bluuebunny/crossref_metadata_2025 huggingface dataset:
P054 Use of corticosteroids at time of diagnosis in ulcerative colitis is common and this practice remains unchanged over time
Authors: Arne Carlsen , Roald Omdal , Lars Aabakken , Normann Karlsen Lars , Terje Kvaløy Jan , Oyvind Steinsbø , Tore Grimstad
Published: July 2019

BACKGROUND:

Corticosteroids (CS) have been the mainstay for treatment of moderate to severe ulcerative colitis for more than 60 years. Side effects and complications are increasingly recognized, and the aim in clinical practice is generally to minimize its use. The aims of this study were to describe whether the practice of administering CS as standard tapered courses at the time of diagnosis had changed during a 6-year period (2012–2017), and also to investigate if patients selected for this regimen overall had more severe and extensive disease.

METHODS:

In total, 203 patients, aged 16 years and above, were consecutively included at time of UC diagnosis in a single center cross sectional study conducted at Stavanger University Hospital, Norway, from 2012 to 2017. Demographic data, medication, CRP, albumin, fecal calprotectin and Partial Mayo Score (PMS) were recorded. In addition, disease distribution (Montreal Classification) and severity (Mayo Endoscopic Score, MES-UC) were assessed at index colonoscopy. A time trend analysis for yearly CS administration was performed using logistic regression, other variables were compared pairwise.

RESULTS:

Overall median (range) age was 34 (16–76) years, and 59% were males. Median CRP concentration was 5.5 mg/L (1–184), albumin 39.5 g/L (10.3–49.6) and fecal calprotectin 695 mg/kg (17–5,466), whereas median PMS was 5 (0–9). Proctitis (E1) was diagnosed in 27.7% of the patients, whereas 28.2% had left sided colitis (E2) and 44.6 % had pancolitis (E3). All patients received 5-ASA treatment (12.5% topical, 35% oral, and 52.5% combined). Antibiotic treatment was prescribed in 13.3 % of the patients, whereas 6.4% received a biological agent and 2% conventional immunosuppressive drugs. CS treatment rate at time of diagnosis was 41.9%, with no significant year-to-year variation, ranging from 30% to 50%, in the selected time period, P = 0.32. Patients treated with CS had higher median CRP (22 vs 2.9 mg/L, P < 0.001), fecal calprotectin (1,052 vs 575 mg/kg, P = 0.02) and PMS (6.5 vs 4, P < 0.001), and a lower albumin (36.0 vs 41.8 g/L, P < 0.001) than patients not receiving CS. CS-treated patients were also more likely to have pancolitis (E3) than left sided colitis (E2), P = 0.001, and more severe disease activity (MES-UC score 3 vs 2), P < 0.001.

CONCLUSION(S):

The practice of administering CS courses at time of diagnosis in UC remained high, with no significantly yearly variation in treatment rate during the selected 6-year period. Commencing CS courses was associated with higher disease activity and more extensive disease. This indicates that CS treatment still has an essential role in the treatment of severe UC disease.
P058 Serum infliximab and corresponding anti-infliximab antibody: Analysis of over 30,000 patient results using lab developed chemiluminescent immunoassays
Authors: Kelly Chun , Imir Metushi , Jeanne Eby , Stephen Phagoo , Morgan Herle , James Iha , Jane Yang
Published: July 2019

BACKGROUND:

Assays to measure TNF inhibitors and anti-drug antibodies (ADAb) in patient serum are being utilized to manage failure to respond and loss of response. These monitoring assays may also be used to proactively titrate doses and dosing intervals (1). Here, 37,165 infliximab (IFX) patient results over 4 years were analyzed.

METHODS:

Measurements of drug and ADAb levels were performed by lab developed chemiluminescent immunoassays (2). The lower limits of quantitation are 0.4 μg/mL for IFX and 22 ng/mL for its ADAb. Drug assays measure free (ADAb-unbound) drug while ADAb assays detect total antibodies (including IgM and IgG subtypes) and are drug- tolerant to the presence of up to >50 μg/mL of drug. Clinical histories and blood collection timing are unknown.

RESULTS:

Of 37,165 measured IFX samples, 55% (20,359) were ADAb-free and 45% (16,806) had measurable anti-infliximab antibodies, ranging in concentration from 22 to 3.5 million ng/mL. In the absence of ADAb, IFX concentrations were from 0.4 to >50 μg/mL, with the majority (>60%) between 3.0 to 20 μg/mL. In the presence of ADAb, an inverse relationship between IFX concentrations and anti-IFX antibodies was demonstrated. As a baseline reference, an ADAb-free mean drug level from 16,463 samples with IFX between 0.4 and 30 μg/mL was found to be 10.0 μg/mL. Mean IFX concentrations decreased in samples with increasing ADAb. Low ADAb (<200 ng/mL) appears to have minimal impact on mean drug levels while high ADAb (>1,000 ng/mL) is invariably associated with severely diminished IFX (10% or less than the mean).

CONCLUSION(S):

Upon analysis of 37,165 infliximab patient samples, 45% exhibited anti-infliximab antibodies. Though collection timing and clinical histories are not known, we found that of all ADAb- free samples, about one third (36%) were within the target range of 3–10 μg/mL for infliximab and 36% of samples were subtherapeutic at <3.0 μg/mL. High titer ADAb are almost invariably associated with very low or absent IFX levels. In contrast, low titer antibodies have little or no impact on drug levels. Our findings are consistent with American Gastroenterological Association Critical Care Pathways for Crohn's Disease and Ulcerative Colitis where low and high antibody scenarios are managed very differently (increase drug dose/consider immunomodulatory vs switch within class). It may be possible to treat away low titer ADAb by increasing drug or adding an immunomodulator (3). Therefore, drug-tolerant anti-drug antibody assays that have been designed both (1) to detect low level ADAb and (2) to distinguish low to intermediate to high titers with high resolution (from 22 to 2,000+ ng/mL) may be most helpful in preventing, managing and treating immunogenicity.
P059 Potential cost avoidance benefits of the early identification of and differentiation Between IBD and IBS
Authors: Thomas Koshy , Sarah Gupta , Philip Cyr , Jessica Richman , Elisabeth Bik , Samantha Tyrrell , Christina Palmer , Daniel Almonacid , Leo Treyzon , Alan Greene
Published: July 2019

BACKGROUND:

Changes in distribution and composition of microbiome species may be associated with inflammatory bowel disease (IBD) and irritable bowel syndrome (IBS). IBD, which includes ulcerative colitis (UC) and Crohn's disease (CD) is an immune-mediated inflammatory disease. IBS is a chronic functional disease characterized by a series of symptoms such as cramping, diarrhea, and constipation. There are specific medications for IBD used to treat the underlying disease and keep it in remission, whereas IBS is more commonly addressed by treating the symptoms and adjusting one's lifestyle to avoid triggers of the condition. Thus, distinguishing between these 2 conditions is important. To address this need uBiome® has developed SmartGutTM, a sequencing-based clinical microbial test that can detect beneficial and pathogenic microorganisms associated with IBS and IBD and help distinguish between these conditions. In this study we developed a model to estimate the cost impact of using SmartGutTM in a US population of patients with gastrointestinal distress.

METHODS:

A model was developed from the perspective of a US payer that provides SmartGutTM as a screening tool for beneficiaries. The model estimates the incidence of gastrointestinal distress from the combined incidence rates of IBD, IBS, and other causes. Utilization was informed by manufacturer patient analysis. The cost of SmartGutTM was based on test costs from the manufacturer.

RESULTS:

For a hypothetical US payer covering 1,000,000 lives, the annual incidence of patients with chronic gastrointestinal distress is estimated to be 68,820 215,820, of which 27% are expected to receive repeat testing with an average of 2.35 SmartGutTM screenings per patient for a total of 93,905 annual screenings. This costs the plan $48,318,761 annually, equating to an additional $4.03 per member per month compared to usual care. However, the SmartGutTM test report details the presence and quantity of microorganisms associated with IBS and IBD. The report includes recommendations for healthcare providers on treatment, lifestyle, and diet that can be discussed with the patient. Testing in these patients may lead to earlier identification of IBS or IBD, which may result in improved downstream outcomes and more efficient use of healthcare resources. Further research is being conducted in order to clearly delineate the test specifications of IBS and IBD as well as downstream health outcomes.

CONCLUSION(S):

Here we present our initial investigations to estimate the cost avoidance benefits of the early identification of and differentiation between inflammatory bowel disease and irritable bowel syndrome using SmartGutTM in a US population of patients, highlighting test costs and improved outcomes.
P060 Is the thickness of the psoas muscle a marker of poor prognosis in Crohn's disease?
Authors: Cátia Arieira , de Castro Francisca Dias , Joana Magalhães , João Moreira Maria , José Cotter
Published: July 2019

INTRODUCTION:

Recent studies point to an association between body composition and clinical outcomes in Crohn's disease (CD).

OBJECTIVE:

To determine the relationship between psoas muscle thickness (PSOAS) as a marker of nutritional status and the prognosis of patients with CD.

METHODS:

Retrospective study, including patients with CD who underwent computed tomography (CT) at diagnosis and with a minimum follow-up of 1 year. The axial (AT) and transverse (TT) thickness of the right PSOAS was measured at the cross-sectional level of L3-L4. AT corresponds to the maximum diameter of the PSOAS on the axial axis. TT corresponds to the diameter of the PSOAS perpendicular to the axial diameter. The thickness was normalized for height. Poor prognosis was defined as the need for surgery and/or introduction of immunosuppressive therapy and/or development of perianal disease and/or altered disease behavior.

RESULTS:

Included 104 patients, 62 (59.6%) female with a mean age at diagnosis of 33.9 ± 12.17 years. Patients were submitted to surgery in 37.5%. We observed a behavior change in 15.4%, development of perianal disease in 22.1% and introduction of immunosuppressive therapy in 76.9%. We found that patients who underwent surgery had lower values ​​of AT (25.23 vs 26.78 mm/m; P = 0.024) and TT (18.70 vs 20.69 mm/m; P = 0.008). The same was observed in patients who presented change in the disease behavior of AT (24.44 vs 26.51 mm/m; P = 0.024) and TT (17.43 vs 20.40 mm/m; P = 0.003).

CONCLUSIONS:

We identified that patients submitted to surgery or with behavior change had lower values ​​of AT and TT at diagnosis. These parameters may identify patients with CD who may progress with worse prognosis, and constitute an extra tool in monitoring patients with CD.
P064 Receptive anal intercourse in patients with inflammatory bowel disease: The role of sexually transmitted infections
Authors: Ian Karrington , Jordan Axelrad , Shannon Chang , Richard Greene , Lisa Malter
Published: July 2019

BACKGROUND:

Receptive anal intercourse (RAI) is a common practice in both men who have sex with men (MSM) and heterosexual populations. While inflammatory bowel disease (IBD), comprising Crohn's disease (CD) and ulcerative colitis (UC), affects over 1 million people in the United States, there have been no studies linking IBD and sexually transmitted infections (STIs). IBD can lead to an inflamed and leaky colonic epithelial barrier, which may increase the risk of rectal STI acquisition. The increased risk of HIV seroconversion in MSM with untreated rectal gonorrhea (GC) and chlamydia (CT) may support this theory.

CASES:

Our first case is of a 24-year-old MSM who was diagnosed with left-sided UC at age 21 in the setting of bloody diarrhea and tenesmus. He was originally treated with topical and oral 5-ASA, and topical steroids, but developed a mesalamine-associated rash and consequently discontinued these agents. At 24, the patient presented to clinic with recurrence of bloody diarrhea and tenesmus, and on questioning was found to engage in RAI. Rectal swab and enteric pathogen PCR panel revealed rectal gonorrhea and shigella. The patient was treated with ceftriaxone and azithromycin and symptoms completely resolved. Our second patient is a 23-year-old MSM male with UC from rectum to 50 cm who had achieved deep remission on adalimumab monotherapy, and presented with tenesmus, increased mucous, and a history of RAI. The patient tested positive for rectal CT and was treated with doxycycline. The patient’s symptoms resolved completely after treatment.

DISCUSSION:

Rectal STIs may complicate IBD. Underlying IBD, especially the presence of active proctitis and the utilization of immunosuppression, may increase susceptibility to STI acquisition via RAI. These cases indicate the importance of careful history taking and frequent rectal STI testing in IBD patients who engage in RAI. Future studies are required to continue to explore the influence of STIs on IBD patients who engage in RAI, including qualitative data on how IBD patients navigate RAI and STIs and quantitative data to gauge how prevalent STIs are in IBD patients compare to the general population.
P066 The relationship between serum adalimumab and corresponding anti-adalimumab antibody levels: analysis of over 20,000 patient results
Authors: Kelly Chun , Imir Metushi , Jeanne Eby , Stephen Phagoo , Morgan Herle , James Iha , Jane Yang
Published: July 2019

BACKGROUND:

Adalimumab (ADL) is a TNF inhibitor administered by injection. Serum assays of ADL and its anti-drug antibodies (ADAb) are utilized to manage failure to respond and loss of response. These monitoring assays may also be used to proactively titrate doses and dosing intervals (1). Here, 22,012 adalimumab (ADL) patient results were analyzed.

METHODS:

Measurements of drug and ADAb levels were performed by lab developed chemiluminescent immunoassays (2). The lower limits of quantitation are 0.6 μg/mL for adalimumab and 25 ng/mL for anti-adalimumab antibodies. Drug assays measure free (ADAb-unbound) drug while ADAb assays detect total antibodies (including IgM and IgG subtypes) and are drug- tolerant to the presence of up to >20 μg/mL of drug. Clinical histories and blood collection timing are unknown.

RESULTS:

Of 22,012 measured adalimumab samples, 60% (13,176) were ADAb-free and 40% (8,836) had measurable anti-adalimumab antibodies. Of all ADAb-free samples, the majority (10,171 or 77%) had ADL concentrations between 3 and 30 μg/mL while drug levels were <3 μg/mL in 2,495 (19%). Of ADAb-positive samples, most were positive in the low to intermediate titer range (25 to 200 ng/mL) Furthermore, as ADAb increase, their corresponding mean drug concentrations diminish. Low concentrations of ADAb (<100 ng/mL) appear to have minimal impact on mean drug levels where the baseline mean adalimumab (6.1 μg/mL) was calculated from 11,085 ADAb-free samples with adalimumab from 0.6 to 15 μg/mL. ADAb titers between 100 and 300 ng/mL are associated with a moderately diminished mean adalimumab (3.4–5.6 μg/mL) while high ADAb titers (>300 ng/mL) are invariably associated with diminished free ADL concentrations <30% of the mean.

CONCLUSION(S):

Of 22,012 samples, 60% were ADAb-free. Of those, about one third (37%) were within the target range of 5–10 μg/mL for adalimumab while 36% of samples were subtherapeutic at <5.0 μg/mL. Anti-adalimumab antibodies occurred in 40% of samples, and ADL drug concentrations were inversely related to anti-adalimumab antibody titers where low titer ADAb may have little or no impact on free drug levels while high titer ADAbs are associated with very diminished or absent drug. These findings are consistent with American Gastroenterological Association Critical Care Pathways for Crohn's Disease and Ulcerative Colitis where low and high antibody scenarios are managed very differently. It may be possible to treat away low titer ADAb by increasing drug or adding an immunomodulator (3). Therefore, drug-tolerant anti-drug antibody assays that have been designed both (1) to detect low level ADAb and (2) to distinguish low to intermediate to high titers with high resolution (from 25 to 2,000+ ng/mL) may be most helpful in preventing, managing and treating immunogenicity.
P068 The utility of contrast-enhanced trans-abdominal ultrasound in the assessment of ileal Crohn's disease
Authors: Samuel Kallus , Mohammad Aboelsoud , Aline Charabaty
Published: July 2019

BACKGROUND:

While ileo-colonoscopy remains the gold standard for luminal evaluation of Crohn’s ileitis, repeated colonoscopies to reassess disease activity can be inconvenient (prep, lost time from work) and put the patient at additional procedure risk and increase health care cost. MRI and CT enterography can be used to assess ileal disease, but the tests involve contrast use, radiation exposure, and are lengthy and costly. Contrast-enhanced ultrasound (CEUS) has been promoted in Europe and Asia as a promising tool for assessment of disease activity with lower cost and no radiation exposure.

METHODS:

This is a prospective study currently enrolling patients with active Crohn's ileitis. All patients underwent evaluation with ileo-colonoscopy and serum inflammatory marker (CRP). Subsequently, all patients underwent CEUS by an independent radiologist who was blinded to the endoscopy results. Ultrasound contrast agent sulfur hexafluoride with gas-filled microbubbles was used (4.8 mL of IV Lumason, Bracco Diagnostics Inc), with real-time visualization of bowel wall microvascularization and perienteric tissue. Bowel wall thickness was measured and a time-signal intensity curve was obtained after calculating the peak enhancement and area under the curve. Prior groups (1) used a cut off point of 18.2 dB for moderate activity and 23.0 dB for severe activity. CEUS findings were compared to the endoscopic findings to assess for correlation in assessing disease activity and severity.

RESULTS:

Four male patients (age 22–65, 3 AA and one Caucasian) with symptomatic Crohns ileitis were enrolled in our study thus far. Patient A had moderate inflammation on CEUS with a peak intensity of 22 dB correlating with Rutgeerts i3 ileitis (large ulcers) above the ileoclonic anastomosis. Patient B had severe inflammation on CEUS with a peak intensity of 27 dB that correlated with moderate to severe ileitis with an inflammatory stricture on endoscopy. Patient C and D both had mild enhancement of distal ileum with a peak intensity of 17 dB; correlating with the findings of aphthous and larger ulcers on endoscopy. Only the 2 patients with a peak intensity of 27 dB had elevated CRP.

CONCLUSION(S):

In our limited experience, CEUS correlates with endoscopic findings of active ileitis and disease severity in Crohn's patients. With further patients enrollment and follow up, we aim to confirm this finding and to assess whether CEUS imaging can also evaluate inactive ileitis in treated Crohn's patients.
P069 Listeria monocytogenes bacteremia in a pregnant ulcerative colitis patient treated with adalimumab and azathioprine
Authors: Sang-Bum Kang , Hoon Jung Sung , Bum Kim Dae , Kang-Moon Lee , Sung-Ae Jung
Published: July 2019

BACKGROUND:

Listeria monocytogenes is an aerobic gram-positive intracellular bacillus, often foodborne and found elsewhere. Although it is an uncommon cause of illness in the general population, it is an important cause of severe infection in neonates, pregnant women, elderly and immunosuppressed patients. Invasive listeriosis, meningitis and meningoencephalitis, bacteremia with or without joint, eye or heart focalization are clinical manifestations of the disease. Maternal listeriosis may develop intrauterine infection of fetus which can lead to severe complications such as amnionitis, preterm labor, spontaneous abortion, stillbirth and neonatal sepsis. Anti-TNF therapy has changed treatment paradigm of inflammatory bowel disease for decades. TNF-α acts as a mediator of local inflammation to contain infection and is crucial in host's response against various microorganisms, particularly intracellular agents like Mycobacterium and Listeria monocytogenes. We report a case of Listeria monocytogenes bacteremia in pregnant ulcerative colitis (UC) patient treated with adalimumab and azathioprine.

CASE:

A 33-year-old pregnant UC patient was hospitalized with high fever after a trip to China. She is at 17 weeks pregnant and being treated with adalimumab and azathioprine for 2 years. The colonoscopy was performed at 6 months before and showed mucosal healing of large intestine. She is currently in clinical remission despite fever. Laboratory finding shows leukocytosis (18,000/mm3), mild anemia (11.2 g/dL) and high CRP (12.5 mg/L). Listeria monocytogenes was identified with her blood culture, and the ampicillin was administered immediately. We decided to stop adalimumab and azathioprine until delivery because of concerns that anti-TNF can go through placenta and may cause an intrauterine infection. After antibiotics were administered to her for 2 weeks, her infection was treated and laboratory findings were normalized. She is currently undergoing routine antenatal visits to the obstetrician, has no evidence of intrauterine infection, and still maintains clinical remission.

DISCUSSION:

We report the first case of Listeria monocytogenes bacteremia in a pregnant UC woman receiving adalimumab and azathioprine. We hope that the treatment policy for discontinuation and re-administration of biological agents will be established in this case in the future.
P070 Stricturing Crohn's disease: Can we predict need for surgery at first hospitalization?
Authors: Sofia Xavier , Tiago Curdia Gonçalves , de Castro Francisca Dias , Joana Magalhães , João Moreira Maria , José Cotter
Published: July 2019

BACKGROUND:

Patients with stricturing Crohn’s disease (CD) are frequently hospitalized and a significant percentage requires surgery in the course of the disease. We aimed to assess if there are any predictors of surgical management by the time of the first admission to hospital with obstructed bowel symptoms.

METHODS:

Retrospective unicentric study. Patients over 18 years old, with structuring ileal or ileocolonic involvement, with at least one hospitalization and a minimum follow up of 1 year were included. Excluded patients with penetrating disease, those who had their first hospitalization before anti-TNF agents became available in our center and those without appropriate records. Several clinical, analytical and radiological variables were assessed. Statistical analysis was performed using SPSS v23.0.

RESULTS:

Included 43 patients of which 53.5% underwent surgery to treat structuring disease. Patients had a mean age of 43.3 ± 10.8 years, 53.5% were females and the median follow up time was 11.0 ± 7.0 years. Comparing patients with and without need for surgery, no significant differences were found between groups regarding age at diagnosis, presence of perianal disease, family history and smoking habits, however females were more frequently submitted to surgery (73.9% vs 30.0%, P = 0.004) as well as patients who already had a structuring behavior at diagnosis when compared with those with inflammatory behavior at diagnosis (65.6% vs 18.2%, P = 0.006). At the first hospitalization, patients with need for surgery were less frequently under anti-TNF (0.0% vs 20.0%, P = 0.039), presented with longer-standing obstructed bowel symptoms (3.0 ± 1.5 days vs 1.0 ± 1.0 days, P = 0.010), higher leukocytes count (12.0 ± 5.3 × 103/μL vs 9.2 ± 6.9 × 103/μL, P = 0.037) and admission computerized tomography (CT) more frequently showed proximal small bowel dilation (86.4% vs 40.0%, P = 0.002) and longer extent of small bowel involved (8.0 ± 12.0 cm vs 5.0 ± 7.0 cm, P = 0.016). Also, patients that were diagnosed by the time of the first hospitalization were more frequently submitted to surgery than those who already had a CD diagnosis (60.9% vs 39.1%, P = 0.043).

CONCLUSION(S):

Females, patients with structuring behavior from diagnosis and those diagnosed in the first hospitalization were more frequently submitted to surgery. Small bowel dilation and extent of small bowel involved in admission CT, leukocyte count and duration of obstructed bowel symptoms at the first admission were also predictors of need for surgery. Anti-TNF therapy before the first admission seems to reduce need for surgery in this group of patients.
P071 Quality of life of patients treated in an Inflammatory Bowel Disease Program in Chile
Authors: Daniela Simian , Lilian Flores , Rodrigo Quera , Patricio Ibáñez , Jaime Lubascher , Carolina Figueroa , Gonzalo Pizarro , Udo Kronberg
Published: July 2019

BACKGROUND:

Inflammatory Bowel Disease impacts patient's quality of life (QoL). Its chronic nature, flares, extraintestinal manifestations, the risk of surgery and cancer, affects their QoL, however, the results depends on each population. The aim of this study was to determine QoL of patients treated in an Inflammatory Bowel Disease Program in Chile.

METHODS:

A descriptive, cross-sectional study was performed between March and July 2018. All patients with Crohn’s Disease (CD) or Ulcerative Colitis (UC) who attended a medical consultation in the IBD Program were evaluated for QoL with the shortened Spanish version of the IBDQ. The IBDQ-9 survey consists of 9 items assessing different aspects of life in IBD patients. Each question has 7 different possible answers, scoring from 1 (poorest) to 7 (best). Higher scores correspond to a better QoL. IBD clinical variables, clinical disease activity and fecal calprotectin were also evaluated in the medical consultation. Patients with a Harvey-Bradshaw score >4 for CD and a Mayo Subscore >2 for UC, and fecal calprotectin >250 μg/g were considered with active disease. Statistical analysis was performed using frequency, medians and Mann Whitney test (P < 0.05).

RESULTS:

During the study period 1,051 medical consultations were performed, assessing QoL in 457 patients; 78 in their first visit in the IBD Program (17%) and 379 follow-up patients (83%). Demographic and clinical variables were: 60% female, median age 35 years (r: 15–88), 326 patients with UC (71%) and 131 with CD (29%), median duration of disease 5 years (r: 0–43), 224 with extraintestinal manifestations (49%). Related to disease activity, 45% were clinically active. From all patients, fecal calprotectin was determined concomitant to the medical consultation in 264 patients (58%), 118 of them with fecal calprotectin >250 μg/g (45%). Of all patients, 4% showed low QoL, 41% medium and 58% high. The median of QoL was lower in patients consulting for the first time in the IBD Program than patients in regular follow-up (38 vs 46; P = 0.005). Patients with active disease showed statistically significant lower QoL than patients in remission, in both groups (33 vs 41; P = 0.002 in the first visit and 35 vs 47; P < 0.0001 in follow-up patients). In addition, in the follow-up group, female gender, CD, presence of extraintestinal manifestations, fecal calprotectin >250 μg/g and not being treated with biological therapy, were significantly associated with lower QoL.

CONCLUSION(S):

A high percentage of patients with IBD refers a low or medium QoL (45%), even more in severe patients. The QoL should be evaluated as an integral part of the management of patients with IBD, considering that the improve of patient’s perception of QoL is one of the goals of the treatment in IBD.
P073 Male gender, smoking and stenosis are risk factors for postoperative endoscopic recurrence after ileocaecal resection for Crohn's disease
Authors: Michel Camargo , Barbara Correa , Daniela Magro , Marcello Rabello , Priscilla Oliveira , Raquel Leal , Maria de Lourdes Ayrizono , Augusto Martinez Carlos , Claudio Coy
Published: July 2019

BACKGROUND:

Colonoscopy is an important exam for diagnosis and follow-up of Crohn’s disease (CD). It has a relevant role in the management of patients after ileocaecal resection (IR), evaluating ileocolonic endoscopic recurrence (ER), performing biopsies and endoscopic dilations. This study describes the colonoscopies performed in patients previously submitted to IR for CD complications, evaluating its impact in the management and evolution of the disease.

METHODS:

Between January 2014 and May 2018, a total of 116 colonoscopies were performed in 62 patients with previous IR for CD. This study describes demographic data, personal and family history, use of medications, Harvey-Bradshaw index (HBI), endoscopic findings, post-colonoscopy alterations of medical treatment and need of new surgery. For endoscopic classification, Rutgeerts index for severity of post-operative CD was used, and ER was defined as scores 3i2. For statistical analysis, software SPSS 20.0 was used. It was considered statiscally significant values of p£0.05.

RESULTS:

Among all patients, 38.7% were male gender, which was a risk factor for ER (P < 0.05). Mean time of CD was 156 months (12–385). Prevalence of smoking was 17.7%, which also was a risk factor for ER (P < 0.05). Family history for CD was positive in 9 cases (14.5%). HBI showed low sensibility for predicting ER. Forty-five patients refered regular use of medication prescribed, while eight patients were in irregular use. Nine patients were without medication. Although there was no statistical significance (P = 0.15), the use of combotherapy was less associated with ER, when compared to other therapies. Regarding ER, 36 cases were i0; 18 cases i1, 38 cases i2; 5 cases i3; and finally, 16 cases i4. On follow-up, patients with ER more frequently had drug optimization or change of medication (P < 0.05). None of the patients classified as i0, i1, i2 e i3 needed new surgery on follow-up. Two cases classified as i4 had indication of new surgery. Ileocolonic stenosis was a risk factor for ER (P < 0.05): in a total of 23 cases, 16 were active disease with ulcerated stenosis. One balloon dilation was done in a patient with non-ulcerated ileocolonic stenosis. There were no cases of bleeding and perforation.

CONCLUSION(S):

Postoperative endoscopic follow-up after ileocaecal resection should be routinely performed. In our study, approximately 46% of the patients were in endoscopic remission. In contrast with previous reports, the majority of our i3 and i4 cases were managed clinically, with a low rate of new surgery (around 5%) Male sex, smoking and stenosis were risk factors for ER.
P076 Cyto-regenerative effect of serum derived bovine immunoglobulin's in DSS induced IBD mice model
Authors: Lubna Majeed , Muhammad Faisal , Wafa Majeed , Alishbah Roobi , Noreen Aslam , Humaira Muzaffar , Aisha Mahmood , Haseeb Anwar , Aziz Rahman , Faqir Muhammad
Published: July 2019

BACKGROUND:

Inflammatory bowel disease is chronic inflammation of the GUT and having 2 major forms such as, UC (Ulcerative colitis) and CD (Crohns disease) derived after oxidative stress in the lumen of the GUT. Serum derived bovine immunoglobulin is a dairy free dietary supplement that is used for dietary management of gastrointestinal disorders. Contemporary study was designed to elucidate the effect of serum derived bovine immunoglobulins on gastrointestinal physiology in DSS induced IBD mice model.

METHODS:

A 3 week research study was planned, 3 groups of mice were arranged, entitled as negative control group, positive control group that was treated with 0.5 mL of 5% DSS solution each day and treatment group was treated with serum derived bovine immunoglobulin's (SBI) after IBD induction with DSS with 3 replicates.

RESULTS:

Physiological parameters revealed highly significant differences (P < 0.001). Hematological analysis (RBCs, WBCs, platelet count, MCHC, MCH and lymphocyte concentration) indicated significant differences (P < 0.05) where as other parameters indicated non-significant results (P > 0.05). White blood cells concentration was raised in positive control group and restoration was occurred in SBI treatment group while Red blood cells were declined in positive control group and recovered in treatment group, showed highly significant difference (P < 0.001). Platelet count were also increased in IBD induce group and improvement was observed in SBI treatment group (P < 0.05). Serum profile testing (TAC, total antioxidant capacity TOS total oxidative status) and histopathological investigation was also done and showed significant results (P < 0.05). mRNA expression level of TRAF-4, TRAF-6 and MAPK8 is MAPK downstream JNK Pathway and calcium signaling (Pias-1, Gerk-2 and Calm-2) cascade were studied through qRT-PCR. In positive control group the mRNA expression level of TRAF-4, TRAF-6, MAPK8, Pias-1, Gerk-2 and Calm-2 was significantly (P ≤ 0.01) increased in comparison to control and SBI treated group. Low mRNA expression level was studied in control as well in SBI treated individuals. All the data attained for each parameter was analyzed using appropriate one-way (ANOVA) and Duncan's Multiple Range (DMR) test by keeping the level of significance at 5% and graph pad prism 6 were used for graph.

CONCLUSION(S):

It is concluded that disruption of mucosal layer of gut was examined in DSS induced positive control group which decreased nutrients absorption by disturbing tight junctions proteins between epithelial cells and caused immune imbalance in mucosal layer while restoration and regeneration of epithelial lining and villi observed in SBI treatment group. Mucosal regeneration normalized the nutrients absorption, immune homeostasis.
P081 Use of immunologic fecal occult blood test as a biomarker in patients with ulcerative colitis
Authors: Udo Kronberg , Daniela Simian , Lilian Flores , Mauricio Moreno , Patricio Ibáñez , Jaime Lubascher , Carolina Figueroa , Rodrigo Quera , Ana Wielandt , Gonzalo Pizarro , Francisco López-Köstner
Published: July 2019

BACKGROUND:

The use of biomarkers for the assessment of inflammatory activity is an important part of current management of Ulcerative Colitis (UC). Fecal calprotectin (FC) has shown to correlate adequately with inflammatory activity, but at an elevated cost in some countries. An immunologic fecal occult blood test (iFOBT) as used in colorectal cancer screening is clearly cheaper, and there have been initial reports about its use in UC. The aim of this study was to determine the diagnostic performance of iFOBT for the assessment of inflammatory activity in UC patients, and to compare it with FC.

METHODS:

A diagnostic, observational, analytic study was performed. UC patients who required colonoscopy were prospectively enrolled between May 2017 and May 2018. FC and iFOBT were determined simultaneously just before starting the bowel preparation for colonoscopy, and patients were asked about their type of test preference. Inflammatory activity was assessed using the Mayo endoscopic sub score, and patients with score 2 or 3 were classified as endoscopically active. In order to identify the cut-off value for iFOBT, logistic regressions and ROC curves and tables were performed, and the value was chosen in order to achieve the highest sensitivity and positive predictive value as desired for a screening test. For the analysis, FC validated standard cut-off value was used (250 mg/g).

RESULTS:

During the above mentioned time period, a total of 50 patients were enrolled, 26 females, with a median age of 33 years (i:19–64). In 38/50 patients (76%) endoscopic activity was observed (Mayo score 2-3). The cut-off value for iFOBT was determined in 50 ng/mL. In terms of diagnostic performance regarding inflammatory activity, iFOBT showed a sensitivity of 89.5%, a specificity of 75%, a PPV of 91.9% and a NPV of 69.2%, with a diagnostic accuracy of 86%, meanwhile, FC showed a sensitivity of 71%, a specificity of 91.7%, a PPV of 96.4%, a NPV of 50% and a diagnostic accuracy of 76%. All the patients (100%) preferred iFOBT over FC in terms of easier sample taking and safer transportation.

CONCLUSION(S):

The diagnostic performance of iFOBT is similar to FC. Further studies performed in a larger sample of patients including follow-up, will allow to confirm that iFOBT could be used as another biomarker for the assessment of inflammatory activity in IBD patients.
P086 Kock pouches in the 21st century: A descriptive study of short-term (30-day) outcomes in a national cohort of 177 patients
Authors: Sherief Shawki , Scott Steele , Jeremy Lipman , Hin Angus Lee Chun , Tracy Hull , Emre Gorgun , Stefan Holubar
Published: July 2019

BACKGROUND:

In 1972, Professor Nils Kock in Gothenburg Sweden developed the continent ileostomy (Koch pouch or KP) as an alternative to permanent end ileostomy. However, the KP was largely supplanted by the ileal pouch-anal anastomosis (IPAA). In the 21st century, KP's are rarely performed, and often only in highly select patients who are a not candidate for an IPAA. Presently, there are only single institution case series with which to guide surgeons' and patients' expectations for postoperative outcomes including length of stay, readmission and complication rates. Thus we aimed to report surgical outcomes in a large national retrospective cohort using the National Surgical Quality Improvement Project (NSQIP).

METHODS:

Using the NSQIP Participant User File from 2005 to 2017 we identified patients who underwent a KP (CPT 44386). Baseline characteristics, operative variables, and postoperative outcomes are reported. Figures represent frequency (proportion) or median (interquartile range).

RESULTS:

Over an 11-year period, a total of 907,146 colorectal operations were performed; of these, we identified a sample of 177 patients who underwent Kock pouch procedures. The median age was 56 (46–76), 50.2% were women, and the median body mass index was 25.3 (22–29.6) kg/m2. Any comorbidity was present in 105 (59%), with a median of 1 (0–2) comorbidities. A total of 13 (7.3%) and 16 (8.5%) were on steroids or had recent weight loss, respectively, and the median albumin was 3.8 (2.9–4.1) mg/dL. Most patients were ASA class 2 (78, 44%). Operative time was 198 (129.5–298.5) minutes, and 127 (72%) had other procedures by the same surgical team, while only 24 (14%) had concurrent procedures by a different surgical team. In terms of short-term outcomes, reoperation was required in 19 (10%) of patients, the post-operative length of stay was 8 (5–14) days. Readmission occurred in 14 (7.9%) of patients. VTE occurred in 4 patients (2.3%). Overall any complication of any severity occurred in 67 (38%) patients. The 30-day mortality rate was 3.4% (6 patients).

CONCLUSION(S):

The Kock pouch procedure, despite its technical complexity, has an acceptable short-term safety profile, and remains an option for a selective group of motivated patients who cannot have IPAA and/or who defer end-ileostomy.
P090  Risk of cancer in pediatric onset inflammatory bowel disease: A nationwide cohort study 1977-2014
Authors: Victoria Kjærgaard , Camilla Jensen , Johan Burisch , Kristine Allin , Tine Jess
Published: July 2019

BACKGROUND:

The prognosis of pediatric onset inflammatory bowel disease (IBD) remains uncertain. We examined the overall and site-specific cancer risk among pediatric onset IBD patients as compared to non-IBD individuals from the general population.

METHODS:

Based on diagnoses from the Danish National Patient Register, we established a nationwide cohort (1977–2014) including all individuals with an IBD diagnosis before the age of 18 (n = 4,221) and 42,210 randomly selected age and sex matched individuals from the general population. The risk of cancer was determined by using Cox proportional hazard regression.

RESULTS:

During 59,563 person-years of follow-up, 126 of 4,221 pediatric onset IBD patients developed cancer (2.1 cases per 1,000 person-years) as compared to 554 of 42,210 non-IBD individuals (1.0 case per 1,000 person-years). Accordingly, the hazard ratio (HR) of any cancer was 2.16 (95% CI, 1.77–2.62). When examining site-specific cancers, the risk was significantly increased for non-melanoma skin: HR, 2.21 (95% CI, 1.41–3.46), liver: HR, 32.83 (95% CI, 9.23–116.78), small bowel, mouth, upper gastrointestinal: HR, 8.4 (95% CI, 2.70–26.14) and colorectal cancer: HR, 18.26 (95% CI, 9.16–36.39). Males with pediatric onset IBD had a significantly higher risk of cancer than females: HR, 3.17 (95% CI, 2.33–4.29) vs 1.71 (95% CI, 1.32–2.21). A slightly higher risk of cancer was observed for Crohn's disease patients than for ulcerative colitis patients: HR, 2.45 (95% CI, 1.82–3.30) vs 1.96 (95% CI, 1.51–2.55).

CONCLUSION(S):

In this nationwide cohort study, individuals with pediatric IBD had significantly increased risk of cancer, especially liver, small bowel, mouth, upper gastrointestinal, and colorectal cancer, but absolute numbers were low. The impact of chronic inflammation, respectively, IBD treatments on cancer risk in early onset IBD merits further investigation.
P091  Preoperative neutrophil to lymphocyte ratio in ulcerative colitis is associated with denovo Crohn's disease after ileal pouch-anal anastomosis
Authors: Phillip Fleshner , Karen Zaghiyan , Talia Kamdjou
Published: July 2019

BACKGROUND:

About 5% to 10% of patients undergoing ileal pouch-anal anastomosis (IPAA) with a diagnosis of ulcerative colitis (UC) at the time of surgery are subsequently diagnosed with denovo Crohn's disease (CD). Previous studies have shown that the neutrophil to lymphocyte ratio (NLR) has high sensitivity, specificity, and predictive values to differentiate CD patients from non-CD controls. The aim of this study was to examine the association of preoperative NLR and denovo CD after IPAA.

METHODS:

Consecutive UC patients undergoing IPAA by one surgeon at a tertiary referral center were prospectively enrolled into a longitudinally updated database. Demographic and clinical factors were tabulated immediately after surgery. Preoperative NLR was collected and calculated from their CBC drawn up to 2 weeks before surgery, without knowledge of the patient's surgical outcome. A cutoff of 1.65, from a previously published study (Forget et al., BMC Research Notes 2017) was used as the reference value. Denovo CD was defined by inflammation involving the small-bowel mucosa proximal to the ileal pouch or when a pouch fistula or other perianal complications developed more than 3 months after ileostomy closure.

RESULTS:

The study cohort of 264 patients had a median age of 42 (5–79) years and included 139 (53%) males. Forty-four patients (17%) developed denovo CD on the basis of afferent limb inflammation (n = 30), perianal disease (n = 8), or both (n = 6). Median length of time to denovo CD until final diagnosis was 9 months after stoma closure. Median NLR of the study cohort was 3.58 (0–54.3). Preoperative clinical features were similar between patients who had a normal (n = 39; 15%) or elevated NLR (n = 225; 85%). Denovo CD developed in 42 patients (19%) with an elevated NLR compared to only 2 patients (5%) with a normal NLR (P = 0.03).

CONCLUSION(S):

This first ever study examining the value of preoperative NLR and surgical outcomes after IPAA showed a significant association of preoperative NLR and denovo CD. An elevated preoperative NLR may be a relatively easy and low-cost clinical biomarker for the development of denovo CD following IPAA in UC patients.
P092 Induction of clinical remission with certolizumab pegol in patients with ulcerative colitis who are not responders in Mexican population
Authors: Tomas Cortes Espinosa , Korely Trujillo de la Fuente , Roxana Rodriguez Romo , Yahaira Rivera Vicencio , Jorge Pineda Castillejos , Dassaev Aleman Abitia , Jesús López Goméz , Mayra Ramos Gómez , Eduardo Ramos Raudry , Rodolfo Ramirez del Pilar , Christian Navarro Gerrard , Jhonatan Aguilar Hernandez
Published: July 2019

BACKGROUND:

The TNF alpha inhibitor have revolutionized the treatment of inflammatory bowel disease (IBD), both in ulcerative colitis (UC) and in Crohn's disease (CD), achieving not only clinical remission even the healing of the affected mucosa. In our population, 70% of patients with IBD are diagnosed as UC and 30% CD. Currently, there are only 2 biologics approved for UC: infliximab and adalimumab. One third of patients will not respond to anti-TNF after induction and up to 50% of them will lose efficacy in the first year. Certolizumab pegol (CZP) has shown therapeutic efficacy in CD. In our country there are no studies that evaluate its use in UC. The aim of this work is to assess the efficacy of CZP in patients with UC with secondary failure to 2 anti-TNF alpha.

METHODS:

Study proof of concept. Six patients with UC diagnosis referred to our hospital center due to secondary failure to 2 anti-TNF alpha were studied. The severity of the disease was staged according to the Mayo score. Prior authorization of the patient for treatment with CZP, we administered it, at a dose of 400 mg subcutaneously at week 0, 2 and every 4 weeks, for 12 weeks. Clinical response was reviewed at 8 and 12 weeks after the beginning of the application of the biological and also endoscopically at 8 and 12 weeks.

RESULTS:

50% corresponded to female sex with a female: male 1 to 1. The median age was: 52.50 [23–63] years. Of the 6 patients, 5 had left colitis and 1 had pancolitis. 4 patients fulfilled criteria of Mayo for severe activity and 2 with moderate activity. 4 patients with an endoscopic subscore Mayo 2 and 2 patients with endoscopic subscore Mayo 3. At the baseline measurement, 50% (3) had a normal CRP and 100% had albumin within normal parameters. At 8 weeks of follow-up, 50% of patients entered clinical remission by Mayo score. 4 patients had an endoscopic subscore May 1 or lower. At 12 weeks of biological application, the same results were observed. By laboratory it was observed at 12 weeks that 83.3% had CRP within normal parameters and 66.7% had normal albumin. No secondary events were observed during the 12 weeks of treatment.

CONCLUSION(S):

In this work proof of concept, CZP seems to be an option in patients with UC who have had secondary failure to other anti-TNF; however, because of the small size of the sample, a prospective and randomized study is required to confirm these findings. The present work does not have conflict of interests.