bluuebunny/crossref_metadata_2025 huggingface dataset:
P257 Is colorectal screening in IBD fit for purpose?
Authors: Saeidinejad M , Dawson H E , Newbury C M , Searle H , Gordon J N
Published: January 2023

Background

Patients with IBD are at increased risk of CRC with it recommended that patients with longstanding colitis undergo regular surveillance endoscopy. However, there is conflicting evidence for the quality and effectiveness of IBD surveillance programmes. We undertook an audit of the effectiveness of our surveillance programme against national standards alongside a case-note review of cases of CRC arising in patients with IBD diagnosed over the same period.

Methods

Sequential colonoscopies for IBD surveillance at Hampshire Hospitals Foundation Trust from 01/01/2019 to 31/12/2020 were reviewed retrospectively. The quality of the surveillance endoscopy programme was assessed against the BSG and SCENIC guidelines. Patients with CRC and IBD were identified using the International Classification of Diseases coding system over the same period with subsequent case-note review of identified cases.

Results

250 colonoscopies were reviewed with 6 excluded (3 inadequate bowel preparation, 3 severe active disease) leaving 244 for analysis. 203 (83.2%) were adherent to the guidelines. Non-compliance was either due to lack of dye-spray or inadequate number of biopsies (35 had 3-10 biopsies, 6 no biopsies). Overall, 2421 random biopsies were taken along with 90 targeted biopsies and/or polypectomies. 1 adenocarcinoma (0.45%), 1 HGD (sporadic polyp), 1 LGD, and 1 indefinite lesion were detected along with 19 sporadic polyps. During the same period 9 patients were diagnosed with CRC that were not in the surveillance programme. 3 had a diagnosis of probable pre-existing IBD made at the time of diagnosis of cancer (2 UC, 1 CD), 2 had a historical diagnosis of UC but were not known to secondary care, 1 was not under surveillance due to age (85), 2 had ileocaecal CD with CRC in unaffected segment of large bowel, and 1 had colitis <8 yrs.

Conclusion

Our audit showed that the quality of the surveillance endoscopy had improved since our previous audit (2016) with the majority of cases now undertaken with dye-spray, and less cases undertaken by non-specialist endoscopists. Though there remains room for improvement with 16.8% non-complaint primarily due to inadequate biopsies, it was reassuring that 83.2% of procedures were performed in adherence with current guidance. Despite this only 1/10 (10%) of cases of CRC in patients with IBD were picked up through surveillance with 9/10 (90%) diagnosed in patients with IBD outside the programme. These results suggest that targeting resources at improving the surveillance programme further is likely to have a limited impact on reducing CRC in patients with IBD and that research is needed to identify and address why the majority of IBD patients that develop CRC are not reached by current surveillance strategies.
P309 Accuracy of PanMayo endoscopic score in predicting long-term disease outcomes in ulcerative colitis– a promising scoring system
Authors: Bacsur P , Wetwittayakhlang P , Resál T , Rutka M , Bessissow T , Atif W , Bálint A , Fábián A , Bor R , Szepes Z , Farkas K , Lakatos P L , Molnár T
Published: January 2023

Background

Ulcerative colitis (UC) is a systemic immune-mediated disease that affects the colon continuously. Colonoscopy plays a crucial role in management of UC that helps to assess mucosal healing objectively along the colon. Different scoring systems are available to assess severity, however most of them does not take into consideration of disease extent. Extension modified (PanMayo) Mayo endoscopic subscore (MES) system has been shown to correlate with UCEIS and Riley scores and calprotectin. Our study aimed to assess the predictive power and accuracy of PanMayo score compared to MES, UCEIS and Dublin to predict mid- and long-term disease outcomes.

Methods

This is retrospective, two-center study. UC patients, who underwent colonoscopy due to any reason between 2016 and 2018, were consecutively enrolled. PanMayo, MES, UCEIS and Dublin scores and additionally the Nancy histology score (where available) were recorded with clinical and demographical data at baseline. Disease flare, need for change in therapy (incl. initiation of biologicals, need for systemic steroids), hospitalisations and colectomy were tracked amongst patients with clinical remission (pMayo<2) during an at least 3-years follow-up to assess predictive value of score systems. Log-rank, Cox regression analysis and Chi2 tests were used to analyse outcomes and Kaplan Meier curves were plotted.

Results

A total of 250 UC patients (male ratio: 0.45, median age 45 (IQR) 22.3 years) were enrolled with 156 (male ratio 0.49; mean age 46 IQR 20.8 years, Table 1.) of UC patients having baseline clinical remission. PanMayo, MES, and Dublin scores were positively associated with risk of disease flare (Figure 1.; p=0.002, p<0.01, p=0.003). Increasing MES score was coupled with risk of relapse (MES0=26.7%, MES1=53.1% and MES2-3=47.6%; p=0.008). PanMayo score (above 12 points), but not MES or UCEIS, was associated with the need of new biological (Figure 2.; 66.7% vs. 21.7%; p<0.001) and treatment escalation (33.3 vs. 11.5%; p=0.018), similar trend was found for the Dublin score for need for new biologicals. There was a strong trend for PanMayo to predict need for hospital admission (p=0.06). All scores were strongly associated with need for systemic corticosteroids. Colectomy rates were low. Nancy score showed only a trend to predict risk of clinical flare and need for corticosteroids.

Conclusion

Our study suggests that combined endoscopic assessment of the extent and severity may be more accurate in predicting disease outcomes in UC in clinical remission. PanMayo scores may be an alternative of the existing scoring system and was associated more granularly with disease outcomes. In addition, outcomes were different in patients with initial MES 0 and 1 scores.
P313 Understanding Inflammatory Bowel Disease patients’ experiences, expectations, and insights in identifying and managing anxiety and depression.
Authors: Zelinsky S , Daley K , Patel A , Jeffs L , Zeng L , Targownik L
Published: January 2023

Background

Patients living with Inflammatory Bowel Disease (IBD) commonly experience mental health (MH) challenges, specifically anxiety and/or depression. Although, there is a growing awareness of the relationship between IBD and MH; detection, treatment, and management amongst care providers is limited. The purpose of this patient-oriented, qualitative study was to explore IBD patient experiences, perspectives, and insights of living with MH challenges and to understand their interactions with GI clinicians, from diverse care settings, to determine how to best support IBD and MH in IBD care.

Methods

Convenient and snowball sampling was used to recruit adult participants diagnosed with IBD and who had experience of living with MH challenges and were seeing a Gastroenterologist in Canada. This qualitative descriptive study used online focus groups to collect data. Focus groups were audio recorded and transcribed verbatim. Data was analyzed using thematic analysis.

Results

Twenty-four participants from across Canada, both from rural and urban locations, participated in the study. IBD patient participants indicated that MH should be discussed by GI’s as part of routine clinical practice. All participants indicated that there is a lack of resources and access to MH services for IBD patients. Four main themes emerged from the data: 1) experiences with IBD: difficulties related to reintegrating into social settings, feelings of loneliness; 2) expectations around mental health support: the need to develop their own resiliency strategies due to the lack of structural resources regarding mental health and IBD in the clinical space; 3) GI engagement: HCPs were dismissive of mental health symptoms, often gaslighting patients when mentioning mental health concerns during clinical encounters; and 4) expectations: a need to standardize mental health care across IBD care settings with a focus on integrating specialized healthcare providers as part of multidisciplinary care teams to help address the need for mental health supports for IBD patients in Canada.

Conclusion

Effective detection, awareness, management, and the integration of patients’ perspectives and insights can help inform the development of mental health supports and services to help improve IBD care to a more wholistic approach to care. Results from this study will be interpreted in line with insights gathered from upcoming interviews of gastroenterologists and HCPs.
P317 Patient satisfaction in a joint fistula clinic at a tertiary Inflammatory Bowel Disease centre in the United Kingdom
Authors: Mukhtar M S H , Lim W J , Tozer P , Hart A
Published: January 2023

Background

Patients with fistulising perianal Crohn’s disease experience significant impairments in their sexual and social relationships, work, and overall life quality. The presence of perianal disease can result in patients avoiding sex, ending intimate relationships, and feeling inadequate or guilty towards their partners. Some participants also report partners’ refusal to engage in sex(1).

Access to joint fistula clinics, where patients can simultaneously meet gastroenterologists and surgeons, may yield better care. However, sharing intimate details about the sexual-, social-, and mental-health effects of fistulising disease can be particularly difficult and anxiety-provoking for patients, when there are multiple healthcare workers present.

Methods

An evaluation questionnaire was developed to assess patients’ overall perception and satisfaction regarding the joint fistula clinic at St. Mark’s Hospital in London. All patients who attended in person and were able to understand English and provide verbal consent were invited to provide their feedback. The questionnaire included items assessing overall comfort, ease of discussing intimate social and sexual topics, and other aspects of provided services.

Results

Between January and August 2022, a total of 25 patients provided their evaluations. Of these participants, 17 (68%) were females. The mean age of participants was 40.2 (+/-13) years. About 56% of these patients attended the clinic accompanied by their partners, parents, or other family members. About 70% of clinic encounters had 3 or more healthcare workers present. Details of encounters are illustrated in table 1. Responses to questionnaire statements are summarized in table 2, graph 1 and 2.

Conclusion

The joint fistula clinic was positively perceived by patients, the majority of whom reported feeling comfortable discussing intimate sexual issues. Contrary to what was expected, the presence of multiple healthcare workers during an encounter did not generally make discussions more difficult.

References:

(1) Spinelli A, et al. “The impact of perianal fistula in Crohn’s disease on quality of life: Results of a patient survey conducted in Europe”. Poster presentations: Clinical: Therapy and Observation 2021
P338 Transmural healing is not associated with less disability than complete endoscopic mucosal healing: a prospective study in a patient with Crohn's disease
Authors: Yzet C , Brazier F , Hautefeuille V , Grados L , Decrombecque C , Diouf M , Fumery M
Published: January 2023

Background

Crohn's disease (CD) is associated with disability by affecting physical and emotional well-being, and by altering social interactions. In the era of treat to target, endoscopic remission has become the therapeutic target to prevent parietal destruction and disability. A deeper remission such as transmural healing would reduce long-term complications related to CD. The impact of transmural healing on disability is currently unknown.

Methods

We conducted a monocentric cross-sectional study between September 2019 and January 2022. Patients followed for CD in endoscopic remission (CDEIS <4) who underwent within < 4 weeks an intestinal ultrasound (IUS) and a disability assessment by an IBD-disk were consecutively included. Four groups were considered: (A) transmural healing defined by the combination of complete endoscopic healing (CDEIS=0) and ultrasound healing (bowel wall thickness (BWT) less than 3 mm), (B) complete endoscopic healing, (C) ultrasound healing and (D) no healing. Moderate to severe disability was defined as an overall score ≥ 40.

Results

A total of 85 patients were included. Forty-four (51.7%) were female, the median age and disease duration were respectively 38 years (interquartile range [IQR], 33-44) and 12.0 years (IQR, 5-20). There was no difference between the four groups in terms of age, sex, BMI, smoking status, disease location or phenotype or number of biologics failure. The median global IBD-Disk score was 25 (IQR, 9-41) and 24 patients (28.2%) had moderate to severe disability. Transmural healing (group A) was observed in 40 patients (47.1%). Moderate to severe disability was identified in 17.5% (7/40) of patients with transmural healing, 25% (4/16) with endoscopic healing, 44.4% (8/18) with ultrasound healing and 45.4 % (5/11) without healing. In univariate analysis, transmural healing reduced the risk of severe disability (group C vs A OR = 3.77, 95% CI [1.10, 13.45], p = 0.035), group D vs A OR = 3 .75, 95% CI [0.91, 17.12], p=0.063). There was no difference in terms of severe disability between patients with transmural healing and complete endoscopic healing (group B versus A OR = 1.57 95% CI [0.36, 6.23], p = 0.525).

Conclusion

Transmural healing did not provide any benefit in terms of disability compared to complete endoscopic healing. Mucosal healing therefore remains the objective to be achieved in order to reduce the risk of short-term disability.
P344 Diverting ileostomy in Inflammatory Bowel Disease's surgery: the real clinical cost analysis
Authors: Ascari F , Barugola G , Ruffo G
Published: January 2023

Background

A loop ileostomy does not prevent an anastomotic leak and it is not risk-free, but it can decrease the clinical impact of dehiscence. Inflammatory bowel disease condition is more complex than other benign situations candidated to colorectal surgery. The aim of our study was to assess the risk of complications related to the stoma presence and to identificate variables related with complications in a series of IBD’s patients undergoing various colorectal surgeries along with primary diverting stoma.

Methods

We conducted a retrospective study of patients who underwent sphincter-preserving elective surgery for IBD between January 2014 to December 2020 at IRCCS Sacro Cuore Don Calabria Hospital. Data were collected regarding baseline demographics, operative techniques and complications. Ileostomy-related complications were separated into three categories: complications related to stoma creation at the time of index surgery within 30 days; complications of having an ileostomy; complications of ileostomy closure.

Results

Fifty-six diverting loop ileostomies were performed and included in our study (table 1). Seventeen patients (30%) at index procedures had the following complications: 5 had anastomotic leak or pelvic abscess (8.9%), 3 had bowel obstruction (5.4%) and 7 (12.5%) bleeding requiring transfusion. Two patients had complications related to ileostomy creation: 1 had prolapse (1.8%) and 1 rotation with obstruction (1.8%). Seven patients (12.5%) required reoperation. Seven patients (12.5%) were readmitted within 30 days after index surgery for dehydratation. Twenty-four patients (42.1%) suffered during the same time from ileostomy management’s problems. Eighteen patients (32.1%) at stoma closure had the following complications: 6 had anastomotic leak or pelvic abscess (10.7%), 7 had SSI (12.5%), 5 had bowel obstruction (8.9%) and 2 bleeding requiring transfusions (3.6%). Nine patients (16%) required reoperation. At univariate analysis complications of ileostomy status are more frequent in male (p=0.01) and in patients who had ileostomy creation complications (p=0.04). Ileostomy closure complications are more common in male patients (p=0.005). Complications at the time of ileostomy creation were found at multivariate analysis statistically related to complications during ileostomy maintenance.

Conclusion

Ileostomy alone cannot mitigate the overall high rate of complications expected in IBD’s patients, also in consideration of potential problems stoma it-self related. Even if our study is retrospective and presents a small court, when resection is necessary despite patient's conditions we propose to resect without anastomosis at the time of index procedure and restore the bowel continuity only after patient's status optimization.
P420 Safety & feasibility of targeted mesenteric approaches to ileocolic resection and anastomosis in Crohn’s Disease
Authors: Holubar S , Cohen B , Uchino T , Lincango E , Prien C , Joseph A , Achkar J P , Gunter R , Lashner B , DeLaney C , Ban K , Bolshinsky V , Lipman J , Liska D , Philpott J , Naseer M , Kanters A , Braga-Neto M , Rieder F , Somovilla J , Qazi T , Regueiro M , Hull T , Steele S
Published: January 2023

Background

More than 80% of patients with Crohn's disease (CD) require surgical intervention during their lifetime. High rates of disease recurrence often necessitate repeat surgery. Recurrence is typically observed at or immediately proximal to the anastomosis, raising the question of whether surgical techniques have the potential to decrease recurrence rates. In addition, the mesentery has recently been implicated in the pathophysiology of CD, and several techniques have been developed to reduce its influence on recurrence. We aimed to describe the short-term safety and feasibility of these approaches.

Methods

This is a comparative retrospective single-center cohort study of consecutive CD patients undergoing primary or redo ileocolic resection with mesenteric excision and exclusion (MEE), extended mesenteric excision (EME) only, or Kono-S anastomosis (KSA) only from 2015-2022. Patients undergoing both EME plus KSA were considered to have MEE. Patients' characteristics, perioperative data, and short-to-midterm outcomes were collected. Univariate analysis was performed.

Results

A total of 186 patients underwent MEE (n=46), EME (n=66), or KSA (n=74). All three groups had comparable (p>0.05) risk factors in terms of mean age at diagnosis and surgery (25.4 and 37.5 years old, respectively), preoperative biologics (63.4%) and corticosteroids (22.6%), smoking, and associated perianal disease. However, the MEE group had more penetrating disease compared to the other groups (MEE 50.0% vs. EME 34.8% vs. KSA 20.4%; p<0.01). Overall there were no differences (p>0.05) in rates of emergency surgery (4.8%), ileostomy creation (14%), and laparoscopy (64.5%) Table 1. Estimated blood loss and length of stay were also comparable between groups (p>0.05). Operative time in the MEE group was longer (median: 187, range: 67-360 minutes) compared to the other two groups (KSA: 170 (56-487); EME: 152 (63-436, p<0.01). Post-operatively, the groups had similar lengths of stay (4 days), rates of readmissions (9.1%) and major postoperative complications (6.5%). After a median overall follow-up of 8 months (0-86), endoscopic (18.8%) and surgical recurrences (1.1%) did not differ between groups (p>0.05) Table 2.

Conclusion

Targeting the mesentery with novel surgical approaches to ileocolic Crohn's disease was observed to be safe and feasible on short-term follow-up. Long-term follow-up is needed to assess the impact of these techniques on post-operative anastomotic disease recurrence.
P423 Effect of tofacitinib on colectomy risk in anti TNF-alfa refractory ulcerative colitis
Authors: Romeo S , Carvalhas Gabrielli A M , Ferretti F , Piazza O Sed N , Mazzola A M , Alicante S , Berté R , Scribano M L , Buscarini E , Ricci C , Caprioli F , Ardizzone S , Cannatelli R
Published: January 2023

Background

Tofacitinib is an oral janus kinase inhibitor (JAK) approved for patients with moderate to severe ulcerative colitis (UC) and either inadequate response or loss of response or intolerance to conventional or biologic therapy. The 5-year and 10-year cumulative risk of colectomy in UC is 10%–15%.1 Due to the increasing number of anti tumor necrosis factor (TNF)-alfa non responders, tofacitinib seems a valuable therapeutic alternative. This study aims to assess the effectiveness of tofacitinib in preventing colectomy in patients with moderate-to-severe UC refractory to anti TNF-alfa agents.

Methods

We performed an observational retrospective and prospective multicenter study in five Italian IBD referral units including adult patients with confirmed diagnosis of moderate-to-severe UC (defined by a total Mayo score ≥ 6), treated with tofacitinib because of response failure or intolerance to anti TNF-alfa agents. Primary aim was the effectiveness of tofacitinib in preventing colectomy during a follow-up of 52 weeks. Secondary aims were: survival without colectomy, survival without tofacitinib discontinuation, clinical remission (defined as Mayo partial score ≤ 2) at week 8, 24 and 52, endoscopic remission (defined as Mayo endoscopic score ≤ 1) and steroid-free clinical remission (Mayo Partial score ≤ 2 without steroid) at week 52; adverse events (AE) to tofacitinib. Descriptive statistics and Kaplan Meier analyses of survival were performed.

Results

From January 2021 to October 2022 45 patients were included. During the follow-up, 6 patients (13%) underwent colectomy and all of them before week 24. Survival without colectomy and survival without tofacitinib discontinuation are represented in Figs.1-2. Clinical remission was reached by 17 patients (37.7%) at week 8, by 20 (44.4%) at week 24, and by 22 patients (48.8%) at week 52. Among the 11 patients with an endoscopic evaluation available after completing 52-week treatment, 9 (82%) achieved endoscopic remission. At week 52, 22 patients (49%) maintained steroid-free clinical remission. In eighteen patients (40%) tofacitinib was interrupted, because of failure in 15 and because of a severe AE in 3. AE occurred in 9 patients (20%), but in 3 only (6.7%) were severe and entailed treatment interruption.

Conclusion

These data confirm effectiveness and safety of tofacitinib in preventing colectomy in moderate-to-severe UC refractory to anti TNF-alfa agents.
P424 Do antiTNF through levels correlate with joint extraintestinal manifestations (EIM) activity in Inflammatory bowel disease (IBD) patients?
Authors: Madero Velázquez L , Jovani V , Andrés M , Más P , Aguas M , Vicens E , Ojeda A , Noguera-Pons J R , Ranieri L , Zabana Y , Pujol M , Barreiro de Acosta M , Pérez-Pampin E , Bernal L , Belen O , Moreno V , García M F , Sempere L , Zapater P , Gutiérrez Casbas A
Published: January 2023

Background

Inflammatory arthropathies are the most common EIM associated to IBD with a prevalence of 20-50% for axial inflammation and 5-20% for peripheral arthritis. AntiTNF is the preferred treatment in patients with axial spondiloarthritis (AxSp) intolerant or refractory to NSAIDs and has shown efficacy in peripheral arthritis (pSp) as well. Nevertheless, an optimal antiTNF through level has not been yet stablished in this clinical setting. Thus, our aims were to evaluate the correlation between antiTNF through levels and joint EIM activity in IBD patients.

Methods

We conducted a prospective, multicenter cohort study. IBD patients diagnosed with articular EIM (AxSp, pSp or both) under antiTNF treatment at least 6 months were included. Anti-TNF concentrations were measured using ELISA. Blood samples were obtained just before the administration of the drug (trough levels), and an simultaneous evaluation by a reumatologist was performed. Definitions: inactive AxSp = ASDAS-CRP <1,3 and BASDAI<2 , low active AxSp: ASDAS-CRP <2,1 and BASDAI<4; inactive pSp=arthritis, enthesitis and dactylitis=0, low active pSp: arthritis, enthesitis and dactylitis ≤1. IBD activity was based on partial Mayo score for ulcerative colitis (UC) patients and on Harvey-Bradshaw score for Crohn′s disease (CD) patients.

Results

A total of 78 patients were included: Median age 52 ±15, 45% women, 82% CD (56% ileal; 18% colic; 24% ileocolic; 2% upper gastrointestinal involvement; 22% stricturing behaviour; 16% penetrating; 14% perianal disease), 18% UC (61% extensive, 15% left-sided, 23% proctitis), 11% had another EIM. HLA B-27 was present in 26% patients. Distribution of spondiloartrhopaties was: AxSp 42%, pSp 37%, or both 20%. Among CD patients, 18,9% presented clinical activity (n=14). Mean IBD disease duration was 11± 9,7 years. Fourteen patients (18%) were also under immunosupressive treatment .Through levels distributed by joint activity are shown in table 1.Figure 1 shows distribution of adalimumab through levels by AxSp activity.

Conclusion

No correlation between antiTNF through levels and joint EIM activity was found in these preliminary results. However, patients with active axial Sp treated with adalimumab had lower through levels than those with inactive axial Sp.
P426 Sex and sexuality in IBD - the pediatric gastroenterologists’ point of view
Authors: Anafy A , Cohen S , Matar M , Shouval D S , Shamir R , Weintraub Y
Published: January 2023

Background

Although sexual dysfunction (SD) and sexually transmitted infections (STI) are occasionally encountered in patients with inflammatory bowel disease (IBD), physicians may be embarrassed to discuss these issues. This is especially true in adolescent patients, where parents are active participants in clinic visits. In addition, data in the literature about SD in this age group is limited. Our aims were to assess pediatric gastroenterologists (PedGI) knowledge and common practice regarding sexual advice and STI in pediatric patients with IBD.

Methods

A questionnaire was sent to all registered PedGI in Israel, and included 24 questions addressing knowledge of adolescent sexual behavior, SD, receptive anal intercourse (RAI) and STI in pediatric patients with IBD.

Results

Overall, 52 physicians completed the questionnaire (27 males, 52%). Only 50% provided the correct answer regarding the mean age at which Israeli youth start practicing sexual activity, whereas none were correct regarding the mean age when RAI is practiced. Fifty eight percent rightfully stated that SD is equally distributed among males and females and 38% responded that it is equally prevalent among patients with Crohn’s and those with Ulcerative Colitis. The most quoted, incorrectly, risk factor for SD was perianal disease. Seventy five percent thought that providers should talk about sex with their patients, but only 19% actually do so, most often in response to a patient’s query. Ninety six percent felt they do not have enough knowledge about SD in IBD. Finally, only 2% routinely obtain bacterial swabs for STI in patients with refractory proctitis, although 15% encountered such as a problem in clinic.

Conclusion

Sexuality and SD are not discussed routinely in the pediatric IBD clinics by the majority of PedGI. Providers should obtain more knowledge in the field, and proactively discuss these issues with teenagers with IBD.
P474 Postoperative disease course after appendectomy as experimental treatment for patients with therapy refractory moderate to severe ulcerative colitis
Authors: Reijntjes M , Heuthorst L , Stellingwerf M , d'Haens G R , Bemelman W A , Buskens C J
Published: January 2023

Background

Increasing evidence suggests appendectomy as a potential experimental therapy for ulcerative colitis (UC). A prospective cohort study of laparoscopic appendectomy for treatment of therapy refractory UC showed a clinical response in nearly half of the patients with a substantial proportion of patients in endoscopic remission, after a postoperative follow-up of 3.7 years1. The current study aimed to explore disease course during long-term follow-up in patients undergoing appendectomy for therapy-refractory UC.

Methods

In this monocenter cohort series, all patients with therapy refractory UC referred for (procto)colectomy between 2012-2015 were counselled to undergo laparoscopic appendectomy instead. The primary endpoint was long-term clinical (≥3 points decrease in partial mayo score) and endoscopic response (Endoscopic Mayo score ≤1) displayed in individual time lines. Secondary endpoints included duration and loss of clinical and endoscopic response, de-escalation of medication, and failure (medical treatment switch or colectomy).

Results

A total of 25 patients (12 men; median age 41.0 years) underwent appendectomy. The median postoperative follow-up time was 7.5 [IQR 6.4-8.6] years. Clinical response was observed in 60% (15/25) after a median follow-up of 4.0 [IQR 3.0-7.0] months, and was 32% (8/25) at the end of follow-up. Endoscopic response was observed in 48% (12/25) after a median follow-up of 17.5 [IQR 3.3-38.8] months and was 24% (6/25) at the end of follow-up. The median duration of clinical and endoscopic response was 80.0 [20.0-93.0] an 45.5 [21.8-56.8] months, respectively. Six (24%) patients de-escalated medication during follow-up, five of which without subsequent failure. Seventeen (68%) patients failed during postoperative follow-up after appendectomy, of which nine patients (36%) required colectomy a median of 5.0 [IQR 2.0-13.5] months after appendectomy.

Figure 1. Disease course after appendectomy per patient.

Conclusion

During the postoperative course following appendectomy for refractory UC, approximately half of the patients demonstrated long-lasting endoscopic response, more than half demonstrated long-lasting clinical response, and one third underwent colectomy.

1Stellingwerf ME, Sahami S, Winter DC, Martin ST, D'Haens GR, Cullen G, Doherty GA, Mulcahy H, Bemelman WA, Buskens CJ. Prospective cohort study of appendicectomy for treatment of therapy-refractory ulcerative colitis. Br J Surg. 2019 Nov;106(12):1697-1704.
P480 Ustekinumab Dose Intensification Is Effective in One-Third of Asian Inflammatory Bowel Disease Patients, Results From A Tertiary Inflammatory Bowel Disease Centre
Authors: Lim C T , Tay S W , Lim G H , Salazar E , Ong W C , Chan W P W , Tan M T K
Published: January 2023

Background

Ustekinumab (UST) is an effective biologic for treatment of Inflammatory Bowel Disease (IBD). However, some patients treated with UST have suboptimal clinical response with standard induction and maintenance doses. In some patients, strategies such as dose intensification (DI) and reinduction have been used to improve response. The aims of this study are to identify factors associated with DI for our IBD cohort and also effectiveness of reinduction during DI.

Methods

This was a retrospective cohort study on patients with Crohn’s disease (CD) and ulcerative colitis (UC) who received UST from September 2017 to October 2022 in a tertiary center. Patients were identified from a prospectively maintained IBD registry. Patient’s demographics, biochemical profile, disease phenotype, UST intervals and previous use of biologics were retrieved. Statistical analysis was performed to identify factors which are predictive of UST DI and effectiveness of UST DI.

Results

A total of 63 patients with IBD on UST were identified, with most being bio-experienced (76.2%). Forty two patients (34 CD, 8 UC) underwent UST DI to either 6-weekly (n=19, 45.2%) or 4-weekly (n=23, 35.9%). The median duration of UST treatment is 108.0 weeks (IQR 44.7-185.9) while the median time to intensification was 31.1 weeks (IQR 17.8-65.7). Presence of perianal disease in CD (HR 4.9; 1.47 – 16.4) was associated with DI. However, prior usage of biologics (HR 1.61; 0.80 - 3.24) and usage of steroids during induction (HR 1.85; 0.69 – 4.91) were not significant factors for DI.

After DI, there were 14 (33.3%) patients who achieved treatment end points (corticosteroid-free clinical remission, biochemical remission, endoscopic healing (for UC) or transmural healing (for CD) by week 52. In patients who had UST DI, UST re-induction was given to 13 (10 CD, 3 UC) and 4 achieved treatment endpoints but this was not statistically significant (p=0.99). There were 26 patients who failed to achieved end point at week 52 of which 8 patients were continued on UST at dose intensified regime while 11 patients were switched to other biologics.

Conclusion

Two third of IBD patients undergo DI while on UST treatment and the median time to DI is about 6 months after induction. CD patients with perianal disease is more likely to undergo DI. One third of dose intensified patients achieved remission at week 52 while reinduction of UST during DI did not improve outcome for patients.
P482 The experiences of people with IBD and comorbid anxiety or depression and their views on an online intervention for people with long term conditions (COMPASS): A qualitative framework analysis
Authors: Harston E
Published: January 2023

Background

IBD has high levels of comorbid mental health conditions, with anxiety and depression being more common in patients with IBD than the general population. Despite this, few studies have qualitatively explored the experience of IBD and comorbid anxiety and depression together, and little is known about how the population would experience a long-term condition (LTC) specific psychological intervention. An online, digital, transdiagnostic therapy for LTCs (COMPASS) has been trialled in a range of health conditions, and the current study aims to qualitatively evaluate the experience of COMPASS from the perspective of IBD patients.

Methods

n=22 adults with IBD and comorbid anxiety/depression that is felt to be related or part-related to their IBD who participated in the intervention arm of the COMPASS parallel-group randomised control trial were interviewed. The interviews covered both their experience of living with IBD and comorbid anxiety or depression, in addition to their experience of the COMPASS intervention. The data was analysed using framework analysis.

Results

'Embarrassment, shame and stigma' was found to be an overarching theme from the experience of adults living with IBD and comorbid anxiety or depression. This theme influenced the core themes of 'isolation', 'identity changes' and the 'perceived lack of control'. The experience of COMPASS was qualitatively reported as being beneficial, in addition to reducing scores on the PHQ-ADS from baseline (M=21.78 SD=9.20) to the end of the intervention (M=11.36, SD=6.05 at 12 weeks). Themes highlighted from the experience of COMPASS included a sense of 'connection and support', 'practical benefits of COMPASS' and 'the empowering process', in addition to highlighting areas of improvement. The themes from these two areas were found to compliment each other and were mapped together to illustrate the potential interaction.

Conclusion

This study highlighted the cyclical, interconnected nature of IBD and anxiety/depression, with participants noting bidirectional influence between their physical and mental health. Participants found the COMPASS intervention to be accessible for people with IBD and felt it addressed the need for psychological support within IBD care. Future research could tailor the COMPASS intervention to further suit the needs of the IBD population, focusing more on IBD-specific anxieties relating to incontinence and toilet access, hypervigilance around physical symptoms and fear of recurrence and progression, as well as doing more to address embarrassment, shame and stigma in this population.
P510 Comparative effectiveness of Ustekinumab against other biologics in Inflammatory Bowel Disease: a propensity score analysis.
Authors: Matos Coelho Bernardo S , Fernandes S , Serrazina J , Rodrigues I , Botto I , Bronze S , Gonçalves A R , Valente A , Santos P M D , Tato Marinho R , Correia L
Published: January 2023

Background

Background: Increasing evidence supports the use of Ustekinumab (USTK) in patients with moderate to severe Crohn’s disease (CD) and Ulcerative colitis (UC). Comparison of USTK against other biologics is still lacking.

Methods

AIMS: to perform a propensity score analysis (PSA) for comparison of USTK against conventional Infliximab (IFX), proactive IFX and vedolizumab in CD and UC

Methods

retrospective study including patients under Ustekinumab (n=71), Vedolizumab (n=98), conventional IFX (n=70) and proactive IFX (n=148). PSA correcting for age, gender, IBD subtype, previous biologic exposure was performed for each comparison. We compared the rates of fecal calprotectin (Fc) remission (<150 µg/g), treatment discontinuation, hospitalization, and surgery at 52 weeks of treatment. Primary non-responders were excluded.

Results

Results: after PSP, ustekinumab showed lower rates of treatment discontinuation compared to vedolizumab (7.4% vs 37%, P< 0.001) with a trend for higher rates of Fc remission (42.6% vs 25.9%, P=0.104). Ustekinumab showed higher rates of Fc remission compared to conventional IFX (53.8% vs 19.2%, P= 0.020) with a trend for lower rates of hospitalization (7.7% vs 30.8%, P= 0.075). There were no differences between ustekinumab and proactive IFX in any of the clinical outcomes.

Conclusion

Conclusion: taking into account the potential limitations of PSP, our results suggest that ustekinumab may be as effective as proactive IFX with some benefits compared to vedolizumab and conventional IFX.
P514 Serum levels of Klotho in inflammatory bowel disease: an exploratory study
Authors: Hernandez-Camba A , Rodriguez-Jimenez J , Carrillo Palau M , Ramos Lopez L , Perez-Mendez L , Martin-Nuñez E , Alonso I , Vela M , Hernandez Alverez Builla N , Arranz L , Hernandez A , Ferraz Amaro I , Navarro-Gonzalez J F
Published: January 2023

Background

Alpha klotho (α-Klotho) is an anti-aging protein recognized as a humoral factor with anti-oxidant and anti-inflammatory effects, showing a bidirectional relationship with inflammation, a main pathophysiologic factor in atherosclerosis. A decrease in Klotho has been associated to cardiovascular disease (CVD), but no previous studies have investigated the relationship between inflammatory bowel disease (IBD), a risk factor for CVD, and Klotho levels. Therefore, we assessed if the serum levels of Klotho differ between patients with IBD and controls, and how this protein is related to the clinical and laboratory characteristics of the disease, subclinical atherosclerosis and metabolic risk factors.

Methods

Cross-sectional multicentric study that included 251 individuals: 191 IBD patients and 60 healthy controls was conducted. Serum Klotho levels were determined by commercial ELISA immunoassay (IBL International GmbH Laboratories). In the IBD patients disease activity was evaluated using CDAI for Crohn’s disease, partial Mayo (pMayo) for ulcerative colitis, specific laboratory parameters, determination of the Systematic Coronary Risk Evaluation (SCORE), and the presence of subclinical atherosclerosis was assessed using carotid ultrasound for identifying carotid plaque and measurement of carotid intima-media thickness.

Results

Serum Klotho levels were significantly higher in the IBD group: 734.31 pg/ml vs. 484.17 pg/ml (p<0.001) compared with controls. In the IBD group, no significant differences in the serum Klotho levels were found between the type of IBD (p=0.911), time from diagnosis (p=0.126), disease activity: CDAI (p=0.277), pMayo (p=0.916), type of treatment (0.76), the presence of plaque (p=0.101) or the intima media thickness (p=0.429). However, a significant inverse correlation between serum Klotho and the SCORE was observed in IBD patients: r = -0.176 (p= 0.014) (figure 1)

Conclusion

Patients with IBD had higher Klotho levels than healthy controls, with an inverse and significant relationship with the SCORE in the IBD patients. Further studies are necessary to clarify the role of Klotho in IBD.
P516 Humoral immune responses to SARS-CoV-2 vaccines in an ozanimod open-label extension study
Authors: Caldera F , Maddux R , Ungaro R , Kaur A , Brown E , Hu S , Sheffield J K , Silva D , Harris S , Cree B A C
Published: January 2023

Background

Ozanimod, an oral sphingosine 1-phosphate receptor modulator, is approved in the European Union and United States for the treatment of moderately to severely active ulcerative colitis (UC) and relapsing multiple sclerosis (RMS). A previous analysis of data from UC and multiple sclerosis (MS) open-label extension (OLE) studies showed that most patients with confirmed coronavirus infection (COVID-19) had nonserious infections, recovered, and did not require ozanimod discontinuation. Some immunomodulators and biologics may attenuate severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccine response; therefore, this analysis evaluated humoral immune responses and predictors of response to SARS-CoV-2 vaccination in patients with RMS treated with ozanimod.

Methods

RMS participants who completed a phase 1–3 ozanimod trial could enter an OLE trial (DAYBREAK; NCT02576717) of ozanimod 0.92 mg/d. This analysis (January 2020‒October 2021) included DAYBREAK participants receiving mRNA or non-mRNA SARS-CoV-2 vaccines (1–2 doses, vaccine-dependent) with no evidence of recent infection (ie, nucleocapsid antibody negative). Receptor binding domain (RBD) antibody titers were analysed (Elecsys Anti-SARS-CoV-2 assay; Roche Diagnostics, Basel, Switzerland) prevaccination, after 1 dose, and <4, 4–8, 8–12, and >12 weeks after full vaccination. Fisher’s exact tests and regression models determined association with seroconversion and log2 antibody levels.

Results

Demographics were similar between the mRNA and non-mRNA vaccine recipients (Table). Seroconversion (≥0.8 U/mL spike RBD antibody) occurred in 100% (80/80) of fully vaccinated mRNA recipients and 62% (18/29) of fully vaccinated non-mRNA vaccine recipients. Higher spike RBD antibody levels were seen with mRNA (grand mean: 512.6 U/mL, range: 1.3–4572.0) vs non-mRNA (grand mean: 39.3 U/mL, range: 0.4–368.5) vaccines at all time points studied. Vaccination with a non-mRNA vaccine predicted lower antibody levels (beta: –5.90 [95% CI: –6.99 to –4.82]; P<0.0001) and less seroconversion (Fisher’s exact: P<0.0001), whereas age, sex, body mass index, and absolute lymphocyte count (ALC) did not.

Conclusion

Participants receiving ozanimod developed humoral immune response to SARS-CoV-2 vaccines, with 100% seroconversion after mRNA vaccination; this was independent of demographic characteristics and ALC levels at time of vaccination. However, some participants developed lower antibody concentrations and may benefit from booster doses. These findings provide important information for physicians managing ozanimod-treated patients with UC or MS.
P520 Thromboembolic and major adverse cardiovascular events among patients in the filgotinib clinical trial programme
Authors: van der Woude J , Schreiber S , Peyrin-Biroulet L , Szekanecz Z , Choy E H , Stiers P J , Van Hoek P , Van Beneden K , de Haas A , Rudolph C , ten Cate H
Published: January 2023

Background

The once-daily, oral, Janus kinase 1 preferential inhibitor filgotinib (FIL) is approved for the treatment of moderately to severely active rheumatoid arthritis (RA) and ulcerative colitis (UC) in the UK, the EU and Japan.1 To further understand the safety profile of FIL across indications, we evaluated the risk of major adverse cardiovascular events (MACEs) and venous thromboembolic events (VTEs) in patients treated with FIL 200 mg (FIL200) or FIL 100 mg (FIL100).

Methods

An integrated analysis was conducted with RA data from five phase 2/3 trials and two long-term extension (LTE) trials of FIL, and UC data from two phase 2/3 trials and one LTE trial of FIL (herein termed ‘overall’ data). Subgroup analyses by age and cardiovascular (CV) risk factors (excluding age) were conducted. Real-world data were extracted from a systematic literature review. Exposure-adjusted incidence rates (EAIRs) or incidence rates per 100 patient-years of exposure and 95% confidence intervals (CIs) were estimated for MACEs and VTEs. For clinical trial data, MACEs and VTEs included positively adjudicated events only.

Results

In pooled data, baseline characteristics were generally similar across treatment arms for RA and UC (Tables 1 and 2). In the RA data, MACE EAIRs were 0.29 and 0.41 for the overall FIL200 and FIL100 arms, respectively (Figure 1). MACE IRs were 0.45–0.77 for the general RA population. Higher MACE EAIRs were reported in the subgroup of patients with RA aged ≥65 years vs <65 years. In the RA subgroup with CV risk, MACE EAIRs were 0.53 for FIL200 and 0.64 for FIL100. VTE rates were 0.19 for both FIL200 and FIL100 overall in patients with RA, and 0.32–0.44 for the general RA population. Numerically higher VTE EAIRs with overlapping CIs were seen in patients with RA aged ≥65 years vs <65 years, and in those with vs without CV risk.

In the UC data, MACE rates were 0.29, 0.35 and 0.87 in the overall FIL200 and FIL100 arms and in the general UC population, respectively (Figure 2). VTE rates were 0.08, 0.18 and 0.39 in the overall FIL200 and FIL100 arms and in the general UC population, respectively. For both MACE and VTE EAIRs, wide CIs were reported in patients with UC aged ≥65 years and in those with CV risk, owing to low numbers of events and/or patients in these subgroups.

Conclusion

No association was identified between FIL200 treatment and an increased risk of MACEs or VTEs compared with the general RA or UC population. Patients aged ≥65 years or with CV risk had slightly higher rates of MACEs and VTEs than those in other subgroups; however, overlapping CIs suggested no real difference. Further work should examine real-world data from FIL-treated patients and longer follow-up.

1. https://www.ema.europa.eu/en/medicines/human/EPAR/jyseleca
P540 The opinions and needs of patients living with refractory ulcerative proctitis, and the health care professionals who care for them; A Delphi consensus survey
Authors: Radford S , Kyriacou M , Moran G
Published: January 2023

Background

Refractory ulcerative proctitis presents a huge clinical challenge not only for the patients living with this chronic, progressive form of inflammatory bowel disease (IBD) but also for the professionals who care for them. Currently, there is limited research and evidence-based guidance on this condition, resulting in the large majority of patients living with the symptomatic burden of disease and reduced quality of life. The aim of this study was to establish a consensus on the thoughts and opinions surrounding refractory proctitis disease burden and management.

Methods

A three-round Delphi consensus survey was conducted among patients living with refractory proctitis and the healthcare experts with knowledge on this disease. A brainstorming stage which involved a focus group where the participants came up with an initial list of fourteen statements was completed. Following this, there were three rounds of Delphi surveys in which the participants were asked to rank the statements in order of importance alongside providing any additional comments or clarifications. Calculation of mean scores, analysis of comments and revision of statements was performed by the research team after each survey round. Statements meeting the pre-defined consensual mean score of at least 7 out of 10 were included in the final list of statements.

Results

In total, fourteen statements were suggested by the focus group at the initial creation stage. Based on these suggestions, the statements were presented to the participants and following completion of three Delphi survey rounds, all fourteen statements reached consensus following appropriate revision. The total response rate for the third Delphi round was 100% (21 out of 21 participants). Statements consider treatment options, areas for further research and clinical decision making factors.

Conclusion

This is the first study of its kind to provide a list of consensual statements on the opinions and needs of those living with refractory ulcerative proctitis. We established consensus on the thoughts and opinions surrounding refractory proctitis from both the experts who manage this disease and the patients living with it. These statements represent the first step towards providing more clinical research date and ultimately guidance aimed at this specific patient group.