{"title":"Advanced combination therapy: is it the best way to break the therapeutic ceiling?","authors":"Panu Wetwittayakhlang, Peter L Lakatos","doi":"10.1177/17562848241272995","DOIUrl":"10.1177/17562848241272995","url":null,"abstract":"<p><p>Current therapeutic strategies for inflammatory bowel disease (IBD) have reached a plateau in the rates of response and/or remission achieved with a single therapeutic agent. Consequently, the advanced combination therapy (ACT) strategy has emerged as a novel treatment concept for IBD. ACT involves the use of two different targeted therapies, whether biologic or small molecules, with the primary goal of overcoming the therapeutic plateau. Real-world evidence is accumulating among patients undergoing ACT, especially those dealing with concurrent IBD and extraintestinal manifestations or grappling with medically refractory IBD. The recently conducted VEGA study, a randomized clinical trial, has provided crucial insights by demonstrating that the short-term combination of dual biological agents can lead to superior disease control compared to single agents in patients diagnosed with ulcerative colitis (UC). This suggests that ACT holds promise as a therapeutic option to enhance disease control effectively. However, there is still limited evidence of ACT in UC patients who have proven refractory to biologic therapy and patients with Crohn's disease. This review aims to discuss whether ACT represents the optimal approach for overcoming the therapeutic ceiling in IBD.</p>","PeriodicalId":48770,"journal":{"name":"Therapeutic Advances in Gastroenterology","volume":"17 ","pages":"17562848241272995"},"PeriodicalIF":3.9,"publicationDate":"2024-10-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11519553/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142548460","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Ayesha Khan, Raakhi Menon, Brooke Corning, Steven Cohn, Cecil Kumfa, Mukaila Raji
{"title":"Mirtazapine for gastrointestinal and neuropsychological symptoms in older adults with irritable bowel syndrome.","authors":"Ayesha Khan, Raakhi Menon, Brooke Corning, Steven Cohn, Cecil Kumfa, Mukaila Raji","doi":"10.1177/17562848241278125","DOIUrl":"10.1177/17562848241278125","url":null,"abstract":"<p><p>Irritable bowel syndrome (IBS) is a common and potentially modifiable contributor to excess disability, morbidity, and poor quality of life. Clinical trials of medications for IBS have largely been in younger adults. Yet, a growing number of adults aged 65 and older are living with IBS. No data exist to guide clinicians in the safe and effective use of medications (e.g., anticholinergics, anti-spasmodics, and tricyclic antidepressants (TCA)) for IBS in the geriatric population. These medications-especially anticholinergics and TCAs-carry a high risk of adverse effects (ADE) in older adults because of age-associated decline in drug metabolism and the high prevalence of multiple chronic conditions. Five or more medications (polypharmacy) are frequently used to treat common psychiatric and medical comorbidities of IBS: anxiety, depression, insomnia, migraine headache, diarrhea, nausea, poor appetite, pruritus/skin atopy, and fibromyalgia. These neurological and psychiatric comorbidities reflect shared pathogenic mechanisms and bidirectional crosstalk of high inflammation, alteration of gut microbiota, and dysregulation of multiple gastrointestinal and central nervous system-active neurotransmitters (e.g., serotonin, neuropeptides). Currently, these IBS-associated conditions are treated with multiple medications-which increase the risk of adverse drug-drug interactions. One way to reduce the number of medications used for IBS-associated conditions is the use of one medication that treats many or all of these conditions-Mirtazapine. In this perspective article, we present evidence from basic science, case series, observational and epidemiological studies, clinical studies, and clinical trials supporting mirtazapine, a noradrenergic and specific serotonergic receptor antagonist-with 5-hydroxytryptamine-2 and 3 antagonism, as a potential pharmacotherapeutic intervention for the myriad symptoms and conditions associated with IBS. Specifically, we found evidence of mirtazapine's role in treating diarrhea, insomnia, migraine headache, nausea, and poor appetite. We propose a large randomized controlled trial to study mirtazapine as a potential one-stop treatment for multiple IBS symptoms, with the potential to reduce polypharmacy and ADEs, especially in the geriatric population.</p>","PeriodicalId":48770,"journal":{"name":"Therapeutic Advances in Gastroenterology","volume":"18 ","pages":"17562848241278125"},"PeriodicalIF":3.9,"publicationDate":"2024-10-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11526313/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142570264","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Benedicte Schelde-Olesen, Anastasios Koulaouzidis, Ulrik Deding, Ervin Toth, Konstantinos John Dabos, Abraham Eliakim, Cristina Carretero, Begoña González-Suárez, Xavier Dray, Thomas de Lange, Hanneke Beaumont, Emanuele Rondonotti, Uri Kopylov, Pierre Ellul, Enrique Pérez-Cuadrado-Robles, Alexander Robertson, Irene Stenfors, Alejandro Bojorquez, Stefania Piccirelli, Gitte Grunnet Raabe, Reuma Margalit-Yehuda, Isabel Barba, Giulia Scardino, Salome Ouazana, Thomas Bjørsum-Meyer
{"title":"Bowel cleansing quality evaluation in colon capsule endoscopy: what is the reference standard?","authors":"Benedicte Schelde-Olesen, Anastasios Koulaouzidis, Ulrik Deding, Ervin Toth, Konstantinos John Dabos, Abraham Eliakim, Cristina Carretero, Begoña González-Suárez, Xavier Dray, Thomas de Lange, Hanneke Beaumont, Emanuele Rondonotti, Uri Kopylov, Pierre Ellul, Enrique Pérez-Cuadrado-Robles, Alexander Robertson, Irene Stenfors, Alejandro Bojorquez, Stefania Piccirelli, Gitte Grunnet Raabe, Reuma Margalit-Yehuda, Isabel Barba, Giulia Scardino, Salome Ouazana, Thomas Bjørsum-Meyer","doi":"10.1177/17562848241290256","DOIUrl":"https://doi.org/10.1177/17562848241290256","url":null,"abstract":"<p><strong>Background: </strong>The diagnostic accuracy of colon capsule endoscopy (CCE) depends on a well-cleansed bowel. Evaluating the cleansing quality can be difficult with a substantial interobserver variation.</p><p><strong>Objectives: </strong>Our primary aim was to establish a standard of agreement for bowel cleansing in CCE based on evaluations by expert readers. Then, we aimed to investigate the interobserver agreement on bowel cleansing.</p><p><strong>Design: </strong>We conducted an interobserver agreement study on bowel cleansing quality.</p><p><strong>Methods: </strong>Readers with different experience levels in CCE and colonoscopy evaluated bowel cleansing quality on the Leighton-Rex scale and Colon Capsule CLEansing Assessment and Report (CC-CLEAR), respectively. All evaluations were reported on an image level. A total of 24 readers rated 500 images on each scale.</p><p><strong>Results: </strong>An expert opinion-based agreement standard could be set for poor and excellent cleansing but not for the spectrum in between, as the experts agreed on only a limited number of images representing fair and good cleansing. The overall interobserver agreement on the Leighton-Rex full scale was good (intraclass correlation coefficient (ICC) 0.84, 95% CI (0.82-0.85)) and remained good when stratified by experience level. On the full CC-CLEAR scale, the overall agreement was moderate (ICC 0.62, 95% CI (0.59-0.65)) and remained so when stratified by experience level.</p><p><strong>Conclusion: </strong>The interobserver agreement was good for the Leighton-Rex scale and moderate for CC-CLEAR, irrespective of the reader's experience level. It was not possible to establish an expert-opinion standard of agreement for cleansing quality in CCE images. Dedicated training in using the scales may improve agreement and enable future algorithm calibration for artificial intelligence supported cleansing evaluation.</p><p><strong>Trial registration: </strong>All included images were derived from the CAREforCOLON 2015 trial (Registered with The Regional Health Research Ethics Committee (Registration number: S-20190100), the Danish data protection agency (Ref. 19/29858), and ClinicalTrials.gov (registration number: NCT04049357)).</p>","PeriodicalId":48770,"journal":{"name":"Therapeutic Advances in Gastroenterology","volume":"17 ","pages":"17562848241290256"},"PeriodicalIF":3.9,"publicationDate":"2024-10-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11500223/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142511035","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Olga Maria Nardone, Yasuharu Maeda, Marietta Iacucci
{"title":"AI and endoscopy/histology in UC: the rise of machine.","authors":"Olga Maria Nardone, Yasuharu Maeda, Marietta Iacucci","doi":"10.1177/17562848241275294","DOIUrl":"10.1177/17562848241275294","url":null,"abstract":"<p><p>The gap between endoscopy and histology is getting closer with the introduction of sophisticated endoscopic technologies. Furthermore, unprecedented advances in artificial intelligence (AI) have enabled objective assessment of endoscopy and digital pathology, providing accurate, consistent, and reproducible evaluations of endoscopic appearance and histologic activity. These advancements result in improved disease management by predicting treatment response and long-term outcomes. AI will also support endoscopy in raising the standard of clinical trial study design by facilitating patient recruitment and improving the validity of endoscopic readings and endoscopy quality, thus overcoming the subjective variability in scoring. Accordingly, AI will be an ideal adjunct tool for enhancing, complementing, and improving our understanding of ulcerative colitis course. This review explores promising AI applications enabled by endoscopy and histology techniques. We further discuss future directions, envisioning a bright future where AI technology extends the frontiers beyond human limits and boundaries.</p>","PeriodicalId":48770,"journal":{"name":"Therapeutic Advances in Gastroenterology","volume":"17 ","pages":"17562848241275294"},"PeriodicalIF":3.9,"publicationDate":"2024-10-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11491880/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142478219","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Carriage of the HLA-DQA1⋆05 haplotype is associated with a higher risk of infratherapeutic drug concentration and higher immunogenicity in patients undergoing treatment with anti-TNF for inflammatory bowel disease.","authors":"Pilar Navajas Hernández, Samer Mouhtar El Halabi, Ana Caridad González Parra, Teresa Valdés Delgado, Belén Maldonado Pérez, Luisa Castro Laria, Cloé Charpentier, Federico Argüelles-Arias","doi":"10.1177/17562848241278145","DOIUrl":"https://doi.org/10.1177/17562848241278145","url":null,"abstract":"<p><strong>Background: </strong>The success of anti-tumor necrosis factor (TNF) drug strategies in the treatment of inflammatory bowel disease (IBD) is altered by the development of anti-drug antibodies that reduce their efficacy. Studies have shown that the HLA-DQA1⋆05 allele increases the risk of immunogenicity to anti-TNF drugs approximately twofold.</p><p><strong>Objective: </strong>Analyze whether the presence of the HLA-DQA1⋆05 allele is associated with the development of immunogenicity and to evaluate the disease response to anti-TNF drugs (infliximab (IFX) and adalimumab (ADA)), according to the presence of this allele.</p><p><strong>Design: </strong>This is an observational retrospective cohort study, single center, to determine the impact of HLA-DQA1⋆05 on disease activity in patients with IBD at the Hospital Universitario Virgen Macarena.</p><p><strong>Methods: </strong>In total, 200 IBD patients were included: 109 treated with IFX and 91 with ADA. Data were collected using the computerized medical records from the DIRAYA program of the Servicio Andaluz de Salud. Response-defined as improvement-and remission-defined as the disappearance of symptoms and analytical/endoscopic signs-were assessed using activity indices (partial Mayo, Harvey-Bradshaw) in all patients. Anti-TNF drug levels were also determined, as well as the presence or absence of anti-IFX and anti-ADA antibodies. The reporting of this study conforms to the Strengthening the Reporting of Observational Studies in Epidemiology statement.</p><p><strong>Results: </strong>The HLA-DQA1⋆05 haplotype was present in 70 (35%) patients, including 39 (36%) treated with IFX and 31 (34%) with ADA. The risk of withdrawal, intensification, as well as antibody development, was higher in patients carrying the allele and on treatment with IFX or ADA.</p><p><strong>Conclusion: </strong>In our study, we demonstrated that there is an increased risk of immunogenicity in patients carrying the HLA-DQA1⋆05 genotype, which would support the idea of screening for this genetic variant before starting anti-TNF therapy, as its prevalence is high in the general population and increases the risk of treatment discontinuation due to loss of response.</p>","PeriodicalId":48770,"journal":{"name":"Therapeutic Advances in Gastroenterology","volume":"17 ","pages":"17562848241278145"},"PeriodicalIF":3.9,"publicationDate":"2024-10-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11483697/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142478220","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Karsten Büringer, Ulrike Schempf, Stefano Fusco, Dörte Wichmann, Dietmar Stüker, Martin Götz, Nisar P Malek, Christoph R Werner
{"title":"Feasibility, safety and efficacy of endoscopic single-operator cholangioscopy: a retrospective single-center study.","authors":"Karsten Büringer, Ulrike Schempf, Stefano Fusco, Dörte Wichmann, Dietmar Stüker, Martin Götz, Nisar P Malek, Christoph R Werner","doi":"10.1177/17562848241288111","DOIUrl":"10.1177/17562848241288111","url":null,"abstract":"<p><strong>Background: </strong>Endoscopic retrograde cholangiopancreaticography (ERCP) is the standard endoscopic procedure for the diagnosis and treatment of diseases of the pancreas and bile ducts. Cholangioscopy provides direct visualization of the bile ducts. It offers the possibility of more detailed diagnostic and therapeutic indications. Today, cholangioscopy is often performed as a single-operator (SOC) procedure.</p><p><strong>Objectives: </strong>We were interested in the clinical efficacy of our SOC procedure in comparison with published studies, and performed this retrospective data analysis of all our consecutive patients from 2016 to 2022 to analyze the feasibility, safety, and efficacy of SOC.</p><p><strong>Design and methods: </strong>A retrospective single-center analysis of patients undergoing SOC at a tertiary center from 2016 to 2022 (<i>N</i> = 196) was performed. Demographic data, indication for SOC, exam-specific data, efficacy, and complications were included. Sensitivity and specificity for diagnosing indeterminate biliary strictures were calculated.</p><p><strong>Results: </strong>The most common indications for SOC were indeterminate biliary strictures (<i>n</i> = 117; 60%), treatment of biliary stones (<i>n</i> = 45; 23%), and other indications (<i>n</i> = 34; 17%), for example, foreign body removal or intraoperative SOC. In 97% of the SOC (<i>n</i> = 191), the procedure was technically successful. The diagnostic or therapeutic goal was achieved in 91% of SOC (<i>n</i> = 173). In the subgroup where the SOC result was confirmed by subsequent surgery (<i>n</i> = 93), sensitivity was 86%, specificity 99%, and SOC treatment of stones was successful in 89%. Complications occurred in (20%; <i>n</i> = 37). The majority of these patients (<i>n</i> = 18; 10%) had minor bleeding requiring no intervention.</p><p><strong>Conclusion: </strong>SOC is an effective and safe procedure that should be the standard of care when primary diagnostic and/or therapeutic ERCP has failed. The sensitivity and specificity for determining the dignity of biliary strictures and the efficacy for the treatment of difficult-to-treat stones are reproducibly very high.</p>","PeriodicalId":48770,"journal":{"name":"Therapeutic Advances in Gastroenterology","volume":"17 ","pages":"17562848241288111"},"PeriodicalIF":3.9,"publicationDate":"2024-10-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11487541/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142478320","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Péter Bacsur, Tamás Resál, Patrícia Sarlós, Ákos Iliás, Liza Dalma Sümegi, Diána Kata, Anett Dávid, Bernadett Farkas, Emese Ivány, Anita Bálint, Zsófia Bősze, Anna Fábián, Renáta Bor, Zoltán Szepes, Waqqas Afif, Talat Bessissow, Klaudia Farkas, Péter L Lakatos, Tamás Molnár
{"title":"Outcomes of treatment cessation after switching to subcutaneous vedolizumab treatment in inflammatory bowel diseases.","authors":"Péter Bacsur, Tamás Resál, Patrícia Sarlós, Ákos Iliás, Liza Dalma Sümegi, Diána Kata, Anett Dávid, Bernadett Farkas, Emese Ivány, Anita Bálint, Zsófia Bősze, Anna Fábián, Renáta Bor, Zoltán Szepes, Waqqas Afif, Talat Bessissow, Klaudia Farkas, Péter L Lakatos, Tamás Molnár","doi":"10.1177/17562848241290636","DOIUrl":"10.1177/17562848241290636","url":null,"abstract":"<p><strong>Background: </strong>The usability of subcutaneous vedolizumab (s.c. VDZ) treatment in inflammatory bowel diseases (IBD; ulcerative colitis (UC), Crohn's disease (CD)) has been proven via clinical trials while real-world data collection is ongoing.</p><p><strong>Objectives: </strong>Our study evaluates the effectiveness, safety, patients' preferences, and psychological factors associated with s.c. VDZ treatment, after switching from intravenous (i.v.) formulation.</p><p><strong>Design: </strong>Prospective, multicenter cohort study including IBD patients switching from i.v. VDZ to s.c. treatment and were evaluated over 52 weeks.</p><p><strong>Methods: </strong>Serum VDZ levels and C-reactive protein (CRP) were measured at the baseline and w52. At w12, a questionnaire on the patient's satisfaction and psychological characteristics was administered. The primary outcome was the drug persistence rate (cessation was due to loss of response (LOR), adverse events, patient request, and other causes) at w52, while the secondary outcomes were the changes in the clinical corticosteroid-free remission (CSFR) and biochemical remission (BR; CRP ⩽ 5 mg/L) rates, safety issues, serum drug levels, patients' preferences, and psychological features.</p><p><strong>Results: </strong>In total, 70 IBD patients were evaluated (32 CD patients, 38 UC patients; male/female ratio: 41.4%; median age: 43.2 years). In the CD group, 81.3% were in CSFR and 65.6% were in BR, while in the UC group, 71.7% were in CSFR and 69.4% were in BR. Overall, 17.1% of the patients ceased s.c. VDZ treatment after a median of 26.2 (interquartile range 20-47) weeks. LOR was registered in 3/12 ceased patients. In addition, CSFR and BR rates were stable, while serum VDZ levels increased by w52 (<i>p</i> < 0.001).</p><p><strong>Conclusion: </strong>The transition from i.v. to s.c. VDZ treatment was effective, the overall persistence rate was associated with high serum drug levels, and no novel safety issues were reported. Although s.c. administration after induction can save resources, some patients still insisted on i.v. VDZ treatment, due to its proven formulation.</p>","PeriodicalId":48770,"journal":{"name":"Therapeutic Advances in Gastroenterology","volume":"17 ","pages":"17562848241290636"},"PeriodicalIF":3.9,"publicationDate":"2024-10-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11503703/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142511037","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Lijuan Feng, Xunchao Cai, Qian Zou, Yao Peng, Long Xu, Linlin Wang, Qing Liu, Ting Lou
{"title":"Exploring the management and treatment of IBD from the perspective of psychological comorbidities.","authors":"Lijuan Feng, Xunchao Cai, Qian Zou, Yao Peng, Long Xu, Linlin Wang, Qing Liu, Ting Lou","doi":"10.1177/17562848241290685","DOIUrl":"https://doi.org/10.1177/17562848241290685","url":null,"abstract":"<p><p>The prevalence of anxiety, depression, and other psychological comorbidities among patients with inflammatory bowel disease (IBD) significantly exceeds that of the general population. Moreover, a bidirectional relationship exists between psychological comorbidities and IBD. This intricate interplay has substantial clinical implications, impacting treatment adherence, therapeutic efficacy, and disease recurrence rates. In this review, we explore the multifaceted mechanisms through which psychological factors influence IBD progression, treatment response, and prognosis. Specifically, we delve into the involvement of the hypothalamic-pituitary-adrenal axis, autonomic nervous system, enteric nervous system, microbiota-gut-brain axis, systemic inflammatory cytokines, and immune cell function. Additionally, we discuss the potential benefits of antidepressant therapy in mitigating IBD risk and the role of psychotropic drugs in reducing peripheral inflammation. Recognizing and addressing psychological comorbidity is pivotal in comprehensive IBD management. We advocate for the integration of biopsychosocial approaches into IBD treatment strategies, emphasizing the need for innovative psychological interventions as adjuncts to conventional therapies. Rigorous research investigating the impact of antidepressants and behavioral interventions on IBD-specific outcomes may herald a paradigm shift in IBD management.</p>","PeriodicalId":48770,"journal":{"name":"Therapeutic Advances in Gastroenterology","volume":"17 ","pages":"17562848241290685"},"PeriodicalIF":3.9,"publicationDate":"2024-10-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11483836/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142478238","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"A retrospective real-world study on the safety and efficacy of budesonide orodispersible tablets for the induction therapy of eosinophilic oesophagitis.","authors":"Rachel Geow, Gina Arena, Chiang Siah, Sherman Picardo","doi":"10.1177/17562848241290346","DOIUrl":"https://doi.org/10.1177/17562848241290346","url":null,"abstract":"<p><strong>Background: </strong>An orodispersible form of budesonide has recently been approved for the targeted treatment of eosinophilic oesophagitis in the United Kingdom, Europe, Australia, Canada and the United States, following favourable results from a randomised controlled trial. This is the first dedicated real-world study exploring the safety and efficacy of budesonide orodispersible tablets for induction therapy in the treatment of eosinophilic oesophagitis while providing insights into its management.</p><p><strong>Objectives: </strong>The primary objective was histologic remission, defined as less than 5 eosinophils per high-powered field. The secondary objectives included histologic response (>50% reduction in peak eosinophil count), clinical remission (complete resolution of symptoms documented on clinic letters), clinical response (improvements in symptoms as reported on clinical letters), endoscopic remission (Endoscopic Reference Score (EREFS) score = 0), and endoscopic response (improvement in EREFS score). The EREFS scores were calculated based on the severity and presence of rings, longitudinal furrows, strictures, oedema and exudates on endoscopic images. Adverse events and safety profiles were also recorded.</p><p><strong>Design: </strong>A multicentre cohort study examining the effectiveness of 1 mg, twice daily, budesonide orodispersible tablet induction therapy for the treatment of eosinophilic oesophagitis.</p><p><strong>Methods: </strong>Ethics approval was obtained through the Western Australia Health: Governance, Evidence, Knowledge, Outcomes system for assessment of Audit and Quality Activities. The study adhered to the Strengthening the Reporting of Observational Studies in Epidemiology guidelines.</p><p><strong>Results: </strong>A total of 43 patients (29 males, 14 females; median age 39) were recruited. Forty-one patients were included in the analysis. After induction therapy, 30 patients (73%) achieved histologic remission, and 35 patients (85%) demonstrated histologic response. Thirty-nine patients (95%) achieved clinical response, and 28 patients (68%) achieved clinical remission. An endoscopic response was seen in 37 patients (90%), and 16 patients (39%) achieved endoscopic remission. No significant adverse events were identified.</p><p><strong>Conclusion: </strong>Budesonide orodispersible tablet is an effective induction therapy for eosinophilic oesophagitis, as evidenced by its high histologic remission rate and favourable safety profile.</p>","PeriodicalId":48770,"journal":{"name":"Therapeutic Advances in Gastroenterology","volume":"17 ","pages":"17562848241290346"},"PeriodicalIF":3.9,"publicationDate":"2024-10-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11483688/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142478218","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Prescribed cumulative dosage of corticosteroids to patients with inflammatory bowel disease diagnosed between 2006 and 2020: a retrospective observational study.","authors":"Johannes Iiristo, Pontus Karling","doi":"10.1177/17562848241288851","DOIUrl":"https://doi.org/10.1177/17562848241288851","url":null,"abstract":"<p><strong>Background: </strong>Treatments and strategies for inflammatory bowel disease (IBD) have gradually evolved in the 2000s.</p><p><strong>Objectives: </strong>We investigated whether the prescription of corticosteroids (prednisolone and budesonide) in patients with IBD in the first 5 years after diagnosis changed in patients diagnosed between 2006 and 2018.</p><p><strong>Design: </strong>Retrospective observational study.</p><p><strong>Methods: </strong>The cumulative prescribed dosage of corticosteroids for the first 5 years after diagnosis was registered in all patients with IBD (<i>n</i> = 386) at our clinic for those diagnosed between 2006 and 2018.</p><p><strong>Results: </strong>The proportion of patients with IBD who were prescribed at least one prescription of corticosteroids in year 1-5 after diagnosis was 55.3%, 27.9%, 22.7%, 14.1%, and 14.6%, respectively. The proportion of patients who had a cumulative dose of prednisolone >1 g in the first 5 years after diagnosis was 40.1% for ulcerative colitis and 34.9% for Crohn's disease (CD). The cumulative prescribed dosage (within 3 years after diagnosis) of prednisolone had declined (rs = -0.164, <i>p</i> = 001), but had increased for budesonide (rs = 0.202, <i>p</i> < 0.001) between 2006 and 2020. The prescription of any immunomodulator for IBD in the first 5 years from diagnosis was stable between 2006 and 2018 (rs = 0.056, <i>p</i> = 0.257), but there was a minor increase in the prescription of Tumor Necrosis Factor (TNF)-inhibitors (rs = 0.119, <i>p</i> = 0.020). The use of five-acetyl salicylic acid (5-ASA) decreased in patients with CD (rs = -201, <i>p</i> = 0.012).</p><p><strong>Conclusion: </strong>There was a decrease in the prescription of prednisolone and an increase in the prescription of budesonide treatment from 2006 to 2023; however, the cumulative exposure to corticosteroids in patients with IBD remains at a relatively high level.</p>","PeriodicalId":48770,"journal":{"name":"Therapeutic Advances in Gastroenterology","volume":"17 ","pages":"17562848241288851"},"PeriodicalIF":3.9,"publicationDate":"2024-10-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11472373/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142478321","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}