Use Of Systemic Steroids Research Articles

Demographic, clinical, chest X-ray characteristics, and outcome of children admitted with acute bronchiolitis in the tertiary care hospital South India

Aim and Objectives: The goal of this research was to assess the demographic, clinical, and radiological characteristics of children brought to the hospital with acute bronchiolitis. Materials and Methods: This is a prospective study of children aged 1–3 years whowere admitted to a tertiary care center with acute bronchiolitis between June and August 2021. The research excludes infants <1 month. Age, sex, comorbidities, tachypnea, respiratory distress, saturations, nebulizations’, oxygen therapy, and mortality were all recorded as variables. The data were analyzed using appropriate statistical methods. Results: About 60% of the 162 children admitted with bronchiolitis are males, and 68% of the babies had been exposed to passive smoking. Cough (98%) and wheeze (91%) were the mostcommon symptoms and signs, respectively. On chest X-rays, 73% of the children had hyperinflated lung fields and 8% had atelectasis. Out of 29 children with severe hypoxemia and respiratory failure, 25 children responded to high-flow nasal cannula or continuouspositive airway pressure, and only four required intubation and invasive ventilation. In our study, there was no mortality. Conclusion: The most common reason for hospitalization among infants is acute bronchiolitis. We have significantly reduced the use of antibiotics,systemic steroids, and bronchodilators in our hospital after developing standard treatment protocols for acute bronchiolitis and strictly following them.

Post-ROCM restrictive strabismus: A challenge for strabismus surgeon

Abstract Restrictive strabismus is characterized by extraocular motility restriction, which is confirmed by performing forced duction test. It can be congenital because of various syndromes or acquired after thyroid eye disease, after long-standing strabismus, after sinus surgery, or after trauma. Recently, we have faced a devastating epidemic of rhino-orbito-cerebral mucormycosis (ROCM) during the second wave of COVID-19 pandemic, which was treated by both surgical (sinus surgery) and medical (antifungal agents) modalities. Diabetes mellitus and the inadvertent use of systemic steroid were the leading risk factors for ROCM outbreak. India being the diabetic capital of the world favored this condition. We are reporting a challenging case of ROCM with diabetes mellitus, who presented to us with troublesome diplopia with extraocular motility restriction. He had a history of right-sided ROCM treated by sinus surgery and systemic antifungal agents 1 year back, followed by a good residual vision and restrictive strabismus leading to the symptoms. A previous history of sinus surgery and post-ROCM scarring and narrow surgical field posed a great challenge for strabismus surgery. In spite of all odds, a good postoperative alignment was achieved by a single-stage strabismus surgery, and the patient was asymptomatic after 3 months of follow-up.

Management of Intracranial Sinusitis Complications in Children and Adolescents: Similarities and Differences Among Otolaryngology Subspecialists.

The purpose of this study was to compare the management of intracranial sinusitis complications in pediatric patients between members of the American Rhinologic Society (ARS) and the American Society of Pediatric Otolaryngology (ASPO). A cross-sectional web-based survey was distributed twice to the ASPO and ARS membership over an 8-month period. The overall survey response rate was 12.1% (7.5% of ARS members and 17.3% of ASPO members). Recommended management was similar with respect to the use of intravenous antibiotics, nasal saline irrigations, topical decongestants, and nasal steroid sprays. Recommendations diverged with regards to systemic steroid use and urgent/emergent endoscopic sinus surgery (ESS). ARS members were more likely to recommend systemic corticosteroids. ASPO members were more likely to recommend immediate ESS. Based on survey responses, we found differences in practice patterns among subspecialists, which indicates additional collaborative research between societies is necessary to develop and disseminate evidence-based guidelines for these patients.Level of Evidence: 4

Inhaled Corticosteroid Exposure in Hospitalized Infants with Bronchopulmonary Dysplasia.

The objective of this paper was to determine inhaled corticosteroid (IC) use in infants with bronchopulmonary dysplasia (BPD), define the interhospital variation of IC administration to infants with BPD, and compare clinical, demographic, and hospital factors associated with IC use. Using the Pediatric Health Information System database, a retrospective multicenter cohort of 4,551 infants born at <32 weeks of gestation with developing BPD was studied. The clinical, demographic, and hospital characteristics of infants exposed and not exposed to ICs were compared. IC use varied markedly between hospitals, ranging from 0 to 66% of infants with BPD exposed to ICs. Increased annual BPD census was not associated with IC use. In total, 25% (1,144 out of 4,551) of patients with BPD and 43% (536 out of 1,244) of those with severe BPD received ICs. Increased IC exposure was associated with lower birth weight and gestational age, days on respiratory support, need for positive pressure ventilation at 36-week postmenstrual age, need for tracheostomy, and increased use of systemic steroids, bronchodilators, and diuretics. IC exposure is common in infants with BPD, with substantial interhospital variability. IC use was associated with more severe disease. Hospital experience did not account for the wide variability in IC use by the hospital. Further research into the effects of ICs use is urgently needed to help guide their use in this vulnerable population. · The risks and benefits of IC use in infants with BPD are incompletely understood.. · IC use is common in infants with BPD (25%) and severe BPD (43%) varies widely by hospital (0-66% of patients with BPD received an IC).. · Hospital experience did not account for the wide interhospital variation in IC use..

Increased Demand for Therapeutic Drugs in Pediatric Ulcerative Colitis Patients With Extraintestinal Manifestations.

BackgroundUlcerative colitis (UC) is a systemic inflammatory disease with a gut predominance, which may involve other organs. The presence of extraintestinal manifestation (EIM) is an important symptom for clinicians as it alters the treatment decisions. In this study, we aimed to evaluate the initial clinical presentation and disease severity of pediatric UC patients with EIMs.MethodsOne hundred forty-two patients under the age of 18 years who were diagnosed with UC from January 2003 to November 2021 were included in this study. Forty-seven patients with confirmed EIMs and 95 patients without EIMs were divided into two groups and their differences were analyzed.ResultsThe most common EIM was peripheral arthritis. The disease extent at the time of diagnosis shows a higher rate of pancolitis in the EIM-positive group (65.9%) than that of the EIM-negative group (33.7%) (p < 0.001). More than 90% of EIM-positive patients had moderate to severe disease activity on the Mayo endoscopic subscore. In the EIM-positive group, the cumulative use of systemic steroids, immunosuppressants, and biological agents from diagnosis to 1 year follow-up were significantly higher than those of the EIM-negative group (p = 0.009, 0.001, and < 0.001, respectively). About 80% of patients in the EIM-negative group reached remission, but only about 50% of the EIM-positive patients reached remission (p = 0.005). The relapse occurred more frequently in the EIM-positive group than in the EIM-negative group with statistical significance (p < 0.001).ConclusionPediatric UC with EIMs had higher disease severity and often manifested upper gastrointestinal tract involvement. Despite EIMs treatment, the occurrence of new EIMs was observed repeatedly. Cumulative drug demand (steroids, immunosuppressants, and biological agents) for the treatment increased steadily over time, and frequent relapses occurred despite the combinatory use of therapeutic drugs.

Predictive Modeling of New-Onset Postoperative Diplopia Following Orbital Decompression for Thyroid Eye Disease.

To identify risk factors for the development of new-onset, postoperative diplopia following orbital decompression surgery based on patient demographics, clinical exam characteristics, radiographic parameters, and surgical techniques. We conducted a multi-center retrospective chart review of patients who underwent orbital decompression for thyroid eye disease (TED). Patient demographics, including age, gender, smoking history, preoperative exophthalmometry, clinical activity score (CAS), use of peribulbar and/or systemic steroids, and type of orbital decompression were reviewed. Postoperative diplopia was determined at a minimum of 3 months postoperatively and before any further surgeries. Cross-sectional area ratios of each extraocular muscle to orbit and total fat to orbit were calculated from coronal imaging in a standard fashion. All measurements were carried out using PACS imaging software. Multivariable logistic regression modeling was performed using Stata 14.2 (StataCorp, College Station, TX). A total of 331 patients without preoperative diplopia were identified. At 3 months postoperatively, 249 patients had no diplopia whereas 82 patients developed diplopia. The average postoperative follow-up was 22 months (range 3-156) months. Significant preoperative clinical risk factors for postoperative diplopia included older age at surgery, proptosis, use of peribulbar or systemic steroids, elevated clinical activity score, and presence of preoperative compressive optic neuropathy. Imaging findings of enlarged cross-sectional areas of each rectus muscle to the overall orbital area also conferred a significant risk of postoperative diplopia. Regarding surgical factors, postoperative diplopia was more common among those undergoing medial wall decompression, bilateral orbital surgery, and balanced decompression, whereas endoscopic medial wall decompression was found to be relatively protective. This study identifies risk factors associated with the development of diplopia following orbital decompression using multivariable data. This study demonstrates that several characteristics including age, clinical activity score, the cross-sectional muscle to orbit ratios, in addition to the type of orbital decompression surgery, are predictive factors for the development of new-onset postoperative diplopia.

Surgical treatment of acute aortic dissection in a patient with SLE and prior antiphospholipid syndrome on therapy for over 30 years: a case report

BackgroundIn patients with systemic lupus erythematosus (SLE), lengthy treatment and long-term steroid use are the main risk factors for developing aortic aneurysms or aortic dissections. In patients with cardiac tamponade, hemodynamic collapse may lead to acute renal and hepatic failure.Case presentationWe report the successful treatment of a 55-year-old woman with SLE since the age of 21. She suddenly felt chest pain approximately 2 weeks before developing fever and vomiting and was admitted to our hospital. Initially, she had severe liver dysfunction and was admitted to the hepatology department, where treatment for fulminant hepatitis was initiated. However, computed tomography (CT) showed an acute aortic dissection (DeBakey type II) and severe bloody pericardial effusion. Therefore, we performed emergency pericardial drainage. Plasma exchange therapy was initiated as emergency aortic surgery was deemed impossible due to impaired liver function tests and coagulation. Ten days later, the patient developed peritonitis due to small bowel perforation, and laparotomy was performed for abscess drainage and perforation closure. She had received steroid pulse therapy at the age of 21. At 40 years of age, she developed deep vein thrombosis due to antiphospholipid antibodies and was prescribed prednisolone. She was ambulatory at 3 months after the onset of acute aortic dissection, and CT revealed a rapidly enlarging true aneurysm in the distal arch. We performed elective aortic surgery. Although there were no antiphospholipid antibodies, surgery could have led to a devastating antiphospholipid syndrome. Therefore, we decided to treat the patient with triple therapy. Methylprednisolone was intravenously administered intraoperatively and at 1 day postoperatively. The patient was discharged without complications after returning to her usual oral prednisolone regimen.ConclusionsThe patient described herein had a systemic circulatory failure due to cardiac tamponade, accompanied by liver failure. This condition is a significant cause of death in patients with aortic dissection-associated SLE and is extremely dangerous. However, multi-specialty intervention helped the patient recover, and she has been attending the outpatient clinic. Aortic surgery requiring hypothermia in SLE patients with antiphospholipid syndrome and a history of thrombocytopenia or thrombosis requires a multi-disciplinary treatment team, including cardiac surgeons and medical experts.

Risk factors and medical resource utilization in US adults hospitalized with influenza or respiratory syncytial virus in the Hospitalized Acute Respiratory Tract Infection study.

BackgroundInfluenza and respiratory syncytial virus (RSV) are associated with substantial morbidity and mortality in the United States. We assessed risk factors for severe disease and medical resource utilization (MRU) among US adults hospitalized with influenza or RSV in the Hospitalized Acute Respiratory Tract Infection (HARTI) study.MethodsHARTI was a prospective global (40 centers, 12 countries) epidemiological study of adults hospitalized with acute respiratory tract infections conducted across the 2017–2019 epidemic seasons. Patients with confirmed influenza or RSV were followed up to 3 months post‐discharge. Baseline characteristics, prevalence of core risk factors (CRFs) for severe disease (age ≥65 years, chronic heart or renal disease, chronic obstructive pulmonary disease, or asthma), and MRU were summarized descriptively.ResultsThe US cohort included 280 influenza‐positive and 120 RSV‐positive patients. RSV patients were older (mean: 63.1 vs. 59.7 years) and a higher proportion had CRFs (87.5% vs. 81.4%). Among those with CRFs (influenza, n = 153; RSV, n = 99), RSV patients required longer hospitalizations (median length of stay: 4.5 days) and a greater proportion (79.8%) required oxygen supplementation during hospitalization compared with influenza patients (4.0 days and 59.5%, respectively). At 3 months post‐discharge, a greater proportion of RSV patients with CRFs reported use of antibiotics, antitussives, bronchodilators, and inhaled and systemic steroids versus those with influenza and CRFs. Many patients with CRFs reported hospital readmission at 3 months post‐discharge (RSV: 13.4%; influenza: 11.9%).ConclusionsMRU during and post‐hospitalization due to RSV in adults is similar to or greater than that of influenza. Enhanced RSV surveillance and preventive and therapeutic interventions are needed.

Use of systemic steroids during pulmonary exacerbations in children and adolescent with Cystic fibrosis.

To determine the role of systemic steroids in cystic fibrosis patients and its effects on pulmonary exacerbation in children and adolescents. The retrospective cohort study was conducted at the Aga Khan University Hospital, Karachi, and comprised data from January 2015 to December 2019 of cystic fibrosis patients aged 3-18 years hospitalised with pulmonary exacerbations. The patients were divided into systemic steroid group A and non-systemic steroid group B. Patients in group A received parenteral steroids during acute exacerbation of cystic fibrosis in the first two weeks of admission, while those in group B did not receive systemic steroids. Length of hospital stay and number of days on oxygen support were compared between the groups. Data was analysed using SPSS 22. Of the 124 patient charts evaluated, 84(67.7%) were included; 40(47.6%) in group A and 44(52.4%) in group B. There were no significant differences between the groups related to age, age at diagnosis, weight, height, and pulmonary exacerbations (p>0.05). Group A had significantly fewer days on oxygen support compared to group B (p<0.001), but there was inter-group difference in mean length of hospital stay (p=0.53). Systemic steroid usage during hospitalisation for acute exacerbation of cystic fibrosis was associated with decreased duration of oxygen requirement with standard treatment.

Specific Therapy for T2 Asthma.

Asthma is a disease with high incidence and prevalence, and its severe form accounts for approximately 10% of asthmatics. Over the last decade, the increasing knowledge of the mechanisms underlying the disease allowed the development of biological drugs capable of sufficiently controlling symptoms and reducing the use of systemic steroids. The best-known mechanisms are those pertaining to type 2 inflammation, for which drugs were developed and studied. Those biological treatments affect crucial points of bronchial inflammation. Among the mechanisms explored, there were IgE (Omalizumab), interleukin 5 (Mepolizumab and Reslizumab), interleukin 5 receptor alpha (Benralizumab) and interleukin 4/13 receptor (Dupilumab). Under investigation and expected to be soon commercialized is the monoclonal antibody blocking the thymic stromal lymphopoietin (Tezepelumab). Seemingly under study and promising, are anti-interleukin-33 (itepekimab) and anti-suppressor of tumorigenicity-2 (astegolimab). With this study, we want to provide an overview of these drugs, paying particular attention to their mechanism of action, the main endpoints reached in clinical trials, the main results obtained in real life and some unclear points regarding their usage.

Risk of Elevated Intraocular Pressure With Difluprednate in Patients With Non-Infectious Uveitis

To evaluate the risk factors associated with clinically important intraocular pressure (IOP) elevation with topical difluprednate treatment in patients with non-infectious uveitis. Retrospective cohort study. Fifty-four eyes of 54 patients with non-infectious uveitis treated with topical difluprednate at the current institution were included. Demographics and clinical characteristics of uveitis patients were collected. The main outcome measure was development of clinically important IOP elevation defined as IOP ≥21 mmHg and an increase of ≥10 mmHg from baseline. A clinically important IOP elevation was observed in 17 patients (31.5%). The mean time to clinically important IOP elevation was 7.4±4.8 weeks (range 3-19). Statistically significant risk factors for incident clinically important IOP elevation were being a child (adjusted hazard ratio [aHR] 7.85 [95% CI 1.48-41.56], P=.02) and concurrent use of systemic steroids (aHR 5.31 [95% CI 1.18-24.00], P=.03). Patients with concurrent systemic corticosteroids developed clinically important IOP elevation earlier than those without systemic corticosteroid (mean 5.7±3.4 [range 3-14] vs 10.4±5.7 [range 4-19] weeks, P=.05). Incident IOP ≥30 mmHg occurred in 7 patients (13.0%). All patients responded well to the cessation of difluprednate and/or use of topical antiglaucomatous agents and no eyes required glaucoma surgery. This study demonstrated that clinically important IOP elevation is common in uveitis patients with topical difluprednate treatment. Children and patients with concurrent systemic corticosteroids are at substantial risk of developing clinically important IOP elevation.

Minimizing the "Kitchen Sink" Approach: De-implementation of Unnecessary Care for Patients with Anaphylaxis in a Pediatric Emergency Department.

Introduction:Epinephrine is the only medication that prevents morbidity and mortality in anaphylaxis. Systemic corticosteroids and H2 receptor antagonists (H2RA) may benefit select cases but are not universally indicated. This study aims to de-implement the universal use of steroids and H2RAs and emphasize epinephrine-focused care for children with anaphylaxis during acute care visits. The study aims to reduce steroid and H2RA use from 81% and 60%, respectively, to 30% by December 2019.Methods:The primary outcome measures were the percent of patients receiving steroids and H2RAs in the emergency department (ED) or urgent care (UC). Process measure was the frequency of intravenous (IV) line placement. Balancing measures were ED/UC length of stay, admission rate, and ED/UC return visit rate. In addition, a multidisciplinary team designed the following interventions: (1) anaphylaxis clinical pathway to emphasize epinephrine-focused care, outline criteria for second-line therapies and a provider guideline for ED/UC observation; (2) standardize unit-based anaphylaxis medication kits; (3) optimize electronic medical record tools, including order sets and discharge instructions to be concordant with guideline recommendations.Results:The study included 870 patients. There was special cause variation in the use of steroids (81%–33%) and H2RAs (60%–11%), ED/UC Length of stay decreased (6.2–5.0 hours). There was no special cause variation in admission rates or ED/UC return visit rates.Conclusion:Universal use of systemic steroids and H2RAs can be safely de-implemented in pediatric patients with anaphylaxis using quality improvement methods.

The Current Consensus on the Management of Post-traumatic Blisters Among Orthopaedic Surgeons.

Post-traumatic blister is often encountered in high-energy injuries and following major limb surgeries. Currently, there is very limited evidence concerning blister management resulting in a lack of comprehensive guidelines for their management. The current survey-based study aims to appraise the current consensus in post-traumatic management among the practising orthopaedic surgeons and compare the same with the evidence in the literature. We conducted an online questionnaire-based survey of orthopaedic surgeons concerning post-traumatic blister management practices. The questionnaire mainly focused on antibiotic prophylaxis, local invasive procedures, antiseptics dressings and additional treatment options regarding blister management. A high prevalence (~ 78%) of systemic antibiotics administration was noticed for post-traumatic blister management. Similarly, large section of respondents (66.4%) advocated for either de-roofing or aspiration of blisters. Approximately 42% of respondents preferred sending blister fluid for cultures. More than half of the respondents used some form of local dressing to cover the blister bed to provide a healing environment. Additional opinions mostly included anti-inflammatory and swelling reducing measures. Few respondents also advocated for oral steroids for inflammation control. The limited evidence available in literature could be the potential contributing factor for varying clinical practices for post-traumatic blister management. The general measures to reduce soft-tissue oedema have been supported by the literature. However, the use of systemic antibiotics and steroids has not been supported by the literature and should be avoided unless indicated due to other reasons. Further evidence is required to strengthen the recommendations for post-traumatic blister management.

Long-term outcome and safety in patients treated with immune checkpoint blockade therapies for urothelial carcinoma: Experience from real-world clinical practice.

474 Background: Anti-tumor activity and manageable safety profile of immune checkpoint blockade therapies (ICT) have been demonstrated in previous clinical trials in patients with metastatic urothelial carcinoma. To the best of our knowledge, very limited real-life data is available with the long follow-up time that confirms the durable antitumor activity and safety of ICT. In this study, we reported the real-life results of 56 months follow-up data of urothelial carcinoma patients who were treated with ICT. Methods: Metastatic urothelial carcinoma patients treated with at least one course of ICT included in the study. The primary endpoint was the overall response rate (ORR); secondary endpoints were overall survival (OS), progression-free survival (PFS), duration of the ICT treatment, and safety. Median follow-up, PFS, and OS were estimated by using the Kaplan-Meier method. Results: Data of 185 eligible patients were analyzed, 11.9% of these patients received the ICT as the first line, 76.8 % as the second line, and 11.3 % as the third or more line of treatment. The median age of the patients was 66 years, and 156 (84.3%) were male (37-86). The majority of patients (93.5%) had ECOG PS scores of 0–1 and primary tumor in the bladder was predominant (86.7%). The median follow-up time was 47(1.15-56) months. The complete response rate to ICT, partial response rate, and ORR were 10.3% (n = 19), 19.5% (n = 36), and 29.8% (n = 55), respectively. The median duration of response was 33.1 months (95% CI, 16.5–49.7). Of the fifty-five patients who responded to treatment, 28 (51%) had an ongoing response at the time of the analysis. Median PFS and OS was 3.8 (2.6–5.1) months and 8.9 (6.8–11.1) months, respectively. 56-month PFS and OS rate was 9.2% and 11.4%, respectively. 56-month PFS and OS rate for CR and PR was 56.2% and 20%, respectively. Fifty-nine percent of patients experienced a treatment-related adverse event of any grade, and 32 (17.3%) of patients had a grade 3–4 treatment-related adverse event. Because of treatment-related side effects, treatment was discontinued in 8 (4.3%) patients and adverse event that required systemic steroid use was reported in only 13 (7%) patients. Four patients (2.2%) died due to treatment-related causes. Conclusions: This 56-month analysis of real-world data confirms the durable response and long-term survival with ICT in metastatic urothelial carcinoma patients. The safety profile was consistent with prior reports, and no new safety signals emerged.

THE EFFECT OF DIFFERENT TREATMENT REGIMENS AMONG PATIENTS WITH INTERSTITIAL LUNG DISEASES OF UNKNOWN ETIOLOGY

Interstitial Lung Diseases (ILD) are a collection of parenchymal lung disorders classified together for its similar clinical, radiographic and pathological manifestations. It is characterized by scarring and fibrosis of the lung interstitium. Several biomarkers including clinical and radiological biomarkers have been proposed to predict the stage and progress of the disease. In Saudi Arabia, there are no studies yet that has discussed the best treatment approach to those patients. For that, our research had focused about gathering informationabout the use of steroids, and whereas it had an effect on the disease progression.Furthermore, this study measured the outcome of the use of an immunosuppressive medications to control the disease. The study is a retrospective cohort study that was done in National Guard Hospital in Jeddah during the period from 2017 to 2019 for patients admitted with ILDs of unknown etiology during the period 2012 to 2016 who are Adults ( 18 years or older ) excluding those who have other chronic lung disease, heart failure, or known triggers to the disease. The data of the patients was collected by looking at their medical records (hardcopy). A data extraction sheet was used that included baseline demographics and disease characteristics, used medications, outcome parameters ( PFT, CT Chest, Subjective Clinical Improvements ) for data interpretation. And Data was analyzed using the software STATA. Results show the use of systemic steroids alone showed clinical improvement in 17% of steroid users and 8% improvement in chest CT. And the addition of immunosuppressive medications showed 33% clinical improvement and 17% chest CT improvement in comparison to those who were not treated with immunosuppressive medications. Concluding that the results were non significant with poor outcome and little improvement.

P130 Comparison of the clinical course of Ulcerative Colitis according to the presence or absence of clinical symptoms at the time of diagnosis

Abstract Background Asymptomatic ulcerative colitis (UC) is increasingly detected by improved screening tests such as the fecal immunochemical test. However, there have been few reports on the difference in the clinical course of UC according to the presence or absence of symptoms at diagnosis. The purpose of this study was to compare the clinical course of UC according to the presence or absence of clinical symptoms at the time of diagnosis. Methods Data were obtained from a retrospective chart review of 64 consecutive patients with UC diagnosed at our hospital between 2014 and 2020. Patients were grouped according to the presence or absence of clinical symptoms at the time of UC diagnosis, and clinical characteristics (age, sex, extent of disease, Mayo Score, endoscopic severity, and hematological findings) at the time of diagnosis were subjected to univariate and multivariate analyses. In the clinical characteristics, propensity score matched analysis was performed, and systemic steroids use, hospitalization within 1 year, and the introduction of therapies for refractory UC were evaluated. Patients with a clinical course of less than 1 year after UC diagnosis, patients intolerant to 5-aminosalicylic acid, patients with carcinoma, pregnant women, and patients under 15 years of age were excluded. Results Eligible patients were 64 UC patients (19 asymptomatic and 45 symptomatic) diagnosed at our hospital during the period of the study. The symptomatic group included 32 cases of bloody stools, 30 cases of diarrhea, 7 cases of abdominal pain, and 4 cases of fever. Multivariate analysis of clinical features at diagnosis showed significant differences in Mayo Score (p=0.003, odds ratio: 3.650, 95% confidence interval: 1.541–8.647) and serum hemoglobin level (p=0.021, odds ratio: 0.367, 95% confidence interval: 0.157–0.859). As a result of propensity score matched analysis, 24 patients (12 asymptomatic, 12 symptomatic) were selected. There were no significant differences in the rates of systemic steroid use (16.7% vs. 16.7%), hospitalization within 1 year (16.7% vs. 8.3%), and the introduction of therapies for refractory UC (16.7% vs. 8.3%) between the two groups (p=1.000 in all items). Conclusion There was no difference in the prognosis of the asymptomatic group compared with the symptomatic group using propensity score matched analysis. The results suggest that asymptomatic UC detected by colonoscopy may be acceptable for follow-up without treatment.

P345 The Effectiveness of Ustekinumab and Vedolizumab as Third-line Therapy in Patients with Refractory Crohn’s Disease

Abstract Background There is no head-to-head trial comparing ustekinumab (UST) and vedolizumab (VDZ) in Crohn’s disease (CD). Recently, real-world studies evaluated the two biologics in patients refractory to anti-TNF therapy, i.e. as second-line agents. Conversely, no study specifically focused on the effectiveness of UST and VDZ as third-line agents, i.e. after failure with at least one TNF-α inhibitor plus failure with VDZ or UST. We performed a multicentre, real-world assessment of the effectiveness of UST and VDZ in these highly-refractory patients with CD. Methods Data of consecutive patients with CD treated with UST and VDZ as third-line therapy until October, 2021 were extracted from the cohort of the Sicilian Network for Inflammatory Bowel Disease (SN-IBD). The effectiveness was evaluated at, 8, 26, and, 52 weeks, and as treatment persistence at the end of follow up. The clinical outcomes were steroid-free clinical remission (SFCR - Harvey-Bradshaw Index &amp;lt;, 5 without steroid use) and clinical response (CR - reduction of the Harvey-Bradshaw Index ≥, 3 points with a concomitant decrease of steroid dosage compared with baseline). Multiple logistic regression models were build to find independent predictors of effectiveness, including the use of UST and VDZ as candidate predictors. Results 143 patients (UST: n=113; VDZ: n=30) were included. After, 8 weeks, SFCR was reported in, 38.1% of patients treated with UST and in, 43.3% of patients treated with VDZ (p=0.75), while CR was reported in, 61.9% of patients treated with UST and in, 60.0% patients treated with VDZ (p=1.00). After, 26 weeks, the rates of SFCR and CR were, 41.6% for UST and, 50.0% for VDZ (p=0.60), and, 61.4% for UST and, 66.7% for VDZ (p=0.81), respectively. After, 52 weeks, the rates of SFCR and CR were, 51.8% for UST and, 57.1% for VDZ (p=0.78), and, 65.9% for UST and, 71.4% for VDZ (p=0.77), respectively. Lack of difference in effectiveness between the two drugs at any time point was confirmed by multiple logistic regression models. After, 26 weeks, 88.7% of patients treated with UST and, 81.4% of patients treated with VDZ were still on treatment. Univariable Cox survival analysis showed a higher probability of treatment discontinuation for VDZ compared with UST (HR for VDZ:, 2.66; p=0.008), even if such difference was not confirmed at the multiple Cox proportional hazard regression model (HR for VDZ:, 1.94; p=0.08), where only age (HR, 0.98; p=0.04) and use of systemic steroids at baseline (HR, 3.29; p=0.003) were found to be independent predictors of treatment discontinuation. Conclusion This is the first real-world study assessing VDZ and UST as third-line therapy in patients with CD. Both drugs showed surprisingly high effectiveness, without significant differences between them.

OP17 Maintenance phase propensity score adjusted effectiveness and persistence at week-52 in biologic-naïve Ulcerative Colitis patients treated with vedolizumab or anti-TNF (VEDO IBD-study)

Abstract Background In this real-world-evidence (RWE) study we aimed to analyse the persistence of biologic therapy in biologic-naïve ulcerative colitis (UC) patients and to compare 1-year effectiveness of vedolizumab (VDZ) and anti-TNF. Methods Between 2017 and 2020, 1200 consecutively enrolled biologic-naïve and biologic- experienced patients with UC and Crohn′s disease (CD) were prospectively included in the VEDOIBD-Registry from 45 IBD-experienced centres across Germany. After exclusion of bio-experienced patients, CD and missing outcomes, the final sample consisted of 274 biologic-naïve UC-patients with 1-year follow-up data. Switchers of a drug were considered as treatment failure (modified intention-to-treat analysis; mITT) while switchers were excluded from per protocol analysis (PP). Clinical response modified (reduction of partial Mayo score (pMayo) from baseline to 1-year by &amp;gt;3 points or a reduction of at least 30% compared to baseline or reaching remission at 1-year) and (steroid-free) remission rates (pMayo ≤1 plus a bleeding subscore=0 (and no systemic use of steroids or budesonide at 1-year)) were predefined as outcomes. To reduce the effect of confounders, PS adjustment with inverse probability of treatment weighting (IPTW) was implemented. A weighted logistic regression was used, and the results were reported as odds ratio (OR) and 95% confidence interval (CI). Results 158 VDZ and 116 anti-TNF (ADA: 27.6%, IFX: 57.8%, GOL: 14.7%) biologic-naïve UC-patients were included in this prospective RWE comparing the effectiveness of VDZ vs anti-TNF. Until week 52 significantly more patients switched to another biologic-drug in the anti-TNF group than in the VDZ group (40.5% vs 16.5%; p&amp;lt;0.001) (Fig. 1). In mITT, clinical response at 1-year was significantly higher in VDZ than in anti-TNF treated patients (61.7% vs. 40.3%; OR 2.39 (95% CI 1.39–4.10)). VDZ also tended to be superior to anti-TNF for (steroid-free) remission (Tab. 1; p=0.058 (p=0.051)). In the PP-analysis, VDZ showed numerically higher 1-year effectiveness, but this did not reach statistical significance (Tab. 1). Analysing week-14 induction phase responders (Tab. 2), VDZ had numerically higher effectiveness rates compared to anti-TNF but without significant difference. Conclusion The 1-year maintenance findings suggested, in line with our previous induction phase data, only moderate long-term effectiveness in both groups. However, besides the significant response data, VDZ showed numerically higher remission rates compared to anti-TNF though only borderline significant. The higher treatment persistence of VDZ vs anti-TNF, along with the higher effectiveness, may suggest VDZ as a first-line biologic therapy option in UC patients.

The impact of the COVID‐19 pandemic on respiratory morbidity during infancy: A birth‐cohort study

To evaluate the incidence of wheezing and overall respiratory morbidity in healthy infants born during the first peak of the coronavirus disease-2019 (COVID-19) pandemic, compared with infants born during the preceding year. This was a single-center retrospective birth cohort study to compare a cohort of children born between February and March 2020 (COVID-19 group) to a control group of children born between February and March 2019 (pre-COVID-19 group). At 1 year of age, we collected respiratory data using parental and telephone questionnaires. wheezing incidence and/or bronchodilator use. recurrent wheezing, emergency-room visits, hospital admissions, pneumonia diagnosis, and admissions due to lower-respiratory-tract-infections (LRTI). We included the following covariate risk factors in the logistic regression models; atopy, daycare attendance, breastmilk feeding, parental smoking, C-section, siblings, and gestational age. We enrolled 588 infants, 294 in each group (48% males). Demographic, perinatal, and atopic characteristics were similar between the groups. Compared to the pre-COVID-19 group, infants born during the COVID-19 period were significantly less likely to report wheezing and/or bronchodilator use (adjusted-odds ratio [OR], 0.4; 95% confidence interval [CI] 0.28-0.59), systemic steroid use, (adjusted-OR, 0.47; 95% CI 0.24-0.91), emergency-room visits (adjusted-OR, 0.36; 95% CI 0.17-0.72), LRTI admissions (adjusted-OR, 0.2; 95% CI 0.05-0.74), or pneumonia diagnosis (adjusted-OR, 0.22; 95% CI 0.09-0.53). This study investigated wheezing and respiratory morbidity over the first year of the COVID-19 pandemic in infants born during the first peak of COVID-19. The study demonstrated a significant decrease in most aspects of respiratory morbidity. A longitudinal follow-up study to explore the subsequent impact of these findings is warranted.

Clinical characteristics and risk factors for mortality of hospitalized cancer patients with COVID-2019 in Mecca, Saudi Arabia.

Cancer patients are particularly vulnerable during the coronavirus disease 2019 (COVID-19) pandemic. This study aimed to evaluate clinical characteristics and mortality among cancer patients with COVID-19. This retrospective, observational cohort study included 53 patients with a malignancy and reverse-transcription polymerase chain reaction-confirmed severe acute respiratory syndrome coronavirus-2 infection in a tertiary care center in Mecca, Saudi Arabia, from March 14, 2020, to October 29, 2020. Clinical, laboratory, and radiological data were collected from institutional electronic records and analyzed. Overall, 53 patients (62% male) were enrolled. The mean age of the patients was 54.9 ± 19.0 years, with 76% aged <65 years. The most common symptoms were fever (66%), dry cough (40%), and dyspnea (36%). Most infections (89%) were community acquired. Hematological malignancies (36%) were the most common cancer type. The most common solid tumors were breast cancer (23%) and colon cancer (9%). Just over half (51%) had a stage 4 tumor, and 30% of the patients had received chemotherapy within 2 weeks before the onset of COVID-19 symptoms. Initial chest radiographs showed pneumonia in 43% of patients; 38%, 9%, and 6% required oxygen support, intensive care unit admission, and invasive mechanical ventilation, respectively. The most common complication was secondary bacterial infection (13.2%). The all-cause mortality rate was 17%. In the multivariable logistic regression, dyspnea, leukocytosis, use of systemic steroids, and secondary bacterial infection were found to be risk factors for death. Hospitalized cancer patients with COVID-19 have a high mortality rate. Our study finds a correlation between multiple independent risk factors and mortality. Patients with dyspnea, leukocytosis, systemic steroid use, or secondary bacterial infection require more care, attention, and possibly more aggressive treatment.