Introduction

Phase III trials have demonstrated the efficacy of risankizumab (RZB), this being the first humanized monoclonal IgG1 antibody which targets the interleukin 23 p19 subunit, in moderate-to-severe Crohn's disease (CD). However, real-world data with this drug is limited.

Aims & Methods

The aim of our study was to assess the real-world effectiveness of RZB in patients with CD.
Adult CD patients that had received treatment with RZB in the ENEIDA registry —a large prospectively maintained Spanish database promoted by the Spanish Working Group of Crohn’s and Colitis (GETECCU)— were included. Clinical and demographical data including number of previous biologics and advanced therapies were included. The primary endpoints were steroid-free clinical remission after induction period (Harvey-Bradshaw [HB] score <5) and long-term steroid free clinical remission at the end of follow-up. Influence of previous use of ustekinumab (UST) and number of previous advanced therapies in short- and long-term efficacy was also evaluated. Statistical analysis was performed using the Chi-square and the Student-t test as appropriate, and multivariate analysis was performed with logistic regression.

Results

857 CD patients (60% male) were included: median age was 50 (18-84) years, median disease duration 14 years, 27% smokers. 50% were L1, 8% L2, 38% L3, and 4% exclusively L4. B1 phenotype was present in 42%, 37% B2, 21% B3. Perianal disease was present in 28%, 46% had previously undergone CD-related surgery and 39% had extraintestinal manifestations. Only 3% were biological naïve, 50% had been exposed to 1-2 advanced therapies, and 47% to 3 or more biologics or JAK inhibitors. Following induction 56% of the patients achieved steroid-free clinical remission. Remission was more frequent in patients who had not previously been treated with UST (64% vs. 53% in those previously exposed to UST, p<0.01). In the multivariate analysis, a higher number of prior advanced therapies was associated with lower remission rates (p<0.01). Long-term efficacy was evaluated in 652 patients (median follow-up 7 months). At the end of the follow-up 61.2% of patients maintained steroid-free clinical remission. Long-term remission rate in patients non-exposed to UST was 72%, and 55% in patients previously exposed to UST (p<0.01). In the multivariate analysis, younger age was associated with higher long-term remission rates (p<0.01). Eleven percent of patients needed dose optimization or reinduction during follow-up. 68 patients (7.9%) presented adverse events but only 18 (2%) needed to give up the treatment.

Conclusion

This study represents the largest cohort of real-world data on RZB in CD, including highly refractory patients with multiple prior drug failures. RZB induced steroid-free clinical remission in 56% of patients after induction and 61% in the long term. Higher remission rates were observed in patients who had never been exposed to UST. Younger age and fewer previous advanced therapies were associated with better outcomes.

Disclosure

Manuel Barreiro: Speaker, consultant and advisory member for or have received research funding from AbbVie, Janssen, Takeda, Pfizer, Lilly, Alphasigma, Sandoz and Oncostellae

Introduction

Gastric cancer ranks as the fifth most common cancer and the second leading cause of cancer-related deaths. Multifocal atrophic gastritis and gastric intestinal metaplasia (GIM) often coexist and are both associated with the risk of developing gastric cancer, with GIM being the first irreversible mucosal transformation to cancer. Endoscopic surveillance was associated with earlier cancer detection and improved survival. This study aims to evaluate the prevalence, epidemiological characteristics, and clinical features of patients with GIM.

Aims & Methods

This is a single-center, retrospective study from January 1, 2022 to December 31, 2023. Including patients aged ≥18 years who underwent esophagogastroduodenoscopy (EGD) with gastric biopsies confirming GIM, All identified cases of GIM were reviewed by gastrointestinal pathologists to confirm the diagnosis. Th primary outcome was to assess the prevalence, epidemiological characteristic, and clinical features of GIM. The secondary outcome was to evaluate adherence to recommended surveillance protocols for GIM.

Results

Among 3,663 patients who underwent EGD, GIM was identified in (4.17%, n=153). The mean age of patients with GIM was 60 years, Males represented more than half of patients (54.2%), the majority were classified as overweight (Body mass index (BMI) 25–29.9; 64%, n=97) or obese (BMI ≥30; 24.3%, n=37).Smoking was reported in (17.6%, n=27), while (5.2%, n=8) reported alcohol consumption. Moreover, (7.2%, n=11) had a history of prior gastric surgeries. Dyspepsia (33.3%) was the most common indication for EGD. Gastritis was the predominant endoscopic finding and the primary reason for performing gastric biopsies (73%, n=112 ).The most common GIM subtype was complete (52%), followed by incomplete (37%) and mixed (11%). In terms of GIM location, extensive GIM was observed in (28.7%), localized GIM in (17.6%), while the location remained unknown in (53.6%) due to the lack of a follow-up EGD for mapping. Coexisting autoimmune atrophic gastritis was observed in (12.4%, n=19), Helicobacter pylori infection was detected in (16.3%, n=25). Furthermore, Dysplasia was identified in (2.6%, n=4), with low-grade dysplasia and high-grade dysplasia each accounting for (1.3%, n=2) (Table 1). Three patients developed.gastric cancer (2%) , while (4.6%, n=7) were found to have neuroendocrine tumors (NET). First degree family history of gastric cancer was reported in (12.4%, n=19).

Conclusion

This study highlights a 4.17% prevalence of GIM among patients who underwent EGD. High BMI and male sex were observed in more than half of the patients. Dysplasia was detected in 2.6%, gastric cancer in 2%, and NET in 4.6% of cases. Many patients lacked follow-up EGD surveillance, limiting effective monitoring. Larger studies with extended follow-up are required to further investigate these associations and their clinical implications.