bluuebunny/crossref_metadata_2025_split huggingface dataset:
P310 Is ileoanal pouch excision a destination therapy for Inflammatory Bowel Disease? Data from a quaternary pouch referral center
Authors: Choi S , Lightner A , Lipman J , Hull T , Steele S , Holubar S , Rieder F 
Published: May 2021

Abstract

Background
Although ileal pouch-anal anastomosis (IPAA) is the surgical procedure of choice of many patients with ulcerative colitis and other conditions, some patients may require pouch excision (PEx). We aimed to describe our experience with pouch excisions and associated outcomes with an emphasis on late medical, endoscopic, and surgical interventions for inflammatory bowel disease (IBD).

Methods
We performed a retrospective review of a prospective colorectal surgery database. All pouch excisions performed at our quaternary pouch center from 2006 – 2019 were included; pelvic exenteration, PEx with neo-IPAA or Kock-pouch were excluded. Early complications occurred &lt;30 days, late complications &gt;30 days. Medications taken prior to PEx were included if taken within 12 weeks of pouch excision. Data are reported in frequency (proportion) or median (interquartile range).

Results
A total of 197 cases met inclusion criteria, and were performed by 23 surgeons, median 6 excision (IQR 2 - 14) cases over a 14-year period: of these, 105 had their index pouch created at our quaternary pouch referral center (overall PE rate 2.7%). Indications for PEx are shown in Table 1. Median time to PEx was 7 years and 94 (48%) patients had re-diversion prior to PEx. Medications prior to PEx: 34 (17%) steroids, 27 (14%) biologics, and 22 (11%) immune-modulators. The median duration of surgery was 4 hours (3.2-5). The median estimated blood loss was 263 ml (150-500) with 24 patients (12%) requiring at least one unit of packed red blood cells intra-operatively. Most pouch excisions were done through laparotomy; 2 cases (1%) were started robotically and 11 cases (10%) laparoscopically with a 26% conversion rate. Intersphincteric dissection was used in 172 cases (87%) while 26 cases (13%) required abdomino-perineal resection, of which 58% had a neoplastic indication. Intra-operative, early and late complications are shown in Table 2; 40 patients (20%) had perineal wound complications in less than 30 days, while 26 patients (13%) had long-term perineal wound complications, of which 15 patients required return to the operating room. After PEx, 23 patients out of 167 patients (14%) required continuation of IBD medications, 6 patients (3.6%) required surgery, and 4 patients (2.4%) required endoscopic intervention for their IBD.

Conclusion
In this large series of ileoanal pouch excisions, we found that perineal wound complications are common, but infrequently require operative intervention. For most IBD patients in this series, pouch excision did appear to be a destination therapy for IBD with a small minority requiring ongoing medical therapy for IBD.
P352 A propensity score-matched, real-world comparison of ustekinumab vs vedolizumab as a second-line treatment for Crohn’s disease. The Cross Pennine study II
Authors: Lenti M V , Dolby V , Clark T , Hall V , Tattersall S , Fairhurst F , Kenneth C , Walker R , Kemp K , Borg-Bartolo S , Limdi J , Taylor J , Townsend T , Subramanian S , Storey D , Assadsangabi A , Stansfield C , Smith P , Byrne D , De Silvestri A , Selinger C 
Published: May 2021

Abstract

Background
The best choice of biological agents after failure to an anti-tumour necrosis factor (TNF)α agent in patients with Crohn’s disease (CD) is yet to be defined. Real-world data dealing with this issue are still emerging.

Methods
This is a multicentre retrospective study including eight UK hospitals (August 2014-April 2020). We retrospectively collected data of patients treated with ustekinumab. Clinical response and remission at 14 and 52 weeks evaluated through Physician Global Assessment (PGA) and adverse events were recorded. Predictors of clinical response were examined, and a propensity score-matched analysis with a cohort of patients treated with vedolizumab was performed.

Results
Overall, 282 patients (mean age 40±15, F:M ratio 1.7:1) treated with ustekinumab were included. Clinical response or remission was reached by 200/282 patients (70.9%) at 14 weeks, and by 162/259 patients (62.5%) at 52 weeks. The most common reason for discontinuation was either primary failure or loss of response, followed by the occurrence of adverse events and by the need for surgery. The rate of non-adherence was rather low (1.4%). Current smoking (OR 2.48, 95% CI 1.13-5.44; p=0.02), baseline PGA (OR 2.4, 95% CI 1.55-3.69, p&lt;0.001), and use of steroids (OR 2.42, 95% CI 1.26-4.65, p=0.008) were associated with 52-week treatment failure. Overall, 74 adverse events occurred, of which 26 were labelled as serious (8.3 per 100 person-year). After exclusion of patients without anti-TNFα exposure prior to starting ustekinumab or vedolizumab and exclusion of patients previously exposed to vedolizumab or ustekinumab, we analysed 275/282 patients (97.5%) from the ustekinumab cohort and 118/135 patients (87.4%) from the vedolizumab cohort. Propensity score analysis revealed that at 14 weeks, patients treated with ustekinumab were 38% (95% CI 25-50%; p&lt;0.001) more likely to achieve a clinical remission, while at 52 weeks, the difference of 9% (95% CI -15-33%; p=0.462) was not significant.

Conclusion
Ustekinumab was effective and well tolerated in this real-world cohort. While ustekinumab proved more effective at 14-week follow-up, we found no statistically significant differences in outcomes at 52 weeks.
P388 Agreement between locally and centrally reviewed Mayo endoscopic subscores in the UNIFI study of ustekinumab in patients with Ulcerative Colitis
Authors: Mishkin D , Marano C , Simi A , Lynch J , Noonan L , Zhang H , Sands B E , Reinisch W 
Published: May 2021

Abstract

Background
In the UNIFI clinical study of ustekinumab (UST) in ulcerative colitis (UC), an endoscopic subscore (ES) was assigned by a local endoscopist, and the video was reviewed by central readers who provided an independent ES. Here, we determined ES agreement between local and central readers.

Methods
UNIFI (NCT02407236) was a placebo-controlled double-blind trial consisting of randomized induction and maintenance studies.1
Endoscopies were performed at screening (I-0), induction Wk 8 (I-8), and maintenance Wk 44 (M-44). Mayo ESs (range 0-3) were assigned by local endoscopists and a central reader reviewing the endoscopy video. The local reader was blinded to treatment, and the central reader was blinded to local ESs, treatment, and visit. If local and central readers assigned the same ES, that was the final ES (FES). If local and central reader ESs did not agree, videos were reviewed by an adjudicator who was blinded to the two previous ESs. If the adjudicator assigned the same ES as the local or central reader, that was the FES. If not, the FES was the median of the 3 ESs.

Results
Agreement between individual local and central reader ESs was fair (κ=0.25-0.33, Figure 1) and was less than the agreement between central reader and adjudicator (κ=0.55–0.56) at all timepoints. However, at I-0, when determining study entry eligibility (ES≥2), local and central reader agreed more than 85% of the time.
At I-0, 98.2% of 1051 endoscopies with FES 2/3 were also scored 2/3 by local ES, while for the 104 with FES 0/1, 49% had a local ES 2/3. At I-8 and M-44 (primary endpoint timepoints), the local ES and FES agreed 87% (785/899) and 80% (497/625), respectively. The proportions of subjects with clinical remission and endoscopic improvement were slightly higher when using the local ES compared to the FES (Figure 2), whereas clinical response rates when using the local ES were similar to FES. Despite these findings, treatment differences between UST and placebo were generally similar when local ES and FES were used to calculate clinical remission at I-8 and M-88.
Approximately 90% of endoscopies had an image quality considered “optimal” or “readable with certainty but with minor technical difficulties” by central readers. Overall, image adequacy did not impact agreement between readers.

Conclusion
Even though agreement between local and central readers was fair and less than that between the central reader and adjudicator, the overall impact on primary and secondary study endpoints was minimal. Overall, the use of both local and central ES to determine the FES yielded a robust and reliable measure for study endpoint determination, however, efforts facilitating reproducible endoscopic assessments in UC are warranted.
P389 Efficacy and safety of ustekinumab in patients with Crohn’s disease refractory to anti-tumour necrosis factor: real clinical practice
Authors: Saiz Chumillas R M , Alba Hernández L , Chivato Martín-Falquina I , Badia Aranda E , Arias García M L , Sicilia Aladrén B 
Published: May 2021

Abstract

Background
The efficacy of ustekinumab in patients with Crohn’s disease (CD) refractory to anti-TNF is worse than in anti-TNF naïve patients.

Methods
Retrospective study of patients with CD refractory or intolerant to TNF initiating ustekinumab between January 2013 and March 2020, with a minimum follow-up of 12 months, and without corticosteroid treatment. Our aim was evaluated clinical response (reduction of CDAI &gt;100), clinical remission (CDAI &lt;150) and biochemical remission (CDAI &lt;100 and CRP &lt;1 mg/L and faecal calprotectin &lt;100 µg/g) in short and long term.

Results
A total of 49 patients with a medium follow-up of 28 months (IQR:13-37) were included. Patients baseline characteristics are reflected in Table 1. In 20% patients the induction was made subcutaneous (90 mg/week for 4 weeks). At week 52, clinical response, clinical remission and biochemical remission was 93%, 82% and 54% respectively (Figure 1). In the long term (3 years), 62% had clinical response, 52% remained in clinical remission, and 48% showed biochemical remission. 1/3 of patients needed intensification every year. Ustekinumab treatment discontinuation was observed in 13 patients (27%) mainly due to lack of response (6[12%]: primary, 7[14%]: secondary). No serious adverse effects have been reported.

Conclusion
About 50% of the patients are in clinical and biochemical remission at week 152 in a real-life cohort of anti-TNF-exposed CD patients. With a harder remission definition including biochemical parameters, our results in real life are similar to pivotal studies at week 152. Nevertheless, at week 52 our remission rates were higher.
P403 Adherence to vaccination recommendations in patients with Inflammatory Bowel Disease: a long way for improving
Authors: Ferreiro Iglesias R , Hernández Camba A , Saldaña R , Rodríguez-Lago I , Zabana Y , Barreiro-de Acosta M 
Published: May 2021

Abstract

Background
Despite the existence of specific recommendations, patients with inflammatory bowel disease (IBD) have shown low immunization rates. The aim of this study was to evaluate the adherence to vaccination recommendations by physicians to their IBD patients.

Methods
An online anonymous survey was sent to 8000 patients from a national patient association (ACCU-Spain). Three invitations were sent between October-December 2020. Questions were jointly designed by ACCU and GETECCU. Potential reasons for vaccination compliance were evaluated and analysed for different vaccines: age, gender, type of IBD, type of healthcare and treatments. Descriptive analyses and logistic regression were performed to identify factors associated with adherence to vaccination recommendations.

Results
1302 patients with IBD responded to the survey (mean age 43 years [SD 12], 72% women). Forty percent of patients had ulcerative colitis, 58% Crohn’s disease and 2% indeterminate colitis. 91% of patients were treated in public facilities, 5% in a private setting and 4% in both. 41% of patients were treated with 5ASA, 35% with azathioprine/methotrexate, 50% with biologics and 8% with corticosteroids. Although [IRL1] [YZ2] physicians recommended vaccination, 45% were not adherent to papilloma virus vaccine, 18% to pneumococcus, 18% to hepatitis B vaccine, 16% to influenza and 12% to tetanus. The main reason for non-compliance to physician recommendation was considering that is not necessary (Table 1). Some factors associated to vaccine compliance are shown in Table 2.

Conclusion
Non-adherence to vaccination recommendations in IBD patients is frequent. Patients with immunosuppressive therapy show less compliance to the vaccination recommendations. The importance and benefits of vaccination needs to be explained to improve the adherence in IBD patients.
P417 Long-term deep remission after adalimumab discontinuation in Crohn’s disease patients
Authors: Melotti L , Rizzello F , Calabrese C , Dussias N , Gionchetti P 
Published: May 2021

Abstract

Background
Adalimumab is a safe and effective drug in treatment of Crohn’s Disease (CD). Current literature is not definitive regarding an exact timing for treatment withdrawal and disease relapses after drug discontinuation.

Methods
We conducted a single-centre, retrospective, observational cohort study involving patients affected by Crohn’s Disease (CD) treated with adalimumab. Of 575 patients treated with adalimumab for CD, 149 patients suspended treatment for stable deep remission (clinical steroid-free, biochemical, endoscopic remission defined as mucosal healing). Of these, 126 have a minimum follow up of 4 years, the other 23 where lost or finished the follow-up. Patients were assessed clinically, laboratoristically and endoscopically for 4 years. Relapse was defined as clinical (HBI &gt; 4) and biochemical (PCR &gt; 0.5 mg/dL).

Results
Of the 126 patients with 4 years follow-up, 64 (51%) maintained deep remission during the 4 year follow-up period. Of these, 38 (59%) were on exit-therapy with thiopurines. Twenty-seven patients (18%) had relapsed by year 1, 24 (18%) by year 2, 8 (6%) by year 3, and 1 (0.8%) by year 4. Relapses needed surgical therapy in 9 (15%) cases, whereas 36 (60%) were retreated with adalimumab and 4 (7%) with another biologic agent. The remaining 11 patients (18%) were treated only with a course of steroids.

Conclusion
Patients who suspend treatment with adalimumab for stable deep remission maintain remission in the long term in approximately half of cases. The majority of relapses occur in the first 24 months after discontinuation.
P420 Comparative efficacy and safety of oral ferric maltol in Inflammatory Bowel Disease patients with mild-to-moderate vs. more severe iron deficiency anaemia
Authors: Akriche F , Jacob I , Schmidt C , Howaldt S 
Published: May 2021

Abstract

Background
The efficacy and safety of ferric maltol (FM) has been demonstrated in inflammatory bowel disease (IBD) patients with mild-to-moderate iron deficiency anaemia (IDA; haemoglobin [Hb] ≥ 9.5 g/dL). New data are available from a recent open-label, Phase 3b non-inferiority study comparing the efficacy and safety of FM to ferric carboxymaltose for IBD patients with more severe IDA (Hb at screening: 8.0 - 11.0/12.0 g/dL [women/men]) (NCT02680756). Though the primary endpoint was not met, this post hoc analysis aimed to utilise patient-level data to confirm the efficacy and safety of FM in patients with baseline Hb &lt; 9.5 g/dL.

Methods
Patients assigned to FM (N=125) were grouped based on baseline Hb: &lt;9.5 g/dL (n=38) and ≥9.5 g/dL (n=87). Univariate and multivariate analyses were performed for primary (Week 12 change from baseline [CFB] Hb) and key secondary endpoints (Week 12 responder rate [≥2 g/dL Hb increase or Hb normalisation] and long-term efficacy). Safety analysis was performed.

Results
Overall, demographic characteristics were broadly comparable with a greater, but not significant, proportion of females (63.2% vs. 50.6%), women of childbearing age (75.0% vs. 63.6%) and active Crohn’s disease (37.5% vs. 32.7%) in patients with baseline Hb &lt; 9.5 g/dL vs. ≥ 9.5 g/dL, respectively. Mean baseline Hb was 8.6 g/dL in patients with baseline Hb &lt; 9.5 g/dL and 10.6 g/dL in patients with baseline Hb ≥ 9.5 g/dL. There was no significant difference in mean CFB Hb at Week 12 (2.92 g/dL vs. 2.35 g/dL, p=0.960) and Week 12 responder rates (70.0% vs. 67.1%, p=0.523) in patients with baseline Hb &lt; 9.5 g/dL and ≥ 9.5 g/dL, respectively. Mean CFB Hb was numerically but not significantly higher in patients with baseline Hb &lt; 9.5 g/dL at every visit up to Week 52 (Table 1). Drug-related treatment emergent adverse events were similar between &lt; 9.5 g/dL and ≥ 9.5 g/dL Hb groups (15.8% vs. 21.3%, respectively); all non-serious.

Conclusion
FM achieved consistent and clinically meaningful increases in Hb in patients with baseline Hb &lt; 9.5 g/dL that were comparable to patients with Hb ≥ 9.5 g/dL. No safety differences were identified between both groups. These data suggest that FM is effective and well tolerated in IBD patients with IDA regardless of baseline Hb.
P443 Haemorrhoidal Artery Ligation – Recto-Anal Repair (HAL-RAR) with mucopexy for grade III hemorrhoids in IBD patients
Authors: Laureti S , Cardelli S , Gionchetti P , Rizzello F , Calabrese C , Poggioli G 
Published: May 2021

Abstract

Background
Symptomatic hemorrhoids represent an important and sometimes underestimate chapter of perianal Inflammatory Bowel Diseases (IBD), with an incidence reported up to 20.7%. At present, there is still no consensus in the scientific community on the exact indications of surgery in IBD patients presenting with symptomatic haemorrhoids, due to the reported high risk of postoperative complications. We describe our experience with Haemorrhoidal Artery Ligation – Recto-Anal Repair (HAL-RAR) hemorrhoidopexy in highly selected patients with IBD.

Methods
This was a single-center longitudinal study of a cohort of patients with both Ulcerative Colitis (UC) and Crohn’s Disease (CD) who underwent HAL-RAR using a dedicated doppler-guided probe (Trilogy™) for symptomatic grade III hemorrhoids not responding to medical therapy. Short and long-term postoperative morbidity were recorded. Severity of hemorrhoid symptoms, specifically bleeding, prolapse, manual reduction, discomfort or pain and impact on quality of life (Giordano score) and fecal continence status (Vaizey score) were evaluated before surgery and at minimum of 6 months after surgery.

Results
Sixteen patients with symptomatic grade III haemorrhoids underwent HAL-RAR (12 female). The mean age was 49 yrs old (37–66). Twelve had CD and 4 UC; none presented with anorectal or perianal involvement. All patients were taking optimal medical treatment for IBD. Only the patients with CDAI&lt;150 and Full Mayo score of 1 (with endoscopic sub-score of 0) were included. Mean follow-up was 27.8 months (9–76). The mean operating time was 46 minutes. Short-term complications included one patient requiring prolonged analgesia with NSAIDs for two weeks, one patients needing hospitalization for bleeding after 10 days, treated conservatively and one patient with acute urinary retention, resolved after catheterization. The was no abscess or fistula formation. During the follow-up period, no patients suffered from recurrent haemorrhoidal bleeding and none had recurrent prolapse. A 66 yrs old female reported at 6 months post-operatively the worsening of Vaizey score from 4 to 6 due to the need of taking costipating medicines. All patients report significant amelioration of quality of life.

Conclusion
Our results show that HAL-RAR Hemorrhoidopexy is a safe and effective technique for treating grade III symptomatic hemorrhoids in highly selected IBD patients without anorectal involvement. These results need to be validated in large and multicenter trials.
P451 Efficacy and safety of tofacitinib in the treatment of patients with active, moderate to severe, Ulcerative Colitis: a systematic review and meta-analysis
Authors: Khorshid Fasge M , Dorgham D , Sharobim A , Attia M , Hussein M , Dorgham N 
Published: May 2021

Abstract

Background
To perform a systematic review and meta-analysis to discuss the efficacy and safety of tofacitinib in patients with moderate to severe ulcerative colitis (UC).

Methods
We searched PubMed, Scopus, Web of Science, in addition to Cochrane Central, until May 2020 using relevant keywords. We included randomized controlled trials (RCTs) in addition to cohort studies that compared tofacitinib oral treatment versus placebo in patients with active UC, with a moderate to severe degree. Quality of included RCTs was assessed by the Cochrane risk of bias assessment tool, whereas the Newcastle-Ottawa scale was applied to assess for bias sources in included cohort studies. Data were pooled, after being extracted, from eligible articles in the review manager software, or the open meta-analyst software. Dichotomous outcomes were pooled as risk ratios (RR) under the fixed effect model, while continuous outcomes were pooled as standardized mean difference (SMD) under the random-effects model.

Results
pooling data from seven RCTs and four cohort studies, 2728 patients, showed that tofacitinib therapy was superior to placebo in inducing a clinical response in UC patients after eight weeks (p = 0.0001) and 26 weeks, in a proportion 0.4 of patients who took tofacitinib 10 mg BID. Additionally, tofacitinib treatment was associated with significantly higher events of clinical remission of UC, after eight weeks (RR= 3.12, 95% CI [2.34, 4.16], p &lt; 0.0001). Likewise, endoscopic, deep, in addition to symptomatic remission rates were higher in the tofacitinib group, compared to the group of placebo (p ≤ 0.008). Most of the drug-related adverse events were comparable between tofacitinib and placebo groups. However, tofacitinib treatment was associated with fewer serious adverse events (RR= 0.68, 95% CI [0.48, 0.98], p = 0.04); adverse events that led to drug discontinuation (RR= 0.53, 95% CI [0.39, 0.73], p&lt; 0.0001); and worsening of UC (RR= 0.48, 95% CI [0.38, 0.61], p &lt; 0.00001). On the other hand, the placebo group had fewer overall infections (p = 0.002); and elevation in laboratory parameters, including LDL cholesterol, total cholesterol, and triglycerides.

Conclusion
Our systematic review and meta-analysis showed that, in patients with active moderate to severe UC, tofacitinib treatment was superior to placebo in inducing clinical response and remission, with less adverse reactions. Additionally, treatment with tofacitinib showed beneficial quality of life and survival benefits for UC patients. Future clinical trials should study the effect of higher doses of tofacitinib in larger RCTs, with longer follow up periods.