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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.

Selected 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

Severe Ulcerative Colitis Complicated by Malakoplakia Resulting in Proctocolectomy.
Alphonsus L, De Silva TA, Driman D, Jairath V.
ACG Case Rep J. 2023 Jan 12;11(1):e01257.

Characteristics of Interventional Trials for Patients Living With Intestinal Stoma Registered in ClinicalTrials.gov With a Focus on Inflammatory Bowel Disease.
Vuyyuru SK, Ma C, Sharma T, Nguyen TM, Bessissow T, Narula N, Singh S, Rieder F, Jairath V.
Inflamm Bowel Dis. 2023 Dec 22:izad293.

Implementation of regulatory guidance for JAK inhibitors use in patients with immune-mediated inflammatory diseases: An international appropriateness study.
Solitano V, Facheris P, Petersen M, D'Amico F, Ortoncelli M, Aletaha D, Olivera PA, Bieber T, Ramiro S, Ghosh S, D'Agostino MA, Siegmund B, Chary-Valckenaere I, Hart A, Dagna L, Magro F, Felten R, Kotze PG, Jairath V, Costanzo A, Kristensen LE, Biroulet LP, Danese S.
Autoimmun Rev. 2023 Dec 20;23(3):103504.

Scoring indices for perianal fistulizing Crohn's disease: A systematic review.
Vuyyuru SK, Solitano V, Singh S, Hanzel J, Macdonald JK, Danese S, Peyrin Biroulet L, Ma C, Jairath V.
J Crohns Colitis. 2023 Dec 21:jjad214.

Development of an MRI-Based Prediction Model for Anti-TNF Treatment Failure in Perianal Crohn's Disease: A Multicenter Study.
McCurdy JD, Munir J, Parlow S, Reid J, Yanofsky R, Alenezi T, Meserve J, Becker B, Lahijanian Z, Eddin AH, Mallick R, Ramsay T, Rosenfeld G, Bessissow A, Bessissow T, Jairath V, Singh S, Bruining DH, Macdonald B; Canadian IBD Research Consortium.
Clin Gastroenterol Hepatol. 2023 Dec 18:S1542-3565(23)01035-2.

Interim Analysis of a Trial Evaluating the Utility of Non-Targeted Biopsies for Colorectal Neoplasia Detection in Inflammatory Bowel Disease.
Murthy SK, Bernstein CN, Nguyen GC, Jairath V, Riddell R, Fergusson D.
Clin Gastroenterol Hepatol. 2023 Dec 18:S1542-3565(23)01036-4.

Use of external control arms in immune-mediated inflammatory diseases: a systematic review.
Zayadi A, Edge R, Parker CE, Macdonald JK, Neustifter B, Chang J, Zhong G, Singh S, Feagan BG, Ma C, Jairath V.
BMJ Open. 2023 Dec 9;13(12):e076677.

Management and treatment optimization of patients with mild to moderate ulcerative colitis.
D'Amico F, Fasulo E, Jairath V, Paridaens K, Peyrin-Biroulet L, Danese S.
Expert Rev Clin Immunol. 2024 Mar;20(3):277-290.

Reliability and Responsiveness of Histologic Indices for the Assessment of Crohn's Disease Activity.
Solitano V, Schaeffer DF, Hogan M, Vande Casteele N, Pai RK, Zou G, Pai RK, Parker CE, Rémillard J, Christensen B, Danese S, Peyrin-Biroulet L, Panaccione R, Sands BE, D'Haens G, Feagan BG, Ma C, Jairath V.
Clin Gastroenterol Hepatol. 2023 Dec 4:S1542-3565(23)00969-2.

Mirikizumab Improves Quality of Life in Patients With Moderately-to-Severely Active Ulcerative Colitis: Results From the Phase 3 LUCENT-1 Induction and LUCENT-2 Maintenance Studies.
Sands BE, Feagan BG, Hunter Gibble T, Traxler KA, Morris N, Eastman WJ, Schreiber S, Jairath V, Long MD, Armuzzi A.
Crohns Colitis 360. 2023 Nov 7;5(4):otad070.

Effects of Mirikizumab on Histologic Resolution of Crohn's Disease in a Randomized Controlled Phase 2 Trial.
Magro F, Protic M, De Hertogh G, Chan LS, Pollack P, Jairath V, Carlier H, Hon E, Feagan BG, Harpaz N, Pai R, Reinisch W.
Clin Gastroenterol Hepatol. 2023 Nov 20:S1542-3565(23)00948-5.

ENTERPRET: A Randomized Controlled Trial of Vedolizumab Dose Optimization in Patients With Ulcerative Colitis Who Have Early Nonresponse.
Jairath V, Yarur A, Osterman MT, James A, Balma D, Mehrotra S, Yang L, Yajnik V, Qasim Khan RM.
Clin Gastroenterol Hepatol. 2023 Nov 10:S1542-3565(23)00912-6.

Integrating Evidence to Guide Use of Biologics and Small Molecules for Inflammatory Bowel Diseases.
Dulai PS, Singh S, Jairath V, Wong E, Narula N.
Gastroenterology. 2023 Nov 8:S0016-5085(23)05228-9.

Pharmacological therapies for the management of fistulising Crohn's disease: A systematic review and meta-analysis.
Vuyyuru SK, Solitano V, Narula N, Lee MJ, MacDonald JK, McCurdy JD, Singh S, Ma C, Jairath V.
J Crohns Colitis. 2023 Nov 2:jjad185.

Advanced Combination Treatment With Biologic Agents and Novel Small Molecule Drugs for Inflammatory Bowel Disease.
Solitano V, Ma C, Hanžel J, Panaccione R, Feagan BG, Jairath V.
Gastroenterol Hepatol (N Y). 2023 May;19(5):251-263.

Washout Periods in Inflammatory Bowel Disease Trials: A Systematic Literature Review and Proposed Solutions.
Wils P, Jairath V, Sands BE, Reinisch W, Danese S, Peyrin-Biroulet L.
Clin Gastroenterol Hepatol. 2023 Sep 22:S1542-3565(23)00747-4.

Vedolizumab, Adalimumab, and Methotrexate Combination Therapy in Crohn's Disease (EXPLORER).
Colombel JF, Ungaro RC, Sands BE, Siegel CA, Wolf DC, Valentine JF, Feagan BG, Neustifter B, Kadali H, Nazarey P, James A, Jairath V, Qasim Khan RM.
Clin Gastroenterol Hepatol. 2023 Sep 22:S1542-3565(23)00746-2.

Real-world effectiveness and safety of ustekinumab in bio-naive patients with moderate-to-severe Crohn's disease: A Canadian multi-center study.
Bessissow T, Narula N, Ma C, In TSH, Eberg M, Karra K, Jairath V; Canadian IBD Research Consortium.
Dig Liver Dis. 2024 Jan;56(1):61-69.

Withdrawal of Immunomodulators or TNF Antagonists in Patients With Inflammatory Bowel Diseases in Remission on Combination Therapy: A Systematic Review and Meta-analysis.
Katibian DJ, Solitano V, Polk DB, Nguyen T, Ma C, Syal G, Kobayashi T, Hibi T, Buhl S, Ainsworth MA, Jairath V, Singh S.
Clin Gastroenterol Hepatol. 2024 Jan;22(1):22-33.e6.

Temporary Faecal Diversion for Refractory Perianal and/or Distal Colonic Crohn's Disease in the Biologic Era: An Updated Systematic Review with Meta-Analysis.
Jew M, Meserve J, Eisenstein S, Jairath V, McCurdy J, Singh S.
J Crohns Colitis. 2023 Sep 14:jjad159.

Standardizing Randomized Controlled Trials in Celiac Disease: An International Multidisciplinary Appropriateness Study.
Lebwohl B, Ma C, Lagana SM, Pai RK, Baker KA, Zayadi A, Hogan M, Bouma G, Cellier C, Goldsmith JD, Lundin KEA, Pinto-Sanchez MI, Robert ME, Rubio-Tapia A, Sanders DS, Schaeffer DF, Semrad CE, Silvester JA, Verdú EF, Verma R, Wu TT, Feagan BG, Crowley E, Jairath V, Murray JA.
Gastroenterology. 2024 Jan;166(1):88-102.

Comparison of treatment effect between phase 2 and phase 3 trials in patients with inflammatory bowel disease.
Wils P, Jairath V, Sands BE, Magro F, Reinisch W, Rubin D, Danese S, Baumann C, Peyrin-Biroulet L.
United European Gastroenterol J. 2023 Oct;11(8):797-806.

Approval Timelines for Advanced Therapeutics in Inflammatory Bowel Disease: A Comparison Between the European Medicines Agency and the Food and Drug Administration.
Hanzel J, Ma C, De Silva TA, Alphonsus L, Guizzetti L, Crowley E, Singh S, Jairath V.
Inflamm Bowel Dis. 2023 Aug 17:izad168.

Systematic review with meta-analysis: Medical therapies for treatment of ulcerative proctitis.
Aruljothy A, Singh S, Narula N, Moran GW, Vuyyuru SK, Hogan M, Zayadi A, MacDonald JK, Caron B, Danese S, Peyrin Biroulet L, Ma C, Jairath V.
Aliment Pharmacol Ther. 2023 Oct;58(8):740-762.

A Comparison of Treatment Effect Sizes in Matched Phase 2 and Phase 3 Trials of Advanced Therapeutics in Inflammatory Bowel Disease: Systematic Review and Meta-Analysis.
Hanzel J, Solitano V, Zou L, Zou GY, Peyrin-Biroulet L, Danese S, Singh S, Ma C, Wils P, Jairath V.
Clin Transl Gastroenterol. 2023 Nov 1;14(11):e00629.

Disease Clearance as a New Outcome in Ulcerative Colitis: a Systematic Review and Expert Consensus.
D'Amico F, Magro F, Siegmund B, Kobayashi T, Kotze PG, Solitano V, Caron B, Al Awadhi S, Hart A, Jairath V, Dignass A, Peyrin-Biroulet L, Danese S.
Inflamm Bowel Dis. 2023 Aug 7:izad159.

Histological Disease Activity as Predictor of Clinical Relapse, Hospitalization, and Surgery in Inflammatory Bowel Disease: Systematic Review and Meta-Analysis.
Shehab M, Al Akram S, Hassan A, Alrashed F, Jairath V, Bessissow T.
Inflamm Bowel Dis. 2023 Aug 4:izad119.

Recommendations for Standardizing MRI-based Evaluation of Perianal Fistulizing Disease Activity in Pediatric Crohn's Disease Clinical Trials.
Crowley E, Ma C, Guizzetti L, Zou G, Lewindon PJ, Gee MS, Hyams JS, Rosen MJ, von Allmen D, de Buck van Overstraeten A, Shackelton LM, Remillard J, Schleicher L, Dillman JR, Rimola J, Taylor SA, Fletcher JG, Church PC, Feagan BG, Griffiths AM, Jairath V, Greer MC.
Inflamm Bowel Dis. 2023 Jul 31:izad134.

Mirikizumab for the treatment of moderate to severe ulcerative colitis.
Hanzel J, Ma C, Jairath V.
Immunotherapy. 2023 Oct;15(15):1199-1208.

Informative cluster size in cluster-randomised trials: A case study from the TRIGGER trial.
Kahan BC, Li F, Blette B, Jairath V, Copas A, Harhay M.
Clin Trials. 2023 Dec;20(6):661-669

Difficult-to-treat inflammatory bowel disease: results from an international consensus meeting.
Parigi TL, D'Amico F, Abreu MT, Dignass A, Dotan I, Magro F, Griffiths AM, Jairath V, Iacucci M, Mantzaris GJ, O'Morain C, Reinisch W, Sachar DB, Turner D, Yamamoto T, Rubin DT, Peyrin-Biroulet L, Ghosh S, Danese S.
Lancet Gastroenterol Hepatol. 2023 Sep;8(9):853-859.

Long Washout Periods Between Biologics for Inflammatory Bowel Disease Clinical Trials Are Unnecessary: A Canadian Retrospective Cohort Study.
Vuyyuru SK, Archer M, Nguyen TM, Beaton M, Jairath V.
Am J Gastroenterol. 2023 Dec 1;118(12):2290-2293.

Delayed Ustekinumab Responders in Ulcerative Colitis Have Greater Inflammatory Burden but Similar Outcomes as Early Responders.
Wong ECL, Dulai PS, Marshall JK, Jairath V, Reinisch W, Narula N.
Clin Gastroenterol Hepatol. 2023 Dec;21(13):3387-3396.e1.

Mirikizumab as Induction and Maintenance Therapy for Ulcerative Colitis.
D'Haens G, Dubinsky M, Kobayashi T, Irving PM, Howaldt S, Pokrotnieks J, Krueger K, Laskowski J, Li X, Lissoos T, Milata J, Morris N, Arora V, Milch C, Sandborn W, Sands BE; LUCENT Study Group.
N Engl J Med. 2023 Jun 29;388(26):2444-2455.

Efficacy and Safety of IL-12/23 and IL-23 Inhibitors for Crohn's Disease: Systematic Review and Meta-Analysis.
Vuyyuru SK, Solitano V, Hogan M, MacDonald JK, Zayadi A, Parker CE, Sands BE, Panaccione R, Narula N, Feagan BG, Singh S, Jairath V, Ma C.
Dig Dis Sci. 2023 Sep;68(9):3702-3713.

Efficacy and Safety of Advanced Oral Small Molecules for Inflammatory Bowel Disease: Systematic Review and Meta-Analysis.
Solitano V, Vuyyuru SK, MacDonald JK, Zayadi A, Parker CE, Narula N, Peyrin-Biroulet L, Danese S, Feagan BG, Singh S, Ma C, Jairath V.
J Crohns Colitis. 2023 Nov 24;17(11):1800-1816.

Standardizing Scoring Conventions for Crohn's Disease Endoscopy: An International RAND/UCLA Appropriateness Study.
Khanna R, Ma C, Hogan M, Zou G, Bessissow T, Bressler B, Colombel JF, Danese S, Daperno M, East JE, Hookey L, Loftus EV Jr, McDonald JWD, Panaccione R, Peyrin-Biroulet L, Rutter M, Sands BE, Vermeire S, Rémillard J, McFarlane SC, Sandborn WJ, D'Haens GR, Feagan BG, Jairath V.
Clin Gastroenterol Hepatol. 2023 Oct;21(11):2938-2950.e6.

Targeting IL-23 for IBD: Rationale and Progress to Date.
Vuyyuru SK, Shackelton LM, Hanzel J, Ma C, Jairath V, Feagan BG.
Drugs. 2023 Jul;83(10):873-891.

Effect of storage time on peripheral blood mononuclear cell isolation from blood collected in vacutainer CPT™ tubes.
Linggi B, Cremer J, Wang Z, Van Viegen T, Vermeire S, Lefevre P, Shackelton LM, Jairath V, Teft W, Vande Casteele N, Verstockt B.
J Immunol Methods. 2023 Aug;519:113504.

Systematic review and meta-analysis of randomised controlled trials: Medical therapies for the treatment and prevention of pouchitis.
Alphonsus L, De Silva TA, Ma C, MacDonald JK, Hanzel J, Beaton M, Bessissow T, Kayal M, Sedano R, Singh S, Jairath V.
Aliment Pharmacol Ther. 2023 Aug;58(3):268-282.

Early Remission With Induction Therapy Predicts Long-Term Remission in Inflammatory Bowel Diseases: A Systematic Review and Meta-Analysis.
Mohan BP, Fatima N, Khan SR, Kassab L, Chandan S, Asokkumar R, Valentine JF, Navaneethan U, Kochhar GS, Ma C, Jairath V, Singh S.
Am J Gastroenterol. 2023 Nov 1;118(11):2084-2087.

Extended delay in endoscopic mucosal resection is not associated with adverse outcomes: Findings from the COVID-19 pandemic.
Liu E, McDonald C, Son S, Hawel J, Hussain N, Khanna N, Yan B, Jairath V, Sey M.
Endosc Int Open. 2023 May 9;11(5):E474-E479.

Epidemiologic Burden and Projections for Eosinophilic Esophagitis-Associated Emergency Department Visits in the United States: 2009-2030.
Lam AY, Lee JK, Coward S, Kaplan GG, Dellon ES, Bredenoord AJ, Jairath V, Crowley E, Gupta M, Jijon H, Nasser Y, Andrews CN, Chehade M, Gonsalves N, Hirano I, Ma C.
Clin Gastroenterol Hepatol. 2023 Nov;21(12):3041-3050.e3.

Comparative Efficacy of Infliximab Versus Tofacitinib for Inducing Remission in Biologic Naive Ulcerative Colitis: A Propensity Matched Study.
Wong ECL, Merat S, Monaco C, Dulai PS, Jairath V, Marshall JK, Reinisch W, Narula N.
Dig Dis Sci. 2023 Jun;68(6):2635-2646.

Predicting Endoscopic Improvement in Ulcerative Colitis Using the Ulcerative Colitis Severity Index.
Wong ECL, Dulai PS, Marshall JK, Jairath V, Reinisch W, Narula N.
Inflamm Bowel Dis. 2023 Apr 28:izad074.

Endoscopy Unit Level Interventions to Improve Adenoma Detection Rate: A Systematic Review and Meta-Analysis.
Arora A, McDonald C, Guizzetti L, Iansavichene A, Brahmania M, Khanna N, Wilson A, Jairath V, Sey M.
Clin Gastroenterol Hepatol. 2023 Dec;21(13):3238-3257.

IL-12 and IL-23 pathway inhibition in inflammatory bowel disease.
Verstockt B, Salas A, Sands BE, Abraham C, Leibovitzh H, Neurath MF, Vande Casteele N; Alimentiv Translational Research Consortium (ATRC).
Nat Rev Gastroenterol Hepatol. 2023 Jul;20(7):433-446.

HLA-DQA1∗05 Genotype and Immunogenicity to Tumor Necrosis Factor-α Antagonists: A Systematic Review and Meta-analysis.
Solitano V, Facciorusso A, McGovern DPB, Nguyen T, Colman RJ, Zou L, Boland BS, Syversen SW, Jørgensen KK, Ma C, Armuzzi A, Wilson A, Jairath V, Singh S.
Clin Gastroenterol Hepatol. 2023 Nov;21(12):3019-3029.e5.

Resolving Histological Inflammation in Ulcerative Colitis With Mirikizumab in the LUCENT Induction and Maintenance Trial Programmes.
Magro F, Pai RK, Kobayashi T, Jairath V, Rieder F, Redondo I, Lissoos T, Morris N, Shan M, Park M, Peyrin-Biroulet L.
J Crohns Colitis. 2023 Oct 20;17(9):1457-1470.

Endoscopic and Histological Placebo Rates in Crohn's Disease Clinical Trials: A Systematic Review and Meta-analysis.
Vuyyuru SK, Nguyen TM, Hogan M, Raine T, Noor NM, Narula N, Verstockt B, Feagan BG, Singh S, Ma C, Jairath V.
Inflamm Bowel Dis. 2023 Apr 1:izad052.

Changes in health-related quality of life and associations with improvements in clinical efficacy: a Phase 2 study of mirikizumab in patients with ulcerative colitis.
Dubinsky MC, Jairath V, Feagan BG, Naegeli AN, Tuttle J, Morris N, Shan M, Arora V, Lissoos T, Agada N, Hibi T, Sands BE.
BMJ Open Gastroenterol. 2023 Mar;10(1):e001115.

Vedolizumab for the Treatment of Chronic Pouchitis.
Travis S, Silverberg MS, Danese S, Gionchetti P, Löwenberg M, Jairath V, Feagan BG, Bressler B, Ferrante M, Hart A, Lindner D, Escher A, Jones S, Shen B; EARNEST Study Group.
N Engl J Med. 2023 Mar 30;388(13):1191-1200.

Comparative Speed of Early Symptomatic Remission With Advanced Therapies for Moderate-to-Severe Ulcerative Colitis: A Systematic Review and Network Meta-Analysis.
Ahuja D, Murad MH, Ma C, Jairath V, Singh S.
Am J Gastroenterol. 2023 Sep 1;118(9):1618-1625.

Correction to: Comparative efficacy of advanced treatments in biologic-naïve or biologic-experienced patients with ulcerative colitis: a systematic review and network meta-analysis.
Lu X, Jarrett J, Sadler S, Tan M, Dennis J, Jairath V.
Int J Clin Pharm. 2023 Apr;45(2):544.

Has the therapeutical ceiling been reached in Crohn's disease randomized controlled trials? A systematic review and meta-analysis.
Magro F, Moreira PL, Catalano G, Alves C, Roseira J, Estevinho MM, Silva I, Dignass A, Peyrin-Biroulet L, Danese S, Jairath V, Dias CC, Santiago M.
United European Gastroenterol J. 2023 Mar;11(2):202-217.

Meta-analysis: Placebo rates in microscopic colitis randomised trials and applications for future drug development using a historical control arm.
Hamilton P, Buhler K, MacDonald JK, Kaplan GG, Seow CH, Lu C, Novak KL, Andrews CN, Singh S, Jairath V, Panaccione R, Ma C.
Aliment Pharmacol Ther. 2023 Apr;57(8):837-850.

Gut virome-colonising Orthohepadnavirus genus is associated with ulcerative colitis pathogenesis and induces intestinal inflammation in vivo.
Massimino L, Palmieri O, Facoetti A, Fuggetta D, Spanò S, Lamparelli LA, D'Alessio S, Cagliani S, Furfaro F, D'Amico F, Zilli A, Fiorino G, Parigi TL, Noviello D, Latiano A, Bossa F, Latiano T, Pirola A, Mologni L, Piazza RG, Abbati D, Perri F, Bonini C, Peyrin-Biroulet L, Malesci A, Jairath V, Danese S, Ungaro F.
Gut. 2023 Oct;72(10):1838-1847.

iSTART-II: An Update on the i Support Therapy-Access to Rapid Treatment (iSTART) Approach for Patient-Centered Therapy in Mild-to-Moderate Ulcerative Colitis.
D'Amico F, Magro F, Caron B, Dignass A, Jairath V, Hart A, Kotze PG, Paridaens K, Awadhi SA, Kobayashi T, Siegmund B, Peyrin-Biroulet L, Danese S.
J Clin Med. 2023 Feb 1;12(3):1142.

Patients With Crohn's Disease and Permanent Ileostomy Are Universally Excluded From Clinical Trials: A Systematic Review.
Vuyyuru SK, Rieder F, Solitano V, Nguyen TM, Crowley E, Narula N, Singh S, Ma C, Jairath V.
Am J Gastroenterol. 2023 Jul 1;118(7):1285-1288.

Declining Enrolment and Other Challenges in IBD Clinical Trials: Causes and Potential Solutions.
Uzzan M, Bouhnik Y, Abreu M, Ahmad HA, Adsul S, Carlier H, Dubinsky M, Germinaro M, Jairath V, Modesto I, Mortensen E, Narula N, Neimark E, Oortwijn A, Protic M, Rubin DT, Oh YS, Wichary J, Peyrin-Biroulet L, Reinisch W.
J Crohns Colitis. 2023 Jul 5;17(7):1066-1078.

Management of Patients With Acute Lower Gastrointestinal Bleeding: An Updated ACG Guideline.
Sengupta N, Feuerstein JD, Jairath V, Shergill AK, Strate LL, Wong RJ, Wan D.
Am J Gastroenterol. 2023 Feb 1;118(2):208-231.

Ozanimod Therapy in a Patient With Ulcerative Colitis and Multiple Sclerosis: Hitting 2 Birds With 1 Stone.
Vuyyuru SK, Morrow SA, Jairath V.
ACG Case Rep J. 2023 Jan 20;10(1):e00955.

A multi-omic analysis reveals the esophageal dysbiosis as the predominant trait of eosinophilic esophagitis.
Massimino L, Barchi A, Mandarino FV, Spanò S, Lamparelli LA, Vespa E, Passaretti S, Peyrin-Biroulet L, Savarino EV, Jairath V, Ungaro F, Danese S.
J Transl Med. 2023 Jan 25;21(1):46.

International Consensus on Definition of Mild-to-Moderate Ulcerative Colitis Disease Activity in Adult Patients.
Caron B, Jairath V, D'Amico F, Al Awadhi S, Dignass A, Hart AL, Kobayashi T, Kotze PG, Magro F, Siegmund B, Paridaens K, Danese S, Peyrin-Biroulet L.
Medicina (Kaunas). 2023 Jan 16;59(1):183.

Vedolizumab and Adalimumab in Biologic-Naïve Ulcerative Colitis: Comparison of Patient-Level Clinical Trial Data and VARSITY for Week 6 Clinical Remission.
Narula N, Wong ECL, Dulai PS, Marshall JK, Jairath V, Reinisch W.
Dig Dis Sci. 2023 Jun;68(6):2658-2666.

REMIT-UC: Real-World Effectiveness and Safety of Tofacitinib for Moderate-to-Severely Active Ulcerative Colitis: A Canadian IBD Research Consortium Multicenter National Cohort Study.
Ma C, Panaccione R, Xiao Y, Khandelwal Y, Murthy SK, Wong ECL, Narula N, Tsai C, Peerani F, Reise-Filteau M, Bressler B, Starkey SY, Loomes D, Sedano R, Jairath V, Bessissow T; Canadian IBD Research Consortium.
Am J Gastroenterol. 2023 May 1;118(5):861-871.

Risk minimization of JAK inhibitors in ulcerative colitis following regulatory guidance.
Danese S, Solitano V, Jairath V, Peyrin-Biroulet L.
Nat Rev Gastroenterol Hepatol. 2023 Mar;20(3):129-130.

Comparative efficacy of advanced treatments in biologic-naïve or biologic-experienced patients with ulcerative colitis: a systematic review and network meta-analysis.
Lu X, Jarrett J, Sadler S, Tan M, Dennis J, Jairath V.
Int J Clin Pharm. 2023 Apr;45(2):330-341.

An Expert Consensus to Standardize Assessment of Bowel Cleansing for Clinical Trials of Bowel Preparations for Crohn's Disease.
Maratt JK, Siegel CA, Barkun AN, Bouhnik Y, Bressler B, Calderwood AH, East JE, Fischer M, Grossmann J, Korzenik JR, Menees SB, Panes J, Rex DK, Sey MSL, Allio MK, Baker KA, Guizzetti L, Remillard J, Sedano R, Feagan BG, Ma C, Jairath V.
Dig Dis Sci. 2023 May;68(5):1718-1727.

Predictors of Clinical Remission to Placebo in Clinical Trials of Crohn's Disease.
Wong ECL, Dulai PS, Marshall JK, Jairath V, Reinisch W, Narula N.
Inflamm Bowel Dis. 2023 Sep 1;29(9):1390-1398.

Non-invasive monitoring and treat-to-target approach are cost-effective in patients with mild-moderate ulcerative colitis.
Cortesi PA, Fiorino G, Peyrin-Biroulet L, Mantovani LG, Jairath V, Paridaens K, Andersson FL, Danese S.
Aliment Pharmacol Ther. 2023 Mar;57(5):486-495.

Placebo Response Rates in Randomized Controlled Trials for Perianal Crohn's Disease: A Systematic Review and Meta-Analysis.
Sharma T, Ma C, Sedano R, Hanzel J, McDonald C, Hogan M, Kochhar GS, Narula N, Peyrin-Biroulet L, Danese S, MacDonald JK, Jairath V.
J Crohns Colitis. 2023 Apr 19;17(4):644-658.

Existing Bowel Preparation Quality Scales Are Reliable in the Setting of Centralized Endoscopy Reading.
Hanzel J, Sey M, Ma C, Zou G, East JE, Siegel CA, Mosli M, Reinisch W, McDonald JWD, Silverberg MS, Van Viegen T, Shackelton LM, Clayton LB, Enns R, Epstein I, Hilsden RJ, Hookey L, Moffatt DC, Ng Kwet Shing R, Telford JJ, von Renteln D, Feagan BG, Barkun A, Jairath V.
Dig Dis Sci. 2023 Apr;68(4):1195-1207.

Most Placebo-Controlled Trials in Inflammatory Bowel Disease were Underpowered Because of Overestimated Drug Efficacy Rates: Results from a Systematic Review of Induction Studies.
Bahnam P, Hanzel J, Ma C, Zou L, Narula N, Singh S, Kahan B, Jairath V.
J Crohns Colitis. 2023 Apr 3;17(3):404-417.

The Real-World Effectiveness and Safety of Ustekinumab in the Treatment of Crohn's Disease: Results From the SUCCESS Consortium.
Johnson AM, Barsky M, Ahmed W, Zullow S, Galati J, Jairath V, Narula N, Peerani F, Click BH, Coburn ES, Dang TT, Gold S, Agrawal M, Garg R, Aggarwal M, Mohammad D, Halloran B, Kochhar GS, Todorowski H, Ud Din NM, Izanec J, Teeple A, Gasink C, Muser E, Ding Z, Swaminath A, Lakhani K, Hogan D, Datta S, Ungaro RC, Boland BS, Bohm M, Fischer M, Sagi S, Afzali A, Ullman T, Lawlor G, Baumgart DC, Chang S, Hudesman D, Lukin D, Scherl EJ, Colombel JF, Sands BE, Siegel CA, Regueiro M, Sandborn WJ, Bruining D, Kane S, Loftus EV Jr, Dulai PS.
Am J Gastroenterol. 2023 Feb 1;118(2):317-328.

Opportunistic Infections in Patients with Inflammatory Bowel Disease Treated with Advanced Therapies: A Systematic Review and Meta-Analysis of Randomized Controlled Trials.
Olivera PA, Lasa JS, Zubiaurre I, Jairath V, Abreu MT, Rubin DT, Reinisch W, Magro F, Rahier JF, Danese S, Rabaud C, Peyrin-Biroulet L.
J Crohns Colitis. 2023 Mar 18;17(2):199-210.

Long-Term Outcomes of Early vs Delayed Responders to Vedolizumab and Adalimumab: A Post Hoc Analysis of the VARSITY Study.
Narula N, Wong ECL, Marshall JK, Jairath V, Dulai PS, Reinisch W.
Am J Gastroenterol. 2023 Jan 1;118(1):121-128.

Predictors of Placebo Induction Response and Remission in Ulcerative Colitis.
Wong ECL, Dulai PS, Marshall JK, Jairath V, Reinisch W, Narula N.
Clin Gastroenterol Hepatol. 2023 Apr;21(4):1050-1060.e9.

Available Methods for Benefit-risk Assessment: Lessons for Inflammatory Bowel Disease Drugs.
Caron B, D'Amico F, Jairath V, Netter P, Danese S, Peyrin-Biroulet L.
J Crohns Colitis. 2023 Jan 27;17(1):137-143.

Comparative Risk of Serious Infections With Biologic Agents and Oral Small Molecules in Inflammatory Bowel Diseases: A Systematic Review and Meta-Analysis.
Solitano V, Facciorusso A, Jess T, Ma C, Hassan C, Repici A, Jairath V, Armuzzi A, Singh S.
Clin Gastroenterol Hepatol. 2023 Apr;21(4):907-921.e2.

Placebo Rates in Randomized Controlled Trials of Proctitis Therapy: A Systematic Review and Meta-Analysis Placebo Response in Proctitis.
De Silva TA, Alphonsus L, Ma C, Hogan M, Sedano R, Narula N, Danese S, Peyrin-Biroulet L, MacDonald JK, Singh S, Jairath V.
J Crohns Colitis. 2023 Jan 27;17(1):123-136.

Comparative Efficacy of Infliximab vs Ustekinumab for Maintenance of Clinical Response in Biologic Naïve Crohn's Disease.
Wong ECL, Dulai PS, Marshall JK, Jairath V, Reinisch W, Narula N.
Inflamm Bowel Dis. 2023 Jul 5;29(7):1015-1023.

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.
Sedano R, Guizzetti L, McDonald C, Beaton M, Chande N, Gregor J, Sey M, Wilson A, Jairath V.
Inflamm Bowel Dis. 2023 Jun 1;29(6):866-874.

Revisiting Triggers: Optimal Thresholds for Transfusion in Gastrointestinal Bleeding May Be Higher Than Restrictive Guidelines.
Nightingale N, Zou G, Murphy MF, Jairath V.
Clin Gastroenterol Hepatol. 2023 Jul;21(7):1955-1956.

The Performance of the Rutgeerts Score, SES-CD, and MM-SES-CD for Prediction of Postoperative Clinical Recurrence in Crohn's Disease.
Narula N, Wong ECL, Dulai PS, Marshall JK, Jairath V, Reinisch W.
Inflamm Bowel Dis. 2023 May 2;29(5):716-725.

Comparison of the Relative Sensitivity of Clinical, Endoscopic, and Histologic Remission for Detection of Treatment Efficacy in Ulcerative Colitis Trials.
Sedano R, Hogan M, Zou G, Narula N, Singh S, Ma C, Feagan BG, Jairath V.
Inflamm Bowel Dis. 2023 Feb 1;29(2):324-327.