Adherence of gastroenterologists to European Crohn's and Colitis Organisation Consensus on Crohn's disease: A real-life survey in Spain

BackgroundThere is no information as to the extent by which Spanish gastroenterologists adhere to Crohn's disease (CD) management guidelines. The objective of this study was to evaluate the degree of adherence of Spanish gastroenterologists to the European Crohn's and Colitis Organisation (ECCO) guidelines and to determine whether differences in adherence exist between gastroenterologists specialized in inflammatory bowel diseases (GSIBDs) and general gastroenterologists (GGs).MethodsThis was a prospective, nation-wide, questionnaire-based survey covering aspects related to diagnosis, treatment, follow-up, and safety considered by the physicians in their daily management of CD, as well as demographic traits seen in clinical practice.ResultsThe overall degree of adherence to guidelines by both GSIBDs and GGs was high. However, the use of imaging techniques in diagnosis, follow-up, and in relapsed patients differed between the two groups. In the diagnosis of perianal disease, GSIBDs used magnetic resonance and surgical exploration under anesthesia more frequently than GGs. In terms of therapeutic choices, the adherence to guidelines was good in both groups. However, GSIBDs showed significantly higher adherence in some areas: thiopurines were used less in refractory cases and methotrexate was used more commonly in corticoid-dependent, azathioprine-intolerant patients, and in patients under biological treatment. Request for infection studies and vaccinations at diagnosis or prior to treatment was more common among GSIBDs.ConclusionsGuideline adherence among Spanish gastroenterologists is high. However, there are significant differences between IBD-specialized (more adherent in general) and non-specialized gastroenterologists.     

Clinicians’ adherence to international guidelines in the clinical care of adults with inflammatory bowel disease

Background: Although evidence-based guidelines have been developed for inflammatory bowel disease (IBD), the extent to which they are followed is unclear. The objective of this study was to review clinicians’ adherence to international IBD guidelines.

Methods: Retrospective data collection of patients attending a tertiary Australian hospital IBD clinic over a 12-month period. Management practices were audited and compared to ECCO (European Crohn’s and Colitis Organization) guidelines.

Results: Data from 288 patients were collected: 47% (136/288) male; mean age 43; 140/288 (49%) patients had ulcerative colitis (UC); 145/288 (50%) patients had Crohn’s disease (CD); 3/288 (1%) patients had IBD-unclassified (IBD-U). Patient care was undertaken by gastroenterologists, trainees and general practitioners. Disease Management: Overall adherence to disease management guidelines occurred in 204/288 (71%) of patient encounters. Discrepancies between guidelines and management were found in: 25/80 (31%) of patients with UC in remission receiving oral 5-aminosalicyclates (5-ASAs) as maintenance therapy, and; 46/110 (42%) of patients with small bowel and/or ileo-cecal CD receiving 5-ASA. Preventive Care: Adherence to ≥1 additional component of preventive care was observed in 73/288 (25%) of patient encounters: 12/133 (9%) on thiopurines underwent annual skin checks; 61/288 (21%) of patients with IBD underwent a bone scan; 46/288 (16%) patients were reminded to have their influenza vaccine. Psychological care: Assessment of psychological wellbeing was undertaken in only 16/288 (6%) of patients.

Conclusions: There remains a gap between adherence to international guidelines and clinical practice. Standardizing practice using evidence-based clinical pathways may be a strategy towards improving the quality of IBD outpatient management.     

Algorithms to facilitate shared decision-making for the management of mild-to-moderate ulcerative colitis

ABSTRACT

Introduction: Nonadherence has been a key barrier to the efficacy of medical treatments in ulcerative colitis (UC). Engaging patients in their IBD care via shared decision-making (SDM) to facilitate self-management may improve adherence to therapy.

Areas covered: This review aims to summarize the most recent trial evidence from 2012 to 2017 for mild-to-moderate UC in order to develop clinical algorithms that guide SDM to facilitate self-management. A structured literature search via multiple electronic databases was performed using the search terms ‘ulcerative colitis,’ ‘treatment,’ ‘management,’ ‘medication,’ ‘maintenance,’ ‘remission,’ ‘5-ASA,’ and ‘inflammatory bowel disease.

Expert commentary: Novel formulations of existing oral and topical medications have expanded the treatment options available for the induction and maintenance therapy for mild-to-moderate UC. Daily dosing of 5-ASA therapy is equivalent to twice daily dosing. The combination therapies of oral plus topical 5-ASA therapy and 5-ASA plus corticosteroid therapy are more effective than monotherapy. Budesonide MMX now plays a role in the management of mild-to-moderate UC. This review collates the evidence on drug efficacy and safety, adherence and tolerability, and noninvasive monitoring of mild-to-moderate UC into SDM-orientated algorithms to facilitate self-management.     

CED: Standards in Diagnostik und Therapie

Over the last few years, German and European guidelines on Crohn’s disease (CD) and ulcerative colitis (UC) were developed. With regard to diagnostics, infectious causes, particularly Clostridium and cytomegalovirus, must be excluded initially and whenever patients do not respond to standard therapy. Acute flare-ups of UC are treated with 5-aminosalicylates (5-ASA) and/or corticosteroids either locally (enema, foam, or suppository), systemically, or both. For CD, oral steroids (e.g. budesonide) are preferred; 5-ASA play only a minor role. For maintenance, smokers with CD are strongly recommended to stop smoking. Steroids have no role in maintenance therapy. 5-ASA and azathioprine are recommended for maintenance of UC, and azathioprine also for CD. Refractory courses require methotrexate and anti-tumor necrosis factor-alpha antibodies, and surgery should always be discussed as alternative treatment in these patients. High-grade dysplasias or malignancy should always lead to proctocolectomy with construction of a pouch.     

Adherence to surveillance guidelines for dysplasia and colorectal carcinoma in ulcerative and Crohn''s colitis patients in the Netherlands

AIM: To study adherence to the widely accepted surveillance guidelines for patients with long-standing colitis in the Netherlands. METHODS: A questionnaire was sent to all 244 gastroenterologists in the Netherlands. RESULTS: The response rate was 63%. Of all gastroenterologists, 95% performed endoscopic surveillance in ulcerative colitis (UC) patients and 65% in patients with Crohn's colitis. The American Gastroenterological Association (AGA) guidelines were followed by 27%, while 27% and 46% followed their local hospital protocol or no specific protocol, respectively. The surveillance was correctly initiated in cases of pancolitis by 53%, and in cases of left-sided colitis by 44% of the gastroenterologists. Although guidelines recommend 4 biopsies every 10 cm, less than 30 biopsies per colonoscopy were taken by 73% of the responders. Only 31%, 68% and 58% of the gastroenterologists referred patients for colectomy when low-grade dysplasia, high-grade dysplasia (HGD) or Dysplasia Associated Lesion or Mass (DALM) was present, respectively. CONCLUSION: Most Dutch gastroenterologists perform endoscopic surveillance without following international recommended guidelines. This practice potentially leads to a decreased sensitivity for dysplasia, rendering screening for colorectal cancer in this population highly ineffective.     

Long-term intermittent treatment with low-dose 5-aminosalicylic enemas is efficacious for remission maintenance in ulcerative colitis

BACKGROUND: The standard remission maintenance treatment for ulcerative colitis (UC) is 5-amino-salicylic acid (5-ASA), given orally and topically and in different doses, with various frequencies and duration of administration. Both the efficacy of long-term intermittent therapy with low-dose 5-ASA enemas in preventing UC relapses and its economic implications were evaluated. METHODS: In accordance with a prospective case control study, 42 adult UC outpatients (29 M and 13 F) were treated with 5-ASA tablets (1.6 g/day) and 5-ASA enemas (2 g/50 mL) twice weekly, and 42 concurrent UC outpatients, matched for sex, age, extension and duration of disease, received only the oral therapy; the median treatment period was 6 years. RESULTS: There was a significant reduction in the number (42%: P = 0.034) and incidence of relapses (43%: P = 0.022) in the patients receiving combined oral + topical 5-ASA, who also had a significantly higher cumulative probability of not experiencing a first relapse (P = 0.001). There were no dropouts or side effects. Local therapy increased drug costs, but decreased the costs of relapses by 48% and completely precluded hospitalization costs. CONCLUSIONS: The scheduled oral + topical 5-ASA treatment, at the lowest cumulative topical dosage tested over the longest known observation period, is efficacious in improving clinical outcome and decreasing overall costs in UC patients.     

Topische Therapie bei chronisch-entzündlichen Darmerkrankungen

Ulcerative colitis is a disease with increasing incidence and prevalence in the western world and also in developing countries. The mainstay of therapy is 5 aminosalicylic acid (5-ASA). Frequently only oral therapy is used in patients with ulcerative colitis (UC); however, there is excellent evidence that topical (rectal) therapy is more effective than oral/systemic therapy especially in left sided colitis. In general, data from cohort studies and center-based investigations indicate that topical therapy is underused in patients with UC. A combination of oral and topical rectal therapy is usually preferable, especially in severe colitis. This review aims to clarify the evidence for topical therapies containing 5-ASA and steroids for patients with ulcerative colitis for an optimization of therapy with satisfying compliance. Patient acceptance of topical therapies is much better after adequate information than generally expected. The evidence for topical therapies in Crohn’s disease is weak.     

Topische Therapie bei chronisch-entzündlichen Darmerkrankungen

Ulcerative colitis is a disease with increasing incidence and prevalence in the western world and also in developing countries. The mainstay of therapy is 5 aminosalicylic acid (5-ASA). Frequently only oral therapy is used in patients with ulcerative colitis (UC); however, there is excellent evidence that topical (rectal) therapy is more effective than oral/systemic therapy especially in left sided colitis. In general, data from cohort studies and center-based investigations indicate that topical therapy is underused in patients with UC. A combination of oral and topical rectal therapy is usually preferable, especially in severe colitis. This review aims to clarify the evidence for topical therapies containing 5-ASA and steroids for patients with ulcerative colitis for an optimization of therapy with satisfying compliance. Patient acceptance of topical therapies is much better after adequate information than generally expected. The evidence for topical therapies in Crohn’s disease is weak.     

Differences in the management of pediatric and adult onset ulcerative colitis — lessons from the joint ECCO and ESPGHAN consensus guidelines for the management of pediatric ulcerative colitis

An expert panel of the European Crohn's and Colitis Organisation (ECCO) and European Society of Pediatric Gastroenterology, Hepatology and Nutrition (ESPGHAN) initiated a consensus process to produce the first pediatric specific ulcerative colitis (UC) guidelines based on a systematic literature review. Treatment strategies must reflect that pediatric-onset UC has a slightly different phenotype than adult-onset disease with more often extensive (pancolitis) and more aggressive disease course. Other pediatric-specific aspects include growth, puberty, bone density accrual and emotional development and body image acquisition. These differences and others influenced the development of pediatric treatment algorithms. It is recommended that virtually all children with UC must be treated with some maintenance therapy and 5-ASA requirement and dosing are often higher in children. A larger number of children are at risk for steroid-dependency, and this should not be tolerated; steroid sparing strategies with early use of immunosuppressors are recommended in high-risk patients. On the other hand, the safety profile of immunosuppressive therapy in children includes the rare forms of lymphomas and many future treatment years. Colectomy and pouch formation should be balanced in the treatment algorithms against the higher rate of future infertility in girls. The acute and on-going management of pediatric UC should be guided by evidence- and consensus-based balanced decisions, reflecting a vision of long-term treatment goals.     

Clinical features and course of ulcerative colitis diagnosed in asymptomatic subjects

Background and AimsAlthough some ulcerative colitis (UC) patients are diagnosed when they do not have any UC-related symptoms, clinical features and prognosis of UC diagnosed in asymptomatic patients remain unclear.MethodsData for UC patients who were asymptomatic at diagnosis were retrospectively reviewed from the IBD database of the Asan Medical Center. The clinical characteristics and prognosis of those patients were analyzed and compared with matched (1:4) symptomatic UC patients.ResultsOnly nineteen asymptomatic UC patients (1.1%) were identified from 1665 UC patients. The proportion of males was 78.9% (n = 15), and their median age at diagnosis was 48 years (range, 34–71 years). At diagnosis, proctitis was noted in 11 patients (57.9%), left-sided colitis in 4 (21.1%), extensive colitis in 0 (0%), and atypical distribution in 4 (21.1%). The 5-year cumulative probability of symptom development was 68.5% (95% confidence interval [CI], 62.8%–74.2%). After UC diagnosis, oral 5-aminisalicylic acid (ASA) and topical 5-ASA were used in 14 (73.7%) and 16 (84.2%) patients, respectively. During follow-up (3.7-year median for asymptomatic patients versus 3.7-year median for symptomatic patients; P = 0.961), the 5-year cumulative probability of corticosteroids (23.7% versus 57.1%; P = 0.022) and azathioprine (0% versus 24.7%; P = 0.003) use was higher in symptomatic patients than in asymptomatic patients.ConclusionsThe frequency of asymptomatic UC patients was 1.1% in our UC patient cohort. A majority of these patients became symptomatic during follow-up. Asymptomatic UC patients at diagnosis appear to have a better prognosis than symptomatic UC patients.     

Topical therapy is underused in patients with ulcerative colitis

The availability of new topical preparations for the treatment of left sided ulcerative colitis offers a therapy optimization for many patients. Rectal application of steroids and 5-aminosalicylic acid (5-ASA) is associated with fewer side effects and has a higher therapeutic efficacy in left-sided colitis as compared to a systemic therapy. Therefore, we were interested in the use of topical therapy in patients with ulcerative colitis. The key question was whether topical treatment is more frequently used than oral therapy in patients with proctitis and left sided colitis. Data of 800 patients of the Swiss IBD cohort study were analyzed.Sixteen percent of patients of the cohort had proctitis, 21% proctosigmoiditis and 41% pancolitis. Topical therapy with 5-ASA or corticosteroids was given in 26% of patients with proctitis, a combined systemic and topical treatment was given in 13%, whereas systemic treatment with 5-ASA without topical treatment was given in 29%. Proportion of topical drug use decreased with respect to disease extension from 39% for proctitis to 13.1% for pancolitis (P = 0.001). Patients with severe colitis received a significantly higher dose of topical 5-ASA than patients in remission.Side effects of topical or systemic 5-ASA or budesonide treatment were less frequently seen compared to other medications. Topical treatment was frequently stopped over time. The quality of life was the same in patients with limited disease compared to patients with pancolitis.Topical treatment in proctitis patients was underused in Switzerland. Since topical treatment is safe and effective it should be used to a larger extend.     

Adherence,risk factors of non-adherence and patient’s preferred treatment strategy of mesalazine in ulcerative colitis: multicentric observational study

Objectives: Compliance to therapy is a key factor in the efficacy of treatment in clinical practice. The aim of our study was to evaluate the rate of compliance with mesalazine in patients with ulcerative colitis (UC), to examine risk factors of noncompliance and especially find ways on how adherence can be improved.

Materials and methods: A total of 198 outpatients with UC completed two anonymous questionnaires including information on basic demographics, details of patient´s disease and the use of mesalazine medication and quality of life.

Results: We found noncompliance (percentage of used medication per day less than 80%) with 5-ASA in 21.2% patients. Our study proved that the education level of patients significantly influenced the compliance of patients using mesalazine. A significant difference (p?=?.014) was found between the compliance of patients with secondary school education (84.1?±?16.73) and those with university education (94.1?±?9.9). The majority of patients preferred mesalazine once daily and are less likely to forget to take medication in the morning. Better quality of life was observed based on our data from WHOQOL-BREF questionnaire in statistically significant way in patients using concomitant therapy of immuosuppressive or biological therapy, lower daily doses and using sachets not tablets.

Conclusions: Our study proved that compliance with mesalazine in patients with UC was related only to education level. If we target mesalazine therapy based on patient’s preferences, we can improve the adherence with mesalazine. Our data could be beneficial for the treatment strategy in clinical practice.     

Low colectomy rate five years after diagnosis of ulcerative colitis. Results from a prospective population-based cohort in Sweden (ICURE) diagnosed during 2005–2009*

Objective: The medical treatment of ulcerative colitis (UC) has seen a change towards a more active attitude during recent years, including both the use of more traditional drugs as well as new biological substances. In this epidemiological study we have evaluated the results of modern treatment of UC in a population-based cohort of patients including all age groups, with regard to relapse rate, colectomy and IBD-associated mortality.

Material and methods: Patients diagnosed with UC in the Uppsala health care region in the middle of Sweden during 2005–2009 were included in the study. Out of 524 patients, 491 (93%) could be followed for five full years or until death.

Results: Nineteen patients (3.9%) had died and two of these deaths could be attributed to UC (one postoperative death and one colonic carcinoma). The following drugs were used by the patients during the study period: 5-ASA (91%), systemic steroids (66%), immunomodulators (IMM), mainly thiopurines (26%) and anti-TNF (11%). During the observation period, 74% experienced at least one relapse and 5.3% were subjected to colectomy. Among patients?<17 years at diagnosis, colectomy was performed in two (4.8%).

Conclusions: Five years after diagnosis of ulcerative colitis, 5.3% had been subjected to colectomy and two patients (0.38%) had died because of the disease.     

The use of oral corticosteroids in inflammatory bowel diseases in Italy: An IG-IBD survey

AimTo evaluate how Italian gastroenterologists use corticosteroids in clinical practice for the treatment of Crohn’s disease (CD) and ulcerative colitis (UC).Material and methodsAll members of the Italian Group for Inflammatory Bowel Disease (IG-IBD) were invited to fill in a web-based questionnaire.Results131/448 (29.2%) members completed the survey. In mild-to-moderate UC and CD relapses, low-bioavailability steroids (LBS) are first-line therapy for 37% and 42% of clinicians, respectively. In case of failure, immediate step-up to biologics or immunosuppressants is considered by 23% and 29%. Regarding conventional corticosteroids (CCS), a fixed starting dose is prescribed by 50%, and a weight-based dose by 22%. Tapering is started after 7–10 days by 41% and after 14 days by 32%. The preferred tapering schedule is 5 mg/week. In case of CCS failure, 47% switch to parenteral steroids before considering shifting to different drug classes. In case of symptoms recurrence during tapering, 14% re-increase the dose and try tapering again. Before prescribing steroids, 72% do not prescribe any specific evaluation whereas during treatment some evaluation is performed by 85%. Vitamin D and calcium supplements are routinely prescribed along with steroids by 38%.ConclusionsSeveral discrepancies and some deviation from the available guidelines were recorded among Italian gastroenterologists regarding corticosteroids use in IBD patients.     

Qualitative investigation of patient adherence to 5-aminosalicylic acid therapy in patients with ulcerative colitis

BACKGROUND: There has been a lack of qualitative research specifically in patients with inflammatory bowel disease relating to reasons for failure to take medication. We aimed to address this gap and also identify factors which might increase adherence. METHODS: Twenty-seven patients from 3 UK hospital sites (Leicester, Norwich, and Cardiff) were recruited to take part in a qualitative study based on semistructured interviews. RESULTS: A model was developed to illustrate the way in which patients appear to balance the benefits and disadvantages of taking 5-aminosalicylic acid (5-ASA) medication. The degree of information held by patients regarding ulcerative colitis (UC) and self-evaluation of the benefits of 5-ASA appears to impact whether patients accept or reject the medication. Decision-making on an ill-informed basis may be a factor leading to a reduction in adherence. Due to the nature of the condition, adherence levels may be affected by potential difficulties in terms of experiencing and understanding the links between the medication and health outcomes. CONCLUSIONS: Important determinants of adherence to 5-ASA medication in patients with UC appear to include the level of information provided and patient beliefs about prescribed 5-ASA. Patient adherence to 5-ASA requires encouragement and reinforcement and the patient-clinician relationship has a crucial role to play in this dynamic.     

Induction with NCB-02 (curcumin) enema for mild-to-moderate distal ulcerative colitis — A randomized,placebo-controlled,pilot study

Background and aimsCurcumin, an active ingredient of turmeric with anti-inflammatory properties, has been demonstrated to be useful in experimental models of ulcerative colitis (UC). It's efficacy in humans needs to be investigated.MethodsA randomized, double-blind, single-centre pilot trial was conducted in patients with distal UC (< 25 cm involvement) and mild-to-moderate disease activity. Forty-five patients were randomized to either NCB-02 (standardized curcumin preparation) enema plus oral 5-ASA or placebo enema plus oral 5-ASA. Primary end point was disease response, defined as reduction in Ulcerative Colitis Diseases Activity Index by 3 points at 8 weeks, and secondary end points were improvement in endoscopic activity and disease remission at 8 weeks.ResultsResponse to treatment was observed in 56.5% in NCB-02 group compared to 36.4% (p = 0.175) in placebo group. At week 8, clinical remission was observed in 43.4% of patients in NCB-02 group compared to 22.7% in placebo group (p = 0.14) and improvement on endoscopy in 52.2% of patients in NCB-02 group compared to 36.4% of patients in placebo group (p = 0.29). Per protocol analysis revealed significantly better outcomes in NCB-02 group, in terms of clinical response (92.9% vs. 50%, p = 0.01), clinical remission (71.4% vs. 31.3%, p = 0.03), and improvement on endoscopy (85.7% vs. 50%, p = 0.04).ConclusionIn this pilot study we found some evidence that use of NCB-02 enema may tend to result in greater improvements in disease activity compared to placebo in patients with mild-to-moderate distal UC. The role of NCB-02 as a novel therapy for UC should be investigated further.     

Does treatment schedule matter? Once daily versus divided doses of 5-ASAs

Sulfasalazine was the first 5-ASA used to treat ulcerative colitis (UC). Because of tolerability issues, it was administered in a three times a day schedule in order to try to minimize side effects. With the development of sulfa-free 5-ASA products, the controlled trials used historical clinical experience and in vitro pharmacokinetic studies to dose their therapies to perhaps be in the most favorable light possible. However, it became clear over the years that outside of the context of a clinical trial, t.i.d. or even q.i.d. dosing led to lower patient satisfaction and overall adherence. Research demonstrated that upwards of 40% of patients were not taking their maintenance 5-ASA, and many patients cited unintentional forgetfulness as the reason. It became clear that simplifying the regimen was paramount for acceptable outcomes. Early pilot data and then controlled trials demonstrated the efficacy and safety of twice daily 5-ASA for active and quiescent UC. Now several large controlled trials demonstrate the non-inferiority and increased patient adherence and satisfaction with once daily dosing. MMX mesalamine was the first 5-ASA to receive US FDA approval in a once daily regimen. Results from the PODIUM and QDIEM trials have demonstrated acceptable effectiveness rates with favorable side effect profiles. Adherence rates remain high in real-world settings when medication is given once daily and data now suggest that once daily may be more effective than more frequently. It thus appears that the majority of patients with UC, whether with active or quiescent disease, can be treated with once daily 5-ASA.