Beatriz Gros, Nathan Constantine-Cooke, Jake Kennedy, Alexander T Elford, Claire O'Hare, Colin Noble, Gareth-Rhys Jones, Ian D Arnott, Charlie W Lees, Nikolas Plevris
{"title":"Tofacitinib versus Vedolizumab Among Bio-naïve Patients with Ulcerative Colitis: A Real-World Propensity-Weighted Comparison.","authors":"Beatriz Gros, Nathan Constantine-Cooke, Jake Kennedy, Alexander T Elford, Claire O'Hare, Colin Noble, Gareth-Rhys Jones, Ian D Arnott, Charlie W Lees, Nikolas Plevris","doi":"10.1093/ecco-jcc/jjae188","DOIUrl":"https://doi.org/10.1093/ecco-jcc/jjae188","url":null,"abstract":"<p><strong>Background and aims: </strong>Over the last decade, treatment options for moderate-to-severe ulcerative colitis (UC) have expanded. However, comparative studies between these agents are limited, especially among biologic-naïve patients. We aimed to compare the persistence, effectiveness and safety of tofacitinib and vedolizumab as the first advanced treatment for patients with UC.</p><p><strong>Methods: </strong>Patients who received either tofacitinib or vedolizumab as their first advanced therapy for UC in NHS Lothian were included. We used inverse probability of treatment weighting (IPTW). The probability of treatment assignment was calculated via logistic regression using age, sex, UC duration, Montreal extent, CRP, concomitant corticosteroids, and partial Mayo score at drug commencement.</p><p><strong>Results: </strong>We included n=158 patients, of whom n=81 (51.3%) received vedolizumab and n=77 (48.7%) tofacitinib. Median follow-up for vedolizumab patients was 3.1 years (IQR 1.6-4.8) and for tofacitinib patients 1.5 years (IQR 0.3-2.3). The cohort was 59.5% male with a median age of 41.1 years (IQR 31.5-51.8). At two years, vedolizumab persistence was superior to tofacitinib (p=0.005). At week 12 and week 52 clinical, biochemical and fecal biomarker steroid free remission were comparable between groups. Primary non-response and secondary loss of response were 9.9% and 17.3% for vedolizumab and 23.4% and 13% for tofacitinib respectively. Frequency of adverse events was comparable (11 [13.6%] vedolizumab vs 19 [24.7%] tofacitinib, p=0.629).</p><p><strong>Conclusions: </strong>We found that the persistence and tolerability of vedolizumab was superior to tofacitinib in bio-naïve UC, although the rates of clinical and biomarker remission were comparable. These data may help inform positioning of advanced therapy.</p>","PeriodicalId":94074,"journal":{"name":"Journal of Crohn's & colitis","volume":" ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-12-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142808901","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Beatriz Gros, Jellyana Peraza, Mehak Bassi, Joseph Sleiman, Sara Abdelhalim, Erica Park, Serre-Yu Wong, Manasi Agrawal, Lauren T Grinspan, Aline Charabaty
{"title":"Disparities in gender and race representation among authors of inflammatory bowel disease clinical trials.","authors":"Beatriz Gros, Jellyana Peraza, Mehak Bassi, Joseph Sleiman, Sara Abdelhalim, Erica Park, Serre-Yu Wong, Manasi Agrawal, Lauren T Grinspan, Aline Charabaty","doi":"10.1093/ecco-jcc/jjae184","DOIUrl":"10.1093/ecco-jcc/jjae184","url":null,"abstract":"<p><strong>Background and aims: </strong>Female physicians, particularly those from minority populations, are significantly underrepresented in research authorship in gastroenterology. This underrepresentation negatively impacts their career progression. This study analyses gender and race representation trends in published clinical trials in inflammatory bowel disease (IBD) and associated factors.</p><p><strong>Methods: </strong>IBD clinical trials were identified from ClinicalTrials.gov and https://www.ibd-eii.com, spanning years 1955 to 2023. The variable gender was extracted for all authors and race was extracted for first, second, senior, corresponding authors and principal investigator (PI) using predictive tools and manual verification. Data on authorship, trial characteristics, and sponsorship were collected.</p><p><strong>Results: </strong>A total of 438 clinical trials involving 5,517 authors were analysed. Females constituted 26.3% of authors, 17.1% of first authors, 6.1% senior authors and 24.2% of PIs, with non-white individuals representing 12.3% of first authors, 5.9% of senior authors and 18.8% of PIs. Female representation increased from 1971 to 2023 but remained substantially lower relative to male representation. Industry-sponsored trials had the lowest female author and PI representation while non-industry, single-center, paediatric, and advanced therapy trials had higher female representation.</p><p><strong>Conclusions: </strong>This study highlights persistent gender and racial disparities in IBD trial authorship and leadership despite some progress over the decades. Female and non-white individuals remain underrepresented, especially in industry-sponsored trials and in senior authorship roles. Systemic interventions are warranted to foster an inclusive and equitable research environment, including mentorship and support for underrepresented groups.</p>","PeriodicalId":94074,"journal":{"name":"Journal of Crohn's & colitis","volume":" ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-12-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142808893","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Giulia Sterpetti, Antonietta Lamazza, Antonio V Sterpetti
{"title":"Decreased Levels Of Atmospheric Pollution And Reduced Prevalence Of Inflammatory Bowel Diseases In Europe.","authors":"Giulia Sterpetti, Antonietta Lamazza, Antonio V Sterpetti","doi":"10.1093/ecco-jcc/jjae185","DOIUrl":"https://doi.org/10.1093/ecco-jcc/jjae185","url":null,"abstract":"","PeriodicalId":94074,"journal":{"name":"Journal of Crohn's & colitis","volume":" ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-12-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142831034","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Vari Wileman, Joseph Chilcot, Christine Norton, Ailsa Hart, Laura Miller, Imogen Stagg, Natasha Seaton, Richard Pollok, Qasim Aziz, Rona Moss-Morris
{"title":"Modifiable psychological factors are associated with clusters of pain, fatigue, faecal incontinence and IBS-type symptoms in inflammatory bowel disease: a latent profile analysis.","authors":"Vari Wileman, Joseph Chilcot, Christine Norton, Ailsa Hart, Laura Miller, Imogen Stagg, Natasha Seaton, Richard Pollok, Qasim Aziz, Rona Moss-Morris","doi":"10.1093/ecco-jcc/jjae183","DOIUrl":"https://doi.org/10.1093/ecco-jcc/jjae183","url":null,"abstract":"<p><strong>Background: </strong>Inflammatory bowel disease (IBD) causes fatigue, pain and faecal urgency/incontinence symptoms. Identifying symptom profile subgroups and related psychological correlates might enable earlier intervention and more effective tailored treatment pathways.</p><p><strong>Methods: </strong>This study was nested within a randomised controlled trial of a digital symptom intervention for people with IBD (n=780). Latent profile analysis (LPA) was conducted on pre-randomisation baseline measures of fatigue, pain, and faecal incontinence. Multinominal logistic regression examined associations between profile membership and clinical, demographic and psychological factors.</p><p><strong>Results: </strong>LPA determined a three-profile model: Moderate (50%), High (40%) and Severe symptoms (10%). Diagnosis and faecal calprotectin were not associated with profile membership, but female gender, comorbidity, time since diagnosis and IBS-type symptoms were associated with High and Severe symptoms profiles. Depression, anxiety, negative symptom perceptions, all-or-nothing and avoidance behaviours significantly increased the relative risk of High and Severe symptoms profile membership.</p><p><strong>Conclusions: </strong>Many participants experienced symptoms even when deemed to be in clinical remission. After controlling for clinical, inflammatory, and demographic factors, the relative risk of High or Severe symptom profile membership was associated with potentially modifiable cognitive behavioural factors. These factors were also associated with IBS-type symptoms. Recognising the potential impact of cognitive behavioural factors in exacerbating symptoms can lead to earlier identification of patients who require support and allows treatment plans to be tailored more precisely. The findings from this study promote a more integrated approach to IBD management, combining medical treatment with cognitive behavioural interventions to enhance patient care and improve outcomes.</p>","PeriodicalId":94074,"journal":{"name":"Journal of Crohn's & colitis","volume":" ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-12-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142831066","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Anat Yerushalmy-Feler, Elizabeth A Spencer, Michael T Dolinger, David L Suskind, Katarina Mitrova, Ondrej Hradsky, Máire A Conrad, Judith R Kelsen, Holm H Uhlig, Christos Tzivinikos, Silvana Ancona, Magdalena Wlazlo, Lukas Hackl, Dror S Shouval, Matteo Bramuzzo, Darja Urlep, Christine Olbjorn, Giulia D'Arcangelo, Gemma Pujol-Muncunill, Dotan Yogev, Ben Kang, Marco Gasparetto, Christine Rungø, Kaija-Leena Kolho, Iva Hojsak, Lorenzo Norsa, Firas Rinawi, Naire Sansotta, Ramit Magen Rimon, Maya Granot, Luca Scarallo, Eunice Trindade, Marta Velasco Rodríguez-Belvís, Dan Turner, Shlomi Cohen
{"title":"Upadacitinib for Induction of Remission in Pediatric Ulcerative Colitis: An International Multi‑center Study.","authors":"Anat Yerushalmy-Feler, Elizabeth A Spencer, Michael T Dolinger, David L Suskind, Katarina Mitrova, Ondrej Hradsky, Máire A Conrad, Judith R Kelsen, Holm H Uhlig, Christos Tzivinikos, Silvana Ancona, Magdalena Wlazlo, Lukas Hackl, Dror S Shouval, Matteo Bramuzzo, Darja Urlep, Christine Olbjorn, Giulia D'Arcangelo, Gemma Pujol-Muncunill, Dotan Yogev, Ben Kang, Marco Gasparetto, Christine Rungø, Kaija-Leena Kolho, Iva Hojsak, Lorenzo Norsa, Firas Rinawi, Naire Sansotta, Ramit Magen Rimon, Maya Granot, Luca Scarallo, Eunice Trindade, Marta Velasco Rodríguez-Belvís, Dan Turner, Shlomi Cohen","doi":"10.1093/ecco-jcc/jjae182","DOIUrl":"https://doi.org/10.1093/ecco-jcc/jjae182","url":null,"abstract":"<p><strong>Background and aims: </strong>Data on upadacitinib therapy in children with ulcerative colitis (UC) or unclassified inflammatory bowel disease (IBD-U) are scarce. We aimed to evaluate the effectiveness and safety of upadacitinib as an induction therapy in pediatric UC or IBD-U.</p><p><strong>Methods: </strong>In this multicenter retrospective study, children treated with upadacitinib for induction of remission of active UC or IBD-U from 30 centers worldwide were enrolled. Demographic, clinical and laboratory data as well as adverse events (AEs) were recorded at week 8 post induction.</p><p><strong>Results: </strong>One hundred children were included (90 UC and 10 IBD-U, median age 15.6 [interquartile range 13.3-17.1] years). Ninety-eight were previously treated with biologic therapies, and 76 were treated with ≥2 biologics. At the end of the 8-week induction period, clinical response, clinical remission, and corticosteroid-free clinical remission (CFR) were observed in 84%, 62%, and 56% of the children, respectively. Normal C-reactive protein and fecal calprotectin (FC) <150 mcg/g were achieved in 75% and 50%, respectively. Combined CFR and FC remission was observed in 18/46 (39%) children with available data at 8 weeks. AEs were recorded in 37 children, including one serious AE of an appendiceal neuroendocrine tumor. The most frequent AEs were hyperlipidemia (n=13), acne (n=12), and infections (n=10, five of whom with herpes viruses).</p><p><strong>Conclusion: </strong>Upadacitinib is an effective induction therapy for refractory pediatric UC and IBD-U. Efficacy should be weighed against the potential risks of AEs.</p>","PeriodicalId":94074,"journal":{"name":"Journal of Crohn's & colitis","volume":" ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-11-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142741875","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pieter Sinonquel, Matthias Lenfant, Tom Eelbode, Hiroki Watanabe, Belian Callaerts, Peter Bossuyt, Bram Verstockt, João Pedro Guedelha Sabino, Gert De Hertogh, Frederik Maes, Séverine Vermeire, Raf Bisschops
{"title":"Development of an automated tool for the estimation of histological remission in ulcerative colitis using single wavelength endoscopy technology.","authors":"Pieter Sinonquel, Matthias Lenfant, Tom Eelbode, Hiroki Watanabe, Belian Callaerts, Peter Bossuyt, Bram Verstockt, João Pedro Guedelha Sabino, Gert De Hertogh, Frederik Maes, Séverine Vermeire, Raf Bisschops","doi":"10.1093/ecco-jcc/jjae180","DOIUrl":"https://doi.org/10.1093/ecco-jcc/jjae180","url":null,"abstract":"<p><strong>Introduction: </strong>Ulcerative colitis (UC) management employs a strategy targeting histological and endoscopic remission. Correlation of white-light endoscopy (WLE) scores with histological activity is limited. Single-wavelength endoscopy (SWE) addressing microvascular changes reflecting histological disease activity, may better assess histological remission.</p><p><strong>Aims and methods: </strong>Our goal was to assess the accuracy of a computer-aided diagnosis (CAD) system for histological activity estimation in UC, based on either WLE or SWE. We collected 6926 sets of corresponding WLE and SWE frames in 112 patients with UC, using a prototype endoscopic system enabling both imaging methods (FUJIFILM, Tokyo, Japan). Histological remission (Geboes score ≤2B.0) assessed at the location of imaging was annotated for all frames and separate WLE-CAD and SWE-CAD models were trained using deep learning for automated detection of histological remission with either imaging modality.</p><p><strong>Results: </strong>Initial training of both models on the same subset of 42 patients, resulted in SWE-CAD outperforming WLE-CAD with a mean sensitivity of 88.0% vs 73.9% (p < 0.001), a mean specificity of 71.7% vs 65.6% (p=0.45), and a diagnostic accuracy of 83.3% vs 67.5% (p<0.005), respectively. Further training of the SWE-CAD model on the entire dataset of 112 patients resulted in SWE-CAD achieving a 95.2% accuracy, 96.4% sensitivity, and 92.9% specificity on a section level.</p><p><strong>Conclusion: </strong>By utilizing automated CAD based on non-magnifying SWE for enhanced capillary visibility versus WLE, histological remission was detected with 95.2% diagnostic accuracy in patients with UC, offering stable objectivity and helping to exclude inter-reader variability.</p>","PeriodicalId":94074,"journal":{"name":"Journal of Crohn's & colitis","volume":" ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-11-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142741871","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Jimmy K Limdi, Sarah Rhodes, Eleanor Liu, Anish J Kuriakose Kuzhiyanjal, Matthew Brookes, Jennifer Farraye, Rachel Cannon, Elisabeth Woodhams, Francis A Farraye
{"title":"Knowledge, Values and Preferences regarding Contraceptive Choices among Women living with Inflammatory Bowel Disease.","authors":"Jimmy K Limdi, Sarah Rhodes, Eleanor Liu, Anish J Kuriakose Kuzhiyanjal, Matthew Brookes, Jennifer Farraye, Rachel Cannon, Elisabeth Woodhams, Francis A Farraye","doi":"10.1093/ecco-jcc/jjae181","DOIUrl":"https://doi.org/10.1093/ecco-jcc/jjae181","url":null,"abstract":"<p><strong>Background and aims: </strong>Active inflammatory bowel disease at conception is associated with adverse pregnancy outcomes. International guidelines address antenatal care, but contraception counselling and risk assessment are not addressed. Data on healthcare professionals' guidance for women with IBD regarding contraception are scarce. We aimed to describe contraceptive use, preferences, knowledge, and barriers among women with IBD.</p><p><strong>Methods: </strong>A 34-item questionnaire was administered to female IBD patients aged 18-45. Disease control was measured using PRO2 and IBD Control questionnaire, and contraceptive preferences were assessed by the Contraceptive Features Survey. Logistic regression explored associations between contraceptive use, attitudes, disease remission status, and other factors.</p><p><strong>Results: </strong>Of 338 women surveyed, 243 (74%) used some form of contraception. Oral birth control pills (28%) and barrier methods (18%) were most used but 20% used long-acting methods. Women with active disease were more likely to use long-acting contraception (23%) compared to those in remission (17%). Contraceptive priorities were effectiveness (78%), ease of use (75%), and minimal side effects (68%). Only 25% women had discussed reproductive issues with their IBD clinician, though 85% were comfortable to do so. Preferred sources for reproductive counselling were IBD nurses (79%), general practitioners (75%), IBD doctors (68%), and gynaecologists (49%).</p><p><strong>Conclusion: </strong>A quarter of women with IBD were not using any contraception, and long-acting contraceptive use was low. Women prefer effective, easy-to-use contraceptives with minimal side effects but lack knowledge on effective contraception-related issues. Better education and proactive discussions between healthcare providers and patients could improve reproductive health in women with IBD.</p>","PeriodicalId":94074,"journal":{"name":"Journal of Crohn's & colitis","volume":" ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-11-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142741873","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Correction to: Influence of Vitamin D Receptor Signalling and Vitamin D on Colonic Epithelial Cell Fate Decisions in Ulcerative Colitis.","authors":"","doi":"10.1093/ecco-jcc/jjae168","DOIUrl":"https://doi.org/10.1093/ecco-jcc/jjae168","url":null,"abstract":"","PeriodicalId":94074,"journal":{"name":"Journal of Crohn's & colitis","volume":" ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-11-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142735441","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Development and Validation of a Sexual Quality of Life Score for Youths with Inflammatory Bowel Disease.","authors":"Alexandre Mancheron, Agnès Dumas, Isabelle Nion Larmurier, Cecilia Landman, Laurent Peyrin Biroulet, Bénédicte Caron, Clotilde Baudry, Matthieu Allez, Mélanie Serrero, Dalal Yahioune, Stéphane Nancey, Céline Roman, Rémi Ducleau-Loras, Stéphanie Coopman, Priscilla Boizeau, Mathilde Husson, Shaya Sable, Iona Tarbet, Corinne Devos, Aurélie Bourmaud, Christine Martinez-Vinson","doi":"10.1093/ecco-jcc/jjae175","DOIUrl":"https://doi.org/10.1093/ecco-jcc/jjae175","url":null,"abstract":"<p><strong>Background and aims: </strong>Inflammatory Bowel Disease (IBD) are known to impact patients 'sexual lives. The aim of this study is to create and validate a sexual QoL designed for youth with IBD.</p><p><strong>Methods: </strong>This study was conducted in two phases: development of the score and validation of the items. A multidisciplinary team created a score called BLOOMI, based on two validated scores: the International Index of Erectile Function (IIEF) and the Sexual Function Questionnaire 28 (SFQ28). It was validated through a French multicentric cross-sectional study among patients aged 15-25 years with IBD by comparison with IIEF and SFQ28 gold standard scores.</p><p><strong>Results: </strong>BLOOMI is a sexual QoL designed with 10 items and formatted as a disk. The score was validated through the participation of 104 patients with a median age of 23.2 years. BLOOMI was well correlated with both goldstandards and had a strong internal consistency. 19.1% of IIEF-responders have erectile dysfunction and median scores for the SFQ domains Desire, Arousal sensation and cognition, and orgasm are below the threshold for the absence of sexual dysfunction. Fatigue, abdominal pain, body image concerns or fear of anal leakages are correlated to a poorer sexual QoL.</p><p><strong>Conclusions: </strong>BLOOMI score is a new validated score to assess the sexual QoL in 15-25 years with IBD. This tool may improve the screening for sexual challenges encountered by youths with IBD and may support future research into the impact of IBD on young patients' lives.</p>","PeriodicalId":94074,"journal":{"name":"Journal of Crohn's & colitis","volume":" ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-11-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142688777","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Marla C Dubinsky, Joseph Wu, Aoibhinn McDonnell, Krisztina Lazin, Martina Goetsch, Diogo Branquinho, Irene Modesto, Alessandro Armuzzi
{"title":"Low Incidence of Macular Edema and Other Ocular Events in the Etrasimod Development Program.","authors":"Marla C Dubinsky, Joseph Wu, Aoibhinn McDonnell, Krisztina Lazin, Martina Goetsch, Diogo Branquinho, Irene Modesto, Alessandro Armuzzi","doi":"10.1093/ecco-jcc/jjae173","DOIUrl":"https://doi.org/10.1093/ecco-jcc/jjae173","url":null,"abstract":"<p><strong>Background and aims: </strong>Sphingosine 1-phosphate receptor modulators have been associated with an increased risk of macular edema. Etrasimod is an oral, once-daily, selective sphingosine 1-phosphate1,4,5 receptor modulator.</p><p><strong>Methods: </strong>We report the proportions and incidence rates [per 100 patient-years of exposure] of Macular edema and other ocular adverse events in the etrasimod clinical program, including patients with ulcerative colitis, Crohn's disease, eosinophilic esophagitis, alopecia areata and atopic dermatitis. Ulcerative colitis data were analyzed in two cohorts: Placebo-controlled ulcerative colitis and All ulcerative colitis [comprising the Placebo-controlled ulcerative colitis cohort plus open-label extension studies].</p><p><strong>Results: </strong>In the Placebo-controlled ulcerative colitis cohort, Macular edema was reported in two patients receiving etrasimod [0.3%; incidence rate: 0.70] and one receiving placebo [0.3%; incidence rate: 0.84]. In the All ulcerative colitis cohort, one patient [0.1%; incidence rate: 0.13] receiving etrasimod reported two events of Cystoid macular edema. All events were non-serious, and one led to treatment discontinuation. No events of Macular edema were reported in other conditions. Nine and four patients receiving etrasimod reported Vision blurred and Visual impairment adverse events, respectively. All events were non-serious and most did not require any intervention.</p><p><strong>Conclusions: </strong>Macular edema and other ocular events were uncommon in patients treated with etrasimod across multiple conditions. Incidence of Macular edema was comparable with placebo.</p>","PeriodicalId":94074,"journal":{"name":"Journal of Crohn's & colitis","volume":" ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-11-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142689613","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}