scholarly journals Disease monitoring of biologic treatment in IBD: early impact and future implications of COVID-19 pandemic

2020 ◽  
pp. flgastro-2020-101563
Author(s):  
Stephanie Shields ◽  
Allan Dunlop ◽  
John Paul Seenan ◽  
Jonathan Macdonald
Keyword(s):  
Clinical Care ◽  
Chronic Illnesses ◽  
Therapeutic Drug ◽  
Disease Monitoring ◽  
Biologic Treatment ◽  
Faecal Calprotectin ◽  
Routine Clinical Care ◽  
Risk Of Disease ◽  
Inflammatory Bowel ◽  
The Impact

COVID-19 has dominated life in 2020 with, at the time of writing, over 4.9M global cases and >320 000 deaths. The impact has been most intensely felt in acute and critical care environments. However, with most UK elective work postponed, laboratory testing of faecal calprotectin halted due to potential risk of viral transmission and non-emergency endoscopies and surgeries cancelled, the secondary impact on chronic illnesses such as inflammatory bowel disease (IBD) is becoming apparent. Data from the Scottish Biologic Therapeutic Drug Monitoring (TDM) service shows a dramatic drop in TDM testing since the pandemic onset. April 2020 saw a 75.6% reduction in adalimumab testing and a 36.2% reduction in infliximab testing when compared with February 2020 data, a reduction coinciding with the widespread cancellation of outpatient and elective activity. It is feared that disruption to normal patterns of care and disease monitoring of biologic patients could increase the risk of disease flare and adverse clinical outcomes. Urgent changes in clinical practice have been instigated to mitigate the effects of the pandemic on routine clinical care. Further transformations are needed to maintain safe, effective, patient-centred IBD care in the future.

scholarly journals P326 An exploratory analysis of the impact of COVID-19 on colonoscopy procedures and new biologic treatment initiation among patients with Inflammatory Bowel Disease in the United States

2021 ◽  
Vol 15 (Supplement_1) ◽  
pp. S350-S351
Author(s):  
R Ungaro ◽  
B Chou ◽  
J Mo ◽  
L Ursos ◽  
R Twardowski ◽  
...  
Keyword(s):  
Inflammatory Bowel Disease ◽  
Bowel Disease ◽  
Claims Data ◽  
Clinical Care ◽  
The United States ◽  
Exploratory Analysis ◽  
Biologic Treatment ◽  
Inflammatory Bowel ◽  
New Treatment ◽  
The Impact

Abstract Background Patients with inflammatory bowel disease (IBD) require frequent colonoscopies to optimize disease management and treatment strategies. At the onset of the COVID-19 pandemic, many routine procedures were postponed to reduce the overall burden on healthcare systems. We characterized the impact of COVID-19 on IBD care by conducting an exploratory analysis of real-world US healthcare claims data to identify changes in treatment patterns and the number of colonoscopy procedures performed in patients with IBD during the first wave of the pandemic. Methods De-identified, open-source health insurance claims data, from Jan 2019 to Oct 2020, were obtained from the Symphony Health Integrated Dataverse® for US adults aged 18–80 years with IBD. Four outcome measures were used: number of colonoscopies performed; number of new biologic treatment initiations or treatment switches; number of new biologic treatment initiations or treatment switches in patients who had a colonoscopy within the previous 60 days; and rate of telehealth consultations per 1000 patients per month. Results During Jan–Dec 2019 and Jan–Oct 2020, 1.54 million and 1.29 million patients with IBD, respectively, were included. The bimonthly number of colonoscopies remained stable throughout 2019, with a maximum change of +5.4% in Jul–Aug (N = 49947) vs Jan–Feb 2019 (N = 47399). Colonoscopy use decreased by 4.7% in Jan–Feb 2020 (N = 45167) vs the same period in 2019. In Mar–Apr 2020, colonoscopy numbers decreased by 55.3% (N = 20191) vs Jan–Feb 2020 (Figure 1a); a reduction of 59.4% vs Mar–Apr 2019 (N = 49780). In May–Jun 2020 (−23.8%) and Jul–Aug 2020 (+2.0%) the difference vs Jan–Feb 2020 gradually decreased (Figure 1a). Bimonthly numbers of new treatment initiations or treatment switches in 2019 varied by up to 6.9% vs Jan–Feb 2019. In May–Jun 2020, numbers of new treatment initiations or treatment switches decreased by 17.0% (N = 10072) vs Jan–Feb 2020 (N = 12133) (Figure 1b); a decrease of 19.3% vs May–Jun 2019 (N = 12488). The number of new treatment initiations or treatment switches in patients who had a colonoscopy within the previous 60 days decreased by 42.5% (N = 892) in Mar–Apr 2020 vs Jan–Feb 2020 (N = 1551) (Figure 1c); a decrease of 44.2% vs Mar–Apr 2019 (N = 1599). Telehealth utilization increased in March 2020 and remained higher than in 2019 up to October 2020 (Figure 2). Conclusion Reduction in colonoscopies and subsequent initiation/switching of treatments during the COVID-19 pandemic first wave suggests lost opportunities for therapy optimization that may have an impact on longer-term patient outcomes. Increased utilization of telehealth services may have helped address gaps in routine clinical care.

scholarly journals Impact of COVID-19 on the diagnosis, assessment and management of children with inflammatory bowel disease in the UK: implications for practice

2020 ◽  
Vol 4 (1) ◽  
pp. e000786
Author(s):  
Abbie Maclean ◽  
James J Ashton ◽  
Vikki Garrick ◽  
R Mark Beattie ◽  
Richard Hansen
Keyword(s):  
Inflammatory Bowel Disease ◽  
Bowel Disease ◽  
Delayed Diagnosis ◽  
High Standard ◽  
Current Evidence ◽  
Faecal Calprotectin ◽  
Paediatric Patients ◽  
Inflammatory Bowel ◽  
Working Practices ◽  
The Impact

The assessment and management of patients with known, or suspected, paediatric inflammatory bowel disease (PIBD) has been hugely impacted by the COVID-19 pandemic. Although current evidence of the impact of COVID-19 infection in children with PIBD has provided a degree of reassurance, there continues to be the potential for significant secondary harm caused by the changes to normal working practices and reorganisation of services.Disruption to the normal running of diagnostic and assessment procedures, such as endoscopy, has resulted in the potential for secondary harm to patients including delayed diagnosis and delay in treatment. Difficult management decisions have been made in order to minimise COVID-19 risk for this patient group while avoiding harm. Initiating and continuing immunosuppressive and biological therapies in the absence of normal surveillance and diagnostic procedures have posed many challenges.Despite this, changes to working practices, including virtual clinic appointments, home faecal calprotectin testing kits and continued intensive support from clinical nurse specialists and other members of the multidisciplinary team, have resulted in patients still receiving a high standard of care, with those who require face-to-face intervention being highlighted.These changes have the potential to revolutionise the way in which patients receive routine care in the future, with the inclusion of telemedicine increasingly attractive for stable patients. There is also the need to use lessons learnt from this pandemic to plan for a possible second wave, or future pandemics as well as implementing some permanent changes to normal working practices.In this review, we describe the diagnosis, management and direct impact of COVID-19 in paediatric patients with IBD. We summarise the guidance and describe the implemented changes, evolving evidence and the implications of this virus on paediatric patients with IBD and working practices.

scholarly journals P136 Management of patients with Inflammatory Bowel Disease and their outcome during the first wave of Covid-19 pandemics

2021 ◽  
Vol 15 (Supplement_1) ◽  
pp. S223-S224
Author(s):  
A Viola ◽  
F Giambò ◽  
M F Chiappetta ◽  
G Costantino ◽  
S Pallio ◽  
...  
Keyword(s):  
Inflammatory Bowel Disease ◽  
Bowel Disease ◽  
Secondary Outcome ◽  
Reference Period ◽  
Disease Flare ◽  
Face To Face ◽  
Risk Of Disease ◽  
Inflammatory Bowel ◽  
Group 2 ◽  
The Impact

Abstract Background The restrictions adopted in Italy during the phase I COVID-19 pandemics with a nationwide lockdown period, represented a challenge in the management of Patients with Inflammatory Bowel Disease (IBD) patients. The aim of the present study was to assess if, and how, a limited course of telemedicine did influence the clinical outcome in patients with Crohn’s disease (CD) and Ulcerative Colitis (UC). Methods IBD patients followed before March 8th, 2020 were included and divided into 3 groups (Fig.1): group 1, patients on endovenous biologics (EV); group 2, patients on biologics administered subcutaneously (SC); and group 3, patients on conventional treatments (CT) at the start of lockdown. The primary outcome was to assess the occurrence of disease flare in the three groups since only the EV group received face-to-face visits during lockdown. As secondary outcome we assessed the number of control endoscopies performed and the start of new biologic therapies, compared with a reference period in 2019. Results A total of 689 patients (CD: 369, UC 320) were included in the study (247 IV, 217 SC and 225 CT, respectively). Telemedicine was more frequently adopted in SC and CS, (p<0.001) both. Treatment delays or transitory stops were more frequent in EV (p<0.001), whereas there was a significantly greater need to change therapy (p= 0.038) and need for steroids (p = 0.008) in the SC group compared with EV (Tab.1). Concerning endoscopies, compared with the reference period in 2019 only 25% of scheduled endoscopies were performed. The only risk factor for disease flare during or shortly after lockdown was belonging to the patient groups subjected to telemedicine (SC and CT groups) (p < 0.001). Conclusion Patients followed with a face-to-face approach instead of telemedicine, had a lower risk of disease flare during lockdown period. The impact of the important reduction of endoscopic assessments still needs to be assessed.

scholarly journals P676 Faecal monitoring is useful in monitoring treatment response in anti-TNF-treated patients

2020 ◽  
Vol 14 (Supplement_1) ◽  
pp. S552-S553
Author(s):  
K Farkas ◽  
K J Szántó ◽  
D Kata ◽  
I Földesi ◽  
T Ferenci ◽  
...  
Keyword(s):  
Drug Concentration ◽  
Drug Monitoring ◽  
Research Work ◽  
Normal Serum ◽  
Therapeutic Drug ◽  
Faecal Calprotectin ◽  
Monitoring Strategies ◽  
Faecal Samples ◽  
Inflammatory Bowel ◽  
Monitoring Treatment

Abstract Background Faecal drug concentration is not routinely measured as per therapeutic drug monitoring strategies in inflammatory bowel disease (IBD) patients receiving anti-TNF therapy. However, our previous research work suggested the importance of faecal drug monitoring of anti-TNF agents since active disease may be present in spite of normal serum anti-TNF levels. The aim of the present study was to examine the correlation between faecal calprotectin and faecal infliximab (IFX) concentration and to evaluate the cut-off value of faecal drug concentration in the respect of faecal calprotectin in patients treated with maintenance IFX therapy. Methods Consecutive patients with IBD receiving maintenance IFX therapy at 1st Department of Medicine, University of Szeged were enrolled in the present study. Faecal samples were obtained before the subsequent IFX infusion. Faecal calprotectin and IFX concentrations were determined with ELISA. The correlation between faecal calprotectin and faecal IFX concentration was statistically assessed. Results Sixty-seven IBD patients were enrolled. Female/male ratio was 49%–51%. Sixty-five point six% of the patients were diagnosed with Crohn’s disease and 34.3% with ulcerative colitis. Mean disease duration was 14.9 years (SD 9.7) at the time of analysis. Mean duration of IFX therapy was 42.3 month (SD 31.6). Twenty-eight point three% of the patients received escalated IFX therapy. Mean faecal calprotectin concentration was 545.7 µg/g (SD 379.4 µg/g). Mean faecal IFX concentration was 1 ng/ml (SD 1.3). Faecal calprotectin and faecal IFX concentration showed significant correlation (r=0.37, p = 0.002). A cut-off value of faecal IFX level of 0.6 ng/ml was determined at faecal calprotectin concentration of 500 µg/g. Conclusion According to our results IFX is detectable in the faeces at a calprotectin concentration of 500 µg/g. The cut-off value for faecal IFX concentration proved to be 0.6 ng/ml. Simultaneous determination of faecal anti-TNF and faecal calprotectin concentration is supposed to have a higher benefit in the evaluation of response to IFX therapy.

scholarly journals P379 Variations in disease monitoring between Inflammatory Bowel Disease patients on intravenous and subcutaneous biologic agents

2021 ◽  
Vol 15 (Supplement_1) ◽  
pp. S393-S393
Author(s):  
P Hilley ◽  
C Li Wai Suen ◽  
A Srinivasan ◽  
M C Choy ◽  
P De Cruz
Keyword(s):  
Disease Activity ◽  
Biologic Therapy ◽  
Objective Assessment ◽  
Assessment Tools ◽  
Disease Assessment ◽  
Disease Monitoring ◽  
Faecal Calprotectin ◽  
Reactive Protein ◽  
Activity Assessment ◽  
Inflammatory Bowel

Abstract Background The availability of subcutaneous (SC) administration devices of biologics in addition to intravenous (IV) administration has influenced patients’ and clinicians’ preferences towards initiating or transitioning to SC administration particularly during the COVID-19 pandemic. Whilst SC administration improves patient convenience and reduces demands on infusion centres we hypothesised that the reduction in healthcare contact associated with SC therapies may reduce the opportunities available for objective disease assessment. We aimed to compare the uptake of objective assessment of disease activity between patients receiving IV and SC biologic therapy. Methods Patients on maintenance infusion-based or subcutaneous biologic therapy for IBD between 09/2020 and 02/2021 were identified from a prospectively maintained database at an Australian tertiary IBD centre. Patients scheduled for review in IBD clinic for a prescription of maintenance biologic therapy during the follow-up period were included. Clinic records were reviewed to determine whether patients had undergone objective disease assessment including: biochemical investigation (C-Reactive protein) and Faecal Calprotectin (FCP) within the preceding 8 weeks and/or endoscopic/imaging assessment within the preceding 6 months of clinic review. Frequency of objective disease assessment was compared between patients who received IV versus SC maintenance biologic therapy. Results A total of 307 patients were included: IV maintenance n=195 (Infliximab n=135; Vedolizumab n= 60) and SC maintenance n=112 (Adalimumab n=54; Ustekinumab n=54; Golimumab n=4). Patients who received IV biologics were more likely than the SC cohort to have had biochemical assessment in the form of CRP (90% vs 72%, p<0.001) and FCP (54% vs 46%, p=0.16). Patients in the SC biologic cohort were more likely not to have had investigations completed prior to their clinical review (20% versus 4%, p<0.001). There was no difference in the overall rates of complete objective disease assessment (CRP/FCP and endoscopy/imaging) between the IV and SC cohort (28% vs 30% (p=0.74). Conclusion Patients on subcutaneous biologic therapies in our cohort were less likely to have had objective disease monitoring than those receiving intravenous biologics prior to scheduled IBD clinic review. Route of of biologic administration may influence rates of uptake of objective disease activity assessment. Tools that safeguard against the disparity of monitoring uptake, including messaging prompts and patient-centric mobile applications may help standardise the approach to objective disease assessment independent of the route of biologic administration.

scholarly journals Inflammatory Bowel Disease Patients’ Perspectives during COVID-19 Pandemic: Results from a Portuguese Survey

2021 ◽  
pp. 1-9
Author(s):  
Joana Branco Revés ◽  
Catarina Frias-Gomes ◽  
Bárbara Morão ◽  
Catarina Nascimento ◽  
Carolina Palmela ◽  
...  
Keyword(s):  
Inflammatory Bowel Disease ◽  
Immunosuppressive Therapy ◽  
Bowel Disease ◽  
Severe Disease ◽  
Professional Life ◽  
Professional Activity ◽  
Biologic Treatment ◽  
Increased Risk ◽  
Inflammatory Bowel ◽  
The Impact

<b><i>Introduction:</i></b> Patients with inflammatory bowel disease (IBD) do not seem to be at increased risk of infection by SARS-CoV-2, but there is a concern whether immunosuppressive therapy may be associated with more severe disease. Several clinical practice recommendations have been published to help guide IBD care during the COVID-19 pandemic. Nonetheless, few studies have addressed patients’ perspectives and fears. We aimed to evaluate Portuguese IBD patients’ perspectives on the clinical management of their disease during the SARS-CoV-2 pandemic as well as the impact on their professional life. <b><i>Methods:</i></b> An anonymous electronic survey was created using REDCap and was distributed by the Portuguese Association of Inflammatory Bowel Disease (APDI) between May and August 2020. Patients’ perspectives on immunosuppressive therapy, disease management, interaction with gastroenterology departments, and the impact of the pandemic in their professional life were assessed. Patients’ proposals to improve medical care were also evaluated. Descriptive analysis and logistic regression were performed. <b><i>Results:</i></b> A total of 137 participants answered the survey (79.6% females, mean age 41.7 ± 12.1 years). Although having IBD and receiving treatment with immunosuppressors (thiopurines, steroids, or biologics) were considered promotors of anxiety, most patients (85.4%) agreed that disease remission was a priority and only a minority of patients interrupted their treatment during the pandemic. In multivariate analysis, active disease, biologic treatment, and use of corticosteroids in the last 3 months were perceived by the patients as high-risk features for increased risk of SARS-Cov-2 infection and more severe disease. Fifty-nine patients (44%) believed that their follow-up was influenced by the pandemic and only 58.8% felt that they had the opportunity to discuss their therapeutic options with their doctor. Sixty-three patients (46.0%) were working from home during the pandemic, although this decision was related to IBD and immunosuppressive therapy in only 36.5 and 39.7% of the cases, respectively. Areas where care could have been improved during the pandemic were identified by patients, namely enhancement of the communication with IBD professionals, conciliation of telemedicine with face-to-face appointments, and facilitation of the interaction between patients and employers. <b><i>Conclusion:</i></b> Most patients agreed that maintaining IBD remission is crucial, and only a minority of the patients stopped their treatment as per their own initiative. IBD status only had a small influence on patients’ professional activity during the COVID-19 outbreak, with most changes being related to the pandemic itself.

scholarly journals P161 The impact of biologic therapies on Extra-Intestinal Manifestations in Inflammatory Bowel Disease: a multicentre observational study

2021 ◽  
Vol 15 (Supplement_1) ◽  
pp. S239-S240
Author(s):  
F Ferretti ◽  
M C Monico ◽  
R Cannatelli ◽  
M V Lenti ◽  
A Di Sabatino ◽  
...  
Keyword(s):  
Inflammatory Bowel Disease ◽  
Bowel Disease ◽  
Cumulative Incidence ◽  
Adjunctive Therapy ◽  
Biologic Therapy ◽  
Biologic Agents ◽  
Biologic Treatment ◽  
Inflammatory Bowel ◽  
The Impact ◽  
New Onset

Abstract Background A high proportion of Inflammatory Bowel Disease (IBD) patients will develop extraintestinal manifestations (EIMs). Choosing the most appropriate therapeutic strategy among currently available biologics for each patient may often be challenging. Data regarding the effects of gut-selective therapies such as vedolizumab (VDZ) on new-onset and pre-existing EIMs are scarce and often discordant. The main aims of this study were to assess the cumulative incidence of new-onset EIMs and the course of pre-existing EIMs in a large cohort of IBD patients treated with VDZ compared to non-gut selective biologic agents. Methods This multicenter retrospective study collected data of IBD patients on biologic therapy in clinical follow-up at 6 tertiary referral IBD units in Lombardy. Clinical and demographic data of IBD patients were collected. We calculated the cumulative incidence of new-onset EIMs since the introduction of the ongoing biologic therapy, comparing patients on VDZ with patients on non-gut selective therapies. Furthermore, we analyzed the course of pre-existing and new-onset EIMs in these two cohorts of patients. Results Data about 973 IBD patients (624 CD, 339 UC, 10 IBD-U; median age 46 years; 59% males) on biologic therapy were collected. Of them, 215 were on VDZ and 758 were on non-gut-selective agents, with a median treatment duration with the ongoing therapy of 3 years. The overall prevalence of EIMs in this IBD cohort of patients was 19.8% (193/973 patients). The overall cumulative incidence of new-onset EIMs was of 4.1 % (40/973): 13 on VDZ (13/215) versus 27 (27/758) in the non-gut selective group (6% vs 3.6%, p = 0.1). Regardless of the type of biologic agents, the female sex and the duration of the ongoing biologic treatment were statistically associated with a higher risk of developing EIMs. About 17% of IBD patients reported a pre-existing EIM. Compared to non-gut selective therapies, patients on VDZ showed a significantly higher rate of worsening or absence of response (8.1% vs 19.4%, 12/148 vs 7/36, p=0.04). However, in both groups, a modification of the therapeutic protocol has been necessary with the introduction of adjunctive therapy, the switch, or the optimisation of the ongoing biologic therapy (27.8% patients on VDZ versus 25% on non-gut selective therapies, p=0.7). Conclusion Our study suggests that the type of biologic treatment does not affect the risk of new-onset of EIMs. However, in the case of pre-existing EIMs, a subtle higher risk of worsening can be speculated after starting VDZ, even if the proportion of patients who will need adjunctive therapy, the optimisation or switch of the ongoing treatment would be similar between gut-selective and non-gut selective therapies.

scholarly journals Organisational changes and challenges for inflammatory bowel disease services in the UK during the COVID-19 pandemic

2020 ◽  
Vol 11 (5) ◽  
pp. 343-350 ◽  
Author(s):  
Nicholas A Kennedy ◽  
Richard Hansen ◽  
Lisa Younge ◽  
Joel Mawdsley ◽  
R Mark Beattie ◽  
...  
Keyword(s):  
Inflammatory Bowel Disease ◽  
Bowel Disease ◽  
Elective Surgery ◽  
Quality Care ◽  
Faecal Calprotectin ◽  
Telephone Consultation ◽  
Ensure Patient Safety ◽  
Inflammatory Bowel ◽  
The Uk ◽  
The Impact

ObjectiveTo determine the challenges in diagnosis, monitoring, support provision in the management of inflammatory bowel disease (IBD) patients and explore the adaptations of IBD services.MethodsInternet-based survey by invitation of IBD services across the UK from 8 to 14 April 2020.ResultsRespondents from 125 IBD services completed the survey. The number of whole-time equivalent gastroenterologists and IBD nurses providing elective outpatient care decreased significantly between baseline (median 4, IQR 4–7.5 and median 3, IQR 2–4) to the point of survey (median 2, IQR 1–4.8 and median 2, IQR 1–3) in the 6-week period following the onset of the COVID-19 pandemic (p<0.001 for both comparisons). Almost all (94%; 112/119) services reported an increase in IBD helpline activity. Face-to-face clinics were substituted for telephone consultation by 86% and video consultation by 11% of services. A variation in the provision of laboratory faecal calprotectin testing was noted with 27% of services reporting no access to faecal calprotectin, and a further 32% reduced access. There was also significant curtailment of IBD-specific endoscopy and elective surgery.ConclusionsIBD services in the UK have implemented several adaptive strategies in order to continue to provide safe and high-quality care for patients. National Health Service organisations will need to consider the impact of these changes in current service delivery models and staffing levels when planning exit strategies for post-pandemic IBD care. Careful planning to manage the increased workload and to maintain IBD services is essential to ensure patient safety.

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