Despite patients being treated early and frequently with immunomodulators and biological therapy in Western Europe, 5-year outcomes including surgery and phenotype progression in this cohort were comparable across Western and Eastern Europe. Differences in treatment strategies between Western and Eastern European centres did not affect the disease course. Treatment with immunomodulators reduced the risk of surgery and hospitalisation.
tain remission in Crohn disease is an unmet medical need. Although formulations of 5-aminosalicylic acid agents remain widely used for this purpose, strong evidence exists that they are not effec-tive. 1 Immunosuppressive agents such as purine antimetabolites, 2,3 methotrexate, 4 and tumor necrosis factor ␣ antagonists 5-8 are moderately effective for maintaining remission; however, their use is associated with an increased risk of infection. 9-11 Therefore, development of a safe, inexpensive, and effective orally administered agent is a research priority.Omega-3 free fatty acids are antiinflammatorysubstancesfoundinmarine fishthathaveseveralhealthbenefits.These compounds have been used to treat inflammatorydisorderssuchasrheumatoid See also Patient Page.
Objectives: To determine the therapeutic equivalence and safety of once daily (OD) versus three times daily (TID) dosing of a total daily dose of 3 g Salofalk (mesalazine) granules in patients with active ulcerative colitis. Design: A randomised, double-blind, double-dummy, parallel group, multicentre, international, phase III noninferiority study. Setting: 54 centres in 13 countries. Patients: 380 patients with confirmed diagnosis of established or first attack of ulcerative colitis (clinical activity index (CAI).4 and endoscopic index >4 at baseline) were randomised and treated. Interventions: 8-week treatment with either 3 g OD or 1 g TID mesalazine granules. Main outcome measures: Clinical remission (CAI(4) at study end. Results: 380 patients were evaluable for efficacy and safety by intention-to-treat (ITT); 345 for per protocol (PP) analysis. In the ITT population, 79.1% in the OD group (n = 191) and 75.7% in the TID group (n = 189) achieved clinical remission (p,0.0001 for non-inferiority). Significantly more patients with proctosigmoiditis achieved clinical remission in the OD group (86%; n = 97) versus the TID group (73%; n = 100; p = 0.0298). About 70% of patients in both treatment groups achieved endoscopic remission, and 35% in the OD group and 41% in the TID group achieved histological remission. About 80% of all patients preferred OD dosing. Similar numbers of adverse events occurred in 55 patients (28.8%) in the OD group and in 61 patients (32.3%) in the TID group, indicating that the two dosing regimens were equally safe and well tolerated. Conclusions: OD 3 g mesalazine granules are as effective and safe as a TID 1 g schedule. With respect to the best possible adherence of patients to the treatment, OD dosing of mesalazine should be the preferred application mode in active ulcerative colitis.
ClinicalTrials.gov Identifier: NCT00449722Aminosalicylates (mesalazine, sulfasalazine, olsalazine, balsalazide) have been the mainstay of inflammatory bowel disease treatment for over 60 years.1 These drugs are prescribed for active disease as well as for relapse prevention in both ulcerative colitis and in Crohn's disease. Aminosalicylates are the undisputed ''gold standard'' for maintaining remission in ulcerative colitis.2-4 Furthermore, they may have chemopreventive properties against colorectal cancer.
5Conventionally, a multiple daily dosing regimen of aminosalicylates is established. This is a demanding drug regimen, which can interfere with the everyday life of a patient, and can therefore reduce the quality of life. Moreover, the inconvenience of this dosing regimen can have a negative impact on adherence to the drugs, and thus, can lead to a poorer long-term prognosis. Adherence rates in prospective, community-based studies range from 40 to 60%, 6 7 and are particularly poor among patients in remission. [8][9][10][11] Three times per day (TID) dosing of mesalazine was the most significant risk factor for partial non-compliance. A total of 57% of patients who were prescribed mesalazine TID...
These analyses reveal important interactions of patients' geographical origin and disease in the interpretation of disease-associated changes in microbial communities and highlight the added value of analysing communities on both the 16S rRNA gene (DNA) and transcript (RNA) level.
Background and aims: Few population-based cohort studies have assessed the disease course of ulcerative colitis (UC) in the era of biological therapy and widespread use of immunomodulators. The aim of this study was to assess the five-year outcome and disease course of patients with UC in the Epi-IBD cohort. Methods: In a prospective, population-based inception cohort of unselected patients with UC patients were followed-up from the time of their diagnosis, which included the collection of their clinical data, demographics, disease activity, medical therapy, and rates of surgery, cancers and deaths. Associations between outcomes and multiple covariates were analysed by Cox regression analysis. Results: A total of 717 patients were included in the study. During follow-up, 43 (6%) patients underwent a colectomy, while 163 (23%) patients were hospitalized. Of patients with limited colitis (distal to the left flexure), 90 (21%) progressed to extensive colitis. In addition, 92 (27%) patients with extensive colitis experienced a regression in disease extent, which was associated with a reduced risk of hospitalization (HR: 0.5 CI95% 0.3-0.8). Overall, patients were treated similarly in both geographical regions and 80 (11%) patients needed biological therapy while 210 (29%) patients received immunomodulators. Treatment with immunomodulators was found to reduce the risk of hospitalization (HR: 0.5 CI95% 0.3-0.8). Conclusions: While patients in this population-based cohort were treated more aggressively with immunomodulators and biological therapy than in cohorts from the previous two decades, their disease outcomes including colectomy rates were no different. However, treatment with immunomodulators was found to reduce the risk of hospitalization.
scite is a Brooklyn-based organization that helps researchers better discover and understand research articles through Smart Citations–citations that display the context of the citation and describe whether the article provides supporting or contrasting evidence. scite is used by students and researchers from around the world and is funded in part by the National Science Foundation and the National Institute on Drug Abuse of the National Institutes of Health.