Search Results (1,700)

Background/Objectives: Sacituzumab govitecan (SG) is an antibody–drug conjugate targeting Trop-2 that has demonstrated clinical benefits in randomised trials for patients with metastatic triple-negative breast cancer (mTNBC) and metastatic hormone receptor-positive/HER2-negative (HR+/HER2− mBC) disease. However, real-world data on its effectiveness and safety are limited, especially in patients with poor performance status or central nervous system (CNS) involvement. This study aimed to evaluate the real-world outcomes of SG in these two subtypes. Methods: We conducted a retrospective, multicentre, observational study across three tertiary hospitals in Spain. Patients with mTNBC or HR+/HER2− mBC treated with SG between June 2022 and March 2025 were included. Clinical data, treatment history, adverse events (AEs), and survival outcomes were also recorded. The median progression-free survival (mPFS) and median overall survival (mOS) were estimated using Kaplan–Meier analysis. Univariate and multivariate analyses were performed to identify the factors influencing outcomes. The association between granulocyte colony-stimulating factor (G-CSF) prophylaxis and neutropenia was assessed using Fisher’s exact test. Results: A total of 56 patients were included in this study (33 with mTNBC and 23 with HR+/HER2− mBC). In the mTNBC group, mPFS was 4.0 months (95% CI: 1.94–5.98) and mOS was 11.0 months (95% CI: 4.80–17.12). In the HR+/HER2− mBC group, mPFS was 3.7 months (95% CI: 2.02–5.44) and mOS was 20.2 months (95% CI: 3.9–36.5). Fatigue, neutropenia, and gastrointestinal toxicity were the most common AEs. Primary G-CSF prophylaxis was not associated with a reduced incidence of neutropenia (p = 0.434). Conclusions: In routine practice, SG shows effectiveness comparable to that of randomised trials across both subtypes, with a safety profile consistent with pivotal studies. The observed toxicity profile was consistent with that described in pivotal clinical trials and other studies. The prophylactic use of G-CSF was not associated with an impact on the occurrence of neutropenia, but the incidence of neutropenia was lower than that in clinical trials and other studies that did not administer G-CSF prophylactically. Full article

Skin cancer is the most common cancer form worldwide, and it is primarily divided into melanoma and non-melanoma types, with non-melanoma being the most prevalent condition. Cutaneous squamous cell carcinoma (cSCC) accounts for 50% of primary skin cancers and is characterized by uncontrolled keratinocyte proliferation. cSCC’s current standard treatment is surgical resection and chemotherapy. Unfortunately, these methods often lead to disfigurement, functional morbiditly, and compromised function. In contrast to immunotherapy, emerging scenarios have shown promising results, especially in neoadjuvant settings. Cemiplimab (Libtayo^®; Regeneron, Tarrytown, NY, USA), a PD-1 monoclonal antibody, has shown efficacy in treating advanced or metastatic cSCC, and its use as a neoadjuvant therapy has been recently explored. This review aims to evaluate Cemiplimab in the neoadjuvant setting for cSCC treatment. The Methodology followed PRISMA guidelines, this review analyzed studies on Cemiplimab as a neoadjuvant therapy for cSCC that were sourced from PubMed, Web of Science, and Scopus. Only controlled trials, cohort studies, case series, and systematic reviews were included. From 341 records, 21 studies were included, and six clinical trials provided key data about neoadjuvant Cemiplimab’s response rates, efficacy, adverse effects, and safety considerations. The targeted data revealed a neoadjuvant Cemiplimab mean pathologic response rate of 72%, with a 62% objective response rate. Treatment-related adverse events (TRAEs) affect 66% of patients, though most cases are not severe. The most common include fatigue, maculopapular rash, and diarrhea. The studies showed high rates of complete pathological responses (cPRs) and major pathological responses (mPRs), suggesting a strong therapeutic potential. Neoadjuvant Cemiplimab for cSCC therapy shows high response rates, low recurrence, improved survival, and manageable side effects. The current literature indicates that Cemiplimab may also be effective when used in immunosuppressed patients. Despite more research still being needed to confirm its long-term benefits and the effects of the drug’s use outside of clinical trials, there is strong evidence to consider neoadjuvant Cemiplimab as a promising and efficient treatment. Full article

Objectives: Silodosin, a selective α1A-adrenoceptor antagonist, is used to treat lower urinary tract symptoms (LUTS) associated with benign prostatic hyperplasia (BPH). Genetic polymorphisms in drug-metabolizing enzymes and transporters may contribute to interindividual variability in its efficacy and safety. This study aimed to investigate the influence of CYP3A4, CYP3A5, UGT2B7, and ABCB1 polymorphisms on silodosin pharmacokinetics, efficacy, and safety in Russian patients with BPH. Methods: A prospective observational study included 103 Russian male patients with moderate-to-severe LUTS (IPSS > 8) due to BPH, treated with silodosin (8 mg daily) for 8 weeks. Genotyping for CYP3A4*1B, CYP3A4*22, CYP3A5*3, UGT2B7 (rs73823859, rs7439366, and rs7668282), and ABCB1 (rs4148738, rs1045642, rs2032582, and rs1128503) was performed using real-time PCR. The silodosin minimum steady-state plasma concentration (Css min) was measured via HPLC-MS. Efficacy was evaluated by the International Prostate Symptom Score (IPSS), quality of life scale, maximum urinary flow rate (Qmax), residual urine volume (RUV), and prostate volume at the baseline and week 8. Adverse drug reactions (ADRs) were recorded. Results: CYP3A4*22 CT carriers (n = 6) exhibited higher Css min (17.59 ± 2.98 vs. 9.0 ± 10.47 ng/mL, p = 0.049) but less absolute IPSS improvement (p < 0.05), likely due to higher baseline symptom severity. However, the change in IPSS (ΔIPSS_1–4) from the baseline to week 8 did not differ significantly (−5.78 ± 5.29 vs. −6.0 ± 4.54, p = 0.939). CYP3A5*3 GG homozygotes (n = 96) showed greater ΔIPSS_1–4 improvement (−6.25 ± 4.60 vs. 0.0 ± 9.53, p = 0.042) and a lower IPSS at day 28 (7.64 ± 4.50 vs. 20.0 ± 6.55, p < 0.001). UGT2B7 rs7439366 TT carriers (n = 34) had an improved Qmax (ΔQmax_1–4 5.4 vs. 3.3 and 2.0 mL/s for CC and CT, p = 0.041). ABCB1 1236C>T TT homozygotes (n = 25) showed a trend toward reduced RUV (p = 0.053). No polymorphisms were associated with adverse drug reactions (15 events in 42 patients, 35.7%). Conclusions: Genetic polymorphisms CYP3A4*22, CYP3A5*3, and UGT2B7 rs7439366 may modulate silodosin pharmacokinetics and efficacy parameters in BPH patients but not safety. Larger-scale studies are warranted to validate these initial findings. Full article

Background/Objectives: Monoclonal antibodies targeting the PD-1/PD-L1 immune checkpoint have achieved clinical success but face drawbacks such as poor oral bioavailability, limited tumor penetration, and immune-related adverse events. Small-molecule inhibitors present a promising alternative that may overcome these challenges. Methods: Here, an integrated computational framework combining ligand-based pharmacophore modeling and structure-based molecular docking was utilized to screen a comprehensive library consisting of traditional Chinese medicine-derived compounds and clinically approved drugs. The binding affinity between identified candidate compounds and PD-L1 was quantitatively assessed using bio-layer interferometry (BLI). In vitro cytotoxicity assays were conducted on A549 human lung carcinoma and LLC mouse lung carcinoma cell lines. In vivo antitumor efficacy was evaluated in LLC tumor-bearing mice through measurement of tumor growth inhibition, serum cytokine levels (IFN-γ and IL-4) by ELISA, and expression levels of IFN-γ and granzyme B (GZMB) within tumor tissues via immunohistochemistry. Results: In vitro, anidulafungin exhibited anti-tumor effects against both human lung cancer A549 cells and mouse Lewis lung carcinoma (LLC) tumor cells, with IC₅₀ values of 170.6 µg/mL and 160.9 µg/mL, respectively. The BLI analysis revealed a dissociation constant (K_D) of 76.9 μM, indicating a high affinity of anidulafungin for PD-L1. In vivo, anidulafungin significantly increased serum levels of IFN-γ and IL-4 in tumor-bearing mice and elevated expression of IFN-γ and granzyme B (GZMB) in tumor tissues, confirming its immune-mediated anti-tumor effects. Conclusions: Anidulafungin represents a promising small-molecule PD-L1 inhibitor, demonstrating significant anti-tumor potential via immune activation and highlighting the feasibility of repurposing approved drugs for cancer immunotherapy. Full article

Background and Objectives: AIDS-related mortality has significantly decreased due to antiretroviral therapy (ART), leading to a substantial increase in average lifespan. Consequently, cardiovascular diseases have become a growing concern among people living with HIV (PLWH). This study aimed to assess the cardiovascular risk profile of people living with HIV receiving ART and to explore the association between traditional and HIV-related factors with increased cardiovascular risk. Materials and Methods: We conducted a case study involving 112 PLWH receiving ART at a specialized clinic in southeastern Romania to estimate cardiovascular risk (CVR) using the Data Collection on Adverse Events of Anti-HIV Drugs (D:A:D^®) score. For participants aged 40 and above, the SCORE2 algorithm was additionally applied. Results: Most participants were male and under 40 years of age, including 34 individuals from Romania’s distinct pediatric HIV cohort. We observed a substantial cardiovascular risk burden: abdominal obesity was present in 24.1% of participants, active smoking was reported by 55.4%, and over 70% had low physical activity levels. Among participants aged 40 and above, the D:A:D^® and SCORE2 scores were strongly correlated, with an average cardiovascular age exceeding chronological age by a mean of 7.5 years. Although CVR remained similarly low among subgroups of PLWH under 40, the prevalence of metabolic syndrome was higher in patients from the pediatric cohort compared to those diagnosed later. Traditional risk factors—such as age, obesity, hypertension, dyslipidemia, smoking, and alcohol use—as well as elevated C-reactive protein levels, were significantly associated with increased CVR. Conclusions: Residual inflammation in PLWH, despite complete viral suppression in combination with metabolic syndrome, is associated with increased cardiovascular risk even in younger and clinically stable populations. Routine integration of metabolic and cardiovascular risk screening into HIV care may support timely prevention and personalized management strategies starting at an early age. Full article

Background/Objectives: Nonsteroidal anti-inflammatory drugs (NSAIDs) are commonly associated with gastrointestinal (GI) adverse events. This study aimed to assess the incidence and patterns of NSAID-induced GI disorders using the FDA Adverse Event Reporting System (FAERS) database and to compare the risks among different NSAIDs. Methods: NSAID-related reports were extracted from FAERS, focusing on 21 ulcer-related GI events with ≥1000 reports each, based on MedDRA v26.0. The number of reports, reporting odds ratios, and p-values were calculated and visualized using a volcano plot. Principal component analysis(PCA) was carried out to reduce the dimensionality of the dataset and revealed under-lying patterns in the data.PCA was performed to identify patterns related to risk, severity, and injury site, whereas hierarchical clustering was used to group NSAIDs based on these patterns. Hierarchical cluster analysis is a method of grouping similar data to generate a classification. Results: Statistically significant signals were identified for 19 of the 21 GI-related adverse events, including the serious condition of perforation. PCA revealed that the first component represented risk, the second severity, and the third the site of injury (upper vs. lower GI tract). Cyclooxygenase-2 (COX-2) selective NSAIDs (e.g., celecoxib, rofecoxib) were associated with a lower incidence but greater severity, primarily in the upper GI tract. Conversely, nonselective NSAIDs (e.g., acetylsalicylic acid, lornoxicam) showed higher incidence rates, though the events were generally milder. In our dataset, acetylsalicylic acid had the highest incidence, whereas meloxicam showed the highest severity. Clustering analysis revealed three distinct NSAID groups with differing patterns in risk, severity, and affected GI site. Mild adverse events may be underreported in FAERS. Dosage-related effects were not assessed in this study. Conclusions: NSAIDs differ significantly in their gastrointestinal adverse event profiles, attributable to COX selectivity. When selecting an NSAID, both the likelihood and the nature of potential GI harm should be considered. Full article

Background/Objectives: Envarsus is a novel prolonged-release formulation of tacrolimus with enhanced bioavailability. The summary of product characteristics recommends an initial dose of 0.17 mg/kg/day for the prophylaxis of rejection in kidney transplant recipients, which may be excessive. This study aimed to compare the pharmacokinetics of four different initial doses of Envarsus: 0.15 mg/kg/day (group 1), 0.12 mg/kg/day (group 2), 0.10 mg/kg/day (group 3), and 0.08 mg/kg/day (group 4). Induction therapy included thymoglobulin, sirolimus, and prednisone, with Envarsus initiated once serum creatinine levels fell below 3 mg/dL. Methods: A comprehensive pharmacokinetic sampling strategy was implemented between 48 and 72 h post-transplant, allowing for the calculation of AUC using the trapezoidal method. Additionally, trough levels at 72 h were assessed, with the therapeutic range defined as 5–8 ng/mL. Patients with trough concentrations above 8 ng/mL either had their tacrolimus dose reduced or their treatment temporarily discontinued for 24 h. Kidney function was evaluated three months post-transplant. Results: A total of 167 patients completed the study (39 in group 1, 43 in group 2, 42 in group 3, and 43 in group 4). The groups were balanced in baseline characteristics. Compared with groups 1 and 2, groups 3 and 4 had significantly lower mean trough concentrations (7.9 ng/mL and 6.5 ng/mL vs. 11.3 ng/mL and 10.8 ng/mL, respectively) and lower AUC values (310 ng·h/mL and 271 ng·h/mL vs. 458 ng·h/mL and 390 ng·h/mL, respectively). Additionally, the proportion of patients with supratherapeutic drug levels was lower in groups 3 and 4 (47.6% and 37.2% vs. 76.9% and 67.4%, respectively), as was the proportion of patients requiring a skipped dose (14.3% and 14.0% vs. 30.8% and 27.9%, respectively). Importantly, the percentage of patients within the therapeutic range was higher in the 0.08 mg/kg/day group (41.9%), demonstrating improved drug level stability at this dose. Despite these differences, kidney function remained similar in all groups at three months, and no significant differences in the incidence of adverse events were observed among the four dosing groups. Conclusions: An initial dose of 0.08 mg/kg/day resulted in adequate tacrolimus exposure, improved the proportion of patients within the therapeutic range, and minimized unnecessary drug accumulation. These findings suggest that a lower initial dose of Envarsus may be preferable to optimize drug exposure while improving therapeutic precision. Full article

Background/Objectives: Medication discontinuation attributable to adverse drug reactions (ADRs) and/or inefficacy remains a concern of psychotropic medications among children and adolescents. Pharmacogenetic (PGx) testing has been proposed to individualize treatment, although its utility remains uncertain. We retrospectively evaluated whether PGx testing of two key metabolism genes (i.e., CYP2C19 and CYP2D6) explains reported episodes of ADRs and treatment inefficacy experienced by children and adolescents with diverse mental health conditions. Methods: PGx testing of CYP2C19 and CYP2D6 was conducted for 100 participants before, during, or after the use of psychotropic medication(s) that have clinical practice guidelines supporting PGx-guided dosing. The theoretical impact on medication dosing was reviewed in the context of clinical guidelines. We then evaluated whether the PGx-inferred metabolizer phenotype was consistent with reported ADR and/or treatment inefficacy. Results: If PGx testing had been performed before the start of treatment, 43% (35/82) of participants would have been recommended dose adjustments or alternative therapy of at least one medication. PGx test results corroborated 8% (6/76) of ADR events and 3% (2/61) of inefficacies. However, no single participant had all prior reported ADRs or inefficacies explained by the results of CYP2C19 nor CYP2D6 testing. Conclusions: Reactive testing of CYP2C19 and CYP2D6 provided limited insight into isolated incidents of psychotropic medication intolerance in this population. No individual’s PGx test results explained all episodes of ADR or suboptimal response. Variation in drug metabolism genes alone does not provide an explanation for multiple episodes of inefficacy or adverse reaction. In the setting of child and adolescent psychiatry, PGx testing is best suited for preemptive use to complement clinical decision making. Full article

People with cystic fibrosis may experience polypharmacy, which can increase the risk of drug induced complications such as adverse events and drug–drug interactions. This study aimed to examine the prevalence of adverse events and to identify potential drug–drug interactions associated with elexacaftor/tezacaftor/ivacaftor (ETI). Three databases, the Australian Therapeutic Goods Administration Database of Adverse Event Notification (TGA DAEN), the Canada Vigilance Adverse Reaction Online Database (CVAROD), and the USA Food and Drug Administration Adverse Event Reporting System (FAERS) Database were searched for spontaneous ETI adverse events between 2019 and 2024. Descriptive analysis of the data was undertaken. The FAERS database was analysed to identify adverse events of interest such as anxiety and depression and concomitant drugs prescribed with ETI. A total of 10,628 ETI associated adverse events were identified in all system organ classes. The incidence of psychiatric adverse events ranged from 7 to 15% across the three databases. Potential drug–drug interactions with CYP 3A4/5 strong inhibitors and strong inducers were identified from the FAERS database and azole antifungals were implicated in several ETI dose modifications. The prevalence and types of ETI adverse events were varied and use of concomitant drugs with potential drug interactions was significant, requiring more research to manage them. Full article

Cyclin-dependent kinase (CDK)4/6 inhibitors have become a key component of adjuvant treatment for patients with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2−) early breast cancer who are at high risk of recurrence. The addition of abemaciclib and ribociclib to standard endocrine therapy has demonstrated clinically meaningful improvements in invasive disease-free survival, supported by the monarchE and NATALEE trials, respectively. With expansion of patient eligibility for CDK4/6 inhibitors, multidisciplinary coordination among medical oncologists, surgeons, nurses, pharmacists, and other health care providers is critical to optimizing patient identification, monitoring, and management of adverse events. This expert guidance document provides practical recommendations for implementing adjuvant CDK4/6 inhibitor therapy in routine clinical practice, incorporating insights from multiple specialties and with patient advocacy representation. Key considerations include patient selection based on clinical trial data, treatment duration, dosing schedules, adverse event profiles, monitoring requirements, drug–drug interactions, and patient-specific factors such as tolerability, cost, and quality of life. This guidance aims to support Canadian clinicians in effectively integrating CDK4/6 inhibitors into clinical practice, ensuring optimal patient outcomes through a multidisciplinary and patient-centric approach. Full article

Pregnane X receptor (PXR) is an important nuclear receptor that regulates diverse physiological functions, including drug metabolism. Although PXR activation is potentially involved in adverse events, the full scope of its impact has yet to be elucidated. In this study, we developed a machine learning model to predict the activity of PXR agonists and applied the model to drugs listed in the US Food and Drug Administration Adverse Event Reporting System database. Analysis of the predicted agonist–active drug interactions and adverse event reports revealed statistically significant risks (lnROR > 1 and −logp > 1.3) for multiple cardiac disorders. These findings suggest that PXR activity is involved in cardiovascular adverse effects and may contribute to drug safety through the early identification of risks. Full article

Background: Thyroid eye disease (TED) is a rare autoimmune orbital disorder predominantly associated with Graves’ disease. It is characterized by orbital inflammation, tissue remodeling, and potential visual morbidity. Conventional therapies, particularly systemic glucocorticoids, offer only partial symptomatic relief, failing to reverse chronic structural changes such as proptosis and diplopia, and are associated with substantial adverse effects. This review aims to synthesize recent developments in understandings of TED pathogenesis and to critically evaluate emerging therapeutic strategies. Methods: A systematic literature review was conducted using MEDLINE, Embase, and international clinical trial registries focusing on pivotal clinical trials and investigational therapies targeting core molecular pathways involved in TED. Results: Current evidence suggests that TED pathogenesis is primarily driven by the autoimmune activation of orbital fibroblasts (OFs) through thyrotropin receptor (TSH-R) and insulin-like growth factor-1 receptor (IGF-1R) signaling. Teprotumumab, a monoclonal IGF-1R inhibitor and the first therapy approved by the U.S. Food and Drug Administration for TED, has demonstrated substantial clinical benefit, including improvements in proptosis, diplopia, and quality of life. However, concerns remain regarding relapse rates and treatment-associated adverse events, particularly hearing impairment. Investigational therapies, including next-generation IGF-1R inhibitors, small-molecule antagonists, TSH-R inhibitors, neonatal Fc receptor (FcRn) blockers, cytokine-targeting agents, and gene-based interventions, are under development. These novel approaches aim to address both inflammatory and fibrotic components of TED. Conclusions: Teprotumumab has changed TED management but sustained control and toxicity reduction remain challenges. Future therapies should focus on targeted, mechanism-based, personalized approaches to improve long-term outcomes and patient quality of life. Full article

Adverse drug events (ADEs) significantly impact patient safety and health outcomes. Manual ADE detection from clinical narratives is time-consuming, labor-intensive, and costly. Recent advancements in large language models (LLMs), including transformer-based architectures such as Bidirectional Encoder Representations from Transformers (BERT) and Generative Pretrained Transformer (GPT) series, offer promising methods for automating ADE extraction from clinical data. These models have been applied to various aspects of pharmacovigilance and clinical decision support, demonstrating potential in extracting ADE-related information from real-world clinical data. Additionally, chatbot-assisted systems have been explored as tools in clinical management, aiding in medication adherence, patient engagement, and symptom monitoring. This narrative review synthesizes the current state of LLMs in ADE detection from a clinical perspective, organizing studies into categories such as human-facing decision support tools, immune-related ADE detection, cancer-related and non-cancer-related ADE surveillance, and personalized decision support systems. In total, 39 articles were included in this review. Across domains, LLM-driven methods have demonstrated promising performances, often outperforming traditional approaches. However, critical limitations persist, such as domain-specific variability in model performance, interpretability challenges, data quality and privacy concerns, and infrastructure requirements. By addressing these challenges, LLM-based ADE detection could enhance pharmacovigilance practices, improve patient safety outcomes, and optimize clinical workflows. Full article

Medication discrepancies at hospital admission are common and may lead to adverse outcomes. Medication reconciliation is a critical process for minimizing medication discrepancies and medication errors at the time of hospital admission. This study aimed to evaluate the role of clinical pharmacists in identifying pharmacotherapy-related issues upon patient admission in a low-resource setting. A prospective observational study was conducted at a university hospital between 1 March and 31 May 2023. Within 24 h of admission, a clinical pharmacist documented each patient’s pre-admission medication regimen and compared it with the medication history obtained by the admitting physician. Discrepancies and pharmacotherapy problems were subsequently identified. Among 65 patients, pharmacists documented 334 medications versus 189 recorded by physicians (p < 0.01). The clinical pharmacist identified 155 discrepancies, 112 (72.26%) of which were unintentional. The most frequent type was drug omission (91.07%), followed by incorrect dosage (4.46%), incorrect dosing interval (2.68%), and medications with unknown indications (1.79%). Most discrepancies were classified as errors without harm (53.57%), while 41.07% were potentially harmful. These findings underscore the importance of integrating clinical pharmacists into the healthcare team. Their active participation during hospital admission can significantly enhance medication safety and reduce preventable adverse drug events. Full article

Background/Objectives: Anti-tumour necrosis factor (anti-TNF) medications were historically commonly prescribed as the first-line biologic treatment for chronic inflammatory pouch conditions. However, their use in these conditions is mainly based on retrospective studies of relatively small numbers of patients with short follow up periods. We aimed to describe the long-term outcomes of first-line anti-TNF therapy in a large, multi-centre, multi-national patient cohort with chronic inflammatory pouch conditions. Methods: This was an observational, retrospective, multi-centre, multi-national study. We included patients with chronic inflammatory pouch conditions initially treated with anti-TNF drugs infliximab (IFX) or adalimumab (ADA), who had a follow up of at least 1 year. The primary outcome was anti-TNF treatment persistence, defined as continuation of anti-TNF throughout the study period. The secondary outcome was pouch failure, defined by the need for a defunctioning ileostomy or pouch excision. Results: We recruited 98 patients with chronic inflammatory pouch conditions initially treated with anti-TNF medications—63 (64.3%) treated with IFX and 35 (35.7%) treated with ADA. Average follow up length was 94.2 months (±54.5). At the end of the study period only 22/98 (22.4%) patients were still on anti-TNF treatment. In those in whom the first-line anti-TNF was discontinued, the median time to discontinuation was 12.2 months (range 5.1–26.9 months). The most common cause for anti-TNF discontinuation was lack of efficacy despite adequate serum drug levels and absence of anti-drug antibody formation (30 patients, 30.6%). Loss of response due to anti-drug antibody formation was the cause for discontinuation in 18 patients (18.4%), while 12 patients (12.2%) stopped treatment because of adverse events or safety concerns. Out of the 76 patients discontinuing anti-TNF treatment, 34 (34.7% of the cohort) developed pouch failure, and 42 (42.8% of the cohort) are currently treated with a different medical therapy. Conclusions: First-line anti-TNF therapy for chronic pouch inflammatory conditions is associated with low long-term persistence rates. This is due to a combination of lack of efficacy and adverse events. A significant percentage of patients initially treated with anti-TNF therapy develop pouch failure. Full article