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 P666 Frequency and outcome of SARS-CoV2 infection in patients with inflammatory bowel disease on different biological therapy

2021 ◽  
Vol 15 (Supplement_1) ◽  
pp. S590-S591
Author(s):  
T Resál ◽  
K Farkas ◽  
T Molnár
Keyword(s):  
Inflammatory Bowel Disease ◽  
Bowel Disease ◽  
Biological Therapy ◽  
Biologic Therapy ◽  
Hospitalization Rate ◽  
World Health ◽  
Tnf Inhibitor ◽  
International Data ◽  
Inflammatory Bowel ◽  
The Impact

Abstract Background Since almost its 1 year outbreak declared by the World Health Organization on 11th March 2020, COVID-19 pandemic still cannot be controlled successfully. Inflammatory bowel disease potentially elevates the risk of infections, independently from the age, while disease activity and medical treatment(s) can increase the risk as well. Based on international data, in total, 4% receives the infection. Furthermore, 1.8% of the patients on biologic therapy needs intensive therapeutic care and 1% passes away. Methods This was an observational, questionnaire based study, carried out in Hungary, between February and March 2021. Our questionnaire consisted of 45 questions, that surveyed the impact of the pandemic among IBD patients, and the severity and outcome of the infection. Participants were on biologic therapy. Our aim was to determine the frequency and outcome of SARS-CoV2 infection in patients with inflammatory bowel disease on different biological therapy. Results In total, 387 respondents completed the questionnaire, and 47 participants (12%) developed COVID-19 infection. 66.9% of them were receiving anti-TNF inhibitor, 16.8% vedolizumab, 12.1% ustekinumab, and 4.1% tofacitinib. Based on our cohort, different biologic therapies didn’t elevate the risk of infection (p=0.3486), nor the hospitalization rate (p=0.277). No one was in ICU or ventilator, and nobody passed away. Furthermore, 38.3% suspended the current biologic therapy, but it didn’t decrease the rate of hospitalization (p=0.533), however, it didn’t cause flare-ups either in the primary disease (p=0.415). Based on our cohort, neither vitamin supplementations meant protection against the infection (p=0.117), only regular mask wearing seems to protect patients with IBD (p=0.009). Conclusion Based on our cohort, more IBD patients develop the infection in Hungary, compared to international data, however, the outcome of the infection is more favourable. It seems, that the different biological treatments don’t affect the infection rate, and neither elevates the hospitalization rate. In generally, there is no need to suspend the current biologic therapy, however, it should be a matter of individual judgment. After all, we claim that mask-wearing still seems to be the most effective form of prevention.

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 PLACEBO USE IN THE CONTEXT OF INFLAMMATORY BOWEL DISEASE CLINICAL TRIALS

2020 ◽  
Vol 57 (1) ◽  
pp. 87-90
Author(s):  
Juan Sebastian LASA ◽  
Ignacio ZUBIAURRE ◽  
Astrid RAUSCH ◽  
Pablo OLIVERA
Keyword(s):  
Inflammatory Bowel Disease ◽  
Clinical Trials ◽  
Bowel Disease ◽  
Biologic Therapy ◽  
Biologic Treatment ◽  
Secondary Failure ◽  
Inflammatory Bowel ◽  
Therapeutic Alternatives ◽  
Near Future ◽  
Intense Debate

ABSTRACT Inflammatory bowel disease comprises two distinct conditions - Crohn’s disease and ulcerative colitis - which can be treated with immunomodulators. A non-neglectable proportion of these patients will need biologic therapy, and many patients under biologic treatment will experience either primary or secondary failure. As a consequence, clinical trials evaluating new therapeutic alternatives are being developed. These trials share common features, such as being controlled with placebo. Placebo use in clinical trials is a matter of intense debate. Those who support placebo use highlight the methodologic advantages placebo-controlled trials have. Those against placebo use argue that it would be against ethical principles in clinical research to expose a patient to placebo when a valid therapeutic alternative exists. In this review, we summarize the existing arguments for and against the use of placebo in the context of inflammatory bowel disease research. We finally suggest that it is very likely that in the near future inflammatory bowel disease trials will no longer be controlled with a placebo arm, but instead they will be non-inferiority trials with an active comparator.

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.

Real-world biologic treatment and associated cost in patients with inflammatory bowel disease

2019 ◽  
Vol 57 (07) ◽  
pp. 843-851 ◽  
Author(s):  
Alina Brandes ◽  
Antje Groth ◽  
Fraence Gottschalk ◽  
Thomas Wilke ◽  
Boris A. Ratsch ◽  
...  
Keyword(s):  
Health Care ◽  
Inflammatory Bowel Disease ◽  
Bowel Disease ◽  
Biologic Therapy ◽  
Health Care Cost ◽  
Maintenance Phase ◽  
Biologic Treatment ◽  
Tnf Α ◽  
Inflammatory Bowel ◽  
The Mean

Abstract Objectives This study aimed to describe biologic treatment of German inflammatory bowel disease (IBD) patients, including biologics’ dosage, health care resource use, and treatment-associated cost. Methods In this retrospective claims data analysis, all continuously insured adult IBD patients (Crohnʼs disease [CD] or ulcerative colitis [UC]) who started a new therapy with an anti-tumor necrosis factor alpha (anti-TNF-α) or vedolizumab (VDZ) were included. Observation started with the date of the first prescription of index biologic therapy and lasted 12 months. Results In the database, 1248 out of 57 296 IBD patients started a biologic treatment of interest (1020 anti-TNF-α, 228 VDZ), and 837 patients were bio-naïve (773 anti-TNF-α, 64 VDZ). The mean age of bio-naïve/bio-experienced anti-TNF-α patients was 39.2/38.1 years (54.9 %/56.7 % female) and 42.6/37.8 years for VDZ patients (56.3 %/54.9 % female). The proportion of patients receiving a maintenance dosage > 150 % compared to SmPC was 15.1 % for Adalimumab, 5.2–39.0 % for Golimumab, 14.7–34.5 % for Infliximab, and 19.7 % for VDZ patients. During the maintenance phase, up to 58.8 % of patients received at least 1 prescription of any CS, and 41.7 %/47.1 % (anti-TNF-α/VDZ) were treated in a hospital due to IBD. The mean IBD-related direct health care cost per patient year was € 30 246 (anti-TNF-α)/ € 28 227 (VDZ) for bio-naïve patients (p = 0.288) and € 34 136 (anti-TNF-α)/ € 32 112 (VDZ) for bio-experienced patients (p = 0.011). Conclusions A substantial percentage of patients receive a high biologic dosage in the maintenance phase. Despite biologic therapy, 30–40 % receive a CS therapy and/or experience at least 1 IBD-associated hospitalization within a year, possibly indicating a remaining disease activity.

scholarly journals P623 The impact of SARS-CoV-2 outbreak on the treatment adherence and clinical outcome of patients with inflammatory bowel disease treated with biological agents

2021 ◽  
Vol 15 (Supplement_1) ◽  
pp. S562-S563
Author(s):  
G Martino ◽  
S Carparelli ◽  
A Marseglia ◽  
M R Pastore ◽  
M Placentino ◽  
...  
Keyword(s):  
Inflammatory Bowel Disease ◽  
General Population ◽  
Clinical Outcome ◽  
Bowel Disease ◽  
Biologic Therapy ◽  
Biological Agents ◽  
Clinical Relapse ◽  
Inflammatory Bowel ◽  
The Mean ◽  
The Impact

Abstract Background The SARS-CoV-2 pandemic has led to a remodeling of care activity, including the inflammatory bowel disease (IBD) centers. According to international recommendations, we did not discontinue immunosuppressive or biologic drugs and reorganized biologic drug infusions’ administration to minimize the risk of infection. The aim of this study is to describe the clinical outcome of SARS-CoV-2 infection and the adherence to the scheduled biologic therapies in a single tertiary center including both IBD adult and pediatric patients treated with biological agents during COVID-19 pandemic. Methods Demographic information, clinical data and the adherence to the therapy were collected in all consecutive IBD patients treated with biologic agents from March 2020 to February 2021. Moreover, we reported the clinical outcome of IBD patients infected with SARS-CoV-2. Results A total of 278 subjects (171 male) treated with a biologic agent (34 children) were included. The mean age was 41.6 ± 17.3 years (range 5 – 88), and the mean disease duration was 12.7 ± 10.1 years (range 0.2 – 49). One hundred eleven patients (39.9 %) had ulcerative colitis, and 167 (60.0 %) had Crohn’s disease. About the therapy: 73 patients were receiving infliximab, 93 adalimumab, 20 golimumab, 59 vedolizumab, 29 ustekinumab, and 4 an experimental compound. 31 patient, including 1 child, (11.1 %) were treated with combination therapy. The mean Charlson Comorbidity Index was 1.5 (range 0 – 8). Twenty one patients (2 pediatrics and nineteen adults) (7.5 %) had a confirmed diagnosis of SARS-COV-2 infection. Only one of them (an adult man) was hospitalized but did not require intensive care unit measures. Compared to cumulative SARS-CoV-2 infection in the general population in our Region, the cumulative incidence of SARS-CoV-2 infection in our cohort was significantly higher (7.5% vs 4.0%, p &lt; 0.002). Twelve adult patients (4.3%) postponed biologic therapy for fear of SARS-CoV-2 infection during the first wave of the pandemic, and two of them (16.6%) experienced a clinical relapse. Conclusion In our cohort, the adherence to biologic therapy was high during the pandemic, but the rate of clinical relapse in patients who postponed the scheduled administration of therapy was relevant. Although the incidence of SARS-CoV-2 infection was significantly higher than in general population, the clinical impact was mild as no patients experienced a severe form of COVID-19.

scholarly journals Exploitation of Marine-Derived Robust Biological Molecules to Manage Inflammatory Bowel Disease

Marine Drugs ◽  
2021 ◽  
Vol 19 (4) ◽  
pp. 196
Author(s):  
Muhammad Bilal ◽  
Leonardo Vieira Nunes ◽  
Marco Thúlio Saviatto Duarte ◽  
Luiz Fernando Romanholo Ferreira ◽  
Renato Nery Soriano ◽  
...  
Keyword(s):  
Inflammatory Bowel Disease ◽  
Bioactive Compounds ◽  
Bowel Disease ◽  
Clinical Translation ◽  
Biologically Active ◽  
Naturally Occurring ◽  
Inflammatory Bowel ◽  
Functional Features ◽  
Biological Entities ◽  
The Impact

Naturally occurring biological entities with extractable and tunable structural and functional characteristics, along with therapeutic attributes, are of supreme interest for strengthening the twenty-first-century biomedical settings. Irrespective of ongoing technological and clinical advancement, traditional medicinal practices to address and manage inflammatory bowel disease (IBD) are inefficient and the effect of the administered therapeutic cues is limited. The reasonable immune response or invasion should also be circumvented for successful clinical translation of engineered cues as highly efficient and robust bioactive entities. In this context, research is underway worldwide, and researchers have redirected or regained their interests in valorizing the naturally occurring biological entities/resources, for example, algal biome so-called “treasure of untouched or underexploited sources”. Algal biome from the marine environment is an immense source of excellence that has also been demonstrated as a source of bioactive compounds with unique chemical, structural, and functional features. Moreover, the molecular modeling and synthesis of new drugs based on marine-derived therapeutic and biological cues can show greater efficacy and specificity for the therapeutics. Herein, an effort has been made to cover the existing literature gap on the exploitation of naturally occurring biological entities/resources to address and efficiently manage IBD. Following a brief background study, a focus was given to design characteristics, performance evaluation of engineered cues, and point-of-care IBD therapeutics of diverse bioactive compounds from the algal biome. Noteworthy potentialities of marine-derived biologically active compounds have also been spotlighted to underlying the impact role of bio-active elements with the related pathways. The current review is also focused on the applied standpoint and clinical translation of marine-derived bioactive compounds. Furthermore, a detailed overview of clinical applications and future perspectives are also given in this review.

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.

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