Crohn's & Colitis 360最新文献

{"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}

{"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}

{"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}

{"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}

{"title":"Association Between Serum Ustekinumab Concentrations and Endoscopic Disease Activity in Moderate-to-Severe Crohn's Disease Patients.","authors":"David M P Di Fonzo, Balqis Alabdulkarim, Russell Yanofsky, Yaqeen Abduallah, Petra Golovics, Peter L Lakatos, Alain Bitton, Gary Wild, Waqqas Afif, Talat Bessissow","doi":"10.1093/crocol/otae071","DOIUrl":"10.1093/crocol/otae071","url":null,"abstract":"<p><strong>Background/aims: </strong>The role of ustekinumab therapeutic drug monitoring in patients with Crohn's disease (CD) remains ambiguous. Examination of the association serum ustekinumab concentrations and endoscopic outcomes has yielded inconsistent results. Our study examined whether serum ustekinumab concentrations were associated with endoscopic healing in patients with moderate-to-severe CD.</p><p><strong>Methods: </strong>This was a cross-sectional study of adult patients with CD on maintenance ustekinumab. Patients were included if they had serum ustekinumab concentrations and endoscopic evaluation taken within 4 months of each other. Endoscopic healing was defined as absence of ulceration on endoscopy or Simplified Endoscopic Score for Crohn's disease (SES-CD) < 3. Quartile analysis of drug levels was performed, and receiver operating characteristic curve was calculated. Multivariate logistic regression assessed for the probability of endoscopic healing based on serum ustekinumab concentration.</p><p><strong>Results: </strong>Seventy-four patients were included in the final analysis. The mean serum ustekinumab concentration of the population was 6.10 mcg/mL. Serum ustekinumab concentration did not predict endoscopic remission based on either the absence of ulceration or SES-CD < 3. There was no difference in the frequency of ulceration at increasing serum ustekinumab concentrations. There was no threshold serum ustekinumab concentration associated with the absence of ulceration (area under the curve [AUC] = 0.50) or SES-CD < 3 (AUC = 0.49).</p><p><strong>Conclusions: </strong>Our study found no association between serum ustekinumab concentrations and endoscopic remission in patients with CD. Exploration of mechanisms accounting for this lack of association is warranted.</p>","PeriodicalId":10847,"journal":{"name":"Crohn's & Colitis 360","volume":"6 4","pages":"otae071"},"PeriodicalIF":1.8,"publicationDate":"2024-11-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11635169/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142817489","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":"A Future Avenue of Treatment Ulcerative Colitis Targeting Macrophage Polarization: A Phytochemical Application.","authors":"Nishant Kumar Saurabh, Mohd Mabood Khan, Annet Kirabo","doi":"10.1093/crocol/otae070","DOIUrl":"10.1093/crocol/otae070","url":null,"abstract":"<p><strong>Background: </strong>Ulcerative colitis (UC) is a prevalent inflammatory bowel disease primarily impacting the mucosa of the colon. It is characterized by recurring and incurable symptoms and causes immense suffering and significant economic burden due to limited treatment options. Typical symptoms of UC include diarrhea, alterations in bowel patterns, bleeding from the rectum, rectal pain or urgency, anemia, and tiredness. Therefore, developing novel and effective treatment strategies for UC is imperative.</p><p><strong>Purpose: </strong>This review aimed to explain how macrophage polarization contributes to UC development and compiled information on natural compounds with promising therapeutic potential that can target the macrophage phenotype and shed light on its potential mode of action.</p><p><strong>Results: </strong>The phenotypic alteration of macrophages profoundly affects the development of UC, and these cells are essential for preserving intestinal immunological homeostasis. Evidence from research suggests that one effective method for UC prevention and therapy is to guide macrophage polarization toward the M2 phenotype. Phytochemicals, which are compounds extracted from plants, possess a wide array of biological activities. For example: Ginsenoside Rg1 emerges as a crucial regulator of macrophage polarization, promoting the M2 phenotype while inhibiting the M1 phenotype. Notably, their low toxicity and high effectiveness render them promising candidates for therapeutic interventions. These compounds have demonstrated encouraging protective effects against inflammation in the colon.</p><p><strong>Conclusions: </strong>Exploring phytochemicals as a therapeutic avenue targeting macrophage polarization presents an innovative approach to treating UC.</p>","PeriodicalId":10847,"journal":{"name":"Crohn's & Colitis 360","volume":"6 4","pages":"otae070"},"PeriodicalIF":1.8,"publicationDate":"2024-11-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11635166/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142817486","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":"Clinical Course of Isolated Recurrent, Persistent Complex Perianal Fistulas Without Luminal Crohn's Disease: A Multicenter Case Series of 24 Patients.","authors":"Hannah W Fiske, Chung Sang Tse, Badr Al-Bawardy, Pooja Magavi, Gauree Gupta Konijeti, Eric Mao, Sean Fine, Alyssa Parian, Mark Lazarev, Samir A Shah","doi":"10.1093/crocol/otae065","DOIUrl":"10.1093/crocol/otae065","url":null,"abstract":"<p><strong>Background: </strong>Isolated complex perianal fistulas, without luminal evidence of inflammatory bowel disease in the gastrointestinal tract, pose diagnostic and treatment dilemmas for gastroenterologists and colorectal surgeons. For patients who develop recurrent complex fistulas, a presumptive diagnosis of Crohn's disease may be made. It is unclear whether these cases of isolated perianal disease in the absence of luminal inflammation truly represent isolated severe cryptoglandular fistulas or rather an early presentation of Crohn's disease. We aimed to investigate the clinical course and outcomes of patients with isolated complex perianal fistulas.</p><p><strong>Methods: </strong>In this retrospective multicenter case series across 6 institutions in the United States, we report the clinical course of patients with isolated recurrent complex perianal fistulas, including their diagnostic evaluation, medical and surgical therapies, and clinical outcomes.</p><p><strong>Results: </strong>All patients (<i>n</i> = 24) required incision and drainage of perirectal abscesses. The majority received setons (<i>n</i> = 19, 79%), more intensive surgical interventions (<i>n</i> = 15, 62.5%, including fistulotomy/sphincterotomy, advancement flap, and ligation of the intersphincteric fistula tract), antibiotics (<i>n</i> = 17, 71%), and biologic therapy (<i>n</i> = 16, 67%). Nine patients (37.5%) underwent a combined medical-surgical approach with biologics and intensive surgical intervention. Despite surgical and/or medical management, active symptomatic complex perianal fistulas persisted in 58% (<i>n</i> = 14) of patients at follow-up (median 5.5 years, interquartile range 2.5-10 years); symptom remission was achieved in 21% (<i>n</i> = 5), and fistula closure in 21% (<i>n</i> = 5).</p><p><strong>Conclusions: </strong>These cases highlight a multidisciplinary and multimodal approach when treating isolated complex perianal fistulas and their propensity to persist despite the incorporation of advanced therapies.</p>","PeriodicalId":10847,"journal":{"name":"Crohn's & Colitis 360","volume":"6 4","pages":"otae065"},"PeriodicalIF":1.8,"publicationDate":"2024-11-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11645454/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142827435","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":"What to Expect When Switching to a Biosimilar: A US Healthcare Professional's Perspective.","authors":"Juanita Belton, Nicholas D'Apice","doi":"10.1093/crocol/otae063","DOIUrl":"10.1093/crocol/otae063","url":null,"abstract":"<p><p>As biosimilars become more available, many patients with inflammatory bowel disease may experience having their treatment switched from a reference product to a biosimilar. In this communication, a physician assistant and a pharmacist discuss the patient experience when switching to a biosimilar.</p>","PeriodicalId":10847,"journal":{"name":"Crohn's & Colitis 360","volume":"6 4","pages":"otae063"},"PeriodicalIF":1.8,"publicationDate":"2024-11-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11852270/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143499634","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":"Predictive Model for Outcomes in Inflammatory Bowel Disease Patients Receiving Maintenance Infliximab Therapy.","authors":"Rochelle Wong, Paris Charilaou, Amy Hemperly, Lihui Qin, Yushan Pan, Prerna Mathani, Randy Longman, Brigid S Boland, Parambir S Dulai, Ariela K Holmer, Dana Lukin, Siddharth Singh, Mark A Valasek, William J Sandborn, Ellen Scherl, Niels Vande Casteele, Robert Battat","doi":"10.1093/crocol/otae052","DOIUrl":"10.1093/crocol/otae052","url":null,"abstract":"<p><strong>Background: </strong>No models predict future outcomes in inflammatory bowel disease (IBD) patients receiving maintenance infliximab therapy. We created a predictive model for unfavorable outcomes.</p><p><strong>Methods: </strong>Adult patients with IBD receiving maintenance infliximab therapy at 2 centers with matched serum infliximab concentrations and blinded histologic scores (Robarts Histopathologic Index [RHI]) were included. The primary endpoint was an unfavorable outcome of active objective inflammation or need for IBD-related surgery or hospitalization at 6-18 months follow-up. Internal variables were identified using univariable analyses, modeling used multivariable analysis, and performance was assessed (area under receiver-operating curve [AUC]) and externally validated.</p><p><strong>Results: </strong>In 81 patients, 40.7% developed unfavorable outcomes at follow-up. Infliximab concentration <9.3 µg/mL (odds ratio [OR] 5.3, <i>P</i> = .001) and RHI > 12 (OR 3.4, <i>P</i> = .03) were the only factors associated with developing the primary unfavorable outcome. A prediction score assigning 1 point to each variable had good discrimination and performed similarly on internal (AUC 0.71) and external (AUC 0.73) cohorts. The risk of primary unfavorable outcomes in internal and external cohorts, respectively, was 23% and 15% for a score of 0, 46% and 50% for a score of 1, and 100% and 75% for a score of 2. Infliximab concentration alone performed similar to the 2-predictor model in internal (AUC 0.65, <i>P</i> = .5 vs. 2-predictor model) and external (AUC 0.70, <i>P</i> = .9, vs. 2-predictor model) cohorts.</p><p><strong>Conclusions: </strong>Using unbiased variable selection, a 2-predictor model using infliximab concentrations and histology identified IBD patients on maintenance infliximab therapy at high risk of future unfavorable outcomes. For practical applicability, infliximab concentrations alone performed similarly well.</p>","PeriodicalId":10847,"journal":{"name":"Crohn's & Colitis 360","volume":"6 4","pages":"otae052"},"PeriodicalIF":1.8,"publicationDate":"2024-11-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11645457/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142827441","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}