PORCSE studygroup: Anneline Cremer (Erasme University Hospital Department of Gastroenterology Brussels Belgium) João A. Cunha Neves (ULS-Algarve Department of Gastroenterology Portimão Portugal) Andreas Kapsoritakis (University Hospital of Larissa IBD unit- Department of Gastroenterology Larissa Greece) Mircea Diculescu (Faculty of Medicine- Carol Davila University of Medicine and Pharmacy- Fundeni Clinical Institute Department of Gastroenterology Bucharest Romania) Lieven Pouillon (Imelda Hospital Bonheiden Department of Gastroenterology and Hepatology Bonheiden Belgium) Ioannis E. Koutroubakis (University Hospital Heraklion Department of Gastroenterology Heraklion- Crete Greece) Laura Nieto (Hospital Clinico Universitario de Santiago de Compostela- Health Research Institute of Santiago de Compostela IDIS Gastroenterology Compostela Spain) Sophie Claeys (AZ Sint-Lucas Department of Gastroenterology Ghent Belgium) Iago Rodríguez-Lago (Hospital Universitario de Galdakao- Biobizkaia Health Research Institute Department of Gastroenterology Galdakao Spain) Pauline Rivière (Bordeaux University Hospitals Department of Gastroenterology Bordeaux France) Serkan Dumanli (Gazi University Department of Gastroenterology Ankara Turkey) Francisco Portela (ULS de Coimbra Department of Gastroenterology Coimbra Portugal) Ian Arnott (Western General Hospital IBD unit Edinburgh United Kingdom) Pinelopi Nikolaou (Venizeleio General Hospital Department of Gastroenterology Heraklion Greece) Joana Revés (Hospital Beatriz Ângelo Division of Gastroenterology- ULS Loures-Odivelas Loures Portugal) Inês Botto (Unidade local de saúde de santa maria- Clinica Universitária de Gastroenterologia- Faculdade de Medicina de Lisboa Servico Gastroenterologia e Hpatologia Lisbon Portugal) Margalida Calafat (Hospital Universitari Germans Trias i Pujol and CIBEREHD Gastroenterology Badalona Spain) The retrospective, multicentric, observational PORCSE study evaluated postoperative recurrence of Crohn’s disease after ileocaecal resection. Early medical prophylaxis (proactive strategy, cohort1) was found to have lower rates of endoscopic (Rutgeerts >i1) and clinical postoperative recurrence compared to expectant management (reactive strategy, cohort2) at first endoscopic evaluation. In this analysis from a subgroup of the PORCSE population, long term outcomes of these 2 strategies are explored. A subgroup analysis was performed in patients with extended follow-up beyond the timeframe of the original PORCSE study (Fig1). Primary endpoints were surgical (sPOR) and clinical (cPOR) recurrence. Endoscopic disease activity and progression were evaluated as secondary endpoints. Progression was defined as an increase in Rutgeerts score (>i1) and/or development of colon inflammation from first to consecutive postoperative endoscopies. Logistic regression models with propensity score matching were fitted to adjust for confounding factors in comparing the proactive and reactive strategy. For 92.2% of the 346 originally included patients, a mean additional follow-up duration of 38.5months (SD24.5) was available (mean total follow-up 110.9months, SD44.8). sPOR and cPOR rate was numerically higher with the reactive strategy. However these differences were not statistically significant (sPOR: cohort1:13.2%, cohort2:18.2%; OR1.78, 95%CI 0.73-4.34, P = 0.202 - cPOR: cohort1: 39.3%, cohort2:49.7%; OR1.73, 95%CI 0.92-3.24, P = 0.089). No difference was found in IBD-related hospitalisation rate (cohort1: 10.8%, cohort2: 10.1%; OR 1.48, 95%CI 0.53-4.18, P = 0.457). Survival analysis did not show a significant difference for time to sPOR (HR1.34, 95% CI 0.59-3.06, P = 0.485) nor in time to cPOR (HR1.28, 95%CI 0.35-4.66, P = 0.713). Rates of endoscopic disease activity (Rutgeerts>i1 and/or colonic inflammation) at consecutive endoscopies after initial postoperative endoscopy did not differ (cohort1:59.2%, cohort2:57.8%, OR0.70, 95%CI 0.31-1.57, P = 0.381). Univariate analysis revealed a higher rate of endoscopic progression with a proactive strategy (cohort1: 20.6%, cohort2: 10.6%, P = 0.041). However, after correction for confounders this difference was no longer significant (OR2.44, 95%CI 0.92-6.48, P = 0.073). In this large subgroup of patients with extended follow-up from the original PORCSE study, proactive medical prophylaxis after ileocaecal resection showed no statistically significant differences compared with a reactive approach in reducing the rate of surgical and clinical posoperative recurrence, despite a numerical trend. Further prospective studies and larger cohorts are required to confirm these findings. References: Geldof, J., Truyens, M., Hanssens, M., Van Gucht, E., Holvoet, T., Elorza, A., Bouillon, V., Barros, S., Martins, V., Argyriou, K., Potamianos, S., Diculescu, M., Stroie, T., Bossuyt, P., Moens, A., Theodoraki, E., Koutroubakis, I. E., Pedro, J., Fernandes, S., … Lobaton, T. (2024). Prophylactic Versus Endoscopy-driven Treatment of Crohn’s Postoperative Recurrence: A Retrospective, Multicentric, European Study [PORCSE Study]. Journal of Crohn’s and Colitis, 18(8), 1202–1214. https://doi.org/10.1093/ecco-jcc/jjae011 Conflict of interest: Dr. Geldof, Jeroen: JG received honoraria as speaker or advisory board member from Galapagos, Viatris, Abbvie, Pfizer, Janssen, Celltrion and Arena Pharmaceuticals. Truyens, Marie: No conflict of interest Van Gucht, Emily: No conflict of interest Argyriou, Konstantinos: No conflict of interest Bouchard, Isaure: No conflict of interest Abrantes, Daniela: No conflict of interest Roseira, Joana Selas: Advisory board fees from Abbvie and Janssen presenter fees from dr. Falk Nicholls, Jack: No conflict of interest. Elorza, Ainara: No conflict of interest Ferreiro Iglesias, Rocio: RF-I has served as a speaker, or has received research or education funding from AbbVie, Takeda, MSD, Pfizer, Janssen, Adacyte, Ferring, Casen Recordati, Palex, Tillotts Pharma, Dr. Falk, Chiesi, Faes Farma, Alphasigma. Eder, Piotr Michał: Travel and educational grants: Takeda, Ferring, Abbvie, Janssen (J & J), Eli Lilly. Lecture and/or consultancy fees: Takeda, Abbvie, Ferring, Janssen (J & J), Eli Lilly, Bristol Myers Squibb, Pfizer, Recordati, Ibsen, Sandoz. Karakan, Tarkan: None Bossuyt, Peter: Grant support for research from AbbVie, EG Consulting fee from AbbVie, Bristol Meyers Squibb, CIRC, Galapagos, Janssen, Jeito capital, Lilly, Pentax, Pfizer, PSI-CRO, Roche, Takeda, Tetrameros Speakers fee from AbbVie, AMC ICP, Amgen, Bristol Myers Squibb, Celltrion, Dr Falk Benelux, EG, Galapagos, Globalport, Lilly, Medtalks, Materia Prima, Pentax, Springer Media Bouillon, Vincent: No conflict of interest Holvoet, Tom: No conflict of interest Peeters, Harald: Disclosures – conflicts of interest Financial support for research: Abbvie, Mylan, Amgen, Sandoz, Takeda Speaker fees: Janssen, Takeda, Abbvie Consultancy fees: Janssen, Fresenius-Kabi, Abbvie, Galapagos Baert, Filip J.: Grants: Abbvie, Amgen, Eurogenerics, J&J, Takeda Lecture fees/Speakers Bureau: AbbVie, Arena Pharmaceuticals, Celltrion, Ferring, Galapagos, J&J, Lilly, Merck Sharp & Dohme, Pfizer, and Takeda Consultancy: AbbVie, Abivax, Amgen, Arena Pharmaceuticals, Celgene, Celltrion, Ferring, Fresenius Kabi, J&J, Merck Sharp & Dohme, Pfizer, Sandoz Desmedt, Valérie: Speakers fee: AbbVie Jauregui-Amezaga, Aranzazu: I declare that I have no personal financial conflicts of interest related to my scientific activities. Any research funding received from Takeda, Johnson & Johnson, and AbbVie has been allocated to the research group to which I belong and has been used exclusively to support institutional or group-based research initiatives, with no personal financial benefit. Van Dyck, Evi: No conflict of interest Stroie, Tudor Gheorghe: No conflict of interest Theodoraki, Eirini: No conflict of interest Casanova, María José: María José Casanova, has received education funding from Pfizer, Takeda, Janssen, MSD, Dr. Falk, Shire, Ferring, Galápagos and Abbvie, and research funding from Lilly. Mañosa Ciria, Miriam: Personal Fees: Abbvie, FAES Pharma, Ferring, Jannsen, MSD, Pfizer, Tillots and Lilly Cristiano, Margarida: No conflict of interest Karmiris, Konstantinos: Personal Fees: Speaker fees from Abbvie, BMS, Eli-Lilly, Genesis, Innovis, Johnson & Johnson, Pfizer and consultancy or advisory board member fees from Abbvie, BMS, Faran, Ferring, Genesis, Johnson & Johnson, Pfizer, Roche and Takeda Fernandes, Samuel Raimundo: None to declare Márquez Mosquera, Lucía: None Mesonero Gismero, Francisco: I ve served as a speaker for and received consulting fees from MSD, AbbVie, Takeda, Janssen, Pfizer, Ferring Pharmaceuticals, Kern Pharma, Dr. Falk Pharma, Galapagos, Lilly, Chiesi Farmaceutici, and Faes Farma. Lobatón Ortega, Triana: No conflict of interest
AIM:This study aimed to evaluate the significance of a stepped nurse-led low anterior resection syndrome (LARS) clinic for patients. METHODS:A Nurse-Led Clinic (NLC) with a stepped intervention approach for patients with LARS was developed and implemented. An exploratory study was conducted in three hospitals to evaluate the nurse-led clinic. Adult rectal cancer patients experiencing LARS who attended the NLC were recruited via maximum variation sampling for semi-structured interviews. Thematic analysis was performed, employing researcher triangulation to enhance reliability. RESULTS:Seventeen participants were interviewed to evaluate the clinic. Participants described five characteristics: (1) presence of the nurse, (2) accessibility, (3) providing recognition, affirmation and understanding, (4) coordinating and (5) timing of the consultation. In addition, participants outlined four principal tasks: (1) providing information, (2) management of symptoms, (3) support and (4) follow-up and continuity of care. CONCLUSION:The NLC offered meaningful support by addressing patients' concerns comprehensively. It normalised the condition, empowered patients with tailored information and provided effective symptom management strategies. REPORTING METHOD:SRQR checklist.
BACKGROUND & AIMS:Upadacitinib (UPA) is an oral, reversible Janus kinase inhibitor approved for the treatment of ulcerative colitis (UC) and Crohn's disease (CD). We assessed the long-term safety of UPA in both inflammatory bowel disease (IBD) entities. METHODS:Safety from 6 UC/CD trials assessed UPA 45 mg (UPA45) once daily (QD) induction, UPA 15 mg and 30 mg (UPA 15/30 QD) maintenance/long-term extension (LTE) doses, and rescue therapy (UPA30 QD). Adverse events (AEs) were reported as events per 100 patient-years (E/100 PY). RESULTS:Overall, 2118 patients received placebo (PBO; n = 725) or UPA45 (n = 1393) induction; 1419 received PBO (n = 468), UPA15 (n = 471), or UPA30 (n = 480) maintenance/LTE. During maintenance/LTE, UPA cumulative exposure was 5149.3 patient-years (n = 1910). Median treatment duration was 8.7 weeks (interquartile range [IQR], 8.0-12.0 weeks) for UPA45 induction; median maintenance/LTE treatment duration was 58.1 weeks (IQR, 30.4-164.0 weeks) for UPA15, and 130.9 weeks (IQR, 39.4-175.1 weeks) for UPA30. AE incidence was comparable between UPA and PBO during induction and maintenance/LTE; AEs leading to study drug discontinuation and serious or severe AEs were lower with UPA. During maintenance/LTE, rates (UPA15/30 vs PBO) of venous thromboembolic events (0.3/0.4 vs 0 E/100 PY), gastrointestinal perforations (0.4/<0.1 vs 0.8 E/100 PY), and AEs leading to death (0.2/<0.1 vs 0 E/100 PY) were low. Herpes zoster, neutropenia, lymphopenia, creatine phosphokinase elevation, hepatic disorder, and COVID-19 were higher across UPA groups vs PBO; COVID-19 and herpes zoster were among the most common AEs during maintenance. CONCLUSIONS:Long-term, UPA was generally well-tolerated. This integrated analysis supports the favorable safety profile of UPA and treatment decisions for patients with IBD. CLINICALTRIALS:gov, Numbers: NCT02819635, NCT03653026, NCT03006068, NCT03345836, NCT03345849, and NCT03345823.
BACKGROUND:Chronic obstructive pulmonary disease (COPD) is characterized by persistent airflow limitation and represents a major global public health burden. Despite optimized guideline-based pharmacological and non-pharmacological management, many patients remain highly symptomatic, largely due to emphysema-related lung hyperinflation. Hyperinflation plays a central role in the pathophysiology of dyspnea and exercise intolerance and is more closely associated with symptom severity and functional impairment than airflow obstruction alone, making it a key therapeutic target in advanced COPD. OBJECTIVES:To provide simplified and context-specific referral criteria for lung volume reduction and lung transplantation (LTx) in Belgian patients with severe COPD and emphysema, with the aim of facilitating timely identification and referral of eligible patients to specialized centers. METHODS:This guidance document was developed by experts of the Belgian Respiratory Society, taking into consideration evidence on lung volume reduction strategies, including lung volume reduction surgery (LVRS) and endoscopic lung volume reduction (ELVR), as well as LTx, and the specific requirements of the Belgian healthcare system, including national reimbursement criteria for ELVR. RESULTS:Lung volume reduction strategies and LTx have demonstrated clinically meaningful improvements in selected patients with severe emphysema. However, access to these interventions remains suboptimal in Belgium, with national registry data indicating substantial under-referral to specialized centers compared with neighboring countries. The proposed recommendations emphasize early referral to prevent irreversible physiological decline, optimize patient selection, facilitate multidisciplinary evaluation, and improve procedural and long-term outcomes. CONCLUSIONS:This standardized, evidence-based referral framework, tailored to the Belgian healthcare system, aims to improve access to advanced interventional therapies for patients with severe COPD and emphysema. Timely referral and appropriate multidisciplinary assessment may ultimately improve functional outcomes, quality of life, and survival in eligible patients.
Importance Anemia is a prevalent condition among patients with traumatic brain injury (TBI); however, the optimal hemoglobin (Hb) threshold to initiate red blood cell transfusion (RBCT) is not well defined. Objective To assess which of 2 different Hb thresholds for guiding RBCT in patients with anemia and TBI is associated with a more favorable neurological outcome. Design, Setting, and Participants This was a preplanned secondary analysis of the Transfusion Strategies in Acute Brain Injured Patients multicentric randomized clinical trial, conducted in 72 intensive care units across 22 countries between September 1, 2017, and December 31, 2022. Follow-up was completed June 30, 2023. Only patients with TBI were included in the present analysis, conducted from February to May 2025. Interventions Liberal (transfusion at Hb <9 g/dL [to convert to g/L, multiply by 10.0]) vs restrictive (transfusion at Hb <7 g/dL) RBCT strategy over a maximum of 28 days. Main Outcome and Measures The primary outcome was the occurrence of unfavorable neurological outcome, defined as a Glasgow Outcome Scale Extended score of 1 to 5 (overall range, 1-8, with higher scores indicating more favorable outcome) at 180 days. In addition, 14 prespecified serious adverse events, including infection and cerebral ischemia, were assessed. Data were analyzed using both the intention-to-treat and per-protocol principles. Results Of 486 patients who presented with TBI (mean [SD] age, 46.8 [17.6] years; 347 [71.4%] male), 475 were included in the primary outcome analysis: 236 were randomized to the liberal transfusion strategy group and 239 to the restrictive transfusion strategy group. Both groups had similar baseline characteristics. In total, 534 RBCTs were administered in the liberal transfusion strategy group, compared with 246 RBCTs in the restrictive group. At 180 days after randomization, 138 patients (58.5%) in the liberal group had unfavorable neurological outcome compared with 161 patients (67.4%) in the restrictive group (relative risk [RR], 0.86 [95% CI, 0.75-1.00]; P = .047; fragility index = 1). There were no significant differences in the occurrence of secondary outcomes (eg, 28-day mortality: 42 of 240 [17.5%] vs 51 of 244 [20.9%]; RR, 0.84 [95% CI, 0.58-1.21]; P = .34) or serious adverse events (eg, RR, 1.13 [95% CI, 0.88-1.43]; P = .34 for infection and RR, 0.87 [95% CI, 0.40-1.90]; P = .72 for cerebral ischemia). After adjustment for several confounders, being randomized to the liberal group was associated with a lower observed probability of unfavorable neurological outcome (odds ratio, 0.60 [95% CI, 0.38-0.94]; P = .03). Conclusions and Relevance In this secondary analysis of a multicenter randomized clinical trial, a liberal RBCT strategy was associated with a lower risk than a restrictive RBCT strategy of unfavorable neurological outcome at 180 days among patients with TBI. These findings should be interpreted with caution in light of the inherent uncertainty of the estimate. Trial Registration ClinicalTrials.gov Identifier: NCT02968654
