AbstractBackgroundRisk factors for intervention in terminal ileal (TI) stricturing Crohn's disease (CD) are poorly defined. Novel and rigorous definitions for TI strictures recently became available.ObjectiveWe aimed to describe the rates of symptoms or need for endoscopic balloon dilation (EBD) or surgery as well as risk factors of progression in a well‐defined stricturing CD cohort.MethodsConsecutive adult patients with non‐penetrating stricturing TI CD, as defined by centrally‐read magnetic resonance enterography CONSTRICT criteria, were separated into a derivation and validation cohort. Clinical and imaging characteristics were collected following prespecified scoring conventions. Primary outcome was a composite endpoint of EBD or surgery (“intervention”). Multivariable analysis was performed.ResultsEighty‐six patients (48.8% female, median age 36 years) met selection criteria, 17.4% had prior EBD, 59.3% previously received biologics and 58.1% of strictures were anastomotic. Median follow‐up was 63.4 [95% CI: 57, 68.9] months. In the derivation cohort, at 12 and 48 months, 26% and 45% of patients had intervention, respectively. Multivariable analysis showed obstructive symptoms (Hazard ratio [HR] 1.444; 95% CI 1.126–1.852), stricture duration (HR 0.974; 95% CI, 0.954–0.995) and length (HR 1.039; 95% CI, 1.011–1.069) predicted intervention. The concordance index for split‐sample validation was 0.74 and 0.67, respectively. Biologics were not associated with intervention. An online risk calculator was constructed.ConclusionIn patients with TI stricturing CD, 26% and 45% required intervention at 1 and 4 years. Obstructive symptoms, stricture duration and length were independent and validated predictors of the need for intervention. These findings are important for clinical practice and aid in the design of future trials for CD strictures.
The impact of body mass index on efficacy and safety in the tofacitinib OCTAVE ulcerative colitis clinical programme
SummaryBackgroundObesity may affect efficacy and safety of biologic treatments for ulcerative colitis (UC). Tofacitinib is an oral, small molecule Janus kinase inhibitor for the treatment of UC.AimsTo assess efficacy and safety of tofacitinib in patients with UC, by baseline body mass index (BMI).MethodsThis post hoc analysis evaluated patients with UC receiving placebo or tofacitinib from the 8‐week OCTAVE Induction 1 and 2 (NCT01465763, NCT01458951) and 52‐week OCTAVE Sustain (NCT01458574) studies. Patients were stratified by BMI at OCTAVE Induction 1 and 2 baseline (<25, 25 to <30 and ≥30 kg/m2). Outcomes included remission, endoscopic improvement, clinical response, sustained steroid‐free remission, Inflammatory Bowel Disease Questionnaire total score and Short Form‐36 Health Survey scores. Adverse events were evaluated.ResultsAt Week 8 of OCTAVE Induction 1 and 2, and Week 52 of OCTAVE Sustain, higher proportions of patients receiving tofacitinib 5 or 10 mg twice daily (b.d.) achieved clinical response vs placebo, regardless of baseline BMI subgroup (all P < 0.05). Proportions of patients achieving efficacy endpoints were generally similar across BMI subgroups; in univariate and multivariate regression analyses, BMI was not a significant predictor (all P ≥ 0.05; univariate BMI [continuous] odds ratio for remission: 0.98 [95% confidence interval 0.95, 1.02]). There was no consistent trend between BMI and adverse events. Among patients receiving tofacitinib 10 mg b.d. in OCTAVE Induction 1 and 2, serious infections were numerically greater in the BMI ≥30 subgroup (3.2%) vs other subgroups (0.4%). Limitations included small patient numbers in the BMI ≥30 subgroup.ConclusionsEfficacy and safety of tofacitinib were similar in patients with UC regardless of baseline BMI.
Managing infliximab infusions after a drug holiday
Abstract Background Inflammatory bowel disease (IBD) is associated with a reduced quality of life. Minority patients with IBD specifically report more impairing symptoms compared with nonminority patients. Sleep quality, a key component of quality of life, is significantly compromised in minority patients compared with nonminority patients. Nevertheless, subjective and objective sleep assessments in minority patients with IBD have not explicitly been assessed. The purpose of this prospective cohort study is to assess and compare objective sleep parameters utilizing wrist actigraphy between minority and nonminority IBD patients. Methods In this institutional review board approved study, 74 patients with IBD were recruited and stratified into 2 cohorts by self-identification: white nonminority patients and minority patients. Patients in the minority cohort included black and Hispanic individuals (black and nonblack). Exclusion criteria included significant comorbidity, a history of an underlying sleep disorder, or patients who did not self-identify into categorized cohorts. Sleep was measured not only through wrist-based actigraphy but also with sleep surveys. Sleep parameters were compared between minority and nonminority cohorts. Regression analyses were performed to assess for factors independently associated with parameters of poor sleep quality. Results Sixty-four patients (86.4%) were included in the final analysis. Thirty-one individuals (48.4%) were categorized into the nonminority cohort, and 33 (51.6%) patients were in the minority cohort. A significantly higher number of minority patients had poorer sleep efficiency and fragmented sleep compared with nonminority patients (90.9% vs 67.7%; P = 0.03 and 87.8% vs 61.3%; P = 0.02). In the adjusted analysis, minority status was independently associated with poor sleep efficiency (odds ratio = 6.41; 95% confidence interval, 1.48-28.17; P = 0.0139) and fragmented sleep (odds ratio = 4.98; 95% confidence interval, 1.09-22.89; P = 0.0389). Conclusions Minority patients with IBD were shown to have poorer objective measures of sleep as assessed through wrist actigraphy compared to nonminority patients. Cultural competency in the care of minority patients with IBD, specifically focusing on the management of psychosocial issues, is needed to address these disparities in sleep. The inclusion of minority patients with IBD in studies investigating sleep and other psychosocial issues are warranted not only to assess potential disparities in disease course but also to determine the etiologies of poor sleep in minority patients with IBD.
Process and Clinical Outcomes of a Biosimilar Adoption Program with Infliximab-Dyyb
INTRODUCTION: Inflammatory Bowel Disease (IBD) is associated with a reduced quality of life, including a high incidence of poor sleep. Minority patients with IBD describe poorer subjective symptoms of disease. Minority patients are more likely to report poorer sleep quality compared to Caucasian patients. There are limited data on the assessment of sleep in minority patients with IBD. In this prospective cohort study, we aim to compare objective sleep parameters assessed by wrist actigraphy in minority IBD patients compared to Caucasian IBD patients. METHODS: 73 patients with a diagnosis of IBD were recruited to take part in this IRB approved study. Subjects were stratified into two cohorts by self-identification: minority subjects (Blacks and Non-Black Hispanic subjects) and Caucasian, non-minority individuals. Subjects were excluded based on significant co-morbidity, a history of a sleep disorder, or demographics which did not fit into categorized cohorts. Subjects completed sleep surveys and were provided with an accelerometer that estimated sleep patterns. Comparisons of actigraphic parameters were performed between minority and non-minority cohorts. Regression analyses were performed to determine whether minority status was independently associated with poorer sleep parameters assessed by actigraphy. Predictors that were found to be different by < 0.1 between cohorts were included in the models. RESULTS: Of the recruited subjects, 64 subjects completed 3 days of actigraphy data. 33 subjects were minority patients and 31 individuals were non-minority patients. The demographics of the cohorts are provided in Table 1. Table 2 details the univariate analyses. A higher proportion of minority patients had poorer sleep efficiency (SE) and fragmented sleep compared to Caucasian patients (90.9% vs. 67.7%, P = 0.03 and 87.8% vs. 61.3%, P = 0.02). Minority status was independently associated with both poor SE (OR: 6.41 CI: 1.48-28.17, P = 0.0139) and fragmented sleep (OR: 4.98, CI: 1.09-22.89, P = 0.0389), (Tables 3.0A and 3.0B). CONCLUSION: In our study minority subjects were found to have poorer objective measures of sleep assessed by actigraphy compared to non-minority subjects. Culturally relevant care addressing psychosocial issues, including sleep are important in the care of minority patients with IBD. Further studies investigating the role of sleep in diverse populations with IBD are warranted to determine the etiologies of poor sleep in these patients.
Pericardial Manifestations in Inflammatory Bowel Disease: A Report of Two Cases
Abstract Pericardial involvement in the setting of inflammatory bowel disease can occur not only as an adverse event related to medical therapy but also as an extraintestinal manifestation of the disease itself. In the following case series, we describe 2 cases of pericarditis in patients diagnosed with Crohn disease. Our first case reviews the clinical presentation of acute pericarditis as an adverse event associated with anti-tumor necrosis factor therapy. In contrast, our second patient is a case of acute pericarditis as a precursor of the clinical recurrence of Crohn disease following operative resection. Pericardial disease should be considered in the differential diagnosis of acute and subacute presentations of chest discomfort and shortness of breath in patients with inflammatory bowel disease.