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Purpose: Engraftment syndrome (ES), a rare post-transplant complication, has been defined differently across the literature. This study aims to determine if budesonide prophylaxis reduces ES after autologous hematopoietic cell transplantation (auto-HCT) for patients with multiple myeloma (MM), as defined by the published Spitzer or Maiolino criteria or by the ES definition used by Dhakal et al. METHODS: A single-center retrospective review was conducted on adult patients who received auto-HCT for MM between January 2017 and October 2023. Patients were divided into those who did not receive budesonide prophylaxis (n = 169) versus those who did (n = 144). The primary endpoint was an incidence of ES by the definition used by Spitzer, Maiolino, and Dhakal et al., respectively. Secondary endpoints included receipt of steroids to treat ES, hospital length of stay, engraftment, and 30- and 100-day mortality rates. Exploratory endpoints were antibiotics started in the peri-engraftment period and number of anti-diarrheal and anti-emetic doses., Results: No difference existed between groups in the primary outcome by the ES definition used by Spitzer, Maiolino, or Dhakal et al. (all p > 0.05). Further, no difference existed with respect to any secondary outcomes (all p > 0.05) except a lower incidence of receipt of antibiotics in the peri-engraftment period for those who received budesonide., Conclusion: Our findings suggest concordance between Spitzer and Maiolino criteria with clinically documented ES, with higher incidences when the ES definition used by Dhakal et al. is utilized. Larger controlled trials need to be performed to validate these findings., Competing Interests: Declarations. Competing interests: The authors declare no competing interests., (© 2025. The Author(s), under exclusive licence to Springer-Verlag GmbH Germany, part of Springer Nature.)

Background: Mucosal healing has become an important goal of Crohn's disease (CD) treatments. Modulen, enriched with transforming growth factor-beta 2, and budesonide are commonly accepted treatments for mild-moderate CD. However, their effects on the small bowel (SB) mucosa remain underexplored., Aim: To prospectively assess clinical and mucosal responses to Modulen vs budesonide in adults with CD, using SB capsule endoscopy., Methods: Thirty patients were divided into two groups: Modulen + home-based diet (21 patients) and budesonide (9 patients) for an eight-week intervention followed by four weeks of follow-up. Clinical, laboratory, and endoscopic responses were evaluated. The mucosal changes were assessed through SB capsule endoscopy., Results: Results indicated significant clinical improvement in the Modulen group with reduced CD activity index ( P = 0.041) and improved inflammatory bowel disease questionnaire score ( P = 0.016). Moreover, Modulen was associated with a significant SB mucosal improvement, evidenced by a decrease in Lewis score ( P = 0.027). No significant changes were observed in calprotectin or other laboratory parameters. Conversely, budesonide exhibited more modest clinical effects, but it improved calprotectin, hemoglobin, and C-reactive protein levels ( P = 0.051, P = 0.014, and P = 0.038, respectively). The capsule endoscopy did not reveal a significant mucosal response in the budesonide group., Conclusion: Both interventions have a role in CD treatment. Yet, their effects differ and may complement each other: Modulen yields clinical and mucosal improvements, while budesonide primarily leads mainly to laboratory improvements., Competing Interests: Conflict-of-interest statement: The authors declare that they have no conflict of interest., (©The Author(s) 2025. Published by Baishideng Publishing Group Inc. All rights reserved.)

Background: Fecal microbiota transplantation (FMT) is an experimental treatment for ulcerative colitis (UC). We aimed to study microbial families associated with FMT treatment success., Methods: We analyzed stools from 24 UC patients treated with 4 FMTs weekly after randomization for pretreatment during 3 weeks with budesonide (n = 12) or placebo (n = 12). Stool samples were collected 9 times pre-, during, and post-FMT. Clinical and endoscopic response was assessed 14 weeks after initiation of the study using the full Mayo score. Early withdrawal due to worsening of UC symptoms was classified as non-response., Results: Nine patients (38%) reached remission at week 14, and 15 patients had a partial response or non-response at or before week 14. With a Dirichlet multinomial mixture model, we identified 5 distinct clusters based on the microbiota composition of 180 longitudinally collected patient samples and 27 donor samples. A Prevotellaceae-dominant cluster was associated with poor response to FMT treatment. Conversely, the families Ruminococcaceae and Lachnospiraceae were associated with a successful clinical response. These associations were already visible at the start of the treatment for a subgroup of patients and were retained in repeated measures analyses of family-specific abundance over time. Responders were also characterized by a significantly lower Simpson dominance compared to non-responders., Conclusions: The success of FMT treatment of UC patients appears to be associated with specific gut microbiota families, such as control of Prevotellaceae. Monitoring the dynamics of these microbial families could potentially be used to inform treatment success early during FMT., Clinical Trial Registration Number: The study was registered in the Netherlands Trial Register, with reference number NL9858., (© The Author(s) 2024. Published by Oxford University Press on behalf of European Crohn’s and Colitis Organisation.)

Introduction: Chronic obstructive pulmonary disease (COPD) is associated with exacerbations which can reduce quality of life and increase mortality. Single-inhaler triple therapy (SITT) is recommended for maintenance treatment of COPD among patients experiencing exacerbations despite dual-therapy use. This real-world comparative effectiveness study compared the impact of SITTs, fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI), and budesonide/glycopyrrolate/formoterol fumarate (BUD/GLY/FORM), on COPD exacerbations and mortality., Methods: Medicare Fee-for-Service (FFS) patients with COPD initiated on FF/UMEC/VI or BUD/GLY/FORM were identified from the Komodo Research healthcare claims dataset (01/01/2016-12/31/2023). Overlap weighting based on high-dimensional propensity scores evaluated from patient characteristics was used to adjust for baseline confounding. Primary outcome was annualized rate of moderate-severe COPD exacerbations (per patient-year; PPY) compared using rate ratios (RRs) with 95% confidence intervals (CIs) from weighted Poisson regression models. Secondary and exploratory outcomes were risk of moderate-severe COPD exacerbations and all-cause mortality, respectively, evaluated using Kaplan-Meier analysis and hazard ratios (HR) with 95% CIs from Cox proportional hazard models. A secondary analysis was conducted among a mutually exclusive population with Medicare Advantage, Medicaid, or commercial insurance., Results: Overall, 32,312 FF/UMEC/VI and 12,230 BUD/GLY/FORM Medicare FFS patients were included. After weighting, median follow-up was 9 months. Compared with BUD/GLY/FORM, FF/UMEC/VI users had a 12% lower rate of annualized moderate-severe COPD exacerbations [0.80 and 0.91 PPY; RR (95% CI): 0.88 (0.85-0.92); P < 0.001] and a 10% lower risk of moderate-severe exacerbations at 12 months post-initiation [HR (95% CI): 0.90 (0.87-0.93); P < 0.001], driven by moderate exacerbations. FF/UMEC/VI compared with BUD/GLY/FORM users had 11% lower risk of all-cause mortality at 12 months post-initiation [5.6% vs. 6.4%; HR (95% CI): 0.89 (0.80-0.98); P = 0.020]. Results were consistent among patients with Medicare Advantage, Medicaid, or commercial insurance., Conclusions: In this real-world comparative effectiveness study, FF/UMEC/VI was associated with significantly lower rate and risk of COPD exacerbations than BUD/GLY/FORM., Competing Interests: Declarations. Conflict of Interest: David Mannino is a consultant for AstraZeneca, the COPD Foundation, Genentech, GSK, Regeneron, and Up-to-Date. David Mannino is also an expert witness on behalf of people suing the tobacco and vaping industries. Stephen Weng, Sergio Forero-Schwanhaeuser, Chris H Compton, Stephen G Noorduyn, and Rosirene Paczkowski are employees of GSK and/or hold financial equities in GSK. Stephen G Noorduyn is also a PhD candidate at McMaster University. Guillaume Germain, Julien Boudreau, Anabelle Tardif-Samson, François Laliberté, and Patrick Gravelle are employees of Groupe d’analyse, which received funding from GSK to conduct this study. Ethical Approval: This study complied with all applicable laws regarding patient privacy, as described in the Declaration of Helsinki. No direct patient contact or primary collection of individual human patient data has occurred in this study. This study used existing, fully de-identified data that complied with the requirements of the Health Insurance Portability and Accountability Act and the patient(s) cannot be identified, directly or through identifiers. Study results were in tabular form and aggregate analyses that omit patient identification; therefore, informed consent, ethics committee or Institutional Review Board approval were not required., (© 2024. The Author(s).)

Microscopic colitis is an inflammatory bowel disease that commonly presents with debilitating chronic watery diarrhea. Recent epidemiologic studies and randomized trials of therapeutics have improved the understanding of the disease. Medications, such as nonsteroidal anti-inflammatories, proton pump inhibitors, and antidepressants, have traditionally been considered as the main risk factors for microscopic colitis. However, recent studies have challenged this observation. Additionally, several epidemiologic studies have identified other risk factors for the disease including older age, female sex, smoking, alcohol use, immune-mediated diseases, and select gastrointestinal infections. The diagnosis of microscopic colitis requires histologic assessment of colon biopsies with findings including increased in intraepithelial lymphocytes with or without expansion of the subepithelial collagen band. The pathophysiology is poorly understood but is thought to be related to an aberrant immune response to the luminal microenvironment in genetically susceptible individuals. Antidiarrheal medications, such as loperamide or bismuth subsalicylate, may be sufficient in patients with mild symptoms. In patients with more severe symptoms, treatment with budesonide is recommended. Maintenance therapy is often necessary and several potential treatment strategies are available. Biologic and small molecule treatments seem to be effective in patients who have failed budesonide. There is an unmet need to further define the pathophysiology of microscopic colitis. Additionally, trials with novel therapies, particularly in patients with budesonide-refractory disease, are needed., (Copyright © 2025 AGA Institute. Published by Elsevier Inc. All rights reserved.)

Rationale: Chronic obstructive pulmonary disease (COPD) is associated with an increased risk of cardiovascular and cardiopulmonary events. In the phase III, 52-week ETHOS trial (NCT02465567), triple therapy with budesonide/glycopyrrolate/formoterol fumarate (BGF) reduced rates of moderate/severe exacerbations and all-cause mortality compared with dual therapy with glycopyrrolate/formoterol fumarate (GFF) or budesonide/formoterol fumarate (BFF). However, the effect of BGF on cardiovascular events versus GFF remains unevaluated. Furthermore, the effect of BGF on time to first severe exacerbation has not been reported. Objectives: To assess the effects of BGF 320/18/9.6 μg (BGF 320) and other inhaled corticosteroid-containing arms on cardiovascular and severe cardiopulmonary endpoints versus GFF in patients with COPD from the ETHOS trial. Methods: Patients with moderate to very severe COPD and a history of exacerbations were randomized to twice-daily BGF 320, BGF 160/18/9.6 μg, BFF 320/9.6 μg, or GFF 18/9.6 μg (GFF). Time to first severe COPD exacerbation was a prespecified endpoint; post hoc cardiovascular and severe cardiopulmonary endpoints included time to first major adverse cardiac event, time to first cardiovascular adverse event (AE) of special interest, time to first cardiac AE, and time to the composite endpoint of first severe cardiopulmonary event. Measurements and Main Results: BGF 320 reduced the rate of first occurrence (hazard ratio [95% confidence interval]) of cardiovascular and severe cardiopulmonary events versus GFF, including for time to first cardiovascular adverse event of special interest (0.63 [0.48, 0.82]), cardiac AE (0.60 [0.48, 0.76]), and severe cardiopulmonary event (0.80 [0.67, 0.95]). Conclusions: BGF had a benefit on cardiovascular endpoints and severe cardiopulmonary events versus GFF in patients with moderate to very severe COPD.

Introduction: Previously, adherence and persistence to treatment have been shown to improve outcomes among patients with chronic obstructive pulmonary disease (COPD). This study aimed to evaluate adherence and persistence to single-inhaler triple therapy with fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI; one inhalation, once-daily) compared with budesonide/glycopyrrolate/formoterol fumarate (BUD/GLY/FOR; two inhalations, twice-daily) among patients with COPD in the USA., Methods: This retrospective weighted cohort study used claims data from the IQVIA PharMetrics ® Plus Database from October 1, 2019 to March 31, 2023, to identify patients with COPD newly initiating FF/UMEC/VI or BUD/GLY/FOR. Index date was the first pharmacy claim for FF/UMEC/VI or BUD/GLY/FOR on or after October 1, 2020. The longest follow-up period was 12 months. Inverse probability of treatment weighting was used to balance baseline characteristics between cohorts. Adherence was measured as mean proportion of days covered (PDC); the proportion of patients with PDC ≥ 0.5 and PDC ≥ 0.8 was also assessed. Persistence was assessed as time to treatment discontinuation using Kaplan-Meier rates., Results: Overall, 8912 and 2685 patients were included in the FF/UMEC/VI and BUD/GLY/FOR cohorts, respectively. After weighting, mean age and proportion of patients with Medicare Advantage insurance was 64.62 years and 40.0% in the FF/UMEC/VI cohort and 63.96 years and 36.1% in the BUD/GLY/FOR cohort. At 6 months post-index, mean PDC was greater in the FF/UMEC/VI versus the BUD/GLY/FOR cohort (0.65 versus 0.59; P < 0.001). A significantly greater proportion of patients in the FF/UMEC/VI versus the BUD/GLY/FOR cohort had PDC ≥ 0.8 (45.6% versus 34.5%; P < 0.001) and PDC ≥ 0.5 (71.8% versus 64.3%; P < 0.001). Results were consistent at 12 months post-index. When a 30-day gap was used to define treatment discontinuation, the FF/UMEC/VI cohort had statistically significantly greater treatment persistence versus the BUD/GLY/FOR cohort at all time points., Conclusion: In this study, patients initiating FF/UMEC/VI had significantly greater adherence and persistence to treatment than patients initiating BUD/GLY/FOR., Competing Interests: Declarations. Conflict of Interest: Corinne Young is an employee of the Association of Pulmonary Advanced Practice Providers and Clinical Services. Lydia Y. Lee was a university worker hired by GSK at the time of this study. Lydia Y. Lee is currently an employee of Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT, USA (Boehringer Ingelheim has no connection to this study). Kristi K. DiRocco, Stephen G. Noorduyn, and Rosirene Paczkowski are employees of GSK and hold financial equities in GSK. Stephen G. Noorduyn is also a PhD candidate at McMaster University, Hamilton, ON, Canada. Guillaume Germain, Jacob Klimek, François Laliberté, and Dominique Lejeune are employees of Groupe d'analyse, Ltée, Montréal, QC, Canada, which received funding from GSK to conduct this study. Ethical Approval: The data reported in this publication are contained in a database owned by IQVIA and contain proprietary elements. Therefore, these data cannot be broadly disclosed or made publicly available at this time. The disclosure of this data to third-party clients assumes certain data security and privacy protocols are in place and that the third-party client has executed IQVIA’s standard license agreement, which includes restrictive covenants governing the use of the data. Permission was obtained from IQVIA to use the data. This study complied with all applicable laws regarding subject privacy. No direct subject contact or primary collection of individual human subject data occurred in this study. This study used existing, fully de-identified data that complied with the requirements of the Health Insurance Portability and Accountability Act, and the subject(s) cannot be identified, directly or through identifiers. The study results are in tabular form and aggregate analyses that omit subject identification. As per Title 45 of CFR, Part 46 ( http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html#46.101 ), informed consent, ethics committee, or institutional review board review were not needed, as the claims data analysis of our study was a retrospective analysis of existing data (hence no patient intervention or interaction), and no patient-identifiable information was included in the claims dataset., (© 2024. The Author(s).)

Background: Guidelines specify steroids as therapy for acute exacerbation of chronic obstructive pulmonary disease (AECOPD). However, the duration of survival benefit associated with steroids and the optimal dosage of nebulized budesonide (NB) during hospitalization remain unclear., Methods: We conducted a retrospective study of hospitalized AECOPD patients. The primary endpoint was all-cause mortality after discharge. Cox regression analysis was used to determine the impact of steroid therapy on survival., Results: Wilcoxon analysis showed the positive impact of systemic corticosteroids (SCs) therapy on survival during the early stage of follow-up (P = 0.038). NB therapy was associated with a significantly reduced risk of death within six months after discharge (adjusted Hazard ratio (HR), 0.36; 95% confidence interval (CI) 0.15-0.88). Subgroup analysis suggested that fewer than two AEs in the previous year (adjusted HR 0.05; 95% CI 0.01-0.38), age >  = 65 years (adjusted HR 0.31; 95% CI 0.11-0.90), body mass index (BMI) < 25 kg/m 2 (adjusted HR 0.33; 95% CI 0.12-0.92), and smoking index > 40 packets/year (adjusted HR 0.17; 95% CI 0.04-0.79) were involved in this association. Finally, treatment with a total dose of NB <  = 60 mg during hospitalization reduced six-month mortality compared to treatment without steroids (adjusted HR 0.39; 95% CI 0.17-0.92), but not the total dose of NB > 60 mg., Conclusions: NB therapy for hospitalized AECOPD patients significantly reduced six-month mortality. Subgroup analysis showed that certain populations benefited more from NB therapy, and <  = 60 mg NB might be suitable treatment for hospitalized AECOPD patients., Competing Interests: Declarations. Competing Interests: The authors declare no competing interests. Ethical Approval: This study was approved by the Ethics Committee of the Second Xiangya Hospital of the Central South University (No. ChiCTR-POC-17010431). Written informed consent was obtained from all the participants. Consent for Publication: Not applicable., (© 2025. The Author(s).)

Background: Evidence regarding high-dose inhaled corticosteroids (HDICS) in asthma exacerbations in adults is insufficient. This study compares the treatment outcomes of HDICS as add-on therapy to the outcomes of standard treatment in adult patients with acute asthma exacerbation in the ED., Methods: This was a single-centre, triple-blind, randomised controlled trial conducted in the ED in Thailand between March 2022 and April 2023. Adult patients with asthma exacerbation were randomly assigned to receive either a placebo (normal saline) or HDICS (budesonide 9000 µg) nebulisation combined with beta agonist and ipratropium within the first hour. The primary endpoints were length of ED stay, hospital admission and ED revisit. The secondary endpoints were dyspnoea scale, pulmonary functions, length of hospital stay and home exacerbation after ED discharge., Results: A total of 88 patients were randomly assigned to one of two groups: 44 patients received a HDICS and 44 patients were placed in the control group. The HDICS group had a significantly shorter ED length of stay (adjusted mean difference -133.6 min; 95% CI -242.4 to -24.8 min; p=0.016), and a higher proportion of ED discharged home within 8 and 16 hours compared with the control group. However, there were no significant differences between the two groups in hospital admission rates, ED revisit, dyspnoea scale, pulmonary functions, length of hospital stay or home exacerbation after ED discharge., Conclusions: HDICS may be useful as an add-on therapy to standard treatment for asthma exacerbation in adults to reduce ED stay., Trial Registration Number: TCTR20201214001., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2025. No commercial re-use. See rights and permissions. Published by BMJ Group.)

Immune checkpoint inhibitors (ICIs) have advanced the treatment of metastatic melanoma. However, some patients develop ICI-associated toxicities like hepatitis (ie, immune-mediated hepatitis; IMH). Although these toxicities usually resolve with steroids, steroid-refractory events may occur, which may be a major source of morbidity and mortality without obviously defined treatment algorithms. Herein, we present 2 patients with metastatic melanoma who had IMH that was steroid-refractory and only partially mycophenolate-responsive, but fully resolved with budesonide. The case suggests that budesonide is a potential option to treat IMH that is refractory to standard treatments, but further investigation in a larger series is needed to identify the most optimal setting for budesonide use., (© The Author(s) 2025. Published by Oxford University Press.)

Pulmonary surfactant (PS) is one of the main treatment for neonates with respiratory distress syndrome (RDS). Budesonide has recently been studied as an additional treatment in such cases, but there is limited evidence supporting this. This study was implemented to determine the efficacy of PS combined with budesonide in premature infants. To achieve this, we conducted a systematic review and meta-analysis of randomized controlled trials by searching PubMed, Scopus, Embase, and the Cochrane Library from inception until July 12, 2024. We utilized a random-effects model to calculate the risk ratio and mean differences (MDs) with 95% confidence intervals (CIs) for the clinical outcomes of PS with budesonide versus PS alone. We used the GRADE approach to assess the quality of the evidence. We included 26 randomized controlled trials with a total of 2701 patients in the analysis. Treatments of PS with budesonide and PS alone were compared in all trials. PS with budesonide reduced bronchopulmonary dysplasia (BPD) incidence (risk ratio, 0.61; 95% CI, 0.51, 0.73), duration of mechanical or invasive mechanical ventilation (MD, -2.21 days; 95% CI, -2.72, -1.71), duration requiring oxygen (MD, -5.86 days; 95% CI, -8.44, -3.29), and hospitalization time (MD, -5.61 days; 95% CI, -8.65, -2.56). These results were based on low to very low evidence certainty. Only moderate-to-severe BPD or severe BPD showed a significant reduction when PS was used in conjunction with budesonide, a finding supported by moderate evidence certainty. Our study showed that the administration of PS with budesonide significantly improved respiratory outcomes, including the incidence of BPD, duration of mechanical or invasive mechanical ventilation, duration requiring oxygen, and hospitalization time in preterm infants, without short-term adverse drug events. However, the evidence certainty was mostly low to very low., Competing Interests: The authors have declared that no competing interests exist., (Copyright: © 2025 Phattraprayoon et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.)

Using a large health insurance database in Japan, we examined the real-world usage of budesonide enteric-coated capsules (BUD) in treating Crohn's disease. We analyzed data from the Japan Medical Data Center claims database for Crohn's disease patients prescribed BUD from April 2016 to March 2021, focusing on prescription status, adverse events (AEs), monitoring tests, and concomitant medications over 2 years following BUD initiation. Patients were categorized into two groups based on BUD usage duration: ≤1 year and >1 year. Of the 7364 registered patients, 1049 (14.2%) were prescribed BUD. Among the 562 followed for 2 years, 505 (89.9%) used BUD for ≤1 year and 57 (10.1%) for >1 year. Over 70% of the patients used at least one biologic, and more than 20% used at least two. The proportions of new thiopurine initiation were 22 and 9% in the ≤1-year and >1-year groups, respectively (p = 0.0181). We did not identify any obvious increase in AEs from long-term BUD use within the confines of our study design. However, regardless of prescription duration, over half of the patients lacked hepatitis B virus screening, glycated hemoglobin measurement, adrenal function quantification, or bone densitometry. Usage of strong CYP3A4 inhibitors was more frequent among patients in the BUD >1-year group. This study revealed that numerous Japanese patients received long-term BUD prescriptions. Although no apparent increase in AEs from long-term BUD was detected, we identified inadequate monitoring of AEs and drug interactions, as well as insufficient use of steroid-sparing agents.

The cornerstone of treatment for mild ulcerative colitis is still the oral or topical (rectal) application of aminosalicylates (5-ASA). 5‑ASA preparations are often only administered orally in mild ulcerative colitis. Study data show that in ulcerative proctitis and left-sided colitis, rectal 5‑ASA preparations are even more effective than oral administration. In a next step, steroid-containing topical therapies should be used. Topical steroids such as budesonide are also primarily used in mild Crohn's disease. However, it is controversial whether treatment is necessary in symptom-free patients. There is still a lack of evidence to prove that more aggressive treatment (using immunosuppressants, biologics or small molecules) has a long-term benefit in these patients. Most guidelines are critical of the use of 5‑ASA in mild Crohn's disease. Nevertheless, there is some evidence for sufficiently high-dose treatment with 5‑ASA, although one must be aware of its limited effectiveness. However, there is clear evidence for the postoperative use of 5‑ASA in cases of mild recurrence., Competing Interests: Einhaltung ethischer Richtlinien. Interessenkonflikt: G. Rogler gibt Beratung für AbbVie, Arena, Augurix, BMS, Boehringer, Calypso, Celgene, FALK, Ferring, Fisher, Genentech, Gilead, Janssen, Lilly, MSD, Novartis, Pfizer, Phadia, Roche, UCB, Takeda, Tillots, Vifor, Vital Solutions und Zeller an; Vortragshonorare von AbbVie, AstraZeneca, BMS, Celgene, FALK, Janssen, MSD, Pfizer, Phadia, Takeda, Tillots, UCB, Vifor und Zeller; Forschungsunterstützung von AbbVie, Ardeypharm, Augurix, Calypso, FALK, Flamentera, MSD, Novartis, Pfizer, Roche, Takeda, Tillots, UCB and Zeller. G. Rogler ist Mitgründer und Miteigentümer von PharmaBiome. Für diesen Beitrag wurden von den Autor/-innen keine Studien an Menschen oder Tieren durchgeführt. Für die aufgeführten Studien gelten die jeweils dort angegebenen ethischen Richtlinien., (© 2024. The Author(s).)

Background: Standard treatments for eosinophilic esophagitis (EoE) may present adherence, tolerance, and efficacy challenges. Dupilumab 300 mg weekly is approved for the treatment of EoE in patients ≥ 1 year old, weighing ≥ 15 kg. This analysis aimed to evaluate dupilumab efficacy in patients from the LIBERTY EoE TREET trial (NCT03633617), with prior history of different EoE interventions., Research Design and Methods: This analysis included patients from Parts B/B - C of LIBERTY EoE TREET. Dupilumab efficacy was analyzed according to prior swallowed budesonide or fluticasone use and in those patients with previously trialed food elimination diet, esophageal dilation, or baseline proton pump inhibitor use, as stratified by prior swallowed topical corticosteroid (STC) use or STC inadequate response/intolerance/contraindication., Results: Dupilumab improved the proportion of patients achieving peak intraepithelial eosinophil count ≤ 6 eosinophils/high-power field, absolute change in Dysphagia Symptom Questionnaire score, and other histologic, symptomatic, and endoscopic endpoints vs. placebo at Week (W) 24, irrespective of prior swallowed budesonide/fluticasone use. Improvements were maintained at W52. Similar results were observed across the other subgroups., Conclusion: Dupilumab was efficacious in patients with EoE irrespective of prior treatments/interventions., Clinical Trial Registration: www.clinicaltrials.gov identifier is NCT03633617.

Objective: to perform a cost-effectiveness analysis of asthma treatment with budesonide/formoterol against other treatment options used at Mexico's National Institute for Respiratory Diseases., Methods: A complete economic evaluation of cost-effectiveness from a public health perspective, comparing the use of budesonide/formoterol as maintenance therapy with fluticasone/vilanterol in 103 female asthma patients managed at INER between 2015 and 2021., Results: Average cost per patient was $743.23 USD, $733.36 USD for budesonide/formoterol and $767.24 USD for fluticasone/vilanterol. Pharmacological treatment represented over 70% of management costs for both groups, followed by follow-up visits and exacerbation management costs. LABA-ICS represented the highest proportion of pharmacologic management costs with a statistically significant difference amongst groups with an incremental cost of $80.17 USD for the fluticasone/vilanterol group. The budesonide/formoterol group showed an ICER of $613.31 USD for reducing the proportion of patients experiencing exacerbations during follow-up. Considering the willingness to pay threshold based on one GDP per capita ($10,902.98 USD in 2022), budesonide/formoterol represented a very cost-effective option., Conclusions: The ICER favored budesonide/formoterol over fluticasone/vilanterol in terms of cost-effectiveness. A 5.5% reduction in patient exacerbations indicated decreased disease burden. While not statistically significant, fewer exacerbations per patient might still cut costs by lowering emergency visits and hospitalizations.

Background: Microscopic colitis (MC) is a chronic inflammatory condition of the colon, primarily characterized by watery diarrhea, with normal or near-normal endoscopic findings. It encompasses two main subtypes: lymphocytic colitis and collagenous colitis., Objective: This position paper from the Brazilian Federation of Gastroenterology aims to review current evidence on the diagnosis and management of MC in Brazil, emphasizing the need for standardization across the country's healthcare systems., Methods: A comprehensive review of the latest scientific literature, clinical guidelines, and consensus statements was performed, focusing on randomized clinical trials, meta-analyses, and cohort studies. The evidence was analyzed by a panel of gastroenterologists and pathologists specializing in MC. The recommendations were based on the consensus of the group, approved by the majority of the panel members., Results: Histological examination with biopsies from multiple segments of the colon remains essential for the accurate diagnosis of MC, as endoscopic findings are often non-specific. Budesonide is the first-line treatment for inducing remission in most patients. However, alternatives such as immunosuppressants and biologics are available for those who are refractory to or intolerant of budesonide. Non-pharmacological interventions, including dietary and lifestyle modifications, can complement medical treatment. The need for long-term follow-up is highlighted due to the high recurrence rates and the impact of MC on the quality of life., Conclusion: Standardizing the diagnosis and treatment of MC in Brazil is crucial, given the significant regional disparities in healthcare access. This position paper provides evidence-based recommendations to optimize care and improve patient outcomes across diverse clinical settings in Brazil. Further research is needed to address the gaps in understanding the epidemiology and management of MC in underserved regions.

Introduction: In Japan, patients with chronic obstructive pulmonary disease (COPD) can be escalated to treatment with inhaled triple therapy. Two single-inhaler triple therapies combining an inhaled corticosteroid/long-acting muscarinic antagonist/long-acting β 2 -agonist (ICS/LAMA/LABA) are approved maintenance therapies for patients with COPD, and multiple-inhaler triple therapies (MITTs) are also available. There is limited evidence regarding real-life treatment patterns and characteristics of patients with COPD initiating triple therapies., Methods: This observational, retrospective cohort study identified patients with COPD in Japan from an administrative claims database (May 2018-December 2021). Demographics, clinical characteristics, and healthcare resource utilization (HCRU) were assessed in four cohorts initiating a triple therapy: budesonide/glycopyrronium/formoterol fumarate dihydrate (BGF) early adopters (initiated ≤ 12 months after market approval [September 1, 2019]), contemporary BGF users (initiated > 12 months after market approval), fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) users, and any MITT users., Results: A total of 636 patients were BGF early adopters, 2558 were contemporary BGF users, 11,187 used FF/UMEC/VI, and 5931 used MITT. The percentage of patients with concomitant asthma in each cohort was 73.0%, BGF early adopter; 74.2%, contemporary BGF; 75.7%, FF/UMEC/VI; and 84.5%, MITT. During the 12-month baseline period, the frequency of patients with ≥ 1 moderate/severe exacerbation was 18.2%, BGF early adopter; 14.3%, contemporary BGF; 13.1%, FF/UMEC/VI; and 14.0%, MITT. ICS/LABA treatment during baseline was the most frequent pathway to triple therapy, ranging from 38.2% to 51.7% across cohorts. HCRU was relatively high across cohorts (range of hospital outpatient visits/patient during the 12-month baseline period, 11.0-14.1). Multimorbidity was observed in > 80% of patients in all cohorts; cardiovascular diseases were among the most common., Conclusion: Many patients initiating triple therapy for COPD had concomitant asthma and had previously received ICS/LABA maintenance therapy. Patients prescribed BGF in the initial post-launch period were more likely to have a previous exacerbation history versus other cohorts, indicating more severe disease., (© 2024. The Author(s).)

Background and Aims: Microscopic colitis has been increasingly recognized as a cause of chronic diarrhoea. We aimed to characterize the role of disease-related factors and treatments on the clinical outcomes of microscopic colitis., Methods: We retrospectively reviewed the medical records of patients with microscopic colitis who were treated at the University of Chicago and Oregon Health & Science University between August 2010 and May 2016. Patient characteristics and treatments were evaluated as predictors of clinical outcomes using univariate and multivariate analyses. Clinical remission was defined as no symptoms associated with microscopic colitis based on physician assessment and histologic remission was defined as no evidence of histological inflammation of microscopic colitis., Results: Seventy-two patients with microscopic colitis were included in the study (28 with lymphocytic colitis and 44 with collagenous colitis). Non-steroidal anti-inflammatory drugs, proton pump inhibitors and selective serotonin reuptake inhibitors were used in 23 (31.9%), 14 (19.4%) and 15 (20.8%), respectively, at the time of diagnosis. Among 46 patients with adequate follow-up data, 25 (54.3%) patients achieved clinical remission. Response to budesonide ( p  = .0002) and achieving histologic remission ( p  = .0008) were associated with clinical remission on univariate analysis. On multivariate analysis, budesonide response ( p  = .0052) was associated with clinical remission (odds ratio 25.00, 95% confidence interval 2.63-238.10). Among 22 patients who underwent a follow-up colonoscopy, five patients (22.7%) achieved histologic remission. All patients with histologic remission maintained clinical remission without medication, whereas only two patients (11.8%) were able to discontinue medical therapy when histologic inflammation was present ( p  = .0002)., Conclusions: In the present cohort of patients with microscopic colitis, a favourable response to budesonide was significantly associated with long-term clinical remission, and all patients achieving histological remission were able to maintain clinical remission without further medical therapy. Larger studies are required to confirm these findings.

Objective: Eosinophilic esophagitis (EoE) is a chronic immune-mediated disease. The budesonide orodispersible tablet (BOT) is recommended as second-line treatment according to the Danish guideline. This study aimed to compare potential treatment disparities before BOT initiation, follow-up practices, clinico-histologic remission rates during BOT treatment, and adherence to the national guideline between the highly specialized EoE-Cph cohort and the population-based DanEoE cohort., Material and Methods: This cohort study compared 65 adult patients from the EoE-Cph cohort with 65 patients from the DanEoE cohort. All patients were diagnosed between 2015-2021. The diagnosis of EoE was defined according to the AGREE consensus. Data were extracted manually from medical records and registries., Results: In the EoE-Cph cohort, 88% were prescribed proton pump inhibitors (PPIs) before started on BOT compared to 100% in the DanEoE cohort (p = 0.0035). Symptomatic follow-up occurred in 89% of EoE-Cph patients compared to 97% of DanEoE patients after BOT treatment (p = 0.0841). No difference was found between patients who underwent histologic follow-up after topical steroid treatment (83% versus 82%, p = 0.8162). Complete clinico-histologic remission was frequently observed, and no significant difference was observed between the two cohorts (67% versus 80%, p =0.1789). One out of four patients had conflicting symptomatic and histological responses., Conclusions: This study did not provide conclusive evidence favoring the treatment of EoE patients exclusively at highly specialized EoE centers. However, the authors acknowledge that further evidence is necessary before considering changes in clinical practice. Conflicting treatment responses, and discontinuation of treatment due to side effects remains a notable concern.

Objective: The aim of this study was to assess the effect of microsoft-based medication guidance on the level of symptoms and serological indicators in children receiving budesonide nebulisation combined with terbutaline for the treatment of Mycoplasma pneumoniae pneumoniae (MPP)., Methods: A total of 109 children with MPP treated in The First Affiliated Hospital of Ningbo University of China between October 2022 and April 2023 were divided into the conventional group (n=54, with medication guidance by telephone follow-up) and the WeChat group (n=55, with medication guidance based on the WeChat platform) using a randomized number table. The time to resolution of symptoms, serological index levels, incidence of adverse drug events, medication adherence scores and satisfaction rate of family guidance were compared between the two groups., Results: The disappearance time of symptoms such as wheezing and cough in the WeChat group was shorter than that in the conventional group (P < .05). After treatment, the C-reactive protein (CRP), interleukin-6 (IL-6) and calcitoninogen (PCT) levels and the incidence of adverse drug events were lower in the WeChat group than in the conventional group (P < .05). After treatment, the levels of forceful spirometry (FVC), 1st-second expiratory volume (FEV1), peak expiratory flow rate (PEF), medication compliance score and family guidance satisfaction rate were higher in the WeChat group than in the conventional group (P < .05)., Conclusion: WeChat-based medication guidance can optimize the therapeutic effect of MPP, improve children's medication compliance and satisfaction rate of family guidance, and reduce the occurrence of adverse drug events.

The fixed-dose combination of beclometasone dipropionate/formoterol fumarate (BDP/FF) delivered via pressurised metered-dose inhaler (pMDI) has demonstrated efficacy in chronic obstructive pulmonary disease (COPD), in studies predominantly conducted in Caucasian adults. The current study evaluated the efficacy and safety of BDP/FF pMDI in Chinese patients with COPD, as part of registration for COPD in China. This double-blind, double-dummy, randomised, parallel-group study was conducted in patients with COPD of Chinese ethnicity aged ≥40 years. After a 4-week open-label budesonide/formoterol fumarate (BUD/FF) run-in period, patients were randomised to BUD/FF or BDP/FF for 24 weeks. The primary objective was to demonstrate non-inferiority of BDP/FF to BUD/FF in terms of change from baseline in pre-dose morning forced expiratory volume in 1 sec (FEV 1 ) at Week 24 (i.e. the lower 95% CI limit of the difference was above the pre-defined non-inferiority margin of -0.07 L). Of 750 patients randomised (377 BDP/FF; 373 BUD/FF), 87.6% completed the study. The primary endpoint was met in both the per-protocol (adjusted mean difference -0.001 L [95% CI: -0.025, 0.022], non-inferiority p  < 0.001) and intention-to-treat populations (-0.001 L [-0.024, 0.022]; non-inferiority p  < 0.001). There were no statistically significant BDP/FF-BUD/FF differences for the secondary endpoints, and a similar proportion of patients had adverse events (BDP/FF, 51.7%; BUD/FF, 51.2%), with most mild/moderate in severity. In conclusion, BDP/FF pMDI was non-inferior to BUD/FF in terms of pre-dose morning FEV 1 , supported by a range of secondary endpoints. Both treatments were similarly tolerated. The study supports the use of BDP/FF pMDI in Chinese patients with COPD., Study Registration: China Centre for Drug Evaluation (CTR20180475).

Oral budesonide exerts local effects with negligible systemic glucocorticoid activity, due to rapid first-pass metabolism, therefore, could potentially be efficacious in preventing gastrointestinal (GI) acute GVHD (aGVHD). We explored the use of budesonide, added to posttransplant cyclophosphamide (PTCy), tacrolimus, and mycophenolate mofetil, for prevention of GI aGVHD after allogeneic hematopoietic stem cell transplantation (AHSCT) in a prospective observational study and treated 80 patients with a median age of 53 years (range 19-74). Results were compared with a publicly available CIBMTR dataset of 646 patients who received PTCy-based GVHD prophylaxis (CIBMTR Study # GV17-02) (control). Cumulative incidence (CI) of 3-month grade 2-4 and grade 3-4 aGVHD in the budesonide and control groups were 3.8% vs. 34.4% (p < 0.001) and 1.3% vs. 9.8% (p = 0.029), respectively. One-year GRFS (70.5% vs. 31.5%, p < 0.001), PFS (73.4% vs. 52.8%, p = 0.003), and OS (80.1% vs. 64.2%, p = 0.038) were significantly higher in the budesonide group compared with control group. Propensity score-adjusted analyses showed that the addition of budesonide significantly decreased risk of aGVHD grade 2-4 (HR 0.29, p < 0.001), grade 3-4 (HR 0.12, p = 0.045), and cGVHD (HR 0.22, p < 0.001), which resulted in better GRFS (HR 0.38, p < 0.001), PFS (HR 0.58, p = 0.012), and OS (HR 0.72, p = 0.044). Similar results were found when using propensity score-matched analysis restricted to recipients of haploidentical transplantation. In conclusion, addition of budesonide to PTCy-based GVHD prophylaxis is safe and effective in preventing severe acute GI GVHD with significantly improved GRFS. These results could facilitate transition to peripheral blood grafts for all allogeneic transplant recipients., (© 2025 Wiley Periodicals LLC.)

Introduction: The AMSA® manosonic nebulizer uses acoustic vibration and a flow of air to create an aerosol from a solution or suspension of a drug. The aerosol created this way is claimed to have enhanced penetration and drug delivery. It is administered under short-term overpressure, meaning that the aerosol is able to penetrate into the middle ear through the Eustachian tube (ET)., Purpose: of the study: The aim of this study is to identify the active substances used in AMSA® manosonic nebulization for treating common ENT diseases in children aged 2-17 years and to evaluate the overall effectiveness of AMSA® manosonic nebulization in this context. Assessments were done by comparing conditions before and after nebulization using the following tests: (1) Eustachian tube function test, (2) tympanometry, and (3) otoscopy., Material and Methods: This study was a retrospective study with ethics committee consent. 129 children, comprising 56 girls and 73 boys. They were aged between 2 and 17 years, with a mean age of 6.9 years (SD = 3.0). There were 74 children up to 6 years and 55 children over 6 years of age. Children had the following conditions: (1) chronic otitis media with effusion, OME (n = 86), (2) Eustachian tube dysfunction, ETD (n = 34) (3) Other conditions (e.g. cholesteatoma, retraction pocket), (n = 9). Combination of medicines administered in this study was: Budesonide + ambroxol (with or without NaCl), Budesonide (with or without NaCl), Budesonide + N-acetylcysteine (with or without NaCl), Budesonide + hyaluronic acid, Budesonide + ambroxol (with hyaluronic acid), Ambroxol (with or without NaCl)., Results: The number of nebulizations ordered was between 1 and 20 treatments, but most commonly, pa-tients were given a nebulization series of 10 treatments. This was the case for 80.6 % of the patients. Most patients with OME and ETD had 10 treatments ordered (79 % and 79.5 %, respectively), while all patients with other conditions had 10 treatments. Analysis of the tympanometry results was done in terms of the number of affected ears (not by individual). There were 210 ears with complete tympanometry (both pre and post), including 142 ears with OME, 54 with ETD, and 14 others. Statistically significant changes (improvements) after AMSA nebulizations were found for statistic compliance and middle ear pressure. Otoscopy assessments were done in all ears. The results were abnormal in 155 ears (73.8 %) and normal in 55 ears (26.2 %). After AMSA nebulizations, the number of abnormal results decreased to 117 ears (55.7 %) and normal results were found in 93 ears (44.7 %)., Conclusion: Use of the AMSA manosonic nebulizer appears to be an effective way of improving chronic medical conditions in children - such as chronic otitis media with effusion and Eustachian tube defect - but only if patient compliance can be achieved. The most frequently used active substance was budesonide, irrespective of whether additional secretolic/mucolytic agent was administered., Competing Interests: Declaration of competing interest We confirm that this work is original manuscript (The AMSA® manosonic nebulizer for ENT disease among children in Poland) and has not been published elsewhere, nor is it currently under consideration for publication elsewhere. We have no conflicts of interest to disclose. Please address all correspondence concerning this manuscript to me at m.skarzynska@csim.pl (corresponding author)., (Copyright © 2024 The Authors. Published by Elsevier B.V. All rights reserved.)

Background: This study was to explore the effectiveness of the ABCLOVE exercise on school-aged children with vocal nodules after the treatment of budesonide., Methods: Eighty-six school-aged children with vocal nodules were divided into control and ABCLOVE therapy groups. Subjective voice assessment and dysphonia severity index (DSI) assessment were performed before and after the 3-month of therapy., Results: A significant improvement was observed in the ABCLOVE therapy group as compared with the control group (p = 0.035). ABCLOVE therapy significantly reduced the hoarseness and roughness scores in school-aged children with vocal nodules. Additionally, a significant reduction in functional score, physical score, emotional score, and total pVHI score was observed in the ABCLOVE therapy group. Moreover, acoustic parameters including jitter (%) and shimmer (%) were significantly reduced, whereas MPT and DSI were increased in school-aged children with vocal nodules who received 3 months of ABCLOVE treatment., Conclusion: ABCLOVE therapy displayed effectiveness on school-aged children with vocal nodules after the treatment of budesonide., Competing Interests: Declaration of competing interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this article., (Copyright © 2024 Taiwan Pediatric Association. Published by Elsevier B.V. All rights reserved.)

Background: Eosinophilic oesophagitis (EoE) is a chronic immune-mediated disease. In Denmark, the budesonide orodispersible tablet (BOT) is recommended as a second-line treatment for proton pump inhibitor-refractory EoE patients., Aims: To evaluate the effectiveness of treatment with BOT in adult EoE patients in a population-based setting in Denmark., Methods: This was a retrospective, registry-based, DanEoE cohort study of all 76 adult EoE patients treated with BOT and diagnosed between 2007 and 2021 in the North Denmark Region. After medical record revision, the EoE diagnosis was defined according to the AGREE consensus. Symptomatic response was based on the information found in the patients' medical reports and histologic remission was defined as <15 eosinophils per high-power field (eos/hpf)., Results: Histologic remission was achieved in 89% of the patients treated with BOT who underwent histologic evaluation. Clinicohistologic remission was achieved in 71% of the patients who underwent both symptomatic and histologic evaluation. Despite histologic remission, 18% of patients still experienced symptoms. Non-responders were found in 7% of the patients. Complications were rare, with dilation of strictures performed in 7% and food bolus obstruction (FBO) occurring in 3%. Discontinuation of the treatment due to unacceptable side effects was observed in 11% of the treated patients., Conclusions: Treatment with BOT effectively induced histologic remission in most of the EoE patients. Despite achieving histologic remission, approximately 1/5 of the patients were still symptomatic. Complications were rare. In non-responders and those with unacceptable side effects, alternative treatment options such as biologic agents might be needed.

Eosinophilic esophagitis (EoE) is a chronic disorder characterized by eosinophilic inflammation of the oesophagus triggered by food allergens and possibly aeroallergens. We present a boy with the diagnosis of EoE at the age of 4 years and the disease responded to topical steroids. When he turned 7 years old he had the concomitant diagnose of grass pollen allergy. A clear difference between both histological (October 2019: 0 eosinophils (Eo's)/High Power Field (HPF), April 2022: 80 Eo's/ HPF) and clinical signs (October 2019: pediatric eoe symptom score (PEESS) 3/100, April 2022: PEESS 31/100) is evident when comparing winter to spring. The boy is currently only using topical budesonide during grass pollen season. There are increasing arguments in favour of aeroallergens as a trigger for EoE. This information is important for determining the timing of endoscopic follow-up. And it may be beneficial to consider upgrading treatment during allergy season, or exclusively administering treatment during allergy season., (© Acta Gastro-Enterologica Belgica.)

Background: Microscopic colitis (MC) is an inflammatory disorder of the colon. To date, the relationship between inflammatory eye diseases and MC is unclear., Objective: To assess whether inflammatory eye disease (iridocyclitis and episcleritis) is a risk factor for MC., Methods: We conducted a nationwide matched case control study in Sweden leveraging the ESPRESSO-study (a Swedish database containing data on all biopsies from the gastrointestinal tract from 1965 to 2017). In total, we identified 14,338 patients with biopsy-verified MC (diagnosed from 1981 to 2017). Patients with MC were matched (by age, sex, county and year of birth) with 68,753 controls from the general population and the occurrence of preceding inflammatory eye diseases (defined as diagnosis of episcleritis or iridocyclitis) in the two groups was compared. Multivariable adjusted odds ratios (aORs) were calculated using conditional logistic regression conditioned on the matching variables., Results: A majority of patients with MC were women (71.9%) and the median age at MC diagnosis was 63.3 years (interquartile range (IQR) = 50.7-72.6). Some 225 (1.6%) MC patients had an earlier record of inflammatory eye disease compared with 614 (0.9%) in controls. These figures corresponded to an aOR of 1.77 (95% CI = 1.52-2.07) for inflammatory eye diseases in patients with MC. Compared to siblings, the aOR for previous inflammatory eye diseases in MC was 1.52 (95% CI = 1.17-1.98) and patients treated with budesonide, as a proxy for clinically significant disease, had a somewhat higher aOR for previous inflammatory eye diseases., Conclusion: Inflammatory eye diseases are more common in patients subsequently being diagnosed with MC. Our findings highlight that these conditions may have shared causes and inflammatory pathways and are of clinical interest to gastroenterologists, ophthalmologists and general practitioners., (© 2024 The Author(s). United European Gastroenterology Journal published by Wiley Periodicals LLC on behalf of United European Gastroenterology.)

Background: Neonatal acute respiratory distress syndrome (NARDS) is an important cause of hypoxemic respiratory failure. This study aimed to investigate the short-term effects of endotracheal surfactant and budesonide combination therapy on NARDS secondary to late-onset neonatal sepsis (LONS)., Methods: This was a retrospective, cross-sectional, and observational study. Newborns with NARDS due to LONS who received endotracheal surfactant and budesonide combination therapy between August 2022 and September 2023 were included in this study. Oxygenation status before endotracheal surfactant and budesonide treatment were compared with the values obtained two hours after treatment., Results: Among 20 neonates, 10 (50%) were diagnosed with severe NARDS, and 10 (50%) were diagnosed with moderate NARDS. The mean corrected gestational age was 33.3±2.9 w when endotracheal surfactant and budesonide were administered to the neonates. The need for the fraction of inspired oxygen (0.75 [0.57-1.00]% vs. 0.55 [0.44-0.80]%; mean difference [MD]: 17.50%, 95% confidence interval [CI]: 14.99 to 22.50) and oxygen saturation index (OSI; 8.03 [4.98-13.94] vs. 4.71 [4.11-8.93]; MD: 2.23, 95% CI: 1.22 to 3.24) decreased ( P =0.001 and P <0.001, respectively) after endotracheal surfactant and budesonide treatment. However, preductal oxygen saturation (SpO 2 ; 93 [91-94]% vs. 95 [94-96]%; MD: -3.50%, 95% CI: -5.00 to -2.00) increased significantly after endotracheal surfactant and budesonide treatment when compared to pre-treatment values ( P <0.001)., Conclusion: The reduction in oxygen demand and OSI, along with an increase in SpO 2 after treatment compared to pre-treatment values, suggests that endotracheal surfactant and budesonide combination therapy could be an effective option to improve oxygenation in NARDS secondary to LONS., (© 2024 The Author(s). This is an open-access article distributed under the terms of the Creative Commons Attribution License (https://creativecommons.org/licenses/by/4.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.)

Objective: This study investigated the utilization of nebulized budesonide for acute asthma and COPD exacerbations as well as for maintenance therapy in adults., Data Sources: We conducted a search on PubMed for nebulized budesonide treatment., Selected Studies: Selecting all English-language papers that utilize Mesh phrases "asthma," "COPD," "budesonide," "nebulized," "adult," "exacerbation," and "maintenance" without temporal restrictions, and narrowing down to clinical research such as RCTs, observational studies, and real-world studies., Results: Analysis of 25 studies was conducted to assess the effectiveness of nebulized budesonide in asthma ( n  = 10) and COPD ( n  = 15). The panel in Thailand recommended incorporating nebulized budesonide as an additional or alternative treatment option to the standard of care and systemic corticosteroids (SCS) based on the findings., Conclusion: Nebulized budesonide is effective and well-tolerated in treating asthma and COPD, with less systemic adverse effects compared to systemic corticosteroids. High-dose nebulized budesonide can enhance clinical outcomes for severe and mild exacerbations with slow systemic corticosteroid response. Nebulized budesonide can substitute systemic corticosteroids in some situations.

In this study, a new and straightforward process for the preparation of budesonide 21-phosphate (Bud-21P) and its disodium salt (Bud-21P-Na2) is described. The method results in a yield comparable to those obtained by diphosphoryl chloride, but it is more manageable, less expensive, and safer. The new compounds are characterized by better water solubility compared to the parent compound. Moreover, they have been evaluated for their anti-inflammatory activity and the obtained results clearly evidence that Bud-21P and Bud-21P-Na2 retained anti-inflammatory activity like the parent compound budesonide (Bud) in mice with cutaneous induced edema.

Some cases of chronic rhinosinusitis (CRS) require surgical treatment and postoperative nasal packing, but bleeding and adhesion are common complications after nasal surgery. Biodegradable drug-loaded implants hold great therapeutic options for the treatment of CRS, but little data are available regarding the safety and efficacy of a novel drug-loaded haemostatic sponge (DLHS) in the sinus. The aim of this study was to investigate the safety and efficacy of DLHS in the sinus. We conducted a prospective, randomized, controlled, double-blind clinical trial. In this clinical trial, 49 patients were enrolled and randomly divided into 2 groups: group A (n = 25) had the DLHS containing 1 mg budesonide and 0.67 mg sodium hyaluronate placed into the sinus, and group B (n = 24) had the Nasopore placed after ESS. Endoscopic follow-up was performed for 12 weeks, and the findings were classified using the discharge, inflammation, polyps/oedema (DIP) endoscopic appearance scores. All patients completed questionnaires to evaluate their sinonasal symptoms by using the sinonasal outcome test-22 (SNOT-22) Chinese version and visual analogue scale (VAS). Serum cortisol concentration in group A was measured prior to surgery and at days 1, 3, 7, and 14 after nasal surgery. Comparing group A and group B, at 2 weeks, no significant differences were observed in either objective or subjective parameters. The mean value of VAS for rhinorrhoea and DIP for oedema and the mean value of nasal adhesion were significantly lower in Group A than in Group B at 6 and 12 weeks, but a significant difference did not occur in SNOT-22 and VAS for dysosmia between the two groups at 6 and 12 weeks. The mean serum cortisol concentrations in group A at the follow-up were within normal limits without remarkable fluctuations. This study demonstrates the safety and efficacy of a novel biodegradable DLHS with the possibility of being used in CRS patients, and this sponge may reduce inflammation and minimize adhesions via controlled local drug delivery without measurable systemic exposure., (© 2024. The Author(s).)

Eosinophilic esophagitis (EoE) is a chronic Th2-mediated inflammatory disease of the esophagus driven by dietary or inhalant allergens which if left untreated, leads to fibrosis and poor esophageal function. Although the inflammation in the esophagus is dominated by eosinophils, there are also elevated levels of T and B cells. Blood samples from ten patients with EoE before and after treatment with orodispersible budesonide and 10 healthy controls were compared using cytometry by time-of-flight. An antibody panel was designed that covers the major immunological cell populations with a particular focus on eosinophils. The data was analyzed with multivariate methods and cluster analysis. Correlation analysis was done between immune markers and endoscopic, histological, and symptomatologic assessments. Our analysis revealed that patients with EoE had lower levels of effector memory T cells after treatment with orodispersible budesonide to the same level as healthy subjects. In addition, more suppressive eosinophils were present in the circulation of EoE patients before treatment and more immature eosinophils were present after treatment. Furthermore, levels of galectin-10+ eosinophils correlated with histological findings in esophageal tissue from EoE patients. In all patients, the peak eosinophils were decreased after treatment with orodispersible budesonide. Intriguingly, 90% of the patients had remission in the histological assessment and 50% improved in the endoscopic assessment. This study reports a detailed immune profile in patients with EoE before and after treatment with orodispersible budesonide and it is a step toward finding blood-based immune parameters that could be useful to monitor response to treatment., (© The Author(s) 2024. Published by Oxford University Press on behalf of the British Society for Immunology.)

Background: Faecal microbiota transplantation [FMT] shows some efficacy in treating patients with ulcerative colitis [UC], although variability has been observed among donors and treatment regimens. We investigated the effect of FMT using rationally selected donors after pretreatment with budesonide or placebo in active UC., Methods: Patients ≥18 years old with mild to moderate active UC were randomly assigned to 3 weeks of budesonide [9 mg] or placebo followed by 4-weekly infusions of a donor faeces suspension. Two donors were selected based on microbiota composition, regulatory T cell induction and short-chain fatty acid production in mice. The primary endpoint was engraftment of donor microbiota after FMT. In addition, clinical efficacy was assessed., Results: In total, 24 patients were enrolled. Pretreatment with budesonide did not increase donor microbiota engraftment [p = 0.56] nor clinical response, and engraftment was not associated with clinical response. At week 14, 10/24 [42%] patients achieved [partial] remission. Remarkably, patients treated with FMT suspensions from one donor were associated with clinical response [80% of responders, p < 0.05] but had lower overall engraftment of donor microbiota. Furthermore, differences in the taxonomic composition of the donors and the engraftment of certain taxa were associated with clinical response., Conclusion: In this small study, pretreatment with budesonide did not significantly influence engraftment or clinical response after FMT. However, clinical response appeared to be donor-dependent. Response to FMT may be related to transfer of specific strains instead of overall engraftment, demonstrating the need to characterize mechanisms of actions of strains that maximize therapeutic benefit in UC., (© The Author(s) 2024. Published by Oxford University Press on behalf of European Crohn’s and Colitis Organisation.)

Introduction: Bile acid sequestrants (BAS) are an option for microscopic colitis (MC) refractory or intolerant to budesonide. There are inconsistent data on the prevalence of bile acid malabsorption (BAM) and utility of bile acid testing in MC. The aim of this systematic review and meta-analysis was to evaluate these outcomes., Methods: A systematic search of randomized control trials and observational studies of adults with MC treated with BAS was conducted using MEDLINE, Embase, Cochrane, and Scopus from inception to January 22, 2024. Data were extracted on (i) prevalence of BAM, (ii) clinical response and adverse events, and (iii) recurrence after BAS discontinuation. Data were pooled using random-effects models to determine weighted pooled estimates and 95% confidence intervals (CIs)., Results: We included 23 studies (1 randomized control trial, 22 observational), with 1,011 patients with MC assessed for BAM and 771 treated with BAS. The pooled prevalence of BAM was 34% (95% CI 0.26-0.42, I2 = 81%). The pooled response rate with BAS induction for all patients with MC, irrespective of BAM, was 62% (95% CI 0.55-0.70, I2 = 71%). There was a higher pooled response rate in patients with BAM compared with those without BAM ( P < 0.0001). The pooled rate of BAS-related adverse effects was 9% (95% CI 0.05-0.14, I2 = 58%)., Discussion: One-third of patients with MC had BAM, and almost two-thirds of all patients responded to BAS with limited side effects. Patients with MC and BAM were more likely to respond to therapy, supporting the value of bile acid testing., (Copyright © 2024 by The American College of Gastroenterology.)

Objective: This study aims to analyze the factors influencing the efficacy of budesonide (BUD) combined with N-acetylcysteine (NAC) treatment in children with Mycoplasma pneumoniae (MP) infection through Lasso-Logistic analysis, construct a Nomogram predictive model, and provide personalized treatment plans for clinicians. Additionally, it aims to fill the knowledge gap regarding the treatment of MP-infected children with BUD combined with NAC., Methods: We retrospectively analyzed clinical data from 96 children treated with BUD and NAC for MP infection at our hospital from January 2022 to May 2023. Treatment outcomes were categorized as good or poor. Logistic regression and Lasso-Logistic analysis were used to identify independent factors influencing outcomes and construct a predictive Nomogram model, which was validated through ROC curve analysis., Results: Logistic regression identified prolonged fever (≥7 days), high fever, and elevated levels of TNF-α, IL-6, and CRP as independent risk factors for poor outcomes. The Nomogram model, based on these factors, demonstrated excellent predictive accuracy with a C-index of 0.992 and AUC values of 0.987 and 0.948 in the modeling and validation cohorts, respectively., Conclusion: The developed Nomogram model provides clinicians with a reliable tool to predict poor treatment outcomes in children with MP infection treated with BUD and NAC, supporting more personalized and effective treatment plans.

Chronic rhinosinusitis with nasal polyps (CRSwNP) is a frequent medical condition. Type 2 inflammation signs CRSwNP in western countries. Type 2 inflammation leads to nasal airflow limitation. Budesonide aqueous nasal spray (BANS) is an intranasal corticosteroid (INCS); it has been launched in the early 1980s. BANS is indicated for treating allergic rhinitis, nonallergic rhinitis, and nasal polyps (both as treatment and prevention after surgery). Consolidated evidence documented its efficacy in treating CRSwNP. In addition, BANS is safe with negligible local and systemic side effects. Recent guidelines for patients with CRSwNP recommend using INCS as the first line in many situations. In particular, patients may assess the perception of symptoms' severity using the Visual Analog Scale (VAS). A score >5/10 means uncontrolled symptoms in both diseases and requires adequate treatment. BANS could appropriately be used in patients with uncontrolled symptoms and/or moderate/severe nasal obstruction. In addition, BANS may adequately integrate surgery and biologics for CRSwNP management. In conclusion, BANS represents a valuable option in managing patients with type 2-mediated CRSwNP.

Background: Fractional exhaled nitric oxide (FeNO) is used for the diagnosis and monitoring of asthma, although its utility to guide treatment and its correlation with other tools is still under discussion. We study the possibility to withdraw inhaled corticosteroid treatment in atopic patients with mild asthma based on the FeNO level, as well as to study its correlation with other clinical control tools., Methods: Prospective and randomized study including atopic patients aged 18 to 65 with mild asthma, stable, on low-dose inhaled corticosteroid (ICS) treatment, who had their treatment withdrawn based on a FeNO level of 40 ppb. Patients were randomized into two groups: control group (treatment with ICS was withdrawn regardless of FeNO level) and experimental group (according to the FeNO levels, patients were assigned to one of two groups: FeNO > 40 ppb on treatment with budesonide 200 mcg every 12 h and SABA on demand; FeNO ≤ 40 ppb only with SABA on demand). Follow-up was conducted for one year, during which medical assessment was performed with FeNO measurements, asthma control test (ACT), lung function tests (FEV1, FEV1/FVC, PEF, and RV/TLC), and recording of the number of exacerbations., Results: Ninety-two patients were included, with a mean age of 39.92 years (SD 13.99); 46 patients were assigned to the control group, and 46 patients to the experimental group. The number of exacerbations was similar between the groups (p = 0.301), while the time to the first exacerbation was significantly shorter in the control group (30.86 vs. 99.00 days), p < 0.001, 95% CI (43.332-92.954). Lung function tests (FEV1, FEV1/FVC, PEF, and RV/TLC) showed no differences between the groups (p > 0.05). Both FeNO and ACT showed significant changes in the groups in which ICS was withdrawn (p < 0.05 for both parameters). A significant negative correlation was observed between FeNO and ACT (r = -0.139, p = 0.008)., Conclusions: In atopic patients with mild asthma, withdrawal of ICS based on an FeNO of 40 ppb led to worsened symptoms but without changes in lung function tests or an increase in exacerbations. There was a negative correlation between FeNO values and symptomatic control measured by the ACT., Trial Registration: Clinical Trial Number: 2012-000372-42. Start Date: 2012-07-23. Trial registered prospectively ( https://www.clinicaltrialsregister.eu/ctr-search/search?query=2012-000372-42 ). This study adheres to CONSORT guidelines of randomised control trials., (© 2024. The Author(s).)

Purpose: To evaluate the therapeutic efficacy of intravenous amoxicillin clavulanate potassium combined with nebulized budesonide and ambroxol hydrochloride in pediatric community-acquired pneumonia (CAP) and its impact across various microbial strains and clinical symptoms. The primary objective of this study is to evaluate the efficacy of intravenous amoxicillin-clavulanate combined with nebulized budesonide and ambroxol hydrochloride in the treatment of pediatric community-acquired pneumonia (CAP), and to analyze their impact on different microbial strains and clinical symptoms. Secondary objectives include assessing the treatment's effect on the improvement of clinical symptoms, hospital stay duration, and the levels of inflammatory markers., Design: Prospective, single-center study., Methods: Fifty-six children with CAP, aged under 6 years, from Affiliated Maternity and Child Health Care Hospital of Nantong University were included. Patients were treated with conventional therapy and the study medication. Clinical characteristics, microbiological data, symptom improvement, and hospitalization times were analyzed., Findings: Young children, particularly under 1 year, exhibited a higher incidence of multiple microbial infections and severe clinical manifestations. Treatment with budesonide and ambroxol hydrochloride led to significant clinical improvement across all age groups, with notable efficacy against various pathogens., Conclusions: Nebulized budesonide and ambroxol hydrochloride are effective in treating pediatric CAP, offering a promising therapeutic option, particularly for young children with severe presentations., (© 2024. The Author(s).)

Allergic rhinitis (AR) is a prevalent disease in childhood and adolescence. A type 2 inflammation characterizes AR and, mainly, sustains nasal obstruction. Budesonide aqueous nasal spray (BANS) is an intranasal corticosteroid (INCS) available since the early 1980s. BANS is indicated for treating allergic rhinitis. There is evidence about its efficacy in treating children and adolescents with seasonal and perennial AR. In addition, BANS is safe with negligible local and systemic side effects. Recent guidelines for patients with AR recommend the use of INCS as first line in many situations. In particular, AR patients (and their parents) may assess the perception of symptoms' severity using the Visual Analog Scale (VAS). A score ≥5/10 means uncontrolled symptoms and requires adequate treatment. BANS could appropriately be used in patients with uncontrolled symptoms and/or moderate/severe nasal obstruction. In conclusion, BANS represents a valuable option in managing children and adolescents with AR.

Key Points: Nebulized budesonide is effective at half dose compared to budesonide irrigation in CRS. Nasal nebulizers provide an alternative for delivery of topical steroids to the sinuses., (© 2024 The Authors. International Forum of Allergy & Rhinology published by Wiley Periodicals LLC on behalf of American Academy of Otolaryngic Allergy and American Rhinologic Society.)

Background: Previous studies have reported reduced acute exacerbation rates and improved symptom control in asthma patients treated using inhaled corticosteroids plus formoterol maintenance and reliever therapy (MART). Fluticasone furoate (FF) and vilanterol (VIL) also provide rapid bronchodilation and sustained anti-inflammatory effects, however no studies have investigated FF/VIL as MART for asthma control., Methods: From October 1, 2021 to September 30, 2023, this retrospective study included asthma patients classified as step 3 or 4 according to the Global Initiative for Asthma guidelines, who were then divided into two groups. One group received BUD/FOR as MART, while the other received FF/VIL as MART. Pulmonary function tests, exacerbation rates, Asthma Control Test (ACT), fractional exhaled nitric oxide (FeNO) levels, and blood eosinophil counts were measured before and after 12 months of treatment., Results: A total of 161 patients were included, of whom 36 received BUD/FOR twice daily as MART, and 125 received FF/VIL once daily as MART. After 12 months of treatment, the FF/VIL group showed a significant increase in ACT scores by 1.57 (p < 0.001), while the BUD/FOR group had an increase of 0.88 (p = 0.11). In terms of FeNO levels, the BUD/FOR group experienced a decline of -0.2 ppb (p = 0.98), whereas the FF/VIL group had a mild increase of + 0.8 ppb (p = 0.7). Notably, there was a significant difference in the change of FeNO between the two groups (∆ FeNO: -0.2 ppb in BUD/FOR; + 0.8 ppb in FF/VIL, p < 0.001). There were no significant alterations observed in FEV1, blood eosinophil count, or acute exacerbation decline in either group., Conclusions: In the current study, patients treated with FF/VIL as MART showed improvements in ACT scores, while those treated with BUD/FOR as MART exhibited a reduction in FeNO levels. However, the difference between the two treatment groups did not reach clinical significance. Thus, FF/VIL as MART showed similar effectiveness to BUD/FOR as MART., (© 2024. The Author(s).)

Objective: To assess the clinical effect of Qingre Bawei capsules combined with budesonide in the treatment of acute exacerbation of chronic obstructive pulmonary disease., Methods: The retrospective study was conducted at the Baoding No.1 Central Hospital, China, and comprised data of patients with acute exacerbation of COPD admitted between June 1, 2020, and June 30, 2022. The patients were divided into two groups based on treatment methods. The group A had been treated with Qingre Bawei capsules in combination with budesonide, while the group B had been treated with budesonide alone. Both the groups had been treated for 2 consecutive weeks. The changes in blood gas indicators, inflammation indicators, and lung function indicators were compared between two groups of patients before and 24 hours after treatment. The time for clinical symptom disappearance and adverse reactions between the two groups of patients was also noted., Results: Of the 120 patients, 60(50%) were in group A; 41(68.3%) males and 19(31.7%) females, with mean age 65.28±4.36 years (range: 47-78 years) and mean course of disease 31.22±4.75 hours (range: 6-65 hours). 60(50%) patients were in group B; 43(71.7%) males and 17(28.3%) females with mean age 65.31±4.31 years (range: 48-78 years) and mean course of disease 31.29±4.71 hours (range: 8-68 hours). The disappearance time of clinical symptoms in group A was better than group B (p<0.05). The levels of blood gas indicators, inflammation indicators, and lung function indicators in both groups significantly improved (p<0.05), but the degree of improvement in group A was better than group B (p<0.05); The total effective rate of group A was better than group B (p<0.05). None of the patients in either group experienced any significant adverse reaction., Conclusions: Qingre Bawei capsules combined with budesonide had a significantly better therapeutic effect on cases of acute exacerbation of chronic obstructive pulmonary disease compared to budesonide alone.

Immunoglobulin A nephropathy (IgAN) is a chronic, immune-mediated kidney disease characterized by the deposition of galactose-deficient immunoglobulin A1 (Gd-IgA1) in the kidneys. Excess Gd-IgA1 production in patients with IgAN is located within the mucosa-associated lymphoid tissue, particularly within the lamina propria in the distal ileum. Nefecon ® is a targeted-release formulation of the corticosteroid budesonide, which became the first treatment approved by the US Food and Drug Administration (FDA; brand name, TARPEYO ® ) and European Medicines Agency (EMA; KINPEYGO ® ) for patients with primary IgAN at risk of rapid disease progression, after demonstrating clinically significant reduction of proteinuria in an interim analysis of the Phase III NefIgArd trial. After showing a significant reduction in estimated glomerular filtration rate decline in the full 2-year analysis of the trial, Nefecon was granted full approval by the FDA to reduce the loss of kidney function. Nefecon was specifically designed to deliver budesonide to the distal ileum, selectively targeting excess Gd-IgA1 production in the gut-associated lymphoid tissue. In this review, we describe the properties of Nefecon and the evidence to date that confirms its localized treatment effect. We also present unpublished evidence from Phase I trials investigating the pharmacokinetics and cortisol suppression effects of Nefecon in healthy participants. These studies demonstrated that Nefecon has a distinct pharmacokinetic profile from other budesonide products, allowing for targeted, localized action in the distal ileum. When considered alongside existing clinical trial data showing the effect of Nefecon on gut-associated biomarkers, available evidence indicates that Nefecon has a selective immunomodulatory mechanism of action and a direct disease-modifying effect in patients with IgAN, while having low systemic exposure and adverse effects., Competing Interests: JB is a consultant to Calliditas Therapeutics AB and reports grants and consultancy and personal fees from Calliditas Therapeutics, Everest Medicines, and STADA Arzneimittel AG. JK and MJ are consultants for Calliditas Therapeutics. CP is an employee of Calliditas Therapeutics. The authors report no other conflicts of interest in this work., (© 2024 Barratt et al.)

To assess the impact of budesonide-formoterol on pulmonary ventilation function and prognosis in patients with mild-to-moderate acute exacerbations of bronchial asthma. A retrospective analysis was conducted on clinical data from 232 patients with acute exacerbations of bronchial asthma. These patients were divided into 2 groups based on their treatment: a control group (n=104) receiving budesonide dry powder inhalation and an observation group (n=107) receiving budesonide-formoterol dry powder inhalation. Clinical efficacy and safety indicators were compared. The results showed that the total treatment effectiveness rate in the observation group was significantly higher than that in the control group. Following treatment, the observation group exhibited significantly higher scores in the Asthma Quality of Life Questionnaire (AQLQ), as well as improved levels of forced expiratory volume in one second (FEV1), forced vital capacity (FVC), and peak expiratory flow (PEF), compared to the control group. Moreover, levels of tumor necrosis factor-alpha, interleukin-6, and C-reactive protein were significantly lower in the observation group. The incidence of adverse reactions between groups was comparable. Based on these findings, the application of budesonide-formoterol demonstrated significant effectiveness in patients with mild-to-moderate acute exacerbations of bronchial asthma. The combination therapy led to improved clinical outcomes, including enhanced pulmonary ventilation function and reduced inflammatory markers. Importantly, the safety profile of budesonide-formoterol was comparable to that of budesonide monotherapy. These results highlight the potential benefits of using budesonide-formoterol as an alternative treatment option for patients experiencing acute exacerbations of mild-to-moderate bronchial asthma.

Background: Limited data exist for management strategies targeting immunotherapy-related enteritis (irEnteritis). Systemic corticosteroids are commonly used but often are limited by adverse events. Enteric corticosteroids such as budesonide offer an attractive alternative; however, the ileocolonic release of enteric-coated budesonide has limited utility for diffuse enteritis. Open-capsule budesonide (OCB) is a novel therapeutic approach that offers drug delivery throughout the small bowel. We report outcomes in patients treated with OCB for confirmed or suspected irEnteritis., Methods: This retrospective cohort included all individuals treated with OCB for irEnteritis at Memorial Sloan Kettering from July 2018 to August 2023. Primary outcomes included clinical response, clinical remission, and corticosteroid-free remission following OCB. Secondary outcomes were OCB-related adverse events and efficacy by gastrointestinal toxicity location., Results: 19 patients (53% female) with irEnteritis were treated with OCB. All patients presented with diarrhea; 15 (79%) reported anorexia with median 6 kg weight loss. 17 patients (89%) underwent esophagogastroduodenoscopy with biopsies revealing enteritis in all; 8 (42%) had concomitant colitis. 15 (79%) patients were treated previously with systemic corticosteroids: 8 (53%) were corticosteroid-dependent while 7 (47%) demonstrated non-response. 18 patients (95%) achieved clinical response, 15 (79%) attained clinical remission, and 11 (58%) had corticosteroid-free remission. Response to OCB was rapid with improvement noted after a median 4 days. 14 (74%) patients restored their pre-irEnteritis weight by OCB cessation. One mild, self-resolving adverse event was reported., Conclusions: OCB is a safe and effective therapy for irEnteritis. OCB avoids systemic immunosuppression and successfully achieves clinical response and remission even in patients previously nonresponsive to systemic corticosteroids. Future studies are needed to optimize indications and duration., Competing Interests: Competing interests: MP has received consulting fees from BMS, Merck, Novartis, Eisai, Pfizer, and Chugai; and institutional support from RGenix, Infinity, BMS, Merck, and Novartis. DF has received consulting fees from AzurRx, Equillium, Gilead, Janssen, Mallinckrodt Pharmaceuticals, OnQuality Pharmaceuticals and Teva. All other authors have no disclosures., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Background: Microscopic colitis (MC) is a common cause of chronic diarrhea. Randomized controlled trials (RCTs) have demonstrated the efficacy of budesonide treatment for MC. However, relapse is frequent after discontinuation of budesonide, and data on maintenance therapy are limited. We performed a systematic review and meta-analysis evaluating these outcomes in clinical trials and real-world settings., Methods: A systematic search was performed on October 31, 2022, of Medline, Embase, Cochrane, and Scopus. Case series, case-control, cohort studies, and RCTs of adults with MC were included. Data were pooled using random effects models to calculate weighted pooled estimates and 95% confidence intervals. Heterogeneity was assessed using the I2 statistic., Results: We included 35 studies (11 RCTs, 24 observational studies) with 1657 MC patients treated with budesonide induction and 146 for maintenance. The overall pooled clinical remission rate with budesonide treatment was similar between RCTs and observational studies. The pooled remission rate with budesonide maintenance therapy was 84% (95% CI, 0.60-1.00; I2 = 91%). After budesonide discontinuation, the pooled relapse rate was 53% (95% CI, 0.42-0.63; I2 = 76%). On maintenance therapy, no differences were noted in adverse events (eg, metabolic bone disease, hypertension, hyperglycemia, cataracts/glaucoma) in those on budesonide vs placebo or other noncorticosteroid medications for MC (P = .9)., Conclusions: Budesonide is an effective maintenance treatment for MC. There is a high risk of recurrence after budesonide discontinuation, but long-term use at the lowest effective dose appears to be relatively safe and have limited adverse effects., (© The Author(s) 2023. Published by Oxford University Press on behalf of Crohn’s & Colitis Foundation. All rights reserved. For commercial re-use, please contact reprints@oup.com for reprints and translation rights for reprints. All other permissions can be obtained through our RightsLink service via the Permissions link on the article page on our site—for further information please contact journals.permissions@oup.com.)

Inflammatory bowel disease (IBD) is a chronic and recurrent inflammatory disease that affects the gastrointestinal tract. The major hurdles impeding IBD treatment are the low targeting efficiency and short retention time of drugs in IBD sites. Nanoparticles with specific shapes have demonstrated the ability to improve mucus retention and cellular uptake. Herein, mesoporous silica nanoparticles (MSNs) with various morphologies were used to deliver budesonide (BUD) for the treatment of IBD. The therapeutic efficacy is strongly dependent on their shapes. The system comprises different shapes of MSNs as carriers for budesonide (BUD), along with Eudragit S100 as the enteric release shell. The encapsulation of Eudragit S100 not only improved the stability of MSNs-BUD in the gastrointestinal tract but also conferred pH-responsive drug release properties. Then, MSNs efficiently deliver BUD to the colon site, and the special shape of MSNs plays a critical role in enhancing their permeability and retention in the mucus layer. Among them, dendritic MSNs (MSND) effectively reduced myeloperoxidase (MPO) activity and levels of inflammatory cytokines in the colon due to long retention time and rapid release in IBD sites, thereby enhancing the therapeutic efficacy against colitis. Given the special shapes of MSNs and pH-responsivity of Eudragit S100, BUD loaded in the voids of MSND (E@MSNs-BUD) could penetrate the mucous layer and be accurately delivered to the colon with minor side effects. This system is expected to complement current treatment strategies for the IBD.

Objectives: Oral viscous budesonide (OVB) is a common medication used to treat eosinophilic esophagitis (EoE). It is typically mixed with Splenda to produce a slurry, but other delivery vehicles have been used in clinical practice. We aimed to evaluate outcomes of pediatric EoE patients treated with OVB using different drug delivery vehicles., Methods: We performed a retrospective chart review of pediatric EoE patients treated with OVB. The primary aim was to evaluate rates of histologic remission (defined by <15 eosinophils per high power field in both mid and distal esophagus) after 6-12 weeks of OVB treatment for each delivery vehicle. Secondary aims were to evaluate histologic response and endoscopic response and remission of different delivery vehicles, and to compare the efficacy of different treatment regimens., Results: A total of 111 patients were included in the study. Median treatment duration was 3.4 months. Overall rate of histologic remission with OVB was 52.6%. There was no difference in rates of histologic remission (p = 0.313) or response (p = 0.195 and p = 0.681 in mid and distal esophagus, respectively) among the different vehicle types or treatment regimens. Similarly, there was no difference in endoscopic remission and response among the different vehicle types (p = 0.853 and p = 0.727) or treatment regimens (p = 0.244 and p = 0.157). Patients who achieve histologic remission were more likely to be non-Hispanic Caucasian., Conclusion: Our findings suggest there is no difference in histologic and endoscopic outcomes with various delivery vehicles or combination therapy with OVB in the treatment of EoE. More palatable and cost-effective vehicles can be used to treat EoE., (© 2024 European Society for Pediatric Gastroenterology, Hepatology, and Nutrition and North American Society for Pediatric Gastroenterology, Hepatology, and Nutrition.)