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Vipul Jairath

Biography: Dr Jairath is Professor of Medicine at the Schulich School of Medicine and Dentistry, and holder of the John and Susan McDonald Endowed Chair in Inflammatory Bowel Disease (IBD) Clinical Research at Western University. He has a cross appointment in the Department of Epidemiology and Biostatistics at Western University, is a Lawson Scientist and Scientist in the Program of Experimental Medicine. He attended medical school at the University of Leeds (UK) followed by specialist training in gastroenterology in London (UK) and Oxford (UK). At the University of Oxford, he was a National Institute for Health Research (NIHR) Clinical Lecturer, NIHR Clinical Trials Fellows (Oxford Clinical Trials Research Unit) and then Consultant Gastroenterologist at Oxford University hospitals NHS Trust. He was recruited to Western University in 2016. He has a degree in Pharmacology (University of Leeds), a Diploma in Clinical Trials (London School of Hygiene and Topical Medicine) and a DPhil (PhD, University of Oxford).

Clinical practice: Dr Jairath’s clinical practice is based at University hospital, London, where he leads a team providing specialist care to patients Crohn’s Disease and Ulcerative colitis including a clinical nurse specialist, several advanced IBD fellows and close collaboration with specialists in colorectal surgery and nutrition. He also established and chairs the citywide multi-disciplinary IBD Rounds which take place every Tuesday afternoon, attended by gastroenterologists, surgeons, radiologists and pathologists, to discuss management strategies for complex cases of Crohn’s Disease and Ulcerative Colitis.

IBD Clinical Trials at University Hospital: Dr Jairath oversees the clinical trials unit for patients with IBD at University Hospital (LHSC), where he is Principal Investigator for multiple clinical trials. He leads a team which includes two full time clinical trials nurses, a full-time regulator co-ordinator and a research assistant. This includes one of the most diverse clinical trials portfolios available to patients with Crohn’s Disease and Ulcerative Colitis in Canada, with multiple compounds available at phase 2, 3 and 4. The current industry trials portfolio covers all major classes in development such as IL-23 inhibitors, anti-integrins, JAK inhibitors, S1P1 inhibitors and microbiome therapies. Clinicians from outside centers who wish to refer patients for clinical trials can contact Dr Jairath and as well as Heather Prins (RN, Heather.Prins@lhsc.on.ca).

Advanced IBD Fellowship: Dr Jairath established the Advanced IBD Fellowship at Western University in 2016 and is the Program Director for the IBD Fellowship.  This is open to trainees in Canada or internationally. Since 2016, fellows have come from Canada, Ireland, Chile, South Africa, Saudi Arabia and the UAE. Interested applicants should visit the website for further details (https://www.schulich.uwo.ca/gastroenterology/education/advanced_ibd_fellowship.html)

Student Research Supervision: Dr Jairath is a supervisor in the School of Graduate and Postdoctoral Studies, Schulich School of Medicine and Dentistry. He supervises students at PhD and Masters level, often in close collaboration with Professor GY Zou in the Department of Epidemiology and Biostatistics. He supervises students for the Summer Research Training Program (SRTP), Summer Research Opportunities Program (SROP), Scholar’s Elective Program as well as multiple Advanced IBD Fellows and GI Fellows. The vast majority of student projects have lead to peer reviewed journal publications as well and national/international presentations.

Research and Scholarly Activities: Dr. Jairath is the Associate Chair, Research, Department of Medicine. Dr Jairath’s research interests focus on clinical therapeutics for IBD where he has made major contributions to index development and outcome measures for clinical trials. He has also made substantial contributions to clinical trials, practice and guidelines for patients with acute gastrointestinal bleeding. His research work streams are broadly centered around: (a) design, conduct and execution of investigator initiated clinical trials; (b) outcome measure and index development and validation for use in clinical trials, including patients reported outcome measures; (c) prediction modeling for outcomes and response to therapy; (d) methodological research in the design and analysis of clinical trials. He has been the primary or co-applicant to peer-reviewed grants of several million dollars from organizations that include the CIHR, AMOSO, NIHR (UK), Helmsley Foundation, Bowel Disease Research Foundation, Crohn’s and Colitis Canada, as well as industry funding.

Investigator Initiated Clinical Trials: Dr Jairath is/has been Principal Investigator or steering committee member on several investigator initiated clinical trials. These include: (1) VERDICT (ClinicalTrials.gov Identifier: NCT04259138) a collaborative trial between Takeda Pharmaceutical and Robarts Clinical Trials, for which he is overall PI. This trial will randomize patients with UC to a target of treating to symptoms, endoscopic healing or histological healing; (2) STATIC (clinicaltrials.gov: NCT03261206) for which is he overall PI. This pragmatic, open-label, adjudicator blinded, non-inferiority withdrawal trial will test whether withdrawal of aminosalicylates is non-inferior to continuation of aminosalicylates for prevention of any CD‑related complication within 24 months of enrolment. Several peer reviewed grants have been awarded from Canadian and UK/European charities and funders (European lead PI, Dr Gordon Moran, University of Nottingham); (3) REACT2 trial (clinicaltrials.gov: NCT01698307) where he is UK PI. This large-scale, pragmatic, cluster-randomized trial conducted in the UK, Canada and US, compares early combined immunosuppression targeted at achieving endoscopic mucosal healing, versus standard clinical care in patients with Crohn’s Disease. Over 1000 patients have been enrolled and results are expected in 2021; (4) IASO (Interleukin-10 blockade in Acute Severe Colitis) trial in collaboration with the study leads, Professor Arthur Kaser/Dr Tim Raine (Cambridge, UK), where Dr Jairath is a TMG member and helped design the trial. This placebo-controlled trial is currently enrolling and is examining the both the efficacy and mechanism of action of Anakinra (interleukin-10 inhibitor) for the treatment of acute severe UC and funded by the UK National Institute for Health Research; (5) HALT-IT trial (clinicaltrials.gov: NCT01658124), where he is member of the TSC, protocol committee and helped design the trial in collaboration with lead investigator Ian Roberts (LSHTM, UK). This pragmatic, placebo-controlled trial is examining the effect of TXA on mortality, morbidity, transfusion and surgical intervention in patients with acute severe GI bleeding. Over 12,000 patients are enrolled with results expected in 2020; (6) TRIGGER trial (clinicaltrials.gov: NCT02105532), where he was overall PI and was published as a first author paper in the Lancet in 2015. This was a pragmatic cluster-randomized trial comparing restrictive versus liberal blood transfusion for gastrointestinal bleeding and has influenced clinical practice and treatment guidelines worldwide, leading to blood conservation strategies for GI bleeding.

Clinical Trial Steering Committees/Data Monitoring Committees: Dr Jairath is a member of several global clinical trial steering committees, as a member or chair. These include trials sponsored by the pharmaceutical industry as well as investigator-initiated trials. He has training and expertise in serving on Independent Data Monitoring Committees. He currently chairs the Data Monitoring Committee for the Wellcome Trust-funded PROFILE trial (predicting outcomes for Crohn’s Disease using a molecular biomarker) and is also a clinical trials expert member for the Data Monitoring Committee of the Medical Research Council funded ATTIRE trial (albumin to prevent infection in liver disease). Industry or academic trialists should email Dr Jairath with enquiries to serve on such committees.

Publications:
Dr Jairath has authored numerous publications, book chapters and regularly presents at local, national and international conferences. He has over 220 peer reviewed publications including publications in top tier GI and Medical journals such as the Lancet, Lancet Gastroenterology and Hepatology, JAMA, Gastroenterology and Gut. A full list of publications can be found at: https://pubmed.ncbi.nlm.nih.gov/?term=jairathV&sort=date&size=200

REMIT-UC: Real World Effectiveness and Safety of Tofacitinib for Moderate-to-Severely Active Ulcerative Colitis.
PMID: 36580497

Risk minimization of JAK inhibitors in ulcerative colitis following regulatory guidance.
PMID: 36536208 No abstract available.

Comparative efficacy of advanced treatments in biologic-naïve or biologic-experienced patients with ulcerative colitis: a systematic review and network meta-analysis.
PMID: 36484968

Evaluating cost per remission and cost of serious adverse events of advanced therapies for ulcerative colitis.
PMID: 36474165

Immunotherapy for Cancer: Common Gastrointestinal, Liver, and Pancreatic Side Effects and Their Management.
PMID: 36455219

An Expert Consensus to Standardize Assessment of Bowel Cleansing for Clinical Trials of Bowel Preparations for Crohn's Disease.
PMID: 36436154

Predictors of Clinical Remission to Placebo in Clinical Trials of Crohn's Disease.
PMID: 36426810

Case Report: Managing Postoperative Crohn's Disease.
PMID: 36397926

Non-invasive monitoring and treat-to-target approach are cost-effective in patients with mild-moderate ulcerative colitis.
PMID: 36377366

Placebo response rates in randomized controlled trials for perianal Crohn's disease: A systematic review and meta-analysis.
PMID: 36271904

Existing Bowel Preparation Quality Scales Are Reliable in the Setting of Centralized Endoscopy Reading.
PMID: 36266592

Most placebo-controlled trials in inflammatory bowel disease were underpowered because of overestimated drug efficacy rates: Results from a systematic review of induction studies.
PMID: 36219564

The Real-World Effectiveness and Safety of Ustekinumab in the Treatment of Crohn's Disease: Results From the SUCCESS Consortium.
PMID: 36191274

Biologics Are Effective in the Management of Inflammatory Bowel Disease Following Liver Transplantation in Combination With Antirejection Therapy.
PMID: 36173888

Is it time to include older adults in inflammatory bowel disease trials? A call for action.
PMID: 36098310

Opportunistic Infections in Patients with Inflammatory Bowel Disease Treated with Advanced Therapies: A Systematic Review and Meta-Analysis of Randomized Controlled Trials.
PMID: 36087107

Long-Term Outcomes of Early vs Delayed Responders to Vedolizumab and Adalimumab: A Post Hoc Analysis of the VARSITY Study.
PMID: 36066459

Association of Trainee Participation in Colonoscopy Procedures With Quality Metrics.
PMID: 36044211

Predictors of Placebo Induction Response and Remission in Ulcerative Colitis.
PMID: 36029969

Definition of mild to moderate ulcerative colitis in clinical trials: A systematic literature review.
PMID: 36029157

Access to unpublished protocols and statistical analysis plans of randomised trials.
PMID: 35978391

Available methods for benefit-risk assessment: lessons for inflammatory bowel disease drugs.
PMID: 35952722

Comparative Risk of Serious Infections With Biologic Agents and Oral Small Molecules in Inflammatory Bowel Diseases: A Systematic Review and Meta-Analysis.
PMID: 35944832

Placebo rates in randomized controlled trials of proctitis therapy: A systematic review and meta-analysis.
PMID: 35930405

Comparative Efficacy of Infliximab vs Ustekinumab for Maintenance of Clinical Response in Biologic Naïve Crohn's Disease.
PMID: 35920382

Simplified Machine Learning Models Can Accurately Identify High-Need High-Cost Patients With Inflammatory Bowel Disease.
PMID: 35905414

Clinical, Endoscopic, and Radiological Effectiveness of Ustekinumab in Bio-naïve Versus Bio-experienced Patients With Crohn's Disease: Real-world Experience From a Large Canadian Center.
PMID: 35851799

Heterogeneity in Efficacy and Safety Endpoints for Pediatric Clinical Trials in Inflammatory Bowel Disease: A Need for Harmonization.
PMID: 35850191

Revisiting Triggers: Optimal Thresholds for Transfusion in Gastrointestinal Bleeding May Be Higher Than Restrictive Guidelines.
PMID: 35840062

CORE-IBD: A Multidisciplinary International Consensus Initiative to Develop a Core Outcome Set for Randomized Controlled Trials in Inflammatory Bowel Disease.
PMID: 35788348

The Performance of the Rutgeerts Score, SES-CD, and MM-SES-CD for Prediction of Postoperative Clinical Recurrence in Crohn's Disease.
PMID: 35762666

Proactive Therapeutic Drug Monitoring Versus Conventional Management for Inflammatory Bowel Diseases: A Systematic Review and Meta-Analysis.
PMID: 35753383

Comparison of the Relative Sensitivity of Clinical, Endoscopic, and Histologic Remission for Detection of Treatment Efficacy in Ulcerative Colitis Trials.
PMID: 35749316

The future of drug development for inflammatory bowel disease: the need to ACT (advanced combination treatment).
PMID: 35701092 Review. No abstract available.

Ustekinumab versus adalimumab for induction and maintenance therapy in biologic-naive patients with moderately to severely active Crohn's disease: a multicentre, randomised, double-blind, parallel-group, phase 3b trial.
PMID: 35691323

Comparison of Risk Scores for Lower Gastrointestinal Bleeding: A Systematic Review and Meta-analysis.
PMID: 35622365

Development and Validation of a Digital Analysis Method to Quantify CD3-immunostained T Lymphocytes in Whole Slide Images of Crohn's Disease Biopsies.
PMID: 35587994

Janus Kinase Inhibitors for the Management of Patients With Inflammatory Bowel Disease.
PMID: 35505771

Comparative Effectiveness of Biologics for Endoscopic Healing of the Ileum and Colon in Crohn's Disease.
PMID: 35435862

Difficult-to-treat inflammatory bowel disease: results from a global IOIBD survey.
PMID: 35397241

Proactive infliximab optimisation using a pharmacokinetic dashboard versus standard of care in patients with Crohn's disease: study protocol for a randomised, controlled, multicentre, open-label study (the OPTIMIZE trial).
PMID: 35365535

Editorial: is it not just PROs, but the most important individual PRO, that really matters in Crohn's disease? Authors' reply.
PMID: 35362140

Reliability of histologic assessment for NAFLD and development of an expanded NAFLD activity score.
PMID: 35332569

Recommendations for standardizing biopsy acquisition and histological assessment of immune checkpoint inhibitor-associated colitis.
PMID: 35296560

Author Correction: Sphingosine 1-phosphate modulation and immune cell trafficking in inflammatory bowel.
PMID: 35256808 No abstract available.

Effectiveness of Tofacitinib for Hospitalized Patients with Acute Severe Ulcerative Colitis: Case Series.
PMID: 35244825

Design of Clinical Trials for Mild to Moderate Crohn's Disease.
PMID: 35240140

A nonparametric approach to confidence intervals for concordance index and difference between correlated indices..
PMID: 35216545

The impact of symptom severity on the humanistic and economic burden of inflammatory bowel disease: a real-world data linkage study.
PMID: 35175166

Similar Clinical Improvement Rates Among Biologic Drug Classes in Crohn's Disease: Systematic Review and Meta-Regression.
PMID: 35166778

Resolution of dominant patient-reported outcome at end of induction predicts clinical and endoscopic remission in Crohn's disease.
PMID: 35166396

Sphingosine 1-phosphate modulation and immune cell trafficking in inflammatory bowel disease.
PMID: 35165437

Responsiveness of Magnetic Resonance Enterography Indices for Evaluation of Luminal Disease Activity in Crohn's Disease.
PMID: 35149220

The Clinical Significance of Eosinophils in Ulcerative Colitis: A Systematic Review.
PMID: 35136998

Reliability and responsiveness of endoscopic disease activity assessment in eosinophilic esophagitis.
PMID: 35120883

Underrepresentation of Minorities and Lack of Race Reporting in Ulcerative Colitis Drug Development Clinical Trials.
PMID: 35078220

A TIGER Among Endoscopic Indices in Inflammatory Bowel Disease.
PMID: 35060602

Risk Stratification in Cancer Patients with Acute Upper Gastrointestinal Bleeding: Comparison of Glasgow-Blatchford, Rockall and AIMS65, and Development of a New Scoring System.
PMID: 35052025

Design of Clinical Trials for Mild to Moderate Ulcerative Colitis.
PMID: 34998800

A Clinical Prediction Model to Determine Probability of Response to Certolizumab Pegol for Crohn's Disease.
PMID: 34951696

Incidence, outcomes, and impact of COVID-19 on inflammatory bowel disease: propensity matched research network analysis.
PMID: 34904240

Expert Panel Review to Compare FDA and EMA Guidance on Drug Development and Endpoints in Nonalcoholic Steatohepatitis.
PMID: 34822801

Systematic review: disease activity indices for immune checkpoint inhibitor-associated enterocolitis.
PMID: 34821404

Food Insecurity Negatively Impacts Gluten Avoidance and Nutritional Intake in Patients With Celiac Disease.
PMID: 34802022

Responsiveness of a Histologic Scoring System Compared With Peak Eosinophil Count in Eosinophilic Esophagitis.
PMID: 34797816

No Benefit of Continuing 5-Aminosalicylates in Patients with Crohn's Disease Treated with Anti-metabolite Therapy.
PMID: 34797442

Epidemiology and Natural History of Perianal Crohn's Disease: A Systematic Review and Meta-Analysis of Population-Based Cohorts.
PMID: 34792604

Recommendations for Standardizing Clinical Trial Design and Endoscopic Assessment in Postoperative Crohn's Disease.
PMID: 34791254

Clinical, Endoscopic, and Safety Placebo Rates in Induction and Maintenance Trials of Crohn's Disease: Meta-Analysis of Randomised Controlled Trials.
PMID: 34758084

Efficacy and Safety of Mirikizumab in a Randomized Phase 2 Study of Patients With Crohn's Disease.
PMID: 34748774

Effectiveness of Reinduction and/or Dose Escalation of Ustekinumab in Crohn's Disease: A Systematic Review and Meta-analysis..
PMID: 34628078

Underrepresentation of Minorities and Underreporting of Race and Ethnicity in Crohn's Disease Clinical Trials.
PMID: 34592174

Development of antifibrotic therapy for stricturing Crohn's disease: lessons from randomized trials in other fibrotic diseases.
PMID: 34569264

The Relationship Between Endoscopic and Clinical Recurrence in Postoperative Crohn's Disease: A Systematic Review and Meta-analysis.
PMID: 34508572

Machine Learning-based Prediction Models for Diagnosis and Prognosis in Inflammatory Bowel Diseases: A Systematic Review.
PMID: 34492100

Impact of Drug Approval Pathways for Paediatric Inflammatory Bowel Disease.
PMID: 34379112

Systematic Review and Meta-Analysis: Clinical, Endoscopic, Histological and Safety Placebo Rates in Induction and Maintenance Trials of Ulcerative Colitis.
PMID: 34309658

Development of a core outcome set for therapeutic studies in eosinophilic esophagitis (COREOS).
PMID: 34242635

Disease Activity Indices for Pouchitis: A Systematic Review.
PMID: 34180986

Biomarkers for the Prediction and Diagnosis of Fibrostenosing Crohn's Disease: A Systematic Review.
PMID: 34089850

Trends in U.S. Health Care Spending on Inflammatory Bowel Diseases, 1996-2016.
PMID: 33988697

Methods for handling missing segments in Crohn's disease clinical trials: analysis from the EXTEND trial.
PMID: 33958434.

International consensus to standardise histopathological scoring for small bowel strictures in Crohn's disease.
PMID: 33952604

Pharmacological Interventions for the Prevention and Treatment of Immune Checkpoint Inhibitor-Associated Enterocolitis: A Systematic Review.
PMID: 33770330

Increased Risk of Infections with Anti-TNF Agents in Patients with Crohn's Disease After Elective Surgery: Meta-Analysis.
PMID: 33634430

Vedolizumab for the Treatment of Noninflammatory Bowel Disease Related Enteropathy.
PMID: 33618025

Spatial Evolution of Histologic and Endoscopic Healing in the Left and Right Colon in Patients With Ulcerative Colitis.
PMID: 33556578

Early Combined Immunosuppression Reduces Complications in Long-standing Crohn's Disease: A Post Hoc Analysis of REACT.
PMID: 33346141

Endoscopic Assessment of Inflammatory Bowel Disease Activity in Clinical Trials.
PMID: 33338657

Modeling Endoscopic Improvement after Induction Treatment With Mesalamine in Patients With Mild-to-Moderate Ulcerative Colitis.
PMID: 33279779

Comparative Safety and Effectiveness of Vedolizumab to Tumor Necrosis Factor Antagonist Therapy for Ulcerative Colitis.
PMID: 33039584