Introduction

Current guidelines suggest upper and lower GI endoscopy to investigate iron deficiency anaemia (IDA) because of a perceived low risk of small bowel pathology. We aimed to identify the Bleeding Location In The Gastrointestinal Tract (BLITGIT) in patients with IDA.

Aims & Methods

Patients referred to three centres (Sheffield, Hong Kong and Szekesfehervar, Hungary) for the investigation of IDA underwent small bowel (SB) capsule endoscopy (Navicam, AnX Robotica, Plano, US) in the week prior to upper and lower gastrointestinal endoscopy. All lesions were described using terms selected from a predetermined diagnostic list and according to the perceived likelihood of bleeding (P0: unlikely; P1: suspected; P2: likely. Saurin et al., Endoscopy 2003).

Results

Gastroscopy pathology (P1/P2)	Small bowel pathology (P1/P2)	Colon pathology (P1/P2)
Oesophagitis- 2 Oesophageal ulcer- 1 Oesophageal varices- 2 Gastric erosions- 9 Gastric ulcer- 5 Gastric polyp with blood- 1 Gastric antral vascular ectasia -2 Portal hypertensive gastropathy – 1 Duodenal ulcer- 3	Angioectasia- 23 Erosion - 18 Ulcers- 16 Polyp with eroded surface- 1 Fresh blood- 3 Portal hypertensive enteropathy- 1	Haemorrhoids- 15 Colorectal cancer- 3 Ulcerative colitis- 2 Diverticulitis-2 NSAID induced Ulcers- 1 Angioectasia- 2 Radiation proctitis- 2

Table-1: Number of patients with P1/P2 pathology identified at gastroscopy, SB capsule and colonoscopy.

92 patients (median age 61 years (IQR 45-72); 54.3% male) had a median haemoglobin of 107.5 g/L (IQR 93.2-121.7), ferritin 8(IQR 8- 18) and iron 3.8(IQR 3.8- 6.4). Completion rates for gastroscopy, colonoscopy and capsule endoscopy were 98.9%, 95.6% and 84.7% respectively. Diagnostic yield of P1/P2 lesions by SB capsule (48.9%) was higher than gastroscopy (27.1%) and colonoscopy (29.3%; p=0.003). On multivariant analysis there was no correlation between age, haemoglobin level, symptoms or medication on pathology. A few patients had more than one P1/P2 lesions. Three patients had colorectal cancer and two patients had a new diagnosis of ulcerative colitis.

Conclusion

The diagnostic yield in the small bowel is higher as compared to the upper and lower GI tract and examination should be considered routinely.

Introduction

Eosinophilic esophagitis (EoE), a chronic, progressive, type 2 inflammatory disease. Dupilumab is a fully human monoclonal antibody that blocks interleukin (IL)-4 and IL-13, key drivers of type 2 inflammation.

Aims & Methods

The aim of this analysis was to assess the impact of dupilumab on caregiver-reported EoE symptoms in children aged 1 to <12 years with active EoE in the placebo-controlled Part A of the Phase 3 EoE KIDS trial (NCT04394351). This analysis was conducted in children randomized to dupilumab higher-exposure or placebo. The Pediatric Eosinophilic Esophagitis Symptom Score (PEESS) version 2.0 (caregiver version) comprises 20 items (items scored 0–4; higher scores indicate greater burden) assessing frequency (11 questions) and severity (9 questions) of symptoms and adaptive behaviors, containing 4 subdomains: dysphagia, nausea/vomiting, gastroesophageal reflux disease, and pain. PEESSv2.0 was evaluated at baseline and Week 16 in EoE KIDS; total, frequency, severity, domain (all scored 0–100), and individual item scores were compared in patients treated with dupilumab higher-exposure or placebo. Reported p-values are nominal.

Results

Baseline characteristics were similar in dupilumab higher-exposure (n=37) and placebo (n=34) groups; baseline mean PEESSv2.0 total scores were 38.0 and 38.3, respectively. At Week 16, PEESSv2.0 total was reduced with dupilumab higher-exposure vs placebo (least squares [LS] mean change [95% confidence interval (CI)] -19.86 [-24.98, -14.74] vs -11.83 [-17.61, -6.05]; LS mean difference [95% CI] -8.03 [-15.39, -0.67], p<0.05). At Week 16, all domain subscores were at least numerically reduced with dupilumab higher-exposure vs placebo with nominal significance observed in LS mean scores for frequency (-22.47 vs -11.88 [p<0.01]), dysphagia (-23.38 vs -13.76 [p<0.05]), and nausea/vomiting (-29.08 vs -15.30 [p<0.05]) domains.

Conclusion

Dupilumab higher-exposure led to improvement in PEESSv2.0 total score vs placebo at Week 16 in EoE KIDS. Frequency, dysphagia, and nausea/vomiting domains were improved with nominal significance, though all domains were improved numerically with dupilumab vs placebo.

Disclosure

Rothenberg ME: Allakos, AstraZeneca, BMS, Celldex, ClostraBio, EnZen Therapeutics, GSK, Guidepoint, Pfizer, PulmOne, Regeneron Pharmaceuticals Inc., Revolo Biotherapeutics, Sanofi, Santa Ana Bio, Serpin Pharma, Spoon Guru, and Uniquitybio – consultant; Allakos, Celldex, ClostraBio, EnZen Therapeutics, PulmOne, Santa Ana Bio, Serpin Pharma, Spoon Guru, and Uniquitybio – equity interest; Receives royalties from Mapi Research Trust (for PEESSv2), Teva Pharmaceuticals (for reslizumab), and UpToDate; and is the inventor of patents owned by Cincinnati Children’s Hospital.
Oliva S: Celgene/Receptos/BMS, Medtronic, Ocean Pharma, Sanofi/Regeneron – advisory board; Medtronic, Sanofi/Regeneron – speaker fees.
Ashok D: Sanofi – speaker fees.
Xia C, Durrani S, Radwan A, Thomas R: Regeneron Pharmaceuticals Inc. – employees and shareholders.
Pela T, Jacob-Nara J, Tilton ST: Sanofi – employee, may hold stock and/or stock options in the company.

Introduction

Upadacitinib (UPA) has demonstrated its efficacy in patients with inflammatory bowel disease (IBD) in clinical trials. However, these results may differ from those achieved in clinical practice. Thus, durability and safety should be analysed in a real-world scenario. Main aim: to evaluate the durability of UPA in real life, both in Crohn’s disease (CD) and ulcerative colitis (UC). Secondary aims: to assess the effectiveness and safety of UPA

Aims & Methods

Multicentre, retrospective study of IBD patients who received UPA in clinical practice. Durability was calculated from the date of the first dose to the date of the last dose of UPA. Active disease was defined as Harvey-Bradshaw index >4 in CD, and partial Mayo score >2 in UC. For effectiveness assessment, only patients with active IBD at baseline were considered. Negative imputation method was used to impute missing data. Cox regression models, and logistic regression analyses were used to identify predictive factors of treatment durability and effectiveness

Results

Fifty-one patients from 21 centres have been included so far, 36 with CD and 15 with UC. All patients have been previously exposed to biologics (median 3, IQR 2-4), and 27% to JAK inhibitors (86% in UC); 33% of them were on steroids at baseline. Regarding UPA survival, 91% of patients remained on UPA at month 6, and 51% at month 12. The induction dose of 45 mg q.d. was prescribed in 94% of patients while the dosage during the maintenance phase was 30 mg q.d. in 43% and 45 mg q.d. in 40%. Loss of response was observed in 21%. Intensification was required in 55% of patients, 83% of whom responded clinically. Finally, 10 patients (20%) interrupted UPA during the follow-up, mainly due to primary non-response (n=4) and secondary loss of response (n=3). Younger age (<40 years) at UPA start was the only variable significantly associated with a higher UPA durability in the multivariate analysis (HR 5.6, 95%CI:1.2-28).
Forty-one patients had active disease at baseline and were considered for the effectiveness analysis. Clinical remission in the short-term was achieved in 54%, 53% and 59% at week 4, 8 and 12; in the long-term, 46% and 37% remained in clinical remission at months 6 and 12. Clinical response (including remission) in the short-term was reached in 68%, 78% and 76% at week 4, 8 and 12 respectively; and in the long-term, in 53% and 37% at months 6 and 12. In multivariate analysis, UC (vs. CD) (OR 7; 95%CI:1.1-43) and mild clinical activity (vs. moderate-severe) (OR 22; 95%CI:3-152) were associated with clinical remission at week 12. Focusing on the type of IBD, clinical remission was achieved in 69% of UC vs. 44% of CD (p=0.1) at week 8.
A total of 24 patients (47%) presented at least one adverse event. The most frequently reported were infections (14%), followed by hypercholesterolemia (12%) and anaemia (8%). According to investigator criteria, 19 adverse events (36%) were related to UPA. Serious adverse events were described in 4 patients (8%), all of them requiring hospital admission: Campylobacter jejuni infection, severe flare-up of CD, acute pancreatitis, and creatinine kinase elevation. Three patients (6%) suffered an adverse event leading to UPA discontinuation

Conclusion

In the largest cohort providing real world evidence about UPA in IBD patients, the proportion of patients maintaining the drug at 12 months seems relatively high, considering that it was a highly refractory population. UPA seems to be effective in inducing and maintaining clinical remission, both in CD and in UC. The safety profile was similar to that previously described

Disclosure

MJ García has received financial support for travelling and educational activities from Janssen, Pfizer, Takeda, Fae Farma and Ferring. M. Barreiro-de Acosta has served as a speaker, consultant and advisory member for or has received research funding from MSD, AbbVie, Janssen, Kern Pharma, Celltrion, Takeda, Gillead, Celgene, Pfizer, Sandoz, Biogen, Fresenius, Ferring, Faes Farma, Dr. Falk Pharma, Chiesi, Gebro Pharma, Adacyte and Vifor Pharma. A. Gutiérrez has served as a speaker, a consultant and advisory member for or has received research funding from MSD, Abbvie, Pfizer, Kern Pharma, Takeda, Janssen, Ferring, Faes Farma, Shire Pharmaceuticals, Tillotts Pharma, Chiesi and Otsuka Pharmaceutical. J.M.Huguet has received founding for educational activities research projects scientific meetings or advisory boards sponsored by MSD, Ferring, Abbvie. M Bosca-Watts declares educational activities, research projects, scientific meetings and advisory boards sponsored by MSD, Ferring, Abbvie, Janssen, Biogen and Takeda. H. Alonso-Galán has received financial support for travelling and educational activities from or has served as an advisory board member to Janssen, MSD, Abbvie, Takeda, Ferring, Pfizer and Falk Pharma. M.D. Martín-Arranz has received fees as a speaker, consultant and advisory member for or has received funding from MSD, AbbVie, Hospira, Pfizer, Takeda, Janssen, Shire Pharmaceuticals, Tillots Pharma, and Faes Pharma. J. P. Gisbert has served as a speaker, a consultant and advisory member for or has received research funding from MSD, AbbVie, Pfizer, Kern Pharma, Biogen, Mylan, Takeda, Janssen, Roche, Sandoz, Celgene, Gilead, Ferring, Faes Farma, Shire Pharmaceuticals, Dr. Falk Pharma, Tillotts Pharma, Chiesi, Casen Fleet, Gebro Pharma, Otsuka Pharmaceutical, and Vifor Pharma. M. Chaparro has served as a speaker, as consultant or has received research or education funding from MSD, AbbVie, Hospira, Pfizer, Takeda, Janssen, Ferring, Shire Pharmaceuticals, Dr. Falk Pharma, Tillotts Pharma, Biogen, Gilead and Lilly.

Introduction

Polypectomy is a common endoscopic procedure with cold snare and hot snare techniques being widely used. Hot snare polypectomy involves cautery, which may increase the risk of thermal injury and related complications. Cold snare polypectomy has a well-established safety and efficacy profile for small colonic polyps, however, comparative data on the clinical outcomes of these two methods for gastric polyps remains limited.

Aims & Methods

A retrospective analysis was conducted on 161 consecutive gastric polypectomies for polyps under 10mm, comprising a sample of 41 patients that underwent cold snare polypectomy and 120 patients that underwent hot polypectomy over a period of 5 years.

Results

The mean polyp size differed significantly between groups, being smaller in the cold snare group (5.20 ± 1.18 mm vs 6.34 ± 1.49 mm; p < 0.001). The Charlson Comorbidity Index averaged 3 points, with no significant differences between the groups regarding the use of anticoagulant or antiplatelet therapy. Statistically significant differences were observed in both the location and histological type of the polyps between the two techniques (p = 0.003 ; p < 0.001). Cold snare polypectomy was more frequently used for polyps located in the fundus and for fundic gland polyps, whereas hot snare polypectomy was more commonly utilized for polyps located in the cardia and antrum. Submucosal injection with gelofusine and adrenaline were more frequently associated with the hot snare technique (p = 0.001). Regarding clinical outcomes, intra-procedural bleeding occurred in 16.1% of cases and was successfully managed endoscopically in all instances, mainly with clips (76.9%). No cases of delayed bleeding or perforation were observed. There were no significant differences between the groups concerning complete histological resection or polyp recurrence.

Conclusion

Cold snare polypectomy demonstrated comparable safety and efficacy to hot snare polypectomy in the resection of small gastric polyps, possibly representing a preferable approach to avoid thermal injury and related complications.