Introduction

Vedolizumab (VDZ), a gut-selective anti-lymphocyte trafficking agent, was approved for the treatment of moderate-to-severe Crohn’s disease (CD) in Europe and the USA in 2014. We conducted a systematic literature review and meta-analysis of studies reporting real-world effectiveness of VDZ in patients with CD. Here we describe treatment persistence in biologic-naïve patients with CD treated with VDZ compared with anti-tumor necrosis factor-alpha (TNFα) treatment at 12 and 24 months to address the gap of long-term data available on patients with CD.

Aims & Methods

Systematic literature reviews were performed using MEDLINE, MEDLINE In-Process, Embase, Cochrane Library, clinicaltrials.gov, and the World Health Organization International Clinical Trials Registry Platform to identify relevant studies published from May 2014 to July 2022. In addition, if the congress abstracts were not indexed in Embase, key congresses from 2015 to July 2022 were hand searched. Data from adults (aged ≥ 18 years) with CD treated with VDZ in observational/real-world studies were extracted for meta-analysis. The analysis was conducted using the DerSimonian-Laird random-effects method to obtain weighted mean rates (percentage of patients) and the corresponding 95% confidence interval (CI) for each treatment persistence or serious adverse event (SAE) as performed for a meta-analysis published in 2018.¹

Results

Overall, data from 78 studies of 30 158 patients with CD had at least one outcome of interest for analysis. Four and three studies of 7082 and 5040 patients with CD, respectively, reported the rate of treatment persistence in biologic-naïve patients treated with VDZ versus anti-TNFα treatment at 12 and 24 months. The rate of treatment persistence was higher with VDZ (83.8% [95% CI 71.4–96.1]) compared with anti-TNFα treatment (75.3% [69.9–80.7]) at 12 months. Similarly, the rate of treatment persistence was higher with VDZ (70.4% [95% CI 61.3–79.6]) compared with anti-TNFα treatment (64.5% [56.9–72.2]) at 24 months. Two studies of 491 and 86 biologic-naïve patients with CD treated with VDZ versus anti-TNFα treatment reported SAEs. In a retrospective study, safety outcomes were followed from treatment initiation up to five half-lives post-treatment discontinuation; 8.3% treated with VDZ experienced SAEs compared with 19.0% with anti-TNFα treatment.² In an additional retrospective study that reported SAEs within the first 12 months of treatment; the rate of SAEs was comparable between patients treated with VDZ (18.2%) and anti-TNFα treatment (17.0%).³ Among these patients, only those receiving anti-TNFα treatment experienced drug-induced SAEs (3.8%; pancreatitis and systemic lupus erythematosus).³

Conclusion

This meta-analysis of real-world studies demonstrated higher rates of long-term treatment persistence and suggests that VDZ may have a favorable safety profile compared with anti-TNFα treatment in biologic-naïve patients with CD.

References

1. Schreiber S et al. J Gastroenterol 2018;53:1048–64.
2. Bressler B et al. J Crohns Colitis 2021;15:1694–706.
3. Moens A et al. Inflamm Bowel Dis 2021;28:1135–42.

Disclosure

This study was funded by Takeda Pharmaceuticals International AG. Medical writing services were provided by Elena Sugrue, PhD, of Oxford PharmaGenesis, and funded by Takeda Pharmaceuticals International AG.
AA Advisory board/lecture fees from AbbVie, Amgen, Arena, Biogen, Boehringer Ingelheim, Bristol-Myers Squibb, Celgene, Celltrion, Eli Lilly, Ferring, Galapagos, Gilead, Janssen, MSD, Novartis, Pfizer, Protagonist Therapeutics, Roche, Samsung Bioepis, Sandoz, Takeda.
RJB is an employee of PHMR Ltd., who received funding for this study from Takeda Pharmaceuticals International AG.
PB is an employee and stockholder of Takeda Pharmaceuticals International AG, Zurich, Switzerland.
MN is an employee and stockholder of Takeda Pharmaceuticals International AG, Zurich, Switzerland.
SW is an employee and stockholder of Takeda Pharmaceutical Company Limited, Cambridge, MA, USA.
SS has received personal fees from AbbVie, Amgen, Arena, Biogen, Bristol-Myers Squibb, Celgene, Celltrion Healthcare, Dr. Falk Pharma, Fresenius, Galapagos/Gilead, Hikma, I-Mab, Janssen, MSD, Mylan, Pfizer, Protagonist Therapeutics, ProventionBio, Takeda and Theravance Biopharma.

Introduction

Capsule endoscopy (CE) is a minimally invasive exam suitable of panendoscopic evaluation of the gastrointestinal tract. Nevertheless, CE is time-consuming, with suboptimal diagnostic yield in the upper GI tract. Convolutional neural networks (CNN) are human brain architecture-based models suitable for image analysis. However, there is no study about their role in capsule panendoscopy.

Aims & Methods

Our aim was to develop an artificial intelligence (AI) model for panendoscopic automatic detection of pleomorphic lesions (namely vascular lesions, protuberant lesions, hematic residues, ulcers, and erosions). 355110 images (6977 esophageal, 12918 gastric, 258443 small bowel, 76772 colonic) from eight different CE and colon CE (CCE) devices were divided into a training and validation dataset in a patient split design. The model classification was compared to three CE experts’ classifications. The model’s performance was evaluated by its sensitivity, specificity, accuracy, positive predictive value, negative predictive value, and area under the precision-recall curve.

Results

The binary esophagus CNN had a diagnostic accuracy for pleomorphic lesions of 83.6%. The binary gastric CNN identified pleomorphic lesions with a 96.6% accuracy. The undenary small bowel CNN distinguished pleomorphic lesions with different hemorrhagic potential with 97.6% accuracy. The trinary colonic CNN (detection and differentiation of normal mucosa, pleomorphic lesions, and hematic residues) had 94.9% global accuracy.

Conclusion

Our group developed the first AI model for panendoscopic automatic detection of pleomorphic lesions in both CE and colon CE from multiple brands, solving a critical interoperability technological challenge. Deep learning-based tools may change the landscape of minimally invasive capsule panendoscopy.

References

1. Pennazio M, Rondonotti E, Despott EJ, Dray X, Keuchel M, Moreels T, et al. Small-bowel capsule endoscopy and device-assisted enteroscopy for diagnosis and treatment of small-bowel disorders: European Society of Gastrointestinal Endoscopy (ESGE) Guideline - Update 2022. Endoscopy. 2023 Jan;55(1):58-95. PubMed PMID: 36423618. Epub 20221124.
2. Le Berre C, Trang-Poisson C, Bourreille A. Small bowel capsule endoscopy and treat-to-target in Crohn's disease: A systematic review. World J Gastroenterol. 2019 Aug 21;25(31):4534-54. PubMed PMID: 31496630. PMCID: PMC6710184.
3. Iddan G, Meron G, Glukhovsky A, Swain P. Wireless capsule endoscopy. Nature. 2000 May 25;405(6785):417. PubMed PMID: 10839527.
4. Rondonotti E, Pennazio M. Colon capsule for panendoscopy: a narrow window of opportunity. Endosc Int Open. 2021 Dec;9(12):E1860-E2. PubMed PMID: 34917450. PMCID: PMC8670997. Epub 20211214.
5. Vuik FER, Moen S, Spaander MCW. Colon capsule endoscopy as panendoscopy: Using current knowledge to enhance possibilities. Endosc Int Open. 2022 May;10(5):E584. PubMed PMID: 35571484. PMCID: PMC9106432. Epub 20220513.

Introduction

Screening for Barrett’s esophagus (BE) could lead to earlier detection (EAC) and improve survival of esophageal adenocarcinoma (EAC). The Cytosponge, a non-endoscopic cell collection device that is coupled with the biomarker Trefoil Factor 3 (TFF3), has been shown in the Barrett’s Esophagus Screening Trial 3 (BEST3) trial, to lead to a 10-fold increase in BE diagnosis in a reflux population. The aims of this study were to: 1) Estimate the proportion of missed BE or stage-1 EAC under the current primary care reflux referral pathway, 2) Define a target screening population and, 3) To estimate the trade-off between the target population to screen and the proportion of BE or stage-1 EAC diagnosed.

Aims & Methods

This was a retrospective analysis and modelling from the multicentre, pragmatic, randomised controlled BEST3 trial that took place across 109 general practices in England. The findings from the main study were previously reported.¹ For aim 1, we used the BEST3 intervention (n=6834) and control arm (n=6388) data to estimate the number of missed BE or stage-1 EAC under the current reflux referral pathway. For aim 2, we determined which clinical risk factors predict a diagnosis of BE or stage-1 EAC in individuals who swallowed the Cytosponge (n=1654) and then modelled the probability of a diagnosis of BE and stage-1 EAC. For aim 3, we used different probabilities of a diagnosis of BE and stage-1 EAC to estimate the starting age to screen, to estimate the trade-off of the number-needed-to-screen and the proportion of BE or stage-1 EAC that would be diagnosed.

Results

Among usual care (control), 0.2% (13/6388) of individuals had BE or stage-1 EAC whereas, the expected prevalence of BE or stage-1 EAC within the intervention (Cytosponge) arm was 10.6% (680/6388), leading to the estimation that the proportion of missed pre-symptomatic BE and stage-1 EAC cases under current care is ~98%. Using logistic regression, we showed that male gender (Odds Ratio, OR 2.46, 95% Confidence Interval, CI 1.67-3.64, p<0.001), age (OR 1.05, 95% CI 1.03-1.07, p<0.001) and family history (OR 1.81, 95% CI 1.04-3.15, p=0.036) were significant predictors of BE or stage-1 EAC diagnosis. Next we modelled and simulate the trade-off for the numbers-needed-to screen on a population level according to different probability thresholds for a diagnosis of BE or stage-1 EAC (≥3%, ≥5%, and ≥10% among individuals with reflux). For these models we set an upper age limit of 74 years for practical considerations (Table 1). These data suggest that a 5% threshold is likely the optimal strategy. This reduces the screening population by 45.2% (males age 55-74 and females 65-74) while still diagnosing 71.0% of cases with a number-needed-to-screen to detect one case of 10.7.

Conclusion

A targeted screening strategy has the potential to substantially improve detection rates for BE and stage-1 EAC compared with current care. The trial data can be used to inform the optimal age for screening in males versus females in order to maximise the yield of screening according to the resources available.

References

Fitzgerald RC, di Pietro M, O'Donovan M, et al. Cytosponge-trefoil factor 3 versus usual care to identify Barrett's oesophagus in a primary care setting: a multicentre, pragmatic, randomised controlled trial. The Lancet 2020;396(10247):333-44.

Disclosure

R.C.F. and M.O. are named inventors on patents pertaining to the Cytosponge and associated technology. R.C.F. and M.O are shareholders of Cyted Ltd., a company working on early detection technology. The other authors declare no conflict of interest.

Introduction

Acute pancreatitis (AP) is one of the most common and widely increasing gastrointestinal diseases leading to hospitalization without specifically available therapy [1]. It is mainly caused by gallstones, possibly by increasing the pressure in pancreatic duct with refluxing of bile acids (BAs) or changing of serum BA concentration due to bile duct obstruction [2]. So far, few existing reports only mentioned total BA measurements without considering their hydrophilic potential. Our data from experimental work showed that systemic BAs can modulate severity of AP depending on their hydrophobicity and the involvement of cholecystokinin [3]. As a further translational step, we aimed to investigate the role of systemic BAs profiles and analysed their association with the etiology and severity of AP in human.

Aims & Methods

Serum from AP patients and a healthy control group was collected and stored at -80⁰C. A profile of 20 different BAs was quantified by liquid chromatography tandem mass spectrometry-based assay using the AbsoluteIDQBAs kit according to the manufacturer’s instruction. The workflow was managed by MetIDQ and the data was analyzed by Oracle database XE software. Acute Physiology and Chronic Health Evaluation (APACHE) II scores were calculated for each patient at the first and third day of hospitalization and were compared by subtraction of the values (Δ APACHE II). Diagnosis criteria and severity of pancreatitis were assessed according to the Revised Atlanta classification and the APACHE II score.

Results

There were 214 AP patients with mean age of 60±16 (range 26-87) years and 50.4 % were female. Biliary origin was diagnosed in 133 (62.1%) patients and non-biliary pancreatitis (mainly alcoholic AP) in 81 (37.9 %) cases. In non-biliary AP, profiles of both hydrophobic and hydrophilic BAs did not differ from controls. In biliary AP, significantly elevated levels were detected for hydrophobic BAs but not hydrophilic one. The total concentrations of hydrophobic BAs were 33.86±4.51 μM in biliary AP and 8.068±1.98 μM in non-biliary AP (p < 0.0001). Cut-off values were 0.30 μM and 3.78 μM for hydrophilic and hydrophobic BAs, respectively. The total amount of hydrophilic BAs was not different between the groups of deteriorated (Δ APACHE II >0) and ameliorated or stable AP (Δ APACHE II ≤ 0). Conversely, total hydrophobic BAs concentrations were significantly higher in the worsened AP (55.8±12.3 μM) group than in those who recovered or at least did not deteriorate (5.9±0.6 μM). However, ursodeoxycholic acid (UDCA), a hydrophilic BA, was significantly decreased in severe disease and showed a reduced trend in moderately severe AP.
Hydrophobic BAs had more predictive potential with an area under the curve (AUC) of 0.762, a sensitivity of 83.75% and a specificity of 60% at the cut-off value 11.84 μM, whereas hydrophilic BAs were only of limited use for the prediction of AP deterioration, as AUC was 0.57 with a sensitivity of 65% and a specificity of 44% at the cut-off 0.7 μM. Additionally, UDCA concentrations of less than 19 nM can be used to distinguish biliary AP from non-biliary AP with an AUC of 0.723, sensitivity 75%, and specificity 65%. For detection of deterioration, UDCA alone with cut-off concentration 18 nM showed a value with an AUC of 0.68, sensitivity 76%, and specificity 61%.

Conclusion

In patients, the sum of hydrophobic but not total hydrophilic BAs associated with the etiology and severity of AP. Serum levels of UDCA, a particular type of hydrophilic BAs, inversely associated with the severity of AP, which suggests a protective role.

References

[1]. Iannuzzi, J.P.; King, J.A.; Leong, J.H.; Quan, J.; Windsor, J.W.; Tanyingoh, D.; Coward, S.; Forbes, N.; Heitman, S.J.; Shaheen, A.A.; et al. Global Incidence of Acute Pancreatitis Is Increasing Over Time: A Systematic Review and Meta-Analysis. Gastroenterology 2022, 162, 122-134, doi:10.1053/j.gastro.2021.09.043
[2]. Lerch, M.M.; Aghdassi, A.A. The role of bile acids in gallstone-induced pancreatitis. Gastroenterology 2010, 138, 429-433, doi:10.1053/j.gastro.2009.12.012
[3]. Tran, Q.T.; Sendler, M.; Wiese, M.L.; Doller, J.; Zierke, L.; Gischke, M.; Glaubitz, J.; Tran, V.H.; Lalk, M.; Bornscheuer, U.T.; Weiss F.U; Lerch, M.M and Aghdassi A.A. Systemic Bile Acids Affect the Severity of Acute Pancreatitis in Mice Depending on Their Hydrophobicity and the Disease Pathogenesis. International journal of molecular sciences 2022, 23, 13592. doi: 10.3390/ijms232113592

Disclosure

The authors declared no Conflict of Interest.

Introduction

The impact of underweight and obesity on clinical outcomes for intestinal Behçet’s disease (BD) is unknown. We aimed to identify the association between body mass index (BMI) and clinical outcomes in patients with intestinal BD.

Aims & Methods

We categorized 760 patients with intestinal BD according to the BMI at diagnosis into four groups (underweight, normal, overweight, obese) at Severance Hospital, Seoul, Korea between 1997 and 2021.We performed a Cox proportional hazard analysis to investigate the predictive capability of BMI for clinical outcomes such as biologics use, surgery, hospitalization and emergency room visit.

Results

Of the 760 patients, 130 patients were classified into underweight group (BMI<18.5), 384 patients into normal group (BMI 18.5~22.9), 152 patients into overweight group (BMI 23~24.9), and 94 patients into obese group (BMI≥25). Patients with a higher BMI group showed significantly lower cumulative rates of biologics use (p trend = 0.001), surgery (p trend = 0.008), hospitalization (p trend = 0.002), and emergency room visits (p trend = 0.003) than those with a lower BMI group. In a multivariate analysis, normal BMI group (HR: 0.667, 95% CI 0.483-0.992, p =0.014), overweight group (HR: 0.589, 95% CI 0.394-0.879, p=0.010), and obese group (HR: 0.515, 95% CI 0.321-0.828, p=0.006) were negatively associated with future hospitalization compared to underweight group. Overweight group (HR: 0.490, 95% CI 0.241-0.996, p =0.049) and obese group (HR: 0.312, 95% CI 0.116-0.840, p =0.021) were negatively associated with future biologics use compared to the underweight group. Normal BMI group (HR: 0.706, 95% CI 0.484-1.029, p=0.070) and obese group (HR : 0.556, 95% CI 0.303-1.020, p=0.058) were negatively associated with future surgery compared to the underweight group. Normal BMI group (HR: 0.711, 95% CI 0.513-0.985, p=0.041) and obese group (HR: 0.602, 95% CI 0.376-0.963, p=0.034) were negatively associated with future emergency room visit compared to the underweight group.

Variables		BMI
		<18.5 (n=130) Underweight	18.5~22.9 (n=384) Normal	23~24.9 (n=152) Overweight	≥25 (n=94) Obese	p value for trend
Biologics use	Event	34 (26.2%)	50 (13.1%)	21 (13.8%)	9 (9.6%)	0.001
	Multivariable-adjusteda	Reference	0.619 (0.366-1.047)*	0.490 (0.241-0.966)**	0.312 (0.116-0.840)**
Surgery	Event	45 (34.6%)	87 (22.7%)	35 (23%)	15 (16%)	0.008
	Multivariable-adjusteda	Reference	0.706 (0.484-1.029)*	0.669 (0.411-1.088)	0.556 (0.303-1.020)*
Hospitalization	Event	87 (66.9%)	194 (50.8%)	69 (45.4%)	46 (48.9%)	0.002
	Multivariable-adjusteda	Reference	0.667 (0.483-0.922)**	0.589 (0.394-0.879)**	0.515 (0.321-0.828)**
Emergency room visit	Event	71 (55%)	144 (37.6%)	61 (40.1%)	32 (34%)	0.003
	Multivariable-adjusteda	Reference	0.711 (0.513-0.985)**	0.775 (0.523-1.149)	0.602 (0.376-0.963)**

*p <0.10
**p <0.05
^aMultivariate Cox proportional hazard analysis, including the confounders such as, age, gender, medical aid, smoking, appendectomy history, family history of BD, marriage status, DAIBD score, extraintestinal manifestation, systemic BD, number of ulcers, shape of ulcers, depth of ulcers, type of ulcers, laboratory findings.

Conclusion

Underweight could affect poor outcomes in intestinal Behçet’s disease. Physicians should pay attention to the patients with underweight and make an effort to improve nutritional status.

Introduction

Colonoscopy is highly effective yet inefficient at colorectal cancer (CRC) prevention with a prevalence of target (advanced adenomas) of only about 8%. Thus, finding a modality to risk-stratify for colonoscopy would be of public health implications One approach is to leverage field carcinogenesis, the concept that the gene/environmental interaction that predispose to neoplastic lesions are diffuse and thus rectal mucosa can predict risk of proximal neoplasia (1). Given the diffuse molecular alterations, our group has focused on transcriptional assessment through chromatin nano-architecture. While epigenetics such as methylation, histone acetylation etc will be reflected in chromatin nano-architecture, microRNAs (mIRs) provide an independent impact on gene expression. We, therefore, wanted to test whether chromatin + miR markers from the rectum would predict concomitant adenomas.

Aims & Methods

Chromatin Nano-architecture: We used a novel nanoscale optics technology, partial wave spectroscopic microscopy (PWS) which enables us to go quantify chromatin heterogeneity through pixel-to-pixel variability in refractive indices (2). The calculated marker correlated with fractal dimension (D).
Human Studies: We recruited patients undergoing screening/surveillance colonoscopy with IRB consent. Following colonoscopy 6 biopsies of endoscopically normal rectum. We had 104 controls and 53 advanced adenoma patients for these studies. Advanced adenomas were defined as size >10mm, >25% villous features or high grade dysplasia. Controls were those without adenomas/carcinomas.
miR: We used RT-PCR with internal controls. We used literature to identify 4 candidates miRs and used the delta delta approach to compute fold change of miR expression (case versus control).

Results

We analyzed D from the rectal biopsies with PWS from our clinical dataset and observed excellent diagnostic performance of area under receiver operator characteristic curve (AUC) of = 0.85 for those with and without advanced adenomas sensitivity = 0.74, specificity = 0.83.
The potential of our biomarker is also evaluated via combining with epigenetic regulators microRNAs (miR) in an independent pilot study. Evaluating the 4 oncomiRs in 20 human rectal biopsies (10 control, 10 advanced adenoma) had increased expressions in patients harboring advanced adenomas (fold changes were miR137=3.4, miR92a=5.97, miR-135b-5p=174 and miR361-5p=2.01).
With our PWS marker, the elevation of miR-92a, miR-135b-5p, and D was synergistic for discriminating patients with vs. without advanced adenomas to 0.9 increase in AUC compared to D alone. AUC) = 0.90, sensitivity = 0.88, specificity = 0.85.

Conclusion

We demonstrate, for the first time, that the chromatin nano-architectural parameter, D had excellent performance for identifying patients screen relevant neoplasia elsewhere in the colon. Furthermore, adding several miR markers to provide a more comprehensive epigenetic profile was synergistic diagnostics with D. Future studies will employ more miRs and combine with artificial intelligence to further improve the already strong performance for potential clinical impact.

References

Rebello D, Rebello E, Custodio M, Xu X, Gandhi S, Roy HK. Field carcinogenesis for risk stratification of colorectal cancer. Adv Cancer Res. 2021;151:305-344. doi: 10.1016/bs.acr.2021.03.004. Epub 2021 Mar 31. PMID: 34148616.
Gladstein S, Damania D, Almassalha LM, Smith LT, Gupta V, Subramanian H, Rex DK, Roy HK, Backman V. Correlating colorectal cancer risk with field carcinogenesis progression using partial wave spectroscopic microscopy. Cancer Med. 2018 May;7(5):2109-2120. doi: 10.1002/cam4.1357. Epub 2018 Mar 23. PMID: 29573208; PMCID: PMC5943438.

Disclosure

Hemant Roy, Vadim Backman, and Hariharan Subramanian are co-founders, have equity stakes, own IP and are on the Board of Directors for Nanocytomics LLC, a biomedical company providing cancer risk-stratification tests based on their proprietary biophotonics technology platform, partial wave spectroscopic (PWS) microscopy which is being utilized in this research. Sravya Prabhala is also an employee of Nanocytomics LLC.

Introduction

The estimated global prevalence of biopsy-confirmed celiac disease (CeD) is 0.7% and sero-positive prevalence is 1.4%. Differences in definitions of CeD cases and at-risk populations, as well as underdiagnosis, may affect accurate estimation of the size of the diagnosed CeD population. In this study, we calculated the 10-year prevalence of diagnosed CeD in the USA using different CeD case definitions and at-risk populations.

Aims & Methods

A prevalence analysis of CeD cases was conducted using data collected from the Optum Clinformatics^® Data Mart, a US claims database. Prevalence calculations were based on two different definitions of CeD cases. Case definition 1 included any of the following: 1) International Classification of Diseases (ICD)-9/-10 diagnostic codes for CeD (≥ 1 inpatient or ≥ 2 outpatient codes), 2) tissue transglutaminase immunoglobulin A (tTG-IgA) positive serology or 3) biopsy-confirmed CeD (defined as esophagogastroduodenoscopy [EGD] followed by an ICD diagnostic code for CeD used as proxy). Case definition 2 was defined as the first ever positive tTG-IgA test followed by biopsy-confirmed CeD. The prevalence of diagnosed CeD was estimated for each study year from 2013 to 2022. Prevalence estimations were age- and sex-standardized using 2022 US Census data.

Results

The total population (denominator) comprised ~81 million individuals; of whom, 110,140 had ≥ 1 inpatient or ≥ 2 outpatient diagnostic codes for CeD, 41,184 had ≥ 1 positive tTG-IgA test and 44,641 had biopsy-confirmed CeD. Among all individuals that were tested for tTG2-IgA, 0.85% (95% confidence interval [CI]: 0.82, 0.89) were positive for CeD. The age- and sex-standardized prevalence of diagnosed CeD according to case definition 1 modestly increased from 0.27% (95% CI: 0.27, 0.27) in 2013 to 0.35% (0.34, 0.35) in 2022. Over the same time period, the age- and sex-standardized prevalence of diagnosed CeD according to case definition 2 increased from 0.01% (0.01, 0.01) to 0.03% (0.03, 0.03), respectively.

Conclusion

The overall prevalence of diagnosed CeD in the USA modestly increased from 2013 to 2022. During this same time period, the proportion of patients who underwent an EGD after a positive tTG-IgA test steadily rose. Validation of the CeD case definitions used in this study will be important to enable these results to be replicated or refuted. Furthermore, a standardized and validated CeD case definition will support comparisons between studies and inform better clinical care/disease management.

Disclosure

MA, SM, NC, KG and DAL are employees of Takeda Development Center Americas, Inc. and receive stock or stock options.