Publications by authors named "David T Rubin"

333 Publications

Treatment of Crohn's Disease and Concomitant Alopecia Areata With Tofacitinib.

ACG Case Rep J 2021 Nov 24;8(11):e00690. Epub 2021 Nov 24.

Section of Gastroenterology, Hepatology, and Nutrition, University of Chicago Medicine Inflammatory Bowel Disease Center, Chicago, IL.

Alopecia areata (AA) is a type of immune-mediated hair loss and is reported in patients with inflammatory bowel disease. This suggests that there might be a shared molecular pathway in the pathogenesis of AA and inflammatory bowel disease. In addition, tumor necrosis factor-alpha antagonists are also rarely associated with new-onset AA. We present a patient with Crohn's disease treated with adalimumab who developed AA that rapidly progressed to alopecia totalis and universalis. We describe the use of tofacitinib, a Janus kinase 1/3 inhibitor, to not only successfully treat the AA but also maintain her Crohn's disease.
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http://dx.doi.org/10.14309/crj.0000000000000690DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8613360PMC
November 2021

Etrolizumab versus adalimumab or placebo as induction therapy for moderately to severely active ulcerative colitis (HIBISCUS): two phase 3 randomised, controlled trials.

Lancet Gastroenterol Hepatol 2021 Nov 16. Epub 2021 Nov 16.

Hospital Clinic of Barcelona, August Pi i Sunyer Biomedical Research Institute, Biomedical Research Networking Center in Hepatic and Digestive Diseases, Barcelona, Spain. Electronic address:

Background: Etrolizumab is a gut-targeted anti-β7 integrin monoclonal antibody. In an earlier phase 2 induction study, etrolizumab significantly improved clinical remission relative to placebo in patients with moderately to severely active ulcerative colitis. The HIBISCUS studies aimed to compare the efficacy and safety of etrolizumab to adalimumab and placebo for induction of remission in patients with moderately to severely active ulcerative colitis.

Methods: HIBISCUS I and HIBISCUS II were identically designed, multicentre, phase 3, randomised, double-blind, placebo-controlled and active-controlled studies of etrolizumab, adalimumab, and placebo in adult (18-80 years) patients with moderately to severely active ulcerative colitis (Mayo Clinic total score [MCS] of 6-12 with an endoscopic subscore of ≥2, a rectal bleeding subscore of ≥1, and a stool frequency subscore of ≥1) who were naive to tumour necrosis factor inhibitors. All patients had an established diagnosis of ulcerative colitis for at least 3 months, corroborated by both clinical and endoscopic evidence, and evidence of disease extending at least 20 cm from the anal verge. In both studies, patients were randomly assigned (2:2:1) to receive subcutaneous etrolizumab 105 mg once every 4 weeks; subcutaneous adalimumab 160 mg on day 1, 80 mg at week 2, and 40 mg at weeks 4, 6, and 8; or placebo. Randomisation was stratified by baseline concomitant treatment with corticosteroids, concomitant treatment with immunosuppressants, and baseline disease activity. All patients and study site personnel were masked to treatment assignment. The primary endpoint was induction of remission at week 10 (defined as MCS of 2 or lower, with individual subscores of 1 or lower, and rectal bleeding subscore of 0) with etrolizumab compared with placebo. Pooled analyses of both studies comparing etrolizumab and adalimumab were examined for several clinical and endoscopic endpoints. Efficacy was analysed using a modified intent-to-treat population, defined as all randomly assigned patients who received at least one dose of study drug. These trials are registered with ClinicalTrials.gov, NCT02163759 (HIBISCUS I), NCT02171429 (HIBISCUS II).

Findings: Between Nov 4, 2014, and May 25, 2020, each study screened 652 patients (HIBISCUS I) and 613 patients (HIBISCUS II). Each study enrolled and randomly assigned 358 patients (HIBISCUS I etrolizumab n=144, adalimumab n=142, placebo n=72; HIBISCUS II etrolizumab n=143; adalimumab n=143; placebo n=72). In HIBISCUS I, 28 (19·4%) of 144 patients in the etrolizumab group and five (6·9%) of 72 patients in the placebo group were in remission at week 10, with an adjusted treatment difference of 12·3% (95% CI 1·6 to 20·6; p=0·017) in favour of etrolizumab. In HIBISCUS II, 26 (18·2%) of 143 patients in the etrolizumab group and eight (11·1%) of 72 patients in the placebo group were in remission at week 10, with an adjusted treatment difference of 7·2% (95% CI -3·8 to 16·1; p=0·17). In the pooled analysis, etrolizumab was not superior to adalimumab for induction of remission, endoscopic improvement, clinical response, histological remission, or endoscopic remission; however, similar numerical results were observed in both groups. In HIBISCUS I, 50 (35%) of 144 patients in the etrolizumab group reported any adverse event, compared with 61 (43%) of 142 in the adalimumab group and 26 (36%) of 72 in the placebo group. In HIBISCUS II, 63 (44%) of 143 patients in the etrolizumab group reported any adverse event, as did 62 (43%) of 143 in the adalimumab group and 33 (46%) in the placebo group. The most common adverse event in all groups was ulcerative colitis flare. The incidence of serious adverse events in the pooled patient population was similar for etrolizumab (15 [5%] of 287) and placebo (seven [5%] of 144) and lower for adalimumab (six [2%] of 285). Two patients in the etrolizumab group died; neither death was deemed to be treatment related.

Interpretation: Etrolizumab was superior to placebo for induction of remission in HIBISCUS I, but not in HIBISCUS II. Etrolizumab was well tolerated in both studies.

Funding: F Hoffmann-La Roche.
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http://dx.doi.org/10.1016/S2468-1253(21)00338-1DOI Listing
November 2021

Quality of Care Program Reduces Unplanned Health Care Utilization in Patients With Inflammatory Bowel Disease.

Am J Gastroenterol 2021 Nov 19. Epub 2021 Nov 19.

Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire, USA.

Introduction: There is significant variation in processes and outcomes of care for patients with inflammatory bowel disease (IBD), suggesting opportunities to improve quality of care. We aimed to determine whether a structured quality of care program can improve IBD outcomes, including the need for unplanned health care utilization.

Methods: We used a structured approach to improve adult IBD care in 27 community-based gastroenterology practices and academic medical centers. Patient-reported outcomes (PRO) and health care utilization were collected at clinical visits. Outcomes were monitored monthly using statistical process control charts; improvement was defined by special cause (nonrandom) variation over time. Multivariable logistic regression was applied to patient-level data. Nineteen process changes were offered to improve unplanned health care utilization. Ten outcomes were assessed, including disease activity, remission status, urgent care need, recent emergency department use, hospitalizations, computed tomography scans, health confidence, corticosteroid or opioid use, and clinic phone calls.

Results: We collected data prospectively from 20,382 discrete IBD visits. During the 15-month project period, improvement was noted across multiple measures, including need for urgent care, hospitalization, steroid use, and opioid utilization. Adjusted multivariable modeling showed significant improvements over time across multiple outcomes including urgent care need, health confidence, emergency department utilization, hospitalization, corticosteroid use, and opioid use. Attendance at monthly coached webinars was associated with improvement.

Discussion: Outcomes of IBD care were improved using a structured quality improvement program that facilitates small process changes, sharing of best practices, and ongoing feedback. Spread of these interventions may facilitate broad improvement in IBD care when applied to a large population.
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http://dx.doi.org/10.14309/ajg.0000000000001547DOI Listing
November 2021

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

Inflamm Bowel Dis 2021 Nov 13. Epub 2021 Nov 13.

Alimentiv Inc., London, Ontario, Canada.

Background: The lack of standardized methods for clinical trial design and disease activity assessment has contributed to an absence of approved medical therapies for the prevention of postoperative Crohn's disease (CD). We developed recommendations for regulatory trial design for this indication and for endoscopic assessment of postoperative CD activity.

Methods: An international panel of 19 gastroenterologists was assembled. Modified Research and Development/University of California Los Angeles methodology was used to rate the appropriateness of 196 statements using a 9-point Likert scale in 2 rounds of voting. Results were reviewed and discussed between rounds.

Results: Inclusion of patients with a history of completely resected ileocolonic CD in regulatory clinical trials for the prevention of postoperative recurrence was appropriate. Given the absence of approved medical therapies, a placebo-controlled design with a primary end point of endoscopic remission at 52 weeks was appropriate for drug development for this indication; however, there was uncertainty regarding the appropriateness of a coprimary end point of symptomatic and endoscopic remission and the use of currently available patient-reported outcome measures. The modified Rutgeerts Score, endoscopic assessment of the anastomosis, and a minimum of 5cm of neoterminal ileum were also appropriate; although the appropriateness of other indices including the Simple Endoscopic Score for CD for endoscopic assessment of postoperative CD activity was uncertain.

Conclusions: A framework for regulatory trial design for the prevention of postoperative CD recurrence and endoscopic assessment of disease activity has been developed. Research to empirically validate end points for these trials is needed.
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http://dx.doi.org/10.1093/ibd/izab259DOI Listing
November 2021

Characteristics, Comorbidities, and Outcomes of SARS-CoV-2 Infection in Patients with Autoimmune Conditions Treated with Systemic Therapies: a Population-based Study.

J Rheumatol 2021 Nov 15. Epub 2021 Nov 15.

This study was sponsored by Pfizer Inc. J.R. Curtis, MD, Division of Clinical Immunology and Rheumatology, University of Alabama at Birmingham, Birmingham, AL, USA; X. Zhou, PhD, Y. Chen, MD, B. Benda, MD, PhD, A. Madsen, PhD, J. Geier, PhD, Pfizer Inc, New York, NY, USA; D.T. Rubin, MD, University of Chicago Medicine Inflammatory Bowel Disease Center, Chicago, IL, USA; W. Reinisch, MD, Medical University of Vienna, Vienna, Austria; J. Yazdany, MD, Division of Rheumatology, Department of Medicine, University of California, San Francisco, CA, USA; P.C. Robinson, MBChB, PhD, School of Clinical Medicine, Faculty of Medicine, The University of Queensland, Herston, QLD, Australia. JRC has received grant support from, and has been a consultant for, Pfizer Inc. DTR has received grant support from Takeda; and has received consulting fees from AbbVie, AbGenomics, Allergan Inc, Boehringer Ingelheim, Bristol-Myers Squibb, Celgene Corp/Syneos, Check-Cap, Dizal Pharmaceuticals, Eli Lilly, GalenPharma/Atlantica, Genentech/Roche, Gilead Sciences, GSK, Ichnos Sciences S.A, Janssen, Narrow River Mgmt, Pfizer Inc, Prometheus Laboratories, Reistone, Shire, Takeda, and Techlab Inc. WR has received grant support from Abbott, AbbVie, AESCA, Centocor, Dr. Falk Pharma, Immundiagnostik, and MSD; has received lecture fees from Abbott, AbbVie, AESCA, Aptalis, Celltrion, Centocor, Danone, Dr. Falk Pharma, Elan, Ferring Pharmaceuticals, Immundiagnostik, Mitsubishi Tanabe Pharma, MSD, Otsuka, PDL, Pharmacosmos, Schering-Plough, Shire, Takeda, Therakos, Vifor, and Yakult; and has received consulting fees from Abbott, AbbVie, AESCA, Amgen, AM Pharma, Astellas, AstraZeneca, Avaxia Biologics, Bioclinica, Biogen Idec, Boehringer Ingelheim, Bristol-Myers Squibb, Celgene, Cellerix, Celltrion, Centocor, ChemoCentryx, Covance, Danone, Dr. Falk Pharma, Elan, Ferring Pharmaceuticals, Galapagos, Genentech, Gilead Sciences, Grünenthal, ICON, Index Pharma, Inova, Janssen, Johnson & Johnson, Kyowa Hakko Kirin Pharma, Lipid Therapeutics, MedImmune, Millennium, Mitsubishi Tanabe Pharma, MSD, Nestlé, Novartis, Ocera, Otsuka, PDL, Pfizer Inc, Pharmacosmos, Procter & Gamble, Prometheus Laboratories, Robarts Clinical Trials, Schering-Plough, Second Genome, SetPoint Medical, Takeda, Therakos, TiGenix, UCB, Vifor, Zyngenia, and 4SC. JY has received consulting fees from AstraZeneca and Eli Lilly; and has received a research grant from AstraZeneca. PCR has received personal fees from AbbVie, Atom Biosciences, Eli Lilly, Gilead Sciences, Janssen, Novartis, Pfizer Inc, Roche, and UCB; and has received grant support from Janssen, Novartis, Pfizer Inc, and UCB. XZ, YC, BB, and AM are employees and shareholders of Pfizer Inc. JG was formerly employed by Pfizer Inc. Address correspondence to Dr. X. Zhou, Pfizer Inc, 235 East 42nd Street, New York, NY 10017, USA. Email:

Objective: To describe characteristics and COVID-19 clinical outcomes in patients with rheumatoid arthritis (RA), psoriatic arthritis (PsA), or ulcerative colitis (UC) receiving systemic therapies vs the general population.

Methods: This descriptive retrospective cohort study used US Optum® deidentified COVID-19 electronic health record dataset (2007-2020) data. Adults with COVID-19 were stratified into 3 disease cohorts (RA, PsA, or UC patients who had received systemic therapy) and a comparator cohort not meeting these criteria. Incidence proportions of hospitalization and clinical manifestations of interest were calculated. Using logistic regression analyses, risk of endpoints was estimated, adjusting for demographics and demographics plus comorbidities.

Results: This analysis (February 1-December 9, 2020) included 315,101 COVID-19 patients. Adjusting for demographics, COVID-19 patients with RA (N=2,306) had an increased risk of hospitalization (odds ratio 1.54 [95% CI 1.39-1.70]) and in-hospital death (1.61 [1.30-2.00]), compared with the comparator cohort (N=311,563). The increased risk was also observed when adjusted for demographics plus comorbidities (hospitalization 1.25 [1.13-1.39] and in-hospital death 1.35 [1.09-1.68]). The risk of hospitalization was lower in COVID-19 patients with RA receiving tumor necrosis factor inhibitors (TNFi) vs non-TNFi biologics (0.32 [0.20-0.53]) and the comparator cohort (0.77 [0.51-1.17]). The risk of hospitalization due to COVID-19 was similar between patients receiving tofacitinib and the comparator cohort.

Conclusion: Compared with the comparator cohort, RA patients were at a higher risk of more severe or critical COVID-19 and, except for non-TNFi biologics, systemic therapies did not further increase the risk.
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http://dx.doi.org/10.3899/jrheum.210888DOI Listing
November 2021

Treatment of pouchitis, Crohn's disease, cuffitis, and other inflammatory disorders of the pouch: consensus guidelines from the International Ileal Pouch Consortium.

Lancet Gastroenterol Hepatol 2021 Nov 10. Epub 2021 Nov 10.

IBD Clinical Center, University Hospital Center Dr Dragiša Mišović, Belgrade, Serbia.

Pouchitis, Crohn's disease of the pouch, cuffitis, polyps, and extraintestinal manifestations of inflammatory bowel disease are common inflammatory disorders of the ileal pouch. Acute pouchitis is treated with oral antibiotics and chronic pouchitis often requires anti-inflammatory therapy, including the use of biologics. Aetiological factors for secondary pouchitis should be evaluated and managed accordingly. Crohn's disease of the pouch is usually treated with biologics and its stricturing and fistulising complications can be treated with endoscopy or surgery. The underlying cause of cuffitis determines treatment strategies. Endoscopic polypectomy is recommended for large, symptomatic inflammatory polyps and polyps in the cuff. The management principles of extraintestinal manifestations of inflammatory bowel disease in patients with pouches are similar to those in patients without pouches.
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http://dx.doi.org/10.1016/S2468-1253(21)00214-4DOI Listing
November 2021

Assessment of Comorbid Depression and Anxiety in Inflammatory Bowel Disease Using Adaptive Testing Technology.

Crohns Colitis 360 2021 Jan 6;3(1). Epub 2021 Feb 6.

University of Chicago Medicine Inflammatory Bowel Disease Center, Chicago, IL.

Background: Depression and anxiety are comorbidities of inflammatory bowel disease (IBD), and it is now recommended to screen IBD patients for these conditions. We screened patients using a novel computerized adaptive testing technology and compared the screening results to measures of disease activity.

Methods: Consecutive patients at our tertiary IBD clinic were asked to complete the validated CAT-MH™ survey (Adaptive Testing Technologies, Chicago, IL); we then reviewed disease and patient characteristics. Clinical remission status was determined based on clinical, laboratory, endoscopy and imaging results. Statistical methods included Fisher's exact test and Pearson Chi-square tests to assess association. Univariable and multivariable analyses were performed.

Results: We included 134 patients, of which 34 (25.3%) screened positive for depression and 18 (13.4%) screened positive for anxiety. We identified 19 (55.9 %) and 10 (55.5%) patients who were previously undiagnosed for depression and anxiety, respectively. Patients in clinical remission were less likely to screen positive for depression (OR 0.19; 95%CI 0.07-0.50) and for anxiety (OR 0.30; 95%CI 0.10-0.91). Compared to patients with negative CRP values, patients with positive CRP were more likely to also screen positive for depression (p=0.025) and anxiety (p=0.15).

Conclusions: We demonstrate the utility of a novel testing technology for screening patients with IBD for depression and anxiety. We found a large number of patients with previously undiagnosed anxiety or depression and a significant positive association between clinically active IBD and these mental health conditions. This work supports and informs recommendations for mental health screening in the IBD population.
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http://dx.doi.org/10.1093/crocol/otaa095DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8570563PMC
January 2021

CANCER PREVENTION IN PATIENTS WITH INFLAMMATORY BOWEL DISEASE.

Pract Gastroenterol 2021 Aug;45(8):12-28

University of Chicago Medicine Inflammatory Bowel Disease Center, Chicago, IL, USA.

Inflammatory bowel disease (IBD) is associated with increased rates of malignancies; some are disease-related (like colorectal cancer) and some are primarily associated with therapy exposures. Although there may be an overlap between disease- and therapy-related cancers, the general strategy for prevention of cancer in patients with IBD lies in understanding the risk factors for these malignancies, educating patients about the recommended screening and surveillance practices, and incorporating general screening recommendations into routine IBD care. An important limitation to our understanding of the effectiveness of our intervention and prevention strategies is the lack of studies assessing mortality benefit, but in part also a reflection of the low mortality in our IBD population. In practice, it is imperative to weigh the risks of cancer or other treatment-related complications in the context of disease progression as a result of lack of or ineffective treatment for IBD when tailoring a management plan for each patient.
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http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8547793PMC
August 2021

Worldwide post-marketing safety surveillance experience with tofacitinib in ulcerative colitis.

Aliment Pharmacol Ther 2021 Oct 9. Epub 2021 Oct 9.

Pfizer Inc, Collegeville, PA, USA.

Background: Tofacitinib is an oral Janus kinase inhibitor for the treatment of ulcerative colitis (UC). Post-marketing surveillance (PMS) is an important part of monitoring adverse events (AEs).

Aims: To report an analysis of PMS case safety reports for tofacitinib in patients with UC METHODS: Worldwide tofacitinib PMS reports received in the Pfizer safety database from 30 May 2018 (first regulatory approval) to 25 August 2020 were analysed. The type and estimated reporting rate (RR) of serious AEs of interest, including infection, gastrointestinal, vascular, respiratory, neoplasm and cardiac events, were reviewed. Patient-years of exposure (PY) was estimated based on worldwide sales data and the calculated daily regimens of tofacitinib 5 or 10 mg twice daily, immediate- or extended-release formulations.

Results: During the 27-month reporting period, worldwide post-marketing exposure to tofacitinib was 8916 PY. Overall, 4226 case reports were received and included 12 103 AEs, of which 1839 were serious AEs (SAEs). Among the cases reported, 1141 (27.0%) included an SAE and 18 (0.4%) were fatal. The RR (per 100 PY) for SAEs of interest by Medical Dictionary for Regulatory Activities System Organ Class were 3.28 for infections, 1.26 for vascular disorders, 0.74 for respiratory disorders, 0.55 for neoplasms and 0.50 for cardiac disorders.

Conclusions: The types of AEs were consistent with those reported in tofacitinib clinical trials. Most reported AEs were non-serious. Limitations of PMS reports and reliance on estimated RRs due to lack of precise values for exposure, required for incidence rate calculation, should be considered when interpreting these results.
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http://dx.doi.org/10.1111/apt.16619DOI Listing
October 2021

Ulcerative Colitis Patients Have Reduced Rectal Compliance Compared With Non-Inflammatory Bowel Disease Controls.

Gastroenterology 2021 Sep 28. Epub 2021 Sep 28.

Inflammatory Bowel Disease Center, University of Chicago Medicine, Chicago, Illinois. Electronic address:

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http://dx.doi.org/10.1053/j.gastro.2021.09.052DOI Listing
September 2021

Inclusion of Under-represented Racial and Ethnic Minorities in Randomized Clinical Trials for Inflammatory Bowel Disease.

Gastroenterology 2021 Sep 22. Epub 2021 Sep 22.

Medicine Inflammatory Bowel Disease Center, MacLean Center for Clinical Medical Ethics, University of Chicago, Chicago, Illinois.

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http://dx.doi.org/10.1053/j.gastro.2021.09.035DOI Listing
September 2021

Stratifying Risks of Ileal Pouch Outcomes.

Clin Gastroenterol Hepatol 2021 Sep 3. Epub 2021 Sep 3.

University of Chicago Medicine, Inflammatory Bowel Disease Center, Chicago, Illinois.

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http://dx.doi.org/10.1016/j.cgh.2021.08.051DOI Listing
September 2021

How to Navigate National Societal Organizations for Leadership Development and Academic Promotion: A Guide for Trainees and Young Faculty.

Gastroenterology 2021 Nov 28;161(5):1361-1365. Epub 2021 Aug 28.

Department of Medicine, University of Chicago Medicine, Chicago, Illinois. Electronic address:

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http://dx.doi.org/10.1053/j.gastro.2021.08.044DOI Listing
November 2021

International consensus on the prevention of venous and arterial thrombotic events in patients with inflammatory bowel disease.

Nat Rev Gastroenterol Hepatol 2021 Dec 27;18(12):857-873. Epub 2021 Aug 27.

Department of Gastroenterology and INSERM NGERE U1256, University Hospital of Nancy, University of Lorraine, Vandoeuvre-lès-Nancy, France.

Patients with inflammatory bowel disease (IBD) are at increased risk of thrombotic events. Therapies for IBD have the potential to modulate this risk. The aims of this Evidence-Based Guideline were to summarize available evidence and to provide practical recommendations regarding epidemiological aspects, prevention and drug-related risks of venous and arterial thrombotic events in patients with IBD. A virtual meeting took place in May 2020 involving 14 international IBD experts and 3 thrombosis experts from 12 countries. Proposed statements were voted upon in an anonymous manner. Agreement was defined as at least 75% of participants voting as 'fully agree' or 'mostly agree' with each statement. For each statement, the level of evidence was graded according to the Scottish Intercollegiate Guidelines Network (SIGN) grading system. Consensus was reached for 19 statements. Patients with IBD harbour an increased risk of venous and arterial thrombotic events. Thromboprophylaxis is indicated during hospitalization of any cause in patients with IBD. Disease activity is a modifiable risk factor in patients with IBD, and physicians should aim to achieve deep remission to reduce the risk. Exposure to steroids should be limited. Antitumour necrosis factor agents might be associated with a reduced risk of thrombotic events.
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http://dx.doi.org/10.1038/s41575-021-00492-8DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8395387PMC
December 2021

Diagnosis and classification of ileal pouch disorders: consensus guidelines from the International Ileal Pouch Consortium.

Lancet Gastroenterol Hepatol 2021 10 18;6(10):826-849. Epub 2021 Aug 18.

Division of Gastroenterology, Hepatology, and Nutrition, Allegheny Health Network, Pittsburgh, PA, USA.

Restorative proctocolectomy with ileal pouch-anal anastomosis is an option for most patients with ulcerative colitis or familial adenomatous polyposis who require colectomy. Although the construction of an ileal pouch substantially improves patients' health-related quality of life, the surgery is, directly or indirectly, associated with various structural, inflammatory, and functional adverse sequelae. Furthermore, the surgical procedure does not completely abolish the risk for neoplasia. Patients with ileal pouches often present with extraintestinal, systemic inflammatory conditions. The International Ileal Pouch Consortium was established to create this consensus document on the diagnosis and classification of ileal pouch disorders using available evidence and the panellists' expertise. In a given individual, the condition of the pouch can change over time. Therefore, close monitoring of the activity and progression of the disease is essential to make accurate modifications in the diagnosis and classification in a timely manner.
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http://dx.doi.org/10.1016/S2468-1253(21)00101-1DOI Listing
October 2021

Extraintestinal Manifestations of Inflammatory Bowel Disease: Current Concepts, Treatment, and Implications for Disease Management.

Gastroenterology 2021 Oct 3;161(4):1118-1132. Epub 2021 Aug 3.

University of Chicago Medicine Inflammatory Bowel Disease Center, Chicago, Illinois. Electronic address:

Inflammatory bowel diseases (IBDs) are systemic diseases that manifest not only in the gut and gastrointestinal tract, but also in the extraintestinal organs in many patients. The quality of life for patients with IBD can be substantially affected by these extraintestinal manifestations (EIMs). It is important to have knowledge of the prevalence, pathophysiology, and clinical presentation of EIMs in order to adapt therapeutic options to cover all aspects of IBD. EIMs can occur in up to 24% of patients with IBD before the onset of intestinal symptoms, and need to be recognized to initiate appropriate diagnostic procedures. EIMs most frequently affect joints, skin, or eyes, but can also affect other organs, such as the liver, lung, and pancreas. It is a frequent misconception that a successful therapy of the intestinal inflammation will be sufficient to treat EIMs satisfactorily in most patients with IBD. In general, peripheral arthritis, oral aphthous ulcers, episcleritis, or erythema nodosum can be associated with active intestinal inflammation and can improve on standard treatment of the intestinal inflammation. However, anterior uveitis, ankylosing spondylitis, and primary sclerosing cholangitis usually occur independent of disease flares. This review provides a comprehensive overview of epidemiology, pathophysiology, clinical presentation, and treatment of EIMs in IBD.
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http://dx.doi.org/10.1053/j.gastro.2021.07.042DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8564770PMC
October 2021

Factors associated with anti-tumor necrosis factor effectiveness to prevent postoperative recurrence in Crohn's disease.

Intest Res 2021 Aug 4. Epub 2021 Aug 4.

Inflammatory Bowel Disease Center, University of Chicago Medicine, Chicago, IL, USA.

Background/aims: We assessed the effectiveness of anti-TNF agents and its associated factors to prevent endoscopic and clinical postoperative recurrence (POR) in Crohn's disease (CD).

Methods: From a prospectively-maintained database, we retrieved 316 CD patients who underwent intestinal resection (2011-2017). Endoscopic (Rutgeerts index ≥ i2 at 6 months) and clinical (recurrence of symptoms leading to hospitalization or therapeutic escalation) POR were assessed.

Results: In 117 anti-TNF-naïve patients, anti-TNF therapy was more effective than immunosuppressive agents (odds ratio [OR], 8.8; 95% confidence interval [CI], 1.8-43.9; P= 0.008) and no medication/5-aminosalicylates (OR, 5.2; 95% CI, 1.0-27.9; P= 0.05) to prevent endoscopic POR. In 199 patients exposed to anti-TNF prior to the surgery, combination with anti-TNF and immunosuppressive agents was more effective than anti-TNF monotherapy (OR, 2.32; 95% CI, 1.02-5.31; P= 0.046) to prevent endoscopic POR. Primary failure to anti-TNF agent prior to surgery was predictive of anti-TNF failure to prevent endoscopic POR (OR, 2.41; 95% CI, 1.10-5.32; P= 0.03). When endoscopic POR despite anti-TNF prophylactic medication (n = 55), optimizing anti-TNF and adding an immunosuppressive drug was the most effective option to prevent clinical POR (hazard ratio, 7.38; 95% CI, 1.54-35.30; P= 0.012). Anti-TNF therapy was the best option to prevent clinical POR (hazard ratio, 3.10; 95% CI, 1.09-8.83; P= 0.034) in patients with endoscopic POR who did not receive any biologic to prevent endoscopic POR (n = 55).

Conclusions: Anti-TNF was the most effective medication to prevent endoscopic and clinical POR. Combination with anti-TNF and immunosuppressive agents should be considered in patients previously exposed to anti-TNF.
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http://dx.doi.org/10.5217/ir.2021.00018DOI Listing
August 2021

Burden of comorbid anxiety and depression in patients with inflammatory bowel disease: a systematic literature review.

Expert Rev Gastroenterol Hepatol 2021 Sep 15;15(9):985-997. Epub 2021 Jun 15.

Susan and Leonard Feinstein IBD Clinical Center, Icahn School of Medicine, Mount Sinai, New York City, USA.

Introduction: Patients with inflammatory bowel disease (IBD), including Crohn's disease and ulcerative colitis, often have comorbid anxiety and depression that affects their quality of life (QoL) and management of their IBD.

Areas Covered: A systematic literature review (SLR) was conducted to identify articles and conference abstracts on comorbid anxiety and depression in IBD patients using MEDLINE® and Embase® (January 2003 - June 2018). The impact of these psychological comorbidities on QoL and economic burden was examined. Non-pharmacologic interventions and disease-specific unmet clinical needs associated with these comorbidities were also evaluated.

Expert Opinion: There is evidence that individual and group-based cognitive behavioral therapy can reduce rates of anxiety and depression in adults and adolescents with IBD. Patients with IBD and anxiety or depression had an increased risk of hospitalization, emergency department visits, readmission, and used outpatient services more often than people without these conditions. Several disease-specific unmet clinical needs for IBD patients were identified. These included lack of reimbursement for mental-health care, inconsistent screening for psychological comorbidities and patients not consulting mental-health professionals when needed. IBD patients may benefit from integrated medical and psychological treatment, and should be considered for behavioral treatment.Plain Language Summary.

Background: People with IBD may have mental-health conditions, such as anxiety and depression. These conditions can affect people's quality of life and how they manage their IBD.

What Did This Review Look At?: We found 79 publications on anxiety or depression in people with IBD, published between January 2003 and June 2018. In people with IBD and anxiety or depression, researchers looked at: the impact on health-related quality of life and healthcare utilization, including access to and reimbursement for mental-health services how effective interventions that do not involve the use of medicines were (known as non-pharmacologic therapy).

What Were The Main Findings From This Review?: People with IBD and anxiety or depression were more likely to be admitted to hospital and visit emergency departments than people without these conditions. Access to mental-health care varied and some people with IBD were not screened for depression.Individual and group-based talking therapy (known as cognitive behavioral therapy) reduced rates of anxiety and depression in some people with IBD.

What Were The Main Conclusions From This Review?: We found evidence that people with IBD and anxiety or depression may benefit from certain non-pharmacologic interventions. However, many people with IBD and anxiety or depression did not have access to mental-health services. Healthcare professionals should address gaps in patient care to improve outcomes in people with IBD and anxiety or depression.See Additional file 1 for an infographic plain language summary.
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http://dx.doi.org/10.1080/17474124.2021.1911644DOI Listing
September 2021

What Are the Most Challenging Aspects of Inflammatory Bowel Disease? An International Survey of Gastroenterologists Comparing Developed and Developing Countries.

Inflamm Intest Dis 2021 May 5;6(2):78-86. Epub 2021 Feb 5.

Section of Gastroenterology, Max Rady School of Medicine and University of Manitoba IBD Clinical and Research Centre, Winnipeg, Manitoba, Canada.

Background And Aims: As inflammatory bowel disease (IBD) becomes more prevalent, the challenges that gastroenterologists face in managing these patients evolve. We aimed to describe the most important challenges facing gastroenterologists from around the world and compare these between those working in developed and developing countries.

Methods: An online questionnaire was developed, and a link distributed to gastroenterologists. Data were analyzed descriptively using Friedman and Wilcoxon matched-pair signed rank tests to compare rankings for responses. Mann-Whitney tests were used to compare rankings between responses from gastroenterologists from developed and developing countries. Lower scores reflected greater challenges.

Results: Of 872 who started, 397 gastroenterologists (45.5%) completed the survey. Respondents represented 65 countries (226 [56.9%] from developed countries). Overall, the challenge ranked most important (smallest number) was increasing IBD prevalence (13.6%). There were significant differences in mean ranking scores for many simple aspects of care for those from developing countries compared to providers from developed countries, such as access to simple IBD treatments (5.52 vs. 6.02, = 0.01), access to anti-TNF drugs including dose escalation (3.33 vs. 3.93, < 0.01), access to good stoma care (2.57 vs. 3.03, < 0.001), access to therapeutic drug monitoring (1.47 vs. 1.84, < 0.001), and access to care for people from low socioeconomic status (2.77 vs. 3.37, < 0.001).

Conclusions: Increasing IBD prevalence is seen by gastroenterologists as the greatest challenge facing them. There are significant differences between the IBD challenges facing gastroenterologists from developed and developing countries that reflect inequities in access to health care.
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http://dx.doi.org/10.1159/000512310DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8160566PMC
May 2021

Older Adult Patients Use More Aminosalicylate Monotherapy Compared With Younger Patients With Inflammatory Bowel Disease: TARGET-IBD.

J Clin Gastroenterol 2021 Jun 11. Epub 2021 Jun 11.

Division of Gastroenterology and Hepatology, University of North Carolina at Chapel Hill, Chapel Hill Atrium Health Gastroenterology and Hepatology, Charlotte Target RWE, Health Evidence Solutions, Durham, NC Department of Gastroenterology, Hepatology & Nutrition, Cleveland Clinic, Cleveland, OH Division of Gastroenterology and Hepatology, University of Wisconsin School of Medicine and Public Health, Madison, WI Henry D. Janowitz Division of Gastroenterology, Icahn School of Medicine at Mount Sinai Division of Pediatric Gastroenterology, The Susan & Leonard Feinstein IBD Clinical Center at Icahn School of Medicine at Mount Sinai, New York, NY IBD Center, The University of Chicago Medicine, Chicago, IL Section of Gastroenterology and Hepatology, Dartmouth-Hitchcock Medical Center, Lebanon, NH.

Goal: The goal of this study was to describe medication utilization patterns in older inflammatory bowel disease (IBD) patients.

Background: Despite a growing population of older patients with Crohn's disease (CD) and ulcerative colitis (UC), questions remain regarding medication utilization patterns in comparison to younger populations.

Materials And Methods: We collected data from the 34 sites in TARGET-IBD, a multicenter, observational cohort. The primary outcome in this study was the IBD-specific therapy utilized among older patients with IBD compared with younger age groups. Therapy use was analyzed using pairwise comparisons and then the odds of IBD-specific therapy use among patients older than age 65 were evaluated using multivariable logistic regression models.

Results: We identified 2980 patients with IBD (61% CD). In multivariable analysis, younger patients with UC were significantly less likely to utilize aminosalicylate monotherapy when compared with patients above 65 years [age 18 to 29: adjusted odds ratio (aOR)=0.51, 95% confidence interval (CI): 0.33-0.78]. In patients with CD, younger patients were significantly less likely to use aminosalicylate monotherapy when compared with patients above 65 (greatest difference age 18 to 29: aOR=0.31, 95% CI: 0.18-0.52). Younger patients with CD and UC were significantly more likely to use anti-tumor necrosis factor monotherapy than patients above 65 years (age 18 to 29: aOR=3.87, 95% CI: 2.47-6.06 and aOR=2.68, 95% CI: 1.29-5.58, respectively).

Conclusions: Older patients with IBD demonstrate significant differences in medication utilization, including more aminosalicylate monotherapy and less anti-tumor necrosis factor monotherapy compared with younger age groups. Given the aging population in the United States, these utilization patterns may have long-term implications for disease control.
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http://dx.doi.org/10.1097/MCG.0000000000001557DOI Listing
June 2021

Response to Tetangco and Hanauer.

Am J Gastroenterol 2021 09;116(9):1959-1960

Inflammatory Bowel Disease Center, University of Chicago Medicine, Chicago, Illinois, USA.

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http://dx.doi.org/10.14309/ajg.0000000000001330DOI Listing
September 2021

Evolving role of endoscopy in inflammatory bowel disease: Going beyond diagnosis.

World J Gastroenterol 2021 May;27(20):2521-2530

University of Chicago Medicine Inflammatory Bowel Disease Center, Chicago, IL 60637, United States.

Inflammatory bowel disease, encompassing Crohn's disease (CD) and ulcerative colitis, are chronic immune-mediated inflammatory bowel diseases (IBD) that primarily affect the gastrointestinal tract with periods of activity and remission. Large body of evidence exist to strengthen the prognostic role of endoscopic evaluation for both disease activity and severity and it remains the gold standard for the assessment of mucosal healing. Mucosal healing has been associated with improved clinical outcomes with prolonged remission, decreased hospitalization, IBD-related surgeries and colorectal cancer risk. Therefore, endoscopic objectives in IBD have been incorporated as part of standard care. With the known increased risk of colorectal cancer in IBD, although prevention strategies continue to develop, regular surveillance for early detection of neoplasia continue to be paramount in IBD patients' care. It is thanks to evolving technology and visualization techniques that surveillance strategies are continuously advancing. Therapeutic endoscopic options in IBD have also been expanding, from surgery sparing therapies such as balloon dilation of fibrostenotic strictures in CD to endoscopic mucosal resection of neoplastic lesions. In this review article, we discuss the current evidence on the use of endoscopy as part of standard of care of IBD, its role in surveillance of neoplasia, and the role of interventional endoscopic therapies.
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http://dx.doi.org/10.3748/wjg.v27.i20.2521DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8160621PMC
May 2021

Fecal Microbiota Transplantation for Recurrent C difficile Infection During the COVID-19 Pandemic: Experience and Recommendations.

Mayo Clin Proc 2021 06;96(6):1418-1425

Gastroenterology and Hepatology, Mayo Clinic, Rochester, MN.

Objective: To report experience with fecal microbiota transplantation (FMT) for recurrent Clostridioides difficile infection (rCDI) and provide recommendations for management of rCDI and donor testing during the COVID-19 pandemic.

Methods: A retrospective study of patients with rCDI who underwent FMT from May 26, 2020, to September 30, 2020, with stool from well-screened donors with health and infectious screening and a newly implemented strategy for COVID-19 screening with every 2-week bookend testing with stool quarantine. Patients were followed up for development of rCDI and COVID-19.

Results: Of the 57 patients who underwent FMT for rCDI, 29 were tested for COVID-19 via nasopharyngeal polymerase chain reaction (PCR) and 22 via serology. All results were negative, except for 1 positive serology. Donor testing every 2 weeks for COVID-19 via serology and nasopharyngeal swab PCR was negative, except for 2 donors at 1 center who were excluded. Three patients had rCDI after FMT, and 1 underwent repeat FMT. One patient developed respiratory symptoms suggestive of COVID-19 and tested negative via nasopharyngeal PCR. Eleven patients who underwent COVID-19 testing for elective procedures or hospitalizations tested negative. No SARS-CoV-2 transmission was noted.

Conclusions: With appropriate donor screening, FMT can be performed safely for rCDI during the COVID-19 pandemic. Development of a validated stool assay for SARS-CoV-2 will simplify this process further.
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http://dx.doi.org/10.1016/j.mayocp.2021.04.005DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8169126PMC
June 2021

New targets in inflammatory bowel disease therapy: 2021.

Curr Opin Gastroenterol 2021 07;37(4):357-363

The University of Chicago Medicine Inflammatory Bowel Disease Center, Chicago, Illinois, USA.

Purpose Of Review: In the rapidly progressing world of inflammatory bowel disease, this review discusses and summarizes new drug targets and results from major clinical trials in order to provide an update to physicians treating patients with inflammatory bowel diseases (IBD).

Recent Findings: Multiple new mechanisms in the treatment of IBD are being developed and many are showing promising results in both ulcerative colitis and Crohn's disease patients. In addition to efficacy, some of these treatments may provide safety benefits over existing therapies.

Summary: The IBD physicians' therapeutic armamentarium is rapidly expanding and keeping abreast of these developments is required in order to provide patients with optimized individualized care.
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http://dx.doi.org/10.1097/MOG.0000000000000740DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8544288PMC
July 2021

Achieving Histologic Normalization in Ulcerative Colitis Is Associated With a Reduced Risk of Subsequent Dysplasia.

Inflamm Bowel Dis 2021 May 25. Epub 2021 May 25.

University of Chicago Medicine Inflammatory Bowel Disease Center, Chicago,  Illinois, USA.

Background: Complete histologic normalization is associated with improved clinical outcomes in ulcerative colitis (UC). However, it is currently unknown what effect achieving histologic normalization has on the development of dysplasia.

Methods: We performed a retrospective analysis of 495 patients with a confirmed diagnosis of UC from a tertiary center. Patients were categorized according to the best histologic assessment they had during their disease course: histologic normalization, histologic quiescence, or persistent histologic activity. We assessed dysplasia rates in these patient groups after achieving histologic normalization or histologic quiescence, or 8 years after UC diagnosis in those with persistent histologic activity. Kaplan-Meier graphs and Cox regression analyses were performed to estimate this effect.

Results: The incidence rate of dysplasia development after achieving histologic normalization was statistically significantly less when compared with the incidence rate after achieving histologic quiescence (P = 0.001) and in those with persistent histologic activity 8 years after UC diagnosis (P = 0.033). In multivariate analysis, at any point throughout UC duration, dysplasia development was statistically lower in those with histologic normalization (adjusted hazard ratio [aHR], 0.32; 95% confidence interval [CI], 0.13-0.81) but not in those with histologic quiescence (aHR, 0.52; 95% CI, 0.25-1.10), compared with those with persistent histologic inflammation. When assessing the time after achieving histologic normalization, histologic quiescence, or 8 years post UC diagnosis in those with persistent histologic activity, we found that patients with histologic normalization had a subsequent decreased risk of developing dysplasia (aHR, 0.09; 95% CI, 0.01-0.72), compared with patients without normalization.

Conclusions: Histologic normalization is associated with a decreased risk in patients with UC of developing subsequent dysplasia, compared with patients without histologic normalization. These findings have implications for surveillance intervals.
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http://dx.doi.org/10.1093/ibd/izab130DOI Listing
May 2021

Extraintestinal manifestations at baseline, and the effect of tofacitinib, in patients with moderate to severe ulcerative colitis.

Therap Adv Gastroenterol 2021 16;14:17562848211005708. Epub 2021 May 16.

Division of Gastroenterology, University of Pennsylvania School of Medicine, Philadelphia, PA, USA.

Introduction: Extraintestinal manifestations (EIMs) in patients with ulcerative colitis (UC) are common. Tofacitinib is an oral, small molecule Janus kinase inhibitor for the treatment of UC. We evaluated the efficacy of tofacitinib in patients with EIMs, and the impact of tofacitinib on EIMs in patients with UC in the OCTAVE clinical program.

Methods: Data from two 8-week induction studies (OCTAVE Induction 1 and 2) and a 52-week maintenance study (OCTAVE Sustain) were analyzed. The effect of tofacitinib on efficacy outcomes stratified by EIM status, proportion of predefined prior and active EIMs at baseline, and change from baseline in EIMs were determined at the end of the treatment period (weeks 8 or 52), or at early termination.

Results: At baseline of OCTAVE Induction 1 and 2, and OCTAVE Sustain, 27.0% and 9.0% of patients had a history of EIMs (prior or active), respectively. Patients treated with tofacitinib 10 mg twice daily (BID) achieved remission and had endoscopic improvement in all studies, irrespective of any history of EIMs. A greater proportion of patients had active peripheral arthritis at baseline of OCTAVE Induction 1 and 2 OCTAVE Sustain. In OCTAVE Induction 1 and 2, similar proportions of tofacitinib and placebo-treated patients with active peripheral arthritis experienced either no change (81.3% and 85.7%, respectively) or an improvement (15.6% and 14.3%, respectively). By week 52 of OCTAVE Sustain, improvements in active peripheral arthritis were only observed in tofacitinib-treated patients (16.7% and 33.3% with tofacitinib 5 and 10 mg BID, respectively).

Conclusion: Any history of EIMs did not influence the efficacy of tofacitinib 10 mg BID for induction or maintenance of UC. The most common active EIM was peripheral arthritis, for which many patients in OCTAVE Induction 1 and 2, and OCTAVE Sustain, reported improvement or no change from baseline with tofacitinib treatment.Clinicaltrials.gov:NCT01465763; NCT01458951; NCT01458574.
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http://dx.doi.org/10.1177/17562848211005708DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8132089PMC
May 2021

A Practical Clinical Approach to the Management of High-Risk Ulcerative Colitis.

Gastroenterol Hepatol (N Y) 2021 Feb;17(2):59-66

University of Chicago Medicine Inflammatory Bowel Disease Center, Chicago, Illinois.

Patients with ulcerative colitis (UC) can experience periods of recurrent disease activity with a range of symptoms, including abdominal pain, rectal bleeding, urgency, and diarrhea. Although long-term remission will be achieved and maintained in most cases, the course of UC varies from patient to patient. Patients can be defined according to whether they are in remission or have mild, moderate, severe, or fulminant disease, and hospitalization can occur under different circumstances. In these cases, determining the next course of therapy is essential. The aim of this article is to present an approach to the treatment of high-risk UC in both the outpatient and inpatient settings. Also presented is a critical appraisal of alternative and emerging approaches to the management of patients with high-risk UC. Fundamental principles are key in the management of high-risk UC, including discussing the goals of treatment with the patient and family, assessing each patient's risk level and prognostic factors in addition to disease activity to inform therapeutic choices, understanding drug mechanisms and pharmacokinetics, and using objective measures to monitor disease response. In the treatment of all patients with high-risk UC, a balanced approach to deciding between medical and surgical options must be maintained.
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http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8132723PMC
February 2021

Combining Cyclosporine With Ustekinumab in Acute Severe Ulcerative Colitis.

ACG Case Rep J 2021 May 14;8(5):e00604. Epub 2021 May 14.

University of Chicago Medicine Inflammatory Bowel Disease Center, Chicago, IL.

We have demonstrated the effectiveness and safety of combining cyclosporine and vedolizumab to treat ulcerative colitis (UC). We present 2 cases of hospitalized acute severe UC who had failed therapy with antitumor necrosis factor and vedolizumab and were treated successfully with induction cyclosporine and safely bridged to ustekinumab maintenance therapy. Both patients have avoided colectomy. There were no adverse events. We propose this novel treatment combination in medically resistant acute severe UC.
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http://dx.doi.org/10.14309/crj.0000000000000604DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8126549PMC
May 2021

Predictability of simple endoscopic score for Crohn's disease for postoperative outcomes in Crohn's disease.

J Gastroenterol Hepatol 2021 Oct 19;36(10):2785-2793. Epub 2021 May 19.

Inflammatory Bowel Disease Center, University of Chicago Medicine, Chicago, Illinois, USA.

Background And Aim: Approximately half of patients with Crohn's disease (CD) who have surgery will experience clinical recurrence within 10 years of their surgery. This study aimed to assess the postoperative outcomes according to disease location and validated the simple endoscopic score for CD (SES-CD) to predict disease-related outcomes.

Methods: We retrospectively assessed medical records of CD patients who underwent ileocolonoscopy within 12 months after surgery at the University of Chicago between 2005 and 2016. We defined patients with postoperative colonic inflammation at the first postoperative ileocolonoscopy or had Montreal classification L2 as colon-dominant disease and patients without colonic involvement or who had L1 as small intestine (SI)-dominant disease. The outcomes included clinical and surgical recurrence.

Results: Among 207 CD patients, 51 (24.6%) and 156 (75.4%) patients had colon-dominant and SI-dominant disease, respectively. Patients with colon-dominant disease had a greater risk of postoperative clinical recurrence compared with those with SI-dominant disease (P = 0.018). Colon-dominant disease was a risk of earlier surgical recurrence compared with SI-dominant disease, although there were no significant differences in the recurrence-free survivals. SES-CD > 2 at the first postoperative ileocolonoscopy was a significant risk of clinical recurrence on log-rank test (P < 0.001) and Cox proportional hazards model (hazard ratio = 2.25; 95% confidence interval = 1.14-4.47; P = 0.020). An SES-CD of 1 was an appropriate cut-off to predict the clinical recurrence of SI-dominant disease, but a higher SES-CD cut-off value of 5 was required for colon-dominant disease.

Conclusions: We demonstrated that SES-CD predicts postoperative clinical recurrence of CD, regardless of disease location.
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http://dx.doi.org/10.1111/jgh.15540DOI Listing
October 2021

International consensus on methodological issues in standardization of fecal calprotectin measurement in inflammatory bowel diseases.

United European Gastroenterol J 2021 05 7;9(4):451-460. Epub 2021 May 7.

Department of Gastroenterology and Inserm U1256, Nutrition - Genetics and Exposure to Environmental Risks, University Hospital of Nancy, University of Lorraine, Vandoeuvre-lès-Nancy, France.

Background: Fecal calprotectin (FC) is a non-invasive marker of gut inflammation which is frequently used to guide therapeutic decisions in patients with inflammatory bowel diseases (IBD). Each step of FC measurement can influence the results, leading to misinterpretations and potentially impacting the management of IBD patients. To date, there is high heterogeneity between FC measurements and no current method is universally accepted as a standard.

Aims: Our aim was to provide clear position statementsabout the pre-analytical and the analytical phases of FC measurement to homogenize FC levels and to minimize variability and risk of misinterpretation through aninternational consensus.

Materials & Methods: Fourteen physicians with expertise in the field of IBD and FC from 11 countries attended a virtual international consensus meeting on July 17th, 2020. A systematic literature was conducted and the literature evidence was shared and discussedamong the participants. Statements were formulated, discussed, and voted. Statements were considered approved if all participants agreed.

Results: Nine statements were formulated and approved. Based on the available evidence, quantitative tests should be preferred for measuring FC. Furthermore, FC measurement, if possible, should always be performed with the same method and factors influencing FC levels should be taken into account when interpreting the results.

Discussion: FC has an increasingly important role in the management of patients with IBD. However, large multicenter studies should be conducted to define the reproducibility and to confirm the diagnostic accuracy of the available FC tests.

Conclusion: FC concentrations guide clinicians' treatment decisions. Our statements have a relevant impact in daily practice and could be applied in clinical trials to standardize FC measurement.
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http://dx.doi.org/10.1002/ueg2.12069DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8259254PMC
May 2021
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