BACKGROUND:Microscopic colitis (MC) is presumably mediated by immune dysregulation, with drug exposure being a substantial risk factor. This study aims to identify contemporary MC-drug associations. METHODS:A pharmacovigilance study of the FDA adverse event reporting system (FAERS) between July 2014 and June 2024. Disproportionate reporting of MC was assessed using reporting odds ratios (RORs), adjusted for age, sex, and concomitant medications. RESULTS:Of 12,109,491 safety reports, 2648 cases of MC were identified and associated with 55 different medications. Several biologic immunosuppressants showed increased MC reporting, including tocilizumab (ROR = 4.93 [95% CI 3.85-6.31]), interleukin-17 inhibitors (ROR = 3.14 [2.47-3.98]), anti-CD20 agents (ROR = 3.03 [2.46-3.74]), and abatacept (ROR = 2.00 [1.44-2.78]). Synthetic immunosuppressants, particularly leflunomide (ROR = 9.89 [7.30-13.39]), methotrexate (ROR = 2.42 [1.63-3.58]), and mycophenolate (ROR = 2.31 [1.41-3.78]), were also implicated. Immune checkpoint inhibitors showed disproportionate MC reporting (ROR = 3.03 [2.49-3.69]), with the strongest associations for ipilimumab and the ipilimumab-nivolumab combination. Traditional MC-related agents (PPIs, SSRIs, NSAIDs) were corroborated. Additional non-immunomodulatory classes (SNRIs, ARBs, ACE inhibitors, statins, and dopaminergic therapies) also emerged. Concomitant exposure to multiple agents increased MC reporting. CONCLUSIONS:This comprehensive pharmacovigilance study mapped drug-MC associations, suggesting potential novel safety signals while corroborating previously reported agents. Immunomodulatory drugs emerged as substantial risk factors. These findings provide practical insights for clinicians managing patients with MC.
Background Mirikizumab, a selective interleukin-23p19 inhibitor, has demonstrated efficacy in randomized controlled trials for moderate-to-severe ulcerative colitis (UC). However, long-term real-world data remain limited, particularly in treatment-experienced populations. Objectives To evaluate the 52-week real-world effectiveness and safety of mirikizumab in a treatment-experienced UC cohort. Design Two-center international retrospective observational cohort study of adults with active UC initiating mirikizumab. Methods This study expands a previously published 12-week real-world cohort from the same centers, adding patients and extending follow-up to 52 weeks. The primary outcome was clinical remission (SCCAI ≤2) at week 52 using non-responder imputation. Secondary outcomes included clinical response, corticosteroid-free remission, and drug persistence at weeks 12, 26, and 52, as well as safety. Results The cohort included 120 patients with prior anti-TNF, vedolizumab, and JAK inhibitor exposure in 75.8%, 75.0%, and 42.5%, respectively. Clinical response rates were 67.5%, 52.3%, and 41.3% at weeks 12, 26, and 52, with corresponding remission rates of 14.2%, 19.8%, and 28.3% (modified NRI: 35.6%). Corticosteroid-free remission at 52 weeks was 26.1%. Drug persistence at 52 weeks was 64.6% (95% CI 54.9–72.7%), without significant differences by prior biologic exposure class. Among 60 patients (50.0%) receiving extended induction, week-26 remission was lower than in standard induction recipients (10.7% vs. 29.1%; p=0.018). Adverse events occurred in 13 patients (10.8%), leading to discontinuation in 5 (4.2%). Conclusion In this large treatment-experienced real-world UC cohort, mirikizumab achieved 52-week clinical remission in 28.3% and drug persistence of 64.6%, with no new safety signals identified, supporting its role across lines of therapy in UC.
Vedolizumab (VDZ) is commonly used as a first-line biologic therapy for moderate to severe ulcerative colitis (UC), but evidence on second-line treatment efficacy following vedolizumab failure is lacking. This study evaluated effectiveness of infliximab and JAK Inhibitors (tofacitinib and upadacitinib) as second-line treatment options after VDZ failure in moderate-severe UC. This multi-center retrospective observational cohort study included all patients with UC who received VDZ as first-line therapy between January 2015 and September 2024, followed by second-line treatment with infliximab, tofacitinib, or upadacitinib were included. The primary outcome was clinical response at week 26. Clinical response and remission were defined as a reduction in Simple Clinical Colitis Activity Index (SCCAI) or partial Mayo score (PMS) of ≥ 3 points, and SCCAI ≤2 or a PMS ≤1, respectively. Secondary outcomes included week 52 response, remission, and drug persistence. We included 89 patients who failed on VDZ as a first-line treatment for UC; 58 patients received second-line infliximab (65.2%) and 31 (34.8%) received second-line JAK inhibitors (26 tofacitinib, 5 upadacitinib). The median duration of VDZ treatment as a first-line therapy was 11 months (IQR 7-21). At week 26, no significant difference was observed between infliximab and JAK inhibitors for clinical response (67% vs. 78%, p = 0.4) and clinical remission (39% vs. 61%, p = 0.1). At week 52, clinical response (73% vs. 77%, p = 1) and clinical remission rates (60% vs. 77%, p = 0.49) were similar between infliximab and JAK inhibitors, respectively. A sensitivity analysis restricted to patients treated with infliximab or tofacitinib demonstrated similar results at week 26 (clinical response 67% vs 71%, p = 0.77 and clinical remission 39% vs 50%, p = 0.45, respectively). Median drug survival at week 52 was 50.9% (95% CI [39.4%-65.7%]) for infliximab and 41.4% (95% CI [26.8%-63.8%]) for JAK inhibitors (p = 0.2). Three patients (3.3%) had an adverse event (2 infliximab, 1 JAK inhibitors) leading to therapy discontinuation. Following first-line VDZ failure in UC patients, infliximab and JAK inhibitors demonstrated comparable efficacy, safety and persistence of treatment. Conflict of interest: Dr. Shohat, Omer: No conflict of interest Weisshof, Roni: No conflict of interest Glusman-Bendersky, Ahinoam: No conflict of interest Ollech, Jacob: No conflict of interest Yanai, Henit: Grant: Pfizer, ISF Personal Fees: AbbVie, Janssen, Pfizer, Takeda, Bristol Myers Squibb, and Elly Lilli. Kopylov, Uri: Grant: Takeda, Janssen,Abbvie, Medtronic, Ely Lilly Other: Takeda, Janssen,Ely Lilly, Roche, Celtrion, Abbvie, Medtronic, CTS, Pfizer, BMS- speaker and advisory fees Levartovsky, Asaf: Honoraria and speaker fees from: Takeda, Sanofi, Rafa
Abstract Background Patients with inflammatory bowel diseases (IBD) face a range of medical and psychosocial challenges . Coping is facilitated by the support of IBD nurse that plays a pivotal role in addressing a large variety of disease related issues and logistical hurdles associated with a long-term disease. Accessibility and easy of contact with an IBD nurse is significant. Text communication is a preferable mode of communication for IBD patients. However, there are scant data about the work-load and the implications of establishing mobile-phone text communication route between patients and IBD nurses. Objective To Characterize volume, time distribution and topics text communications between an IBD nurse and patients treated in IBD unit Methods Text communications were carried out using WhatsApp application. WhatsApp messages between September 2020 and September 2024 were extracted. A series of messages exchanged within a three-day period continuously , was defined as a 'conversation'. Communication that followed a break of more than one day was considered a new 'conversation'. The analysis framework process chat text data that extracted and underwent conversation segmentation based on temporal gaps (>1 days), feature extraction including message types, timestamps and participant roles. The system employed model for conversation classification across six pre defined categories (medical problems, medical instructions, administrative guidance, general administrative, scheduling and other) with severity scoring (1-10) and handling multilingual content (Hebrew, Arabic, English).. Results Between September 2020 –September 2024 (1476 days) a total of 3,927 patients had at least 1 visit to our IBD unit, 1,623 (49.2%) received at least 1 advanced therapy. 2,173 (55.3%) contacted an IBD nurse at least once during the study period. 15,962 conversations were conducted , with 174,814 messages, average of 118 messages per day. Median response time was 1.9minutes (36 sec-19.3min). Most of the conversations occurred in weekdays (92.4%) , in office hours (8am-4pm, 60.5%). Main topics of communication were administrative scheduling , administrative guidance (26.4%, 20.5% respectively), medical – problem 15.8%, medical instruction 12.8%, administrative general 9.9%, other 14.6%. Conversation severity levels were defined as acute (grades 7-10; 2.1%), non-severe(grads 1-3; 50.1%) and intermediate (grades 4-6; 25.6%) Conclusion High volume and efficiency of communication, combined with the nurses' quick response times, contribute to faster treatment and potentially prevent complications. However, their workload might benefit from utilizing AI tools like chatbots for routine tasks, allowing nurses to focus on more complex aspects of care. References Rosso, C.; Aaron, A.A.; Armandi, A.; Caviglia, G.P.; Vernero, M.; Saracco, G.M.; Astegiano, M.; Bugianesi, E.; Ribaldone, D.G. Inflammatory Bowel Disease Nurse—Practical Messages. Nurs. Rep. 2021, 11, 229–241. Chang S, Hamilton M, Lees C, Atreja A. Mobile Health in IBD: Enhancing Care, One Phone at a Time. Inflamm Bowel Dis. 2020 Jan 6;26(2):163-166. doi: 10.1093/ibd/izz262. PMID: 31675058 Bernstein, K.I., Promislow, S., Carr, R., Rawsthorne, P., Walker, J.R., Bernstein, C.N. (2011) Information needs and preferences of recently diagnosed patients with inflammatory bowel disease. Inflamm Bowel Dis 17: 590–598. Sturm, A., & White, L. (Eds.), Inflammatory Bowel Disease Nursing Manual (1 ed., pp. 417-422). Springer Cham.
Abstract Background The Mayo Endoscopic Subscore (MES) is a widely utilized measure for assessing endoscopic disease activity in ulcerative colitis (UC). This assessment has a key role in clinical practice as endoscopic remission is a long-term therapeutic objective. Artificial intelligence has emerged as a promising tool for enhancing diagnostic precision and addressing inter-observer variability among endoscopists. This study aims to evaluate the diagnostic accuracy of ChatGPT-4, a multimodal large language model (LLM), in identifying and grading endoscopic images of UC patients using the MES as a reference standard, without prior configuration or fine-tuning. Methods Real-world endoscopic images of UC patients were obtained for severity assessment and reviewed by an expert consensus board. Each image was classified by severity grade (0-3) based on the MES. Only images that were uniformly graded by the consensus board were subsequently provided to three IBD specialists and ChatGPT-4 in three separate sessions. Severity gradings of the IBD specialists and ChatGPT-4 were compared with assessments made by the expert consensus board. Results Fifty endoscopic images were initially evaluated by the expert consensus board. Of those, 30 images (60%) were graded with complete agreement of MES among the experts. Compared to the consensus board, ChatGPT4’s MES gradings were accurate in 26/30 (86.7%), 21/30 (70%) and 24/30 (80%) with a mean accuracy rate of 78.9%. The IBD specialists gradings were accurate in 24/30 (80%), 24/30 (80%) and 25/30 (83.3%) with a mean accuracy rate of 81.1% (figure 1). There was no statistically significant difference in mean accuracy rates between the two groups (p = 0.71). Conclusion ChatGPT-4 has the potential of assessing mucosal inflammation severity from endoscopic images of UC patients, without prior configuration or fine-tuning. Performance rates were comparable to IBD specialists. Further research and validation are warranted to explore the broader applications of LLMs and their integration into diagnostic workflows.
Background and study aims:The Mayo Endoscopic Subscore (MES) is widely utilized for assessing mucosal activity in ulcerative colitis (UC). Artificial intelligence has emerged as a promising tool for enhancing diagnostic precision and addressing interobserver variability. This study evaluated the diagnostic accuracy of ChatGPT-4, a multimodal large language model, in identifying and grading endoscopic images of UC patients using the MES. Patients and methods:Real-world endoscopic images of UC patients were reviewed by an expert consensus board. Each image was graded based on the MES. Only images that were uniformly graded were subsequently provided to three inflammatory bowel disease (IBD) specialists and ChatGPT-4. Severity gradings of the IBD specialists and ChatGPT-4 were compared with assessments made by the expert consensus board. Results:Thirty of 50 images were graded with complete agreement among the experts. Compared with the consensus board, ChatGPT-4 gradings had a mean accuracy rate of 78.9% whereas the mean accuracy rate for the IBD specialists was 81.1%. Between the two groups, there was no statistically significant difference in mean accuracy rates ( P = 0.71) and a high degree of reliability was found. Conclusions:ChatGPT-4 has the potential to assess mucosal inflammation severity from endoscopic images of UC patients, without prior configuration or fine-tuning. Performance rates were comparable to those of IBD specialists.
Abstract Background JAK inhibitors (JAKi) can induce and maintain remission in inflammatory bowel disease (IBD). Around 5% of IBD patients develop primary sclerosing cholangitis (PSC). Given the potential involvement of JAK/STAT signaling in PSC pathogenesis, JAKi may have a role in modulating IBD-related PSC. We aim to explore the course of PSC in IBD-PSC patients on JAKi for IBD. Methods Following a call-for-cases via ECCO CONFER (Round 10), we retrospectively collected baseline and outcome data for both PSC and IBD, before and after JAKi treatment, including laboratory tests, imaging and endoscopic findings, histopathology and adverse effects. The data were analyzed both descriptively and comparatively. A p-value of less than 0.05 was considered statistically significant. Results We collected data from 58 patients (53 ulcerative colitis), with a median of disease duration of 5.5 (IQR 2-9) years (Table 1). The median age at PSC diagnosis was 26 (18.25-40.5) years. Each patient had been treated with a median of 2.5 different types of drugs before starting JAKi; 57% received tofacitinib, 26% upadacitinib, 17% filgotinib. At the time of data analysis, the median time of JAKi exposure was 32 (15.75-69) weeks and we will refer to that median time of exposure when analysing each data related to JAKi exposure. At baseline, alkaline phosphatase (ALP) was elevated in 71% of patients (median, 292 U/L, 185-471). After JAKi exposure, ALP dropped to a median of 203.5 U/L (138.7-394.5), p=0.0004. Among this specific group, 30% of subjects reached normal ALP values. Gamma-glutamyl transferase (GGT) was elevated in 80% of patients (350 U/L, 164-552) and dropped to a median value of 127 U/L (95-270), p=0.0055; 13% of this specific group reached normal values of GGT after JAKi exposure. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) levels were high in 58% and 50% of patients, respectively; following JAKi exposure, the median value of both went down significantly. After a median time of 32 weeks of JAKi treatment, 39,6% of patients had to change therapy: 23% due to primary non-response, 62% due to lack of response, 15% underwent colectomy. Patients who had to change therapy were divided into: switch group, treated with additional 40 (36-46) weeks with a different JAKi; swap group, swapped to biologic for additional 27 (24-40) weeks. Better control of liver biomarkers was observed in the switch group (Figure 1). Conclusion Treatment with JAKi can positively impact liver inflammation in terms of cholestasis and cytolysis indexes in patients with PSC and concomitant IBD. References Schregel I, Ramos GP, Ioannou S, Culver E, Färkkilä M, Schramm C; International PSC Study Group. Evaluation of Tofacitinib in Primary Sclerosing Cholangitis and Associated Colitis: A Multicenter, Retrospective Study. Clin Gastroenterol Hepatol. 2023;21(13):3448-3450.e3. doi: 10.1016/j.cgh.2023.01.014. Khrom M, Long M, Dube S, Robbins L, Botwin GJ, Yang S, Mengesha E, Li D, Naito T, Bonthala NN, Ha C, Melmed G, Rabizadeh S, Syal G, Vasiliauskas E, Ziring D, Brant SR, Cho J, Duerr RH, Rioux J, Schumm P, Silverberg M, Ananthakrishnan AN, Faubion WA, Jabri B, Lira SA, Newberry RD, Sandler RS, Xavier RJ, Kugathasan S, Hercules D, Targan SR, RB Sartor, Haritunians T, McGovern DPB. Comprehensive association analyses of Extraintestinal Manifestations in Inflammatory Bowel Disease. Gastroenterology. 2024;167(2):315-332. doi: 10.1053/j.gastro.2024.02.026. Dold L, Kalthoff S, Frank L, Zhou T, Esser P, Lutz P, Strassburg CP, Spengler U, Langhans B. STAT Activation in Regulatory CD4 (+) T Cells of Patients with Primary Sclerosis Cholangitis. Immune Inflamm Dis. 2024;12(4):e1248. doi: 10.1002/iid3.1248.
Background The comprehensive evaluation of multimodal large language models (LLMs) in gastroenterological image-analysis remains limited. We aimed to assess the accuracy of the Eosinophilic Esophagitis Endoscopic Reference Score (EREFS) scoring system for Eosinophilic Esophagitis (EoE) across gastroenterology (GI) clinicians with varying levels of experience. Methods Fifty real-world endoscopic images of EoE patients were graded based on the original EREFS score by a gold standard anchor-rater. EREFS gradings of GI specialists, fellows and three multimodal LLMs (ChatGPT-4o, Claude Sonnet 3.5, Perplexity Sonar) were compared with the anchor-rater's scoring. LLMs were provided with both single-shot and few-shot prompting strategies to optimize performance. Results Overall assessment accuracy was significantly higher among GI fellows (72.4 %) compared to specialists (65.3 %, p = 0.004) and LLMs (58.9 %, p < 0.001). In the detection of edema, LLMs outperformed specialists (83.3 % vs 49.3 %, p < 0.001). However, LLMs showed significantly poor performance in rings assessment (30 %) compared to specialists (58 %) and fellows (58.7 %, both p < 0.001). After implementation of few-shot prompting, the overall performance of LLMs was comparable to GI specialists (62.7 % vs 65.3 %, p = 0.3). Conclusions This study uncovers variability in EREFS scoring across human raters with different expertise and multimodal LLMs, and demonstrates that few-shot prompting can optimize LLM accuracy.
Background: Longer cecal withdrawal time has been linked to a higher adenoma detection rate (ADR), with a minimum duration of 6 min recommended. Therefore, we developed the cecal withdrawal vocal timer (CWVT), a novel software tool that is command-activated at cecal intubation and vocally informs the endoscopist of the withdrawal duration every minute. Objectives: Evaluating the efficacy of the CWVT in enhancing adenoma detection. Design: A retrospective, single-center study of screening colonoscopies with adequate preparation and documented cecal intubation. Methods: The primary endpoint was the change in the department’s ADR before (2022) and after the CWVT introduction (January 2023–February 2024). Secondary endpoints included the ADR change between procedures with and without CWVT after its introduction and the ADR change among individual endoscopists. Results: The study included 1098 and 1330 eligible colonoscopies pre- and post-CWVT introduction, respectively. Following CWVT introduction, 67.3% of colonoscopies were performed with activated CWVT, with a median withdrawal time of 8.7 (interquartile range: 6.9–11.8) min. The department ADR was 25.5% following CWVT introduction, without a significant difference compared to the year before (26.2%, p = 0.71). During the post-CWVT implementation period, colonoscopies with activated CWVT had higher ADR than those without (28.4% vs 19.5%, respectively, p < 0.001). The improvement was mainly driven by the detection of adenomas smaller than 10 mm and was consistent across 11 out of 12 months in this period and among most endoscopists. Conclusion: While an overall ADR improvement was not achieved with the CWVT, the ADR was higher in post-CWVT procedures that utilized the CWVT than those that did not, warranting further prospective studies to evaluate CWVT’s contribution to screening colonoscopy performance.
Background:Mirikizumab is a first-in-class IL-23p19 inhibitor, which is approved for the treatment of adults with moderate to severe ulcerative colitis (UC). Objectives:We aimed to assess the effectiveness and safety of mirikizumab in moderate to severe UC in a real-world cohort from two inflammatory bowel disease referral centers. Design:This was a two-center international retrospective observational cohort study. Methods:This study aimed to assess the effectiveness and safety of mirikizumab for 12 weeks of induction. Clinical response and remission were defined as a reduction in the Simple Clinical Colitis Activity Index (SCCAI) of ⩾3 points, and SCCAI ⩽ 2, respectively. The primary outcome was the clinical remission rates after 12 weeks of induction. Results:We included 74 adult patients (58.1% female, 56.8% pan-colitis extent). Most patients (69/74, 93%) were previously exposed to a biological or a small-molecule therapy, and 39 (52.7%) started mirikizumab while on corticosteroids. By the end of induction, 8.1% discontinued therapy due to either lack of efficacy or an adverse event. Overall, clinical response, clinical remission, and corticosteroid-free-remission were 70.3%, 17.6%, and 16%, respectively. Week-12 clinical response and clinical remission rates were comparable between exposed and naïve patients for anti-tumor necrosis factor agents, ustekinumab, vedolizumab, and Janus-kinase inhibitors. Conclusion:Mirikizumab was effective for inducing clinical response and well-tolerated in a substantial cohort of treatment-experienced patients with UC. This positions mirikizumab as a valuable option to the expanding therapeutic armamentarium for UC.
This quality improvement study investigates the association of demographic characteristics with large language model–generated recommendations for simulated gastroenterology clinic cases.
BACKGROUND & AIMS:Microscopic colitis (MC) is a leading cause of chronic diarrhea, particularly in older adults. Although many patients respond to budesonide, refractory and dependent cases pose major therapeutic challenges. Although the off-label use of advanced inflammatory bowel disease therapies is expanding, robust real-world data remain scarce. METHODS:Through the ECCO CONFER network, we conducted a multinational, retrospective study in patients with MC treated with biologics or small molecules following budesonide failure or intolerance. We systematically analyzed clinical outcomes, treatment durability, and predictors of therapeutic success. RESULTS:Among 229 treatment cycles in 142 patients, anti-tumor necrosis factor (TNF) agents were most frequently initiated (55.9%), followed by vedolizumab (28.8%) and Janus kinase (JAK) inhibitors (9.2%). Short-term clinical response and remission rates were highest with JAK inhibitors (95.2% and 81.0%, respectively), significantly outperforming anti-TNFs, vedolizumab, and ustekinumab (P < .01). Long-term drug persistence mirrored these findings: JAK inhibitors demonstrated a markedly lower discontinuation rate (23.8%) compared with other agents (56.3%; odds ratio, 5.07; 95% confidence interval, 1.52-16.9; P = .008). Multivariate analysis confirmed drug class as the only independent predictor of therapy continuation. Despite advanced therapies, 4.2% of patients ultimately required surgical intervention. CONCLUSIONS:This real-world study demonstrates the promising short- and long-term effectiveness of advanced therapies-particularly JAK inhibitors-in budesonide-refractory and budesonide-dependent MC. These findings pave the way for dedicated prospective trials and highlight evolving therapeutic strategies in MC.
OBJECTIVES:The real-world efficacy of computer-aided detection (CADe) in improving surveillance colonoscopy performance for patients with inflammatory bowel disease (IBD) has not been established. METHODS:A retrospective, single-center study of surveillance colonoscopies in patients with IBD. Only colonoscopies indicated for surveillance, with adequate preparation and documented cecal intubation, were included. The study compared the collective adenoma detection rate (ADR) between the periods before (pre-CADe) (June 2020 to June 2021) and after (July 2021 to September 2022) the introduction of the CADe in all endoscopy units. An adjusted ADR was calculated using a multivariable logistic regression model. RESULTS:The study included 225 eligible colonoscopies performed during the pre-CADe period and 750 during the CADe period. Neoplastic lesions or colorectal cancer were detected in 13 (5.8%) of 225 procedures in the pre-CADe period and 27 (3.6%) of 750 procedures during the CADe period. The collective ADR was 5.2% (95% confidence interval, 3.9-6.6) in the pre-CADe period and 3.8% (95% confidence interval, 1.1-6.5) -following CADe implementation (P = .315). Subgroup analyses stratified by endoscopist experience, IBD type, and procedure timing (daytime vs after hours) corroborated a similar nonsignificant declining trend in ADR after CADe introduction. CONCLUSIONS:In a real-world, single-center experience, the introduction of CADe did not improve neoplasms detection in patients with IBD and was associated with a nonsignificant decline in ADR. These findings call into question the utility of generic CADe systems in IBD surveillance and emphasize the need to foster IBD-specific CADe systems, as well as addressing challenges arising from physician-artificial intelligence interactions.
Background: Inflammatory bowel disease (IBD) presents unique challenges in elderly patients due to comorbidities and treatment-related risks. Objectives: This study evaluates ustekinumab (UST) and vedolizumab (VDZ) efficacy and safety in elderly Crohn’s disease (CD) patients. Design: A retrospective cohort study at a tertiary medical center. Methods: CD patients aged ⩾60 years (elderly) treated with UST, compared to non-elderly (<60 years) patients treated with UST and elderly patients treated with VDZ. Clinical response was evaluated using the Harvey–Bradshaw index (HBI) and clinical biomarkers, alongside monitoring steroid use, hospitalization rates, treatment persistence, and surgical interventions. Results: The study included 166 CD patients: 32 elderly and 65 non-elderly patients treated with UST, and 69 elderly patients treated with VDZ. The mean duration of follow-up was 10.8 ± 2.8 months in the non-elderly group, 9.97 ± 3.28 months in the elderly UST group, and 10.0 ± 3.29 months in the VDZ group. Elderly UST patients were more likely to receive corticosteroids at initiation than non-elderly UST patients (44% vs 14%, p = 0.001). At 12 months, clinical response rates did not significantly differ between elderly and non-elderly UST groups, respectively (48% vs 40%, p = 0.5). However, elderly UST patients exhibited higher hospitalization rates over time compared to non-elderly UST patients (6-month: 19% vs 6.2%, p = 0.077; 12-month: 19% vs 4.6%, p = 0.055; log-rank p = 0.004). No significant differences were observed in clinical response and remission rates between elderly UST and elderly VDZ patients at 6 and 12 months. At 6 months, a higher hospitalization rate was observed in the UST group (19% vs 4.3% p = 0.027), but this difference did not persist over time. Conclusion: UST and VDZ are effective and safe treatments for elderly CD patients, despite higher hospitalization rates compared to non-elderly patients, likely due to age-related complications.
Background: Ustekinumab and tofacitinib have recently been approved for the management of moderate to severe ulcerative colitis (UC). However, there is no evidence on how they should be positioned in the therapeutic algorithm. The aim of this study was to compare tofacitinib and ustekinumab as third-line therapies in UC patients in whom anti-TNF and vedolizumab had failed. Methods: This was a multicenter retrospective observational study. The primary outcome was disease progression, defined as the need for steroids, therapy escalation, UC-related hospitalization and/or surgery. Secondary outcomes were clinical remission, normalization of C-reactive protein, endoscopic remission, treatment withdrawal, and adverse events. Results: One-hundred seventeen UC patients were included in the study and followed for a median time of 11.6 months (q(1) -q(3,) 5.5-18.7). Overall, 65% of patients were treated with tofacitinib and 35% with ustekinumab. In the entire study cohort, 63 patients (54%) had disease progression during the follow-up period. Treatment with ustekinumab predicted increased risk of disease progression compared to treatment with tofacitinib in Cox regression analysis (HR: 1.93 [95% CI: 1.06-3.50] p = 0.030). Twenty-eight (68%) patients in the ustekinumab group and 35 (46%) in the tofacitinib group had disease progression over the follow-up period (log-rank test, p < 0.054). No significant differences were observed for the secondary outcomes. Six and 22 adverse events occurred in the ustekinumab and tofacitinib groups, respectively (15% vs. 31%, p = 0.11). Conclusions: Tofacitinib was more efficacious in reducing disease progression than ustekinumab in this cohort of refractory UC patients. However, prospective head-to-head clinical trials are needed as to confirm these data.
Abstract Background Microscopic colitis (MC) is a chronic inflammatory condition of the colon, resulting in an impaired quality of life due to debilitating watery diarrhea. First-line therapy consists of budesonide, though a subset of patients is refractory or becomes budesonide- dependent. Evidence for the efficacy of biologicals or small molecules in MC is sparse and limited to small case series. Hence, we aimed to generate more real-life efficacy data. Methods This retrospective series was collected as part of the CONFER project by ECCO and supported by the European Microscopic Colitis Group (EMCG). Cases of MC patients treated with advanced therapies were included through a standardised collection form. Clinical response was defined as a 50% reduction in stool frequency (SF); clinical remission was defined according to the Hjortswang criteria as < 3 stools/day or < 1 watery stool/day. Results Ninety-nine patients were identified (Table 1), of whom all but one were previously treated with budesonide. Reasons for budesonide discontinuation included primary non-response (PNR, 16.3%), refractory disease (34.7%), budesonide dependency (38.8%), or adverse events (AE, 10.2%). In total, 165 treatment cycles with advanced therapy (47 IFX, 40 ADA, 47 VDZ, 10 UST, 14 JAK inhibitors, 7 other) were reported. First-line advanced therapies included mainly anti-TNF (76.8%) and VDZ (20.2%) (Figure 1A). Patients were exposed to anti-TNF therapy for a median of 1.4 [0.5-3.1] years, with a significant drop in SF after induction (p<0.001), resulting in 50.0% clinical remission (Figure 1B). However, 63.0% ultimately discontinued anti-TNF therapy, mainly due to PNR (37.9%), loss-of-response (LOR, 36.2%) or AE (20.7%). VDZ induced 46.8% clinical remission, reflected in a significant drop in SF (p<0.001). Though, a 59.6% discontinuation rate was observed after a median 0.6 [0.3-1.3] years, mainly due to PNR (63.0%) and LOR (22.2%). Similarly, for UST a 40.0% clinical remission rate was accompanied by 60.0% therapy withdrawal, primarily due to PNR (83.3%). In contrast, JAK inhibition resulted in 78.6% clinical remission, with a substantial drop in SF (p=0.002) and 21.4% discontinuation rate after a median exposure of 0.6 [0.3-1.6] years. Conclusion Almost all advanced therapies are used in budesonide refractory or dependent MC, with anti-TNF agents the most often used first-line options. However, anti-TNF discontinuation is frequent due to lack/loss of efficacy. VDZ and UST could be alternatives, but also have a substantial discontinuation rate. In this retrospective series, the small number (n=14) of JAK inhibitor treated patients had the highest remission rate, suggesting further research on the role of JAK inhibitors in MC.
This study explores the potential of OpenAI's ChatGPT as a decision support tool for acute ulcerative colitis presentations in the setting of an emergency department. We assessed ChatGPT's performance in determining disease severity using TrueLove and Witts criteria and the necessity of hospitalization for patients with ulcerative colitis, comparing results with those of expert gastroenterologists. Of 20 cases, ChatGPT's assessments were found to be 80% consistent with gastroenterologist evaluations and indicated a high degree of reliability. This suggests that ChatGPT could provide as a clinical decision support tool in assessing acute ulcerative colitis, serving as an adjunct to clinical judgment.