bluuebunny/crossref_metadata_2025_split huggingface dataset:
P253 A qualitative study exploring meaningful improvement in bowel urgency among adults with moderate to severe Ulcerative Colitis
Authors: Newton L , Guobyte A , McFadden S , Symonds T , Delbecque L , Donaldson J , Naegeli A 
Published: May 2021

Abstract

Background
Ulcerative Colitis (UC) is a chronic disease with periods of relapse and remission. Bowel urgency, the sudden or immediate need for a bowel movement, is one of the most bothersome symptoms experienced by patients with UC. This study explored how patients define urgency severity and what would be a meaningful improvement based on a numeric rating scale (NRS).

Methods
In-depth interviews were conducted in the United States with 19 adults with clinician-confirmed moderate to severe UC. Participants were asked to define levels of bowel urgency severity using an 11-point NRS (where 0 = no urgency and 10 = worst possible urgency) and to describe what would be a meaningful improvement based on how this change would impact their daily life. Interviews were audio-recorded, transcribed, and coded using thematic coding in NVivo.

Results
Mild bowel urgency was described as ranging between 0 to 3 on the 11-point scale by most UC patients (n=16, 84%). Mild was described as “almost normal” or “normal urgency” (n=6, 32%) and being able to make it to the bathroom with ease (n=5, 25%). Most participants (n=15, 79%) rated moderate urgency between 4 to 6 on the 11-point scale. At this level, participants commented that they would need to ensure they are close to a bathroom (n=7, 37%). Finally, ratings for severe urgency clustered between 6 to 8 (n=7, 37%) and 8 to 10 (n=12, 63%). Severe bowel urgency was described as an immediate or uncontrollable need (n=8, 42%) which impacts their ability to leave the home (n=7, 37%). When asked about what change on the urgency NRS would be meaningful, n=10 (53%) participants reported that a 1-point change would be meaningful, with most stating that any change was an improvement. Participants commented that a 1-point change would reflect improved emotional well-being and greater confidence to leave the home. In contrast, 9 (47%) participants wanted improvements of more than 1-point change; 5 (26%) indicated that a 2-point improvement was required to consider the change meaningful and 4 (21%) felt a 3-point change or more was needed. With this greater level of change, participants described having a significant improvement in urgency, with less frequent urges and improved emotional well-being.

Conclusion
This qualitative study revealed that UC patients largely agreed regarding ratings of ‘mild’ and ‘moderate’ bowel urgency on an 11-point severity scale. ‘Severe’ bowel urgency was split between two ranges suggesting the existence of ‘very severe’ bowel urgency. In addition, the majority of UC patients perceived a 1 or 2-point reduction on the urgency NRS as a meaningful change in their lives.
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

Abstract

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

Abstract

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

Abstract

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

Abstract

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 &lt; 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 &lt; 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

Abstract

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 &gt;1 and without any steroid exposure at assessment. Biological remission was defined as faecal calprotectin &lt;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

Abstract

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 &gt; 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

Abstract

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.