Effectiveness, safety, and cost of combination advanced therapies in inflammatory bowel disease.

BACKGROUND: A significant proportion of inflammatory bowel disease (IBD) patients fail to respond to advanced therapies. Combining advanced therapies may improve treatment outcome. This study aimed to assess the effectiveness, adverse events, and costs associated with combining advanced therapies in IBD patients. METHODS: Combination advanced therapy was defined as the concurrent use of two biological agents or one biological agent with a small molecule therapy. Clinical data, including disease characteristics, treatment regimens, and adverse events, were collected from electronic patient records. Clinical response rates, biochemical markers, and treatment costs were evaluated. RESULTS: The study included 109 IBD patients receiving combination advanced therapies from 9 academic centers in Ireland. Corticosteroid-free clinical response rates at 12 weeks and 52 weeks were 39 % and 38 %, respectively. Adverse events occurred in 26 % of therapeutic trials, with disease-related events being the most common. Notably, there were 3 cases of non-melanomatous skin cancer and 10 infectious complications. The annual cost of maintenance therapy for combination advanced therapies ranged from €17,560 to €30,724 per patient. CONCLUSION: Combination advanced therapies demonstrated effectiveness and acceptable safety profiles in a cohort of treatment-refractory IBD patients. Further large, prospective trials are required to definitively evaluate the role of combination advanced therapies in IBD.

The second Irish Helicobacter pylori Working Group consensus for the diagnosis and treatment of Helicobacter pylori infection in adult patients in Ireland.

BACKGROUND: There has been an increase in resistance to many of the antimicrobials used to treat Helicobacter pylori ( H. pylori ) nationally and internationally. Primary clarithromycin resistance and dual clarithromycin and metronidazole resistance are high in Ireland. These trends call for an evaluation of best-practice management strategies. OBJECTIVE: The objective of this study was to revise the recommendations for the management of H. pylori infection in adult patients in the Irish healthcare setting. METHODS: The Irish H. pylori working group (IHPWG) was established in 2016 and reconvened in 2023 to evaluate the most up-to-date literature on H. pylori diagnosis, eradication rates and antimicrobial resistance. The 'GRADE' approach was then used to rate the quality of available evidence and grade the resulting recommendations. RESULTS: The Irish H. pylori working group agreed on 14 consensus statements. Key recommendations include (1) routine antimicrobial susceptibility testing to guide therapy is no longer recommended other than for clarithromycin susceptibility testing for first-line treatment (statements 6 and 9), (2) clarithromycin triple therapy should only be prescribed as first-line therapy in cases where clarithromycin susceptibility has been confirmed (statement 9), (3) bismuth quadruple therapy (proton pump inhibitor, bismuth, metronidazole, tetracycline) is the recommended first-line therapy if clarithromycin resistance is unknown or confirmed (statement 10), (4) bismuth quadruple therapy with a proton pump inhibitor, levofloxacin and amoxicillin is the recommended second-line treatment (statement 11) and (5) rifabutin amoxicillin triple therapy is the recommend rescue therapy (statement 12). CONCLUSION: These recommendations are intended to provide the most relevant current best-practice guidelines for the management of H. pylori infection in adults in Ireland.

Helicobacter pylori: High dose amoxicillin does not improve primary or secondary eradication rates in an Irish cohort.

BACKGROUND: Helicobacter pylori (H. pylori) eradication rates have fallen globally, likely in large part due to increasing antibiotic resistance to traditional therapy. In areas of high clarithromycin and metronidazole resistance such as ours, Maastricht VI guidelines suggest high dose amoxicillin dual therapy (HDADT) can be considered, subject to evidence for local efficacy. In this study we assess efficacy of HDADT therapy for H. pylori eradication in an Irish cohort. AIM: To assess the efficacy of HDADT therapy for H. pylori eradication in an Irish cohort as both first line, and subsequent therapy for patients diagnosed with H. pylori. METHODS: All patients testing positive for H. pylori in a tertiary centre were treated prospectively with HDADT (amoxicillin 1 g tid and esomeprazole 40 mg bid × 14 d) over a period of 8 months. Eradication was confirmed with Urea Breath Test at least 4 wk after cessation of therapy. A delta-over-baseline > 4% was considered positive. Patient demographics and treatment outcomes were recorded, analysed and controlled for basic demographics and prior H. pylori treatment. RESULTS: One hundred and ninety-eight patients were identified with H. pylori infection, 10 patients were excluded due to penicillin allergy and 38 patients refused follow up testing. In all 139 were included in the analysis, 55% (n = 76) were female, mean age was 46.6 years. Overall, 93 (67%) of patients were treatment-naïve and 46 (33%) had received at least one previous course of treatment. The groups were statistically similar. Self-reported compliance with HDADT was 97%, mild side-effects occurred in 7%. There were no serious adverse drug reactions. Overall the eradication rate for our cohort was 56% (78/139). Eradication rates were worse for those with previous treatment [43% (20/46) vs 62% (58/93), P = 0.0458, odds ratio = 2.15]. Age and Gender had no effect on eradication status. CONCLUSION: Overall eradication rates with HDADT were disappointing. Despite being a simple and possibly better tolerated regime, these results do not support its routine use in a high dual resistance country. Further investigation of other regimens to achieve the > 90% eradication target is needed.

Cloud technology and capsule endoscopy: A single-center users' experience of remote online video analysis and reporting.

Background and study aims Telemedicine has progressed significantly in recent years, with newer, more integrated information technology systems improving healthcare delivery. The development of the world's first cloud-based capsule platform could allow safe and timely virtual analysis of videos from a network of linked hospital centers. We aimed to assess the efficacy of Medtronic's PillCam Remote Reader System. Methods PillCam remote reader technical data were collected from the capsule endoscopy (CE) database over 8 months. User-reported performance was collect using an online survey. Outcomes included overall procedure success, video-upload/report-download rates and speeds, encryption/decryption rates, and user/reader satisfaction. Results Data from 377 studies encompassing seven different readers was collected (318 small bowel capsules, 59 colon capsules). Overall procedure success was 100% (all videos reported). Two upload delays occurred (< 24 hours). There were no encryption/decryption errors. Seven of seven respondents felt it easy to access and use vs one of seve for the old system. Six of seven respondents felt department efficiency increased. Benefits included off-site reading and multisite-conferences. Issues included offsite difficulty accessing other hospital systems. Conclusions PillCam remote reader is a reliable, secure, and effective capsule analysis platform and should be incorporated into any CE service development plan.

Low Colon Capsule Endoscopy (CCE) False Negative Rate for Polyps Excluding Reader Error.

BACKGROUND: CCE is a diagnostic tool lacking clinical data on false negative rates. We aimed to assess this rate and the reader/technical error breakdown. METHODS: False negative CCEs were identified after comparing to a colonoscopy database. Missed pathology characteristics and study indications/quality were collated. Cases were re-read by experts and newly identified lesions/pathologies were verified by an expert panel and categorised as reader/technical errors. RESULTS: Of 532 CCEs, 203 had an adequately reported comparative colonoscopy, 45 (22.2%) had missed polyps, and 26/45 (57.8%) reached the colonic section with missed pathology. Of the cases, 22 (84.6%) had adequate bowel preparation. Indications included 13 (50%) polyp surveillance, 12 (46%) GI symptoms, 1 (4%) polyp screening. CCE missed 18 (69.2%) diminutive polyps and 8 (30.8%) polyps ≥ 6 mm, 18/26 (69.2%) of these were adenomas. Excluding incomplete CCE correlates, colonoscopy total and significant polyp yield were 97/184 (52.7%) and 50/97 (51.5%), respectively. CCE total polyp and significant polyp false negative rate was 26.8% (26/97) and 16% (8/50), respectively. Following re-reading, reader and technical error was 20/26 (76.9%) and 6/26 (23.1%). Total and significant missed polyp rates were 20.6% (20/97) and 14% (7/50) for reader error, 6.2% (6/97) and 2% (1/50) for technical error. CONCLUSIONS: False negative CCE rate is not insubstantial and should be factored into clinical decision making.