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E-health in inflammatory bowel diseases: More challenges than opportunities?
Digestive and Liver Disease, Available online 24 August 2017
Inflammatory bowel disease (IBD) has an unpredictable relapsing and remitting character often requiring lifelong treatment. Low treatment adherence and suboptimal control of inflammation are drivers of poor outcomes, resulting in a decreased quality of life. A growing body of evidence suggests that a “treat-to-target” is highly valuable in IBD and leads to better outcomes  . However, a “treat-to-target” approach requires close patient monitoring. This is difficult to achieve with the traditional management approach in IBD. At present, patients are typically evaluated every 3 to 6 months in an outpatient setting, and this may lead to suboptimal patient care for several reasons. Firstly, the evaluation may suffer from recall bias and misinterpretation of the symptoms reported by the patient. Secondly, it assumed that a continuous clinical response has beneficial effects on outcome, but this can only be assessed by continuous close monitoring. To this end, easily accessible and effective tools are required. Lastly, the patient has a passive role in the traditional model, with limited control and little involvement in the clinical decision process. Currently, a real participatory medical approach in IBD is rare. Engaging patients in their health-related decisions involves them in the treatment algorithm. This engagement may boost treatment adherence and can result in a better disease-related and patients-related outcome.
“E-health” is a general, overarching term for a constantly changing domain that includes different modalities. The different modalities overlap and undergo a continuous evolution. In general the e-health applications can be subdivided in five groups ( Fig. 1 ). (1) Web-based applications are specific websites for patient education or data collection, these applications can also be used for self-monitoring and self-treatment by the patient  . These websites can be used on mobile or fixed devices. They can be integrated into virtual clinics. (2) m-Health is a general term for the use of mobile applications in medicine. The most common applications are those running on mobile phones and communication devices for direct care, educational purposes (prevention and disease-specific patient education), disease surveillance, treatment support and psychosocial support. Currently m-health devices are becoming the dominant method of e-health 3 4 5 . (3) Virtual clinics are planned, virtual contact between a healthcare provider and a patient for the purposes of clinical consultation, advice and treatment planning  . This contact can be preceded by completion of disease-related questionnaires by the patient and the measurement of biomarkers. (4) Social media are any online venue that allows users to network and share information [4 7] . Most sites are not health-specific or validated by an official body but are valuable communication channels for health interests, information-sharing and support [8 9] . (5) Telemedicine is defined as the use of remote video telephone consultation/monitoring and inter-centre multidisciplinary team meetings. But telemedicine is sometimes a component of a virtual clinic [10 11] .
The patient has a principal role in all of these different modalities. Optimally the e-health tools should be developed to facilitate the care for the patient by decreasing the work-load for the physician and other health-care provider (HCP). The patient provides the data that are analysed by the e-health tool and the medical team should have a rather supporting and controlling role in these.
In parallel with the digital evolution, e-health tools are becoming more important  . For this, governments have acknowledged e-health as one of their top priorities in healthcare, because they assume that integration of e-health leads to better outcomes, by nullifying the shortcoming of the traditional healthcare model. This idea is strengthened by the fact that currently more than two thirds of the population in the United States of America uses smartphones  . Indeed, e-health modalities create unlimited possibilities for interaction between the health care providers, patients and the medical community and it scales up the volume of clinical data collection and monitoring. However in the field of IBD, e-health is in its infancy compared to other chronic conditions. For example in diabetes, many randomized trials of e-health applications have reported beneficial effects  .
Diabetes has, similar to IBD, a high medical burden, psychosocial impact and disease specific complications. For this improving adherence, rigorous monitoring and secondary prevention are pivotal for a successful management and e-health can be in instrument to achieve this  . Hundreds of e-health studies have been published but the majority are heterogeneous in quality, completeness and outcome measures  . But still lessons can be drawn by mirroring the progress made with e-health in these fields to IBD.
Monitoring and regulation of glycaemia is the cornerstone of the diabetes mellitus treatment  . Glycaemia monitoring can be seen as the equivalent of monitoring inflammation in IBD. Garabedian et al published a systematic review on m-health trials in the last 5 years in diabetes  . Most trials were uncontrolled, descriptive or narrative and after a robust selection of the studies only 20 trials could be used in the systematic review  . Most randomized controlled trials (RCT) focused on the effectiveness of glucose monitoring in relation to HbA1c as primary outcome. The highest impact on HbA1c where seen in the studies in which both the patient and the healthcare provider where actively involved  . Based on this evidence the federal Food and Drugs Administration (FDA) gave approval for a first mobile medical app for continuous glucose monitoring in 2015  . The monitoring in IBD is more difficult since biomarkers are less sensitive and specific, compared to the control of glycaemia in diabetes. The absence of good biomarkers and the poor correlation between symptoms and inflammatory activity in IBD can be a hurdle for the implementation of e-health in IBD  .
Diabetes mellitus frequently leads to complications. The most important complications are retinopathy, cardiovascular diseases, nephropathy and neuropathy with diabetic foot. As in IBD those complications accumulate over time  . Prevention and early recognition are essential to adequately treat these complications. In diabetes several e-health screening applications have been developed. Most evidence is available for retinopathy screening by digital imaging techniques  . Early recognition of complications in IBD is more challenging, since most of the complications are diagnosed by cross-sectional imaging (fistulae, abscesses, strictures), biochemical test (anaemia, deficiencies) or endoscopy (cancer).
In diabetes mellitus behaviour changes in daily life like dietary measures and physical activity are principal factors for a good outcome. In IBD similar behavioural modifications are needed (e.g. smoking cessation, medication adherence). Studies demonstrate that e-health applications improve education and awareness of the patients, even in the absence of clinical effects on biomarkers  . Additionally, targeting both behavioural changes and biomarkers showed to have a synergistic effect  . The fact that several studies could not prove superiority of e-health in diabetes can be partially explained by the fact that e-health interventions were often compared to intensive standard care during a short study period [22 23] . With the introduction of IBD nurses a similar situation exists in IBD, where the comparator for e-health becomes stronger reducing the supplementary effect of e-health.
The need for further integration of e-health in the therapeutic algorithm of IBD seems obvious. But some important questions need to be answered if we want to integrate e-health in the practical management of IBD. Is the evidence for the impact of e-health on outcomes in IBD robust enough to start a widespread implementation? Is the digital infrastructure ready for e-health in IBD? Is the legal framework for e-health solid enough? And, most important, is the patient ready for e-health in IBD?
2 Evidence for e-health in IBD
In IBD, only few randomized controlled trials of e-health have been published. The e-health trials in IBD focused on different modalities and have been reviewed recently 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 : ( Table 1 ). The current evidence has underscored the current weaknesses and opportunities of e-health in IBD ( Fig. 2 ).
|Author||Year||Setting/objective||RCT||Duration (months)||Number of patients||Conclusion||Reference|
|Van Deen WK et al.||2015||Development and validation of patient-reported outcomes for e-health use.||No||NA||219 + 566||Patient-reported outcomes detect clinical disease activity in CD and UC and endoscopic disease activity in UC.|||
|Marin-Jimenez I et al.||2016||Validation of self-administrated SCCAI.||No||NA||119||High percentage of agreement with health care provider, high negative predictive value for disease activity.|||
|Elkjaer M et al.||2010||Feasibility and outcome of web-based self-management vs. standard care.||Yes||12||333||A web-based approach is feasible, safe and cost-effective. Shorter relapse duration but no other impact on outcome.|||
|Cross RK et al.||2012||Feasibility and outcome of web-based self-management vs. standard care.||Yes||12||47||A web-based approach did not improve disease activity, quality of life or adherence.|||
|McCombie A et al.||2016||Evaluating the effect of computerised cognitive behavioural therapy (vs. standard care) on health-related quality of life.||Yes||6||199||Short-term improvement (at 3 months) but not retained at 6 months.|||
|McCormick M et al.||2010||Evaluating the effect of teaching followed by a web-based skill development programme (vs. standard care) for disease-related coping.||Yes||1.5||24||A web-based strategy reduces adolescents’ somatic symptoms and improves adaptive coping strategies.|||
|Pedersen N et al.||2014||Evaluating web-guided treatment with mesalazine in UC, based on self-administered SCCAI and calprotectin self-testing.||No||3||95||Web-guided treatment optimises the dose and improves treatment adherence.|||
|Pedersen N et al.||2012||Evaluating web-guided treatment with infliximab in CD based on self-administered activity index and calprotectin self-testing.||No||12||27||Web-guided treatment is feasible and safe.|||
|Johnson MW et al.||2014||Evaluating the feasibility and effect of a web-based self-management programme.||No||12||420||A web-guided programme is effective, safe and cost efficient.|||
|Hunter J et al.||2012||Evaluating the feasibility of virtual clinics for IBD care.||No||NA||509||Virtual clinics are feasible and give high levels of patient satisfaction.|||
|Akobeng et al.||2014||Evaluating telephone consultations vs. face-to-face consultations in a paediatric setting.||Yes||24||86||Telephone consultation is not inferior to face-to-face consultation and reduced the consultation time.|||
|Krier et al.||2011||Feasibility of telemedicine encounters vs. standard encounters.||Yes||9||34||No difference in patient satisfaction.|||
|Hommel et al.||2013||Evaluating the impact of telemedicine on adherence in adolescents.||No||5||9||Cost reduction and slight impact on adherence.|||
|Castiglione F et al.||2016||Evaluating the impact of a telephone helpline dedicated to IBD.||No||24||NA||The telephone helpline reduced the hospitalisation rate.|||
|Regueiro et al.||2014||Feasibility of multi-institution case discussion by teleconferencing.||No||NA||NA||The method is feasible.|||
|De Jong et al.||2017||Evaluating the effects of self-management with a telemedicine system, on health-care utilisation and patient-reported quality of care vs. standard care.||Yes||12||909||Similar clinical outcomes in both groups with lower number of outpatient visits and hospital admission in the telemedicine group.|||
One of the cornerstones for accurate disease monitoring is validated measurements. Since the focus of data collection shifts from the HCP to the patient, a validated measurement tool is essential for the effectiveness of e-health. It has been demonstrated that the diagnostic performance of the online, self-administered Simple Clinical Colitis Activity Index (SCCAI) in UC patients is acceptable and correlates well with the scoring by the HCP  . But the use of clinical score by the patient is only a surrogate for a patient reported outcome (PRO). By definition, a PRO must be a direct report by the patient of his/her health status and should not be interpreted by a clinician. Van Deen et al. reported on the development and validation of a PRO-based IBD score for disease-monitoring apps  . A composite score for CD and UC was first developed. For CD, the score included liquid stool frequency, abdominal pain, patient well-being, and patient-assessed disease control. For UC, the score was based on stool frequency, abdominal pain, rectal bleeding, and patient-assessed disease control. These scores were then validated in 301 patients with CD and 265 patients with UC. A good correlation was seen between the composite CD and UC scores and available clinical indexes. These scores are currently implemented in the eIBD patient app of the University of Califorinia Los Angeles (UCLA) (Supplementary Table 1)  . Evidence based e-health does not only mean validated measurement tools. E-health must be more than a fancy tool. Robust evidence showing that e-health has beneficial impact on the disease outcome is required. Currently no dramatic paradigm shift has been established by the use of e-health in IBD. Most of the e-health trials have been performed in patients in remission or with mild disease activity. This of course makes it more difficult to demonstrate a beneficial effect of the e-health tools since the endpoints are weaker. The duration of the e-health trials has a maximum of 24 months, this is rather short to see a superiority of e-health tools when compared to standard care, which is mostly quite intensive as well. The biggest advantages of e-health could probably be seen in patients in an early stage of the disease initiating treatment. In this setting a close monitoring and high adherence is most important and can be effectuated by e-health applications. The study with the largest patient population (n = 333) was performed in Denmark and Ireland  . In this trial patients with mild to moderate UC were monitored for 12 months and randomized 1:1 to standard care or the intervention group (an intensive patient education and self-treatment via the website). The intervention led to greater adherence, a shorter flare-up duration, and greater cost effectiveness (due to fewer outpatient visits), but no impact on harder endpoints like the relapse frequency, hospitalisation or surgery was observed. In a similar trial with a tele-management system patients with UC (n = 47) were monitored for 12 months  . Via a home unit, the patient received disease-specific education and completed weekly questionnaires on symptoms, side effects and adherence. Customized clinical alerts and actions were sent to the patient for self-management. There were no significant differences between the intervention and standard care groups in terms of a colitis activity index, quality of life or adherence. A randomized trial evaluating computerized cognitive behavioural therapy (CCBT) in IBD patients during 12 weeks demonstrated a significant improvement in quality of life but no impact on clinical disease activity in the intervention group  . In two non-randomized cohort studies Pedersen et al. evaluated a web-based treatment monitoring system for biological and 5-aminosalicylic acid (5-ASA) treated patients. These studies included a web-based questionnaire and a home-based faecal calprotectin (FC) monitoring. Quality of life and disease activity (according to the Harvey Bradshaw index and FC levels) remained stable over the course of the trial in the biological treated patients with CD (n = 27)  . In the second study with 5-ASA treated patients with UC (n = 95), the use of the web-based system was associated with a significant improvement in the SCCAI and a significant reduction in FC levels  . These studies had no control group. Also the evidence for the use of virtual clinics is weak. In the only randomized trial Akobeng et al. randomly assigned 86 patients to either telephone consultations or standard, face-to-face outpatient clinics for 24 months  . After one year, there was no difference in quality of care between the two approaches. However, the virtual clinic was associated with reductions in consultation time and direct costs (no data on indirect cost available). Telemedicine overlaps partially with the concept of virtual clinics and has multiple modalities  . Recently the results of a pragmatic randomized trial using “myIBDcoach” were presented [10 11 41] . In this trial all patients with IBD independent of phenotype, treatment or disease severity were followed for 12 months (n = 909). The intervention group was monitored by a web application and visited the hospital at least once yearly. After 1 year there were significantly less hospitalizations in the intervention group, but no differences were observed in flares, corticosteroid use, emergency visits or surgeries. A beneficial impact on disease outcome by the use of social media like twitter or facebook does not exist. Currently multiple mobile health apps are freely available for IBD (Supplementary Table 2: available apps android). Most apps focuses on monitoring of symptoms (stools, abdominal pain) in a rather incoherent way. Currently apps with well integrated biometrics, biomarker assays, disease activity and psychosocial parameters are lacking. The value of only two apps has been studied. Serial testing of FC is valuable in the monitoring IBD in remission  . Already 3–6 months before clinical relapse an increase in FC is seen in UC patients on maintenance therapy with Infliximab  . For this bimonthly self-monitoring by the patient has the potential to prevent relapse. Systems have been developed to allow the patient to test the level of FC at home. The CalproSmart™ test is a mobile tool for semi-quantitative FC measurement The result is displayed as a traffic light (green (0–200 mg/kg) = mild disease state, yellow (200–500 mg/kg) = moderate disease state, red (over 500 mg/kg) = severe disease state). Vinding et al evaluated the test by comparing it to the gold standard enzyme linked immunosorbent assay  .
UCLA (Los Angeles, CF, USA) have launched the UCLA eIBD application  . This is an e-health instrument to optimise the care for IBD patients. They use the Value Quotient™ (VQ™) of the patient as measurement. The VQ™ includes disease control, increasing quality of life and work productivity. To increase the VQ™ patient are followed in a tight control programme. This had beneficial but no significant impact on surgeries, hospitalizations and emergency admissions  . The eIBD application facilitates patient empowerment by patient education and can be used as fast lane for contact with the IBD nurse specialist. The patient can also follow his clinical and laboratory results, see his disease activity state or productivity and update on this by means of the application  . There is a link to supporting applications for further IBD education, support for work reintegration and psychosocial care. Some other institutions and international societies have launched mobile apps. Kings college hospital (London, UK) have launched the KCH IBD application. This app is a practical information app for the patient visiting Kings College IBD unit. The patient can also submit his health questionnaires to the department ahead of the hospital visit. Extra links are included to education on IBD. Similar apps are available for Brigham and Women's Hospital (Boston, MA, USA): IBD circle and The Hospital for Sick Children (Toronto, Canada): myIBD+. Several international IBD organizations have their own apps. The European Crohn and colitis organization (ECCO) released an app for educational purposes. This provides news, information on guidelines and workshops. The Crohn’s and colitis federation of America (CCFA) has an app for patients: GI Buddy. This app is patient focused and is an accessible tool to log the symptoms, treatments, diet and wellbeing. This app sends email reports to the user. This reports give an overview of the health status of the patient and can be useful for discussion with the healthcare provider. In France, l’association François Aupetit (a French IBD patient organization) and Abbvie have developed an app called Carmelia. Identical to GI Buddy, the patient can log his symptoms, wellbeing and treatment intake. All this information can be shared electronically with the physician of choice. It also includes an agenda for outpatient clinic visits.
3 Digital infrastructure for e-health in IBD
Interaction between various e-health tools is sometimes difficult and often impossible. A broader framework is needed, if possible on the national or regional level. The base for an effective e-health programme is an infrastructure that is ubiquitous available and accessible by the HCP. Standardized medical or care data on this platform need to be entered by both the patient and the HCP. This must also strengthen the safety and privacy of the communication, which is not the case by email or social media communication between patient and HCP. Currently a lack of interoperability of electronic health records prevents realizing the full potential of e-health. For this a standardisation of the collected data, a unique patient identification and a web-based non-vendor-constrained information infrastructure is required. This can only be achieved if public and private partners are closely collaborating. Recently the American College of Cardiology recognised this and made a plea for of the adoption of Integrating the Healthcare Enterprise (IHE) standards. IHE is a non-profit international organization that develops standards-based profiles. These profiles provide better interoperability by well-defined systems and specific standards. Each profile offers developers clear communication standards that have been reviewed and tested by industry partners. Currently no initiatives have been undertaken in IBD and this retards the further development of e-health. The IBD community as such cannot build a digital infrastructure. This is the task of the government and the health authorities. But the IBD community should first of all focus on standardized collection of the data using validated activity scores and biomarkers. Next to that outcome measure and treatment targets should be clearly demarcated in IBD. In this way they can be used as measurement tool on the long term for e-health applications.
4 Legal and socio-economic issues for e-health for IBD
The success of e-health applications is based on the users’ trust. One of the main challenges is to ensure data privacy and security. Policy-makers will need to proactively regulate the concept of information-sharing. In principle, the so-called right to be forgotten should be executed on all e-health tools. A recent study of the 600 most popular e-health apps showed that only 30.5% had privacy policies  . Furthermore, there is legal vacuum on liability for the patient and the HCP. No agreement exists on the HCP liability if a patient is injured as the result of faulty or inaccurate information that he/she provides or if e-health data are neglected by the HCP. A risk exist that the patient is overestimating his/her own role in the decision process of the medical treatment. It is key that the e-health application detects adequately “red flags” and that the HCP has sufficient control mechanisms. But the supervisory role of the HCP may increase the healthcare provider’s workload and require additional staff: the patient-logged data must be reviewed, the lab test results must be entered, and management plans must be issued. Greater availability of the healthcare provider may lead to time-consuming activities and poor efficiency. A study of an integrated healthcare delivery system with online patient access found that costs increased as clinical services were used more  . Lastly, the system has to be financially viable for physicians; a reimbursement policy for e-health contacts and telemedicine consultations is needed.
5 Patients’ perspective for the implementation of e-health in IBD
Patients are in quest of high value medical information and they are eager to have more physician-provided healthcare information via (for example) institution Internet sites or m-health apps. The fact that mobile technology is intensively used in the community does not directly mean that e-health will be adopted for chronic diseases like IBD. In a straightforward study of the implementation of e-health for colonoscopy preparation, only 6% of the patients followed the app’s instructions  . Randomized trials of e-health in IBD also had trouble recruiting and retaining patients. At one hand, feasibility trials showed that web-based interventions are feasible and well accepted by the patient. But at other hand, randomized trials show high drop-out rates up the 44–74%. E-health gives the patient a central role. And this can boost the effectiveness of IBD therapy, that is highly dependent on adherence and self-management. Conversely, the integration of the patient creates unavoidably a setting in which the patient is continuously reminded of the limitations imposed by his/her chronic disease. This may have a negative impact on coping and may lead to higher attrition rates. There is also a risk of increasing disparities in access to healthcare as a function of a patient’s e-health literacy and Internet access. E-health will only be successful in chronic disease settings if the attrition rate is low. A systematic review suggested that attrition rates depend on the patient’s educational level  . For this e-health in IBD should be tailored on the profile of the patient, taking into account his mental status, disease activity, educational level and digital literacy. Based on this the ideal interval for data collection and level of self-management can be determined.
E-health in IBD is in its infancy. Most trials include small numbers of patients, and the study period is generally shorter than one year. Several further steps are needed to implement e-health in a real-world setting. By analogy with the development of a new drug, e-health tools must be carefully developed, tested and validated before they are launched; this will enhance the acceptance of e-health tools. Based on current evidence, e-health in IBD should focus on stable patients in remission for at least 3 months rather than use as a monitoring tool soon after a severe flare-up. Direct, face-to-face discussion with newly diagnosed patients is crucial for building a good long-term patient-healthcare provider relationship. It is also necessary to determine the optimal monitoring interval. Even when e-health is used in an appropriate setting, a yearly, face-to-face evaluation seems mandatory. For more inclusive monitoring, biomarker assay data coming from point-of-care tests (measuring trough levels of monoclonal antibodies and faecal markers) must be digitally integrated into mobile applications. The general view is that e-health reduces waiting times and the overall burden on outpatient clinics. However, all these processes must be cost-effective and must raise the quality of IBD care. In our opinion, future research needs to focus on four specific points of interest.
Evidenced based e-health: Currently sufficient evidence is lacking to unroll e-health in IBD. What we need is well designed clinical trials with clearly predefined outcomes in a large cohort. The HealthPROMISE trial from Mount Sinai (New York, NY, USA) for example is a trial comparing an educational IBD app with an interactive app (HealthPROMISE)  . Furthermore trials should focus on both patients in remission and with active IBD, since these settings are associate with different therapeutic goals and the psychological impact on the patient is diverse.
Multi-model tools: Monitoring of the patient only based on PRO is insufficient. We suggest to develop e-health tools that integrate multiple monitoring models. The best option is to build on three pillars: biometrics, biochemical assessments and PROs. The Dutch IBD-live study currently uses a so called flarometer in a paediatric population with quiescent IBD  . This web-based tool automatically cumulates the disease activity based activity index and faecal calprotectin self-measurements to estimate probability of relapse. But the use of validated e-health PRO can also be further validated and integrated in clinical trials for drug development in IBD. This is particularly interesting since these trials focus on patients with active IBD and integrated biochemical, quality of live, endoscopic and histological data which can help to develop multi-model e-health tools.
Anticipating attrition: Understanding patients’ resistance will help to create the ideal profile of patients suitable for e-health applications. Internet-based patient resources may not be suitable for all older patients or those with limited education. Probably the best is to start with patients with high digital literacy.
Digital framework: The interaction between the different e-health tools is difficult and often impossible. A bigger frame work is needed, potentially organized on a national or regional level. In Iceland a national eHealth infrastructure encompassing a secure HealthNet, interconnected electronic health records, e-prescriptions, a national medication database and a patient portal has been implemented  . This type of national frameworks might be robust and secure enough to also integrate specific mobile apps. Development of apps should be focused on the potential to be imbedded in an existing national framework.
In conclusion e-health has enormous potentialities in IBD but currently the field is not ready yet for a widespread implementation. An intense cooperation between authorities, IBD organizations and patients is needed for a successful uptake of e-health in IBD with as primary goal better disease outcomes and less complications.
Conflict of interest
P.B. has received consulting fees from Dr Falk Benelux, Hospira, Janssens-Cilag, MSD, Mundipharma, Roche, Pfizer and Takeda, has received lecture fees from Abbvie, Takeda and Vifor Pharma, and has received an educational grant from Abbvie.
L.P. declares no competing interests.
G.B. has received consulting fees from Abbvie, Aptalis, Ferring, Merck, Takeda and received lecture fees from Abbvie, Aptalis, Medtronic, Ferring, HAC-pharma, Hospira, Norgine, Merck, Takeda.
SD has served as a speaker, a consultant and an advisory board member for Abbvie, Ferring, Hospira, Johnson & Johnson, Merck, Millennium Takeda, Mundipharma, Pfizer, Tigenix, UCB Pharma and Vifor.
L.P.-B. has received consulting fees from Abbvie, Amgen, Biogaran, BMS, Boerhinger-Ingelheim, Celgene, Celltrion, Ferring, Forward Pharma, Genentech, HAC-Pharma, Hospira, Index Pharmaceuticals, Janssen, Lilly, Merck, Mitsubishi, Norgine, Pfizer, Pharmacosmos, Pilège, Sandoz, Takeda, Therakos, Tillots, UCB-pharma and Vifor; received lecture fees from Merck, Abbvie, Takeda, Janssen, Takeda, Ferring, Norgine, Tillots, Vifor, Therakos, Mitsubishi, HAC-pharma.
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