Introduction

Immunoglobulin G4-related disease (IgG4-RD) is an immune-mediated fibroinflammatory disorder that often affects multiple organs. Glucocorticoids (GCs) are often used first-line for the treatment of IgG4-RD.¹ Despite their therapeutic benefits, long-term GC use is known to be associated with toxicities that can affect several organ systems.¹ While the association between GC exposure and toxicities has been well characterized in other conditions, little is known about the real-world use of GCs and the associated clinical burden in the context of IgG4-RD.

Aims & Methods

Commercially insured adults (age ≥18 years) diagnosed with IgG4-RD were identified in the IQVIA PharMetrics® Plus database (01/01/2011-06/30/2022) using a validated algorithm. This algorithm considered IgG4-RD-related diagnoses, prescription medication fills, and medical procedures.² The index date was defined as the first observed IgG4-RD-related diagnosis code, and the baseline and follow-up periods were defined as the 12 months before and after the index date, respectively. GC use during the follow-up period was calculated as the total cumulative prednisone equivalent dose divided by 365 days. Patients were classified into two mutually exclusive cohorts based on GC use. The low GC use cohort comprised patients with a mean GC dose of <5 mg/day, including patients with no GC use; the high GC use cohort comprised those with a mean GC dose of ≥5 mg/day. Incident GC toxicities were defined as toxicities with ≥1 diagnosis during the follow-up period and no diagnosis during the baseline period. Demographic characteristics were reported as of the index date; GC use and incident toxicities were reported during the follow-up period. Descriptive comparisons of incident toxicities between cohorts were analyzed using Chi-square tests.

Results

A total of 295 patients with IgG4-RD were identified, with 150 (50.8%) included in the low GC use cohort (mean age 48.9 years, 55.3% female) and 145 (49.2%) in the high GC use cohort (mean age 50.8 years, 45.5% female). In the first year after diagnosis, most patients (84.1%) received ≥1 GC fill, with a mean of 4.1 fills, corresponding to 3.9 months of treatment. Patients in the low GC use cohort received a mean of 1.8 fills, corresponding to 1.4 months of treatment or a mean dose of 1.4 mg/day over the 12-month follow-up period. Patients in the high GC use cohort received 6.4 fills, corresponding to 6.5 months of treatments or a mean dose of 12.0 mg/day over the follow-up period. Higher GC use was associated with higher rates of incident GC toxicities, such that patients in the high GC use cohort had a greater mean number of GC toxicities (1.8 vs. 1.2; p<0.01) and were more likely to have ≥3 toxicities (29.0% vs. 13.3%; p<0.01) than the low GC use cohort. In particular, cardiovascular (29.0% vs. 18.7%; p=0.04), gastrointestinal (29.7% vs. 16.0%; p<0.01), and infectious (31.0% vs. 17.3%; p<0.01) toxicities were more commonly observed among patients with high GC use than low GC use.

Conclusion

In the first year after diagnosis, patients with IgG4-RD experienced a substantial GC burden, as evidenced by nearly half of them exposed to high GC use. Higher GC use was associated with an increased incidence of GC toxicities across multiple organ systems. These findings suggest an unmet need for safe and effective treatments to mitigate prolonged exposure to GCs and improve patient outcomes, particularly in the absence of targeted FDA-approved therapies for IgG4-RD.

References

1. Yasir M, et al. 2023. Available from: https://www.ncbi.nlm.nih.gov/books/NBK531462/.
2. Wallace ZS, et al. ACR Open Rheumatol. 2022;4(4):371–7.

Disclosure

Z.S. Wallace, E. Serra, A. Guérin, and V.K. Singh have received consulting fees from Amgen Inc.
J. Park, K.R. Patterson, H. Patel are employees of Amgen Inc. and hold stock.

Study and abstract were funded by Amgen Inc.

Introduction

Thermal ablative methods (such as argon plasma coagulation (APC) and soft tip snare coagulation (STSC) are commonly used to treat polyp margins.

Aims & Methods

We aim to appraise the current literature and compare clinical outcomes between patients with treated (with APC vs STSC) and non-treated EMR margins.
We searched major databases from inception until November 2023 for RCTs comparing EMR of large non-pedunculated colorectal polyps with and without treated margins. Pooled data was analyzed for the primary outcome of recurrence at first screening colonoscopy, as well as adverse events. Analysis was performed using a random effects model and data was reported using 95% confidence intervals (CI).

Results

A total of five RCTs were found which included 1020 polyps (577 in treatment and 443 in control groups). Three studies included treatment with STSC and three studies used APC as the modality for margin ablation. Of included patients, 53% were female and average age was similar between treatment and control groups (65.9 vs 66.1 years). Overall, 71% of lesions were proximal to the splenic flexure. Mean follow up to first colonoscopy and average polyp size were comparable (6.3 vs 6.2 months; 28.2 mm vs 28.0 mm, respectively). Pooled analysis showed that margin ablation was associated with significantly lower rates of recurrence (OR = 0.267, 95% CI 0.18 - 0.4, P< 0.001) with low heterogeneity between studies (I²=0%, P = 0.47). Pooled analysis showed no significant difference between STSC and APC in terms of recurrence (OR = 0.6, 95% CI 0.27 - 1.7, I²=0%, P=0.3) or adverse events (OR = 0.67, 95% CI 0.3 - 1.6, I² 13%, P = 0.46).

Conclusion

Our study shows that ablation of EMR margins is very effective at preventing recurrence at first surveillance colonoscopy. We found no difference between STSC or APC in terms of polyp recurrence or adverse outcomes.

Introduction

Helicobacter pylori (HP) is regarded as a class I carcinogenic factor and eradication therapy can reduce the risk of gastric cancer. Patients with HP infections are administered with bismuth quadruple therapy (BQT), triple and dual therapies based on their eradication effectiveness. BQT (bismuth + acid suppressants + 2 antibiotics) and dual therapy are both recommended in China now. Comprehensive understanding on the distribution of current eradication therapies is required to identify gaps observed in real-world practice.

Aims & Methods

This multicenter, retrospective, real-world study (NCT05073367) extracted preexisting electronic data including adult patients (aged ≥18 years) with HP infection between January 1, 2019 and March 31, 2021 from 3 hospitals to assess the diagnosis and treatment pattern of HP infection and effectiveness of eradication therapy in China. In this abstract, we reported the distribution of eradication therapies, difference in initiation year for treatment, and treatment duration.

Results

Of the 22,971 eligible patients with HP infection, 13,233 (57.61%) were prescribed eradication regimens. Mean ± SD age of patients with eradication treatment was 43.7 ± 14.0 years; 65.94% of patients had medical insurance; and 54.50% of patients were women.
In patients who received eradication therapy, the BQT therapy was predominantly prescribed (85.39%; n=11301), followed by triple therapy (7.55%; n=999) and dual therapy (7.06%; n=934). Among those receiving BQT, use of amoxicillin + clarithromycin based regimens (38.72%; n=4376) were the most prevalent, followed by amoxicillin +furazolidone (18.35%; n=2074) and amoxicillin + levofloxacin (17.76%; n=2007) based combination regimens. Proportion of patients receiving BQT decreased over years: 97.24% patients in 2019, 79.98% in 2020, and 78.71% in 2021. The proportion of patients receiving dual and triple therapy increased over the years in 2019, 2020, and 2021 were shown in Table 1. A total of 10,903 patients were analyzed according to various treatment durations with the usage of various eradication therapies. Treatment duration is defined as the number of days that prescribed drugs can cover. Out of the three types of treatments, BQT had the highest proportion of 14-day treatment duration at 90.16%, followed by triple therapy at 76.78%, while dual therapy had the least proportion at 14.42%. For treatment duration >14 days, BQT, dual and triple therapy had a proportion of 4.38%, 82.35%, and 17.27% respectively.
Table 1. Distribution of eradication therapy based upon the type and year of treatment initiation

Treatment	Type of Eradication therapy (N=13, 234) n (%)a	Year of treatment initially prescribed , 2019 (N=4492) n (%)a	Year of treatment initially prescribed, 2020 (N=4125) n (%)a	Year of treatment initially prescribed, 2021 (N=4616) n (%)a
Total Bismuth quadruple therapy Amoxicillin and Clarithromycin Amoxicillin and Furazolidone Amoxicillin and Levofloxacin Amoxicillin and Metronidazole Amoxicillin and Tetracycline Furazolidone and Tetracycline Other Bismuth quadruple Triple therapyc Dual therapyc	13,234b (-) 11,301 (85.39) 4376 (38.72) 2074 (18.35) 2007 (17.76) 76 (0.67) 9 (0.08) 12 (0.11) 2747 (24.31) 999 (7.55) 934 (7.06)	4492 (-) 4368 (97.24) 1800 (41.21) 689 (15.77) 1021 (23.37) 27 (0.62) 5 (0.11) 1 (0.02) 825 (18.89) 105 (2.34) 19 (0.42)	4125 (-) 3299 (79.98) 1324 (40.13) 480 (14.55) 516 (15.64) 10 (0.30) 1 (0.03) 0 (0.00) 968 (29.34) 551 (13.36) 275 (6.67)	4617 (-) 3634 (78.71) 1252 (34.45) 905 (24.90) 470 (12.93) 39 (1.07)) 3 (0.08) 11 (0.30) 954 (26.25) 343 (7.43) 640 (13.86)

Abbreviations: N, total number; n, number in respective category.
^a% = The total usage count of BQT or Triple or Dual eradication therapy/the total usage count of all standard eradication therapies received by eligible participants. Of BQT, the total usage count of different BQT/the total usage count of all BQT.
^bThere is a recurrent patient who changed the treatment pattern from triple therapy (ilaprazole, clarithromycin, levofloxacin) to dual therapy (ilaprazole, ornidazole) after the recurrence.
^cConsidering the table size, outcomes of different treatment regimens under dual and triple therapy were not included in the table.

Conclusion

BQT-based regimen for 14 days was the predominant eradication regimens in all therapies, amoxicillin + clarithromycin based BQT was the most prevalent. Use of dual therapy gradually increased with years for HP eradication in the Chinese real-world clinical practice.

Disclosure

The study was funded by Takeda China. Wensheng Pan, Yan Zhao, and Hongwei Xu have no conflicts of interest. Pengfei Li, Fang Zhou, Li Xie are the employees of Takeda, and they hold Takeda stock options. Medical writing for the development of this abstract was provided by Kusuma Kumari G, PhD, of Indegene Private Limited, and funded by Takeda China. Authors retained full control of the abstract content.

Introduction

Splanchnic vein thrombosis (SVT) is a local complication of acute pancreatitis (AP) that may lead to subsequent complications such as portal hypertension, gastrointestinal bleeding, and mesenteric ischemia.^1,2 Despite its clinical significance, there is limited data in the literature concerning the temporal development and associated risk factors of SVT.

Aims & Methods

Our aim was to understand the time course and risk factors of SVT in the early phase of AP. To identify relevant studies we conducted a systematic search across four major medical databases (Embase, MEDLINE via PubMed, Scopus, and Cochrane Central Register of Controlled Trials) on 27th of October 2022. We included studies that employed appropriate imaging techniques in adult patients with AP, reported SVT data from the early phase of AP, and provided reliable information about the timing of imaging relative to AP symptom onset or hospital admission. We excluded studies that reported data on patients with a recent history of malignant disease or recent surgical procedures. We calculated the proportion of patients affected by SVT with 95% confidence intervals (CI). We conducted subgroup analyses based on diagnostic timing and disease characteristics. To assess the risk of bias we used the Joanna Briggs Institute Critical Appraisal Checklist for Prevalence Studies and the GRADEpro tool to determine the level of evidence. The protocol for this method was registered prospectively in the PROSPERO database, with registration number CRD42022367578.

Results

Data from 14 eligible studies and 1,951 patients was pooled; the proportion of patients with SVT in the early phase of AP (within 11 days after symptom onset or 5 days after hospital admission) was 0.13 (CI 0.07-0.23). The occurrence was lowest 0-3 days after symptom onset at 0.06 (CI 0.03-0.1), it increased to 0.23 (CI 0.16-0.31) between 3-11 days. Disease factors influencing SVT occurrence were severity (mild: 0.14 (CI 0.04-0.39), moderate: 0.23 (CI 0.09-0.47), severe: 0.31 (CI 0.15-0.54), p=0.21), etiology (alcoholic 0.31 (CI 0.13-0.58), biliary 0.12 (CI 0.04-0.3), p=0.03), and pancreatic necrosis (absent 0.10 (CI 0.04-0.25), under 30% 0.25 (CI 0.1-0.5), over 30% 0.55 (CI 0.29-0.78), p= 0.01).

Conclusion

One in eight patients develops SVT in the early phase of AP. Alcoholic etiology and pancreatic necrosis increase the risk of SVT. In addition, this risk seems to increase with the duration of AP; therefore, looking for and diagnosing SVT with imaging is important in the management of AP.

References

1. Nawacki L, Matykiewicz J, Stochmal E, Gluszek S. Splanchnic Vein Thrombosis in Acute Pancreatitis and Its Consequences. Clin Appl Thromb Hemost. 2021;27.
2. Valeriani E, Riva N, Di Nisio M, Ageno W. Splanchnic Vein Thrombosis: Current Perspectives. Vascular Health and Risk Management. 2019;15.

Introduction

Pouchoscopy is indicated for pouch assessment and surveillance following ileal pouch-anal anastomosis (IPAA) surgery. Annual surveillance is suggested in cases who are at high risk of neoplasia (i.e. Primary Sclerosing Cholangitis (PSC)/ colonic dysplasia/ neoplasia), and 5 yearly in low risk patients^1,2. Biopsies are recommended. With the pressures on endoscopy services continuing we reviewed endoscopy utilisation in our cohort of pouch patients.

Aims & Methods

We searched via health informatics for all patients who underwent IPAA surgery at our centre the Queen Elizabeth Hospital, Birmingham, United Kingdom, from 2012 to 2022. Via case note review, we reviewed indication, timing, presence of high-risk features and pouchoscopy report

Results

56 patients underwent surgery for formation of new IPAA during this study period. The majority were performed were performed from 2012- 2015 (36 cases, 62%). 6 (10%) were undertaken as a single stage procedure, the remainder were 2 stage and 1 (1.8%) was a conversion from an ileo-rectal anastamosis. Indication for IPAA was medically refractory inflammatory bowel disease (IBD) in 48 (86%) cases, colonic dyslpasia in the context of IBD in 5 (9%), and 3 (5%) had an underlying genetic disorder for malignancy e.g. FAP or HNPCC. 16 patients had high risk features (PSC colitis=5, Dysplasia/neoplasia =11), although 2 were referred elsewhere for surveillance.
148 pouchoscopies were performed on this cohort of patients, with an average of 1 pouchoscopy every 3 years from IPAA date (range: 1 pouchoscopy per 0.4 – 10 years). The majority (113, 76%) of procedures were for pouch symptoms e.g. frequency, pain. Biopsies were taken in 98 (66%). Dye spray surveillance was not performed. No biopsy showed pouch or rectal neoplasia, but 73 (74%) showed pouchitis/cuffitis/inflammation.
Despite high resource utilisation, adherence to surveillance protocols remained poor.

	Appropriate number of pouchoscopies as per guidelines	Appropriate number of pouchoscopies with biopsies	Number of patients who did not undergo pouchoscopy despite pouch duration >1 years (high risk) or >5 years (low risk)
High risk (n=14)	2 (14%)	1 (7%)	3 (21%)
Low risk (n=40)	30 (75%)	29 (73%)	10 (25%)

2 patients went on to have their IPAA excised, and 5 have since died; 2 due to PSC associated liver failure, 2 due to non-pouch malignancy and 1-details unavailable.

Conclusion

This study shows poor implementation of pouch surveillance guidelines yet high use of endoscopy for pouch assessment often without biopsy. Our findings suggest that surveillance for neoplasia is an overlooked component of the care of patients who have under IPAA surgery. Furthermore, there is uncertainty within guidelines about frequency of surveillance particularly in low risk groups, although these patients do have a recognised risk of neoplasia^2,3.
We recommend that endoscopists take biopsies routinely when assessing pouch such as Type C mucosa in the pouch (mucosa exhibiting permanent persistent atrophy and severe inflammation) has a greater propensity for neoplastic changes. In addition, more data is needed to determine the risk of neoplasia in different subgroups of patients who have undergone IPAA surgery, as well as develop robust guidelines on use of endoscopy in pouch management.

References

1 = Derikx LA, Nissen LH, Oldenburg B, Hoentjen F. Controversies in Pouch Surveillance for Patients with Inflammatory Bowel Disease. J Crohns Colitis. 2016 Jun;10(6):747-51. doi: 10.1093/ecco-jcc/jjw035. Epub 2016 Jan 28. PMID: 26822612.
2 = Lamb CA, Kennedy NA, Raine T, et al British Society of Gastroenterology consensus guidelines on the management of inflammatory bowel disease in adults Gut 2019;68:s1-s106.
3=Samaan MA, Forsyth K, Segal JP, De Jong D, Vleugels JLA, Elkady S, Kabir M, Campbell S, Kok K, Armstrong DG, Penez L, Arenaza AP, Seward E, Vega R, Mehta S, Rahman F, McCartney S, Bloom S, Patel K, Pollok R, Westcott E, Darakhshan A, Williams A, Koumoutsos I, Ray S, Mawdsley J, Anderson S, Sanderson JD, Dekker E, D'Haens GR, Hart A, Irving PM. Current Practices in Ileal Pouch Surveillance for Patients With Ulcerative Colitis: A Multinational, Retrospective Cohort Study. J Crohns Colitis. 2019 May 27;13(6):735-743. doi: 10.1093/ecco-jcc/jjy225. PMID: 30590513.

Clinical Case Summary

Introduction: While endoscopic retrieval of gastric bezoars has been described involving various instruments and adjuncts, there is no consensus about the management of large non-obstructing gastric trichobezoars¹. This case report describes how a novel endoscopic device primarily developed to resect recurrent or scarred gastrointestinal lesions or pancreatic necrosis, was used to safely remove a large gastric trichobezoar after unsuccessful attempts with standard endoscopic adjuncts.
Case report: A 19-year-old female presented to our ED with CT-proven trichobezoar within the gastric lumen, measuring 123 x 51 mm (image 1).
An initial attempt at endoscopic removal was performed under general anaesthesia. Despite the use of multiple standard instruments (hot and cold snares, biopsy forceps, argon plasma coagulation, and endoscopic scissors) the congealed trichobezoar could not be sufficiently fragmented for removal.
A decision was made to repeat the procedure using EndoRotor™ (Interscope Inc, Whitinsville, Massachusetts), an endoscopic ‘morcellator’ device (image 2), which we have used to safely resect large or scarred, recurrent colorectal and duodenal polyps². The device allowed us to make dents in the trichobezoar, which facilitated the use of hot snares for complete fragmentation and retrieval via Roth net. Our novel use of this for trichobezoar removal was assisted by a team from EndoRotor.
Conclusion: We report the use of this new endoscopic technique to remove a large trichobezoar, which would otherwise have had to been removed surgically. Apart from reduced therapeutic morbidity, this approach facilitated a shorter hospital stay and quicker return to normal activity for our patient, compared to surgical intervention.

References

1. Gorter, R. R., Kneepkens, C. M. F., Mattens, E. C. J. L., Aronson, D. C., & Heij, H. A. (2010). Management of trichobezoar: Case report and literature review. In Pediatric Surgery International (Vol. 26, Issue 5, pp. 457–463). https://doi.org/10.1007/s00383-010-2570-0
2. Emmanuel A, Williams S, Gulati S, Ortenzi M, Gunasingam N, Burt M, Ratcliff S, Hayee B, Haji A. Incidence of microscopic residual adenoma after complete wide-field endoscopic resection of large colorectal lesions: evidence for a mechanism of recurrence, Gastrointestinal Endoscopy, (Volume 94, Issue 2, 2021, Pages 368-375). https://doi.org/10.1016/j.gie.2021.02.010.

Introduction

The introduction of biological drugs has led to great expectations and growing optimism in the possibility that this new therapeutic strategy could favourably change the natural history of Inflammatory Bowel Disease (IBD) and in particular that it could lead to a significant reduction in surgery in the short and long term. The evaluation of the incidence of intestinal resection after the introduction of biological therapy is very complex and subject to several potential bias, the most prominent being the shift in IBD management over the last few decades.

Aims & Methods

This study aims to assess the impact of biological versus conventional therapy on surgery-free survival time (from the diagnosis to the first bowel resection) and on the overall risk of surgery in patients with Crohn’s disease (CD) who were never with the surgical option.
This is a retrospective, double-arm study including CD patients treated with either biological or conventional therapy (mesalamine, immunomodulators, antibiotics, or steroids). All CD patients admitted at the GI Unit of the S. Salvatore Hospital (L’Aquila, Italy) and treated with biological therapy since 1998 were included in the biological arm. Data concerning the CD patients receiving a conventional therapy were retrospectively collected from our database. These patients were divided into a pre-1998 and post-1998 group (pre and post biologic era, respectively). Our primary outcome was the evaluation of the surgery-free survival since CD diagnosis to the first bowel resection. Surgery-free time and event incidence rates were calculated and compared among all groups, both in the original population and in the propensity-matched population.

Results

203 CD patients (49 biological, 93 conventional post-1998, 61 conventional pre-1998) were included in the study. Kaplan-Mayer survivorship estimate shows that patients in the biological arm had a longer surgery-free survival compared to those in the conventional arm (p=0.03). However, after propensity matching analysis, no significant difference was found in surgery-free survival (p=0.3). A sub-group analysis showed shorter surgery-free survival in patients on conventional therapy in the pre-biologic era only (p=0.02) while no significative difference was found between the biologic and conventional post-biologic groups (p=0.15).

Conclusion

This study shows that the introduction of biological therapy had only a slight impact on the occurrence of surgery in CD patients over a long observation period. Despite the milder disease, patients in the conventional group in the biologic era had the same surgery-free survival compared to patients in biological therapy. Nevertheless, biological therapy appears to delay the first intestinal resection. However, the cumulative incidence of first intestinal resection between patients who underwent biological or conventional therapy ends up being similar considering a very long period.

Disclosure

None