Disease course of inflammatory bowel disease unclassified in a European population-based inception cohort: An Epi-IBD study.

BACKGROUND AND AIM: A definitive diagnosis of Crohn's disease (CD) or ulcerative colitis (UC) is not always possible, and a proportion of patients will be diagnosed as inflammatory bowel disease unclassified (IBDU). The aim of the study was to investigate the prognosis of patients initially diagnosed with IBDU and the disease course during the following 5 years. METHODS: The Epi-IBD study is a prospective population-based cohort of 1289 IBD patients diagnosed in centers across Europe. Clinical data were captured prospectively throughout the follow-up period. RESULTS: Overall, 476 (37%) patients were initially diagnosed with CD, 701 (54%) with UC, and 112 (9%) with IBDU. During follow-up, 28 (25%) IBDU patients were changed diagnoses to either UC (n = 20, 71%) or CD (n = 8, 29%) after a median of 6 months (interquartile range: 4-12), while 84 (7% of the total cohort) remained IBDU. A total of 17 (15%) IBDU patients were hospitalized for their IBD during follow-up, while 8 (7%) patients underwent surgery. Most surgeries (n = 6, 75%) were performed on patients whose diagnosis was later changed to UC; three of these colectomies led to a definitive diagnosis of UC. Most patients (n = 107, 96%) received 5-aminosalicylic acid, while 11 (10%) patients received biologicals, of whom five remained classified as IBDU. CONCLUSIONS: In a population-based inception cohort, 7% of IBD patients were not given a definitive diagnosis of IBD after 5 years of follow-up. One in four patients with IBDU eventually was classified as CD or UC. Overall, the disease course and medication burden in IBDU patients were mild.

Assessing medication adherence in inflammatory bowel diseases. A comparison between a self-administered scale and a pharmacy refill index.

BACKGROUND: Medication non-adherence in inflammatory bowel disease (IBD) has a negative impact on disease outcome. Different tools have been proposed to assess non-adherence. We aimed to compare a self-administered scale and a pharmacy refill index as a reliable measure of medication adherence and to determine what factors are related to adherence. METHODS: Consecutive non-active IBD outpatients were asked to fill in the self-reported Morisky Medication Adherence Scale (MMAS-8) and the Beliefs about Medication Questionnaire (BMQ). Pharmacy refill data were reviewed from the previous three or six months and the medication possession ratio (MPR) was calculated. Non-adherence was defined as MMAS-8 scores < 6 or MPR < 0.8. RESULTS: Two-hundred and three patients were enrolled (60% ulcerative colitis, 40% Crohn's disease); 51% were men, and the mean age was 46.3 (14) years. Seventy-four per cent of patients were on monotherapy and 26% on combination therapy; altogether, 65% received mesalazine, 46% thiopurines and 16% anti-tumor necrosis factor alfa. Non-adherence rate assessed by MPR was 37% and 22.4% by MMAS-8. Receiver operator curve analysis using a MMAS-8 cut-off of six gave an area under the curve of 0.6 (95% CI 0.5-0.7), p = 0.001. This score had an 85% sensitivity and 34% specificity to predict medication non-adherence, with negative and positive predictive values of 57% and 70% respectively. High scores in the BMQ potential for harm of medication were significantly associated with MPR non-adherence (p = 0.01). CONCLUSION: The accuracy of MMAS-8 to identify medication non-adherence in inactive IBD outpatients in our setting is poor due to a low specificity and a negative predictive value. Psychosocial factors such as beliefs about medication seem to be related to IBD non-adherence.

European experience with methotrexate treatment in Crohn's disease: a multicenter retrospective analysis.

INTRODUCTION: Methotrexate (MTX) has been utilized for the treatment of Crohn's disease (CD) for decades. Nevertheless, current data provide equivocal evidence on the efficacy of MTX in CD.The aims of this study were to describe the efficacy of MTX for maintenance of remission in CD and to identify the factors associated with the probability of steroid-free clinical remission in a multicenter European referral center cohort. PATIENTS AND METHODS: This was a retrospective cohort analysis. Consecutive patients treated with MTX for CD were included from 11 referral centers. Patients receiving concomitant treatment with tumor necrosis factor inhibitors or thiopurines were excluded. The main outcome was steroid-free clinical remission; the secondary outcomes included the rate of complications leading to MTX discontinuation and duration of relapse-free survival in patients achieving the main outcome. RESULTS: Between July 1992 and January 2012, 118 patients were identified for inclusion. MTX administration route was oral for induction in 31.4% and for maintenance in 49.1% of the patients. Steroid-free remission was achieved in 44/118 (37.2%) patients and was maintained relapse free by 28/44 (63.6%) for a median of 12 (3.5-18.5) months. At least one adverse effect was reported by 28.9% of the patients. No clinical or demographic factors were associated with either likelihood of achieving a clinical response or duration of relapse-free survival. CONCLUSION: MTX treatment induced steroid-free clinical remission in over a third of CD patients and maintained it for a year in almost two-thirds of the responders. MTX should be considered a viable therapeutic option in CD patients refractory to other therapies.

Costs and resource utilization for diagnosis and treatment during the initial year in a European inflammatory bowel disease inception cohort: an ECCO-EpiCom Study.

BACKGROUND: No direct comparison of health care cost in patients with inflammatory bowel disease across the European continent exists. The aim of this study was to assess the costs of investigations and treatment for diagnostics and during the first year after diagnosis in Europe. METHODS: The EpiCom cohort is a prospective population-based inception cohort of unselected inflammatory bowel disease patients from 31 Western and Eastern European centers. Patients were followed every third month from diagnosis, and clinical data regarding treatment and investigations were collected. Costs were calculated in euros (€) using the Danish Health Costs Register. RESULTS: One thousand three hundred sixty-seven patients were followed, 710 with ulcerative colitis, 509 with Crohn's disease, and 148 with inflammatory bowel disease unclassified. Total expenditure for the cohort was €5,408,174 (investigations: €2,042,990 [38%], surgery: €1,427,648 [26%], biologicals: €781,089 [14%], and standard treatment: €1,156,520 [22%)]). Mean crude expenditure per patient in Western Europe (Eastern Europe) with Crohn's disease: investigations €1803 (€2160) (P = 0.44), surgery €11,489 (€13,973) (P = 0.14), standard treatment €1027 (€824) (P = 0.51), and biologicals €7376 (€8307) (P = 0.31). Mean crude expenditure per patient in Western Europe (Eastern Europe) with ulcerative colitis: investigations €1189 ( €1518) (P < 0.01), surgery €18,414 ( €12,395) (P = 0.18), standard treatment €896 ( €798) (P < 0.05), and biologicals €5681 ( €72) (P = 0.51). CONCLUSIONS: In this population-based unselected cohort, costs during the first year of disease were mainly incurred by investigative procedures and surgeries. However, biologicals accounted for >15% of costs. Long-term follow-up of the cohort is needed to assess the cost-effectiveness of biological agents.

Seguridad y efectividad de los balones gástricos asociados a una dieta hipocalórica en el tratamiento de la obesidad / Safety and effectiveness of gastric balloons associated with hypocaloric diet for the treatment of obesity

Introducción: el balón gástrico produce saciedad precoz favoreciendo la pérdida de peso en un corto plazo de tiempo. El objetivo de este estudio fue evaluar la seguridad y la efectividad del tratamiento mediante balón gástrico y dieta hipocalórica en la obesidad. Material y métodos: estudio de cohortes prospectivo en 91 pacientes obesos sometidos a balón gástrico durante 6 meses. Como criterio de efectividad se consideró el porcentaje de peso perdido (PPP) >= 5 % 6 meses tras su colocación y 6 y 12 meses tras su retirada. Analizamos los resultados por intención de tratar, considerando significativos los valores de p < 0,05. Resultados: empleamos 73 balones rellenos de líquido (80,2 %) y 18 de aire (19,8 %). Tras 6 meses un 73,7 % de pacientes alcanzó el objetivo terapéutico mostrando descenso de peso (13,3 ± 8,8 kg) e IMC (5 ± 3,4 kg/m2) (p < 0,0001), con PPP 11 ± 7 %. Transcurridos 6 y 12 meses de la retirada un 45,1 % y 28,6 % mantenían un PPP >= 5 %. La efectividad a corto y medio plazo se asoció negativamente con obesidad en familiares (p = 0,003 y p = 0,04). La pérdida ponderal lograda tras 6 meses se asoció con efectividad a medio plazo (p = 0,0001). No existió mortalidad, observando 2 desinflados espontáneos y 8 retiradas complicadas, requiriendo cirugía 1 paciente. Los balones rellenos de aire presentaron más complicaciones (p = 0,0005). Conclusiones: la efectividad del tratamiento combinando balón gástrico y dieta hipocalórica en la obesidad disminuye a lo largo del tiempo. Las complicaciones ocurrieron mayoritariamente durante la retirada endoscópica y con el empleo de balones rellenos de aire (AU)

Introduction: intragastric balloons provide early satiety and thereby induce short-term weight loss. The aim of this study was to evaluate safety and short and medium-term effectiveness of gastric balloons associated to hypocaloric diet in obesity. Material and methods: from May 2004 to June 2011 91 obese patients, body mass index [BMI] 45.2 ± 7.2 kg/m2 were prospectively followed after endoscopic implantation of a gastric balloon associated to restricted diet. Successful therapy was defined as percent loss of total weight (%LTW) >= 5 % at six months after balloon placement and 6 and 12 months after their withdrawal. All analyses followed intention-to treat principles considering significant p-values < 0.05. Results: we placed 73 fluid-filled balloons (80.2 %) and 18 air-filled ones (19.8 %). Compared to baseline values, at 6-month 73.7 % subjects succeeded, showing significant reductions in weight (13.3 ± 8.8 kg), BMI (5 ± 3.4 kg/m2) (p < 0.0001), with % LTW 11 ± 7 %. Six and twelve months after retrieval 45.1 % and 28.6 % patients reached % LTW >= 5 %. Short-term and medium-term effectiveness was negatively associated to obesity in first-grade relatives (p = 0.003 and p = 0.04). Higher weight loss 6 months after balloon placement independently predicted medium-term effectiveness (p = 0.0001). Mortality was absent but there were two spontaneous deflations of air-filled balloons and severe withdrawal difficulties in 8 patients, leading to surgery in one case. Retrieval complications associated to air-filled balloons (p = 0.0005). Conclusions: in obesity, effectiveness of gastric balloons associated to hypocaloric diet decreases over time. Complications occurred mainly in the retrieval endoscopic procedure and related to air-filled balloons (AU)

Safety and effectiveness of gastric balloons associated with hypocaloric diet for the treatment of obesity.

INTRODUCTION: intragastric balloons provide early satiety and thereby induce short-term weight loss. The aim of this study was to evaluate safety and short and medium-term effectiveness of gastric balloons associated to hypocaloric diet in obesity. MATERIAL AND METHODS: from May 2004 to June 2011 91 obese patients, body mass index (BMI) 45.2 +/- 7.2 kg/m2 were prospectively followed after endoscopic implantation of a gastric balloon associated to restricted diet. Successful therapy was defined as percent loss of total weight (%LTW) > or = 5 % at six months after balloon placement and 6 and 12 months after their withdrawal. All analyses followed intention-to treat principles considering significant p-values < 0.05. RESULTS: we placed 73 fluid-filled balloons (80.2 %) and 18 air-filled ones (19.8 %). Compared to baseline values, at 6-month 73.7 % subjects succeeded, showing significant reductions in weight (13.3 +/- 8.8 kg), BMI (5 +/- 3.4 kg/m2) (p < 0.0001), with % LTW 11 +/- 7 %. Six and twelve months after retrieval 45.1 % and 28.6 % patients reached % LTW > or = 5 %. Short-term and medium-term effectiveness was negatively associated to obesity in first-grade relatives (p = 0.003 and p = 0.04). Higher weight loss 6 months after balloon placement independently predicted medium-term effectiveness (p = 0.0001). Mortality was absent but there were two spontaneous deflations of air-filled balloons and severe withdrawal difficulties in 8 patients, leading to surgery in one case. Retrieval complications associated to air-filled balloons (p = 0.0005). CONCLUSIONS: in obesity, effectiveness of gastric balloons associated to hypocaloric diet decreases over time.Complications occurred mainly in the retrieval endoscopic procedure and related to air-filled balloons.

Efficacy, safety, and tolerance of two types of intragastric balloons placed in obese subjects: a double-blind comparative study.

The intragastric balloon is a temporary treatment for obese patients. Fluid-filled devices have shown efficacy and safety, and are widely used. Recently, although there are no comparative studies between them, an air-filled balloon, Heliosphere® bag, has been proposed. Prospective, double-blind study in 33 patients with morbid and type 2 obesity: 23 female, 43.9±10 years, 120.3±17 kg, and body mass index (BMI) of 44.2±5 kg/m2, placing 18 gastric balloons filled with 960 cm3 of air (Heliosphere® bag) or 15 balloons filled with 700 ml of saline (Bioenterics-BIB®). Both balloons were placed with conscious sedation and removed under general anesthesia 6 months later. Intravenous drugs were given to control symptoms for 48 h. Patients were sent home on a 1000-kcal diet, multivitamin supplements, and oral proton pump inhibitors, and were followed monthly. Complications, symptoms, weight, and quality of life evaluated by the Gastrointestinal Quality of Life Index (GIQLI) scale were recorded. At 6 months, mean weight loss (12.8±8 vs 14.1±8 kg), BMI loss (4.6±3 vs 5.5±3 kg/m2) and percent excess weight loss (27±16 vs.30.2±17) showed no significant differences between both groups. At removal, two Heliosphere® bags were not found in the stomach, and four patients required extraction of the balloon by rigid esophagoscopy or surgery (p=0.02). Tolerance was good in both groups, but early removal occurred in three BIB® (20%) due to vomits and dehydration. The GIQLI total scores remained unchanged. Both balloons achieve a significant weight loss with good tolerance in obese patients. Nevertheless, Heliosphere® bag has severe technical problems that need to be solved before recommending it.