Information Needs and Concerns of Patients with Inflammatory Bowel Disease: What Can We Learn from Participants in a Bilingual Clinical Cohort?

BACKGROUND: Inflammatory Bowel Disease (IBD) patients are confronted with needs and concerns related to their disease. AIM: To explore information expectations of patients included in a national bilingual IBD cohort in Switzerland (SIBDC). METHODS: This is a mixed-methods study, comprising 1) a semi-narrative survey sent to 1506 patients from the SIBDC and 2) two focus groups conducted with 14 patients to explore and assess the relevance of the survey's findings. Data collected within the framework of the SIBDC was used to characterize survey's responders. RESULTS: 728 patients (48%) replied to the survey: 52.5% females, 56% Crohn's disease (CD), 87% secondary/tertiary level educated, 70% full/part-time employed. On average, 47% of patients sought for information, regardless of the disease stage; 27% of them were dissatisfied with information received at the time of first symptoms. During flares, 43% were concerned about drugs and therapies; in remission, 57% had concerns on research and developments; 27% searched for information linked to daily disease management. Information-seeking increased when active disease, for CD with high levels of perceived stress (OR = 2.47; p = 0.003), and for all with higher posttraumatic stress symptoms. The focus groups confirmed a perceived lack of information about general functioning, disease course, treatments and their risks, extra-intestinal symptoms and manifestations. CONCLUSIONS: Information remains insufficient for IBD patients. Lack of information in specific domains can potentially cause stress and hinder detection of symptoms. Better information should be considered as a potentially important component in improving patients' outcomes in IBD.

Patients' information-seeking activity is associated with treatment compliance in inflammatory bowel disease patients.

BACKGROUND: Despite the chronic and relapsing nature of inflammatory bowel diseases (IBD), at least 30% to 45% of the patients are noncompliant to treatment. IBD patients often seek information about their disease. AIM: To examine the association between information-seeking activity and treatment compliance among IBD patients. To compare information sources and concerns between compliant and noncompliant patients. METHODS: We used data from the Swiss IBD cohort study, and from a qualitative survey conducted to assess information sources and concerns. Crude and adjusted odds ratios (OR) for noncompliance were calculated. Differences in the proportions of information sources and concerns were compared between compliant and noncompliant patients. RESULTS: A total of 512 patients were included. About 18% (n = 99) of patients were reported to be noncompliant to drug treatment and two-thirds (n = 353) were information seekers. The OR for noncompliance among information seekers was 2.44 (95%CI: 1.34-4.41) after adjustment for confounders and major risk factors. General practitioners were 15.2% more often consulted (p = 0.019) among compliant patients, as were books and television (+13.1%; p = 0.048), whereas no difference in proportions was observed for sources such as internet or gastroenterologists. Information on tips for disease management were 14.2% more often sought among noncompliant patients (p = 0.028). No difference was observed for concerns on research and development on IBD or therapies. CONCLUSION: In Switzerland, IBD patients noncompliant to treatment were more often seeking disease-related information than compliant patients. Daily management of symptoms and disease seemed to be an important concern of those patients.

Efficacy and safety of certolizumab pegol in an unselected crohn's disease population: 26-week data of the FACTS II survey.

BACKGROUND: Certolizumab pegol (Cimzia, CZP) was approved for the treatment of Crohn's disease (CD) patients in 2007 in Switzerland as the first country worldwide. This prospective phase IV study aimed to evaluate the efficacy and safety of CZP over 26 weeks in a multicenter cohort of practice-based patients. METHODS: Evaluation questionnaires at baseline, week 6, and week 26 were completed by gastroenterologists in hospitals and private practices. Adverse events were evaluated according to World Health Organization (WHO) guidelines. RESULTS: Sixty patients (38F/22M) were included; 53% had complicated disease (stricturing or penetrating), 45% had undergone prior CD-related surgery. All patients had prior exposure to systemic steroids, 96% to immunomodulators, 73% to infliximab, and 43% to adalimumab. A significant decrease of the Harvey-Bradshaw Index (HBI) was observed under CZP therapy (12.2 ± 4.9 at week 0 versus 6.3 ± 4.7 at week 6 and 6.7 ± 5.3 at week 26, both P < 0.001). Response and remission rates were 70% and 40% (week 6) and 67% and 36%, respectively (week 26). The complete perianal fistula closure rate was 36% at week 6 and 55% at week 26. The frequency of adverse drug reactions attributed to CZP was 5%. CZP was continued in 88% of patients beyond week 6 and in 67% beyond week 26. CONCLUSIONS: In a population of CD patients with predominantly complicated disease behavior, CZP proved to be effective in induction and maintenance of response and remission. This series provides the first evidence of CZP's effectiveness in perianal fistulizing CD in clinical practice.

[High frequency of cutaneous adverse effects under infliximab. Geneva experience, 1999-2008]. / Fréquence elevée d'effets secondaires cutanés sous infliximab. Expérience a Genève, 1999-2008.

Geneva experience, 1999-2008 Infliximab has been used for 10 years in the treatment of chronic inflammatory bowel diseases in the gastroenterology and hepatology department at the University Hospitals of Geneva. This retrospective study shows the follow-up of these patients treated with infliximab and reveals a high rate of cutaneous adverse events, which, although often mild, can sign a definitive intolerance to treatment.

Infliximab for Crohn's disease in the Swiss IBD Cohort Study: clinical management and appropriateness.

OBJECTIVE: Antitumor necrosis factor a agents have significantly improved the management of Crohn's disease (CD), but not all patients benefit from this therapy. We used data from the Swiss Inflammatory Bowel Disease Cohort Study and predefined appropriateness criteria to examine the appropriateness of use of infliximab (IFX) in CD patients. METHODS: EPACT II (European Panel on the Appropriateness of CD Therapy, 2007; www.epact.ch) appropriateness criteria have been developed using a formal explicit panel process combining evidence from the published literature and expert opinion. Questionnaires relating to EPACT II criteria were used at enrollment and follow-up of all Swiss Inflammatory Bowel Disease Cohort Study patients. A step-by-step analysis of all possible indications for IFX therapy in a given patient allowed identification of the most appropriate indication and final classification in a single appropriateness category (appropriate, uncertain, inappropriate). RESULTS: Eight hundred and twenty-one CD patients were prospectively enrolled between November 2006 and March 2009. IFX was administered to 146 patients (18%) at enrollment and was most frequently used for complex fistulizing disease and for the maintenance of remission induced by biological therapy. IFX therapy was considered appropriate in 44%, uncertain in 44%, and inappropriate in 10% of patients. CONCLUSION: In this cohort, 9 out of 10 indications for IFX therapy were clinically generally acceptable (appropriate or uncertain) according to EPACT II criteria. Uncertain indications resulted mainly from the current more liberal use of IFX in clinical practice as compared with the EPACT II criteria.

Clinical experience with adalimumab in a multicenter Swiss cohort of patients with Crohn's disease.

BACKGROUND: Controlled clinical trials have demonstrated the efficacy and safety of adalimumab in patients with moderate-to-severe Crohn's disease (CD), but there is, however, only limited long-term experience with adalimumab in daily practice. AIM: To assess the long-term effectiveness and safety of adalimumab in a multicenter cohort of practice-based patients with moderate-to-severe CD. METHODS: We retrospectively reviewed the charts of CD patients who received adalimumab over a 3-year period. Disease severity was scored using the Harvey-Bradshaw index (HBI). Remission was defined as an HBI of 3 points at evaluation compared to the baseline. Univariate logistic regression analysis was used to identify the predictive variables associated with response. RESULTS: The charts of 55 patients were reviewed; remission and response rates observed at weeks 4-6 were 52.7 and 83.6%, respectively. Remission was maintained at weeks 12, 24 and 52 in 89.6, 72.4 and 44.7% of patients, respectively. Remission and response rates were not influenced by smoking status, disease location or duration, the first month total dose, or previous infliximab therapy. The remission rate at weeks 4-6 was significantly higher in patients intolerant of infliximab as compared to those who lost response to this drug. Adalimumab was well tolerated overall. CONCLUSION: Adalimumab can be considered a suitable option in patients with moderate-to-severe CD, demonstrating sustained long-term effectiveness.

Efficacy and safety of certolizumab pegol induction therapy in an unselected Crohn's disease population: results of the FACTS survey.

BACKGROUND: Switzerland was the first country to approve certolizumab pegol (Cimzia, CZP) for the treatment of patients with moderate to severe Crohn's disease (CD) in September 2007. This phase IV study aimed to evaluate the efficacy and safety of CZP in a Swiss multicenter cohort of practice-based patients. METHODS: Baseline and Week 6 evaluation questionnaires were sent to all Swiss gastroenterologists in hospitals and private practices. Disease activity was assessed with the Harvey-Bradshaw Index (HBI) and adverse events were evaluated according to WHO guidelines. RESULTS: Fifty patients (31 women, 19 men) were included; 56% had complicated disease (stricture or fistula) and 52% had undergone prior CD-related surgery. All patients had prior exposure to systemic steroids, 96% to immunomodulators, 78% to infliximab, and 50% to adalimumab. A significant decrease in HBI was observed at Week 6 (versus Week 0) following induction therapy with CZP 400 mg subcutaneously at Weeks 0, 2, and 4 (12.6 +/- 4.7 Week 0 versus 6.2 +/- 4.4 Week 6, P < 0.001). Response and remission rates at Week 6 were 54% and 40%, respectively. We identified 8/11 CD patients undergoing a 50% fistula response (P = 0.021). The frequency of adverse drug reactions attributed to CZP was 6%. CZP was continued in 80% of patients beyond Week 6. CONCLUSIONS: In a population of CD patients with complicated disease behavior, CZP induced a response and remission in 54% and 40% of patients, respectively. This series provides the first evidence of the effectiveness of CZP in perianal fistulizing CD.

Perforated Meckel's diverticulitis complicating active Crohn's ileitis: a case report.

INTRODUCTION: In Crohn's disease, the extension of active terminal ileitis into a Meckel's diverticulum is possible, but usually has no impact on clinical decision-making. We describe an original surgical approach in a young woman presenting with a combination of perforated Meckel's diverticulitis and active Crohn's ileitis. CASE PRESENTATION: We report the case of a 22-year-old woman with Crohn's disease, who was admitted for abdominal pain, fever and diarrhoea. CT scan demonstrated active inflammation of the terminal ileum, as well as a fluid collection in the right iliac fossa, suggesting intestinal perforation. Laparoscopy was performed and revealed, in addition to extensive ileitis, a 3 x 3 cm abscess in connection with perforated Meckel's diverticulitis. It was therefore possible to avoid ileocaecal resection by only performing Meckel's diverticulectomy; pathological examination of the surgical specimen revealed the presence of transmural inflammation with granulomas and perforation of the diverticulum at its extremity. CONCLUSION: Crohn's disease of the ileum may be responsible for Meckel's diverticulitis and cause perforation which, in this case, proved to be a blessing in disguise and spared the patient an extensive small bowel resection.

Cyclosporine treatment of steroid-refractory ulcerative colitis during pregnancy.

BACKGROUND: Cyclosporine is considered a safe and effective treatment of severe steroid-refractory ulcerative colitis (UC). However, few data are available concerning its safety profile in pregnant women. We report here the experience of 5 GETAID centers. METHODS: In a retrospective study data on patients with severe UC treated with cyclosporine during pregnancy were extracted from medical records of consecutive patients treated between 2001 and 2007. RESULTS: Eight patients (median age 30.5 years old) were identified. At the time of flare-up the median duration of pregnancy was 11.5 weeks of gestation (range 4-25). Seven patients had pancolitis. All patients had more than 3 commonly used clinical and biological severity criteria. Three patients had severe endoscopic lesions and 5 patients had not. All patients received intravenous corticosteroids for at least 7 days before introduction of cyclosporine. Two patients received azathioprine during treatment with cyclosporine. No severe infections or other complications due to treatment were observed. Treatment was effective in 7/8 patients. One patient received infliximab due to cyclosporine therapy failure with a good outcome. No colectomy was performed during pregnancy. Seven pregnancies were conducted to term, but 1 in utero death occurred due to maternal absence of S-protein. Two newborns were premature, including 1 case of hypotrophy. No malformations were observed. CONCLUSIONS: In our experience, treatment with cyclosporine for steroid-refractory UC during pregnancy can be considered safe and effective.

Management of the returning traveler with diarrhea.

Traveler's diarrhea (TD) strikes 20-60% of travelers visiting developing countries. It occurs shortly after the return and can be distinguished into two categories: acute and persistent TD. Acute TD, mostly caused by bacterial and viral pathogens, is usually mild and self-limited, and deserves empirical symptomatic and/or antibiotic therapy in selected cases. Fluoroquinolones are progressively superseded in this indication by azithromycin, a well tolerated macrolide active against most bacteria responsible for TD, including the quinolone-resistant species of Campylobacter jejuni that are now pervasive, especially in Southeast Asia and India. Persistent TD in the returning traveler is much rarer than its acute counterpart and may be associated with three types of causes. Persistent infections, among which Giardia and possibly Entamoeba predominate, account for a significant proportion of cases. Postinfectious processes represent a second cause and comprise temporary lactose malabsorption and postinfectious irritable bowel syndrome, now considered a major cause of persistent TD. Finally, apparently unrelated chronic diseases causing diarrhea are occasionally unmasked by TD and represent a third type of persistent TD, among which the well established case of incident inflammatory bowel disease poses intriguing pathogenesis questions. This review discusses recent advances in the field and provides practical recommendations for the management of TD in adult, immunocompetent returning travelers.

Appendectomy, smoking habits and the risk of developing ulcerative colitis: a case control study in private practice setting.

OBJECTIVES: The strongest environmental factors identified for ulcerative colitis (UC) are cigarette smoking and appendectomy. However, most studies have been performed using case-controls from hospital-based populations. The purpose of this study was to compare the history of previous appendectomy and smoking habits in a group of patients with UC and a control group, followed by gastroenterologists in private practice. METHODS: We performed a case control study in which 100 physicians recruited UC-patients and age and sex matched controls. Data were collected during a single visit. Based on a standardized questionnaire, UC patients and controls were divided into never, former or current smokers, and into subjects with or without a previous history of appendectomy. RESULTS: One hundred and ninety eight age- and sex-matched pairs of UC patients and controls were included. The prevalence of appendectomy in the UC-patients and control group was 12% and 46%, respectively. The pairwise-matched OR of ulcerative colitis for previous appendectomy was 0.10 (95% CI, 0.05-0.21) (P<0.0001). The OR for former and never smokers versus current smokers was 2.40 (95% CI 1.31-4.38) (P=0.004). In UC-patients, the OR of family history of UC compared with controls was 2.80 (95% CI, 1.01-7.77) (P=0.048). CONCLUSIONS: This case-control study confirmed a strong negative correlation between both appendectomy and tobacco smoking, and ulcerative colitis in patients followed-up by gastroenterological practitioners.

Severe delayed complication after percutaneous endoscopic colostomy for chronic intestinal pseudo-obstruction: a case report and review of the literature.

Percutaneous endoscopic colostomy (PEC) is increasingly proposed as an alternative to surgery to treat various disorders, including acute colonic pseudo-obstruction, chronic intestinal pseudo-obstruction and relapsing sigmoid volvulus. We report on a severe complication that occurred two months after PEC placement. A 74-year-old man with a history of chronic intestinal pseudo-obstruction evolving since 8 years was readmitted to our hospital and received PEC to provide long-standing relief. The procedure was uneventful and greatly improved the patient's quality of life. Two months later, the patient developed acute stercoral peritonitis. At laparotomy, the colostomy flange was embedded in the abdominal wall but no pressure necrosis was found at the level of the colonic wall. This complication was likely related to inadvertent traction of the colostomy tube. Subtotal colectomy with terminal ileostomy was performed. We review the major features of 60 cases of PEC reported to date, including indications and complications.