Vipul Jairath
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View article: Gastric and Duodenal Mucosal Healing With Risankizumab in Upper Gastrointestinal Crohn's Disease
Gastric and Duodenal Mucosal Healing With Risankizumab in Upper Gastrointestinal Crohn's Disease Open
There are very limited data on the efficacy of medical therapies for upper gastrointestinal Crohn's disease (CD), and no data exist for the efficacy of IL-23 p19 inhibition on upper gastrointestinal CD. We present the case of a 21-year-old…
View article: Systematic Review: Ultrasound Goes Echo—Decarbonising Inflammatory Bowel Disease Care Through Intestinal Ultrasound
Systematic Review: Ultrasound Goes Echo—Decarbonising Inflammatory Bowel Disease Care Through Intestinal Ultrasound Open
Background Inflammatory bowel disease (IBD) is a chronic, resource‐intensive condition requiring repeated diagnostic assessments. Healthcare contributes ~5% of global greenhouse gas emissions, and key diagnostic tools in IBD—gastrointestin…
View article: Integrating Intestinal Ultrasound to Clinical Trials in Patients With Crohn’s Disease: Opportunities and Challenges
Integrating Intestinal Ultrasound to Clinical Trials in Patients With Crohn’s Disease: Opportunities and Challenges Open
This narrative review summarizes the current knowledge on using intestinal ultrasonography (IUS) to evaluate disease activity in patients with Crohn’s disease (CD) and explores its potential role in clinical trials. Current trial endpoints…
View article: Primary Sclerosing Cholangitis Worsens Prognosis in Patients With Inflammatory Bowel Disease: A Propensity‐Matched Cohort Study
Primary Sclerosing Cholangitis Worsens Prognosis in Patients With Inflammatory Bowel Disease: A Propensity‐Matched Cohort Study Open
Background Few data are available on the impact of primary sclerosing cholangitis (PSC) on inflammatory bowel disease (IBD). Objective We conducted a retrospective study using TriNetX to compare the outcomes of patients with IBD and those …
View article: IBD 2024: Charting a New Course in IBD Proceedings of the Takeda Symposium 22–23 November 2024 W Hotel, Brisbane, Queensland, Australia
IBD 2024: Charting a New Course in IBD Proceedings of the Takeda Symposium 22–23 November 2024 W Hotel, Brisbane, Queensland, Australia Open
The symposium IBD 2024: Charting a New Course in IBD was held in Brisbane, Australia, in November 2024. This was the fifth such meeting for the Australian inflammatory bowel disease (IBD) healthcare community. This symposium provided an ov…
View article: Efficacy and safety of upadacitinib maintenance therapy in patients with moderately to severely active Crohn’s disease: 2-year results from the U-ENDURE Long-Term Extension study
Efficacy and safety of upadacitinib maintenance therapy in patients with moderately to severely active Crohn’s disease: 2-year results from the U-ENDURE Long-Term Extension study Open
Background and Aims The long-term efficacy and safety of upadacitinib in patients with moderate to severe Crohn’s disease (CD) were evaluated in the U-ENDURE Long-Term Extension (LTE) study. Here we report the results after 2 years of tota…
View article: Spatiotemporal analysis of Crohn’s disease reveals PECAM2 signaling at the basis of the inflammation-to-fibrosis transition
Spatiotemporal analysis of Crohn’s disease reveals PECAM2 signaling at the basis of the inflammation-to-fibrosis transition Open
Background and Aims Crohn’s disease (CD) is a chronic inflammatory disease of the bowel, often complicated by fibrotic strictures, for which medical treatment is lacking, and surgery is commonly required. The mechanisms underlying the prog…
View article: Mirikizumab impact on disease clearance in patients with moderately to severely active ulcerative colitis: analysis of a pre-specified LUCENT trial endpoint
Mirikizumab impact on disease clearance in patients with moderately to severely active ulcerative colitis: analysis of a pre-specified LUCENT trial endpoint Open
Background and aims Concurrent achievement of symptomatic, endoscopic, and histologic remission, known as disease clearance, has been proposed as a treatment target in ulcerative colitis. Mirikizumab, an anti-interleukin-23p19 antibody, ha…
View article: Comparison of the FDA and EMA guidance on drug development in ulcerative colitis: an expert panel review
Comparison of the FDA and EMA guidance on drug development in ulcerative colitis: an expert panel review Open
Background and Aims The Food and Drug Administration (FDA) and European Medicines Agency (EMA) ensure the safety, efficacy, and security of treatments, including therapies for immune-mediated disorders such as inflammatory bowel disease (I…
View article: Metabolism and response to stress gene signatures reveal ulcerative colitis heterogeneity and identify patients with increased response to therapy
Metabolism and response to stress gene signatures reveal ulcerative colitis heterogeneity and identify patients with increased response to therapy Open
Background and Aims Ulcerative colitis (UC) therapies lead to variable remission and response rates in patients participating in clinical trials, likely due to interindividual target variability, differences in active biological pathways, …
View article: An International Consensus on Appropriate Management of Corticosteroids in Clinical Trials in Inflammatory Bowel Disease
An International Consensus on Appropriate Management of Corticosteroids in Clinical Trials in Inflammatory Bowel Disease Open
These recommendations will serve to optimize trial design and facilitate appropriate, acceptable, and standardized RCT corticosteroid handling practices.
View article: The Effectiveness of Medical Therapies for Joint, Skin and Eye Extraintestinal Manifestations in IBD—An Umbrella Review
The Effectiveness of Medical Therapies for Joint, Skin and Eye Extraintestinal Manifestations in IBD—An Umbrella Review Open
Background Extraintestinal manifestations (EIMs) occur commonly in patients with inflammatory bowel disease (IBD), affecting joints, skin, eyes and other organs, and contributing to morbidity and long‐term disability. Aims To synthesise ev…
View article: Letter: Re‐Examining Seton Efficacy in Perianal Crohn's Disease—Critical Considerations for Outcome Measurement and Clinical Interpretation. Authors' Reply
Letter: Re‐Examining Seton Efficacy in Perianal Crohn's Disease—Critical Considerations for Outcome Measurement and Clinical Interpretation. Authors' Reply Open
View article: Disease Clearance in Ulcerative Colitis: A Narrative Review
Disease Clearance in Ulcerative Colitis: A Narrative Review Open
Ulcerative colitis (UC) is a chronic relapsing disease with significant associated risks such as colectomy, hospitalization, or colorectal cancer. A treat‐to‐target approach that mitigates disease activity and progression from an early sta…
View article: The Impact of Setons on Perianal Fistula Outcomes in Patients With Crohn's Disease Treated With Anti‐<scp>TNF</scp> Therapy: A Multicentre Study
The Impact of Setons on Perianal Fistula Outcomes in Patients With Crohn's Disease Treated With Anti‐<span>TNF</span> Therapy: A Multicentre Study Open
Background and Aims We aimed to assess the impact of setons on perianal fistula outcomes in patients with perianal fistulising Crohn's disease (PFCD) treated with anti‐TNF therapy. Methods We included patients treated with their first anti…
View article: Efficacy and safety of advanced therapies for moderately to severely active ulcerative colitis in induction and maintenance: systematic literature review and Bayesian network meta-analysis
Efficacy and safety of advanced therapies for moderately to severely active ulcerative colitis in induction and maintenance: systematic literature review and Bayesian network meta-analysis Open
Aim: Several therapies have recently been licensed for the treatment of patients with moderately to severely active ulcerative colitis (UC). To provide comparative evidence of newly available treatments, Bayesian network meta-analyses were…
View article: Novel outcomes in inflammatory bowel disease
Novel outcomes in inflammatory bowel disease Open
Inflammatory bowel diseases (IBD), Crohn’s disease (CD), and ulcerative colitis (UC) are lifelong chronic, relapsing, and remitting conditions that culminate in disease progression in many patients. Effective management of CD and UC requir…
View article: Matching-adjusted indirect comparisons of efficacy outcomes between etrasimod and ozanimod for moderately to severely active ulcerative colitis
Matching-adjusted indirect comparisons of efficacy outcomes between etrasimod and ozanimod for moderately to severely active ulcerative colitis Open
Aim: Etrasimod and ozanimod are selective sphingosine 1-phosphate receptor modulators targeting the S1P 1,4,5 , and S1P 1,5 receptors, respectively, for the treatment of patients with moderately to severely active ulcerative colitis (UC). …
View article: A64 VALIDATION OF THE MODIFIED MULTIPLIER OF SES-CD (MM-SES-CD) TO PREDICT ENDOSCOPIC REMISSION IN CROHN’S DISEASE: A POST HOC ANALYSIS OF THE SEAVUE TRIAL
A64 VALIDATION OF THE MODIFIED MULTIPLIER OF SES-CD (MM-SES-CD) TO PREDICT ENDOSCOPIC REMISSION IN CROHN’S DISEASE: A POST HOC ANALYSIS OF THE SEAVUE TRIAL Open
Background The modified multiplier of the SES-CD (MM-SES-CD) has been shown to have prognostic value for predicting endoscopic healing (EH) in patients with Crohn’s disease. Aims The purpose of this analysis was to validate baseline catego…
View article: Editorial: Striking the Right Balance for Eligibility Criteria for Clinical Trials in Inflammatory Bowel Disease
Editorial: Striking the Right Balance for Eligibility Criteria for Clinical Trials in Inflammatory Bowel Disease Open
View article: International Consensus on the Use of Intestinal Ultrasound in Inflammatory Bowel Disease Trials
International Consensus on the Use of Intestinal Ultrasound in Inflammatory Bowel Disease Trials Open
View article: Improvement in serum eosinophilia is observed in clinical responders to ustekinumab but not adalimumab in inflammatory bowel disease
Improvement in serum eosinophilia is observed in clinical responders to ustekinumab but not adalimumab in inflammatory bowel disease Open
Introduction In inflammatory bowel disease (IBD), the number of eosinophils increases in the lamina propria of the intestinal tract, but their specific patho-mechanistic role remains unclear. Elevated blood eosinophil counts in active IBD …
View article: Acute Severe Ulcerative Colitis: An International Delphi Consensus on Clinical Trial Design and Endpoints
Acute Severe Ulcerative Colitis: An International Delphi Consensus on Clinical Trial Design and Endpoints Open
View article: Meta‐Analysis: Evaluating Placebo Rates Across Outcomes in Eosinophilic Oesophagitis Randomised Controlled Trials
Meta‐Analysis: Evaluating Placebo Rates Across Outcomes in Eosinophilic Oesophagitis Randomised Controlled Trials Open
Background High placebo responses have limited drug development in eosinophilic oesophagitis. The optimal configuration of trial outcomes is uncertain. Aims To inform more efficient future trial designs, to characterise clinical, endoscopi…
View article: Heterogeneity of definition of upper gastrointestinal tract in different guidelines of Crohn's disease: A scoping review
Heterogeneity of definition of upper gastrointestinal tract in different guidelines of Crohn's disease: A scoping review Open
Crohn's Disease (CD) can affect any part of the gastrointestinal (GI) tract, including the upper GI tract (UGIT). However, the definitions and classifications of upper GI CD (UGICD) vary. We conducted a scoping review to explore how UGIT a…
View article: Upadacitinib Versus Filgotinib in Ulcerative Colitis: Is the Evidence Sufficient to Inform Treatment Decisions?
Upadacitinib Versus Filgotinib in Ulcerative Colitis: Is the Evidence Sufficient to Inform Treatment Decisions? Open
View article: Use of Modified Multiplier of the Simple Endoscopic Score for Crohn’s Disease Endoscopic Improvement Thresholds Enhances Effect Size Differentiation Between Adalimumab Versus Placebo: A Post Hoc Analysis of the EXTEND Trial
Use of Modified Multiplier of the Simple Endoscopic Score for Crohn’s Disease Endoscopic Improvement Thresholds Enhances Effect Size Differentiation Between Adalimumab Versus Placebo: A Post Hoc Analysis of the EXTEND Trial Open
Introduction The Modified Multiplier of the Simple Endoscopic Score for Crohn’s Disease (MM-SES-CD) refines the assessment of endoscopic CD severity by differentially weighting parameters in the original SES-CD. A threshold of <22.5 for…
View article: Letter: Bowel Preparation Quality in Patients With Crohn's Disease—Authors' Reply
Letter: Bowel Preparation Quality in Patients With Crohn's Disease—Authors' Reply Open
View article: Risankizumab Is Associated With Normalization of Biomarkers in Patients With Crohn’s Disease: Results From the Phase 3 ADVANCE, MOTIVATE, and FORTIFY Studies
Risankizumab Is Associated With Normalization of Biomarkers in Patients With Crohn’s Disease: Results From the Phase 3 ADVANCE, MOTIVATE, and FORTIFY Studies Open
Background and Aims Normalization of high-sensitivity C-reactive protein (hs-CRP) and fecal calprotectin (FCP) are suggested as intermediate treatment targets for Crohn’s disease (CD). This analysis evaluates achievement of biomarker norma…
View article: Placebo Rates in Crohn’s Disease Randomized Clinical Trials: An Individual Patient Data Meta-Analysis
Placebo Rates in Crohn’s Disease Randomized Clinical Trials: An Individual Patient Data Meta-Analysis Open
Patient- and trial-level characteristics influence placebo rates in Crohn's disease trials. Careful implementation of eligibility criteria, outcome definitions, and patient stratification may reduce placebo rates.