bluuebunny/crossref_metadata_2025 huggingface dataset:
P280 Introduction of subcutaneous infliximab CT-P13 and vedolizumab in daily clinical practice: outstanding questions demonstrate the need for post-marketing studies
Authors: Ferrante M , Sabino J , Lobaton T , Dreesen E , Hoefkens E , Fierens L , Liefferinckx C
Published: May 2021

Background

Although clinical trials led to the registration of subcutaneous (SC) infliximab CT-P13 (IFX) and SC vedolizumab (VDZ) for patients with Crohn’s disease (CD) and ulcerative colitis (UC), many practical aspects have not been addressed yet. We explored what strategy Belgian clinicians plan to follow once these formulations become available.

Methods

A 3-round Delphi process was initiated in Jan 2021. A core panel (4 IBD clinicians, 1 PKPD expert, 1 IBD nurse, 1 methodologist) developed a neutral video on the available data, as well as 65 statements and 9 multiple-choice questions related to the practical use of SC IFX and VDZ. The expert panel, consisting of 45 IBD clinicians (median [IQR] years of practice 19 [11-26] years), scored all statements on a 10-point Likert scale. We here present the results of the first Delphi round. The complete report will be available after the final Delphi round in May 2021. A ≥70% consensus level (scores 1-4 for disagreement, scores 7-10 for agreement) is foreseen.

Results

The majority of IBD clinicians expressed the need for more scientific data on switching from intravenous (IV) to SC therapy (Table 1). Furthermore, a minority would consider starting SC therapy after only two IV induction doses (Figure 1).

Most clinicians would restrict switching to patients who achieved both clinical, biological response, and endoscopic response (Figure 2) and this only when receiving standard IV dosing of 5mg/kg IFX (75.5%) or 300mg VDZ every 8 weeks (68.9%). Both for IFX and VDZ, 57.1% of IBD clinicians would administer a first SC dose no later than 6 weeks after the last IV administration.

The IBD clinicians highlighted the role of the IBD nurse in explaining and guiding a potential switch (82.2% IFX, 88.9% VDZ) and supervising the first SC administration (100.0% IFX, 95.5% VDZ). They emphasized the need for a clinical follow-up within 8 weeks (88.6% IFX, 88.9% VDZ).

Although reactive therapeutic drug monitoring under SC therapy was considered helpful by IBD clinicians (77.8% IFX, 68.9% VDZ), they acknowledged the lack of an optimal serum concentration (73.4% IFX, 84.3% VDZ).

Round one did not result in a consensus on using SC formulations in patients with quiescent perianal fistulising disease or a prior episode of acute severe UC. Finally, the optimal strategy in case of an objectified clinical relapse after switching to SC therapy seems is clearly unknown (83.3% IFX, 76.2% VDZ).

Conclusion

Although both SC IFX and SC VDZ will become available soon, the majority of IBD clinicians expressed the need for more scientific data on switching from IV to SC therapy. This Delphi process may indicate pivotal remaining research questions to be answered through post-marketing studies.
P355 Preferences and satisfaction of IBD patients in whom the adalimumab regimen was changed from 40 mg weekly to 80 mg every other week: the ADASCAL study
Authors: Taxonera Samso C , Martínez-Montiel P , Barreiro-De-Acosta M , Vera I , Lorente R , Vega P , Diz-Lois M T , Fuentes Coronel A M , Pérez Calle J L , Casis B , Ferreiro R , Calvo M , Olivares D , Alba C
Published: May 2021

Background

Adalimumab (ADA) dose escalation from 40 mg SC every other week (EOW) to 40 mg weekly is approved for IBD patients with loss of response. A recently registered device containing 80 mg of ADA will allow an alternative dose escalation regimen with SC doses of 80 mg EOW. The ADASCAL study aimed to evaluate the preferences and satisfaction of patients with modifying the ADA regimen from 40 mg weekly to 80 mg EOW.

Methods

This multicentre cross-sectional study included patients with IBD in whom the ADA regimen was changed from 40 mg weekly to 80 mg EOW according to clinical practice. Patients who have received at least 4 doses of 80 mg EOW completed a 4-item self-questionnaire (a Likert-like 5-point scale for preferences, 2 closed questions for convenience, and a 100-point visual analogue scale [VAS] to evaluate patient’s preference for weekly or EOW ADA) (Figure 1); and the 14-item Treatment Satisfaction Questionnaire for medication (TSQM 1.4) that covers 4 domains: effectiveness, side effects, convenience, and overall satisfaction.

Results

Seventy-seven patients (64 CD, 13 UC; 67.5% men; mean age 48 years, SD 14.1) were included. The overall mean duration of exposure to ADA was 66 months (SD 34), with mean exposure to ADA 40 mg weekly of 40 months (SD 25), and mean exposure to ADA 80 mg EOW of 12 months (SD 5). At the time of the survey, 87.1% of CD patients and all UC patients were in clinical remission (Harvey-Bradshaw index ≤4 for CD, Partial Mayo score ≤1 for UC). According to the results of the questionnaires, 74% of the patients preferred the 80 mg EOW ADA regimen (59.7% had a strong preference and 14.3% had a slight preference) (Figure 1). Patients referred that ADA EOW regimen interferes less with daily activity and with travel plans. Most patients wanted to continue with ADA 80 mg EOW, as reflected by a mean VAS score of 84.7 (SD 24.1), where 0 indicated a choice for weekly ADA, 100 for ADA EOW, and 50 indifferent. Overall, 77% of patients preferred to continue with ADA EOW, 4% with ADA weekly, and 17% were indifferent. Attending physicians also reported a greater preference for the EOW ADA regimen (mean VAS score 93, SD 7.8). The mean global satisfaction according to the TSQM was 84.3% (SD 13.5), where 0 indicated extremely dissatisfied and 100 extremely satisfied. Patients reported very high TSQM scores for individual components: effectiveness 77.6% (SD 16.9), convenience 83.7% (SD 14.5), and side effects 86.1% (SD 23.4).

Conclusion

IBD patients in whom the ADA regimen was changed from 40 mg weekly to 80 mg EOW reported a higher preference for the EOW regimen. TSQM results indicated that patients had a high level of satisfaction with the current EOW regimen. Therefore, most patients wanted to continue with ADA 80 mg EOW.
P362 Longitudinal antibody response to SARS-CoV-2 infection and antibody responses to COVID-19 vaccination in Inflammatory Bowel Disease patients receiving biologics
Authors: Wong S Y , Dixon R , Gold S , Vicky M , Helmus D , Cadwell K , Colombel J F
Published: May 2021

Background

Given that IBD patients were excluded from COVID-19 vaccine trials, there is a lack of vaccine efficacy data in this population. In this study, we evaluated longitudinal serological responses to SARS-CoV-2 infection as well as to COVID-19 vaccination in IBD patients.

Methods

We collected clinical data and sera from IBD patients enrolled in an observational SARS-CoV-2 sero-surveillance study at our large hospital center in New York City during routine infusions and clinic visits. To distinguish between infection and vaccination, sera was collected prior to vaccination where possible, and all sera was tested for both antibodies to SARS-CoV-2-specific RBD, the target of current available vaccines in the U.S., and nucleocapsid proteins.

Results

Our results reveal waning antibody titres in 13 of 16 (81%) patients infected with SARS-CoV-2 over a course of 6-7 months. Of 48 vaccinated patients, 16 patients completed vaccine schedules with two doses, and all 16 (100%) achieved seroconversion above the threshold required for convalescent plasma donation.

Conclusion

While antibody responses to infection in IBD patients have questionable stability, completion of the COVID-19 vaccine series in IBD patients results in robust serological responses. To our knowledge is the first data confirming adequate serological responses to COVID-19 vaccination in IBD patients with and without biologic medications. Studies are needed to assess adequacy of dosing schedules, medication effects, measurement of cell-mediated responses, durability of immune responses, and clinical efficacy of COVID-19 vaccines in IBD patients.
P393 Treatment patterns of patients with perianal fistulizing Crohn’s disease from a US administrative claims database
Authors: Cazzetta S , Chen G , Pedarla V , Null K , Rana Khan Q , Schwartz D
Published: May 2021

Background

Perianal fistula (PAF), a complication of Crohn’s disease (CD), is indicative of high disease severity and poor prognosis. We estimated the cumulative prevalence and treatment patterns of PAF CD in the USA.

Methods

In this retrospective study of IBM® MarketScan® Commercial and Medicare databases (conducted 1 October 2015 to 30 September 2018), patients (pts) were 18 to 89 years of age with at least two diagnoses of CD at least 30 days apart, and had continuous health plan enrolment for at least 12 months pre- and post-index date (first PAF diagnosis or procedure [PAF pts]). Non-PAF CD pts were assigned the same index date as matched PAF pts based on birth year, sex, presence/lack of CD diagnosis before index date, CD disease location and follow-up duration. Descriptive analysis was used for all variables. Treatment patterns and costs related to opioid use were compared among PAF pts. We also assessed four PAF pt cohorts with PAF-related surgery treated with one (cohort 1) or more than one (cohort 2) opioid within 7 days of index date or one (cohort 3) or more than one (cohort 4) opioid more than 7 days after index date.

Results

Cumulative prevalence of PAF CD (n = 81 862) was 7.7% (0.01% of the US population) over 3 years. The economic impact and treatment patterns were assessed in PAF (n = 1218; mean age 42 years; 52.4% men; 56.5% preferred provider organization [PPO] health plan) and matched non-PAF CD pts (n = 4095; mean age 43 years; 50.9% men; 57.6% PPO health plan). During follow-up, 65.8% of PAF and 42.3% of non-PAF pts were treated with at least one biologic agent. In the 30 days post-index, 31.9% of PAF pts were treated with biologics, with this percentage increasing over time; steroid use also remained high (Figure 1). Opioid treatment was associated with higher mean per patient per year (PPPY) total gastrointestinal (GI)-related costs for PAF pts (p < 0.0001). Mean PPPY total GI-related costs for pts with PAF-related surgery and opioid treatment were $50 605, $53 984, $82 973 and $92 375 for cohorts 1, 2, 3 and 4, respectively (Figure 2). Generalized linear model-adjusted mean PPPY PAF-related surgeries were 7.2 versus 0 for PAF pts and non-PAF pts (p < 0.0001), respectively. In the 30 days post-index date, 22.5% of PAF pts had minor surgeries and 20.0% had definitive surgeries.

Conclusion

Based on treatment guidelines as well as the study population’s use of inflammatory bowel disease medications and opioids, and higher rates of PAF-related surgeries, a need for better disease state management of patients with PAF CD is warranted.

Sponsor: Takeda Pharmaceuticals USA, Inc.
P465 One year endoscopic and histologic outcomes to tofacitinib therapy in refractory ulcerative colitis
Authors: Verstockt B , Aden K , Alsoud D , Outtier A , Sabino J , Rosenstiel P , Vermeire S , De Hertogh G , Schreiber S , Ferrante M
Published: May 2021

Background

Long-term real-life data on the efficacy of the Janus kinase inhibitor tofacitinib in moderate-to-severe ulcerative colitis (UC) are limited. We here report efficacy of tofacitinib in refractory UC patients with an emphasis on endoscopic and histologic outcome.

Methods

Fifty-four consecutive UC patients (Mayo endoscopic sub-score ≥2) initiating tofacitinib in 2 tertiary IBD referral centres were prospectively included (Table 1). Almost all were refractory to both anti-TNF (96.4%) and vedolizumab (92.7%) and received tofacitinib in standard dosage. Steroid-free clinical remission was defined as partial Mayo score of ≤2 with no single sub-score >1 and without any steroid exposure at assessment. Biological remission was defined as faecal calprotectin <250mcg/g, endoscopic remission as Mayo endoscopic sub-score of 0, endoscopic improvement as Mayo endoscopic sub-score of ≤1, and histologic remission as Nancy histology index of 0. A combination of endoscopic and histologic remission was referred as mucosal healing. All outcomes were assessed at year 1. Non-responder imputation and last observation carried forward analysis were applied.

Results

Patients were followed for a median [IQR] of 91.7 [67.2–102.4] weeks, with an exposure to tofacitinib of 23.9 [14.6–51.6] weeks. By year one, 31.5% of patients were in steroid-free clinical remission (Figure 1). Biological remission was observed in 26.9% of patients. Endoscopic improvement, endoscopic remission, histologic remission and mucosal healing, were observed in 31.5%, 24.1%, 22.0% and 18.0% of patients, respectively. Multivariate analysis identified baseline Mayo endoscopic sub score (OR 0.03, p=0.03); endoscopic improvement by week 16 (OR 36.5, p=0.008) and disease extent (OR 0.11, p=0.05) as independent predictors for endoscopic remission at year 1. Patients with left-sided colitis or proctitis experienced higher endoscopic remission rates (33.3% and 25.0%) then patients with extensive colitis (10.5%, p=0.09; p=0.6). Ultimately, 61.1% of all patients discontinued tofacitinib therapy after a median of 15.9 [9.2–24.5] weeks, due to primary non-response (n=25), loss-of-response (n=6) or (serious) adverse events (n=2). Thirteen patients (24.1%) required colectomy. During follow-up, no venous thrombo-embolisms or cancers were observed. One patient had to be admitted at ICU due to several life-threatening opportunistic infections.

Conclusion

In this highly refractory cohort of UC patients, tofacitinib induced and maintained endoscopic and histologic remission in up to one quarter of patients. UC patients with moderate left-sided colitis and proctitis had a numeric higher likelihood for a sustained effect than patients with extensive colitis.
P466 Acute Severe Ulcerative Colitis in the modern era: biologic therapy-exposed patients and salvage therapy with intensified infliximab
Authors: Fasoulas K , Soufleris K , Kafalis N , Kevrekidou P , Bouzoukas S , Stergiou E , Dimitriadis N , Chatzopoulos E , Tzilves D
Published: May 2021

Background

Acute Severe Ulcerative Colitis (ASUC) is still associated with significant morbidity and risk of colectomy, almost 70 years since the landmark study of Truelove-Witts established steroid efficacy and 15 years since the Järnerot study introduced infliximab as an effective rescue therapy. It remains unclear if management of ASUC in the modern era (biologic-exposed patients and intensified infliximab regimens) leads to different outcomes.

Methods

A retrospective review of all recently hospitalized ASUC patients was performed. We aimed to compare rates of colectomy, response to steroids, and response to salvage infliximab in bio-naive and bio-exposed patients. Intensified infliximab was used as salvage therapy: 10 mg/kg infusions, aiming a trough level of at least 10 μg/ml at Week 10. We also tried to identify disease and patient related characteristics predictive of colectomy or response to medical therapy.

Results

50 patients were included (male 66%, mean age: 47.4 years) and followed up for a mean of 24.2 months. 24 patients (48%) experienced ASUC while on biologic therapy: 11 on infliximab, 6 on vedolizumab, 5 on adalimumab, 2 on golimumab. Endoscopy showed deep ulcers at 23 patients (47%). Fecal calprotectin was > 1800 ng/ml in all patients. Half the patients (25) received rescue therapy with Infliximab due to steroid refractoriness. Eleven patients (22%) underwent colectomy, 2 (4%) of which during the index hospitalization. Although colectomy rates were similar among bio-naïve and bio-exposed (20% vs 25%, p:0.675), bio-exposed patients were more refractory to steroids (0dds Ratio:3.6 ;95% CI:1.01–13.2, p:0.047). Response to rescue infliximab was similar (Odds Ratio:0.45 ;95% CI:0.13–1.5, p:0.215), even in patients failing standard dosed infliximab. High CRP levels (4.89 mg/dl vs 2.64 mg/dl, p:0.014) and low albumin levels (3.4 g/dl vs 3.9 g/dl, p:0.013) were predictive of colectomy in contrast to endoscopic severity and disease extent.

Conclusion

ASUC remains a therapeutic challenge in the modern era, with considerable refractoriness to medical therapy and colectomy risk: 50% of our group of ASUC patients responded to steroids and 22% underwent colectomy within two years of follow-up. High inflammatory burden, depicted by high CRP values and hypoalbuminemia can predict need for colectomy. Bio-exposed patients were more refractory to steroids but they showed comparable response to intensified infliximab, so they can be managed in the same way, at least until therapy with small molecules proves more efficient by future studies.
P486 Iron deficiency anaemia in inflammatory bowel disease: Diagnosis, quality of life and iron treatment preferences among European patients
Authors: Francis D , Hudson O
Published: May 2021

Background

Iron-deficiency anaemia (IDA) is a major complication in inflammatory bowel disease (IBD). A European patient survey was conducted to analyse the IDA diagnostic journey and the impact of IDA on patients’ quality of life (QoL).

Methods

This quantitative survey was conducted in the UK, Spain, Italy and Germany between 28 May and 24 August 2020. The questions had been pre-validated by patients in an initial qualitative research phase. Adult patients with IDA associated with IBD and current or last haemoglobin level(s) greater than 8 g/dl, or IDA perceived to be mild or moderate were included. Patients on ferric maltol were excluded due to focus on traditional iron therapies. Selected Short Form-36 measures were used to assess the QoL. Results are presented as the percentage of respondents.

Results

A total of 173 patients were included (54% female; 98% aged ≤67 years). For months before their IDA diagnosis, most patients experienced IDA symptoms such as extreme fatigue 57%, weakness 45%, headache/dizziness 38% and sleeping difficulty 36%. IDA was typically diagnosed during either regular IBD check-ups or when the patient asked about their symptoms (37% each). Patients felt limited in carrying out daily activities such as running (77%), climbing stairs (65%), or walking more than a mile (64%). As a result of being fatigued, most patients (58%) also felt limited in their ability to complete work or college/university activities. Initially most patients (66%) received oral iron, and 34% received intravenous iron (IV). At the time of the survey, 71% were receiving oral iron and 28% IV iron. In 27% patients, side-effects with both oral and IV irons were the main challenge with IDA treatment. The three most frequently experienced side-effects were, with oral iron: black faeces 42%, stomach pain 37% or constipation 30%; and with IV iron: diarrhoea 23% or headache 21%. One in two patients had to wait 2 or more weeks to start their IV treatment. Once given, 57% patients had to return at least every 1–2 months for new IV iron injections. The majority patients who experienced both oral and IV therapies preferred oral treatments over IV (59% versus 41%). Home-based administration was the predominant reason (by 50%) for oral treatment preference. Most patients (64%) who preferred IV treatment valued fewer side-effects versus oral iron.

Conclusion

Patients with IBD and IDA are limited in their daily activities. Enduring IDA symptoms such as extreme fatigue often precede and trigger the IDA diagnosis. While challenges remain with both oral and IV irons, oral iron tablets are preferred due to home-based administration. The ongoing COVID pandemic may thus increase the demand for better oral iron treatments of IDA in patients with IBD.
P539 Unmet needs in advanced therapy-naïve (ATN) and advanced therapy-experienced (ATE) moderate-to-severe (mod-sev) ulcerative colitis (UC) patients in the United States (US)
Authors: Afzali A , Kakehi S , Lapensee K , Lukanova R , Hennessy F , Knight H , Singh K
Published: May 2021

Background

About a third of patients with mod-sev UC receiving advanced therapy (AT, i.e. biologics and tofacitinib) do not respond initially and another third lose response. We examined reasons for treatment choice and outcomes in ATN and ATE mod-sev UC patients.

Methods

A point-in-time survey of US gastroenterologists and their respective consulting UC patients was conducted from Jan 2020–Feb 2021 (ongoing) using the Adelphi Disease Specific Programme™ for Inflammatory Bowel Disease. Physicians completed patient record forms for UC patients with a history of mod-sev disease covering treatment history and clinical status. Patients were classified as ATN and ATE based on treatment. Response to treatment status was identified by factor and cluster analyses using flare, remission and change in symptoms. Descriptive and comparative statistics were calculated for reasons for initiating/switching therapy and patient-reported outcomes (satisfaction, pain/fatigue, and quality of life via the EuroQol-5 dimension questionnaire [EQ-5D]).

Results

Based on the interim sample, 66 physicians and 394 mod-sev UC patients were analysed. Of patients who were ATN (n=82) and ATE (n=312), 29% and 32% were classified as non-responders respectively. Comparing ATN vs ATE patients, mean age was directionally lower (38.4 vs 40.7 years), proportion of males was directionally higher (65% vs 55%), and mean time since diagnosis was similar (3.9 vs 3.8 years). In general, non-responders experienced gastrointestinal-related (90% vs 41%), anorectal (38% vs 6%), and fatigue-related symptoms (66% vs 23%) more frequently than responders. ATN patients eligible to receive AT (n=26) reported dislike of injections/infusions (46%) or unwillingness to go to infusion centres (31%) as reasons for not receiving AT. Most common reasons for switching therapy in ATN patients were disease progression (40%) and lack of tolerability (27%), and in ATE patients were loss of response over time (43%) and disease progression (35%). In the ATE group, patient and physician satisfaction rates were higher in responders vs non-responders (>93% vs <79%), pain and fatigue scores were lower (0.8 vs 2.3 and 1.1 vs 2.3, p<0.0001), and EQ-5D scores higher (0.93 vs 0.81, p=0.005). In the ATN group, comparisons were not conducted due to small sample sizes.

Conclusion

In this point-in-time survey study with data collected during the COVID-19 pandemic period, about a third of mod-sev UC patients did not respond to current therapy. These results suggest an opportunity for new therapies that increase response rates, provide long-term disease control, provide alternatives to parenteral routes of administration, and enhance patient satisfaction.
P554 Does vitamin D level correlates with disease activity in inflammatory bowel disease patients?
Authors: Sina M , Pemaj X , Akshija I , Hysa A , Koçollari A , Prifti S
Published: May 2021

Background

Vitamin D exerts an important role in the immune regulation. Several studies from the Western countries showed low level of vitamin D among inflammatory bowel disease (IBD) patients. They also showed that vitamin D may have an influence on disease activity. Data from the Eastern Europe are scarce. The aim of this study was to evaluate vitamin D level and the association between vitamin D and disease activity in biologic naïve patients with IBD.

Methods

This is a prospective study carried out at a tertiary hospital center in Albania from 2016–2020 including consecutive biologics–naïve IBD patients. Demographic and clinical data [age, gender, body mass index (BMI), disease location, extent, activity and duration) were collected. All patients underwent ileocolonoscopy. Vitamin D level and C-reactive protein (CRP) were measured within 2 weeks of their ileocolonoscopy. Montreal classification was used to evaluate the disease extent, while total Mayo score and Crohn’s disease activity index (CDAI) were used to assess disease activity in patients with ulcerative colitis (UC) and Crohn’s disease (CD) respectively. Vitamin D levels were considered as: normal >30ng/ml; insufficient 10–30 ng/ml; deficient <10ng/ml.

Results

A total of 96 patients were included in this study; mean age was 43.5±15.8 years, 52% females; 85.4% UC, mean disease duration 6.5±5 years. Vitamin D levels ranged from 3–58 ng/mL, with a mean level of 18 ±9.9 ng/ml (CD:17.5±12.4 ng/mL, UC:18.1±9.5, p=0.826). 63/96 patients (66%) had vitamin D deficiency (73.2% UC and 21.4% CD, p<0.001), while 21/96 (22%) had vitamin D insufficiency. There was no significant difference in vitamin D insufficiency and IBD type (p>0.05), although the insufficiency was found higher among CD that UC patients [7/14 (50%) vs 14/82 (17%) respectively]. No statistically significant association was found between vitamin D level and age, gender, BMI, disease type, activity, location, extent and duration. There was a negative correlation between CRP and vitamin D level (r=−0.178, p=0.054).

Conclusion

Low vitamin D levels are common in biologic-naïve patients with IBD. These levels are not associated with clinical data such as disease type, extent, duration or severity in IBD patients, but it seems that vitamin D influences the presence of inflammation in these patients.
P588 Steroid sparing effect of adalimumab in cortisone–depended ulcerative colitis patients
Authors: Sina M , Pengili E , Pemaj X , Osmanaj D , Bibolli I , Prifti S
Published: May 2021

Background

Corticosteroids are indicated for induction of remission in moderate to severe ulcerative colitis (UC) patients. However, due to their adverse effects associated with long-term use, steroids are not indicated as a maintenance therapy. The aim of this study was to assess the steroid sparing effect of adalimumab (ADA) in steroid-dependent UC patients.

Methods

This is a prospective study carried out at a tertiary hospital center in Albania from 2016–2020, including consecutive moderate-to-severe UC patients. All patients received biologic therapy with subcutaneous ADA 160/80mg at weeks 0/2 followed by 40mg every 2 weeks. We evaluated the steroid-sparing effect of ADA measuring the number of steroid–free patients and the average steroid dose at baseline before initiating biologic treatment and at week 8, 24, 52, 104, 156. Clinical remission was defined as total Mayo score ≤ 2 points.

Results

We enrolled 26 UC patients, mean age 47.3 ± 16.1 (24–85) years, 55.6% were females. The average disease duration before starting ADA was 7.3 ± 7.0 years (range 1–33); 44.4% had pancolitis and 55.6% left side colitis. 8(29.6%) patients were on combination therapy with azathioprine. 17/26 (65.4%) patients were taking prednisone at the time of the first ADA injection with an average dose of 17.7mg. The number of steroid-free patients at week 8, 24, 52, 104 and 156 was 12/26 (46.2%), 16/26 (61.5%), 15/21 (71.4%), 11/14 (78.6%), 8/9 (88.9%) respectively. At the end of the follow-up (week 156), the proportion of steroid free patient was significantly higher than at baseline [88.9% (8/9) vs 34.6% (7/26), p=0.005]. The reduction of the average dose of prednisone (8.8 mg, 4 mg, 6.8mg, 3.8mg and 3,8mg at week 8, 24, 52, 104 and 156 respectively), was also statistically significant (p<0.01). Clinical remission rates were 7.7% (2/26) at week 8, 47.6% (10/21) at week 52, 42.9% (6/14) at week 104 and 44.4 % (4/9) at week 156.

Conclusion

In our cohort, ADA administration to moderate–to severe UC significantly reduced the steroid dose and the proportion of patients taking cortisone during 3 years follow-up.
P595 Finding predictors of azathioprine-induced pancreatitis in patients with inflammatory bowel disease
Authors: Freitas M , Capela T , Macedo Silva V , Arieira C , Cúrdia Gonçalves T , Dias de Castro F , Moreira M J , Cotter J
Published: May 2021

Background

Azathioprine (AZA)-induced pancreatitis (AIP) is a common, idiosyncratic side effect, whose incidence, clinical course and risk factors data in inflammatory bowel disease (IBD) patients are scarce. We aimed to establish the incidence, describe the clinical course and identify risk factors for AIP.

Methods

Retrospective study including all IBD patients on AZA between January 2013 and July 2020. Patients with AIP were considered. Demographic, clinical, biochemical and imaging data were collected.

Results

AIP occurred in 33 patients (7.5%; 442 patients on AZA): 81.8% had Crohn’s disease, 54.5% were male, and the mean age was 35±13 years. The mean time under AZA till AIP was 25±11 days, with a mean dosage of 88±44mg. Eighteen patients (54.4%) were hospitalized, with a mean hospital stay of 4±2days. All patients had a mild course of disease which resolved with suspension of AZA, and with no complications or need of invasive interventions or complications. Smoking (p=0.02), single daily dose of AZA (p<0.001) and concomitant treatment with budesonide (p=0.001) were risk factors for AIP. In multivariate analysis, concomitant treatment with budesonide (OR: 5.3; p=0.002) and single daily dose of AZA (OR: 4.8; p=0.002) were the only predictors of AIP.

Conclusion

Although AIP was a relatively common side effect, it presented a mild course in all patients. Smoking, concomitant treatment with budesonide and single daily dose of AZA were risk factors for AIP. This study suggests that smoking, concomitant use of budesonide and single dose regimen of AZA should be avoided in IBD patients treated with AZA.
P613 Social Media Analytics for Inflammatory Bowel Disease – What Are We Missing?
Authors: Kumar L , Kiely L , O’Riordan A , Barry P
Published: May 2021

Background

Increasingly, Inflammatory Bowel Disease (IBD) patients are using social media to disseminate information, share experiences and address queries. Gastroenterologists can play an important role in IBD care by better understanding trends in patients’ perception of their disease. This study aimed to identify trending topics and misconceptions of disease for early targeted education based off patients’ interactions and activity on social media.

Methods

Utilising an established social media analytics program, we extracted social media posts relating to IBD over a 30-day period between 11/05/2020 and 10/06/2020. The most common hashtags and frequently used words were retrieved from these posts, analysed and qualitatively coded. Additional analysis was performed to evaluate user mentions for specific key words identified from the ECCO consensus for Complementary and Alternative Medicine (CAM) and psychotherapy.

Results

22,375 social media posts were reviewed. Twitter was the most common platform with 12,977 posts (58%). Most posts originated from North America and Europe (81%).

Amongst common hashtags and words, patients most frequently referenced community groups (n=8094) for example “#crohnswarrior”, followed by terms related to treatment (n=3256), and lifestyle (n=2446). Symptom-related terms were less frequently referenced (n=2031). Of mentions relating to diet and nutrition, ‘gluten free’ was mentioned most frequently (466/2911, 16.0%), followed by ‘vegan’ (374/2911, 12.8%), and ‘plant based’ (342/2911, 11.7%).

There was a temporal association with these posts which was demonstrated by hashtags (n=1397) and mentions (n=485) referencing ‘World IBD Day’ which occurred on the 19th of May as well as hashtags (n=391) and mentions (n=1475) referencing the COVID 19 pandemic.

Analysis of CAM mentions highlighted patients’ interest in “exercise” as a manipulative and body-based intervention (2015/2088, 96.5%), “cannabinoids” as a herbal and dietary intervention (816/2144, 38.1%) and “yoga” as a mind-body intervention (175/415, 42.2%). 3435 mentions were generated from our psychological key word search. These included terms such as fatigue (28.2%), anxiety (20.1%), depression (13.8%) and suicide (2.2%).

Conclusion

Our study identified areas where patients’ needs, concerns and queries may be unmet by current clinical practices. Further development of our analytical model can aid gastroenterologists in bridging this gap and providing more holistic patient care.
P639 Epidemiology and patient burden of rectovaginal and anovaginal fistulas in patients with Crohn’s disease: A systematic review
Authors: Iglay K , Bennett D , Kappelman M , Thai S , Aldridge M , Karki C , Cook S
Published: May 2021

Background

Rectovaginal fistulas (RVF) and anovaginal fistulas (AVF) in Crohn’s disease (CD) are rare, debilitating conditions that present substantial disease and treatment burdens for women. In this systematic literature review (SLR), articles relating to the epidemiology and burden of CD-related RVF and AVF were assessed in order to summarize evidence from observational studies and highlight knowledge gaps.

Methods

Articles published in the past 10 years in PubMed and Embase that provide data on incidence, prevalence and insight into the patient experience and disease burden of CD-related RVF and AVF (PROSPERO registration number CRD42020177732) were identified. Two trained reviewers used pre-specified eligibility criteria to identify studies for inclusion and evaluate risk of bias using the Risk Of Bias In Non-randomized Studies of Interventions (ROBINS-I) tool for observational studies. Data were extracted for a range of variables, including study type and design, population, outcomes and limitations.

Results

Of the 582 records identified, 316 full-text articles were assessed, and 16 studies that met a priori eligibility criteria were included (Figure). Three epidemiology studies were identified, with one study estimating the prevalence of RVF to be 2.3% in women with CD. No studies relating to the incidence or prevalence of AVF were identified. Seven of 12 treatment-pattern studies reported that patients had or required additional procedures before and/or after the intervention of interest, demonstrating substantial treatment burden. Of the nine studies that reported healing/success across multiple surgical types, rates ranged from 14.4% to 81.0%. In the seven studies that assessed clinical outcomes, healing rates were in the range 50–75%, with varying estimates dependent on population and intervention. Two studies reported recurrence rates of 13.3–55.8% across multiple surgical interventions. Patient-reported outcomes obtained using standardized measures were reported in only one of the 16 studies and were limited to overall health related quality of life, faecal incontinence-related quality of life and female sexual function index. None of the 16 studies included reported healthcare-resource utilization in this patient population.

Conclusion

This SLR shows the high disease and treatment burdens of RVF and AVF in patients with CD and identifies multiple evidence gaps in this field. The published literature lacks robust, generalizable data and demonstrates a compelling need for substantial novel research into these rare and debilitating sequelae of CD.

Sponsor: Takeda Pharmaceuticals USA, Inc.
Outcome of patients with different clinical presentations of high-risk pulmonary embolism
Authors: Ebner Matthias , Sentler Carmen , Harjola Veli-Pekka , Bueno Héctor , Lerchbaumer Markus H , Hasenfuß Gerd , Eckardt Kai-Uwe , Konstantinides Stavros V , Lankeit Mareike
Published: May 2021

Aims

The 2019 European Society of Cardiology (ESC) guidelines provide a revised definition of high-risk pulmonary embolism (PE) encompassing three clinical presentations: Cardiac arrest, obstructive shock, and persistent hypotension. This study investigated the prognostic implications of this new definition.

Methods and results

Data from 784 consecutive PE patients prospectively enrolled in a single-centre registry were analysed. Study outcomes include an in-hospital adverse outcome (PE-related death or cardiopulmonary resuscitation) and in-hospital all-cause mortality. Overall, 86 patients (11.0%) presented with high-risk PE and more often had an adverse outcome (43.0%) compared to intermediate-high-risk patients (6.1%; P < 0.001). Patients with cardiac arrest had the highest rate of an in-hospital adverse outcome (78.4%) and mortality (59.5%; both P < 0.001 compared to intermediate-high-risk patients). Obstructive shock and persistent hypotension had similar rates of adverse outcomes (15.8% and 18.2%, respectively; P = 0.46), but the only obstructive shock was associated with an increased all-cause mortality risk. Use of an optimised venous lactate cut-off value (3.8 mmol/L) to diagnose obstructive shock allowed differentiation of adverse outcome risk between patients with shock (21.4%) and persistent hypotension (9.5%), resulting in a net reclassification improvement (0.24 ± 0.08; P = 0.002).

Conclusion

The revised ESC 2019 guidelines definition of high-risk PE stratifies subgroups at different risk of in-hospital adverse outcomes and all-cause mortality. Risk prediction can be improved by using an optimised venous lactate cut-off value to diagnose obstructive shock, which might help to better assess the risk-to-benefit ratio of systemic thrombolysis in different subgroups of high-risk patients.
Evaluation of transport-related outcomes for neonatal transport teams with and without physicians
Authors: Abdelmawla Mohamed , Hansen Gregory , Narvey Michael , Whyte Hilary , Ilodigwe Don , Lee Kyong-Soon ,   Canadian Neonatal Transport Network, Singh Avash , Ting Joseph , Tierney Anne , Thomas Sumesh , Phillips Ernesto , Byrne Paul , Toye Jennifer , Bingham William , Daspal Sibasis , Kalapesi Zarin , Murthy Poornima , Caces Rebecca , Roukema Henry , Marrin Michael , Redpath Stephanie , Beaumier Louis , Perrault Thérèse , Piuze Geneviève , Massé Edith , Jangaard Krista , Deshpandey Akhil
Published: May 2021

Objective

The aim of this study was to evaluate if the presence of a physician in the neonatal transport team (NTT) affects transport-related outcomes and procedural success.

Design

Retrospective cohort study with propensity score matching.

Setting

Canadian national study.

Patients

Neonatal transports from nontertiary centres between January 2014 and December 2017.

Interventions

Comparison of transports conducted by NTTs with physicians (MD Group) and without physicians (noMD Group).

Main outcome measures

The primary outcome was the change in patient acuity as measured by the transport risk index of physiologic severity (TRIPS) score. Secondary outcomes included mortality within 24 hours of NICU admission, clinical complications during transport, procedural success, and stabilization time.

Results

Among 9,703 eligible cases, 899 neonatal transports attended by NTTs with physicians were compared to 899 neonatal transports without physicians using propensity score matching. No differences were seen in the improvement of TRIPS score or mortality ≤24 hours of NICU admission. The MD Group had more clinical complications (7.7% versus 5.0%, P=0.02). No differences were seen in success rates of invasive procedures. The MD Group had shorter stabilization times. In multivariable analysis, the MD Group was not a significant predictor for the improvement in TRIPS score after adjustment for covariates.

Conclusions

Neonatal transports conducted by teams including physicians compared to teams without physicians, did not have higher improvement in TRIPS scores and had similar success rates for procedures. These results provide insights for the planning of the structure and training of specialized interfacility neonatal transport programs.
Time to reopen schools: COVID-19, health disparity and education
Authors: Kahambing Jan Gresil S
Published: May 2021

Weighing the dilemma of reopening schools during the pandemic is no longer a matter of self-determination but harm. Coronavirus disease 2019 has shown gross health inequality and, by extension, the inequality of society per se. The assertion that ‘education continues despite the pandemic’ using access to technological means is a privileged position.
Rapid Transition to a Virtual Multiple Mini-Interview Admissions Process: A New Medical School’s Experience During the COVID-19 Pandemic
Authors: Carroll Turpin Michelle A. , Steele Kenya , Matuk-Villazon Omar , Rowland Kevin , Dayton Catherine B. , Horn Kathryn V.
Published: May 2021

Problem

The University of Houston College of Medicine (UH COM) began its first admissions cycle after receiving preliminary accreditation in February 2020. With the advent of remote learning in response to the COVID-19 pandemic, the school moved its admissions process, including multiple mini-interview (MMI), from an in-person to online format in mid-March 2020.

Approach

The UH COM selected Zoom as the video conferencing platform for its virtual admissions process, including MMI. On each interview day (3–4 hours), 14–16 applicants joined administrators, faculty, and staff in a virtual meeting room. Applicants were divided into 2 groups: one viewed short presentations about the school, curriculum, and departments, while the other participated in 7 MMI stations (one-on-one interactions with interviewers) via virtual breakout rooms; the groups then switched. The MMI stations were the same as those used in-person in early March. Applicants were able to ask questions at multiple points during the day. Technical support was provided for participants with connectivity issues or unfamiliar with Zoom.

Outcomes

Of the 180 applicants interviewed in March–April 2020, 134 (74%) participated in the virtual process and 46 (26%) in the on-site process. Twenty-five (83%) of the 30 members of the inaugural class of 2024 interviewed virtually. Advantages of the virtual format included ease of access for faculty and more flexibility and less expense for applicants. Challenges included the need for applicants to decide whether to accept an offer of admission from a new school without visiting and missed opportunities for faculty to have relatively unstructured interactions with applicants.

Next Steps

This virtual admissions process was a feasible alternative for the inaugural class but is not sustainable. UH COM plans to leverage lessons learned to refine the virtual format for use in future admissions cycles, even when in-person interviews are possible.
Incidence of HPV-related Anogenital Intraepithelial Neoplasia and Cancer in Men With Diabetes Compared With the General Population
Authors: Reinholdt Kristian , Thomsen Louise Thirstrup , Munk Christian , Dehlendorff Christian , Carstensen Bendix , Jørgensen Marit Eika , Kjaer Susanne Krüger
Published: May 2021

Background:

Diabetes may increase risk of human papillomavirus (HPV)–related precancer and cancer. We estimated incidence of penile and anal high-grade intraepithelial neoplasia (hgPeIN, hgAIN) and squamous cell carcinoma (SCC) in men with diabetes compared with the entire Danish male population without diabetes.

Methods:

In this registry-based cohort study, we included all men born 1916–2001 and residing in Denmark (n = 2,528,756). From nationwide registries, we retrieved individual-level information on diabetes, educational level, and diagnoses of hgPeIN, hgAIN, penile SCC, and anal SCC. We used Poisson regression models to estimate incidence of hgPeIN, hgAIN, penile SCC, and anal SCC as a function of diabetes status, attained age, calendar period, and education. We estimated incidence rate ratios (IRRs) of each outcome in men with diabetes compared with nondiabetic men, both for diabetes overall and separately for type 1 (T1D) and type 2 diabetes (T2D).

Results:

Men with diabetes had increased incidence rate of penile SCC compared with nondiabetic men (IRR = 1.5, 95% CI = 1.2, 1.9). We saw similar trends for anal SCC, hgPeIN, and hgAIN. The combined incidence rate of penile and anal SCC was increased in men with T2D (IRR = 1.5, 95% CI = 1.3, 1.8), but not with T1D (IRR = 0.53, 95% CI = 0.20, 1.4) compared with men without diabetes.

Conclusion:

The incidence of penile and anal high-grade intraepithelial neoplasia and SCC in men with diabetes was increased compared with men without diabetes. For penile and anal SCCs, this was primarily due to an increased risk in men with T2D.
Safe balloon inflation parameters for resuscitative endovascular balloon occlusion of the aorta
Authors: Maleckis Kaspars , Keiser Courtney , Jadidi Majid , Anttila Eric , Desyatova Anastasia , MacTaggart Jason , Kamenskiy Alexey
Published: May 2021

BACKGROUND

Noncompressible hemorrhage is a leading cause of preventable death in civilian and military trauma populations. Resuscitative endovascular balloon occlusion of the aorta (REBOA) is a promising method for controlling noncompressible hemorrhage, but safe balloon inflation parameters are not well defined. Our goal was to determine the balloon inflation parameters associated with benchtop flow occlusion and aortic/balloon rupture in ex vivo human aortas and test the hypothesis that optimal balloon inflation characteristics depend on systolic pressure and subject demographics.

METHODS

Aortic occlusion parameters in human thoracic aortas (TAs) and abdominal aortas (AAs) from 79 tissue donors (median ± SD age, 52 ± 18 years [range, 13–75 years]; male, 52; female, 27) were recorded under 100/40, 150/40, and 200/40 mm Hg flow pressures for ER-REBOA and Coda balloons. Rupture tests were done with Coda balloons only without flow.

RESULTS

In the TA, the average balloon inflation volumes and pressures resulting in 100/40 mm Hg flow occlusion were 11.7 ± 3.8 mL and 174 ± 65 mm Hg for the ER-REBOA, and 10.6 ± 4.3 mL and 94 ± 57 mm Hg for the Coda balloons. In the AA, these values were 6.2 ± 2.6 mL and 110 ± 47 mm Hg for the ER-REBOA, and 5.9 ± 2.2 mL and 71 ± 30 mm Hg for the Coda. The average balloon inflation parameters associated with aortic/Coda balloon rupture were 39.1 ± 6.5 mL and 1,284 ± 385 mm Hg in the TA, and 27.7 ± 7.7 mL and 1,410 ± 483 mm Hg in the AA. Age, sex, and systolic pressure all had significant effects on balloon occlusion and rupture parameters.

CONCLUSION

Optimal balloon inflation parameters depend on anatomical, physiological, and demographic characteristics. Pressure-guided rather than volume-guided balloon inflation may reduce the risk of aortic rupture. These results can be used to help improve the safety of REBOA procedures and devices.
Pain management for casualties receiving lifesaving interventions in the prehospital scenario: Raising awareness of our human nature
Authors: Betelman Mahalo Yaar , Avital Guy , Radomislensky Irina , Vysokovsky Moshe , Avital-Cohen Rotem , Gelikas Shaul , Tsur Avishai M. , Nadler Roy , Bodas Moran ,   Israel Trauma Group, Chen Jacob , Glassberg Elon , Benov Avi
Published: May 2021

BACKGROUND

Lifesaving interventions (LSIs) are the hallmark of medical care in trauma casualties, reducing mortality and morbidity. Analgesia is another essential treatment, which has been shown to improve outcomes and decrease long-term complications. However, oligoanalgesia is common, and information regarding its relation to the performance of LSIs is scarce. The purpose of this study was to assess the relation between the performance of LSIs and analgesia administration in the prehospital environment.

METHODS

A retrospective database-based study was performed, including all trauma casualties treated by Israeli Defense Forces physicians and paramedics during 2006 to 2017 and admitted to hospitals participating in the Israeli National Trauma Registry. Included LSIs were tourniquet application, administration of tranexamic acid and freeze-dried plasma, and administration of chest decompression. Casualties treated with endotracheal intubation or cricothyroidotomy were excluded.

RESULTS

In the multivariable logistic regression analysis, LSIs were associated with prehospital analgesia administration (odds ratio [OR], 3.59; confidence interval [CI], 2.56–5.08; p < 0.001). When assessing for the different LSIs, tourniquet application (OR, 2.83; CI, 1.89–4.27; p < 0.001) and tranexamic acid administration (OR, 4.307; CI, 2.42–8.04; p < 0.001) were associated with prehospital analgesia administration.

CONCLUSION

A positive association exists between performance of LSIs and administration of analgesia in the prehospital environment. Possible explanations may include cognitive and emotional biases affecting casualty care providers.

LEVEL OF EVIDENCE

Retrospective study, level IV.