Negative Screening Does Not Rule Out the Risk of Tuberculosis in Patients with Inflammatory Bowel Disease Undergoing Anti-TNF Treatment: A Descriptive Study on the GETAID Cohort.

AIM: to describe the characteristics of incident cases of tuberculosis [TB] despite negative TB screening tests, in patients with inflammatory bowel disease [IBD] undergoing anti-TNF treatment, and to identify the risk factors involved. METHODS: A retrospective descriptive study was conducted at GETAID centers on all IBD patients undergoing anti-TNF treatment who developed TB even though their initial screening test results were negative. The following data were collected using a standardized anonymous questionnaire: IBD, and TB characteristics and evolution, initial screening methods and results, and time before anti-TNF treatment was restarted. RESULTS: A total of 44 IBD patients [including 23 men; median age 37 years] were identified at 20 French and Swiss centers at which TB screening was performed [before starting anti-TNF treatment] based on Tuberculin Skin Tests [n = 25], Interferon Gamma Release Assays [n = 12], or both [n = 7]. The median interval from the start of anti-TNF treatment to TB diagnosis was 14.5 months (interquartile range [IQR] 25-75: 4.9-43.3). Pulmonary TB involvement was observed in 25 [57%] patients, and 40 [91%] had at least one extrapulmonary location. One TB patient died as the result of cardiac tamponade. Mycobacterium tuberculosis exposure was thought to be a possible cause of TB in 14 cases [32%]: 7 patients [including 6 health care workers] were exposed to occupational risks, and 7 had travelled to endemic countries. Biotherapy was restarted on 27 patients after a median period of 11.2 months [IQR 25-75: 4.4-15.2] after TB diagnosis without any recurrence of the infection. CONCLUSION: Tuberculosis can occur in IBD patients undergoing anti-TNF treatment, even if their initial screening results were negative. In the present population, TB was mostly extrapulmonary and disseminated. TB screening tests should be repeated on people exposed to occupational risks and/or travelers to endemic countries. Restarting anti-TNF treatment seems to be safe.

Randomized, multicenter study: on-demand versus continuous maintenance treatment with esomeprazole in patients with non-erosive gastroesophageal reflux disease.

BACKGROUND: Most patients with gastroesophageal reflux disease experience symptomatic relapse after stopping acid-suppressive medication. The aim of this study was to compare willingness to continue treatment with esomeprazole on-demand versus continuous maintenance therapy for symptom control in patients with non-erosive reflux disease (NERD) after 6 months. METHODS: This multicenter, open-label, randomized, parallel-group study enrolled adults with NERD who were heartburn-free after 4 weeks' treatment with esomeprazole 20 mg daily. Patients received esomeprazole 20 mg daily continuously or on-demand for 6 months. The primary variable was discontinuation due to unsatisfactory treatment. On-demand treatment was considered non-inferior if the upper limit of the one-sided 95 % confidence interval (CI) for the difference between treatments was <10 %. RESULTS: Of 877 patients enrolled, 598 were randomized to maintenance treatment (continuous: n = 297; on-demand: n = 301). Discontinuation due to unsatisfactory treatment was 6.3 % for on-demand and 9.8 % for continuous treatment (difference -3.5 % [90 % CI: -7.1 %, 0.2 %]). In total, 82.1 and 86.2 % of patients taking on-demand and continuous therapy, respectively, were satisfied with the treatment of heartburn and regurgitation symptoms, a secondary variable (P = NS). Mean study drug consumption was 0.41 and 0.91 tablets/day, respectively. Overall, 5 % of the on-demand group developed reflux esophagitis versus none in the continuous group (P < 0.0001). The Gastrointestinal Symptom Rating Scale Reflux dimension was also improved for continuous versus on-demand treatment. Esomeprazole was well tolerated. CONCLUSIONS: In terms of willingness to continue treatment, on-demand treatment with esomeprazole 20 mg was non-inferior to continuous maintenance treatment and reduced medication usage in patients with NERD who had achieved symptom control with initial esomeprazole treatment. TRIAL REGISTRATION: ClinicalTrials.gov identifier (NCT number): NCT02670642 ; Date of registration: December 2015.

Prevalence of esophageal squamous papilloma (ESP) and associated cancer in northeastern France.

BACKGROUND AND STUDY AIMS: Esophageal squamous papilloma (ESP) is a rare lesion. The aims of this study were to assess the prevalence of ESP in northeastern France and the risk of associated squamous cell carcinoma (SCC). PATIENTS AND METHODS: The charts of 78 patients who were diagnosed with ESP between January 2005 and February 2013 at three hospitals in northeastern France were reviewed. RESULTS: A total of 55 305 endoscopies were performed and 78 ESP were diagnosed (0.01 %). Patients with ESP included 44 males (56.4 %), 34 females (43.6 %); median age 50, interquartile range (IQR) 19 - 86. Median follow-up was 21 months (IQR 0 - 91 mo) and median time between first and second endoscopy was 7 months (IQR 0.5 - 74 mo). Of the total number of patients, 35 (44.9 %) had a second endoscopy. Main endoscopy indication was dyspepsia (24.4 %). Most ESP were isolated (93.6 %) and located at distal esophagus (27 cm, IQR 16 - 40 cm). Median size was 3 mm (IQR 1 - 20 mm). ESP-associated endoscopic lesions were hiatal hernia in 12 patients and esophagitis in 11 patients. Endoscopic treatment was mainly excisional biopsies (60.3 %). Human papillomavirus (HPV) was not detected in the 6 patients with available data. Low dysplasia was found in 2 ESP. During follow-up endoscopies, 2 SCC were detected in 2 different patients; the first SCC was located at the previous resection site of the ESP and the second had a different location. Prevalence of associated cancer was 1.3 %. CONCLUSION: Prevalence of ESP in northeastern France is similar to that previously reported. Endoscopic findings were also broadly the same as in previous reports. The occurrence of dysplasia and SCC should strongly encourage the endoscopist to totally remove the ESP and to start an endoscopic surveillance, given the potential risk of malignant transformation.

Cumulative incidence of, risk factors for, and outcome of dermatological complications of anti-TNF therapy in inflammatory bowel disease: a 14-year experience.

OBJECTIVES: The broader and prolonged use of anti-tumor necrosis factor (TNF) agents in inflammatory bowel disease (IBD) could expose patients to an increased risk of adverse reactions, including dermatological complications. We assessed the cumulative incidence of anti-TNF-induced cutaneous adverse reactions in IBD patients, their risk factors, their dermatological management, and their outcome in a large cohort of IBD patients. METHODS: In a single-center observational retrospective study, including all consecutive adult IBD patients treated with an anti-TNF agent between 2001 and 2014, all patients with dermatological complications under anti-TNF therapy were identified in a well-defined cohort of IBD patients. We conducted a survival analysis to determine the cumulative incidence of dermatological complications and risk factors for developing any dermatological complications, cutaneous infections, and psoriasiform lesions. Survival curves were estimated by the Kaplan-Meier method, and we used a Cox proportional hazards model to test the association between parameters and time to each event: any dermatological complication, cutaneous infections, and psoriasis lesions. RESULTS: Among 583 IBD patients, 176 dermatological complications occurred, involving 20.5% of patients. Median duration of follow-up was 38.2 months (range: 1-179). Psoriasiform lesions (10.1%; 59/583) and cutaneous infections (11.6%, 68/583) were the most frequently observed, with a cumulative incidence of, respectively, 28.9% and 17.6% at 10 years. They led to anti-TNF discontinuation, respectively, in 18.6% and 2.9% of patients. In case of switching to another anti-TNF agent for psoriasiform lesions, recurrence occurred in 57% of patients. Ulcerative colitis was associated with a lower risk of developing cutaneous infections than Crohn's disease (hazard ratio (HR)=0.25; 95% confidence interval (CI)=0.09-0.68; P=0.007). Higher dosing of anti-TNF agent was associated with a higher risk of developing cutaneous infections (HR=1.99; 95% CI=1.09-3.64; P=0.025). A younger age at time of anti-TNF initiation was associated with a higher risk of dermatological complications (HR=2.25; 95% CI=1.39-3.62; P<0.001). CONCLUSIONS: Dermatological complications involve one of five patients treated with anti-TNF therapy after a 14-year follow-up. Association of cutaneous infections with higher anti-TNF dosing suggests a dose-dependent effect. Discontinuation of anti-TNF therapy due to dermatological complications is required in one out of five patients with psoriasiform lesions, but specific dermatological treatment allows to continue anti-TNF therapy in half of them.

Impact of immunosuppressive therapy on hepatitis B vaccination in inflammatory bowel diseases.

BACKGROUND AND AIMS: The vaccination rate against hepatitis B virus (HBV) is low in inflammatory bowel disease (IBD) patients. The Consensus from the European Crohn's and Colitis Organisation on opportunistic infections recommends testing all IBD patients for HBV at diagnosis and vaccinating all HBV-negative patients. We compared the efficacy of HBV vaccine between IBD patients and healthy controls and investigated the impact of immunosuppressive therapy on vaccine response in IBD patients. MATERIALS AND METHODS: IBD patients and healthy adult workers were vaccinated against HBV following a standard protocol (at 0, 1, and 6 months; Engerix B). The efficacy of vaccination was evaluated at 8 months by a titer of antibodies against hepatitis B surface antigen (anti-HBs). RESULTS: Among 164 participants (96 with IBD and 68 healthy workers), the level of anti-HBs was greater than 10 IU/l in 80.2 and 94.1% (P=0.0115) of IBD patients and healthy controls, respectively, and anti-HBs levels greater than 100 IU/l were seen in 45.8 versus 77.9% (P<0.0001) of IBD patients and healthy controls, respectively. The median level of anti-HBs was significantly higher in healthy controls (497.0±386.2) than in IBD patients (253.9±34.5) (P<0.0001). None of the baseline characteristics of IBD patients, including immunomodulators and antitumor necrosis factor therapy, influenced the vaccine response. In the multivariate analysis, ileal disease was the only factor associated with a lower response to the vaccine (odds ratio=3.2; 95% confidence interval=1.0-9.7; P=0.049). CONCLUSION: The response rate to HBV vaccination is significantly lower in IBD patients than in the general population. Immunosuppressive therapy for IBD did not influence the vaccine response.

Beliefs and behaviour about smoking among inflammatory bowel disease patients.

BACKGROUND AND AIMS: We investigated the beliefs and behaviours about tobacco among inflammatory bowel disease (IBD) patients. MATERIALS AND METHODS: A questionnaire of 18 items was developed and administered to all consecutive patients followed for IBD at Nancy University Hospital from October 2012 to March 2013. RESULTS: Two hundred and thirty-one patients participated in the survey [Crohn's disease (CD)=171, ulcerative colitis (UC)=60]. Among IBD patients who were smokers at diagnosis, 10.5% of CD patients versus 14.3% of UC patients believed that tobacco could have triggered their IBD; about half the CD smokers at diagnosis were not aware that smoking might promote their disease. Three quarters of smokers after diagnosis knew that tobacco was not beneficial for their CD, whereas all UC were aware that smoking had a beneficial effect on their disease course. About half of the CD patients had stopped smoking during a flare-up. Four former smokers with UC (21.1%) resumed smoking during a relapse. Nearly 90% of IBD current smokers wished to quit smoking. About half the IBD patients were aware of the relation between smoking and IBD, and the Internet was a source for 24.3% of these patients. CONCLUSION: The majority of IBD patients are unaware of the effects of tobacco on their disease. Better information through a therapeutic education programme should be systematically recommended in IBD.

Self-insertion of a nasogastric tube for home enteral nutrition: a pilot study.

BACKGROUND: Enteral tube feeding can be a source of discomfort and reluctance from patients. We evaluated for the first time the tolerability of self-insertion of a nasogastric (NG) tube for home enteral nutrition (EN). MATERIALS AND METHODS: All patients requiring enteral tube feeding for chronic diseases were enrolled in a therapeutic patient education (TPE) program at Nancy University Hospital. RESULTS: In our department, between November 2008 and August 2012, 66 patients received EN with an NG tube. Twenty-nine of 66 had self-insertion of the NG tube (median age, 44 years), 17 had an anatomical contraindication, and 20 were excluded because of cognitive disability or language barrier or refusal. Twenty-eight of 29 patients completed the TPE program. One patient died of pancreatic cancer in palliative care during the study. Median follow-up was 20 months (interquartile range [IQR], 4-31). Median gain weight was 3.1 kg (IQR, 1.8-6.0) (P = .0002). Median duration of self-insertion of the NG tube was 3 months (IQR, 2-5), and it was well tolerated by all 29 patients. Two patients described minor adverse events: abdominal pain and nausea for 1 patient and epistaxis leading to temporary discontinuation of EN for another patient. A group of 10 consecutive patients previously had a long-term NG tube for EN. If they had the choice between a self-inserted NG tube and a long-term NG tube, all 10 patients reported they would prefer to start again with the self-inserted NG tube. CONCLUSION: This pilot study suggests that self-insertion of an NG tube may be efficacious and well tolerated in patients receiving EN for chronic conditions.

Tolerability of one hour 10mg/kg infliximab infusions in inflammatory bowel diseases: a prospective multicenter cohort study.

BACKGROUND AND AIM: In patients with inflammatory bowel disease (IBD) tolerating 2-h infusions of 5mg/kg infliximab scheduled maintenance therapy, the infusion time can be shortened to 1-h with good tolerability. A retrospective study with small sample size demonstrated the feasibility of 1-hour infusion time for 10mg/kg infliximab in IBD patients. METHODS: Between November 2011 and July 2012, 63 patients received 1-hour 10mg/kg infliximab infusions under standard operating procedures and were enrolled in a prospective observational study. Intravenous steroid premedication was given to all patients. RESULTS: Sixty-three IBD patients on infliximab maintenance therapy (43 Crohn's disease, 34 males) received 1-hour 10mg/kg infusions during the study period. A total of 182 infliximab infusions were administered. Seventeen (26%) patients were receiving concomitant immunomodulators. Two patients experienced (2/182, 1%) severe acute infusion reactions consisting on a cutaneous lupus and one severe anaphylactic reaction. We also observed one (1/182, 0.5%) severe delayed reaction after the first 1-hour infliximab infusion consisting on acne generalis. All 3 reactions led to infliximab discontinuation. No mild acute reactions and 6 mild delayed reactions (6/182, 3%) occurred. CONCLUSIONS: In patients with IBD receiving infliximab scheduled maintenance therapy, 1-hour infusion time for 10mg/kg infliximab seems to be well tolerated. This option might be considered in clinical practice in order to decrease the extra-burden of infliximab infusions in this patient population.

The extra burden of infliximab infusions in inflammatory bowel disease.

BACKGROUND: Infliximab (IFX) infusions require repeated hospitalizations. The median duration of each hospitalization stay, including time for infusion and the cost for the health care system, are unknown. We assessed the extra burden of IFX infusions in inflammatory bowel disease (IBD). METHODS: This was a prospective cross-sectional study enrolling all consecutive patients with IBD treated with IFX at the Nancy IBD Unit (January to March 2012). Four parameters were assessed: median travel duration, median time that patients stayed at the IBD unit, reimbursement for transport by the health care system, and impact of IFX infusions on their work. RESULTS: Among 137 IBD patients, 48.9% were women, 74.5% had Crohn's disease, and the median age was 35 (range, 18-65) years. The median travel duration backward and forward from home to the Nancy IBD unit was 2 (range, 0.5-4) hours. The patients stayed at the IBD unit for a median period of 4.5 (range, 2.8-6.7) hours. For 63.5% of the patients (87/137), transport was reimbursed by the health care system. Of the patients receiving IFX infusions, 10.9% (15/137) were unemployed, 24.8% (34/137) had the agreement of their employer to spend 1 day at the hospital for their IFX infusion, 27.0% (36/137) asked specifically a vacation for the IFX infusion, and 13.9% (19/137) were in sick leave. CONCLUSIONS: The patients spend a median of 6.5 hours outside their home for each IFX infusion, and they often take a day of vacation or rest. This represents an extra burden for IFX-treated patients and for the health care system.

Submucosal plexitis as a predictor of postoperative surgical recurrence in Crohn's disease.

BACKGROUND: The presence of submucosal or myenteric plexitis was associated with clinical and endoscopic Crohn's disease (CD) recurrence after ileocolonic resection. We assessed the value of both submucosal and myenteric plexitis for predicting postoperative surgical recurrence in CD. METHODS: We performed a retrospective study using the database of the Department of Pathology of Nancy University Hospital. All patients who underwent CD-related resection between 1996 and 2008 were analyzed. The proximal resection margin was analyzed blindly by 2 expert pathologists. Plexitis was evaluated by counting each cell type (mast cell, plasmocyte, lymphocyte, eosinophil, and neutrophil) in both submucosal and myenteric plexuses. The optimal cut-off value for each cell type was determined by using receiver operating characteristic analysis. Cox proportional hazards regression analysis was used to identify independent predictors of the second CD-related surgery. RESULTS: Sixty-seven patients were included in the study. Median duration of follow-up was 46 months. Using Kaplan-Meier survival analysis, the proportion of patients without second surgery was 68% at 5 years. In multivariate analysis, using Cox proportional hazards regression analysis, early surgical revision after the first ileocecal resection (hazard ratio = 9.56; 95% confidence interval, 2.02-45.19; P = 0.0046), the presence of at least one eosinophil in the submucosal plexus (hazard ratio = 8.02; 95% confidence interval, 1.87-34.47; P = 0.0054), and the presence of more than 6 lymphocytes in the submucosal plexus (hazard ratio = 5.84; 95% confidence interval, 1.23-27.65; P = 0.0269) were independently associated with risk of surgical recurrence. CONCLUSIONS: Early surgical revision and submucosal plexitis in proximal margins of ileocolonic resection specimens are independently associated with CD surgical recurrence.

Long-term outcome of perianal fistulizing Crohn's disease treated with infliximab.

BACKGROUND & AIMS: Little is known about the long-term efficacy of infliximab for patients with fistulizing perianal Crohn's disease. We evaluated outcomes and predictors of outcomes in these patients. METHODS: The medical records of 156 patients treated with infliximab for fistulizing perianal Crohn's disease at 2 referral centers from 1999 through 2010 were reviewed through September 2011. Cumulative probabilities of fistula closure and recurrence were estimated by using the Kaplan-Meier method. Predictors of outcomes were identified by using a Cox proportional hazards model. RESULTS: When infliximab treatment began, only 17.9% of patients had a simple fistula; seton drainage was performed for 97 patients (62%). Concomitant immunosuppressants were given to 90 patients (56%). After a median follow-up period of 250 weeks, 108 patients (69%) had at least 1 fistula closure. Cumulative probabilities of first fistula closure were 40% and 65% at 1 and 5 years, respectively. Factors that predicted fistula closure were ileocolonic disease (hazard ratio [HR] = 1.88), concomitant immunosuppressants (HR = 2.58), duration of seton drainage <34 weeks (HR = 2.31), and long duration of infliximab treatment (HR = 1.76). Of the 108 patients with fistula closure, cumulative probabilities of first fistula recurrence were 16.6% and 40.1% at 1 and 5 years, respectively. Forty-four patients (28.9%) developed an abscess during follow-up. A number of infliximab infusions greater than 19 was associated with less abscess recurrence (HR = 0.33). At the maximal follow-up time, 55% of patients had fistula closure. CONCLUSIONS: About two-thirds of patients with fistulizing perianal Crohn's disease had fistula closure, and one-third had fistula recurrence after infliximab initiation. Combination therapy, duration of seton drainage less than 34 weeks, and long-term treatment with infliximab were associated with better outcomes.

Colonoscopic perforations in inflammatory bowel disease: a retrospective study in a French referral centre.

BACKGROUND: Whether inflammatory bowel disease patients are at increased risk of colonoscopic perforations remains controversial. Aim of this study was to investigate whether these patients are at increased risk of perforations. METHODS: Electronic charts of all patients enrolled in the Nancy IBD cohort (1999-2012) were reviewed. All non-inflammatory bowel disease patients who underwent colonoscopy (1999-2012) were used as controls. RESULTS: Of 17,992 colonoscopies, 2375 (13.2%) were performed for inflammatory bowel disease: 1547 for Crohn's disease and 828 for ulcerative colitis. Four IBD patients (0.168%) experienced perforation. Perforation occurred in the sigmoid colon (n = 3) and right colon (n = 1) during disease monitoring or colonic stenosis dilatation. Three patients underwent surgery (2 stomas and no death). Colonoscopic perforation occurred in 16/15,617 controls (0.102%): colonic cancer diagnosis (n = 5, 31.3%) or dilatation (n = 2, 12.5%), polypectomy (n = 5, 31.3%) or mucosectomy (n = 1, 6.3%), and follow-up after diverticulitis (n = 2, 12.5%). Perforation rate was not different between IBD and controls (p = 0.57). Perforations occurred in the sigmoid colon (n = 10, 62.5%), the right colon (n = 4, 25%) and the rectum (n = 2, 12.5%). Twelve controls underwent surgery (9 stomas and one death). CONCLUSION: In this referral centre-based cohort, inflammatory bowel disease patients were not at increased risk of colonoscopic perforation compared to non-IBD controls.

Dietary beliefs and behavior among inflammatory bowel disease patients.

BACKGROUND: We investigated dietary beliefs and behavior in a large population of adult inflammatory bowel disease (IBD) patients and evaluated their impact on patients' social life. METHODS: A questionnaire of 14 items was administered to all consecutive IBD patients followed at the Nancy University Hospital Department of Gastroenterology from February to July 2011. RESULTS: A total of 244 patients participated in the survey; 15.6% (n = 38) of patients believed that diet could initiate the disease, while 57.8% (n = 141) believed that food can play a role in causing a relapse. Forty percent (107/244) of patients identified food as a risk factor for relapse. Seventy-three percent of respondents reported having already received nutritional advice. The majority of respondents (47.5%, n = 116) reported that the disease had changed the pleasure of eating. Only one-quarter of patients had a normal diet in case of relapse. Almost two out of three patients (66.8%, n = 163) reported not eating certain foods they usually like to eat in order to prevent a relapse. Dietary beliefs and behavior had an impact on their social life for one-fifth of patients. Excluding food was associated with refusing outdoor dining for fear of causing relapse (P = 0.006) and not sharing the same menu as the other members of the family living under the same roof (P = 0.002). CONCLUSIONS: The majority of IBD patients are avoiding certain foods. Dietary beliefs and behavior have a strong impact on their social life.

Tolerability of one hour 10 mg/kg infliximab infusions in patients with inflammatory bowel disease.

BACKGROUND AND AIM: In patients with inflammatory bowel disease (IBD) tolerating 2-h infusions of 5mg/kg infliximab scheduled maintenance therapy, the infusion time can be shortened to 1-h with good tolerability. The tolerability of one 1-hour 10 mg/kg infliximab infusion in patients with IBD is unknown. METHODS: Between August and September 2011, 8 patients received one 1-hour 10mg/kg infliximab infusion. All patients were treated in our infusion unit under standard operating procedures. Intravenous steroid premedication was given to all patients. These 8 patients were compared to 26 IBD patients who received one 1-hour 5mg/kg infliximab infusion during the same study period at Nancy University Hospital. The charts of these 34 patients were reviewed to assess tolerability of 1-hour infliximab infusions. RESULTS: A total of 34 patients with IBD on infliximab maintenance therapy (82.4% Crohn's disease, 17.6% ulcerative colitis; 22 females) received one 1-hour 5 or 10mg/kg infusion. Four patients were receiving concomitant immunomodulators. No severe infusions reactions were reported in the 34 IBD patients. Two mild acute reactions (7.7%) and two delayed reactions (7.7%) occurred in the 5mg/kg infliximab group. We did not observe any acute or delayed infliximab reactions in the 10mg/kg patients group. CONCLUSIONS: In patients with inflammatory bowel disease receiving infliximab scheduled maintenance therapy, 1-hour infusion time for 10mg/kg infliximab appears to be well tolerated. Large prospective studies are needed to confirm our findings.

Ocular symptoms are not predictive of ophthalmologic inflammation in inflammatory bowel disease.

BACKGROUND: Ocular manifestations are frequent in patients with inflammatory bowel disease. AIM: To evaluate for the first time the value of ocular symptoms in predicting ophthalmologic inflammation in inflammatory bowel disease. METHODS: All consecutive inflammatory bowel disease patients seen in the Department of Gastroenterology (Nancy, University Hospital, France) between April 2009 and July 2011 were interviewed for this cross-sectional study using a pre-established questionnaire. If the patient had at least one ocular symptom, he systematically underwent an ophthalmologic examination (visual acuity, Break-Up Time test, Schirmer Test, slit-lamp exam with fundus examination). RESULTS: This cross-sectional survey was completed by 305 patients: 169 were women (55.2%), 228 had Crohn's disease (74.5%). Ninety-eight patients (32%) reported at least one ocular symptom: ocular irritation (56.8%), red eye (40.5%), blurred vision (37.8%), progressive visual loss (34.4%), ocular pain (31.1%), myodesopsia (23.3%), eyelid secretion (12.2%), dry eye (9.5%), watering (6.8%), diplopia (5.4%), metamorphopsia (4%), and sudden visual loss (4%). Following ophthalmologic examination (n=74), 41.9% patients had evidence of dry eye (n=31), 14.9% blepharitis (n=11) and 1.4% scleritis (n=1). No uveitis was reported. CONCLUSION: Ocular symptoms are frequent in inflammatory bowel disease, but are non-specific and rarely associated with ocular inflammation. Systematic ocular symptoms assessment is of poor value for diagnosing ocular inflammation in inflammatory bowel disease.

Gaviscon® vs. omeprazole in symptomatic treatment of moderate gastroesophageal reflux. a direct comparative randomised trial.

BACKGROUND: Medical management of GERD mainly uses proton pump inhibitors. Alginates also have proven efficacy. The aim of this trial was to compare short-term efficacy of an alginate (Gaviscon®, 4 × 10 mL/day) and omeprazole (20 mg/day) on GERD symptoms in general practice. METHODS: A 14-day multicentre randomised double-blind double-dummy non-inferiority trial compared Gaviscon® (4 × 10 mL/day) and omeprazole (20 mg/day) in patients with 2-6 day heartburn episodes weekly without alarm signals. The primary outcome was the mean time to onset of the first 24-h heartburn-free period after initial dosing. Secondary outcomes were the proportion of patients without heartburn by D7, pain relief by D7, and reduction in pain intensity by D7 and D14. RESULTS: 278 patients were recruited; 120 were included in the Gaviscon® group and 121 in the omeprazole group for the per protocol non-inferiority analysis. The mean time to onset of the first 24-h heartburn-free period after initial dosing was 2.0 (± 2.2) days for Gaviscon® and 2.0 (± 2.3) days for omeprazole (p = 0.93); mean intergroup difference was 0.01 ± 1.55 days (95% CI = -0.41 to 0.43): i.e., less than the lower limit of the 95% CI of -0.5 days predetermined to demonstrate non-inferiority. The mean number of heartburn-free days by D7 was significantly greater in the omeprazole group: 3.7 ± 2.3 days vs. 3.1 ± 2.1 (p = 0.02). On D7, overall quality of pain relief was slightly in favour of omeprazole (p = 0.049). There was no significant difference in the reduction in pain intensity between groups by D7 (p = 0.11) or D14 (p = 0.08). Tolerance and safety were good and comparable in both groups. CONCLUSION: Gaviscon® was non-inferior to omeprazole in achieving a 24-h heartburn-free period in moderate episodic heartburn, and is a relevant effective alternative treatment in moderate GERD in primary care. TRIAL REGISTRATION: ISRCTN62203233.

Plasma soluble triggering receptor expressed on myeloid cells-1 in Crohn's disease.

BACKGROUND: No definite conclusions can be drawn from available data on the accuracy of soluble triggering receptor expressed on myeloid cells-1 (sTREM-1) to assess disease activity in Crohn's disease. AIMS: Plasma sTREM-1 levels were correlated with disease activity markers in Crohn's disease. METHODS: 191 consecutive patients from a single referral centre (Nancy IBD cohort) were prospectively enrolled between June 1, 2005 and December 12, 2008. Plasma sTREM-1 levels were also assessed amongst 20 healthy controls. RESULTS: The sTREM-1 was detectable in 87 Crohn's disease patients (46%). Plasma sTREM-1 level was higher in Crohn's disease patients (interquartile range, 0-356) than in healthy controls (interquartile range, 0-15.1; P=0.01). It was neither correlated with Crohn's disease activity index (r=0.05, P=0.56), C-reactive protein (r=0.06, P=0.53), nor with albumin (r=-0.041, P=0.66). Crohn's disease activity index, C-reactive protein and albumin median levels were similar between patients with positive sTREM-1 levels and those with undetectable sTREM-1 levels. Azathioprine (P=0.06), infliximab (P=0.68) and methotrexate (P=0.56) did not influence sTREM-1 levels. CONCLUSION: Plasma sTREM-1 does not appear to be an accurate marker of disease activity in Crohn's disease and cannot be recommended for assessing disease activity in these patients.

Incidence of and impact of medications on colectomy in newly diagnosed ulcerative colitis in the era of biologics.

BACKGROUND: The cumulative incidence of colectomy and the impact of 5-aminosalicylates (5-ASA), azathioprine, and antitumor necrosis factor (TNF) treatment on the long-term need for surgery are unknown in ulcerative colitis (UC) in the era of biologics. METHODS: This was an observational study of a referral center cohort. The cumulative incidence of UC-related colectomy was estimated using the Kaplan-Meier method. Independent predictors of surgery were identified using Cox proportional hazards regression with propensity scores adjustment. The electronic charts of 151 incident cases of UC from Nancy University Hospital, France, diagnosed between 2000 and 2008, were reviewed through January 2010. RESULTS: The median follow-up time per patient was 58 months. Twenty-one (14%) underwent surgery. The cumulative probabilities of colectomy were respectively 1.3% and 13.5% at 1 and 5 years from the time of diagnosis. The probability of receiving oral mesalamine at 5 years was 68.1%. The corresponding figures were 48.9% for azathioprine and 29.0% for infliximab. For corticosteroids, methotrexate, and cyclosporin these figures were 75%, 8.8%, and 11.5%, respectively. Using multivariate Cox proportional hazards regression analysis after propensity score adjustment, previous use of cyclosporin was the only independent predictor for colectomy (hazard ratio = 4.41; 95% confidence interval 1.75-1.13). CONCLUSIONS: About one-tenth of patients still require colectomy for UC at 5 years in the era of biologics. Oral 5-ASA, azathioprine, and anti-TNF therapy are not associated with a reduced need for colectomy.

Urinary tract infections in hospitalized inflammatory bowel disease patients: a 10-year experience.

BACKGROUND: Cystitis is the most common genitourinary complication in Crohn's disease (CD). We assessed the prevalence of and risk factors for urinary tract infections (UTI) in inflammatory bowel diseases (IBD). METHODS: Among the 1173 IBD patients of the "Nancy IBD cohort" seen between January 1, 2000 and December 31, 2009, 56 hospitalized patients had 76 documented UTI. Prevalence of UTI in IBD was calculated using rates of UTI among non-IBD patients hospitalized during the same period. The cases were compared to 175 matched IBD patients without UTI hospitalized during the same period to identify risk factors for UTI. RESULTS: Prevalence of UTI was 4% in IBD patients versus 3.3% in non-IBD patients (P = 0.1). Prevalence of UTI was 4.5% and 2.1% in ulcerative colitis (UC) and CD patients, respectively (P = 0.6). Risk factors for UTI in CD patients were perianal disease (odds ratio [OR] = 2.28, 95% confidence interval [CI], 1.06-4.89; P = 0.04) and colonic disease (OR = 2.42, 95% CI, 1.05-5.58; P = 0.04). Male gender (OR = 0.38, 95% CI, 0.17-0.85, P = 0.02) and noncomplicated behavior (OR = 0.26, 95% CI, 0.11-0.60, P = 0.002) were protective factors against UTI in CD. In UC patients, age over 40 years (OR = 9.59, 95% CI, 1.93-47.74; P = 0.006) and disease duration over 11 months (OR = 10.77, 95% CI, 1.68-68.89, P = 0.01) were risk factors for UTI. Male gender was negatively associated with UTI (OR = 0.04, 95% CI, 0.01-0.36, P = 0.00006). CONCLUSIONS: Hospitalized IBD patients are not at increased risk of UTI. Risk factors for UTI include perianal disease and colonic disease in CD and age and longer disease duration in UC.

Guidance on the use of over-the-counter proton pump inhibitors for the treatment of GERD.

OBJECTIVE: The aim of this paper was to develop a guideline on the over-the-counter management of gastroesophageal reflux disease with proton pump inhibitors (i.e. omeprazole). SETTING: A meeting of internationally renowned gastroenterologists in January 2009, in Berlin, Germany. METHODS: An expert panel group of gastroenterologists convened to develop a consensus-based algorithm for pharmacists for over-the-counter (OTC) treatment with proton pump inhibitors (PPIs). Key considerations were the short-term safety and efficacy of PPIs, and the extent of the risk to the sufferer, owing to the treatment not being controlled by a physician. Main outcome measures A consensus-based treatment algorithm for the OTC management of gastroesophageal reflux disease and evidence-based guidance on the use of OTC PPIs. RESULTS: As defined by the treatment algorithm, the pharmacist should first confirm the diagnosis based on the presence of typical symptoms and secondly, as a result, rule out general practitioner referral. The third step focuses on the nature, severity and frequency of the symptoms--the patients who might have the highest benefit from a short course (14 days) of OTC PPIs are those with less than three episodes of heartburn and/or acid regurgitation per week. Patients who have three or more episodes per week can use the OTC PPIs but should also be encouraged to visit a physician, and those who already have a diagnostic work-up can use proton pump inhibitors as rescue treatment if they are known responders. Guidance for pharmacists, in the form of questions and answers, summarises the current published clinical experience with PPIs in terms of their efficacy and safety, and optimal treatment schedule. Conclusions Gastroesophageal reflux disease imposes a considerable burden on sufferers. Owing to their accepted efficacy and safety, PPIs are becoming popular as OTC options for the treatment of gastroesophageal reflux disease symptoms such as heartburn and acid regurgitation. Effective self-management of gastroesophageal reflux disease with OTC PPIs, e.g. omeprazole, could lead to lasting freedom from symptoms and improved quality of life for sufferers.