{"title":"Development and Validation of a Scoring System to Predict 2-Year Clinical Remission in Ulcerative Colitis Patients on Vedolizumab.","authors":"Thanaboon Chaemsupaphan, Aviv Pudipeddi, Huiyu Lin, Sudarshan Paramsothy, Viraj Kariyawasam, Melissa Kermeen, Rupert W Leong","doi":"10.1093/crocol/otae068","DOIUrl":"https://doi.org/10.1093/crocol/otae068","url":null,"abstract":"<p><strong>Background and aims: </strong>Vedolizumab is s gut-selective advanced therapy that is safe and efficacious for the treatment of ulcerative colitis (UC). Once patients achieve successful induction, there is a risk of loss of response leading to eventual flare. We aimed to identify these predictive factors and develop a practical scoring system to determine the ongoing efficacy of vedolizumab.</p><p><strong>Methods: </strong>We performed logistic regression on prospectively recruited UC subjects from the Vedolizumab Immunomodulator Enforced Withdrawal Study (VIEWS). All patients were in corticosteroid-free clinical remission and endoscopic improvement at baseline and continued vedolizumab. Predictive factors of 2-year corticosteroid-free clinical remission were determined and modeled into the VIEWS score, then validated in a real-world UC cohort.</p><p><strong>Results: </strong>Of 62 patients in the derivation cohort, 48 (77.4%) maintained clinical remission over two years. The predictive factors of remission were female (odds ratio [OR] 6.0, 95% confidence interval [CI], 1.2-29.7), antitumor necrosis factor naive (OR 3.8, 95% CI,1.0-14.0), baseline histological remission (OR 10.8, 95% CI, 2.4-48.4), thiopurine combination (OR 3.6, 95% CI, 0.7-18.0), and fecal calprotectin level ≤250 µg/g (OR 6.3, 95% CI, 0.9-42.2). These factors were incorporated into VIEWS score, yielding an area under the receiver-operating characteristic (AUROC) curve of 0.89 (95% CI, 0.81-0.98) in the prediction of 2-year clinical remission. Of 64 UC patients in the validation cohort, 40 (62.5%) remained in clinical remission at 2 years with AUROC of 0.77 (95% CI, 0.60-0.94). At the cut-off threshold of 4, the VIEWS score identified 2-year clinical remission with a sensitivity of 88.4% and specificity of 63.6%.</p><p><strong>Conclusions: </strong>Our study determined predictive factors and proposed a scoring system of ongoing clinical remission in UC patients on maintenance vedolizumab. In patients at high risk of relapse, combination therapy with thiopurine may be beneficial.</p>","PeriodicalId":10847,"journal":{"name":"Crohn's & Colitis 360","volume":"7 1","pages":"otae068"},"PeriodicalIF":1.8,"publicationDate":"2024-12-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11700619/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142930854","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Crohn's & Colitis 360Pub Date : 2024-12-23eCollection Date: 2025-01-01DOI: 10.1093/crocol/otae069
Brittaney Bonhomme, Neilanjan Nandi, Shivali Berera, Helen Lee, Galen Leung, Chung Sang Tse, Alexandra Weiss, Lisa Nessel, Yue Ren, Hongzhe Li, Faten N Aberra, James D Lewis
{"title":"Greater Fatigue and Reduced Neurocognitive Speed With Symptomatic Crohn's Disease.","authors":"Brittaney Bonhomme, Neilanjan Nandi, Shivali Berera, Helen Lee, Galen Leung, Chung Sang Tse, Alexandra Weiss, Lisa Nessel, Yue Ren, Hongzhe Li, Faten N Aberra, James D Lewis","doi":"10.1093/crocol/otae069","DOIUrl":"10.1093/crocol/otae069","url":null,"abstract":"<p><strong>Background: </strong>While patients with Crohn's disease commonly report fatigue, an association of Crohn's disease with mild neurocognitive impairment has also been suggested. This study investigated the relationship between Crohn's disease activity, fatigue, and neurocognitive functioning.</p><p><strong>Methods: </strong>In this cross-sectional study, adults with Crohn's disease (<i>n</i> = 25) and healthy controls (<i>n</i> = 26) completed the PROMIS Fatigue 7a form and Multidimensional Fatigue Inventory and neurocognitive testing across 6 domains. Symptomatic and endoscopic remission were assessed with a short Crohn's Disease Activity Index and Simple Endoscopic Score for Crohn's Disease. Linear regression adjusting for age and sex was used to compare fatigue and neurocognition among patients with Crohn's disease versus controls and those with active Crohn's disease versus those in remission.</p><p><strong>Results: </strong>Compared to controls, adults with Crohn's disease reported greater overall and domain-specific fatigue (general, physical, and mental) (<i>P</i> < .05 for all comparisons). Patients in symptomatic remission had significantly less fatigue (<i>P</i> < .05). No differences were found in neurocognitive accuracy or speed between Crohn's disease and controls. Disease activity was not associated with accuracy on neurocognitive testing; however, patients with symptomatic Crohn's disease had longer correct response times for social cognition and episodic memory compared to asymptomatic patients (<i>P</i> < .05). Endoscopic disease activity was associated with longer correct response times for tasks linked to social cognition, episodic memory, and complex cognition (<i>P</i> < .05). These differences persisted after adjusting for fatigue.</p><p><strong>Conclusions: </strong>Patients with symptomatic Crohn's disease experience greater fatigue and have slower response times on neurocognitive testing. However, fatigue does not appear to mediate the slower response times.</p>","PeriodicalId":10847,"journal":{"name":"Crohn's & Colitis 360","volume":"7 1","pages":"otae069"},"PeriodicalIF":1.8,"publicationDate":"2024-12-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11684080/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142913860","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Crohn's & Colitis 360Pub Date : 2024-12-21eCollection Date: 2025-01-01DOI: 10.1093/crocol/otae073
Linda A Feagins, Page Moore, Margaux M Crabtree, Melissa Eliot, Celeste A Lemay, Anita M Loughlin, Jill K J Gaidos
{"title":"Impact of Fatigue on Work Productivity, Activity Impairment, and Healthcare Resource Utilization in Inflammatory Bowel Disease.","authors":"Linda A Feagins, Page Moore, Margaux M Crabtree, Melissa Eliot, Celeste A Lemay, Anita M Loughlin, Jill K J Gaidos","doi":"10.1093/crocol/otae073","DOIUrl":"10.1093/crocol/otae073","url":null,"abstract":"<p><strong>Objectives: </strong>Fatigue is commonly reported in patients with Crohn's disease (CD) and ulcerative colitis (UC), including patients with inactive disease. We explored the impact of fatigue on healthcare utilization (HCU) and work productivity and activity impairment (WPAI).</p><p><strong>Methods: </strong>Data collected between 2017 and 2022 were analyzed from the CorEvitas IBD Registry. We compared HCU and WPAI among subjects with high fatigue (PROMIS ≥55) versus low fatigue at enrollment and subjects whose fatigue score worsened or persisted versus low fatigue at 6 months. HCU was defined as an inflammatory bowel disease-related hospitalization or emergency room visit. WPAI included presenteeism, absenteeism, and lost WPAI. Logistic regression analysis was performed.</p><p><strong>Results: </strong>Study patients (640 CD, 569 UC) reported high rates of fatigue, 47% in CD and 38% in UC, that persisted at least 6 months in 88%-89% of patients. Patients with UC with high fatigue had 3-fold higher rates of HCU and 2-3-fold more absenteeism and activity impairment than patients with low fatigue. Patients with CD with high fatigue had no difference in HCU but did experience 2-4-fold more absenteeism, presenteeism, work productivity loss, and activity impairment. On subgroup analysis of patients in remission, those with high fatigue did not have higher rates of HCU but continued to have higher rates of WPAI.</p><p><strong>Conclusions: </strong>Fatigue is associated with an increase in HCU only in the setting of concomitantly active disease. On the other hand, fatigue is associated with a negative impact on WPAI in the setting of both active and inactive disease.</p>","PeriodicalId":10847,"journal":{"name":"Crohn's & Colitis 360","volume":"7 1","pages":"otae073"},"PeriodicalIF":1.8,"publicationDate":"2024-12-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11684069/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142913861","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Crohn's & Colitis 360Pub Date : 2024-12-20eCollection Date: 2025-01-01DOI: 10.1093/crocol/otae066
Ahmed Nadeem, Sydney Donohue, Fatima Zehra Shah, Jaime Abraham Perez, Elleson Harper, Preetika Sinh, Ruthvik Padival, Gregory Cooper, Jeffry Katz, Fabio Cominelli, Miguel Regueiro, Emad Mansoor
{"title":"Early Onset Active Inflammatory Bowel Disease Is Associated With Psychiatric Comorbidities: A Multi-Network Propensity-Matched Cohort Study.","authors":"Ahmed Nadeem, Sydney Donohue, Fatima Zehra Shah, Jaime Abraham Perez, Elleson Harper, Preetika Sinh, Ruthvik Padival, Gregory Cooper, Jeffry Katz, Fabio Cominelli, Miguel Regueiro, Emad Mansoor","doi":"10.1093/crocol/otae066","DOIUrl":"10.1093/crocol/otae066","url":null,"abstract":"<p><strong>Background: </strong>Psychiatric disease burden in patients with Inflammatory bowel disease (IBD) has risen substantially over the past few decades. However, there is limited data on the relationship between IBD disease activity and the incidence of psychiatric comorbidities. We sought to conduct a population-based study to investigate the impact of early onset disease activity in newly diagnosed IBD patients on psychiatric disease diagnoses and medication usage.</p><p><strong>Methods: </strong>We performed a retrospective cohort study using the TriNetX database. We identified all adult patients diagnosed with IBD and documented IBD-specific medication use. We stratified these IBD patients into 2 cohorts based on IBD Disease Activity, occurring 6 months to 1 year after initial IBD diagnosis. Active IBD was defined as the utilization of steroids and/or elevated fecal calprotectin [≥200 µg/g] occurring 6 months to 1 year after initial IBD diagnosis. We examined the outcomes of psychiatric disease diagnoses and psychotropic medication prescriptions occurring 1 year after the initial diagnosis.</p><p><strong>Results: </strong>Out of 69 105 patients with an IBD diagnosis during the study period, after propensity score matching, 16 922 IBD patients each were included in the 2 cohorts based on disease activity. Patients with active IBD had significantly higher odds of developing major depressive disorder, anxiety disorder, bipolar disorder, alcohol use disorder, opiate use disorder, attention deficit hyperactivity disorder, and obsessive-compulsive disorder. Additionally, patients with active IBD also had significantly higher odds of using all studied psychotropic medications, including antidepressants, antipsychotic medications, anxiolytics, sedatives, hypnotic medications, mood stabilizers, stimulant medications, and medications used for substance use disorders (including alcohol, opioid, and tobacco use).</p><p><strong>Conclusions: </strong>Active IBD shortly after the IBD diagnosis is associated with a higher incidence of psychiatric comorbidities. Awareness of behavioral health in IBD is important, and proper treatment is necessary.</p>","PeriodicalId":10847,"journal":{"name":"Crohn's & Colitis 360","volume":"7 1","pages":"otae066"},"PeriodicalIF":1.8,"publicationDate":"2024-12-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11694680/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142920927","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Crohn's & Colitis 360Pub Date : 2024-12-20eCollection Date: 2025-01-01DOI: 10.1093/crocol/otae078
Erica J Brenner, Mary E Grewe, Catalina Berenblum Tobi, Amy G Bryant, Marla C Dubinsky, Xian Zhang, Millie D Long, Michael D Kappelman, Mara Buchbinder
{"title":"Perspectives on Contraception, Pregnancy, and Reproductive Health Counseling from Young Women With Inflammatory Bowel Disease.","authors":"Erica J Brenner, Mary E Grewe, Catalina Berenblum Tobi, Amy G Bryant, Marla C Dubinsky, Xian Zhang, Millie D Long, Michael D Kappelman, Mara Buchbinder","doi":"10.1093/crocol/otae078","DOIUrl":"10.1093/crocol/otae078","url":null,"abstract":"<p><strong>Background/aims: </strong>Active inflammatory bowel disease (IBD) increases the risk of pregnancy complications and contraceptive side effects, and contraceptive use may impact the clinical course of IBD. Although young people are at elevated risk for unintended pregnancy, those with IBD receive minimal disease-specific contraceptive guidance. We characterized perspectives and preferences on contraception and reproductive health counseling from young <i>cis-</i>women with IBD.</p><p><strong>Methods: </strong>We conducted 60-min semi-structured interviews with <i>cis</i>-women with IBD ages 18-30 (recruited nationwide and from North Carolina IBD clinics; February-June 2023). Interview guides included questions about reproductive health and preferences for receiving reproductive health information. Audio-recordings were professionally transcribed and coded using an inductive, thematic approach and Dedoose software.</p><p><strong>Results: </strong>Participants included 30 <i>cis-</i>women with IBD (ages 18-30, 77% White, 7% Hispanic, and 55% Crohn's disease). Some participants shared that IBD increased their menstrual symptom burden, prompting contraceptive use to control menses. Participants discussed the impact of IBD on their contraceptive decision-making, including concerns regarding blood clots. For a participant subset, IBD did not impact contraceptive decision-making. Participants discussed how IBD impacted their perspectives on childbearing, including concerns about IBD heritability, infertility, and peripartum IBD flares. Participants wanted their gastroenterology provider to proactively address reproductive health, provide appropriate resources, and coordinate care with reproductive health providers.</p><p><strong>Conclusions: </strong>Young <i>cis</i>-women with IBD may have IBD-specific concerns about contraceptives, pregnancy, and menstrual symptoms and desire better IBD-related reproductive health counseling. Inflammatory bowel disease providers can improve reproductive health counseling by proactively addressing IBD-specific reproductive health questions, providing reproductive health resources, and coordinating care.</p>","PeriodicalId":10847,"journal":{"name":"Crohn's & Colitis 360","volume":"7 1","pages":"otae078"},"PeriodicalIF":1.8,"publicationDate":"2024-12-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11700615/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142930855","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Crohn's & Colitis 360Pub Date : 2024-12-17eCollection Date: 2025-01-01DOI: 10.1093/crocol/otae080
Syed Adeel Hassan, Courtney Perry, Patrick Carey, Durham Colohan, Mohamed Gebril Eltaher, Nabila Dawoud, Mahmoud Elkammar, Waqas Rasheed, Casie Mayne, Amy Stuffelbeam, Deborah Flomenhoft, Terrence A Barrett
{"title":"Dual Biologic Therapy Induces Remission in Refractory Crohn's Disease With Vedolizumab and Ustekinumab.","authors":"Syed Adeel Hassan, Courtney Perry, Patrick Carey, Durham Colohan, Mohamed Gebril Eltaher, Nabila Dawoud, Mahmoud Elkammar, Waqas Rasheed, Casie Mayne, Amy Stuffelbeam, Deborah Flomenhoft, Terrence A Barrett","doi":"10.1093/crocol/otae080","DOIUrl":"10.1093/crocol/otae080","url":null,"abstract":"<p><strong>Background: </strong>Despite advancements in the therapeutic armamentarium for Crohn's disease (CD), biologic and small molecule monotherapies are associated with sub-optimal response and remission rates. Utilizing dual biologic therapy (DBT) holds the potential to increase efficacy in the treatment of refractory or partially responsive CD. Evidence pertaining to this strategy remains limited.</p><p><strong>Methods: </strong>We retrospectively examined refractory CD patients treated with a combination of ustekinumab and vedolizumab. Outcomes to DBT at week (wk) 52 were compared to monotherapy. The primary outcome constituted corticosteroid-free remission. Secondary outcomes included adverse events, infections, hospitalizations, surgeries, treatment persistence, and disease clearance.</p><p><strong>Results: </strong>Sixteen of 21 active refractory CD patients (76%) on DBT achieved disease remission at wk 52. Mucosal healing was observed in 38% (<i>n</i> = 6), biochemical remission in 25% (<i>n</i> = 4), and both clinical and biochemical remission in 38% (<i>n</i> = 6). Of these patients, 50% (<i>n</i> = 8) achieved corticosteroid-free remission. Three patients (37.5%) with corticosteroid-free remission achieved complete disease clearance. Paired median fecal calprotectin decreased from 508 to 118 µg/g (<i>P</i> < .0001). Paired C-reactive protein median decreased from 1.04 to 0.50 mg/dL (<i>P</i> < .0001). Median Harvey Bradshaw Index score reduced from 7 to 2 (<i>P</i> = .003). Endoscopic healing was achieved with a paired simple endoscopic score for CD decrease from 6 to 3 (<i>P</i> = .013). Corticosteroid dependency reduced from 17 to 8 patients discontinuing altogether. Patients still requiring corticosteroids experienced a decrease in average daily dose from 9 to 6 mg (<i>P</i> = .045). At wk 52, 5 patients (24%) did not meet the criteria for remission with 4 requiring CD-related surgical intervention. Mean CD-related hospitalizations reduced from 2.95 ± 2.33 to 0.52 ± 1.12 (<i>P</i> < .001) and surgeries from 1.76 ± 1.3 to 0.14 ± 0.4 (<i>P</i> < .001). Three infections with 1 requiring hospitalization and 1 report of headache were noted. Two patients discontinued DBT.</p><p><strong>Conclusions: </strong>Dual biologic therapy with ustekinumab and vedolizumab is a safe and effective strategy to induce disease remission in refractory CD. Large-scale studies are necessary to validate findings in a prospective setting.</p>","PeriodicalId":10847,"journal":{"name":"Crohn's & Colitis 360","volume":"7 1","pages":"otae080"},"PeriodicalIF":1.8,"publicationDate":"2024-12-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11759274/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143045800","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Exit Interviews Exploring Patients' Experience of Change in Crohn's Disease Symptoms During the Mirikizumab Phase 3 Clinical Trial In Adult Patients With Moderately-to-Severely Crohn's Disease.","authors":"Theresa Hunter Gibble, Jake Macey, Harriet Makin, Rodica Rosu, Katie Mellor, Helen Kitchen, Emily Hon, Marla Dubinsky","doi":"10.1093/crocol/otae079","DOIUrl":"10.1093/crocol/otae079","url":null,"abstract":"<p><strong>Background: </strong>Exit interviews with patients who completed the Phase 3 VIVID-1 mirikizumab clinical trial for moderately-to-severely active Crohn's disease explored the content validity of bowel urgency, stool frequency, and abdominal pain patient-reported outcome measures and perceptions of meaningful within-patient change and remission in these key Crohn's disease symptoms.</p><p><strong>Methodology: </strong>Cognitive debriefing explored patient understanding of the bowel urgency numeric rating scale (Urgency NRS), Crohn's Disease Activity Index: Stool Frequency (CDAI-SF) and Abdominal Pain (CDAI-AP), and patient global rating/impression of severity/change (PGRS/PGIC). Perceptions of meaningful change and remission were explored qualitatively. Transcripts were analyzed using directed content and framework analysis.</p><p><strong>Results: </strong>Interviewed participants (<i>N</i> = 62; mean age 44.8 years, 55% female, mean 12.0 years since Crohn's disease diagnosis) were from the United States (<i>n</i> = 29), Czech Republic (<i>n</i> = 10), Poland (<i>n</i> = 8), Germany (<i>n</i> = 7), Canada (<i>n</i> = 4), Australia (<i>n</i> = 3), and the United Kingdom (<i>n</i> = 1). Participants understood the Urgency NRS, CDAI-SF, and CDAI-AP and could use them to rate their bowel urgency, stool frequency, and abdominal pain. Participants considered these symptoms when responding to the PGRS/PGIC. Meaningful change was described as symptom relief resulting in the ability to live daily life without pain or fear/need of rushing to the toilet. Most participants agreed with a proposed remission definition of ≤3 type 6/7 bowel movements and None/Mild abdominal pain.</p><p><strong>Discussion: </strong>The Urgency NRS, CDAI-SF, and CDAI-AP are content-valid patient-reported outcome measures in Crohn's disease. The PGRS/PGIC are conceptually related global assessments of bowel urgency, stool frequency, and abdominal pain. Patients considered reduction in these symptoms as meaningful and remission.</p>","PeriodicalId":10847,"journal":{"name":"Crohn's & Colitis 360","volume":"7 1","pages":"otae079"},"PeriodicalIF":1.8,"publicationDate":"2024-12-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11744098/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143001640","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Crohn's & Colitis 360Pub Date : 2024-12-07eCollection Date: 2024-10-01DOI: 10.1093/crocol/otae067
Sam Rosenfeld, Kindra Clark-Snustad, Kendra J Kamp, Jeffrey Jacobs, Mitra Barahimi, Jason Harper, Scott David Lee
{"title":"Mycophenolate Mofetil Appears Effective for the Treatment of Patients With Refractory Crohn's Disease.","authors":"Sam Rosenfeld, Kindra Clark-Snustad, Kendra J Kamp, Jeffrey Jacobs, Mitra Barahimi, Jason Harper, Scott David Lee","doi":"10.1093/crocol/otae067","DOIUrl":"10.1093/crocol/otae067","url":null,"abstract":"<p><strong>Background: </strong>Medically refractory Crohn's disease (CD) is associated with a high risk of complications. Mycophenolate mofetil (MMF), a small molecule immunosuppressant, has limited data in patients with CD, and objective endoscopic response to MMF has not been reported.</p><p><strong>Aims: </strong>We evaluated the safety and clinical, endoscopic, and biochemical effectiveness of off-label MMF for refractory CD as monotherapy or in combination with a biologic in patients with CD.</p><p><strong>Methods: </strong>We retrospectively assessed adverse events (AEs), clinical response (Harvey-Bradshaw index), endoscopic response (simple endoscopic score in Crohn's disease), and physician global assessment at an academic medical center and county hospital.</p><p><strong>Results: </strong>60 patients received MMF as monotherapy (<i>n</i> = 40) or in combination with a biologic (<i>n</i> = 20) between 2008 and 2021 at a dose ranging from 1000 to 4000 mg daily. Median age was 39 years and median disease duration was 12 years. All patients previously failed ≥ 1 advanced therapy (median = 4). The median MMF therapy duration was 27 weeks. 54% achieved clinical response and 19% achieved clinical remission after a mean of 19.5 weeks (SD 14.5). Endoscopic response occurred in 32%, endoscopic remission in 16%, and endoscopic healing in 4% after a mean of 46.6 weeks (SD 31.0). 48% of patients experienced AEs, most commonly mild infection, nausea/vomiting, and headache. One serious AE occurred, which was assessed as unrelated to MMF.</p><p><strong>Conclusions: </strong>MMF resulted in clinical, endoscopic, and biochemical benefits in some patients with refractory CD, and was tolerated by most patients. Further randomized controlled trials are needed to define optimal dosing and long-term efficacy and safety.</p>","PeriodicalId":10847,"journal":{"name":"Crohn's & Colitis 360","volume":"6 4","pages":"otae067"},"PeriodicalIF":1.8,"publicationDate":"2024-12-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11655623/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142863453","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Crohn's & Colitis 360Pub Date : 2024-12-07eCollection Date: 2024-10-01DOI: 10.1093/crocol/otae075
Samantha Winders, Linda Yoo, Margaret Heitkemper, Kendra Kamp
{"title":"Multilevel Factors and Sleep in Adults With Inflammatory Bowel Disease: A Qualitative Study.","authors":"Samantha Winders, Linda Yoo, Margaret Heitkemper, Kendra Kamp","doi":"10.1093/crocol/otae075","DOIUrl":"10.1093/crocol/otae075","url":null,"abstract":"<p><strong>Background: </strong>This study aimed to describe the patient-reported factors that impact sleep among individuals with inflammatory bowel disease (IBD), aligning with the Social Ecological Model of Sleep. This addresses the gap in IBD sleep research, which predominantly focuses on individual-level factors and their impact on sleep.</p><p><strong>Methods: </strong>Adults (ages 18-65) with IBD were recruited online through ResearchMatch in June 2023. Participants filled out survey questions on their demographic characteristics, health history, sleep, and IBD-related symptoms. Content analysis was conducted on 2 open-ended questions about factors that impacted their sleep.</p><p><strong>Results: </strong>This analysis included 163 adults with IBD (<i>M</i> = 39 years of age, 76.7% White, 91.4% non-Hispanic or Latino, 66.9% female, and 83.4% active IBD) who answered open-ended questions with comments about their sleep. Most participants indicated an individual-level factor impacted their sleep quality (85.3%, <i>n</i> = 139), categorized into 5 subthemes: Mental health, health, behavior and choices, physiology, and attitudes. Additionally, participants (43.6%, <i>n</i> = 71) mentioned social-level factors divided into 7 subthemes: Family, work, home, neighborhood, social network, and school. A smaller group of participants (17.2%, <i>n</i> = 28) mentioned societal-level factors designated into 4 subthemes: Natural environment and geography, technology, 24/7 society, and economics.</p><p><strong>Conclusions: </strong>This study highlights the need for tailored sleep interventions for those with IBD that consider not only disease activity but also mental health, family, work, and the natural environment. IBD clinics should prioritize sleep health using an interdisciplinary approach to holistically address the unique needs of those with IBD.</p>","PeriodicalId":10847,"journal":{"name":"Crohn's & Colitis 360","volume":"6 4","pages":"otae075"},"PeriodicalIF":1.8,"publicationDate":"2024-12-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11649995/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142845964","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Crohn's & Colitis 360Pub Date : 2024-11-29eCollection Date: 2025-01-01DOI: 10.1093/crocol/otae074
Jim Kershaw, Myrlene Sanon, Sumesh Kachroo, Sophie Barlow, Dominik Naessens, Cynthia J Willey, Grace O'Neill, Timothy Hoops
{"title":"Real-World Impact of Uncontrolled Symptoms and Suboptimal Treatment Response in Patients With Crohn's Disease in the United States and Europe.","authors":"Jim Kershaw, Myrlene Sanon, Sumesh Kachroo, Sophie Barlow, Dominik Naessens, Cynthia J Willey, Grace O'Neill, Timothy Hoops","doi":"10.1093/crocol/otae074","DOIUrl":"10.1093/crocol/otae074","url":null,"abstract":"<p><strong>Background: </strong>Despite a wide range of available treatments, there is limited evidence as to why significant numbers of Crohn's disease (CD) patients do not achieve disease remission or continue to have residual symptom burden. We aimed to quantify the impact of this suboptimal treatment on patient symptom incidence and severity, quality of life (QoL), and work impairment.</p><p><strong>Methods: </strong>Data were derived from the Adelphi Real World CD Disease Specific Programme, a cross-sectional survey of CD patients and their treating physicians in France, Germany, Italy, Spain, the United Kingdom, and the United States between January 2020 and March 2021. Physicians reported on patients' clinical history, disease status, symptom load, and treatment. Patients reported their QoL and activity impairment using the EQ-5D-5L and Work Productivity and Activity Impairment measures. Patients were divided into remitters, partial remitters, and non-remitters. Multivariate regression models were used to assess the impact of remission status on clinical and QoL outcomes.</p><p><strong>Results: </strong>Of 1786 patients, 24.1% were remitters, 53.2% were partial remitters, and 22.7% were non-remitters. Partial remitters and non-remitters had a significantly higher symptom load than remitters (<i>P</i> < .05), and non-remitters were up to 15 times more likely to experience key symptoms than remitters. Both non-remitters and partial remitters were also significantly more likely to have increased symptom severity (<i>P</i> < .05). Non-remitters were more likely to have switched treatment and received more treatment lines, as well as having significantly worse QoL, than remitters.</p><p><strong>Conclusions: </strong>Suboptimal treatment response was associated with increased symptoms and QoL burden. Despite the increased burden experienced, partial remitters were not more likely to switch or receive more treatment lines than remitters, demonstrating the need to initiate effective therapy.</p>","PeriodicalId":10847,"journal":{"name":"Crohn's & Colitis 360","volume":"7 1","pages":"otae074"},"PeriodicalIF":1.8,"publicationDate":"2024-11-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11744185/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143001561","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}