Corticosteroid Usage Research Articles

INDIVIDUAL ARTICLE: Appraisal of Ruxolitinib 1.5% Cream as a First-Line Topical Therapeutic Agent for Adolescents and Adults With Mild-to-Moderate Atopic Dermatitis.

Dermatology has entered the long-awaited paradigm shift from steroidal to non-steroidal therapeutics for the topical treatment of atopic dermatitis. Topical Janus kinase (JAK) inhibitors have garnered a strong recommendation for the treatment of adult atopic dermatitis (AD) by the American Academy of Dermatology in the most recent updated guidelines as of 2023. Ruxolitinib 1.5% cream is the only FDA-approved topical JAK inhibitor available in the US and is approved for the short-term and intermittent chronic treatment of mild-to-moderate AD in adolescents and adults aged >= 12 years with up to 20% affected body surface area (BSA). Since approval in 2021, ruxolitinib cream has been shown to be consistently effective across disease severities, age groups, and anatomic sites of special interest (ie, head and neck region, hands). Real-world usage as monotherapy and in combination with other topicals have confirmed its efficacy in practice and further led to reduced usage of topical corticosteroids. Ruxolitinib cream also has the potential to reduce economic costs due to AD-related decline in work productivity. Here, we review the most up-to-date clinical trial and real-world efficacy data that position ruxolitinib 1.5% cream as a first-line AD therapeutic. J Drugs Dermatol. 2025;24:2(Suppl 2):s5-15.

High-Titer Rheumatoid Factor is Associated with Worse Clinical Outcomes and Higher Needs for Advanced Therapies in Rheumatoid Arthritis Under Real-Life Conditions.

Rheumatoid factor (RF) plays an important role in rheumatoid arthritis (RA) pathophysiology, yet the differential effects of varying RF titers remain understudied. We evaluated associations between different RF titers and clinical outcomes in long-standing RA. This multicenter, cross-sectional study included adults meeting ACR/EULAR (2010) criteria for RA. Circulating RF titers and clinical-epidemiological characteristics were evaluated. Bivariate (Student's t and chi-squared tests) tests and multiple logistic and linear regression analyses were conducted. We included 1097 participants; 78.7% had positive RF, with high titers (≥ 3 × the upper limit of normality) in 56.2%. Negative vs. low-positive RF groups performed similarly concerning all clinical outcomes, being subsequently aggregated as "non-high" RF group. High RF titers (compared to "non-high") were associated with tobacco use (odds ratio, OR [95% confidence interval, CI]: 2.04 [1.35, 3.08]; p < 0.001), multiraciality (OR [95% CI] 1.31 [1.03, 1.67]; p = 0.028, compared to White race), and higher body mass index (mean difference [95% CI] 0.69 [0.05, 1.33] kg/m2; p = 0.033). In multivariate analyses, high-titer RF was independently associated with higher disease activity (Clinical Disease Activity Index, CDAI: β = 2.44 [0.89, 3.99], p = 0.002), worse functional capacity (Health Assessment Questionnaire Disability Index, HAQ-DI: β = 0.112 [0.018, 0.205], p = 0.020); extra-articular manifestations (OR 1.48 [1.09, 2.00], p = 0.011); increased corticosteroid (OR 1.53 [1.19, 1.96], p = 0.001) and biological disease-modifying antirheumatic drugs (bDMARD) use (OR 1.41 [1.08, 1.84], p = 0.011). High RF titers in long-standing RA were associated with worse disease activity, lower physical functionality, increased extra-articular manifestations, and higher usage of corticosteroids and bDMARDs. Comparing high vs. non-high RF titers (rather than positive vs. negative RF) seems more useful for evaluating the clinical effects of RF in RA. This approach should be considered in future studies of RF.

Xylometazoline-induced change in aspirated nasal nitric oxide detects obstructed paranasal ostia

The concentrations of nasal nitric oxide (nNO) vary in patients with chronic rhinosinusitis (CRS) supposedly depending upon whether the paranasal ostia are open or obstructed. Our aim was to assess whether nNO levels and their response to topical xylometazoline (a local vasoconstrictor used to alleviate nasal congestion) in patients with CRS differ between those with open or obstructed ostia and if the results were altered by the use of nasal corticosteroids. Sixty-six patients with CRS (43% with nasal polyps) or recurrent acute rhinosinusitis and 23 healthy controls were included. Nasal NO was measured (EcoMedics CLD 88p analyser) before and after two xylometazoline sprays during three consecutive visits: with the medication they were using when they were referred, after 4 weeks of medication pause, and after 4 weeks of using intranasal fluticasone propionate. The relative difference between the nNO before and after dosing of xylometazoline was calculated, and ostial obstruction was evaluated with cone-beam computed tomography at every visit. The nNO measurements were lowest in the patients with CRS and obstructed paranasal ostia. The presence or absence of nasal polyps did not affect the results. Xylometazoline did not significantly affect nNO in the subjects with obstructed ostia, but there was a significant reduction of nNO in those with open ostia. The Xylometazoline-induced change in nNO between the groups with open or obstructed ostia was significantly different at each visit: 'on previous medication' 10% (-5-25) versus -14% (-19 to -9),p= 0.004, 'after medication pause' 6% (-5-17) versus -16% (-23 to -9),p= 0.001 and 'after regular fluticasone spray' 6% (-3-15) versus -9% (-16 to -3),p= 0.04. The native nNO and xylometazoline-induced change in nNO can be used to detect the status of ostial obstruction in patients with CRS irrespective of their topical corticosteroid usage.

P0982 Efficacy of upadacitinib in patients with Crohn’s disease and an ostomy: A matched retrospective real-world cohort analysis

Abstract Background Upadacitinib (UPA) is an oral selective Janus kinase inhibitor approved for the management of moderate-to-severe Crohn’s disease (CD). One in ten CD patients may need a permanent ostomy (colostomy or ileostomy) during their disease course, and this may impact the efficacy of UPA, given its extended-release formulation. However, there is no data available in this population since patients with an ostomy are excluded from registrational CD trials. This study addresses this gap by comparing the real-world clinical effectiveness of UPA in CD patients with and without ostomy. Methods This retrospective cohort study analyzed data from the TriNetX US Collaborative Network of sixty-eight tertiary institutions, to examine adult (≥18 years) CD patients treated with UPA from May 19th, 2023 (FDA approval date) to October 31st, 2024. Patients were categorized based on presence or absence of an ostomy during the previous 5 years, after exclusion of patients with rheumatologic disease indications for UPA usage. A 1:1 propensity score matching (PSM) was performed to balance cohorts on demographics, baseline comorbidities, and CD severity indicators (CD phenotype, extraintestinal manifestations, concurrent corticosteroid and other biologics usage, hemoglobin, and body weight). Cox proportional hazards model estimated hazard ratios (HRs) in matched cohorts for clinical effectiveness as a composite outcome (corticosteroid use, hospitalizations, emergency room visits) and secondary individual outcomes, at one year post-treatment, with a significance threshold set at p &amp;lt; 0.05. Results The study sample of CD patients on UPA included 170 with and 1,428 without a prior ostomy. There were 144 patients in each cohort after PSM. Baseline characteristics of the cohorts are shown in Figure 1. After PSM (Figure 2), there were no significant differences between patients with CD on UPA, with and without prior ostomy, for composite outcomes (HR 0.93, p = 0.64), corticosteroid use (HR 0.78, p = 0.18), hospitalizations (HR 1.13, p = 0.64), or emergency room visits (HR 0.99, p = 0.97). Additionally, no significant differences were observed in opioid use (HR 0.95, p = 0.76), switch to another advanced therapy (HR 1.62, p = 0.06), or elevated biomarkers, including CRP (&amp;gt;10 mg/L, HR 1.00, p = 0.99) and fecal calprotectin (&amp;gt;150 µg/g, HR 0.85, p = 0.63) at the 1-year follow-up. Conclusion In CD patients, UPA demonstrated similar effectiveness for clinical outcomes of corticosteroid use, hospitalizations, emergency room visits and other secondary outcomes, regardless of their ostomy status.

Epidemiological and clinical characteristics of hospitalized pediatric patients with Mycoplasma pneumoniae pneumonia before and after the COVID-19 pandemic in China: a retrospective multicenter study

BackgroundIn China many respiratory pathogens stayed low activities amid the COVID-19 pandemic due to strict measures and controls. We here aimed to study the epidemiological and clinical characteristics of pediatric inpatients with Mycoplasma pneumoniae pneumonia (MPP) after the mandatory COVID-19 restrictions were lifted, in comparison to those before the COVID-19 pandemic.MethodsWe here included 4,296 pediatric patients with MPP, hospitalized by two medical centers in Jiangsu Province, China, from January 2015 to March 2024. Patients were divided into the pre-COVID (n = 1,662) and post-COVID (n = 2,634) groups. Their baseline characteristics, laboratory test results and radiological patterns were separately assessed and compared between the two groups to determine the substantial changes in the disease profile of MPP after the COVID-19 pandemic.ResultsEpidemiological results suggested a higher annual incidence of MPP after the COVID-19 pandemic when the outbreak reached a peak in October, two months delayed in seasonality compared to that in the pre-COVID era. For pediatric patients with MPP, there was no difference in their median ages, gender ratios, and severe case percentages between the two groups, where most patients were younger than 14 years old. With significance, the post-COVID group had more occurrences of cough and expectoration and higher incidences of influenza A/B virus (IAV/IBV) co-infection than the pre-COVID group. Many hematological parameters and radiological features between the two groups displayed alteration, but comparatively there demonstrated no worsened severity in hospitalized children with MPP after COVID-19 pandemic. Concurrently, the post-COVID group was administered with fewer antibiotics but more corticosteroids for effective treatment than the pre-COVID group.ConclusionThrough the COVID-19 pandemic, the epidemiological and clinical characteristics of pediatric patients with MPP differed, but there was no evident change in the disease severity. After the COVID-19 pandemic, the increased incidence of IAV/IBV co-infection may contribute to the differences in clinical symptoms and hematological profiles, while the adding usage of corticosteroids might treat more effectively.

Is there an Increase in Total Hip Arthroplasty Due to Osteonecrosis of Femoral Head After Covid-19 Pandemic?: A Retrospective Study Among Patients in Central Karnataka, India.

Coronavirus disease 2019 (COVID-19) infection or corticosteroid usage during the COVID-19 pandemic as risk factors for avascular necrosis (AVN) of the femoral head (osteonecrosis of the femoral head/femoral head AVN [FHAVN]), as well as its link to clinical and radiological outcomes, are poorly understood. Osteonecrosis, which results from a disruption in vascular supply to the femoral head, is a prevalent cause of hip joint deterioration and one of the most common reasons for total hip arthroplasty (THA)/total hip replacement in India and other Asian countries. This study will aid in understanding the condition's epidemiology and statistically determining the risk of disease related with pandemic exposure. This is a retrospective study of 100 hips diagnosed with osteonecrosis/osteoarthritis of the femoral head that underwent THA at a tertiary care center before and after the COVID-19 pandemic between February 2014 and February 2024. Late stages of FHAVN, when the diagnosis requiring THA, following the pandemic have increased exponentially. It has also switched from affecting the middle-aged to the younger age groups. Furthermore, the bilaterality necessitating THA has increased considerably. There is a clear shift in the presentation of this disabling illness, as well as the need for THA, which otherwise is rarely carried out on younger people. Furthermore, data on how much corticosteroids were used in the treatment is disturbingly scant, and how it may have contributed to this ailment in India is still questionable. The COVID-19 pandemic could be the most serious threat, causing late-stages FHAVN (stages 3 and 4 of the Ficat and Arlet classification), in an accelerated manner, necessitating THA and overburdening existing medical care.

Risk of avascular necrosis in patients with inflammatory bowel disease: Insights from a nationwide cohort study and the impact of corticosteroid use

Corticosteroid use is a risk factor for avascular necrosis (AVN) and inflammatory bowel disease (IBD) patients are often exposed to higher corticosteroid usage. We investigated the epidemiology and risk factors of AVN in a nationwide population-based cohort of IBD patients. Patients newly diagnosed with IBD were identified, and sex- and age-matched participants from the general population were selected in a 1:3 IBD:non-IBD ratio. We investigated newly diagnosed AVN and assessed the incidence rates and risk of AVN with multivariate Cox regression models. During the median follow-up period of 7.22±3.85 years, 357 (0.62 %) were newly diagnosed with AVN. The risk of AVN was higher in IBD (aHR = 1.42, 95 % CI: 1.25-1.62). Ulcerative colitis (UC) patients showed a particularly elevated risk of developing AVN. IBD patients with higher cumulative corticosteroid intake and exposed to a mean prednisolone-equivalent daily dose>20 mg for >1 month were at higher risk of AVN. In Crohn's disease (CD), longer exposure time to >20 mg prednisolone-equivalent presented a trend in increased risk. AVN risk was higher in IBD than in those without, particularly in UC and corticosteroid use in IBD could pose a crucial role. These underscore the importance of considering the AVN etiological factors, particularly corticosteroid use.

Optimizing growth in pediatric renal transplant recipients: An update.

Growth retardation is a significant complication observed in pediatric renal transplant recipients, originating from a multifactorial etiology. Factors contributing to growth impairment encompass pre-transplant conditions such as primary kidney disease, malnutrition, quality of care, growth deficits at the time of transplantation, dialysis adequacy, and the use of recombinant human growth hormone. Additionally, elements related to the renal transplant itself, such as living donors, corticosteroid usage, and graft functioning, further compound the challenge. Although renal transplantation is the preferred renal replacement therapy, its impact on achieving final height and normal growth in children remains uncertain. The consequences of growth delay extend beyond the physiological realm, negatively influencing the quality of life and social conditions of pediatric renal transplant recipients, and ultimately affecting their educational and employment outcomes. Despite advancements in graft survival rates, growth retardation remains a formidable clinical concern among children undergoing renal transplantation. Major risk factors for delayed final adult height include young age at transplantation, pre-existing short stature, and the use of specific immunosuppressive drugs, particularly steroids. Effective management of growth retardation necessitates early intervention, commencing even before transplantation. Strategies involving the administration of recombinant growth hormone both pre- and post-transplant, along with protocols aimed at minimizing steroid usage, are important for achieving catch-up growth. This review provides a comprehensive outline of the multifaceted nature of growth retardation in pediatric renal transplant recipients, emphasizing the importance of early and targeted interventions to mitigate its impact on the long-term well-being of these children from birth to adolescence.

The economic burden of asthma in Italy: evaluating the potential impact of different treatments in adult patients with severe eosinophilic asthma.

Asthma is a prevalent chronic respiratory condition that significantly impacts public health, with severe asthma subtypes, such as severe eosinophilic asthma, imposing substantial socioeconomic burdens. Real-world data from the Italian Health Information System were analyzed to evaluate the economic consequences of asthma in Italy. An in-depth comparative analysis was conducted to investigate the economic implications of various asthma subtypes, focusing on severe eosinophilic asthma. Additionally, the study projected the potential cost-effectiveness of novel treatments aimed at reducing hospitalization rates, specialist visits, and oral corticosteroid use for patients with severe eosinophilic asthma in Italy. The analysis revealed that severe asthma, and notably severe eosinophilic asthma, places a substantial economic burden on the Italian National Health System. Estimates demonstrated that implementing innovative treatments to mitigate the risks of hospitalization and specialist visits, as well as reducing oral corticosteroid usage in severe eosinophilic asthma patients, could lead to significant cost savings. The cost-consequence analysis indicated potential yearly reductions of €50.0 million (27%) for the treatment of severe asthma and €31.7 million (26%) for severe eosinophilic asthma. This study presents a comprehensive evaluation of the economic repercussions of severe asthma in Italy. The findings emphasize the necessity of identifying and developing effective therapeutic strategies to improve the management of severe asthma while simultaneously reducing the economic burden on the healthcare system. These results offer valuable insights for healthcare policymakers and practitioners, facilitating evidence-based decisions in asthma management and healthcare policy in Italy.

Assessment of Attack Frequency in PFAPA Patients Based on Therapeutic Modalities.

This study aims to present the clinical characteristics of patients with PFAPA syndrome, and to compare the effects of corticosteroid usage, colchicine prophylaxis, and tonsillectomy on the frequency of attacks in patients with PFAPA syndrome. Patients aged between 6 months and 18 years presenting to our Paediatric Rheumatology clinic between 2017 and 2021 who were diagnosed with PFAPA syndrome and followed up for a minimum of 12 months were included in this study. The demographic and clinical characteristics of the patients, laboratory findings, attack durations, and treatments were recorded. Our study, comprised of 195 patients, included four groups: untreated (n = 58), corticosteroid (n = 43), colchicine (n = 62), and tonsillectomy (n = 32). There was no significant difference between the treatment groups in terms of attack frequencies before treatment initiation (p > 0.05). When attack frequencies before and after treatment initiation were observed, a decrease in attack frequency compared to the pre-treatment period was observed in the tonsillectomy group (from 12 to 3 attacks) (p < 0.001) and the colchicine group (from 12 attacks to 1 attack) (p < 0.001). It was noted that using steroids during three or more attacks increased attack frequency compared to the pre-treatment period (p < 0.0001). Tonsillectomy resulted in a more significant reduction in attack frequency compared to the colchicine group (p < 0.001). Using corticosteroids during an attack has been shown to effectively control attacks. However, the repeated use of corticosteroids increases the frequency of attacks. Colchicine prophylaxis leads to a reduction in attack frequency in the majority of cases. Tonsillectomy can successfully control the disease in most cases.

Clinical Outcomes Through Two Years for Infants With Bronchopulmonary Dysplasia and Tracheomalacia.

Tracheomalacia (TM) is common in infants with bronchopulmonary dysplasia (BPD) and associated with respiratory morbidity. Assessment of TM was historically via bronchoscopy, but recent studies demonstrate that ultrashort echo-time (UTE) magnetic resonance imaging (MRI) can accurately assess TM in neonates. Do neonates with MRI-identified TM and BPD have increased respiratory morbidity through age 2 years? We performed an observational cohort study of 54 subjects with BPD and assessed TM using UTE MRI at term-equivalent age. TM was defined as an airway minor/major axis ratio (rd,min) of < 0.7. Outcomes through 2 years of life were evaluated via electronic medical record review. There were 23 subjects (43%) with TM. Modified Ochiai MRI scores were similar between the subjects with and without TM (7.3 ± 4.1 vs. 7.4 ± 4.1). Subjects with TM were more likely to require respiratory support at age 2 years (62% vs. 30%, p = 0.04) and be prescribed systemic corticosteroids (71% vs. 27%, p = 0.004). Most patients with TM were prescribed bronchodilators (90% vs. 60%, p = 0.04). A 10% increase in tracheal collapse correlated with a 28-day increased hospital length of stay (p = 0.047), increased likelihood of pneumonia (p = 0.05), and treatment with antibiotics (p = 0.04) and systemic steroids (p = 0.008). TM in the neonatal period was associated with increased respiratory morbidity through age 2 years, demonstrated by increased respiratory support and more frequent usage of systemic corticosteroids and bronchodilators, independent of the severity of BPD. These results highlight the significance of central airway disease in neonates with BPD.

Budesonide/formoterol turbuhaler vs pMDI salbutamol for acute asthma in outpatient emergency department: a prospective, randomized, open-label study

Background The Global Initiative for Asthma (GINA) has suggested the need for more studies on inhaled corticosteroid (ICS)-formoterol in the Emergency Department (ED). Objectives We aimed to compare the outcomes of budesonide/formoterol (160/4.5 mcg/inhalation) turbuhaler versus pressurized metered-dose inhaler (pMDI) salbutamol (100 mcg/puff) in acute asthma in the outpatient ED. Methods This single-centre, prospective, randomized, and open-label study involved adult asthma patients with mild to moderate asthma exacerbation who attended the outpatient ED of a tertiary hospital in Malaysia. The intervention arm received budesonide/formoterol (Symbicort® 160/4.5 mcg) turbuhaler, while the control arm received pMDI salbutamol with a valved holding chamber. Stratified randomization with variable baseline ICS use was employed. Direct discharge rate from outpatient ED was the primary outcome. Vital signs pre- and post-treatment between the two arms were also compared. Results Seventy-four (n = 37 for each arm) asthma patients were recruited. Baseline clinical characteristics were comparable between the two arms. Direct discharge rates from ED were comparable between the intervention (94.6%) and the control (91.9%) arms (p = 1.000). Post-treatment outcomes (respiratory rate, oxygen saturation, peak expiratory flow rate) were similar between the two arms, except for the higher increment of heart rate (p < 0.001) and lesser reduction of blood pressure in the control arm (p = 0.013). Intravenous hydrocortisone use was significantly higher in the control arm (n = 19, 51.4%) than in the budesonide/formoterol arm (n = 6, 16.2%) (p = 0.001). Conclusion Budesonide/formoterol turbuhaler is as effective as pMDI salbutamol in treating asthma exacerbation in the outpatient ED with less effect on heart rate and lower usage of intravenous corticosteroids.

CTNI-54. RESPONSE BY RANO2.0 CRITERIA IN ONC201 (DORDAVIPRONE)-TREATED PATIENTS WITH RECURRENT H3 K27M-MUTANT DIFFUSE MIDLINE GLIOMA

Abstract PURPOSE Response assessment in neuro-oncology (RANO) 2.0 is a recently established response assessment for glial tumors that is agnostic to WHO grade. This updated response assessment includes quantitative evaluation of enhancing and non-enhancing disease and recommendations to account for pseudoprogression. This analysis evaluated response to ONC201 by RANO2.0 in recurrent, H3K27M-mutant diffuse midline glioma (DMG), which was previously assessed by RANO-HGG/RANO-LGG (Arrillaga-Romany, JCO, 2024). METHODS Fifty patients with recurrent H3 K27M-mutant DMG were selected based on criteria designed with input from regulators to evaluate objective response to ONC201 monotherapy. Patients had contrast-enhancing, measurable, progressive disease, and were ≥90 days from radiation, with adequate washout from other anti-cancer therapies. Diffuse intrinsic pontine glioma, primary spinal tumors, leptomeningeal spread, or CSF-disseminating tumors were ineligible. Response was assessed using RANO2.0 criteria by two-party blinded independent central review. RESULTS Best response by RANO2.0 included one complete response (CR, 2.0%), nine partial responses (PR, 18.0%), and four minor responses (MR, 8.0%). Overall response rate (CR+PR+MR) by RANO2.0 criteria was 28.0% (n=14; 95%CI, 16-42). Disease control rate (CR+PR+MR+SD) was 40.0% (n=20; 26-55). Median duration of response was 10.4 months (95%CI, 7.4-15.4). Median time to response was 4.6 months (range, 1.6-15.9). 6- and 12-month progression free survival rates were 32.0% (95%CI, 19-47) and 27.0% (15-41), respectively. RANO2.0 response as a time-varying covariate was significantly associated with overall survival in a multivariate analysis considering baseline performance score, multiple enhancing target lesions, enhancing tumor size, and number of prior recurrences (HR [95%CI], 0.22 [0.08–0.58]; p=0.0023). Patients with an objective response by RANO2.0 were more likely to be alive at 12 (100%) and 24 (86%) months, have reduced corticosteroid usage, and have improved performance status. Responses occurred at a higher rate among patients with a higher performance score and fewer target lesions. CONCLUSIONS RANO2.0 assessment of ONC201-treated patients suggests durable and clinically meaningful efficacy in recurrent H3K27M-mutant DMG.

Recommendations for the timing, dosage, and usage of corticosteroids during cytokine release syndrome (CRS) caused by chimeric antigen receptor (CAR)-T cell therapy for hematologic malignancies.

Recommendations for the timing, dosage, and usage of corticosteroids during cytokine release syndrome (CRS) caused by chimeric antigen receptor (CAR)-T cell therapy for hematologic malignancies.

Prediction of the Short-Term Effectiveness of Ustekinumab in Patients with Moderate to Severe Crohn's Disease.

Ustekinumab (UST) is recommended as the first-line treatment for patients with moderate to severe Crohn's disease (CD). However, the efficacy of certain patients may be suboptimal and necessitate intensive treatment or modification of the treatment regimen. We sought to establish a nomogram model to predict the short-term effectiveness of UST in moderate to severe CD patients. We established a derivation cohort comprising patients diagnosed with CD and treated with UST at the Sixth Affiliated Hospital of Sun Yat-sen University from May 2020 to July 2023. The patient data, including demographic and clinical characteristics as well as treatment details, were systematically collected. The achievement of clinical remission (defined as Crohn's Disease Activity Index, CDAI < 150, without corticosteroid usage) after induction therapy was the endpoint observed during follow-up. Potential predictors were identified through the Least Absolute Shrinkage and Selection Operator (LASSO) regression analysis. Subsequently, a multivariate logistic regression analysis was conducted to construct a nomogram model. The predictive accuracy and discriminative power of the model were assessed by Receiver Operating Characteristics (ROC) curves and calibration curves. Decision curve analysis (DCA) was employed to assess the clinical application value of the model. 162 patients were included in the derivation cohort. The predictor's selection was according to the minimum criteria. Prognostic factors, including duration, body mass index (BMI), smoking, extraintestinal manifestations (EIMs), perianal lesions (P), history of Vedolizumab therapy, and albumin levels (ALB), were identified and included in the nomogram. The model showed good discrimination and calibration on internal validation based on the bootstrap method (C-index: 0.843, 95% confidence interval: 0.768-0.903). Moreover, DCA demonstrated that the nomogram was clinically beneficial. We constructed a practical tool to assist clinicians in identifying moderate to severe CD patients who are expected to have a good clinical response to UST, promoting personalized treatment and the development of precision medicine.

A novel risk-stratification model that predicts long-term clinical outcomes in patients with recurrent pericarditis

Abstract Background Recurrent Pericarditis (RP) is condition associated with significant debility and morbidity. Previous studies have identified variables such as elevated C-Reactive protein, corticosteroid usage, and presence of delayed hyper-enhancement (DHE) on cardiac magnetic resonance imaging are associated with recurrence. To date however, there is no established model for risk stratifying outcomes in these patients, therefore we attempted to develop a model that could predict long-term outcomes in patients with RP and stratify them into groups based on risk. Methods A total of 365 consecutive patients with RP from 2012-2019 were retrospectively examined. Our primary outcome was clinical remission (CR) defined as symptom resolution in addition to complete cessation of all anti-inflammatory therapy. We employed 5 survival models: CoxPH, RSF, SSVM, GBSA and XGBoost with Cox loss function to determine the likelihood of achieving CR within 5 years and to stratify patients into specific risk groups. We divided the dataset into training (70%) and test (30%) sets. Model training and optimization of the training set occurred via 5-fold cross validation. Model evaluation and selection was based on C-index. Finally, we employed an explainable artificial intelligence approach, SHapley Additive exPlanations to generate both individual and global explanation of the models decision. Results Amongst the cohort, the mean age was 46 ± 15 years, 205 (56%) were female, and the main etiology was idiopathic in 223 (61%). CR was achieved in 118 (32%) patients. The final model included steroid dependency, total number of recurrences, pericardial DHE, age, etiology, gender, ejection fraction and heart rate as its most important parameters. We observed similar CR rates across three risk score ranges and accordingly stratified patients into low (n=62), intermediate (n=154), and high-risk (n=149) groups. Scores of 3 or lower were categorized as low risk, with CR rates exceeding 90%. Scores of 4 to 7 were associated with CR rates of 50%. Scores of 8 or higher were deemed high-risk, with CR rates notably below 10%. Overall, the model predicted the outcome with C-index of 0.800 on the test set and exhibited a significant ability in stratification of patients into low-, intermediate-, and high-risk groups (log-rank test; P &amp;lt;0.0001). Conclusion We created a novel risk prediction model that can aid in predicting rates clinical remission in patients with recurrent pericarditis as well as aid in stratification into low, medium, and high risk groups. This risk prediction model may be helpful in diagnosis and management of these complicated patients.Figure 1

Corticosteroid Use in Randomized Clinical Trials of Biologics and Small Molecules in Inflammatory Bowel Disease: A Systematic Review.

This systematic review aims to elucidate the use of corticosteroids in randomized clinical trials (RCTs) evaluating biologics and small molecules for inflammatory bowel disease (IBD). We analyzed corticosteroid use during both the induction and maintenance phases, highlighting areas needing standardization and improvement in clinical research. We selected placebo-controlled phase 3 RCTs involving adults with moderate to severe IBD. These studies included detailed reports on corticosteroid use during induction and maintenance phases, with clinical remission and/or corticosteroid-free clinical remission (CSF-CR) as primary endpoints. Initially, 324 studies were identified and refined to 26 RCTs after screening. Analysis revealed variability in corticosteroid administration. Over time, corticosteroid use showed a decreasing trend (Spearman ρ = -0.42, P = .045). Studies allowing higher corticosteroid doses (up to 40mg/day of prednisone or equivalent) reported a higher proportion of corticosteroid users (51.8%, range: 42.9%-61%) compared to those excluding patients on doses >20mg/day (37.5%, range: 31.6%-51.8%; P = .007) or >30mg/day (41.1%, range: 29.6%-53.7%; P=.023). Trials with mandatory tapering protocols showed a narrower gap between overall clinical remission and CSF-CR rates, with an average difference of 6% in the group without mandatory tapering and 1.2% in the group with forced tapering (T-test P=.038; Cohen's d ≈ 1.1). This review highlights the variability in corticosteroid use across RCTs and its impact on evaluating new IBD therapies. Standardizing tapering protocols and defining CSF-CR are essential for accurate outcomes.

The Impact of Pre-biopsy Corticosteroids Use on CD20 Staining Pattern in B-cell Lymphomas

Abstract Introduction/Objective Diffuse large B-cell lymphomas, the most common Non-Hodgkin’s lymphoma are heterogeneous in terms of varied clinical presentation. The pathological work up these lymphomas is usually initiated with a CD20/CD3 immunohistochemical panel. Due to the aggressive nature of these lymphomas, pre-diagnosis corticosteroids are necessitated in some cases. However, the corticosteroids treatment can significantly alter the antigen staining of the lymphoma delaying the pathological diagnosis and subsequent treatment. This study investigates how pre-biopsy corticosteroids administration affects CD20 staining in B-cell lymphoma cells along with CD3 and PAX5, aiming to provide insights to the practicing pathologist for prompter diagnosis in these challenging cases. Methods/Case Report 14 biopsy cases of B-cell lymphoma pretreated with corticosteroids were included in this study. Clinicopathological parameters including corticosteroids usage are collected. H&amp;E and immunohistochemistry slides were reviewed to analyze CD20, CD3 and PAX5 staining patterns. Results (if a Case Study enter NA) Of 14 cases, 10 cases showed cytoplasmic and granular staining with CD20, with extracellular spilling instead of the typical membranous pattern. This change was more frequent with intravenous dexamethasone (7/9) compared to oral prednisone (3/5), high dose (80%) compared to moderate and low dose (67%), short-term corticosteroids usage (86%) compared to intermediate-term and long-term (57%) usage and shorter dosing interval (100% in Q6H). The impact of prebiopsy corticosteroids was seen more on lymph node (5/7) compared to bone marrow (3/5). This cytoplasmic granularity was also observed in CD3 in the background non-neoplastic T lymphocytes in 25% of the cases. Though nuclear stains such as PAX5, Ki67, MUM1 and BCL6 also showed granularity in a significant number of cases, it was limited to the nucleus. Conclusion Pre-biopsy corticosteroids leads to alteration in CD20 staining pattern of the lymphoma cells leading to cytoplasmic granularity with extracellular spillage, which causes diagnostic challenge. This effect varies according to the type, route, dose, and duration of corticosteroids usage.

S3145 A Hidden Danger: GI Perforation Presenting as Pneumomediastinum in Chronic Corticosteroid User

S3145 A Hidden Danger: GI Perforation Presenting as Pneumomediastinum in Chronic Corticosteroid User

Identifying the predictive value of fractional exhaled nitric oxide (FeNO) for uncontrolled asthma in 3-7-year-old Thai children.

Fractional exhaled nitric oxide (FeNO) is the method for monitoring airway inflammation. However, a singular FeNO value cutoff may not adequately represent the control status across different ages and demographics. This study aimed to evaluate the correlation between FeNO values and asthma control levels, identifying an optimal cutoff point for children aged 3 to 7 years. This cross-sectional study was conducted at Naresuan University Hospital from April 1, 2023 to July 31, 2023. Inclusion criteria were asthmatic patients aged 3 to 7 years who were capable of following commands. Exclusion criteria included children who had a coronavirus disease 2019 (COVID-19) infection, those experiencing difficulty breathing, or unable to perform the FeNO measurement. Eligible patients were classified according to their level of asthma control and underwent FeNO testing. Out of 108 participants who successfully completed FeNO measurements, a significant difference in FeNO values was observed across controlled, partially controlled, and uncontrolled asthma groups, with uncontrolled asthma presenting significantly higher values. The optimal FeNO cutoff point for predicting uncontrolled asthma was identified as ≥15 ppb with a sensitivity 46.7%, specificity 86.0%, positive predictive value (PPV) 35.0%, negative predictive value (NPV) 90.9%. This study established a significant correlation between FeNO levels and uncontrolled asthma, FeNO cutoff point ≥15 ppb as the optimal value in predicting uncontrolled asthma in Thai children aged 3-7 years. Factors such as uncontrolled allergic rhinitis, symptoms at onset, smoking exposure, treatment compliance, and inhaled corticosteroid (ICS) usage were associated with FeNO values. The application of FeNO measurement should be integrated with clinical assessments and consideration of these associated factors.