Introduction

Clinical remission and mucosal healing have been advocated as treatment goals for patients with ulcerative colitis (UC). Novel molecularly targeted drugs for the treatment of UC have enabled to target not only clinical remission but also endoscopic remission and even histologic remission.
Recently, the usefulness of novel image enhanced endoscopy (IEE) such as texture and color enhancement imaging (TXI) and red dichromatic imaging (RDI) have been reported in endoscopic evaluation of UC. We aimed to verify the usefulness of the novel IEE in prediction of maintenance of clinical remission in UC patients.

Aims & Methods

Patients with UC in clinical remission who underwent colonoscopy with IEE from March 2021 to December 2023 at our hospital were enrolled in this prospective study.
Disease activities in six segments (cecum, ascending colon, transverse colon, descending colon, sigmoid colon, and rectum) were assessed using white-light imaging (WLI), TXI and RDI. Endoscopic evaluation of disease activity using WLI was performed using Mayo endoscopic score (MES) and the Ulcerative Colitis Endoscopic Index of Severity (UCEIS). IEE evaluation was performed using predefined TXI score (0-2: 2 indicates maximum severity) and RDI score (1-4: 4 indicates maximum severity) for UC. MES of ≤1 and UCEIS of ≤1 were defined as endoscopic remission. With IEE, TXI score 0-1 and RDI score 1 were defined as endoscopic remission in accordance with previous reports. We evaluated the correlation of those scores by Spearman’s rank correlation coefficient. Moreover, relationships between endoscopic remission of WLI, TXI and RDI, and maintenance of clinical remission were evaluated by Kaplan-Meier analysis. Relapse was defined as worsening of clinical symptoms that required additional medical therapies for UC.

Results

Total 117 patients with UC were enrolled. Of these, 17 were excluded because adequate images could not be obtained. Therefore, total 100 patients were assessed. The median MES, UCEIS, TXI, and RDI scores were 1 (range 0-3), 1 (range 0-5), 2 (range 1-3) and 2 (range 1-4), respectively. The average follow-up period was 10.1 months, and 8 cases showed clinical relapse during the observation period.
Evaluation of endoscopic images at each colonic site revealed that UCEIS (P<0.001), TXI score (P<0.001), and RDI score (P<0.001) were significantly associated with MES, respectively. In addition, scores at the most inflamed area showed a positive correlation between MES and UCEIS (r=0.91, P<0.001), MES and TXI (r=0.73, P<0.001), and MES and RDI (r=0.77, P<0.001).
In Kaplan-Meier analysis, MES remission (log-rank, P=0.245), UCEIS remission (log-rank, P=0.701), and RDI remission (log-rank, P=0.827) were not significantly associated with subsequent maintenance of clinical remission. On the other hand, TXI remission (log-rank, P=0.045) was significantly associated with subsequent maintenance of clinical remission.

Conclusion

TXI score and RDI score were significantly associated with existing endoscopic score. In particular, TXI remission was significantly associated with subsequent maintenance of clinical remission. Novel IEE may be useful option in prediction of maintenance of remission in UC patients.

Introduction

Patients with gastric intestinal metaplasia (GIM) can be stratified into non-extensive and extensive GIM. In patients with extensive GIM surveillance is recommended based on a higher risk of neoplastic progression. The updated Sydney protocol is the most widely accepted biopsy system to identify extended GIM, and includes, besides biopsies of the corpus and antrum also biopsies of the incisura angularis (IA). However, data on the added value of additional biopsies of the IA in patients with premalignant gastric lesions is scarce. Our aim is to evaluate the yield and added value of the updated Sydney protocol in a low incidence gastric cancer region.

Aims & Methods

This prospective cohort study included patients with GIM who underwent follow-up endoscopies. Biopsies were taken according to the updated Sydney protocol.

Results

In total 177 patients with GIM were included. Median age was 62 (IQR 20) and 55.9% was male. During follow-up seven (4.0%) patients developed gastric neoplasia after a median follow-up of 37 months (IQR 38). At baseline 50 patients were classified as extensive GIM (28.2%), of which only one patient showed neoplastic progression. The other six patients that showed progression were classified as non-extensive GIM. At baseline, angular GIM was found in 97 (54.8%) patients of which six showed neoplastic progression; two patients had GIM in antrum and IA, two patients had GIM in IA and corpus, one patient had GIM in antrum, IA and corpus and in one patient there was GIM in the IA only.

Conclusion

In patients with gastric intestinal metaplasia angular GIM might be a better risk factor for neoplastic progression than the extension of GIM.

Introduction

Per the STRIDE II consensus, mucosal healing and normalization of quality of life are considered long-term treatment goals in ulcerative colitis (UC). Results from Phase 2/3 induction and maintenance trials (U‑ACHIEVE and U‑ACCOMPLISH) showed that patients with moderately to severely active UC treated with upadacitinib (UPA) had significant improvements in these outcomes individually. However, there is a need to understand better the extent to which patients treated with UPA can achieve both treatment goals jointly within one year of maintenance therapy.

Aims & Methods

In the U-ACHIEVE and U-ACCOMPLISH trials, patients with a clinical response after 8-week induction treatment with UPA 45 mg QD were re-randomized 1:1:1 to UPA 15 mg QD, UPA 30 mg QD or placebo (PBO) QD. Long-term treatment goals were determined based on the percentage of patients who achieved the composite endpoint of endoscopic remission (ER), complete symptom resolution (CSR), and Inflammatory Bowel Disease Questionnaire (IBDQ) remission at the end of induction week 8 and maintenance week 52. ER was defined as an endoscopic score of 0; CSR as stool frequency subscore ≤1, rectal bleeding subscore of 0, no bowel urgency, no abdominal pain; and IBDQ remission as IBDQ total score ≥170. The response rate between PBO and UPA was calculated using the Cochran-Mantel-Haenszel test, adjusting for baseline characteristics. The percentage of patients who maintained vs achieved ER+CSR+IBDQ remission during maintenance week 52 was also calculated.

Results

At induction week 8, a significantly greater percentage of patients treated with UPA 45 mg achieved ER+CSR+IBDQ remission vs PBO (6.4% vs 0.9%, respectively, p<0.001, Table). At maintenance week 52, the percentage of induction responders who achieved ER+CSR+IBDQ remission reached 18.3% with UPA 30 mg and 13.1% with UPA 15 mg vs 4.5% with PBO (p<0.001). Of the patients who achieved ER+CSR+IBDQ remission by week 0 of maintenance, 42.1% (8/19), 23.5% (4/17), and 22.2% (4/18) in the UPA 30 mg, UPA 15 mg, and PBO groups, respectively, sustained the composite endpoint at week 52. Among patients who did not achieve this composite endpoint by week 0 of maintenance, 16.2% (35/214), 12.3% (26/208), and 2.9% (6/205) in the UPA 30 mg, UPA 15 mg, and PBO groups, respectively, achieved it at week 52.

Conclusion

Results of this post hoc analysis indicate that the rigorous, long-term treatment goals of ER+CSR+IBDQ remission can be achieved with UPA in some patients with moderately to severely active UC by week 8 of induction. By maintenance week 52, nearly one in five patients treated with UPA 30 mg and approximately one in eight patients treated with UPA 15 mg achieved the stringent target. Sustained maintenance treatment with UPA results in an increasing proportion of patients achieving or maintaining these long-term goals of treatment after only one year.

Disclosure

J Panes received financial support for research from AbbVie and Pfizer; consultancy fees/honorarium from AbbVie, Arena, Athos, Atomwise, Boehringer Ingelheim, Celgene, Celsius, Celltrion, Ferring, Galapagos, Genentech/Roche, GlaxoSmithKline, Janssen, Mirum, Morphic, Nestlé, Origo, Pandion, Pfizer, Progenity, Prometheus, Protagonist, Revolo, Robarts, Sanofi, Takeda, Theravance and Wasserman; reports payment for lectures including service on speaker bureau from Abbott, Ferring, Janssen, Pfizer and Takeda; and reports payment for development of educational presentations from Abbott, Janssen, Pfizer Roche and Takeda.
R Panaccione has received consulting fees, speaker fees, research/educational support from, and/or advisory board member for AbbVie, Abbott, Alimentiv (formerly Robarts), Amgen, Arena, AZ, BI, BMS, Celgene, Celltrion, Cosmos, Eisai, Elan, Ferring, Galapagos, Genentech, Gilead, GSK, Janssen, Lilly, Merck, Mylan, Oppilan, Pandion, Pfizer, Progenity, Protagonist, Roche, Satisfai, Sandoz, Schering-Plough, Shire, Sublimity, Theravance, Takeda, and UCB.
MC Dubinsky has received consultancy fees from AbbVie, Allergan, Amgen, BI, Celgene, Gilead, Janssen, Lilly, Pfizer, Prometheus, Roche, Takeda, and UCB; and is a shareholder of Trellus Health.
Y Ishiguro has received a research grant from Mitsubishi Tanabe Pharmaceutical; speaker/consultation fees from AbbVie, Janssen, Daiichi-Sankyo, Kissei Pharmaceutical and EA Pharma.
J Tran is currently a contractor at AbbVie and a funded PhD candidate at the University of Washington.
D Ilo, J Eccleston, Y Sanchez Gonzalez are full-time employees of AbbVie and may hold AbbVie stock and/or stock options.
B Feagan is a consultant, member of the speakers bureau, and/or member of the scientific advisory board for AbbVie, AbolerIS, AgomAB, Allianthera, Amgen, AMT, AnaptysBio, Arena, Atomwise, Avoro Capital Advisors, Axio, BI, BioJamp, Biora, Boxer, Celgene/BMS, Celsius, Connect BioPharma, Cytoki, Disc Medicine, Duality, EcoR1, Equillium, Ermium, First Wave, First Word Group, Galapagos, Galen Atlantica, Genentech/Roche, Gilead, Gossamer, GSK, Hinge Bio, Hot Spot, Imhotex, Immunic, Index, JAKAcademy, Janssen, Japan Tobacco, Kaleido, Landos, Leadiant, L.E.K. Consulting, Lenczner Slaght, LifeSci Capital, Lilly, Lument AB, Millennium, MiroBio, Morgan Lewis, Morphic, Mylan, OM Pharma, Origo BioPharma, Orphagen, Pandion, Pendopharm, Pfizer, Prometheus, Play to Know AG, Progenity, Protagonist, PTM, Q32 Bio, Rebiotix, REDX, Roche, Sandoz, Sanofi, Seres, Silverback, Surrozen, Takeda, Teva, Thelium, Tigenix, Tillotts, Ventyx, VHSquared, Viatris, Ysios, Ysopia, and Zealand; is a stock shareholder for Gossamer; is an employee of Western University; and is Senior Scientific Director of Alimentiv Inc.