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Background: Tumor necrosis factor (TNF) inhibitors have improved treatment of ulcerative colitis (UC), but loss of response remains a frequent problem. The anti-TNF agent, golimumab, was approved in Switzerland for the treatment of UC in 2014. This study aims to summarize the experience of golimumab in a real-world setting in Switzerland. Methods: We analyzed real-world data from 1769 UC patients from the Swiss Inflammatory Bowel Disease Cohort (SIBDC) study and performed a chart review of golimumab-treated patients. We extracted the partial Mayo score at t0 (baseline), t1 (2–16 weeks), t2 (17–35 weeks), and t3 (36–89 weeks). The primary endpoint was clinical response at t1, defined as marked improvement in partial Mayo score and objective parameters. Clinical remission was defined as resolution of symptoms and normalization of objective parameters. Results: Our chart review included 103 UC patients with golimumab treatment (5.8% of all SIBDC UC patients); only 16 (15.5%) were anti-TNF naïve. Sixty-three patients remained on golimumab (61.2%) after 180 days, 51 (44.7%) after 365 days, and 34 (33%) after 630 days after the start of treatment. Upon golimumab treatment, the partial Mayo score decreased from 4 [interquartile range (IQR): 2–6] at t0 to 2 (IQR: 0–4) at t1, 1 (IQR: 0–3.5) at t2, and 1 (IQR: 0–3) at t3 (p < 0.001 for all comparisons with t0). The primary endpoint, clinical response at t1, could be evaluated in 52 patients and was met in 15 individuals (28.8%). Clinical remission at t1 was observed in 8 out of 52 patients (15.4%). Golimumab was generally well tolerated, one patient developed meningitis. The most frequent reasons to stop treatment were primary and secondary non-response. Conclusion: Golimumab was used in 5.8% of Swiss UC patients, mainly in biologic-experienced individuals. Golimumab treatment was associated with a sustained reduction of symptoms and clinical response in approximately 30% of patients. [ClinicalTrials.gov identifier: NCT00488631] [ABSTRACT FROM AUTHOR]

Background: Patients with inflammatory bowel disease (IBD) have a higher risk of infection and are frequently not up to date with their immunizations. Objectives: This study aims to review vaccination status and evaluate whether age, disease type, or treatment regimen could predict the absence of seroprotection against selected vaccine-preventable infection in adults with IBD. Methods: Cross-sectional study using questionnaire, immunization records review, and assessment of tetanus-specific, varicella-specific, and measles-specific immunoglobulin G concentrations. ClinicalTrials.gov: NCT01908283. Results: Among the 306 adults assessed (median age 42.7 years old, 70% with Crohn's disease, 78% receiving immunosuppressive treatment), only 33% had an immunization record available. Absence of seroprotection against tetanus (6%) was associated with increasing age and absence of booster dose; absence of seroprotection against varicella (1%) or measles (3%) was exclusively observed in younger patients with Crohn's disease. There was no statistically significant difference in immunoglobulin concentrations among treatment groups. Although vaccinations are strongly recommended in IBD patients, the frequencies of participants with at least 1 dose of vaccine recorded were low for nearly all antigens: tetanus 94%, diphtheria 87%, pertussis 54%, poliovirus 22%, measles-mumps-rubella 47%, varicella-zoster 0%, Streptococcus pneumoniae 5%, Neisseria meningitidis 12%, hepatitis A 41%, hepatitis B 48%, human papillomavirus 5%, and tick-borne encephalitis 6%. Conclusions: Although many guidelines recommend the vaccination of IBD patients, disease prevention through immunization is still often overlooked, including in Switzerland, increasing their risk of vaccine-preventable diseases. Serological testing should be standardized to monitor patients' protection during follow-up as immunity may wane faster in this population. [ABSTRACT FROM AUTHOR]

Background: Patient care in ulcerative colitis (UC) remains challenging despite an array of established treatment options and emerging new therapies. The management of UC therapy should be guided by the endoscopic extent of inflammation, disease severity, and prognostic factors of poor outcome. Complete remission, defined as durable symptomatic and endoscopic remission without corticosteroid therapy, is the desired treatment goal. Summary: This review focuses on treatment recommendations for different clinical scenarios in moderate-to-severe UC: Active UC of any extent not responding to aminosalicylates, steroid-dependent UC, steroid-refractory UC, immunomodulator-refractory UC, and acute severe UC. Comprehensive treatment algorithms for daily clinical practice were developed based on published guidelines and current literature. Key Messages: While current treatment options including a number of biologicals and small molecules have evolved UC treatment to achieve sustained remission in a majority of patients, upcoming treatment options with different molecular pathways and different modes of actions will further increase the need for personalized medicine. [ABSTRACT FROM AUTHOR]

During the course of disease, a majority of inflammatory bowel disease (IBD) patients requires long-term immunosuppressive therapy with either immunomodulatory agents, biologics, or newer immunosuppressive therapies such as Vedolizumab, a selective α4β7 inhibitor, Ustekinumab, an IL 12/23 p40 inhibitor, or the Janus kinase inhibitor Tofacitinib. Due to this, they are at increased risk for infectious diseases, many of which are possible to prevent by vaccination. This review focuses on recommended vaccinations in IBD patients and stresses special issues which have to be paid attention to. The aim of the review is to increase gastroenterologists' awareness of the importance of vaccination and to stress why especially the gastroenterologist should assess the vaccination status of the patient and initiate vaccination as soon as diagnosis is established. [ABSTRACT FROM AUTHOR]

Background: Loss of response is frequently encountered in patients with inflammatory bowel disease (IBD) treated with antitumor necrosis factor (TNF) agents. Therapeutic drug monitoring (TDM) and antidrug antibody measurement are increasingly used in this setting. Methods: To establish a consensus on the use of TDM in the context of loss of response to anti-TNFs, we performed a vote using a Delphi-style process followed by an expert panel discussion among 8 IBD specialists practicing in Switzerland, Europe. Statements were rated on an even Likert-scale ranging from 1 (strong disagreement) to 4 (strong agreement), based on expert opinion and the available literature. Results: The experts agreed on the following statements: (i) loss of response is associated with inadequate drug levels in both Crohn's disease and ulcerative colitis; (ii) best timepoint for measuring drug levels is prior to the next application (= trough levels) with different thresholds for anti-TNF agents (infliximab 5 μg/mL, adalimumab 8 μg/mL, certolizumab pegol 10 μg/mL); (iii) antidrug antibodies are predictive for loss of response; and (iv) antidrug-antibody titers and drug trough levels are key determinants in the treatment algorithm. Data about non-anti-TNF biologics were considered too limited to propose recommendations. Conclusion: A Delphi-style consensus among 8 IBD experts shows that TDM and measurement of antidrug-antibody titers are useful in the context of loss of response to anti-TNF. Optimal cutoff levels depend on the type of anti-TNF. These values are critical in the decision making process. More studies are needed to address the value of such measurements for non-anti-TNF biologics. [ABSTRACT FROM AUTHOR]

Background: Patient-reported experience is an important component of a holistic approach to quality of care. Patients’ expectations of treatments and global disease management may indicate their illness representations and their satisfaction and hopes regarding quality of care. Objective: To study expectations of patients with inflammatory bowel disease. Methods: Two focus groups were conducted with 14 patients to explore their expectations about treatments and disease management. From qualitative content analyses of focus group discussions, we built a 22-item expectations questionnaire that was sent to 1756 patients of the Swiss IBD cohort. Answers were collected on a visual analog scale from 0 to 100, and medians (interquartile range [IQR]) calculated. Factor analysis identified main expectation dimensions, and multivariate analyses were performed to describe associations with patient characteristics. Results: Of 1094 patients (62%) included in the study, 54% were female, 54% had Crohn’s disease, 35% had tertiary education, and 72% were employed. Expectation dimensions comprised realistic, predictive, and ideal expectations and were linked to information, communication, daily care, and disease recognition. Half (11 of 22) of the expectations were ranked as very high (median score > 70), the 2 most important being good coordination between general practitioners and specialists (median score: 89, IQR: 71–96) and information on treatment adverse events (89, IQR: 71–96). Women had overall higher levels of expectations than did men. Expectations were not associated with psychosocial measures, except those related to disease recognition, and most of them were highly associated with increased concerns on disease constraints and uncertainty. Conclusions: Patients have high expectations for information and communication among caregivers, the levels varying by gender and region. Patients also appear to request more active participation in their disease management. [ABSTRACT FROM AUTHOR]

Background: Patient-reported disease perceptions are important components to be considered within a holistic model of quality of care. Gender may have an influence on these perceptions. We aimed to explore gender-specific concerns of patients included in a national bilingual inflammatory bowel disease cohort. Methods: Following a qualitative study, we built a questionnaire comprising 37 items of concern. Answers were collected on a visual analog scale ranging from 0 to 100. Principal axis factor analysis was used to explore concern domains. Linear multiple regressions were conducted to assess associations with patient characteristics. Results: Of 1102 patients who replied to the survey, 54% were female and 54% had Crohn’s disease. We identified six domains of concern: socialization and stigmatization, disease-related constraints and uncertainty, symptoms and their impact on body and mind, loss of body control (including sexuality), disease transmission, and long-term impact of the disease. Cancer concerns were among the highest scored by all patients (median 61.8). Severity of symptoms was the only factor associated with concerns, unrelated to dimension and gender (p<0.015). In women, being >40 years decreased disease-related constraints and uncertainty concerns, and being at home or unemployed increased them. Treatments were associated with increased socialization and stigmatization and with increased disease-related constraints and uncertainty concerns in men. Overall, psychosomatic characteristics were highly associated with concerns for both men and women. Depending on the concern dimensions, increased levels of concern were associated with the highest signs of anxiety in women or depression in men, as well as lower health-related quality of life in men. Conclusions: Patients have numerous concerns related to their illness that need to be reassessed regularly. Concerns differ between men and women, suggesting that information and communication about the disease should take gender differences and subjective perceptions of quality of life into consideration. [ABSTRACT FROM AUTHOR]

Background:Perceptions of appropriateness of treatments may differ between gastroenterologists (GIs) and inflammatory bowel disease (IBD) patients. The aim of this study was to explore and compare GIs’ and patients’ perceptions of risks and benefits of treatments and prioritization of expected outcomes. Methods:Four vignette cases were drawn from clinical situations and used in three independent focus groups with GIs (n = 7), ulcerative colitis (UC-p,n = 8) and Crohn’s disease patients (CD-p,n = 6). Content analysis was performed based on the conversation transcripts. Results:UC-p agreed more often with GIs’ treatment choices than CD-p. CD-p often considered 5-ASA as a placebo. UC-p saw topical 5-ASA as a temporary solution, neither comfortable nor practical when professionally active. Azathioprine was considered as the treatment for which the risks versus benefits were perceived as the highest. The main risk perceived by patients on anti-TNFs was a potential loss of response. Divergences were observed on 1) stop of treatment: UC-p did not easily concur with stopping a treatment, which differed from GIs’ expectation of patients’ perceptions; CD-p were more prone to consider stopping treatment than GIs, 2) perception of outcomes: physicians had a focus on long-term objective goals. Patients’ expectations were of shorter term and mainly concerned stress management, nutritional advice, and information on the treatments effects. Conclusions:Overall, patients and GIs agreed on perceptions of IBD treatments. GIs seemed more concerned about objective and scientific measures of remission whereas patients focused on quality of life and social outcomes when it came to evaluating a therapy. [ABSTRACT FROM PUBLISHER]

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. [ABSTRACT FROM AUTHOR]