Comparing the efficacy of vedolizumab between males and females: a post-hoc analysis of GEMINI-1 and VARSITY.

Vedolizumab is a first-line treatment option for ulcerative colitis. There are differences in incidence of ulcerative colitis between males and females, but whether sex affects treatment outcomes is less clear. We examined sex-based differences in patients with ulcerative colitis initiated on vedolizumab from two major randomized controlled trials (RCTs). We conducted a post-hoc analysis on participants with ulcerative colitis from the VARSITY and GEMINI-1 RCTs who received vedolizumab. Outcomes of interest were rates of clinical improvement, clinical remission, and endoscopic improvement at weeks 6, 14, and 52 in male and female participants, as were differences in concentrations of trough vedolizumab and C-reactive protein; 1009 persons in GEMINI-1 and VARSITY trials were included. Male and female patients had similar disease characteristics aside from males being more likely to have Mayo 3 grade endoscopic severity at baseline (62.8 vs. 48.9%, P  < 0.001). At week 6, females were more likely to have endoscopic improvement (47.4 vs. 35.2%, P  = 0.001) and increased vedolizumab trough levels [34.0 (23.0-44.5) vs. 28.9 (19.0-34.6), P  < 0.001]. The probability of achieving clinical remission (28.9 vs. 34.5%, P  = 0.057) or endoscopic improvement (35.5 vs. 39.3%, P  = 0.212) at week 52 was not different between males and females. Females with ulcerative colitis treated with vedolizumab appear more likely to achieve early endoscopic improvement than males, though longer-term outcomes demonstrated no difference. Further studies are required to better understand mechanisms through which sex or sex-associated factors could influence response to therapy in ulcerative colitis.

Significant Racial and Ethnic Disparities Exist in Health Care Utilization in Inflammatory Bowel Disease: A Systematic Review and Meta-analysis.

BACKGROUND: The incidence of inflammatory bowel disease (IBD) is rising worldwide, though the differences in health care utilization among different races and ethnicities remains uncertain. We aimed to better define this through a systematic review and meta-analysis. METHODS: We explored the impact of race or ethnicity on the likelihood of needing an IBD-related surgery, hospitalization, and emergency department visit. Pooled odds ratios (ORs) with 95% confidence intervals (CIs) were calculated with I2 values reporting heterogeneity. Differences in IBD phenotype and treatment between racial and ethnic groups of IBD were reported. RESULTS: Fifty-eight studies were included. Compared with White patients, Black patients were less likely to undergo a Crohn's disease (CD; OR, 0.69; 95% CI, 0.50-0.95; I2 = 68.0%) or ulcerative colitis (OR, 0.58; 95% CI, 0.40-0.83; I2 = 85.0%) surgery, more likely to have an IBD-hospitalization (OR, 1.54; 95% CI, 1.06-2.24; I2 = 77.0%), and more likely to visit the emergency department (OR, 1.74; 95% CI, 1.32-2.30; I2 = 0%). There were no significant differences in disease behavior or biologic exposure between Black and White patients. Hispanic patients were less likely to undergo a CD surgery (OR, 0.57; 95% CI, 0.48-0.68; I2 = 0%) but more likely to be hospitalized (OR, 1.38; 95% CI, 1.01-1.88; I2 = 37.0%) compared with White patients. There were no differences in health care utilization between White and Asian or South Asian patients with IBD. CONCLUSIONS: There remain significant differences in health care utilization among races and ethnicities in IBD. Future research is required to determine factors behind these differences to achieve equitable care for persons living with IBD.

Frequency of Opioid Prescription at Emergency Department Discharge in Patients with Inflammatory Bowel Disease: A Nationwide Analysis.

BACKGROUND & AIMS: Patients with inflammatory bowel disease (IBD) frequently experience chronic pain. Patients will often seek out care in the emergency department (ED) where short-term opioid use may be associated with potential treatment-related complications. We aimed to assess the rate and factors associated with opioid prescription in IBD patients discharged from the ED. METHODS: We conducted a cross-sectional analysis of data collected in the US National Hospital Ambulatory Medical Care Survey (NHAMCS) from 2006-2017. We determined the proportion of adult patients (≥18 years) with IBD prescribed an opioid in ED or at ED discharge. Logistic regression was used to evaluate predictors of opioid prescription. Time-trend analysis was performed to evaluate temporal patterns in opioid use. All analyses were adjusted for complex survey design. RESULTS: We identified ∼965,000 weighted discharges from the ED for patients with IBD. In total, 51.9% [95% CI: 42.2% -61.6%] of visits resulted in opioid administration in ED and 35.3% [95% CI: 26.5% -45.2%] of IBD-related ED discharges were associated with an opioid prescription. IBD patients with moderate/severe pain (adjusted odds ratio aOR 5.06 [95% CI: 1.72 -14.90], p < 0.01) were more likely to receive opioids whereas older age (aOR 0.73 per decade [95% CI: 0.55 -0.98], p = 0.04) were less likely. In temporal analysis, a trend towards decreasing opioid use in ED and opioid prescriptions at discharge was observed in 2015-2017. CONCLUSIONS: More than one third of IBD patients are prescribed an opioid at discharge from ED, highlighting a potential gap in care for accessing effective pain management solutions in this population.

Is there room for immunomodulators in ulcerative colitis?

Introduction: The management of patients with ulcerative colitis (UC) has evolved over the past few decades. While aminosalicylates remain the mainstay of induction and maintenance therapy in patients with mild-to-moderate UC, the advent of biologic agents and novel oral small molecules has substantively changed the treatment landscape for patients with moderate-to-severe disease and confounded the role of traditional immunomodulators (IMMs) such as thiopurines and methotrexate in the UC management algorithm.Areas covered: We summarize the mechanism of action of thiopurines and methotrexate, identify clinical parameters for their use, and appraise the evidence supporting the efficacy and safety of IMMs in UC as both monotherapy and in combination with other therapies, emphasizing on prospective, controlled data.Expert opinion: With the advent of several classes of highly effective treatments for UC, emergence of data demonstrating no benefit of IMMs over placebo, and concerns about the relative safety profile of long-term IMM exposure, we propose that the role of thiopurines or methotrexate be restricted to patients with milder disease failing to maintain corticosteroid-free remission on aminosalicylates alone or in combination therapy with tumor necrosis factor antagonists in patients with moderate-to-severe UC.

Health Care Indicators of Moderate to Severe IBD and Subsequent IBD-Related Disability: A Longitudinal Study.

BACKGROUND: We aimed to determine how health care utilization indicators in IBD that reflect moderate to severe disease relate to disability later in life. METHODS: Persons in the population-based University of Manitoba IBD Research Registry completed a survey and gave permission to access their Manitoba Health records. Of 2478 people in the Registry aged 18 to 65 years, 854 participated between April 2015 and March 2016. The survey included the IBD Disability Index (IBDDI). The health data included surgeries and hospitalizations since 1984 and prescriptions since 1995. We explored the association between indicators of moderate to severe disease (ie, surgeries, hospitalization, and new corticosteroids and anti-tumor necrosis factor [anti-TNF] prescriptions) and high IBD-related disability (IBDDI ≥35). In addition, among those who had at least 1 IBD-related surgery, we determined predictors of low or no postsurgery disability (IBDDI <21). RESULTS: Eighty-five percent required at least 1 IBD-related surgery since diagnosis or had >2 hospitalizations or were ever prescribed corticosteroids or anti-TNF. Surgery was more common in Crohn's disease (55%) than in UC (13%, P < 0.001). High disability was more prevalent among those ever prescribed anti-TNF (49%) vs never prescribed (28%, P < 0.001), those ever prescribed corticosteroids (35%) vs never prescribed (26%, P = 0.02), and those who had had 1 IBD-related surgery (36%) or >1 surgery (53%) vs those who had had none (28%, P < 0.001). CONCLUSIONS: Health care utilization indicators of moderate to severe disease (ie, surgeries, hospitalizations, corticosteroid or anti-TNF use) were associated with subsequent higher IBD-related disability. Persons experiencing those indicators should be followed more closely for social, mental, and physical consequences of IBD-related disability. Previous health care utilization can serve as a proxy for IBD-related disability.

Association Between IBD Disability and Reduced Work Productivity (Presenteeism): A Population-Based Study in Manitoba, Canada.

Background: One effect of IBD disability is reduced productivity when at work (presenteeism). We explored potential predictors of work presenteeism and compared the predictive ability of the recently developed IBD Disability Index (IBDDI) with 4 other scales in predicting presenteeism. Methods: Participants (aged 18-65 years) were recruited from the University of Manitoba IBD Research Registry. We calculated a presenteeism score (range, 0-24) from the Stanford Presenteeism Scale (SPS), with higher scores representing greater degrees of presenteeism. Using receiver operating characteristic curves and linear regression, we explored associations between presenteeism and the IBDDI, the World Health Organization Disability Assessment Schedule (WHODAS 2.0), the Work and Social Adjustment Scale (WSAS), the Inflammatory Bowel Disease Questionnaire (IBDQ), and the Kessler-6 (K6) distress scale. Results: Out of 744 respondents working at least half-time (20+ hours/wk), 472 (63%) reported no reduced productivity in the previous 14 days. Reduced productivity was reported for 1-2 days by 131 (18%), for 3-9 days by 119 (16%), and on most days by 22 (3%). When predicting the SPS, similar model fits were found for the IBDDI, WHODAS, WSAS, IBDQ, and K6. Each increase of 10 on the IBDDI score was associated with an increase of 2.19 (95% confidence interval, 2.00-2.37) on the SPS. Each additional year of disease duration was associated with a reduction in SPS score of 0.08 (P < 0.01). Conclusions: More than one-third of persons with IBD report presenteeism. We found strong associations between presenteeism and disability, lower quality of life, and emotional distress. The IBDDI performs equally as well as the more established scales in predicting presenteeism.

Health Care Services in IBD: Factors Associated with Service Utilization and Preferences for Service Options for Routine and Urgent Care.

BACKGROUND: We aimed to explore factors associated with health service utilization and preference for services, including alternatives to attending the emergency department (ED) when experiencing mild to moderate or severe symptoms. METHODS: A total of 1143 persons (46% response rate) aged 18 to 65 years in the population-based University of Manitoba IBD Research Registry participated in the survey. RESULTS: Although 61% had a gastroenterologist, when experiencing active symptoms, only 29% felt they could call their gastroenterologist for an urgent appointment, and 42% could call their gastroenterologist for telephone advice. Nine percent of the respondents visited the ED in the previous year. If having severe symptoms, 48% said that they would attend the ED. Visits to the ED were related to higher bowel symptom severity and high health anxiety. When experiencing severe symptoms, women, persons with Crohn's disease and those with high health anxiety, indicated that they would be more likely to use the ED. Considering services which could be available in the future respondents indicated that if acutely symptomatic they would be very likely or likely to use the following services: phone contact with inflammatory bowel disease nurse (77%), phone contact with a gastroenterologist (75%), and going to a walk-in gastroenterology clinic (71%). CONCLUSIONS: Persons with inflammatory bowel disease are receptive to options other than the ED when experiencing inflammatory bowel disease symptoms; however, attending the ED remains a prominent choice. Improved access to specialized care may improve timeliness of care and reduce ED attendance. Future research should include the impact of health anxiety on health care utilization.

Workplace Accommodation for Persons With IBD: What Is Needed and What Is Accessed.

BACKGROUND & AIMS: People with inflammatory bowel disease (IBD) often experience periods of illness that interfere with their ability to work. We aimed to understand the need for workplace accommodation during periods of acute illness among persons IBD. METHODS: Participants were recruited from the population-based University of Manitoba Research Registry and received a survey including questions assessing experiences with workplace accommodations. Data were analyzed using descriptive statistics and multivariate logistic regression modelling. RESULTS: A total of 1143 individuals responded to the survey (46% response rate), of whom 881 had experienced IBD symptoms in the workplace and were included in the analysis. The mean age was 48.3 years (standard deviation, 10.9); 61% were female. Mean IBD duration was 20.6 years (standard deviation, 10.5). Most respondents (73%) described IBD symptoms experienced in the workplace as severe to very severe. The most commonly required accommodations were time to go to medical appointments during working hours (81%), easy access to a toilet (71%), and a chance to take a break when not feeling well (54%). Most accommodations were arranged informally or through a supervisor. The accommodations required were very or somewhat easy to arrange about half the time. Being female, having high symptom severity, and high level of current distress were associated with a need for more accommodations, difficulty implementing accommodations, and not asking for needed accommodations. CONCLUSIONS: This study provides important information as to the types of accommodations that are necessary, common practices arranging for these, and level of difficulty arranging accommodations. Furthermore, characteristics associated with greater need for accommodation, reluctance to ask for them, and difficulty in arranging them were identified.