Crohn's & Colitis 360最新文献

{"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}

{"title":"Real-World Ustekinumab Experience in Ileum-Dominant Versus Colonic Crohn's Disease.","authors":"Sandy Vien, Elvis Jovanie Arteaga, Sirisha Grandhe, Nuen Tsang Yang, Eric J Mao","doi":"10.1093/crocol/otae059","DOIUrl":"10.1093/crocol/otae059","url":null,"abstract":"<p><strong>Background: </strong>Crohn's disease (CD) presents with diverse phenotypes. It remains unclear if CD location affects therapy efficacy. The aim of this study was to compare the real-world performance of ustekinumab in ileum-dominant and colonic CD.</p><p><strong>Methods: </strong>We performed a single-center, IRB-approved, retrospective review of all adult CD patients who received ustekinumab. We stratified patients by ileal involvement: ileum-dominant (ileal and ileocolonic) and colonic CD. The primary outcome was the absence of ulcers on follow-up colonoscopy. The secondary outcomes included CRP, calprotectin, surgery, and hospitalization. Chi-square tests (or Fisher's exact test) and 2-sample <i>t</i>-tests (or Wilcoxon's rank-sum test) were used to compare categorical and numeric variables between groups, respectively; analyses were performed using R Computing Software versions 3.6.1.</p><p><strong>Results: </strong>Eighty-four patients with ileum-dominant CD and 27 patients with colonic CD were treated with ustekinumab. The median time to follow-up endoscopy was 13 months. Follow-up colonoscopy after ustekinumab therapy was ulcer-free in 45% of ileum-dominant CD and 76% of colonic CD (<i>P</i> = .02). Of patients with ulcers prior to starting ustekinumab, 24% of ileum-dominant CD and 67% of colonic CD were ulcer-free (<i>P</i> = .01). There were similar rates of hospitalizations and surgery and no significant differences in mean calprotectin and CRP between the two groups on follow-up after ustekinumab therapy.</p><p><strong>Conclusions: </strong>This real-world experience of ustekinumab demonstrates higher rates of endoscopic healing among colonic CD when compared to ileum-dominant CD. Disease location may predict endoscopic healing by ustekinumab. Further studies are necessary to expand our understanding of ustekinumab responsiveness to different CD phenotypes.</p>","PeriodicalId":10847,"journal":{"name":"Crohn's & Colitis 360","volume":"6 4","pages":"otae059"},"PeriodicalIF":1.8,"publicationDate":"2024-11-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11586627/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142715462","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":"Upadacitinib in Patients With Difficult-to-Treat Crohn's Disease.","authors":"Cristina Bezzio, Gianluca Franchellucci, Edoardo V Savarino, Mauro Mastronardi, Flavio Andrea Caprioli, Giorgia Bodini, Angela Variola, Franco Scaldaferri, Federica Furfaro, Emma Calabrese, Maria Beatrice Principi, Giuseppe Biscaglia, Manuela Marzo, Andrea Michielan, Carolina Cavalli, Annalisa Aratari, Michele Campigotto, Linda Ceccarelli, Maria Cappello, Simone Saibeni, Paola Balestrieri, Alessandra Soriano, Valentina Casini, Lorenzo Bertani, Brigida Barberio, Francesco Simone Conforti, Silvio Danese, Alessandro Armuzzi","doi":"10.1093/crocol/otae060","DOIUrl":"https://doi.org/10.1093/crocol/otae060","url":null,"abstract":"","PeriodicalId":10847,"journal":{"name":"Crohn's & Colitis 360","volume":"6 4","pages":"otae060"},"PeriodicalIF":1.8,"publicationDate":"2024-10-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11549494/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142616326","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 Experience of the Association of HLADQA1*05 Allele With Loss of Response to Anti-TNF Inhibitors.","authors":"Aastha Chokshi, Christina A Raker, Sean Fine","doi":"10.1093/crocol/otae058","DOIUrl":"https://doi.org/10.1093/crocol/otae058","url":null,"abstract":"<p><strong>Background: </strong>Antitumor necrosis factor (anti-TNF) biologics have revolutionized the treatment of inflammatory bowel disease (IBD). Previously, studies have shown an association between the HLADQA1*05 allele and the development of antibodies and were predictive of loss of response. We sought to investigate the rate of the HLADQA1*05 allele in patients with IBD at a New England center and its association with antibody development and discontinuation of anti-TNF therapy.</p><p><strong>Methods: </strong>A single center retrospective cohort study with patients on anti-TNF inhibitor therapy being followed at our IBD clinic who had testing performed for the HLADQA1*05 allele were identified and separated into 2 different groups: HLADQA1*05 positive (HLA carriers) or HLADQA1*05 negative (HLA noncarriers). Persistence of remaining on anti-TNF therapy, measurement of drug/antibody levels, and need for dose escalation were collected and stratified amongst the 2 groups.</p><p><strong>Results: </strong>The prevalence of the HLADQA1*05 allele among all IBD patients followed was 53%. We identified 67 IBD patients being treated with anti-TNF medications, 46 (69%) patients with Crohn's disease and 21 (31%) with ulcerative colitis. Most of the HLA carriers (85%) and HLA noncarriers (92%) remained on anti-TNF therapy at the end of the study period. Thirty-six (84%) patients had therapeutic drug monitoring performed during maintenance therapy. Three patients in the HLA carrier group had meaningful antidrug antibody levels necessitating cessation of therapy compared to one patient in the HLA noncarrier group (<i>P</i> = .61). Only 3 (13%) of HLA carriers and 4 (21%) of HLA noncarriers were on combination therapy with an immunomodulator. 65% of HLA carriers required dose escalation compared to 50% of HLA noncarriers (<i>P</i> = .70).</p><p><strong>Conclusions: </strong>The prevalence of the HLADQA1*05 allele was 53% in our New England IBD patient population, similar to what has previously been reported in European studies. The majority of patients remained on anti-TNF therapy at the end of the study period despite carrier status. While there was a trend toward increased need for dose escalation among HLA carriers, this was not statistically significant. Future studies are needed to determine if the presence of the HLADQA1*05 allele leads to antibody development against anti-TNF inhibitors and treatment failure in patients with IBD.</p>","PeriodicalId":10847,"journal":{"name":"Crohn's & Colitis 360","volume":"6 4","pages":"otae058"},"PeriodicalIF":1.8,"publicationDate":"2024-10-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11549495/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142616324","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 Treatment Outcomes Associated With Early Versus Delayed Vedolizumab Initiation in Patients With Ulcerative Colitis.","authors":"Noa Krugliak Cleveland, Ninfa Candela, John A Carter, Maja Kuharic, Joyce Qian, Zhaoli Tang, Robin Turpin, David T Rubin","doi":"10.1093/crocol/otae061","DOIUrl":"10.1093/crocol/otae061","url":null,"abstract":"<p><strong>Background: </strong>Patients with ulcerative colitis (UC) typically receive a targeted inflammatory bowel disease therapy after treatment with conventional therapies and after the development of significant morbidity. Evidence suggests that early biologic treatment after diagnosis could improve treatment response and prevent disease complications compared with delayed biologic treatment after conventional therapy.</p><p><strong>Methods: </strong>RALEE was a retrospective study using claims data from IBM® MarketScan® Research Databases between January 1, 2016 and December 31, 2019. Adults with UC and at least one claim for vedolizumab were categorized into Early or Delayed Vedolizumab groups according to whether they had received vedolizumab within 30 days of diagnosis or after conventional therapy (5-aminosalicylates, corticosteroids, and immunomodulators), respectively. Treatment response was assessed at 2, 6, and 12 months after vedolizumab treatment initiation and was analyzed with logistic regression (bivariate).</p><p><strong>Results: </strong>At 2 months, Delayed Vedolizumab was associated with significantly higher odds of nonresponse than Early Vedolizumab (odds ratio [OR], 2.509; 95% confidence interval [CI], 1.28-4.90). Delayed Vedolizumab was not significantly associated with odds of nonresponse at 6 months (OR, 1.173; 95% CI, 0.72-1.90) or at 12 months (OR, 0.872; 95% CI, 0.55-1.37). Mean total healthcare costs were similar in the Early Vedolizumab ($6492) and Delayed Vedolizumab ($5897) groups, although there were small differences in costs from different types of claims.</p><p><strong>Conclusions: </strong>Patients who received vedolizumab early after UC diagnosis were less likely to experience nonresponse at 2 months and incurred similar healthcare costs at 12 months compared with patients who received delayed vedolizumab.</p>","PeriodicalId":10847,"journal":{"name":"Crohn's & Colitis 360","volume":"6 4","pages":"otae061"},"PeriodicalIF":1.8,"publicationDate":"2024-10-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11535256/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142582236","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":"Like a Punch in the Gut: A Novel Perspective On Annual Recurrences of Ulcerative Colitis.","authors":"Sasha Johnston, Aileen Fraser, Carrie Biddle, Jennifer Wild","doi":"10.1093/crocol/otae050","DOIUrl":"10.1093/crocol/otae050","url":null,"abstract":"<p><strong>Background: </strong>Ulcerative colitis (UC), a chronic inflammatory bowel disease, causes stomach pain, diarrhea, and rectal bleeding. The exact cause is unknown, but it is thought to involve genetic, environmental, and psychological factors. Some people experience annual flare-ups without obvious reason. This article adopts a theory-driven approach to consider how and why past traumatic events may contribute to annual flare-ups.</p><p><strong>Methods: </strong>We applied learning theory, which explains the development of re-experiencing phenomena in post-traumatic stress disorder (PTSD), to better understand the occurrence of annual flares in patients living with UC.</p><p><strong>Results: </strong>Two possibilities emerged in which associative learning may contribute to annual UC flares. First, flare-ups could be a physical response to sensory cues in the present that overlap with trauma experienced at the first onset of UC. Annual episodes may strengthen the UC flare as a learned physiological response to trauma reminders. Second, flare-ups may result from elevated stress due to trauma re-experiencing at anniversaries. Sensory features of the initial UC trauma may be associated with strong reactions, which generalize to similar stimuli, triggering re-experiencing symptoms and increasing psychological stress. Elevated stress raises glucocorticoid levels, promoting UC-specific inflammation. Stimulus discrimination from cognitive therapy for PTSD may help to over-ride the associations that have formed between sensory features of past trauma, linked reactions, and similar cues in the present.</p><p><strong>Conclusions: </strong>Research is needed to understand how traumatic events influence the onset and recurrence of ulcerative colitis, as well as the potential benefits of stimulus discrimination for reducing the frequency of annual flares.</p>","PeriodicalId":10847,"journal":{"name":"Crohn's & Colitis 360","volume":"6 4","pages":"otae050"},"PeriodicalIF":1.8,"publicationDate":"2024-10-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11535257/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142582230","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":"Interventions for Adjunctive Care in Patients With Inflammatory Bowel Disease and Permanent Ileostomy: A Systematic Review.","authors":"Sudheer Kumar Vuyyuru, Virginia Solitano, Yuhong Yuan, Neeraj Narula, Siddharth Singh, Christopher Ma, Florian Rieder, Vipul Jairath","doi":"10.1093/crocol/otae056","DOIUrl":"10.1093/crocol/otae056","url":null,"abstract":"<p><strong>Background: </strong>The evidence for the management of patients with Crohn's disease (CD) and permanent ileostomy (PI) is limited. We aimed to summarize the interventional studies related to the provision of adjunctive ostomy care in this population.</p><p><strong>Methods: </strong>MEDLINE, Embase, and Cochrane CENTRAL were searched from inception to January 5, 2024. Eligible studies were non-randomized or randomized controlled trials (RCTs), or comparative cohort studies predominantly recruiting participants with CD and/or ulcerative colitis (UC) with PI assessing interventions for the management of high stoma output, disease recurrence, peristomal skin care, pouching systems, behavioral interventions, mental health support, and diet.</p><p><strong>Results: </strong>Out of 3217 records, 6 were eligible and all were RCTs (<i>n</i> = 95). Out of these, 5 adopted a crossover design, and 1 study was a double-blind parallel-group RCT. All except 1 were published more than 20 years ago (1976-2003). Two studies exclusively included patients with UC, one included CD, and the remaining included both UC and CD. Four studies assessed pharmacological interventions (loperamide, 5-aminosalysilate [5-ASA], azodisal sodium, and budesonide), one assessed oral supplement with different osmolarities, and one assessed dietary intervention (unrefined vs refined carbohydrate). A decrease in ileostomy output was the primary outcome of interest in 4 studies. None of the studies assessed interventions for peristomal skin care, quality of life, stoma pouching systems, behavioral interventions, mental health, or CD recurrence.</p><p><strong>Conclusions: </strong>This study highlights that the evidence base to inform care for patients with IBD and PI is almost non-existent. There is an urgent need for focused research in this area to inform evidence-based treatment decisions.</p>","PeriodicalId":10847,"journal":{"name":"Crohn's & Colitis 360","volume":"6 4","pages":"otae056"},"PeriodicalIF":1.8,"publicationDate":"2024-10-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11503213/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142496655","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 Approach to STRIDE-II in Real-Life Settings: Analysis and Practical Recommendations.","authors":"Elena Ricart, Guillermo Bastida, Daniel Carpio, Daniel Ceballos, Daniel Ginard, Ignacio Marín-Jimenéz, Luis Menchén, Fernando Muñoz, Yago González-Lama","doi":"10.1093/crocol/otae055","DOIUrl":"https://doi.org/10.1093/crocol/otae055","url":null,"abstract":"<p><strong>Background: </strong>We aimed to (1) analyze the applicability of the updated Selecting Therapeutic Targets in Inflammatory Bowel Disease (STRIDE-II) recommendations in real-world clinical practice, (2) identify barriers to their implementation, and (3) propose practical measures to overcome these obstacles.</p><p><strong>Methods: </strong>This qualitative study was based on a survey, a literature review, and expert opinions. Nine inflammatory bowel disease (IBD) experts identified 7 areas likely to be controversial or potential implementation barriers in daily clinical practice: endoscopy, histology, ultrasound, quality of life, biomarkers, symptom control, and patient-reported outcomes (PROs). Based on this, a survey was carried out among educational course participants. The experts discussed the literature review and survey results and proposed several statements and practical actions.</p><p><strong>Results: </strong>A total of 55 gastroenterologists answered the survey. The reported difficulty level in reaching STRIDE-II treatment goals in clinical practice was high. Only 22% of participants performed clinical remission assessments using clinical indexes and PROs. Seventy percent of responders did not use fecal calprotectin cutoffs and considered changes from the previous levels instead. Mucosal healing as a long-term therapeutic goal was considered necessary to be individualized in specific patient subgroups (eg, elderly/fragile patients, multiple treatment failures, and last-line therapies). Other barriers, like the lack of access to imaging techniques or insufficient knowledge and skills among healthcare professionals, were detected. The experts suggested adding less stringent treatment goals and measurements, patient stratification, local adaptations, educational activities, and research.</p><p><strong>Conclusions: </strong>STRIDE-II recommendations face various implementation barriers needing careful evaluation in order to enhance their adoption in clinical practice, and ultimately improve outcomes in IBD patients.</p>","PeriodicalId":10847,"journal":{"name":"Crohn's & Colitis 360","volume":"6 4","pages":"otae055"},"PeriodicalIF":1.8,"publicationDate":"2024-10-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11497081/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142496654","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":"Evaluation of the Symptoms and Clinical Characteristics of Crohn's Disease and Ulcerative Colitis That Affect Healthcare Providers' Treatment Choices.","authors":"Theresa Hunter Gibble, Carolyn Sweeney, Daniel Wolin, David McSorley, Jinyi Wang, Richard Moses, Marla Dubinsky","doi":"10.1093/crocol/otae053","DOIUrl":"https://doi.org/10.1093/crocol/otae053","url":null,"abstract":"<p><strong>Background: </strong>Treatment of inflammatory bowel disease-Crohn's disease (CD) and ulcerative colitis (UC)-is dependent on healthcare providers' (HCPs') clinical assessment of patient symptoms. We therefore evaluated which CD and UC symptoms impact HCPs' treatment choices and assessed the impact of those symptoms on treatment decision-making. We also examined the role of complete control (mucosal/histologic healing, clinical remission, no bowel urgency) in treatment decision-making, considerations for dose escalation or switching treatments, and HCPs' willingness to use the Urgency Numeric Rating Scale (NRS) to assess bowel urgency severity.</p><p><strong>Methods: </strong>We conducted an observational, cross-sectional, self-administered survey among HCPs (<i>N</i> = 459, across types/specialties) who work in direct patient care and treat patients with CD and UC in the United States. Data were collected from eligible participants between November 21, 2022, and December 6, 2022, and responses were summarized through descriptive statistics.</p><p><strong>Results: </strong>For CD and UC, the symptoms of greatest importance when deciding on the course of treatment included cramping or abdominal pain, rectal bleeding, diarrhea, anemia, weight loss, and bowel urgency. Furthermore, most HCPs ranked rectal bleeding, clinical remission, abdominal pain, and complete control as \"very\" to \"extremely\" important in decisions about the course of treatment, dose escalation, or switching treatments. In total, 22.9% of HCPs indicated that they use the Urgency NRS, while 89.3% were at least somewhat willing to use it in the future.</p><p><strong>Conclusions: </strong>Our study provides real-world insights into the symptoms and clinical characteristics that most impact HCPs' treatment choices for CD and UC in clinical practice.</p>","PeriodicalId":10847,"journal":{"name":"Crohn's & Colitis 360","volume":"6 4","pages":"otae053"},"PeriodicalIF":1.8,"publicationDate":"2024-10-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11471961/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142460003","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":"Patient and Healthcare Professional Satisfaction, Acceptability, and Preference Experiences With Mirikizumab Administration for Ulcerative Colitis: An International Survey.","authors":"David Clemow, Christine Radawski, Joe Milata, Karla Alaka, Theresa Hunter Gibble, Adam Schaum, Obi Ezennia, Nicholas Martinez, Tibor Szaloki, Yuka Ito, Danielle Rodriguez, Katherine Kirk","doi":"10.1093/crocol/otae054","DOIUrl":"https://doi.org/10.1093/crocol/otae054","url":null,"abstract":"<p><strong>Background: </strong>There is a need to better understand ulcerative colitis (UC) patient and healthcare provider (HCP) treatment satisfaction, acceptability, and preferences.</p><p><strong>Methods: </strong>Two international, cross-sectional, web-based surveys were conducted among participants of a phase 3 mirikizumab study (NCT03519945). The questions captured moderate-to-severe UC patients' experience, HCPs' perception of patients' experience, and HCPs' own experience with mirikizumab administration through intravenous (IV) infusions and subcutaneous (SC) injections.</p><p><strong>Results: </strong>Respondents included 93 patients and 42 HCPs from 11 countries. The majority of patients had UC >4 years (74.2%), were bionaive (68%), in remission at the time of the survey (63%). HCPs were primarily from the United States (57%), generally nurses (41%) or gastroenterologists (26%) with ≥6 years of experience in treating UC (57%). Most patients were \"very satisfied/satisfied\" (IV, 83%; SC, 91%), \"completely/somewhat\" accepting of mirikizumab administration (IV, 87%; SC, 97%), and agreed that improvement to their UC outweighed any administration dissatisfaction (90%). HCPs' perspectives of patients' experiences were higher: \"very satisfied/satisfied\" (IV, 93%; SC, 100%); \"completely/somewhat\" accepting (IV, 90%; SC, 98%). HCPs themselves were \"very satisfied/satisfied\" (IV, 81%; SC, 95%); gastroenterologists were \"very satisfied\" (IV, 82%; SC, 82%) more than nurses (IV, 29%; SC, 65%) who were generally at least \"satisfied\" (IV, 53%; SC, 35%). Two SC and monthly SC injections were \"completely acceptable\" by the patients (76% and 85%) and per HCPs' perceptions of patients' preferences (69% and 100%).</p><p><strong>Conclusions: </strong>Both patients and HCPs were satisfied with and accepted mirikizumab IV induction followed by monthly maintenance SC injections. UC improvement outweighed any administration dissatisfaction.</p>","PeriodicalId":10847,"journal":{"name":"Crohn's & Colitis 360","volume":"6 4","pages":"otae054"},"PeriodicalIF":1.8,"publicationDate":"2024-10-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11520749/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142544255","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}