ECCO IBD Curriculum
6.3. Recognises the importance of patient choice in deciding therapy and in helping to ensure adherence.
This course has been developed for gastroenterologists, surgeons, paediatricians, pathologists and other interdisciplinary medical experts interested in Inflammatory Bowel Disease(s) (IBD). One major aim of this e-learning activity is to provide evidence-based guidance for clinical practice so that physicians can make informed decisions in partnership with their patients regarding their optimal exit strategies.
After this course you will:
- To recognise risks, benefits and timing of stopping anti-TNF used as monotherapy or in combination with IM in IBD.
- To know optimal monitoring following withdrawal of biologic therapy
This course has been developed by physicians who had recently participated in the writing of the ECCO Crohn's disease consensus Guidelines. This course is intended for those who are interested in Inflammatory Bowel Disease(s) (IBD). One major aim of this e-learning activity is to increase competence and knowledge with regard to Perianal disease in order to improve patient outcomes.
After this case you will:
- To appreciate the Crohn’s disease natural history
- To appreciate the rationale behind specific treatment decisions
- To understand the right investigations to prescribe to Crohn’s disease patient in specific settings
- To learn appropriate clinical management of Crohn’s disease patients with perianal involvement
This course has been developed by physicians who had recently participated in the writing of the ECCO Crohn's disease consensus Guidelines. This course is intended for those who are interested in Inflammatory Bowel Disease(s) (IBD). One major aim of this e-learning activity is to increase competence and knowledge with regard to Luminal disease in order to improve patient outcomes.
Upon completion of this case you will:
- Know the evidence for induction of remission in mild-to-moderate Crohn’s disease;
- Know the evidence for maintaining remission in Crohn’s disease;
- Know the evidence on how to react upon disease flares, immediately after induction therapy or during maintenance therapy;
- Understand the benefits and risks of several medical therapies;
- Achieve familiarity how to use immunomodulatory agents in mono- or combination therapy;
- Achieve familiarity how to monitor Crohn’s disease patients who initiated medical therapy or who underwent surgery;
- Recognise indications for surgical management.
This course is designed for gastroenterologists, surgeons, paediatricians, pathologists and other interdisciplinary medical experts interested in Inflammatory Bowel Disease(s) (IBD). One major aim of this e-learning activity is to increase competence and knowledge with regard to the prediction, diagnosis and management of Ulcerative Colitis (UC) patients and to harmonise diagnostics and treatment in order to improve patient outcomes.
Upon completion of this activity learners will:
- Have insights into the basic epidemiology of ulcerative colitis
- Know current treatment options for severe ulcerative colitis, including colectomy
- Be able to use ciclosporin correctly in severe ulcerative colitis
- Understand when to order thiopurine methyltransferase (TPMT) activity when starting azathioprine
An overview of the use of 5-ASA, steroids and immunomodulators in IBD
1. To understand the role of IL-12 and IL-23 in the development of IBD
2. To review the pivotal UNITI and UNIFI trials
3. To review the place of ustekinumab in IBD therapy
4. To have an overview on practical modalities of ustekinumab therapy
5. To get insight in the anti-IL23 drugs that are in development
1. To understand the mechanism of action of vedolizumab and other anti interns
2. To review the key phase III clinical data
3. To highlight studies from real world cohort and discuss the safety profile of Vedolizumab
4. To understand how to position Vedolizumab in clinical practice
1. Typical symptoms presented by a patient
2. Epidemiological IBD data from Austria
3. Ulcerative colitis: typical symptoms, endoscopy examples, complications, extraintestinal involvement, differential diagnoses
4. Crohn´s disease: typical symptoms, clinical investigation, typical endoscpy, differential diagnoses, environmental risk factors, extraintestinal complications
Inflammatory Bowel Diseases are chronic diseases often with complex treatment. The treatment is lifelong and complex and may include several different pharmaceutical groups and sometimes surgery. Not rarely is treatment resistance developed and the treatment may come with different degrees of side effects. Earlier research has shown insufficient to medication adherence and a lower degree of health-related quality of life in patients with inflammatory bowel disease.
The aim is to describe the relationship between medication adherence and health-related quality of life in a Swedish population diagnosed with inflammatory bowel disease. Additional research questions are if any risk factors of low medication adherence can be identified from the collected variables.Methods
This cross-sectional study included N=206 patients from three different regions in Sweden. The questionnaires MMAS-8 and Short Health Scale were used combined with a questionnaire regarding patient characteristics. The data and patient characteristics were described and analyzed using descriptive statistics.
Ethical approval has been received from the Regional Ethical Review Board, Linköping, Sweden (no.: 2015/369-31).
The majority of patients had Ulcerative Colitis (62.6%) There were no significant differences between the different groups of Inflammatory Bowel Disease regarding patient characteristics apart from having gone through surgical procedures, which were more common in patients with Crohn’s disease. A small correlation was shown between medication adherence and the health-related quality of life dimension social function (rho = -0.146; p <0.05). Medication adherence showed no significant correlations to the remaining health-related quality of life dimensions: disease related worry, symptom burden and sense of general well-being. Possible risk factors identified for low medication adherence were age between 30 and 50, working at high occupational level, and higher educational level.Conclusion
The complexity of measuring medication adherence has been established, making it difficult to make any certain conclusions regarding the hypothesis in this report. This study showed no clear association between medication adherence and health-related quality of life in patients with inflammatory bowel disease. However, it visualized the need of optimizing the instruments used to measure medication adherence in individuals with a non-conventional treatment plan
1) Description of immune pathways that drive inflammation in IBD
2) Discussion of the pathways targeted by current and future therapies
3) review of clinical evidence supporting use of novel therapies (selective Jaki, Sphingosine modulators, anti p19 therapies)
4) Highlight the data on adverse effects of new therapies
5) Stem cell therapies for perianal fistulae
6) Discuss novel formulations of existing agents (low systemic bioavailable steroids)
1. Aspects of risk stratification
2. Utility of drugs that may alter the natural history (reducing rates of surgeries and complications)
3. Timing of intervention
4. Evidence base data comparing different classes
5. Economic consideration/medical economics including the utility of biosimilars
The educational objectives of the presentation are:
1. To understand that the choice of long-term treatment of IBD must take into account the benefit-risk balance of old and new IBD drugs
2. To review the most important aspects of IBD drug-induced cancers and serious infections
3. To understand that in most cases benefits outweigh risks, and that patients should not be undertreated
4. To understand, based on the example of tofacitinib, that it is important keep prudent with recently approved IBD drugs until powered data is available
After introducing the concept of benefit-risk balance, the presentation will review the three major aspects of IBD drug potential complications: drug-class specific complications, malignancies, and serious infections, including opportunistic infections. A special focus will be made on thiopurine-induced lymphomas, thiopurine and anti-TNF-induced serious bacterial and viral infections, and how to manage these risks. We will then discuss the difficult choice of immunosuppressants in frail and older patients, based on drug-class specific safety data. Finally, using the example of tofacitinib, we will illustrate the importance of prescribing with caution recently approved drugs, until we have extensive safety data.
1. Optimisation, Therapeutic Drug Monitoring of biological
2. Management of anti-drug-antibodies, allergic reaction
3. Strategies PRO / RE-active
Subcutaneous (SC) formulations of CT-P13 and vedolizumab (VED) are currently available as new treatment option for patients with inflammatory bowel disease (IBD). The decision to switch requires a shared decision making based on adequate education of the patient, to avoid negative outcomes due to a nocebo effect. The aims of this study were (1) to evaluate the percentage of patients with IBD in favour of switching to SC formulations and (2) to compare two educational strategies.Methods
This was a multicentre study in patients with IBD on maintenance intravenous (IV) CT-P13 or VED. Patients attending the infusion unit were invited to complete a survey exploring the willingness to switch to SC formulations. In centre A, all patients were informed on the new SC formulations and the accompanying care pathway by an information leaflet and a face-to-face interaction with the IBD nurse, prior to completing the survey. In centre B, patients on a minimal interval of q8w were digital invited to the same survey via the e-health application of the hospital. Demographics, patient reported outcomes, willingness to switch and reasons for IV vs. SC preferences were captured.Results
In total, 447 (n=183 Centre A; n=264 Centre B; participation ratio 83.6%) patients completed the survey (m/f: 212/235; CD/UC/IBD-U: 275/161/11; median age 45 IQR 33-57; remission CD/UC: 75%/82%) see table. Most patients were open to SC treatment (47% yes, 33% doubt, 20% no). The main driver to switch was an anticipated decrease in hospital visits (86%) and overall time gain (78%). The main reason to continue IV was fear of change (60%) and uncertainty in case of relapse after switch to a SC formulation (46%). In univariate analysis, the self-estimated compliance rate was associated with the willingness to switch (p<0.0001). To evaluate the impact of the approach in patient education between the two centres, we compared the subgroup of patients on ≥q8w interval with a dosing of 5-10mg/kg CT-P13 or 300 mg VED (n=335). The willingness to switch was higher after a face-to-face approach (centre A) compared to a merely digital approach (centre B; 53.9 % vs. 40.9 % p=0.038), although patients in centre B had a higher educational level (p=0.003), more prior experience with other IBD SC medication (p=<0.001), lived further from the hospital (p<0.001) and had a younger age at diagnosis (p=0.019).Conclusion
In this multicentre comparative study exploring the willingness to switch from IV to SC maintenance therapy with CT-P13 and VED, the majority is open to switch to a SC formulation. The direct approach and education of the patient by the IBD nurse impacts significantly the willingness to switch. In a follow-up we will investigate the actual switch rates.
1. Screening before immunosuppression and immunisation
2. Indications for biological therapy
3. Evaluation of response
IBD patients are eligible to treatment with biologic agents if they have failed or cannot tolerate conventional treatment with corticosteroids and/or immunomodulators (IMMs) or are corticosteroid dependent. Early introduction of biologic therapy is also recommended for patients who at diagnosis have clinical features that predict a disabling course of disease. Ideally, patients should be screened for infectious diseases, malignancies, and complete all essential vaccinations before starting any therapy. Selecting the best biologic amongst the currently available different classes, depends on several patient- and disease-related parameters, such as age, disease activity, comorbidities, and the overall burden of disease. As for any therapy, it is important to define short-, medium- and long-term goals, monitor the progress of disease and adapt treatment accordingly (treat to target).
The first biologic is the best shot. Thus, it is key to adapt dosing to disease activity to avoid primary non-response or partial response and thus achieve a better long-term response. Co-treatment with an IMM may influence the pharmacokinetics in particular of anti-TNF and prevent early development of anti-drug antibodies ADA). Once clinical remission has been achieved, patients should be closely followed by monitoring clinical activity (patient reported outcomes), biomarkers (serum CRP, faecal calprotectin), imaging (US, MRE), endoscopy and/or histology. Treatment optimization in case patient loses response can be achieved either empirically (Standard of Care) by increasing the dose of the biologic or halving the administration interval, or both, or by adding an IMM, or by therapeutic drug monitoring (TDM), i.e., by measuring drug levels and ADA. Pro-active TDM has not been proven superior to reactive TDM, still, it serves to discriminate between pharmacokinetic and pharmacodynamic failure of treatment. However, proactive TDM is increasingly used to achieve clinical response and/or remission during induction, to de-escalate, or stop biologic therapy.
4. Screening before immunosuppression and immunisation
5. Indications for biological therapy
6. Evaluation of response