bluuebunny/crossref_metadata_2025_split huggingface dataset:
P603 INSPIRE: 6-month interim analysis from an observational post-marketing registry on the effectiveness and safety of darvadstrocel in patients with Crohn’s disease and complex perianal fistulas
Authors: Zmora O , Baumgart D C , Faubion W , Ferrante M , Gecse K , Genestin E , Geransar P , Hantsbarger G , Karki C , Tozer P , Panés J 
Published: January 2022

Abstract

Background
Darvadstrocel (DVS) is a suspension of expanded allogeneic adipose-derived mesenchymal (stromal) stem cells approved for the treatment of complex Crohn’s perianal fistulas (complex CPF). The INSPIRE (EUPAS24267) registry is a European observational, post-approval study designed to evaluate the real-world effectiveness and safety of DVS in patients with complex CPF for up to 36 months after DVS administration. Here we report clinical and safety outcomes from the first interim analysis at 6 months post treatment.

Methods
Patients with complex CPF treated with DVS according to local standard practice were eligible to enrol. Primary outcomes were clinical response (defined as closure despite gentle finger compression of ≥50% of external openings treated with DVS that were draining at baseline) and clinical remission (defined as closure despite gentle finger compression of all external openings treated with DVS that were draining at baseline). Outcomes were evaluated in the All Treated (AT) and Treated Per Protocol (PP) cohorts (Table 1) 6 months post treatment in patients who had received a single administration of DVS. The number and nature of adverse events (AEs), serious AEs (SAEs) are reported for the AT cohort.

Results
As of September 2021, 230 patients had enrolled, 225 met the inclusion criteria and 205 had complete treatment data and comprised the AT cohort, of these, 176 were treated per protocol. A total of 138 (AT) and 120 (PP) patients were 6 months post treatment, 66% (92/138) and 58% (69/120) had a 6-month visit, of which, 85% (78/92) and 100% (69/69) had evaluable data at Month 6, respectively. Baseline demographics and clinical and fistula characteristics are shown in Tables 1 and 2. In the AT and PP cohorts, respectively, 73% (57/78) and 74% (51/69) of patients had a clinical response, and 65% (51/78) and 65% (45/69) had clinical remission. Changes in Crohn’s disease (CD) activity (assessed with the Harvey–Bradshaw Index) post treatment were minimal, and most patients had no change in CD activity from baseline. In the AT cohort, 20% (41/205) of patients had ≥1 AE and 9.3% (19/205) had ≥1 SAE. There were no reports of ectopic tissue formation and no deaths.

Conclusion
This is the first real-world, multi-centre study reporting the effectiveness and safety data after DVS treatment for complex CPF. These interim analysis data are consistent with the pivotal ADMIRE-CD study in terms of effectiveness and safety. The ongoing status of the registry and small number of evaluable patients mean these data should be interpreted with caution, pending future analyses in larger numbers of patients with longer follow-up times.
P614 Proactive infliximab is superior to either conventional infliximab and vedolizumab in Inflammatory Bowel Disease
Authors: Rodrigues I , Serrazina J , Botto I , Fernandes S , Bernardo S , Gonçalves A R , Moura Santos P , Valente A , Correia L , Tato Marinho R 
Published: January 2022

Abstract

Background
Available evidence suggests that vedolizumab may be as effective as Infliximab (IFX) in patients with inflammatory bowel disease. However, it is unknown if proactive therapeutic drug monitoring may improve these results.

Methods
Retrospective study including consecutive patients under conventional management with IFX (n=108), vedolizumab (n=80) and proactive IFX (n=139) aiming at a trough level (IFXTL) between 5–10 µg/mL. We evaluated the rates of fecal calprotectin remission (&lt;250 µg/g) at week 14 and 2 years, and clinical remission, treatment discontinuation, hospitalization, and surgery at 2 years. Primary non-responders were excluded.

Results
Proactive IFX was superior to vedolizumab in respect to Fc remission at week 14 (56.8% vs 34.2%; P=0.001) and at 2-years (74.8% vs 35.9%, P&lt;0.001), clinical remission (79.9% vs 58.0%, P=0.001), and treatment discontinuation (24.5% vs 39.5%, P=0.015), without significance for other outcomes. These results remained significant after correcting for prior anti-TNF use (P=0.027, P&lt;0.001, P=0.01, and P=0.03). Conventional IFX was superior to vedolizumab in respect to Fc remission at 2-years (51.9% vs 35.9%, P=0.022), and treatment discontinuation (15.7% vs 39.5%, P&lt;0.001), without significance for other outcomes. However, these results were not significant after correcting for prior anti-TNF use (P=0.367 and P=0.065).

Conclusion
Our findings suggest that vedolizumab is as effective as conventional IFX. However, proactive IFX was superior to vedolizumab in most clinical outcomes.
P616 Safety of COVID-19 vaccines in patients with IBD
Authors: Dussias N , Carbone A , Melotti L , Privitera Hrustemovic H , Salice M , Scaioli E , Calabrese C , Rizzello F , Gionchetti P 
Published: January 2022

Abstract

Background
COVID-19 vaccines have demonstrated excellent efficacy and safety profiles among the general population. However, studies have shown that vaccine hesitancy remains a significant problem especially in patients with chronic diseases, in part because of a lack of data regarding vaccine safety in these special populations. With this in mind, we investigated rates of vaccine-related side effects and disease flares in patients with inflammatory bowel disease (IBD).

Methods
We conducted an online survey of patients with Crohn’s disease (CD) and ulcerative colitis (UC) who were vaccinated from January 23 to October 15, 2021 with COVID-19 vaccines approved in Europe. We collected data regarding patient demographics, disease type, treatment and activity at the time of vaccination, patient-reported systemic side effects, and rates of disease flares and outcomes within 15 days of both vaccine doses.

Results
A total of 329 (179 M, 150 F) patients participated in the survey, 162 with CD and 167 with UC. Mean age was 47.1 years (range 19–80). Patients were vaccinated with Pfizer-BioNTech (46.8%), Moderna (51.7%) or Oxford/AstraZeneca (1.5%). Three patients received only one dose because of recent prior infection, and one patient received a single dose dose due to infection before vaccine cycle completion. At the time of vaccination most patients (63.8%) reported disease remission, 22.8%= mild activity, 12.8%= moderate, 0.6%= severe. Mesalazine monotherapy was reported in 174 patients, 89 were on biologics, 8 were on azathioprine, and 58 were not undergoing treatment at the time of vaccination. Nineteen were on concomitant corticosteroid treatment.
After the first dose, the most common side effects were mild: fatigue (38.6%), arthromyalgia (16.7%), headache (14.3%), fever (6.7%) and nausea (1.8%). Side effects after the second dose were more frequent but similar in nature (fatigue= 54.8%, fever= 34.8%, arthromyalgia= 31.7%, headache= 22.8%, nausea= 2.5%).
Fourteen patients (4.3%) reported disease flare after the first dose and 26 patients (8%) after the second dose. Characteristiscs of these patients are summarized in Table 1. Most flares were self-limiting and did not require modification in treatment. In the five cases where treatment modification was required, two already had moderate/severe disease at the time of vaccination, one had suspended biologic treatment, and two patients had autonomously suspended maintenance therapy.

Conclusion
Disease flares are infrequent and generally self-limiting after COVID-19 vaccination in patients with IBD. Other side effects are mild and comparable to the general population. Vaccination is strongly recommended in patients with IBD, and patients should be reassured about their safety.
P617 Switching from an intensified regimen of infliximab to a subcutaneous standard dose in adults with Inflammatory Bowel Disease: our experience in a tertiary hospital
Authors: Chivato Martín Falquina I , Saiz Chumillas R M , Arias Garcia L , Vicente González B , Revilla Cuesta N , Alba Hernández L , Andrés Pascual L , Sicilia Aladrén B 
Published: January 2022

Abstract

Background
Intravenous (IV) infliximab is a first line treatment for moderate or severe flare of inflammatory bowel disease. Recently a new formulation of infliximab with subcutaneous (SC) administration has been developed and approved for this indication.

Methods
From March 2021, 14 patients diagnosed with inflammatory bowel disease (Crohn’s disease-CD- or ucerative colitis-UC), in clinical remission for at least 6 months with infliximab IV who had needed previous intensification, either because of a reactive therapeutic drug monitoring and loss of response, or because of a proactive drug monitoring (trough levels &lt;3µg/ml), were switched to SC infliximab. We analized retrospectively from the start of SC infliximab until week 8 after switch, fecal calprotectin levels (FC), C reactive protein (CRP), concomitant treatment, trough levels, treatment adherence, need for intensification or relapse, and adverse events.

Results
Four patients (28,57%) were diagnosed with CD, 10(71,4%) were diagnosed with UC (Table 1). Median duration of IV treatment was 53 months (IQR 33–59). Reasons for starting infliximab were corticodependence in 6 patients (42,8%), corticorefractoriness in 6(42,8%) and topdown strategy in B2 phenotipe with Crohn’s disease in 2 (14,3%). Reasons for intensification were: loss of response in 5 patients (35,7%), intensified induction in one (7,1%), proactive therapeutic drug monitoring in 8 (57,14%) (graphic 1). Intensification regimens are shown in graphic 2. Eleven patients (78,57%) were still in an intensified regimen when switched. All patients were in clinical and biochemical remission (FC&lt;200 µg/g and CRP&lt;10 mg/dl) before switch. Median basal infliximab trough levels before switch were 6,98µg/ml (IQR 2,4-10,5); median trough levels 8 weeks after switch were 14,12 (IQR 12,22-22,7) (p=0,003) (graphic 3). Thirteen patients (92,8%) followed treatment and stayed in clinical remission. One patient, treated with original IV infliximab before switch, relapsed after third subcutaneous administration, and did not respond to reintroduction of original IV infliximab. There were no adverse events.

Conclusion
In our centre, switching from IV to standard dose SC infliximab maintained clinical and biochemical remission in patients that previously needed intensified regimen, improving trough levels without any adverse events. These findings provide potential therapeutic insights into SC infliximab as a monotherapy agent for inflammatory bowel disease.
P628 Processed and ultra-processed food and risk of Inflammatory Bowel Disease in the European Prospective Investigation into Cancer and Nutrition cohort (EPIC-IBD)
Authors: Dong C , Casagrande C , Chan S , Huybrechts I , Nicolas G , Boutron-Ruault M C , Carbonnel F 
Published: January 2022

Abstract

Background
During the past decades, human diet has evolved towards higher intakes of processed and ultraprocessed food. We have investigated the association between these food groups and the risk of inflammatory bowel disease (IBD) in the European Prospective Investigation into Cancer and Nutrition.

Methods
413 590 participants from 8 European countries were included. Dietary data were collected at baseline from validated food frequency questionnaires. All EPIC food items were expressed as g/day and categorized according to the NOVA classification: “group 1—unprocessed or minimally processed foods”; “group 2—processed culinary ingredients”; “group 3—processed foods”; and “group 4—ultra-processed foods (UPFs)”. Because the EPIC dietary questionnaires were conceived before the NOVA classification, the food items were retrospectively categorized into this classification. Some food items collected in the EPIC questionnaires were difficult to categorize into group 3 or 4. We therefore merged them into a single category. We tested three scenarios for the estimation of the dietary content of this merged category: lower, middle and upper contents of groups 3 + 4. The association between the proportion of each NOVA group in the diet and IBD were estimated using Cox proportional hazard models to obtain Hazards Ratios (HRs) and 95% confidence intervals. We adjusted the HR for smoking status, educational level, physical activity, BMI, alcohol consumption and energy intake and stratified by centre, age at baseline (1-y interval), and sex.

Results
After a mean follow-up of 16 years, 179 Crohn’s disease (CD) and 431 ulcerative colitis (UC) cases were identified. NOVA group 1 was negatively associated with CD risk (adjusted HR for the fourth vs. the first quartile = 0.58; 95% CI = 0.35–0.95; P-trend = 0.03). Within group 1, fruit intake was the only food item to be negatively associated with the risk of IBD (adjusted HR for the fourth vs. the first quartile = 0.42; 95% CI = 0.24–0.73; P-trend = 0.003). We found numerical associations between group 3 + 4 and the risk of CD with the middle or upper scenarios (adjusted HRs for the fourth vs. the first quartile = 1.50; 95% CI = 0.92–2.46; P-trend = 0.12 and 1.41; 95% CI = 0.88–2.27; P-trend = 0.09 respectively). There was no association between any category of the NOVA classification and UC risk.

Conclusion
In the EPIC cohort, consumption of non-processed food was associated with a lower risk of CD while consumptions of processed or ultra-processed food were numerically associated with increased risk of CD. We found no association with UC.
P631 Impact of Covid-19 pandemic on initiation of immunosuppressive treatment in immune-mediated diseases. -A nationwide, retrospective study
Authors: Kutschera M , Ritschl V , Berthold R , Stamm T , Kiener H , Maier H , Reinisch W , Benka B , Novacek G 
Published: January 2022

Abstract

Background
Immunosuppressive and biological medications are a mainstay in the treatment of immune-mediated diseases, such as inflammatory bowel diseases (IBD), rheumatic diseases, and psoriasis. However, the COVID-19 pandemic caused concerns over the safety of these drugs pertaining to risk and severity of infection with SARS-CoV2. Moreover, pandemic mitigation strategies may negatively impacted treatment start with immunosuppressive and biological treatment fostering worse long-term disease outcomes. The aim of this study was to examine the impact of the COVID-19 pandemic on new starts of immunosuppressive and biological treatment in Austria.

Methods
We conducted a retrospective analysis with a 4-year observation period from 2017 to 2020 on real-world data on prescriptions for immune-mediated diseases of the Austrian health insurance funds covering 98% of the Austrian population. Data from all patients with incident biologic or conventional immunosuppressive treatment (Table 1) were included. Incidence of biologic (including small molecules) and immunosuppressive therapy was defined as all first prescriptions of one of the listed substances from 2017. The incidence rate for biologic and immunosuppressive treatments was recorded monthly in 2020 and compared with the three previous years (2017 – 2019).

Results
During the first lockdown in Austria in spring 2020 (week 12 – week 20), there was a significant decrease in the overall starts of biologic (including small molecules) and immunosuppressive treatments (both p&lt;0.0001), especially in April (Figure 1 and 2). After that lockdown, new starts of immunosuppressive and biological treatments rapidly re-achieved pre-lockdown levels despite higher infection rates with SARS-CoV-2 and subsequent lockdown periods (Figure 3). Independent from the COVID-19 pandemic, we observed a continuous increase of biological medication (bDMARDs) and small molecules (p&lt;0.0001) and a decrease of conventional immunosuppressive medications (cDMARDS) (p&lt;0.0120) during all observed years (Figure 1 and 2)

Conclusion
In patients with immune-mediated diseases in Austria the COVID-19 pandemic led to a significant decrease of newly started immunosuppressive and biological treatments only during the first lock-down. Over the last four years, we can observe a continuous increase of small molecules and biological medication as well as a continuous decrease of conventional immunosuppressive medication.
P637 Risks of Development of COVID-19 among Patients with Inflammatory Bowel Disease
Authors: Kappelman M , Zhang X , Lewis J , Melmed G , Siegel C , Cerciello E , Dobes A , Weaver A , Weisbein L , Long M 
Published: January 2022

Abstract

Background
Patients with inflammatory bowel disease (IBD) may be at risk for development of COVID-19 infection due to innate immune dysfunction and/or immunosuppressive medication use. We sought to 1) evaluate the incidence of COVID-19 infection in a large, U.S. cohort of patients with IBD and 2) evaluate associations between demographic, clinical, and treatment-related factors and the development of COVID-19 infection.

Methods
Participants in 3 adult IBD studies sponsored by the Crohn’s & Colitis Foundation, IBD Partners, IBD QORUS (Improving the Quality of Care for Adults with Inflammatory Bowel Disease), and SPARC IBD (Study of a Prospective Adult Research Cohort with IBD), were invited to participate in a prospective, direct-to-patient cohort study about COVID-19 from April 23, 2020 until August 30, 2021. Each cohort received online surveys with questions on comorbidities, medication utilization and development of laboratory confirmed COVID-19 at times 0, 2, 4, 6, 8 weeks and then every 6 months. We calculated the incidence rate of COVID-19 and performed bivariate and multivariate analyses to describe associations between age, immunosuppression use, obesity, and race on the development of COVID-19.

Results
A total of 3953 patients with IBD were followed for a mean duration of 212 days (SD 157). Demographic, clinical and treatment factors are shown in Table 1. A total of 103 individuals developed COVID-19 during follow up (2.6%, rate of 45 per 1,000 person-years). Severity of infection was generally mild. Clinical characteristics were similar among those who developed COVID-19 as compared to not. African American race was associated with incident COVID-19 infection (OR 3.37, 95% CI 1.18–9.59). Immunosuppression use was not associated with development of COVID-19 (OR 1.19, 95% CI 0.72–1.75), nor was age (OR 1.00, 95% CI 0.99–1.02), nor obesity (OR 1.01, 95% CI 0.61–1.66).

Conclusion
The overall incidence of COVID-19 infection among this large U.S. cohort of IBD patients was relatively low. Immunosuppression use did not increase the risk of development of COVID-19. Therapeutic management of IBD should not be altered to prevent a risk of developing COVID-19.
P664 Bidirectional association between inflammatory bowel disease and psoriasis in a pediatric population: A nationwide insurance claim data analysis in South Korea
Authors: Kim D H , Cho S I 
Published: January 2022

Abstract

Background
Inflammatory bowel disease (IBD) and psoriasis are chronic inflammatory diseases and have been reported to have an association between them. However, most of the patients included in the previous reports were adults. As both diseases are related to each other, special consideration is required in managing each disease, as there is a high possibility of co-occurrence. In this regard, to figure out the association between the two diseases in childhood and adolescence is needed.

Methods
A nationwide population-based retrospective cohort study was performed using the Korean National Health Insurance claims database. A birth cohort from January 2002 to December 2006. Claim data related to IBD and psoriasis was evaluated up to December 2019 and was analyzed to figure the association between the two diseases.

Results
The datasets contained a total of 2,347,591 individuals. A total of 2,444 IBD patients and 5,165 psoriasis patients were identified. Thirteen patients had both IBD and psoriasis. Compared to the age and sex-matched control group, IBD patients showed a higher association of psoriasis (Odd ratios (ORs), 2.476; 95% confidence interval (CI), 1.240–4.945). In contrast, psoriasis patients did not show a statistically significant association compared to the control group (ORs, 1.857; 95% CI, 0.962–3.585). However, the proportion of patients with severe IBD was significantly higher (ORs, 6.000; 95% CI, 1.003–35.908).

Conclusion
The association between IBD and psoriasis is observed in pediatric patients. Recognizing and early diagnosis of related diseases in children with IBD and psoriasis is necessary for better clinical outcomes
P686 Outcomes of COVID-19 among patients with inflammatory bowel diseases and the influence of IBD-related medications– A Danish prospective population-based cohort study
Authors: Attauabi M , Dahlerup J F , Poulsen A , Rosager Hansen M , Vester-Andersen M K , Eraslan S , Prahm A P , Pedersen N , Larsen L , Jess T , Neumann A , Haderslev K V , Molazahi A , Lødrup A B , Glerup H , Oppfeldt A M , Jensen M D , Theede K , Kiszka-Kanowitz M , Seidelin J B , Burisch J 
Published: January 2022

Abstract

Background
Population-based data regarding outcomes of coronavirus disease 2019 (COVID-19) among patients with ulcerative colitis (UC) and Crohn’s disease (CD) remain limited.

Methods
We conducted a population-based study investigating the outcomes of COVID-19 among patients with UC and CD in Denmark. The Danish COVID-19 IBD Database is an extensive population-based database which prospectively monitors the disease course of laboratory-confirmed COVID-19 among patients with UC and CD. Severe COVID-19 was defined as COVID-19 necessitating intensive care unit admission, ventilator use, or death, while adverse COVID-19 was defined as requirement of COVID-19 related hospitalization. Regression analysis was adjusted for age, sex, disease type, disease activity, cardiovascular disease, and corticosteroids. Outcomes of COVID-19 among patients with UC and CD were compared with those among the background population covering all incidents of COVID-19 in Denmark.

Results
The study included 319 patients with UC and 197 patients with CD from January 28th, 2020, to April 1st, 2021. Baseline characteristics are presented in Table 1. A significantly higher risk of COVID-19-related hospitalization was observed among patients with UC (N=46(14.4%), RR=2.49 (95%CI 1.91–3.26)) and CD (N=24(12.2%), RR=2.11 (95%CI 1.45–3.07)) as compared with the background population (N=13,306 (5.8%)). A similar pattern was observed for admission to intensive care (UC: N=8(2.51%), RR=27.88 (95%CI 13.88–56.00); CD: N=3 (1.52%), RR=16.92 (95%CI 5.46–52.46)) (Figure 1). The association between these outcomes and IBD-related clinical characteristics and treatments is presented in Tables 2–3. As shown, none of the IBD-related medications were associated with severe COVID-19 in univariate and multivariable analysis. However, systemic steroids were found to be associated with an increased risk of adverse COVID-19 among patients with CD (adjusted odds ratio (aOR)=13.62 (95% CI 1.98–17.77)).

Conclusion
This Danish population-based study on COVID-19 outcomes among patients with UC and CD demonstrated severe COVID-19 among only a minority of patients, which was not associated with IBD-related medications. Apart from systemic steroids, this study encourages continued use of IBD therapy to prevent IBD relapse and complications.