Patient Preferences for Ulcerative Colitis Treatment in the Middle East Region: A Discrete-Choice Experiment.

Background and Aims: Treatments for ulcerative colitis (UC) differ in safety, efficacy, and route of administration; patient preferences for treatment attributes should be considered in treatment decisions. No study to date has explored patient preferences for moderate-to-severe UC treatment in Middle Eastern countries. Methods: A discrete-choice experiment aimed to quantify treatment preferences in patients with moderate-to-severe UC in 5 Middle Eastern countries (Saudi Arabia, Kuwait, Jordan, the United Arab Emirates, and Lebanon). Respondents chose between experimentally designed profiles for hypothetical UC treatments with varying efficacy (time until UC symptoms improve and chance of UC symptom control after 1 year), side effects (annual risk of serious infection, 5-year risk of malignancy), mode and frequency of administration, and need for occasional steroid use. A random-parameters logit model was used to estimate preference weights for these attributes, from which conditional relative importance estimates and maximum acceptable increases in risks of serious infection and malignancy were derived. Results: Among 365 adults with moderate-to-severe UC who completed the survey (mean age, 36 years; 50% female), 5-year risk of malignancy and symptom control after 1 year had the greatest conditional relative importance. Respondents were generally willing to accept statistically significant increases in annual risk of serious infection and 5-year risk of malignancy in exchange for better efficacy, changes in mode of administration and dosing schedule, and avoiding occasional steroid use. Conclusion: Of the attributes evaluated, individuals with UC in Middle Eastern countries most value avoiding 5-year risk of malignancy and a higher probability of symptom control, on average.

Inflammatory bowel disease training assessment of gastroenterology fellows in Saudi Arabia.

BACKGROUND: Recent advancement and complexity in the management of inflammatory bowel disease (IBD) has made it challenging for gastroenterology (GI) fellows to obtain competency and confidence in managing the complex IBD patient. We aimed to evaluate the confidence and training in IBD among GI fellows in Saudi Arabia. METHODS: We conducted an electronic, voluntary, and anonymous multicenter survey study of GI fellows in Saudi Arabia, from 1/5/2023 to 1/9/2023. The survey evaluated the fellows' confidence level in IBD management, methods of training received, and the amount of additional training desired in 20 core IBD domains. GI fellows' preferred learning method was also evaluated. RESULTS: A total of 65 GI fellows responded to the survey. In the entire cohort, >50% of fellows reported low confidence in 7 out of 20 IBD management domains, which included 71% in managing j-pouch disorders, 67% in managing the elderly/frail patient with IBD, 60% in managing extraintestinal manifestations, 57% in recommending preventative health services, and 54% in counseling patients on small molecules. Receiving >4 IBD didactic sessions per year was significantly associated with high confidence in managing j-pouch disorders (44.4% vs 13.3%, P = 0.05) and managing the elderly/frail patient with IBD (86.7% vs 50.0%, P = 0.03). Doing an external rotation to expand IBD knowledge was associated with high confidence in managing the elderly/frail patient with IBD (100% vs 26.7%, P = 0.01). CONCLUSION: Many GI fellows lacked confidence and training in key domains of IBD management. Enhancing IBD exposure with didactics and external rotations improved fellows' confidence in specific domains.

Association between vedolizumab and risk of clostridium difficile infection in patients with ulcerative colitis: A systematic review and meta-analysis.

BACKGROUND: The medical treatment of ulcerative colitis (UC) includes the use of biological agents such as vedolizumab, a gut-selective alpha4beta7 (ɑ4ß7) antagonist. The mechanism of action of vedolizumab involves interfering with leukocyte trafficking into the gut vasculature, which halts inflammation. Due to this mechanism of action, concerns have arisen regarding an increased risk of gut infections, specifically, clostridium difficile infection (CDI). The aim is to provide clarity regarding the association between the use of vedolizumab as a therapy for ulcerative colitis and the risk of developing CDI. METHODS: A systematic literature review was conducted, starting with the scoping search, followed by backward snowballing parallel with keyword-based search to identify related articles. A quality assessment was conducted on the initially selected articles and excluded low-quality papers. RESULTS: Pooled analyses indicated that there was no significant association between the use of vedolizumab and the risk of developing CDI (effect size = 0.03 [-0.02, 0.07]). CONCLUSIONS: Vedolizumab does not increase the risk of CDI in patients with UC. Further studies are needed to confirm these findings.

A Retrospective Observational Study of Patterns of Biologic Drug Change in Inflammatory Bowel Disease.

Introduction: Multiple therapies are currently available for inflammatory bowel disease (IBD); it is therefore crucial to understand patterns of drug change. This study aimed to examine the patterns of biological drug change and identify predictors of change in patients with IBD. Methods: We performed a retrospective study of patients diagnosed with IBD who were initiated on treatment with biologics between June 2017 and October 2022. The study's primary objective was to describe biologic drug change patterns. Secondary outcomes included identifying predictors of drug change. Results: 910 patients were screened; 475 patients were eligible, 319 (67%) had Crohn's disease (CD), and 253 (53.3%) were males. The most selected first and second choices of biologic were adalimumab (58.2% and 39.1%, p < 0.001) and infliximab (37.6% and 48.9%, p = 0.004) for both CD and ulcerative colitis (UC), respectively. On multiple regression analysis, a history of venous thromboembolism (VTE) (OR = 3.60, p = 0.025) and smoking (OR = 0.34, p = 0.026) were associated with drug change for all patients. When stratified by disease subtype, drug change was associated with a diagnosis made between age 17 and 40 years (OR = 0.46, p = 0.024) and extra-intestinal manifestations (OR = 2.07, p = 0.015) in CD while selecting vedolizumab as the first biologic (OR = 0.30, p = 0.041), male gender (OR = 2.40, p = 0.043), and history of VTE (OR = 7.32, p = 0.031) were associated with drug change in UC. Conclusions: Despite introducing several new biologics, anti-TNF therapies remain the preferred first and second choice of biologics for patients with IBD. Multiple predictors of drug change over time exist for both diseases. Selecting vedolizumab as the first biologic for UC is associated with a lower risk of drug change.

Gut microbiota in MAFLD: therapeutic and diagnostic implications.

Metabolic dysfunction-associated fatty liver disease (MAFLD), formerly known as nonalcoholic fatty liver disease, is becoming a significant contributor to chronic liver disease globally, surpassing other etiologies, such as viral hepatitis. Prevention and early treatment strategies to curb its growing prevalence are urgently required. Recent evidence suggests that targeting the gut microbiota may help treat and alleviate disease progression in patients with MAFLD. This review aims to explore the complex relationship between MAFLD and the gut microbiota in relation to disease pathogenesis. Additionally, it delves into the therapeutic strategies targeting the gut microbiota, such as diet, exercise, antibiotics, probiotics, synbiotics, glucagon-like peptide-1 receptor agonists, and fecal microbiota transplantation, and discusses novel biomarkers, such as microbiota-derived testing and liquid biopsy, for their diagnostic and staging potential. Overall, the review emphasizes the urgent need for preventive and therapeutic strategies to address the devastating consequences of MAFLD at both individual and societal levels and recognizes that further exploration of the gut microbiota may open avenues for managing MAFLD effectively in the future.

Selecting first-line advanced therapy for ulcerative colitis: A clinical application of personalized medicine.

Ulcerative colitis (UC) is a chronic autoimmune inflammatory disease that affects the colon, leading to symptoms of bloody diarrhea, abdominal cramps, and urgency. The treatment of UC has evolved over the past few decades from locally active anti-inflammatory compounds to more selective therapies that target specific arrays of the immune system. The challenge of selecting the first advanced therapy became apparent in this rapidly expanding landscape of medications. No current investigational tools, such as genetic, immunologic, or biological markers, can guide the identification of the safest and most effective therapeutic option for each patient. Hence, physicians must carefully assess patient/disease characteristics and match them with the most suitable drug through a clinically driven assessment. In this paper, we outline patient and drug characteristics that play a role in selecting first-line advanced therapies for UC and propose an algorithm for selection.

Decision-Utility Analysis of Empiric Treatment Versus Test and Treat Strategies for Helicobacter pylori in Patients With Duodenal Ulcer.

OBJECTIVES: The optimal strategy of Helicobacter pylori eradication in patients with duodenal ulcer is unclear. In this study, we aimed to compare the utility and the ulcer recurrence rate using the empiric treatment versus the test and treat strategies in patients with uncomplicated duodenal ulcer. METHODS: A decision-utility analysis was performed using a decision tree. The empiric treatment strategy was compared with the test and treat strategy. The probabilities of recurrent ulcers were determined and utilities of the 2 strategies were compared using the quality-adjusted life-year (QALY). Sensitivity analysis was performed to evaluate for model robustness. RESULTS: The probability of recurrent ulcer with the empiric strategy was 10.5%. The probabilities of recurrent ulcer with the test and treat strategy were 12.6%, 14.7%, 16.8%, and 17.9% based on 95%, 90%, 85%, and 80% sensitivity for histopathology, respectively. At the 95% estimate for the sensitivity of histopathology, the empiric strategy was associated with greater QALY compared with the test and treat strategy, 0.9875 versus 0.9853. The empiric treatment strategy was associated with greater QALY at extreme values for the estimates in our model. CONCLUSIONS: The empiric treatment strategy is associated with 2.1% to 7.4% lower recurrence rate for a range of test sensitivity between 95% and 80%, and results in greater QALY compared with the test and treat strategy.

Saudi consensus guidance for the management of inflammatory bowel disease during pregnancy.

ABSTRACT: The management of inflammatory bowel disease (IBD) in pregnant women is challenging and must be addressed on a patient-by-patient basis. Optimal patient management requires a multidisciplinary team and clear evidence-based recommendations that cater to this subset of patients. In this article, we provide concise guidelines and clinical care pathway for the management of IBD in pregnant women. Our recommendations were developed by a multidisciplinary working group that includes experts from the Saudi Ministry of Health in collaboration with the Saudi Gastroenterology Association and the Saudi Society of Clinical Pharmacology. All recommendations are based on up-to-date information following an extensive literature review. A total of 23 evidence-based expert opinion recommendations for the management of IBD in pregnant women are herein provided.

Transition Readiness Into Adult Health Care in Children With Inflammatory Bowel Disease.

Background and aim Approximately 25% of inflammatory bowel disease (IBD) cases are diagnosed before the age of 18 years. Compared to adults, pediatric IBD is more aggressive and progresses rapidly. It is important to have a well-structured transition process in place when patients are transferred from pediatric to adult care. We aimed to evaluate the readiness of Saudi adolescents with IBD to be transitioned from pediatric to adult care using the Transition Readiness Assessment Questionnaire (TRAQ). Materials and methods This cross-sectional study was carried out at King Abdulaziz University Hospital (KAUH), Jeddah, Saudi Arabia, between January and December 2021. Pediatric patients aged between 12-18 with confirmed IBD were recruited. The mean TRAQ component and the overall scores were calculated and analyzed. Results A total of 54 patients with IBD were included. The overall mean TRAQ scores were moderately high (3.60±0.78), including high mean values for individual domains of the TRAQ. In terms of components of TRAQ, no significant differences between males and females were encountered; however, there was a trend for males having higher scores than females in tracking health issues (P=0.07). Patients older than 15 years had higher overall scores than younger patients (P=0.04). The level of child education was found to be the only independent variable that correlated with higher overall scores (P=0.005). Conclusions In this cohort of Saudi adolescents with IBD, patients showed moderately high overall mean TRAQ scores reflecting high readiness for transitioning. While males demonstrated a trend for higher scores compared to females in tracking health issues, patients older than 15 had higher total scores relative to younger patients. More studies are needed to examine the impact of better transition readiness on the long-term outcome of IBD.

Treatment of Patients with Mild to Moderate Ulcerative Colitis: A Middle East Expert Consensus.

The prevalence of ulcerative colitis (UC) in the Middle East is increasing, impacting the economic and healthcare burden. The management of patients with mild to moderate UC is still a challenge as several factors can affect optimal care, including drug choice, induction and maintenance dose, treatment optimization and de-escalation, therapy duration, monitoring, and safety profile. We conducted an expert consensus to standardize the management of patients with mild to moderate UC. Sixteen experts in inflammatory bowel diseases, through a well-established and accepted Delphi methodology, voted and approved eight statements in order to provide practical guidance to clinicians in the Middle East.

Correlation between physician- and patient-directed disease assessments in ulcerative colitis patients from Saudi Arabia and Kuwait: Data from ICONIC.

Background: The aim of the observational, prospective study was to validate a novel, nonverbal assessment tool for perceived disease burden-Pictorial Representation of Illness and Self-Measure (PRISM)-in ulcerative colitis (UC) against established patient health questionnaires. The cumulative burden of patients recently diagnosed (<3 years) with UC was also evaluated. Methods: "ICONIC" - Understanding the impact of ulcerative colitis and its associated disease burden on patients - was a noninterventional, multicountry, multicenter study performed in a 2-year follow-up format in adult patients with recently diagnosed UC in 33 countries, regardless of disease severity or treatment. Data collection consisted of five visits, scheduled at approximately 6-month intervals. For the current analysis, patient data from Saudi Arabia and Kuwait were evaluated. The collected data comprised demographics, disease-related data, UC treatment, and healthcare resources, as well as physician- and patient-assessed quality-of-life and disease burden questionnaires. Correlations between selected questionnaire scores were performed using Spearman's rho. Results: Disease severity at baseline and throughout the study was slightly less favorable in this country analysis compared with the global study cohort. Disease burden was assessed by PRISM and improved within 24 months. Conclusions: The detected moderate correlation between PRISM and other assessment methods supports the validity of PRISM. Differences in perceptions of UC-related burden between physician and patient may reflect to some degree insufficient patient-physician communication.

Rare variant burden analysis from exomes of three consanguineous families reveals LILRB1 and PRSS3 as potential key proteins in inflammatory bowel disease pathogenesis.

Background: Inflammatory bowel disease (IBD) is a chronic autoimmune disorder characterized by severe inflammation and mucosal destruction of the intestine. The specific, complex molecular processes underlying IBD pathogenesis are not well understood. Therefore, this study is aimed at identifying and uncovering the role of key genetic factors in IBD. Method: The whole exome sequences (WESs) of three consanguineous Saudi families having many siblings with IBD were analyzed to discover the causal genetic defect. Then, we used a combination of artificial intelligence approaches, such as functional enrichment analysis using immune pathways and a set of computational functional validation tools for gene expression, immune cell expression analyses, phenotype aggregation, and the system biology of innate immunity, to highlight potential IBD genes that play an important role in its pathobiology. Results: Our findings have shown a causal group of extremely rare variants in the LILRB1 (Q53L, Y99N, W351G, D365A, and Q376H) and PRSS3 (F4L and V25I) genes in IBD-affected siblings. Findings from amino acids in conserved domains, tertiary-level structural deviations, and stability analysis have confirmed that these variants have a negative impact on structural features in the corresponding proteins. Intensive computational structural analysis shows that both genes have very high expression in the gastrointestinal tract and immune organs and are involved in a variety of innate immune system pathways. Since the innate immune system detects microbial infections, any defect in this system could lead to immune functional impairment contributing to IBD. Conclusion: The present study proposes a novel strategy for unraveling the complex genetic architecture of IBD by integrating WES data of familial cases, with computational analysis.

The prevalence and risk factors for hiatal hernia among patients undergoing endoscopy: A retrospective analysis.

OBJECTIVES: To determine the prevalence of hiatal hernia (HH) and its association with age, gender, and body mass index (BMI). METHODS: We retrospectively included patients who underwent esophagogastroduodenoscopy (EGD) at an academic tertiary care hospital. Data were collected on the presence of HH as well as patient demographics including age, gender, and BMI. Univariate and multivariate analysis were done to determine risk factors for HH. RESULTS: A total of 2805 patients were included in this study. The mean age was 48.6 (±18.6) years and males constituted 28.8% of the study population. The mean BMI was 29.7 (±8.6) kg/m². The prevalence of HH was 29.8% among all patients and 48.6% among those who underwent EGD for gastroesophageal reflux disease-related indications. There was no significant association between HH and female gender (OR 1.04, 95%CI: 0.88 -1.26, p=0.53), older age (OR 0.77, 95%CI: 0.72 - 1.06, p=0.19) or BMI (OR 1.07, 95%CI: 0.9 - 1.2, p=0.39). CONCLUSION: The prevalence of HH was 28.9% based on this large endoscopy-based population. We found no association between HH and gender, age, or BMI.

A Regional Survey of Awareness of Inflammatory Bowel Disease among the Saudi Population.

Introduction: Inflammatory bowel disease (IBD) is common worldwide, including the gulf region. Early diagnosis of IBD can improve patients' outcomes. However, early diagnosis is dependent on patients' awareness of the disease to seek medical advice. This study aimed to survey the awareness of IBD in the general population of the western region of Saudi Arabia. Methods: A questionnaire about Crohn's disease (CD) and ulcerative colitis (UC) was distributed to the general public. A score of 1 was given for the right response and 0 for an incorrect response, giving a maximum of 3 and a minimum of 0 for the three questions in the questionnaire. Results: 1,304 participants responded. Twenty nine percentage had not heard or read about CD, while 19% had not heard or read about UC. The mean awareness level score was 1.72 ± 1.19. Females showed a significantly higher score compared to males (p < 0.001). The age-group 31 to 40 had the highest score (p = 0.002). Moreover, responders who had a PhD. showed significantly higher scores than those with other educational degrees (p < 0.001). Responders who dealt with CD or UC patients showed significantly higher scores than their peers (p < 0.001) for both. Conclusion: The general population in Saudi Arabia has an unacceptable level of awareness of IBD. Females, young adults (age-group: 31-40 years), educated individuals (with a PhD), and those who had dealt with IBD patients previously had better awareness compared to the rest of the population. National acts are essential to improve public awareness toward the disease.

Inflammatory bowel disease in the elderly: A focus on disease characteristics and treatment patterns.

Background: As the population ages, the number of elderly inflammatory bowel disease (IBD) patients is expected to increase. The clinical features and therapeutic options for young and old patients may differ, as elderly IBD patients are likely to have different comorbidities and disease characteristics. The goal of this study was to examine the clinical aspects and therapeutic choices for elderly Saudi IBD patients. Methods: We conducted a retrospective study aimed at describing the demographic, clinical, and management characteristics of IBD in elderly patients (≥60 years) who followed up at King Abdulaziz University Hospital (KAUH), Jeddah, Saudi Arabia. The data was extracted from the KAUH inflammatory bowel disease information system (IBDIS) registry. The primary outcome was to describe disease characteristics in accordance with the Montréal classification and the secondary outcomes were to describe treatment patterns and identify significant clinical associations. Results: Our data were collected from 76 patients who fulfilled the study inclusion criteria. Females outnumbered males (53.9% vs 46.1%) and the mean age was 51.5 ± 9.7 years. Essential hypertension (26.3%) was the most common comorbidity followed by diabetes mellitus (23.6%), and malignant neoplasms (9.21%). More than half of the patients with Crohn's disease (CD) had disease onset after forty years of age. The most common form of disease distribution was ileocolonic disease (64.7%). Less than 17% of patients had a penetrating disease phenotype. About 88 percent of patients with UC presented >40 years of age. Approximately, half of the cohort had left-sided ulcerative colitis (UC) (48%), followed by pancolitis (40%). The most prescribed medication class for IBD was 5-aminosalicylic acid (5-ASA) derivatives (56.58%) followed by corticosteroids and immunosuppressive drugs. Conclusions: In Saudi Arabia, age-specific concerns including comorbidities and polypharmacy remain the major challenges in the management of elderly IBD patients.

Composition of the gut microbiota in patients with inflammatory bowel disease in Saudi Arabia: A pilot study.

Conclusions: The results of this study provide an overview of the variations in microbiota diversity present in Saudi IBD patients compared to healthy controls. Results: The key finding was three negative bacterial biomarkers, Paraprevotellaceae, the Muribaculaceae families of Bacteroidetes phylum, and the Leuconostocaceae family of Firmicutes phylum, which had a higher relative abundance in healthy individuals compared to IBD patients. It was also found that primary microbiota signatures at certain genera and species levels, including Prevotella copri, Bifidobacterium adolescentis, Ruminococcus callidus, Coprococcus sp., Ruminococcus gnavus, Dorea formicigenerans, Leuconostoc, Dialister, Catenibacterium, Eubacterium biforme, and Lactobacillus mucosae, were absent in almost all IBD patients, while Veillonella dispar was absent in all healthy individuals. Methods: After obtaining an informed consent, fecal samples were collected from 11 participants with IBD (patients) and 10 healthy individuals (controls). The bacterial components of the microbial population were identified by next-generation sequencing of partial 16S rRNA. Statistically significant dissimilarities were observed between samples for all metrics. Background: Inflammatory bowel disease (IBD) is a chronic intestinal inflammatory condition attributed to a complex interaction between imbalances in the gut microbiome, environmental conditions, and a deregulated immune response. The aim of the study was to investigate the composition of the gut microbiome of Saudi patients with IBD.

The use of therapeutic drug monitoring for early identification of vedolizumab response in Saudi Arabian patients with inflammatory bowel disease.

Vedolizumab is a humanized monoclonal antibody used to treat moderate-to-severe inflammatory bowel disease (IBD). The aim of the study was to assess the effectiveness of the induction of vedolizumab trough level in predicting short-term (week 14) clinical outcomes, and covariates that affect the response in Saudi Arabian patients. This prospective, real-life study included a total of 16 patients (4 Crohn's disease (CD) and 12 ulcerative colitis (UC)) with a confirmed diagnosis of IBD and generally naïve to receiving vedolizumab therapy. Using ELISA assay, vedolizumab induction trough and peak levels were measured at weeks 0, 2, and 6. The follow-up assessment was at week 14, where clinical outcomes were measured using the partial Mayo score for UC, and the CD activity score (CDAI), and Harvey Bradshaw index (HBI) for CD. At week 14, 9 patients (52.9%) out of 16 patients demonstrated response to therapy; clinical remission was reported in 5 patients (29.4%), and in 4 cases a clinical response was noted (23.5%). Clinical remission at week 14 was linked significantly with week 6 median vedolizumab levels in responders (25.1 µg/ml 95% CI: 16.5-42.9) compared to non-responders (7.7 µg/ml, 95% CI: 4.6-10.6) (P = 0.002). Receiver operator curve analysis at week 6 identified a cut-off > 8.00 µg/mL for short-term clinical remission. Also, at week 14, BMI significantly correlated with week 6 vedolizumab trough levels (P = 0.02). No other covariates correlated with drug levels at any time point examined. Week 6 early vedolizumab trough level measurements in IBD patients predicted short-term week 14 clinical remission.

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

BACKGROUND: Development of bowel preparation products has been based upon colon cleansing rating by a local endoscopist. It is unclear how bowel preparation scales perform when centrally evaluated. AIMS: To evaluate the reliability of bowel preparation quality scales when assessed by central readers. METHODS: Four central readers evaluated 52 videos in triplicate, 2 weeks apart, during the entire endoscopic procedure (insertion/withdrawal of the colonoscope) and exclusively on colonoscope withdrawal using the Boston Bowel Preparation Scale (BBPS), Chicago Bowel Preparation scale, Harefield Cleansing Scale, Ottawa Bowel Preparation Quality Scale (OBPQS), Aronchick score, a visual analogue scale, and additional items proposed in a modified Research and Development/University of California Los Angeles appropriateness process. Reliability was assessed with intraclass correlation coefficients. RESULTS: Intraclass correlation coefficients (95% confidence interval) for inter-rater reliability of the quality scales ranged from 0.51 to 0.65 (consistent with moderate to substantial inter-rater reliability) during the entire procedure. Corresponding intraclass correlation coefficients for intra-rater reliability ranged from 0.69 to 0.77 (consistent with substantial intra-rater reliability). Reliability was highest in the right colon and lowest in the left colon. No differences were observed in reliability when assessed for the procedure overall (insertion/withdrawal) relative to assessment on withdrawal alone. CONCLUSION: All five bowel preparation quality scales had moderate to substantial inter-rater reliability. Panelists considered the Aronchick score too simplistic for clinical trials and recognized that assessment of residual fluid in the Ottawa Bowel Preparation Quality Scale was not amenable to central assessment.

Long-Term Improvement in the Patient-Reported Outcomes of Rectal Bleeding, Stool Frequency, and Health-Related Quality of Life with Tofacitinib in the Ulcerative Colitis OCTAVE Clinical Program.

BACKGROUND: Tofacitinib is an oral small molecule Janus kinase inhibitor for the treatment of ulcerative colitis (UC). The tofacitinib OCTAVE clinical program included phase III induction (OCTAVE Induction 1 and 2) and maintenance (OCTAVE Sustain) studies, and an open-label, long-term extension study (OCTAVE Open). OBJECTIVE: This post hoc analysis assessed selected long-term, disease-specific patient-reported outcome (PRO) and health-related quality-of-life (HRQoL) measurements in patients with UC receiving tofacitinib in the OCTAVE clinical program. METHODS: Analyses included patients from OCTAVE Open assigned to tofacitinib 5 mg twice daily (subpopulation in remission at Week 52 of OCTAVE Sustain). OCTAVE Open data from the final analyses are shown to Month 48. Endpoints included rectal bleeding subscore (RBS) = 0, stool frequency subscore (SFS) ≤ 1, and HRQoL measure, Inflammatory Bowel Disease Questionnaire (IBDQ) remission (IBDQ total score ≥ 170); with non-responder imputation for missing data at all visits, and last observation carried forward for visits after a patient advanced to the next study (NRI-LOCF). Observed cases were also assessed. RESULTS: At Month 48, of 175 patients, 95 (54.3%) and 96 (54.9%) achieved/maintained RBS = 0 and SFS ≤ 1, respectively (NRI-LOCF). Additionally, 93 (53.1%) patients achieved/maintained IBDQ remission at Month 48 (NRI-LOCF). CONCLUSIONS: Among patients who entered OCTAVE Open in remission, most maintained normalization of rectal bleeding and improvement in stool frequency for ≤ 4 years of follow-up in OCTAVE Open. IBDQ remission was also generally maintained in OCTAVE Open. These data show robust maintenance of key UC PROs and durability of response with tofacitinib 5 mg twice daily. TRIAL REGISTRATION: http://www. CLINICALTRIALS: gov (NCT01465763 [21/10/2011]; NCT01458951 [21/10/2011]; NCT01458574 [21/10/2011]; NCT01470612 [21/10/2011]).

Inflammatory bowel disease and COVID-19 outcomes: a meta-analysis.

There is conflicting evidence concerning the effect of inflammatory bowel disease (IBD) on COVID-19 incidence and outcome. Hence, we aimed to evaluate the published evidence through a systematic review process and perform a meta-analysis to assess the association between IBD and COVID-19. A compressive literature search was performed in PubMed/Medline, Scopus, Embase, and Cochrane Library from inception to July 2021. A snowball search in Google, Google Scholar, Research Gate, and MedRxiv; and bibliographic research were also performed to identify any other relevant articles. Quantitative observational studies such as cohort, cross-sectional, and case-control studies that assessed the incidence, risk, and outcomes of COVID-19 among the adult IBD patients published in the English language, were considered for this review. The incidence and risk of COVID-19, COVID-19 hospitalization, the severity of COVID-19, and mortality were considered as the outcomes of interest. The Joanna Briggs Institute critical appraisal checklist was used for quality assessment. A subgroup and sensitivity analysis were performed to explore the heterogeneity and robustness of the results, respectively. A total of 86 studies out of 2828 non-duplicate records were considered for this meta-analysis. The studies were single or multicentric internationally from settings such as IBD centres, medical colleges, hospitals, or from the general public. Most of the studies were observed to be of good quality with an acceptable risk of bias. The pooled prevalence of COVID-19, COVID-19 hospitalization, severe COVID-19, and mortality in the IBD population were 6.10%, 10.63%, 40.43%, and 1.94%, respectively. IBD was not significantly (p > 0.05) associated with the risk of COVID-19, COVID-19 hospitalization, severe COVID-19, and mortality. In contrast, ulcerative colitis was significantly associated with a higher risk of COVID-19 (OR 1.37; p = 0.01), COVID-19 hospitalization (OR 1.28; p < 0.00001), and severe COVID-19 (OR 2.45; p < 0.0007). Crohn's disease was significantly associated with a lesser risk of severe COVID-19 (OR 0.48; p = 0.02). Type of IBD was a potential factor that might have contributed to the higher level of heterogeneity. There was a significant association between ulcerative colitis and increased risk of COVID-19, COVID-19 hospitalization, and severe COVID-19 infection. This association was not observed in patients with Crohns' disease or in those diagnosed non-specifically as IBD.