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The Inflammatory bowel disease (IBD) Disability Index is a validated tool that evaluates functional status; however, it is used mainly in the clinical trial setting. We describe the use of an iterative Delphi consensus process to develop the IBD Disk—a shortened, self-administered adaption of the validated IBD Disability Index—to give immediate visual representation of patient-reported IBD-related disability.MethodsIn the preparatory phase, the IBD CONNECT group (30 health care professionals) ranked IBD Disability Index items in the perceived order of importance. The Steering Committee then selected 10 items from the IBD Disability Index to take forward for inclusion in the IBD Disk. In the consensus phase, the items were refined and agreed by the IBD Disk Working Group (14 gastroenterologists) using an online iterative Delphi consensus process. Members could also suggest new element(s) or recommend changes to included elements. The final items for the IBD Disk were agreed in February 2016.ResultsAfter 4 rounds of voting, the following 10 items were agreed for inclusion in the IBD Disk: abdominal pain, body image, education and work, emotions, energy, interpersonal interactions, joint pain, regulating defecation, sexual functions, and sleep. All elements, except sexual functions, were included in the validated IBD Disability Index.ConclusionsThe IBD Disk has the potential to be a valuable tool for use at a clinical visit. It can facilitate assessment of inflammatory bowel disease-related disability relevant to both patients and physicians, discussion on specific disability-related issues, and tracking changes in disease burden over time.

Abstract Background Active inflammatory bowel disease increases the risk of adverse pregnancy outcomes. Tofacitinib is an oral, small molecule Janus kinase inhibitor for the treatment of ulcerative colitis (UC). As a small molecule, tofacitinib is likely to cross the placental barrier; however, information on the effects of tofacitinib on pregnancy outcomes is limited. We report pregnancy and newborn outcomes among patients in UC clinical studies with prenatal (maternal/paternal) exposure to tofacitinib. Methods Pregnancies with maternal/paternal exposure to tofacitinib were identified and outcomes reported in 5 tofacitinib UC interventional studies (up to March 2017). Outcomes from tofacitinib rheumatoid arthritis (RA), psoriasis, and psoriatic arthritis interventional studies, and RA noninterventional postapproval safety studies, spontaneous adverse event reporting, and registry data are also reported. Results Of 1157 patients enrolled in the UC interventional studies, 301 were women of childbearing age. Eleven cases of maternal exposure and 14 cases of paternal exposure to tofacitinib (doses of 5 mg or 10 mg twice daily) before/at the time of conception or during pregnancy were identified. Outcomes included 15 healthy newborns, no fetal deaths, no neonatal deaths, no congenital malformations, 2 spontaneous abortions, and 2 medical terminations. Outcomes across other tofacitinib studies and postmarketing cases were consistent, with a healthy newborn being the most common outcome and no fetal deaths. Conclusions Based on the limited data available, pregnancy and newborn outcomes among patients with prenatal (maternal/paternal) exposure to tofacitinib in UC studies appear similar to those reported for other tofacitinib clinical study populations and the general population.

Abstract Background The purpose of this study was to compare the long-term safety of infliximab and nonbiologic agents as Crohn's disease (CD) therapy. Methods Patients with CD were prospectively evaluated in this large, observational registry. Results Patients (n = 6273) participated in this observational registry from July 1999 through March 2012; 3440 (54.8%) received infliximab (20,971 patient-years), and 2833 (45.2%) received other treatments only (14,806 patient-years). Overall, 59,875 infliximab infusions were administered (80%, 5 mg/kg); 3006 (89.9%) patients received ≥2 infusions. Adverse events (AEs), most commonly those related to CD (eg, abdominal pain, diarrhea), and serious AEs occurred at a higher rate among infliximab-treated patients. Mortality (0.57/100 patient-years, 0.67/100 patient-years) and malignancy rates (0.69/100 patient-years, 0.71/100 patient-years) for infliximab-treated and other-treatments-only patients, respectively, were generally similar. Serious infection rates were higher for infliximab-treated (2.15/100 patient-years) than other-treatments-only patients (0.86/100 patient-years). Infliximab dose was not associated with mortality or serious infection. An increased risk of serious infection was observed with age (>52 years vs ≤30 years) when examined in infliximab-treated patients. Nonserious cerebrovascular accidents (13 events, 0.06/100 patient-years; 5 events, 0.03/100 patient-years) and pulmonary embolisms (11 events, 0.05/100 patient-years; 4 events 0.03/100 patient-years) also occurred at higher rates among infliximab-treated patients than other-treatments-only patients. Conclusions Through more than 13 years of registry experience and an overall median duration of patient follow-up >6 years, mortality was similar between the infliximab-treated and other-treatments-only groups. These final cumulative results are representative of real-world experience among infliximab-treated patients with CD and are consistent with the known risks of disease activity and tumor necrosis factor antagonist therapy.

Abstract Background We evaluated the validity and reliability of multiple symptom scales for depression and anxiety for persons with inflammatory bowel disease (IBD). Methods IBD participants in a cohort study completed a Structured Clinical Interview for DSM-IV-TR Axis I Disorders (SCID) and completed the Patient Health Questionnaire (PHQ-9), Hospital Anxiety and Depression Scale (HADS), Kessler-6 Distress Scale, PROMIS Emotional Distress Depression Short-Form 8a (PROMIS Depression) and Anxiety Short-Form 8a (PROMIS Anxiety), Generalized Anxiety Disorder 7-item Scale, and Overall Anxiety and Severity Impairment Scale. We computed sensitivity, specificity, and positive and negative predictive values for the screening measures with the SCID diagnoses as the reference standard, conducted receiver operating curve (ROC) analysis, and assessed internal consistency and test-retest reliability. Results Of 242 participants, the SCID classified 8.7% as having major depression and 17.8% as having anxiety disorders. Among the depression scales, the PHQ-9 had the highest sensitivity (95%). Specificity was generally higher than sensitivity and was highest for the HADS-D (cut-point of 11; 97%). The area under the ROC curve (AUC) did not differ significantly among depression scales. Among the anxiety scales, sensitivity was highest for the PROMIS (79%). Specificity ranged from 82% to 88% for all tools except the HADS-A (cut-point of 8; 65%). The AUC did not differ between depression and anxiety tools. Conclusions Overall, the symptom scales for depression and anxiety were similar in their psychometric properties. The anxiety scales did not perform as well as the depression scales. Alternate cut-points may be more relevant when these scales are used in an IBD sample.

We analyzed in-office communication between patients with ulcerative colitis (UC) and their gastroenterologists.MethodsParticipating gastroenterologists (United States N = 15; Europe N = 8) identified eligible patients with scheduled clinic visits. Patients (United States N = 40; Europe N = 28; ≥18 yr old; physician-defined moderately-to-severely active ulcerative colitis for approximately ≥1 yr; ≥1 flare in preceding year; prior or current therapy with 5-aminosalicylates and/or corticosteroids) consented to have their visit recorded. Follow-up interviews were conducted separately with gastroenterologists and patients. Transcripts were analyzed using sociolinguistic methods to explore quality of life (QoL) impacts, treatment goals, and attitudes to therapies.ResultsIn the European and U.S. research, the trend was for patients not to discuss ulcerative colitis QoL impacts during their visits. In the U.S. research, complete patient–physician alignment on QoL impacts (patient and physician stating the same impacts) was seen in 40% of cases. Variation in treatment goals was seen between gastroenterologists and patients: 3% of U.S. patients described absence of inflammation as a treatment goal versus 25% of gastroenterologists. This goal was not always conveyed to the patient during visits. Consistent with guidelines, physicians generally framed biologic therapy as suitable for patients refractory to conventional therapies. However, although putative efficacy offered by biologic therapy is generally aligned with patients' stated treatment goals, many considered biologic therapy as more appropriate for more severe disease than theirs.ConclusionsAlignment between patients and physicians on ulcerative colitis QoL impact, treatment goals, and requirement of advanced therapies is poor. New tools are needed to cover this gap.

Abstract Background Opioids are commonly prescribed for relief in inflammatory bowel disease (IBD). Emerging evidence suggests that adolescents and young adults are a vulnerable population at particular risk of becoming chronic opioid users and experiencing adverse effects. Objectives This study evaluates trends in the prevalence and persistence of chronic opioid therapy in adolescents and young adults with IBD in the United States. Method A longitudinal retrospective cohort analysis was conducted with the Truven MarketScan Database from 2007 to 2015. Study subjects were 15-29 years old with ≥2 IBD diagnoses (Crohn's: 555/K50; ulcerative colitis: 556/K51). Opioid therapy was identified with prescription claims within the Truven therapeutic class 60: opioid agonists. Persistence of opioid use was evaluated by survival analysis for patients who remained in the database for at least 3 years following index chronic opioid therapy use. Results In a cohort containing 93,668 patients, 18.2% received chronic opioid therapy. The annual prevalence of chronic opioid therapy increased from 9.3% in 2007 to 10.8% in 2015 (P < 0.01), peaking at 12.2% in 2011. Opioid prescriptions per patient per year were stable (approximately 5). Post hoc Poisson regression analyses demonstrated that the number of opioid pills dispensed per year increased with age and was higher among males. Among the 2503 patients receiving chronic opioid therapy and followed longitudinally, 30.5% were maintained on chronic opioid therapy for 2 years, and 5.3% for all 4 years. Conclusion Sustained chronic opioid use in adolescents and young adults with IBD is increasingly common, underscoring the need for screening and intervention for this vulnerable population.

Abstract Background Inflammatory bowel disease (IBD) is associated with poor quality of life and disability. The short inflammatory bowel disease questionnaire (SIBDQ) is validated to determine patients quality of life at single time points, or improvement over time. Few studies have evaluated if sustained poor quality of life is associated with future healthcare utilization patterns. Methods We analyzed patients from a prospective IBD natural history registry with 4 consecutive years of follow-up. SIBDQ was measured at outpatient visits. Healthcare utilization data were temporally organized into a 2-year observation period, and 2-year follow-up period. Mean SIBDQ score <50 during the first 2 years was categorized as having \"poor quality of life\". Primary outcomes of interest were measures of unplanned healthcare utilization and opioid use. Results From a total of 447 participants (56.1% female, 66.1% Crohn's disease, 34.9% ulcerative colitis), 215 (48.1%) were classified as having poor quality of life. Poor quality of life was significantly associated with Crohn's disease (P < 0.01), history of IBD related surgery, and tobacco use (all P < 0.01). In the follow-up period, the same patients with poor quality of life were more likely to have abnormal biomarkers of inflammation, more telephone calls and office visits, experience unplanned care, and be exposed to opiates (all P < 0.05). After multivariable analysis, poor quality of life remained an independent predictor of future opiate use (odds ratio: 2.2, P = 0.003) and decreased time to first opiate prescription (hazard ratio: 1.67, P = 0.019) in the follow-up period. Conclusions IBD patients with sustained poor quality of life are at an increased risk of opiate use and decreased time to opiate exposure. Routine measurement of quality of life in the outpatient setting may provide insight into those at risk for narcotic use and healthcare utilization. 10.1093/ibd/izy040_video1 izy040.video2 5791709872001

Abstract Background Progressive multifocal leukoencephalopathy is a serious condition linked to certain diseases and immunosuppressant therapies, including the α4 integrin antagonist natalizumab. No cases have been reported to date with vedolizumab, a selective antagonist of the α4β7 integrin expressed on gut-homing lymphocytes. This analysis aimed to describe the current and future expected occurrence of progressive multifocal leukoencephalopathy with vedolizumab use, were the risk the same as in other populations in which this disease has been studied. Methods The expected number of vedolizumab-associated progressive multifocal leukoencephalopathy cases was estimated up to May 19, 2016, and modeled up to 2034. These estimates were based on the cumulative exposure to the drug, assuming an equivalent risk to that of patients treated with natalizumab or those from other reference populations where progressive multifocal leukoencephalopathy has been examined. Future cases were modeled based on similar risks and projected sales. Results The cumulative vedolizumab exposure was estimated at 54,619 patient-years, with a 95% confidence interval of 0.0 to 6.75 cases per 100,000 patient-years. An estimated 30.2 (95% confidence interval, 19.4-40.9) cases of progressive multifocal leukoencephalopathy would have occurred if vedolizumab had the same risk as that of natalizumab. There would be a 50% chance of the first case occurring by 2018, assuming an equivalent risk to the general population. Conclusions These analyses indicate that the risk of progressive multifocal leukoencephalopathy with vedolizumab is small, and unlikely to be above 6.75 cases per 100,000 patient-years.

Abstract Background Monogenic diseases have been shown to contribute to complex disease risk and may hold new insights into the underlying biological mechanism of Inflammatory Bowel Disease (IBD). Methods We analyzed Mendelian disease associations with IBD using over 55 million patients from the Optum's deidentified electronic health records dataset database. Using the significant Mendelian diseases, we performed pathway enrichment analysis and constructed a model using gene expression datasets to differentiate Crohn's disease (CD), ulcerative colitis (UC), and healthy patient samples. Results We found 50 Mendelian diseases were significantly associated with IBD, with 40 being significantly associated with both CD and UC. Our results for CD replicated those from previous studies. Pathways that were enriched consisted of mainly immune and metabolic processes with a focus on tolerance and oxidative stress. Our 3-way classifier for UC, CD, and healthy samples yielded an accuracy of 72%. Conclusions Mendelian diseases that are significantly associated with IBD may reveal novel insights into the genetic architecture of IBD.

Abstract Background Social media is commonly used among the adolescent and young adult population, including those with chronic diseases. For adults, these platforms have been shown to be a major source of health information. Our aims were to explore how youth with inflammatory bowel disease (IBD) use social media for (1) disease information gathering, (2) provider communication, (3) sense of belonging to the IBD community, (4) self-expression around IBD, and (5) disease management/monitoring. Methods An anonymous and voluntary survey was administered to IBD patients age 12 to 25 years at a single center over 4 months. Results Of 218 patients approached, there were 109 respondents. The mean age of the cohort (SD) was 18 (2.9) years, 65% were male, and 82% had Crohn's disease. Almost all patients accessed the Internet daily, but only 17% reported looking up information about IBD \"always\" or \"often.\" Less than half (47%) turned to medical websites (WebMD or Crohn's and Colitis Foundation) for information. A small number (16%) connected with other IBD patients. Patients' preferred communication with provider was by e-mail (88%) compared with a phone call to the office (67%) or hospital website/patient portal (52%). Few patients used mobile applications to monitor symptoms (2%) or for medication reminders (9%), although there was professed interest. Conclusions Adolescents and young adults with IBD are less likely than adults to use social media for health-related activities. They prefer e-mail rather than oral communication between visits, and privacy seems to be less of a concern. Targeted education and skill building may be helpful for this transitioning population.