Pub Date : 2026-02-05DOI: 10.1093/ecco-jcc/jjaf229
Jordan Axelrad, Anders Forss, Jonas Söderling, Karl Mårild, Jonas Halfvarson, Pontus Naucler, Jonas F Ludvigsson, Ola Olén
Background: We aimed to assess the risk of serious infections in patients with inflammatory bowel disease (IBD) exposed to different advanced therapies.
Methods: We linked nationwide registers and compared rates of incident serious infections in patients with Crohn's disease (CD) and ulcerative colitis (UC) exposed to medical therapies versus matched general population comparators during 2007-2023. We 1:1 propensity score-matched individuals with IBD to compare infection risk across therapies.
Results: We identified 55 866 patients with IBD naïve to immunomodulators (IMM) and advanced therapies, 20 392 exposed to IMM, 15 973 to anti-tumor necrosis factor (anti-TNF), 9035 to IMM with anti-TNF, 3948 to vedolizumab, 2926 to ustekinumab, 659 to tofacitinib, 987 to upadacitinib, 262 to filgotinib, and 163 to risankizumab with 987 366 matched comparators with up to 18 years of follow-up. Compared to the general population (incidence rate range 0.39-1.13 per 100 person-years [PY]), patients with IBD had a higher incidence of serious infections (naïve 2.31 per 100 PY; adjusted hazard ratio [aHR] 1.89, 95% confidence interval [CI] 1.84-1.94), IMM 3.27 per 100 PY (aHR 4.45, 95% CI 4.24-4.66), and advanced therapies 3.14-8.10 per 100 PY (aHR 3.45-10.55, 95% CI 3.04-26.65). Relative risks were elevated in the pediatric population, and for opportunistic and gastrointestinal infections. No differences in infection rates were observed in propensity score-matched comparisons of different advanced therapies.
Conclusion: Patients with IBD were at an increased risk of infections, even among those naïve to IMM and advanced therapies. There was no significant difference in the risk of infections across advanced therapy exposures.
{"title":"Risk of serious infections in patients with inflammatory bowel disease treated with biologic and small molecule therapies: a nationwide cohort study.","authors":"Jordan Axelrad, Anders Forss, Jonas Söderling, Karl Mårild, Jonas Halfvarson, Pontus Naucler, Jonas F Ludvigsson, Ola Olén","doi":"10.1093/ecco-jcc/jjaf229","DOIUrl":"10.1093/ecco-jcc/jjaf229","url":null,"abstract":"<p><strong>Background: </strong>We aimed to assess the risk of serious infections in patients with inflammatory bowel disease (IBD) exposed to different advanced therapies.</p><p><strong>Methods: </strong>We linked nationwide registers and compared rates of incident serious infections in patients with Crohn's disease (CD) and ulcerative colitis (UC) exposed to medical therapies versus matched general population comparators during 2007-2023. We 1:1 propensity score-matched individuals with IBD to compare infection risk across therapies.</p><p><strong>Results: </strong>We identified 55 866 patients with IBD naïve to immunomodulators (IMM) and advanced therapies, 20 392 exposed to IMM, 15 973 to anti-tumor necrosis factor (anti-TNF), 9035 to IMM with anti-TNF, 3948 to vedolizumab, 2926 to ustekinumab, 659 to tofacitinib, 987 to upadacitinib, 262 to filgotinib, and 163 to risankizumab with 987 366 matched comparators with up to 18 years of follow-up. Compared to the general population (incidence rate range 0.39-1.13 per 100 person-years [PY]), patients with IBD had a higher incidence of serious infections (naïve 2.31 per 100 PY; adjusted hazard ratio [aHR] 1.89, 95% confidence interval [CI] 1.84-1.94), IMM 3.27 per 100 PY (aHR 4.45, 95% CI 4.24-4.66), and advanced therapies 3.14-8.10 per 100 PY (aHR 3.45-10.55, 95% CI 3.04-26.65). Relative risks were elevated in the pediatric population, and for opportunistic and gastrointestinal infections. No differences in infection rates were observed in propensity score-matched comparisons of different advanced therapies.</p><p><strong>Conclusion: </strong>Patients with IBD were at an increased risk of infections, even among those naïve to IMM and advanced therapies. There was no significant difference in the risk of infections across advanced therapy exposures.</p>","PeriodicalId":94074,"journal":{"name":"Journal of Crohn's & colitis","volume":" ","pages":""},"PeriodicalIF":8.7,"publicationDate":"2026-02-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145764878","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}
Pub Date : 2026-02-01DOI: 10.1093/ecco-jcc/jjaf203
Amit Thakor, Saiumaeswar Yogakanthi, Nurulamin M Noor, Miles Parkes
Both Crohn's disease and ulcerative colitis are associated with heterogeneity of presentation, disease course, and outcomes between individuals. The frequency of flares and progression to complications can have a profound impact on quality of life for people living with IBD. Indeed, many patients report suboptimal disease control and major disruption to their lives from active, uncontrolled inflammation. Two major factors potentially contributing to adverse outcomes are delays to establish a diagnosis of IBD and delays in the introduction of effective treatment. Several recent studies have addressed the role of early diagnosis and early treatment, including differences to consider between Crohn's disease and ulcerative colitis. In this review we summarize the important insights obtained and highlight how outcomes for patients can be improved with a focus on timely diagnosis and timely, effective treatment interventions.
{"title":"Rapid diagnosis and treatment of inflammatory bowel diseases.","authors":"Amit Thakor, Saiumaeswar Yogakanthi, Nurulamin M Noor, Miles Parkes","doi":"10.1093/ecco-jcc/jjaf203","DOIUrl":"https://doi.org/10.1093/ecco-jcc/jjaf203","url":null,"abstract":"<p><p>Both Crohn's disease and ulcerative colitis are associated with heterogeneity of presentation, disease course, and outcomes between individuals. The frequency of flares and progression to complications can have a profound impact on quality of life for people living with IBD. Indeed, many patients report suboptimal disease control and major disruption to their lives from active, uncontrolled inflammation. Two major factors potentially contributing to adverse outcomes are delays to establish a diagnosis of IBD and delays in the introduction of effective treatment. Several recent studies have addressed the role of early diagnosis and early treatment, including differences to consider between Crohn's disease and ulcerative colitis. In this review we summarize the important insights obtained and highlight how outcomes for patients can be improved with a focus on timely diagnosis and timely, effective treatment interventions.</p>","PeriodicalId":94074,"journal":{"name":"Journal of Crohn's & colitis","volume":"20 Supplement_2","pages":"ii3-ii10"},"PeriodicalIF":8.7,"publicationDate":"2026-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146222089","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}
Pub Date : 2026-02-01DOI: 10.1093/ecco-jcc/jjaf227
Hyder Said, Calum D Moulton, Ailsa Hart, Laurie Keefer
There is a growing body of evidence supporting the value of multidisciplinary teams in delivering comprehensive, holistic care for individuals with inflammatory bowel disease (IBD). Members of this team often include gastroenterologists, psychologists, nurses, dieticians, and other specialists and allied healthcare professionals, each of whom have a significant role in the treatment of IBD and its associated complications. Common symptoms that impact quality of life include persistent abdominal pain, fatigue, urgency, sleep disturbances, and mood disorders. Holistic care models are particularly well-suited to address these challenges, offering targeted symptom-based interventions. Further, holistic care models can modify broader health behaviors that can influence disease activity, such as nutrition, smoking cessation, and stress management. The implementation of holistic care can take various forms, ranging from fully integrated medical homes embedded within IBD centers to partially integrated or community-based programs. Antidepressant medications can help to restore the gut-brain axis, thereby improving mental health and physical symptoms concurrently, and we provide practical guidance in their dosing, side-effect profiles, and appropriate combination therapies. Additionally, digital health technologies have provided diagnostic and therapeutic insights into advancing IBD care, enhancing the delivery of longitudinal, patient-centered care. To improve long-term outcomes and enhance quality of life for individuals with IBD, clinicians and healthcare systems must prioritize the development and integration of holistic, multidisciplinary care models into routine practice.
{"title":"Holistic care in inflammatory bowel disease: is it in REACH?","authors":"Hyder Said, Calum D Moulton, Ailsa Hart, Laurie Keefer","doi":"10.1093/ecco-jcc/jjaf227","DOIUrl":"https://doi.org/10.1093/ecco-jcc/jjaf227","url":null,"abstract":"<p><p>There is a growing body of evidence supporting the value of multidisciplinary teams in delivering comprehensive, holistic care for individuals with inflammatory bowel disease (IBD). Members of this team often include gastroenterologists, psychologists, nurses, dieticians, and other specialists and allied healthcare professionals, each of whom have a significant role in the treatment of IBD and its associated complications. Common symptoms that impact quality of life include persistent abdominal pain, fatigue, urgency, sleep disturbances, and mood disorders. Holistic care models are particularly well-suited to address these challenges, offering targeted symptom-based interventions. Further, holistic care models can modify broader health behaviors that can influence disease activity, such as nutrition, smoking cessation, and stress management. The implementation of holistic care can take various forms, ranging from fully integrated medical homes embedded within IBD centers to partially integrated or community-based programs. Antidepressant medications can help to restore the gut-brain axis, thereby improving mental health and physical symptoms concurrently, and we provide practical guidance in their dosing, side-effect profiles, and appropriate combination therapies. Additionally, digital health technologies have provided diagnostic and therapeutic insights into advancing IBD care, enhancing the delivery of longitudinal, patient-centered care. To improve long-term outcomes and enhance quality of life for individuals with IBD, clinicians and healthcare systems must prioritize the development and integration of holistic, multidisciplinary care models into routine practice.</p>","PeriodicalId":94074,"journal":{"name":"Journal of Crohn's & colitis","volume":"20 Supplement_2","pages":"ii52-ii65"},"PeriodicalIF":8.7,"publicationDate":"2026-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146222142","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}
Pub Date : 2026-02-01DOI: 10.1093/ecco-jcc/jjaf205
Johan Burisch, Rupa Banerjee, Gillian Watermeyer
The global burden of inflammatory bowel disease (IBD) is rising rapidly, not only in high-income countries but also in low- and middle-income countries (LMICs). At the same time, access to high-quality care remains uneven. Patients in LMICs and rural regions often face shortages of gastroenterologists, limited diagnostic capacity, and poor access to advanced therapies. In high-income countries, disadvantaged groups encounter financial barriers, food insecurity, and caregiver strain. Ethnic and racial minorities are more often diagnosed late, less likely to receive biologics, and remain underrepresented in clinical trials, reducing the generalizability of evidence. Structural factors add further challenges. Shortages of IBD nurses and allied specialists, fragmented care pathways, and lack of multidisciplinary teams widen disparities. Strategies to improve equity must address several levels: policy reforms that include social determinants of health and secure reimbursement; expansion of diagnostic and therapeutic capacity; use of cost-effective innovations such as telemedicine and intestinal ultrasound; and greater involvement of patients and communities. Training, awareness, and cultural competence are also important to reduce stigma and shorten diagnostic delay. Future efforts should embed equity into value-based care models, scale digital health while preventing digital exclusion, and apply artificial intelligence in ways that support fair allocation of resources. Global partnerships are needed to build capacity where it is lacking. Achieving equitable access to IBD care will require coordinated action between clinicians, policy-makers, patients, and industry to ensure sustainable, patient-centered, and inclusive care worldwide.
{"title":"Equitable access to inflammatory bowel disease care: challenges, strategies, and future directions.","authors":"Johan Burisch, Rupa Banerjee, Gillian Watermeyer","doi":"10.1093/ecco-jcc/jjaf205","DOIUrl":"https://doi.org/10.1093/ecco-jcc/jjaf205","url":null,"abstract":"<p><p>The global burden of inflammatory bowel disease (IBD) is rising rapidly, not only in high-income countries but also in low- and middle-income countries (LMICs). At the same time, access to high-quality care remains uneven. Patients in LMICs and rural regions often face shortages of gastroenterologists, limited diagnostic capacity, and poor access to advanced therapies. In high-income countries, disadvantaged groups encounter financial barriers, food insecurity, and caregiver strain. Ethnic and racial minorities are more often diagnosed late, less likely to receive biologics, and remain underrepresented in clinical trials, reducing the generalizability of evidence. Structural factors add further challenges. Shortages of IBD nurses and allied specialists, fragmented care pathways, and lack of multidisciplinary teams widen disparities. Strategies to improve equity must address several levels: policy reforms that include social determinants of health and secure reimbursement; expansion of diagnostic and therapeutic capacity; use of cost-effective innovations such as telemedicine and intestinal ultrasound; and greater involvement of patients and communities. Training, awareness, and cultural competence are also important to reduce stigma and shorten diagnostic delay. Future efforts should embed equity into value-based care models, scale digital health while preventing digital exclusion, and apply artificial intelligence in ways that support fair allocation of resources. Global partnerships are needed to build capacity where it is lacking. Achieving equitable access to IBD care will require coordinated action between clinicians, policy-makers, patients, and industry to ensure sustainable, patient-centered, and inclusive care worldwide.</p>","PeriodicalId":94074,"journal":{"name":"Journal of Crohn's & colitis","volume":"20 Supplement_2","pages":"ii11-ii22"},"PeriodicalIF":8.7,"publicationDate":"2026-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146222148","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}
Pub Date : 2026-02-01DOI: 10.1093/ecco-jcc/jjaf222
Stephanie Williams, Laween Meran, Sara McCartney, Paul Harrow, James C Lee
Inflammatory bowel disease (IBD) arises from a multifaceted interplay of genetic predisposition, environmental triggers, microbial dynamics, and immune dysregulation. This complex network of interacting factors disrupts gut homeostasis, leading to chronic relapsing inflammation in the gastrointestinal tract. This review synthesizes the current understanding of the multifactorial causes of IBD. Central to disease pathogenesis is the altered relationship between the host immune system and the intestinal microbiome, which culminates in a persistent cycle of tissue damage and inflammation, involving both innate and adaptive immunity as well as non-immune cells. Efforts to elucidate these integrated pathways have underscored the importance of both intrinsic host factors and extrinsic environmental triggers in IBD pathogenesis. Despite this, a better understanding of disease mechanisms is still needed, and will be essential to developing better therapies that can target relevant axes of the disease process and restore immune balance, facilitate tissue repair, and induce lasting remission.
{"title":"REACH: C-cause.","authors":"Stephanie Williams, Laween Meran, Sara McCartney, Paul Harrow, James C Lee","doi":"10.1093/ecco-jcc/jjaf222","DOIUrl":"https://doi.org/10.1093/ecco-jcc/jjaf222","url":null,"abstract":"<p><p>Inflammatory bowel disease (IBD) arises from a multifaceted interplay of genetic predisposition, environmental triggers, microbial dynamics, and immune dysregulation. This complex network of interacting factors disrupts gut homeostasis, leading to chronic relapsing inflammation in the gastrointestinal tract. This review synthesizes the current understanding of the multifactorial causes of IBD. Central to disease pathogenesis is the altered relationship between the host immune system and the intestinal microbiome, which culminates in a persistent cycle of tissue damage and inflammation, involving both innate and adaptive immunity as well as non-immune cells. Efforts to elucidate these integrated pathways have underscored the importance of both intrinsic host factors and extrinsic environmental triggers in IBD pathogenesis. Despite this, a better understanding of disease mechanisms is still needed, and will be essential to developing better therapies that can target relevant axes of the disease process and restore immune balance, facilitate tissue repair, and induce lasting remission.</p>","PeriodicalId":94074,"journal":{"name":"Journal of Crohn's & colitis","volume":"20 Supplement_2","pages":"ii38-ii51"},"PeriodicalIF":8.7,"publicationDate":"2026-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146222173","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}
Pub Date : 2026-02-01DOI: 10.1093/ecco-jcc/jjaf168
Britta Siegmund, Ailsa Hart
{"title":"REACHing forward-a strategic vision for ECCO and the future of IBD care.","authors":"Britta Siegmund, Ailsa Hart","doi":"10.1093/ecco-jcc/jjaf168","DOIUrl":"https://doi.org/10.1093/ecco-jcc/jjaf168","url":null,"abstract":"","PeriodicalId":94074,"journal":{"name":"Journal of Crohn's & colitis","volume":"20 Supplement_2","pages":"ii1-ii2"},"PeriodicalIF":8.7,"publicationDate":"2026-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146222176","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}
Pub Date : 2026-02-01DOI: 10.1093/ecco-jcc/jjaf189
Olga Maria Nardone, Beatriz Gros, Tommaso Lorenzo Parigi, Aimen Farooq, Lumir Kunovsky, Shaji Sebastian
The global burden of inflammatory bowel disease (IBD) is expanding into newly industrialized and lower- and lower-middle-income countries and is projected to place increasing pressure on healthcare systems. Advances in treat-to-target strategies have extended care trajectories and intensified monitoring demands, raising urgent questions about how to deliver durable benefits within fiscal, system, and environmental constraints. Stringent targets may come at the cost of higher expenses, increased treatment burden, and adverse effects. In addition, there is potential adverse environmental impact of intensive management and monitoring strategies which may involve increased waste and use of single-use materials. Attaining sustainability in IBD care requires a patient-centered approach that balances clinical effectiveness with feasibility, affordability, sustainability, and environmental responsibility. In this narrative review, we examine the environmental footprint of IBD care and explore the broader concept of sustainability, including clinical, financial, equity, and environmental dimensions. We further highlight strategies to reduce harm while preserving-and potentially enhancing-patient outcomes. A clear understanding of sustainable IBD care is what enables the transition from fragmented efforts to coordinated, evidence-based strategies that can support both patient care and planetary health.
{"title":"Attaining sustainability in inflammatory bowel disease.","authors":"Olga Maria Nardone, Beatriz Gros, Tommaso Lorenzo Parigi, Aimen Farooq, Lumir Kunovsky, Shaji Sebastian","doi":"10.1093/ecco-jcc/jjaf189","DOIUrl":"https://doi.org/10.1093/ecco-jcc/jjaf189","url":null,"abstract":"<p><p>The global burden of inflammatory bowel disease (IBD) is expanding into newly industrialized and lower- and lower-middle-income countries and is projected to place increasing pressure on healthcare systems. Advances in treat-to-target strategies have extended care trajectories and intensified monitoring demands, raising urgent questions about how to deliver durable benefits within fiscal, system, and environmental constraints. Stringent targets may come at the cost of higher expenses, increased treatment burden, and adverse effects. In addition, there is potential adverse environmental impact of intensive management and monitoring strategies which may involve increased waste and use of single-use materials. Attaining sustainability in IBD care requires a patient-centered approach that balances clinical effectiveness with feasibility, affordability, sustainability, and environmental responsibility. In this narrative review, we examine the environmental footprint of IBD care and explore the broader concept of sustainability, including clinical, financial, equity, and environmental dimensions. We further highlight strategies to reduce harm while preserving-and potentially enhancing-patient outcomes. A clear understanding of sustainable IBD care is what enables the transition from fragmented efforts to coordinated, evidence-based strategies that can support both patient care and planetary health.</p>","PeriodicalId":94074,"journal":{"name":"Journal of Crohn's & colitis","volume":"20 Supplement_2","pages":"ii23-ii37"},"PeriodicalIF":8.7,"publicationDate":"2026-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146222178","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}
Background: With the increasing number of effective therapies for inflammatory bowel diseases (IBD), determining optimal treatment sequences is challenging. Given the impracticality of conducting randomized head-to-head trials for every comparison, this study assessed whether phase 3 placebo-controlled trials can reliably predict outcomes of published head-to-head studies.
Methods: Three randomized head-to-head trials without placebo arms were analyzed alongside their corresponding phase 3 placebo-controlled trials. Effect sizes for clinical and endoscopic endpoints were extracted for comparison.
Results: In the VARSITY trial, vedolizumab achieved an 8.8% higher clinical remission rate than adalimumab at week 52 in patients with ulcerative colitis. Placebo-controlled studies estimated a 17.3% advantage for vedolizumab; however, differences in trial design and patient populations between GEMINI-1 and ULTRA-2 limit the robustness of this indirect comparison.In Crohn's disease, indirect comparisons of IM-UNITI, CLASSIC-II, and CHARM suggested an 11.6-18.6% higher efficacy for adalimumab compared with ustekinumab in biologic-naïve patients, yet the SEAVUE head-to-head trial found no significant difference at week 52.Most recently, the SEQUENCE trial demonstrated a + 15.6% superiority of risankizumab over ustekinumab in endoscopic remission at week 48 among bio-exposed Crohn's disease patients, whereas indirect comparisons between FORTIFY and IM-UNITI were confounded by clinically relevant population differences.
Conclusion: Significant heterogeneity in trial design, populations and outcome reporting limits the predictive value of placebo-controlled trials. Randomized head-to-head trials remain essential for optimizing IBD therapeutic strategies.
{"title":"A Descriptive Comparison of Phase 3 Results and Head-to-Head Trials in Inflammatory Bowel Diseases.","authors":"Zlata Chkolnaia, Laurent Peyrin-Biroulet, Mathieu Uzzan","doi":"10.1093/ecco-jcc/jjag009","DOIUrl":"https://doi.org/10.1093/ecco-jcc/jjag009","url":null,"abstract":"<p><strong>Background: </strong>With the increasing number of effective therapies for inflammatory bowel diseases (IBD), determining optimal treatment sequences is challenging. Given the impracticality of conducting randomized head-to-head trials for every comparison, this study assessed whether phase 3 placebo-controlled trials can reliably predict outcomes of published head-to-head studies.</p><p><strong>Methods: </strong>Three randomized head-to-head trials without placebo arms were analyzed alongside their corresponding phase 3 placebo-controlled trials. Effect sizes for clinical and endoscopic endpoints were extracted for comparison.</p><p><strong>Results: </strong>In the VARSITY trial, vedolizumab achieved an 8.8% higher clinical remission rate than adalimumab at week 52 in patients with ulcerative colitis. Placebo-controlled studies estimated a 17.3% advantage for vedolizumab; however, differences in trial design and patient populations between GEMINI-1 and ULTRA-2 limit the robustness of this indirect comparison.In Crohn's disease, indirect comparisons of IM-UNITI, CLASSIC-II, and CHARM suggested an 11.6-18.6% higher efficacy for adalimumab compared with ustekinumab in biologic-naïve patients, yet the SEAVUE head-to-head trial found no significant difference at week 52.Most recently, the SEQUENCE trial demonstrated a + 15.6% superiority of risankizumab over ustekinumab in endoscopic remission at week 48 among bio-exposed Crohn's disease patients, whereas indirect comparisons between FORTIFY and IM-UNITI were confounded by clinically relevant population differences.</p><p><strong>Conclusion: </strong>Significant heterogeneity in trial design, populations and outcome reporting limits the predictive value of placebo-controlled trials. Randomized head-to-head trials remain essential for optimizing IBD therapeutic strategies.</p>","PeriodicalId":94074,"journal":{"name":"Journal of Crohn's & colitis","volume":" ","pages":""},"PeriodicalIF":8.7,"publicationDate":"2026-01-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146088638","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}
Pub Date : 2026-01-23DOI: 10.1093/ecco-jcc/jjag005
A Barney Hawthorne, Paul Christiansen, Ian Arnott, Fraser Cummings, Liz Dobson, Alexandra Kent, Jimmy K Limdi, Robert J Mulligan, Gareth C Parkes, Fiona Rees, Christian P Selinger, Jessica Turner, Nathaniel Woo, Lisa Younge, Christopher A Lamb
Introduction: The IBD U.K. Benchmarking surveys, conducted in 2019 and 2023 collected repeated data regarding the quality of inflammatory bowel disease (IBD) care across the U.K. using both service self-assessments and patient-reported experience measures (PREMs). We aimed to assess variation between patient and provider perspectives.
Methods: All U.K. hospitals offering specialist IBD services were invited to complete online surveys. Patients were invited through social media, charities, and clinical services. This study compared changes over the four-years and examined alignment between healthcare-reported and patient-reported assessments.
Results: From 26,760 patient responses and 154 service assessments, patient perceived care quality (PPCQ) declined between 2019 and 2023 (P <0.001). Male sex and older age were associated with higher PPCQ. Greater disease severity was associated with lower PPCQ (P <0.001). More patients reported IBD symptoms to impact activities of daily living in 2023 (P <0.001). Factors associated with higher PPCQ included rapid diagnosis, being supported by an IBD team and having knowledgeable IBD nurses. Access, information, communication and empowerment were identified by patients as needing improvement (P <0.001). Services with lowest quartile quality scores in 2019, demonstrated significant improvement over time, whilst those with highest 2019 scores demonstrated significant deterioration in PPCQ (P <0·001). Services reported better performance than patients (P <0.001).
Conclusions: This data underscores the importance of assessing lived experience and the care quality perception gap between patients and service providers. Regular benchmarking including PREMs should be used to drive and assess service-level, national and international quality improvement initiatives.
{"title":"Comparative analysis of inflammatory bowel disease patient and service reported quality of care using 2019 and 2023 UK benchmarking data from more than 26,000 adult patient respondents and 154 IBD services.","authors":"A Barney Hawthorne, Paul Christiansen, Ian Arnott, Fraser Cummings, Liz Dobson, Alexandra Kent, Jimmy K Limdi, Robert J Mulligan, Gareth C Parkes, Fiona Rees, Christian P Selinger, Jessica Turner, Nathaniel Woo, Lisa Younge, Christopher A Lamb","doi":"10.1093/ecco-jcc/jjag005","DOIUrl":"https://doi.org/10.1093/ecco-jcc/jjag005","url":null,"abstract":"<p><strong>Introduction: </strong>The IBD U.K. Benchmarking surveys, conducted in 2019 and 2023 collected repeated data regarding the quality of inflammatory bowel disease (IBD) care across the U.K. using both service self-assessments and patient-reported experience measures (PREMs). We aimed to assess variation between patient and provider perspectives.</p><p><strong>Methods: </strong>All U.K. hospitals offering specialist IBD services were invited to complete online surveys. Patients were invited through social media, charities, and clinical services. This study compared changes over the four-years and examined alignment between healthcare-reported and patient-reported assessments.</p><p><strong>Results: </strong>From 26,760 patient responses and 154 service assessments, patient perceived care quality (PPCQ) declined between 2019 and 2023 (P <0.001). Male sex and older age were associated with higher PPCQ. Greater disease severity was associated with lower PPCQ (P <0.001). More patients reported IBD symptoms to impact activities of daily living in 2023 (P <0.001). Factors associated with higher PPCQ included rapid diagnosis, being supported by an IBD team and having knowledgeable IBD nurses. Access, information, communication and empowerment were identified by patients as needing improvement (P <0.001). Services with lowest quartile quality scores in 2019, demonstrated significant improvement over time, whilst those with highest 2019 scores demonstrated significant deterioration in PPCQ (P <0·001). Services reported better performance than patients (P <0.001).</p><p><strong>Conclusions: </strong>This data underscores the importance of assessing lived experience and the care quality perception gap between patients and service providers. Regular benchmarking including PREMs should be used to drive and assess service-level, national and international quality improvement initiatives.</p>","PeriodicalId":94074,"journal":{"name":"Journal of Crohn's & colitis","volume":" ","pages":""},"PeriodicalIF":8.7,"publicationDate":"2026-01-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146042433","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}