.

Immunohistochemical Analysis of IL-19 and IL-24 Expression in Inflammatory Bowel Disease (IBD) Patients: Results From a Single Center Retrospective Study.

Background IL-19 and IL-24 induce proinflammatory cytokine production through the Janus kinase-signal transducer and activator of transcription (JAK-STAT) pathway. The primary objective of this study was to investigate any changes in IL-19 and IL-24 expression between inflammatory bowel disease (IBD) patients and healthy controls, as well asbefore and after the initiation of biologics. The secondary objective was to investigate any relation betweentheir expression anddisease phenotype and activity. Methods IL-19 and IL-24 expression was measured in intestinal tissue samples from 121 patients with moderate to severe IBD versus healthy controls using immunohistochemistry. Their expression was then measured 12 months after treatmenton the patient group treated with biologics. The disease activity was measured before and after treatment using the Harvey Bradshaw Index (HBI) for Crohn's disease (CD) patients and the Mayo Score (MS) for ulcerative colitis (UC) patients. Data were analyzed using SPSS (IBM Inc., Armonk, New York). Results IL-19 expression was raisedin the IBD group versus healthy controls. In the CD group, the IL-19 expression was related with the disease activity scorepost-biologic treatment. IL-24 was also highly expressed in patients with active UC and CD and was increased post-treatment. Itsexpression in UC was statistically related with the MS. Conclusions IL-24 and IL-19 are key factors in IBD-related intestinal inflammation and this is one of the few human studies to suggest that. An immunosuppressive role of IL-24 was demonstrated in the UC group. A future use as biomarkers of disease activity and response to treatment might be feasible.

Efficacy, drug sustainability, and safety of ustekinumab treatment in Crohn’s disease patients over three years

Long-term data on ustekinumab in real-life Crohn’s disease patients are still missing, though randomized controlled trials demonstrated it as a favorable therapeutic option. We aimed to evaluate ustekinumab's clinical efficacy, drug sustainability, and safety in a prospective, nationwide, multicenter Crohn’s disease patient cohort with a three-year follow-up. Crohn’s disease patients on ustekinumab treatment were consecutively enrolled from 9 Hungarian Inflammatory Bowel Disease centers between January 2019 and May 2020. Patient and disease characteristics, treatment history, clinical disease activity (Harvey Bradshaw Index (HBI)), biomarkers, and endoscopic activity (Simple Endoscopic Score for Crohn’s Disease (SES-CD)) were collected for three-years’ time. A total of 148 patients were included with an overall 48.9% of complex behavior of the Crohn’s disease and 97.2% of previous anti-TNF exposure. The pre-induction remission rates were 12.2% (HBI), and 5.1% (SES-CD). Clinical remission rates (HBI) were 52.2%, 55.6%, and 50.9%, whereas criteria of an endoscopic remission were fulfilled in 14.3%, 27.5%, and 35.3% of the subjects at the end of the first, second, and third year, respectively. Dose intensification was high with 84.0% of the patients on an 8-weekly and 29.9% on a 4-weekly regimen at the end of year 3. Drug sustainability was 76.9% during the follow-up period with no serious adverse events observed. Ustekinumab in the long-term is an effective, sustainable, and safe therapeutic option for Crohn’s disease patients with severe disease phenotype and high previous anti-TNF biological failure, requiring frequent dose intensifications.

Lemann Index for Assessing Bowel Damage in Crohn’s Disease: A Real-world Study

Abstract Background and Aims The Lemann Index [LI], an endpoint to measure cumulative structural bowel damage in Crohn’s disease [CD], has been recently updated and validated. We applied this to investigate predictors of bowel damage in a real-world cohort. Methods We performed a retrospective study [2008–2022] involving two tertiary referral IBD centres in the USA. Magnetic resonance imaging [MR] or computed tomography [CT] enterographies were reviewed by study radiologists with endoscopy reports by study gastroenterologists, to calculate LI scores. Baseline and follow-up LI scores were calculated. We defined high bowel damage as LI ≥ 2. Factors associated with high LI were identified in patients with ≥ 2 LI scores, using multivariate logistic regression, and then assessed for a change in LI [increase vs no change/decrease], using a multivariate linear mixed-effects model. Results A total of 447 patients with CD had a median first LI of 7 (interquartile range [IQR], 1.25–14.55). Median LI scores were significantly different when categorised by disease duration; 2.0 [IQR, 0.6–5.9] for &amp;lt; 2 years, 2.6 [IQR, 0.6–9.6] for ≥ 2 and &amp;lt; 10 years, and 12.5 [IQR, 6.4–21.5] for ≥ 10 years, with a p &amp;lt; 0.01. Disease duration, presence of perianal disease, elevated C-reactive protein, and Harvey–Bradshaw index, were associated with a high LI at inclusion and increase in LI during follow-up [all p &amp;lt; 0.01]. Conclusions The updated LI quantified cross-sectional and longitudinal cumulative bowel damage in a real-world cohort of patients with CD, with predictors identified for a longitudinal increase in LI. Further studies for prospective validation of LI and identification of multi-omic predictors of bowel damage are needed.