Biologic Therapy for Ulcerative Colitis.

Five biologics are approved for the treatment of ulcerative colitis (UC): infliximab, adalimumab, golimumab, vedolizumab, and ustekinumab. These drugs have varying levels of efficacy and are recommended as first-line treatment of moderate to severe UC. There has been only 1 head-to-head trial comparing the efficacy of the biologics, adalimumab and vedolizumab, which has important implications for management. Therapeutic drug monitoring of biologics, especially anti-TNF alpha agents, may improve the long-term efficacy of these agents. The future of treatment may include personalization of medications, based on patient-specific and disease-specific characteristics as well as biomarkers, along with appropriate therapeutic drug monitoring.

Effects of introduction of an inflammatory bowel disease nurse position on the quality of delivered care.

BACKGROUND AND AIMS: Inflammatory bowel diseases (IBDs) are chronic gastrointestinal conditions requiring long-term outpatient follow-up, ideally by a dedicated, multidisciplinary team. In this team, the IBD nurse is the key point of access for education, advice, and support. We investigated the effect of the introduction of an IBD nurse on the quality of care delivered. METHODS: In September 2014, an IBD nurse position was instituted in our tertiary referral center. All contacts and outcomes were prospectively recorded over a 12-month period using a logbook kept by the nurse. RESULTS: Between September 2014 and August 2015, 1313 patient contacts were recorded (42% men, median age: 38 years, 72% Crohn's disease, 83% on immunosuppressive therapy). The contacts increased with time: Q1 (September-November 2014): 144, Q2: 322, Q3: 477, and Q4: 370. Most of the contacts were assigned to scheduling of follow-up (316/1420), start of new therapy (173/1420), therapy follow-up (313/1420), and providing disease information (227/1420). In addition, 134 patients contacted the IBD nurse for flare management and a smaller number for administrative support, psychosocial support, and questions about side effects. During the study period, 30 emergency room and 133 unscheduled outpatient visits could be avoided through the intervention of the IBD nurse. A faster access to procedures and other departments could be provided for 136 patients. CONCLUSION: The role of IBD nurses as the first point of contact and counseling is evident from a high volume of nurse-patient interactions. Avoidance of emergency room and unscheduled clinic visits are associated with these contacts.

Costs of ulcerative colitis from a societal perspective in a regional health care area in Spain: A database study.

OBJECTIVES: To estimate the management of UC associated costs from the societal perspective in Spain. METHODS: Observational, longitudinal study with retrospective data collection based on reviews of outpatient health records. Socio-demographic, clinical and sick leave information was gathered. Patients diagnosed of UC between 2002 and 2012, older than 18 years, followed-up by a minimum of 12 months post diagnosis, with at least two clinical and use of resources data recorded, were included. RESULTS: 285 UC patients [51.2% men; 44.5 (SD: 15.6) years old; 88.4% without family history of UC; 39.3% proctitis; 5.6 (2.5) years disease follow-up] participated. More than half (65.6%) were active workers, 75.9% were on sick leave for reasons different from UC [mean 0.66 (0.70) times per year] during (mean) 28.43 (34.45) days. Only 64 patients were on UC-related sick-leaves, lasting (mean) 26.17 (37.43) days. Absenteeism due to medical visits caused loss of 29.55 (21.38) working hours per year. Mean direct and indirect annual cost per UC patient were €1754.10 (95%CI: 1473.37-2034.83) and €399.32 (282.31-422.69), respectively. Absenteeism was estimated at €88.21(32.72-50.06) per patient per year, in which sick-leaves were the main component of indirect costs (88.2%). Age, UC family history, diarrhea at diagnosis, blood and blood-forming organs diseases and psychological disorders were the main predictors of indirect costs. CONCLUSIONS: UC is a costly disease for the society and the Spanish National Healthcare System. Indirect costs imply a major burden by affecting the most productive years of patients. Further research is needed considering all components of productivity loss, including presenteeism-associated costs.

Cost-effectiveness of infliximab for the treatment of acute exacerbations of ulcerative colitis.

BACKGROUND: Infliximab has been shown to be efficacious in acute exacerbations of ulcerative colitis (UC). AIM: To evaluate the cost-effectiveness of infliximab treatment in patients hospitalised with acute exacerbations of UC. METHODS: A decision analysis model was constructed to simulate the progression of acute UC patients treated with infliximab induction regimen over 1 year. Infliximab treatment was compared with standard care, ciclosporin and surgery using transitions derived from infliximab and ciclosporin randomised trials. Costs and outcomes were discounted at 3.5%. Intermediate outcomes of colectomy and post-surgery complications were translated into the primary effectiveness measurement, which was quality-adjusted life years (QALYs) estimated using EQ-5D. One-way and probabilistic sensitivity analyses were performed to estimate the uncertainty around the results. RESULTS: The incremental cost effectiveness ratio (ICER) for infliximab was pound19,545 per QALY compared to ciclosporin, which in turn dominated standard care. Sensitivity analysis indicated patient body weight, utility estimates and treatment effect of alternative treatment strategies to be the most important factors affecting cost-effectiveness. CONCLUSION: Infliximab induction regimen appears to be a cost-effective treatment option for UC patients hospitalised with an acute exacerbation.

A review of infliximab use in ulcerative colitis.

BACKGROUND: Infliximab is a chimeric immunoglobulin G1kappa monoclonal antibody that binds with high affinity and specificity to the soluble form of tumor necrosis factor (TNF)-alpha, preventing it from binding to cellular receptors. Infliximab also binds to membranebound TNF-alpha found on inflammatory cell surfaces, inducing apoptosis. Currently, infliximab is used for the induction and maintenance of remission in Crohn's disease (CD), with documented success. Infliximab's efficacy in the treatment of ulcerative colitis (UC) is now being investigated due to the similarities in the pathophysiology of CD and UC. OBJECTIVE: The aim of this study was to review and evaluate the current literature of infliximab use in steroid-refractory UC to assess its role in treatment. METHODS: A search of MEDLINE was conducted (1950-November 2007). Key terms included, but were not limited to, infliximab, inflammatory bowel disease, ulcerative colitis, cost, and quality of life. Studies included for review were limited to English-language, full-text, randomized, double-blind, placebo-controlled trials. Clinical trials were reviewed and summarized. RESULTS: Four controlled clinical trials of infliximab in the treatment of steroid-refractory UC were found and assessed. In a double-blind, randomized, controlled trial in 43 patients with moderately severe, glucocorticoid-resistant UC, infliximab and placebo were not significantly different with respect to clinical and sigmoidoscopic remission or quality of life 2 and 6 weeks after infliximab treatment. In a multicenter, randomized, double-blind, placebo-controlled study in 45 patients with moderately severe to severe glucocorticoid-resistant UC, infliximab was associated with a significantly reduced need for colectomy compared with placebo (29% vs 67%; P=0.017). The Active Ulcerative Colitis Trials (ACT) 1 and 2 together included 728 patients with moderate to severe glucocorticoid-resistant UC. The primary outcome, the rate of clinical response at 8 weeks, was significantly higher with infliximab compared with placebo (5 mg/kg: ACT 1, 69.4%, ACT 2, 64.5%; 10 mg/kg: ACT 1, 61.5%, ACT 2, 69.2%; placebo: ACT 1, 37.2%;, ACT 2, 29.3%; all, P < 0.001 vs placebo). Based on the data from ACT 1 and 2, infliximab was associated with improved health-related quality-of-life (HRQOL) scores based on the Inflammatory Bowel Disease Questionnaire and the 36-item Short Form Health Survey. CONCLUSIONS: Current data suggest that infliximab is an effective alternative treatment option for patients with moderate to severe UC with an inadequate response to conventional glucocorticoid treatment. Further trials are needed to assess infliximab's impact on the treatment and progression of UC, the HRQL of patients with UC, and the economic impact on the health care system.