Oral Systemic Corticosteroids Research Articles

P0474 Five-Year Clinical Outcomes and Disease Course of Newly-Diagnosed Moderate-to-Severe Ulcerative Colitis: A Prospective Nationwide Multicentre MOSAIK Cohort Study in Korea

Abstract Background While the incidence of moderate-to-severe ulcerative colitis (UC) is rising in Asia, comprehensive data on its long-term disease course in Asian populations remain scarce. Methods The MOSAIK (MOderate-to-Severe ulcerAtive colItis in Korea) study is a prospective, multicentre, hospital-based, inception cohort that enrolled 353 patients newly diagnosed with moderate-to-severe UC between August 2014 and February 2017.1 Clinical outcomes and predictors of a disabling disease course were evaluated over 5 years of follow-up. Results Among 353 patients, the median age at UC diagnosis was 37.6 years (standard deviation, 15.2) with male predominance (58.9%, 208/353) (Table 1). Baseline disease activity was predominantly moderate (93.2%, 329/353) rather than severe (6.8%, 24/353), with median full Mayo Clinic Score (MCS) of 8 (Interquartile range [IQR], 7–9) and partial MCS of 6 (IQR, 5–7). Disease extent at diagnosis showed proctitis (10.7%, 37/353), left-sided colitis (46.7%, 162/353), extensive colitis (42.7%, 148/353). The median duration of follow-up was 4.9 years (IQR, 2.1–5.0), with 214 patients (60.6%) completing the 5 years (week 260). Treatment patterns during follow-up included: oral 5-aminosalicylates (96.3%, 340/353), topical 5-aminosalicylates (70.8%, 250/353), systemic corticosteroids (65.7%, 232/353), immunomodulators (38.5%, 136/353), biologics (20.1%, 71/353), and JAK inhibitors (1.7%, 6/353). At 5 years, the major disease outcomes were: relapse (62.9%), hospitalisation (26.9%), and proximal disease extension (29.5%). The colectomy rate was notably low (0.6%) with no mortality. A disabling disease course occurred in 171 patients (48.4%), with cumulative probabilities increasing from 41.0% at 1 year, 51.1% at 3 years, to 53.9% at 5 years. Baseline elevated white blood cell count was independently associated with a disabling disease course (adjusted hazard ratio, 1.062, 95% confidence interval, 1.004–1.123, P=0.0353). Using unsupervised clustering analysis (K-Means) of partial MCS, with missing data imputed using random forest, we identified 5 distinct disease trajectory patterns. These trajectories effectively discriminated clinical outcomes including relapse, persistent disease activity, hospitalisation, and disabling disease course (Figure 1). Conclusion In this Korean inception cohort, 48.4% of patients with moderate-to-severe UC revealed a disabling disease course over 5 years. Novel clustering analysis based on partial MCS identified 5 distinct disease trajectories that effectively predicted clinical outcomes, providing a potential framework for risk stratification. Funding This study was supported by Janssen Korea Ltd..

COVID-19 Clinical Features and Outcome in Italian Patients Treated with Biological Drugs Targeting Type 2 Inflammation.

This is a multicentric investigation involving two Italian centers that examined the clinical course of COVID-19 in patients receiving biological therapy targeting type 2 inflammation and those not receiving biologicals. Since the beginning of the COVID-19 pandemic, the management of respiratory and allergic disorders and the potential impact of biological therapy in the most severe forms has been a point of uncertainty. Our multicentric investigation aimed to compare the clinical course of COVID-19 and the impact of vaccination in an Italian cohort of patients with atopic disorders caused by a type 2 inflammation, such as eosinophilic asthma, chronic rhinosinusitis with nasal polyposis (CRSwNP), atopic dermatitis (AD), and chronic spontaneous urticaria (CSU). A questionnaire was given to patients coming to our outpatient clinic for the first evaluation or follow-up visit, asking for the clinical characteristics of the infection, the ongoing therapy during the infection, any relevant change, and the patient's vaccination status. We enrolled 132 atopic patients from two Italian centers; 62 patients were on biological therapy at the time of infection (omalizumab 31%, mepolizumab 26%, benralizumab 19%, and dupilumab 24%). The median age was 56 (IQR 22.8) for patients on biologicals and 48 (IQR 26.5) for those not on biologicals (p = 0.028). The two groups were comparable in terms of sex, body mass index (BMI), smoking history, and systemic oral corticosteroid use (OCS). There were no significant differences in non-biological therapy and comorbidity between the two groups. The patients not on biological therapy had a prevalence of 87% for asthma, 52% for CRSwNP, 10% for CSU, and 6% for AD. The patients on biologicals had a prevalence of 93% for asthma, 17% for CRSwNP, and 10% for CSU. In our work, we observed that mAbs targeting type 2 inflammation in patients with COVID-19 appeared to be safe, with no worsening of symptoms, prolongation of infection, or increase in hospitalizations. Between the two groups, there were no significant differences in the duration of swab positivity (p = 0.45) and duration of symptoms (p = 0.38). During COVID-19, patients on biologicals experienced a significant increase in common cold-like symptoms (p = 0.038), dyspnea (p = 0.016), and more, but not significant, asthma exacerbations, with no significant differences between the different biologicals. Regarding the vaccination status, we observed that there was an increased number of hospitalizations among unvaccinated patients in both groups, although the difference did not reach statistical significance. No patients on biologicals reported safety issues or adverse effects associated with the use of biological treatments during COVID-19. Our investigation showed that mAbs against type 2 inflammation given during Coronavirus Disease 2019 are safe and do not impact the clinical course or main outcomes. Therefore, we found no signals suggesting that anti-Th2 biological therapy should be discontinued during SARS-CoV-2 infection. Controlled studies and analysis, including data from registries and real-life studies, are required to draw firm conclusions regarding the safety or possible advantages that anti-type 2 mAbs could offer in particular clinical contexts, such as infections.

Disease burden and treatment satisfaction in patients with prurigo nodularis in Japan.

Prurigo nodularis (PN) is a chronic inflammatory skin disorder with a high disease burden. In this cross-sectional, web-based survey, Global Questions (GQ), the Numerical Rating Scales (NRS) for pruritus, burning sensation and sleep disturbance, the Short-Form-8 (SF-8) Health Survey, Dermatology Life Quality Index (DLQI), Patient Health Questionnaire 9 (PHQ-9), Work Productivity and Activity Impairment (WPAI), and Treatment Satisfaction Questionnaire for Medication-9 (TSQM-9) scores were used to assess the current disease burden and treatment satisfaction among patients with PN in Japan. In total, 97 patients were included (55.7% male, median age 51 years, median duration of PN 36 months). Based on GQ scores, 35.1% of patients had mild disease, 50.5% moderate, and 14.4% severe disease. Disease burden increased as the severity of PN increased, as indicated by worsening of pruritus NRS scores and quality of life (DLQI, PHQ-9, WPAI presenteeism, work productivity loss, and activity impairment scores). Patients with comorbid atopic dermatitis (AD) also had more intense pruritus than those without AD. Mean ± standard deviation TSQM-9 scores for effectiveness, convenience, and global satisfaction were 54.7 ± 18.1%, 62.4 ± 15.2%, and 57.4 ± 15.9%, respectively. TSQM-9 scores were lowest in patients receiving the most intensive guideline-directed treatment (i.e., topical corticosteroids + systemic oral corticosteroids or cyclosporine), highlighting an unmet need for more effective treatment options for patients with PN. In summary, Japanese patients with PN reported increased disease burden and reduced treatment satisfaction with increased disease severity, despite the use of guideline-recommended therapies.

Economic evaluation and budgetary burden of mepolizumab in severe refractory eosinophilic asthma

ObjectiveMepolizumab is indicated as an additional treatment of severe refractory eosinophilic asthma. The observed differences in population subgroups according to plasma eosinophil count, the existence of patients with high levels of immunoglobulin E who are candidates of omalizumab and mepolizumab, as well as mepolizumab's economic impact, lead to make efficient economic studies for clinical decision making. The aim was to analyze mepolizumab's cost-efficacy and budget impact. MethodCost comparison and the use of mepolizumab's budgetary impact was performed, from the Spanish National Health System's perspective. Among the assessed alternatives, inhaled systemic corticosteroids, plus long acting beta agonist (β2) and/or oral systemic corticosteroids in patients with non immunoglobulin E-mediated severe allergic asthma, and said treatment along with omalizumab in patients with immunoglobulin E mediated eosinophilic allergic asthma were included. Its efficacy was evaluated through avoided clinically relevant exacerbations. The direct costs associated with exacerbation were assessed. ResultsMepolizumab's long run average incremental cost regarding omalizumab's is 797 euros per patient a year. Considering omalizumab's alternative discounted price, including mepolizumab for patients with immunoglobulin E mediated eosinophilic allergic asthma would increase public spending from 2.3 to 4.6 million euros. Given omalizumab's notified price, the gradual introduction of mepolizumab in the Spanish National Health System would save 3.6 million euros in three years. For non immunoglobulin E-mediated severe asthma patients, the avoided cost/exacerbation by introducing mepolizumab is 15,085 euros, assuming a gradual market penetration of mepolizumab. In patients with ≥ 500 eosinophils/µL, this cost decreases to 7,767 euros per avoided exacerbation with a budgetary impact of 183.2 million euros in three years with a progressive penetration of mepolizumab. ConclusionsThe cost comparison between mepolizumab and omalizumab in immunoglobulin E mediated eosinophilic asthma patients suggests a use of the lower cost drug, promoting price competition. Additionally, prioritizing its use among non immunoglobulin E-mediated severe refractory eosinophilic asthma patients and ≥ 500 eosinophils/µL plasma level patients, would improve its efficiency as well as reducing its budgetary impact.

Clinical standards for the diagnosis and management of asthma in low- and middle-income countries.

BACKGROUND: The aim of these clinical standards is to aid the diagnosis and management of asthma in low-resource settings in low- and middle-income countries (LMICs).METHODS: A panel of 52 experts in the field of asthma in LMICs participated in a two-stage Delphi process to establish and reach a consensus on the clinical standards.RESULTS: Eighteen clinical standards were defined: Standard 1, Every individual with symptoms and signs compatible with asthma should undergo a clinical assessment; Standard 2, In individuals (>6 years) with a clinical assessment supportive of a diagnosis of asthma, a hand-held spirometry measurement should be used to confirm variable expiratory airflow limitation by demonstrating an acute response to a bronchodilator; Standard 3, Pre- and post-bronchodilator spirometry should be performed in individuals (>6 years) to support diagnosis before treatment is commenced if there is diagnostic uncertainty; Standard 4, Individuals with an acute exacerbation of asthma and clinical signs of hypoxaemia or increased work of breathing should be given supplementary oxygen to maintain saturation at 94-98%; Standard 5, Inhaled short-acting beta-2 agonists (SABAs) should be used as an emergency reliever in individuals with asthma via an appropriate spacer device for metered-dose inhalers; Standard 6, Short-course oral corticosteroids should be administered in appropriate doses to individuals having moderate to severe acute asthma exacerbations (minimum 3-5 days); Standard 7, Individuals having a severe asthma exacerbation should receive emergency care, including oxygen therapy, systemic corticosteroids, inhaled bronchodilators (e.g., salbutamol with or without ipratropium bromide) and a single dose of intravenous magnesium sulphate should be considered; Standard 8, All individuals with asthma should receive education about asthma and a personalised action plan; Standard 9, Inhaled medications (excluding dry-powder devices) should be administered via an appropriate spacer device in both adults and children. Children aged 0-3 years will require the spacer to be coupled to a face mask; Standard 10, Children aged <5 years with asthma should receive a SABA as-needed at step 1 and an inhaled corticosteroid (ICS) to cover periods of wheezing due to respiratory viral infections, and SABA as-needed and daily ICS from step 2 upwards; Standard 11, Children aged 6-11 years with asthma should receive an ICS taken whenever an inhaled SABA is used; Standard 12, All adolescents aged 12-18 years and adults with asthma should receive a combination inhaler (ICS and rapid onset of action long-acting beta-agonist [LABA] such as budesonide-formoterol), where available, to be used either as-needed (for mild asthma) or as both maintenance and reliever therapy, for moderate to severe asthma; Standard 13, Inhaled SABA alone for the management of patients aged >12 years is not recommended as it is associated with increased risk of morbidity and mortality. It should only be used where there is no access to ICS.The following standards (14-18) are for settings where there is no access to inhaled medicines. Standard 14, Patients without access to corticosteroids should be provided with a single short course of emergency oral prednisolone; Standard 15, Oral SABA for symptomatic relief should be used only if no inhaled SABA is available. Adjust to the individual's lowest beneficial dose to minimise adverse effects; Standard 16, Oral leukotriene receptor antagonists (LTRA) can be used as a preventive medication and is preferable to the use of long-term oral systemic corticosteroids; Standard 17, In exceptional circumstances, when there is a high risk of mortality from exacerbations, low-dose oral prednisolone daily or on alternate days may be considered on a case-by-case basis; Standard 18. Oral theophylline should be restricted for use in situations where it is the only bronchodilator treatment option available.CONCLUSION: These first consensus-based clinical standards for asthma management in LMICs are intended to help clinicians provide the most effective care for people in resource-limited settings.

2023 Canadian Thoracic Society Guideline on Pharmacotherapy in Patients with Stable COPD

Chronic obstructive pulmonary disease (COPD) patient care must include confirming a diagnosis with postbronchodilator spirometry. Because of the clinical heterogeneity and the reality that airflow obstruction assessed by spirometry only partially reflects disease severity, a thorough clinical evaluation of the patient should include assessment of symptom burden and risk of exacerbations that permits the implementation of evidence-informed pharmacological and nonpharmacological interventions. This guideline provides recommendations from a comprehensive systematic review with a meta-analysis and expert-informed clinical remarks to optimize maintenance pharmacological therapy for individuals with stable COPD, and a revised and practical treatment pathway based on new evidence since the 2019 update of the Canadian Thoracic Society (CTS) Guideline. The key clinical questions were developed using the Patients/Population (P), Intervention(s) (I), Comparison/Comparator (C), and Outcome (O) model for 3 questions that focuses on the outcomes of symptoms (dyspnea)/health status, acute exacerbations and mortality. The evidence from this systematic review and meta-analysis leads to the recommendation that all symptomatic patients with spirometry-confirmed COPD should receive long-acting bronchodilator maintenance therapy. Those with moderate to severe dyspnea (modified Medical Research Council ≥2) and/or impaired health status (COPD Assessment Test ≥10) and a low risk of exacerbations should receive combination therapy with a long-acting muscarinic antagonist/long-acting ẞ2-agonist (LAMA/LABA). For those with a moderate/severe dyspnea and/or impaired health status and a high risk of exacerbations should be prescribed triple combination therapy (LAMA/LABA/ICS) azithromycin, roflumilast or N-Acetylcysteine is recommended for specific populations; a recommendation against the use of theophylline, maintenance systemic oral corticosteroids such as prednisone and mono-ICS is made for all COPD patients.

Long COVID outcomes in an asthmatic cohort and its implications for asthma control

Long COVID outcomes in an asthmatic cohort and its implications for asthma control

The 2021 Questionnaire Survey of the Korean Uveitis Society: Current Trends of Uveitis Diseases

Purpose: To report the results of a 2021 questionnaire survey assessing the current trends and practice patterns in the treatment of uveitis, conducted by the Korean Uveitis Society (KUS).Methods: To understand the current treatment and trends for uveitis in Korea, a total of 11 questions were surveyed in November 2021 among 300 members of the KUS. This survey comprised 11 multiple choice and dichotomy questions.Results: Of 300 participants, 179 responded, and the response rate was 59.7%. Among the respondents, 92.7% were retina specialists and 66.9% reported less than 10% of uveitis patients among outpatients. As imaging tests performed in patients with anterior uveitis, fundus photography and optical coherence tomography were typically performed (83.8% vs. 73.2%, respectively). The frequently performed blood tests for general screening were complete blood count, blood chemistry test, erythrocyte sedimentation rate, and C-reactive protein (89.9% vs. 86.2% vs. 85.5% vs. 82.4%, respectively). Regarding local steroid treatment, subtenon injection was the most preferred (74.9%). Regarding systemic oral corticosteroids, 83.7% of respondents commonly used initial doses of 0.5-1 mg/kg. Cyclosporine, methotrexate, mycophenolate mofetil, and azathioprine were used for steroid-refractory uveitis patients in that order (36.2% vs. 34.8% vs. 21.7% vs. 7.3%, respectively). Concerning the currently used biologic agent, adalimumab was the most preferred, at 96.7%.Conclusions: This survey highlights the recent trends and practice patterns in the treatment of uveitis in Korea.

A 4-Year Retrospective Claims Analysis of Oral Corticosteroid Use and Health Conditions in Newly Diagnosed Medicare FFS Patients with COPD.

PurposeWe analyzed population-level administrative claims data for Medicare fee-for-service (FFS) beneficiaries to provide insights on systemic oral corticosteroid (OCS) use patterns and associated health conditions and acute events among patients newly diagnosed with chronic obstructive pulmonary disease (COPD).BackgroundCOPD is a progressive inflammatory disease of the lungs, characterized by acute exacerbations that may lead to increased mortality. Short courses of systemic corticosteroids (SCS) are recommended to reduce recovery time from exacerbations, although SCS use has been associated with increased risk of adverse events.MethodsThis study used 2013–2019 Medicare 100% FFS research identifiable files, which contain all Medicare Parts A, B, and D paid claims incurred by 100% of Medicare FFS beneficiaries. Descriptive statistics for patients newly diagnosed with COPD were analyzed, including OCS use, select health conditions and acute events, and COPD exacerbations. Statistical models were used to analyze the relationship between the incidence of select health conditions and events and cumulative OCS dosage.ResultsOf Medicare FFS patients newly diagnosed with COPD, 36% received OCS in the 48 months following diagnosis, and 38% of OCS episodes lasted longer than the recommended 5–7 days. Patients had a variety of health conditions or acute events in the 24-month period prior to new COPD diagnosis, such as hypertension, depression/anxiety, type 2 diabetes, or osteoporosis, that could heighten the risks of OCS use. Patients treated with >1000 mg of prednisolone equivalent OCS in the 48 months following COPD diagnosis had a higher incidence of new conditions or events, including cardiovascular disease, heart failure, hypertension, obesity, dyspepsia, infections, and depression/anxiety, than patients with no OCS use.ConclusionThese results highlight the potential risks of OCS in COPD treatment, including prolonged use among complex Medicare patients, and reinforce the importance of preventive treatment strategies and therapy optimization early in the disease course.

Implementing Oral Systemic Corticosteroids for Pediatric Asthma into EMS Treatment Guidelines: A Qualitative Study

Introduction: Respiratory distress accounts for approximately 14% of all pediatric emergency medical services (EMS) encounters, with asthma being the most common diagnosis. In the emergency department (ED), early administration of systemic corticosteroids decreases hospital admission and speeds resolution of symptoms. For children treated by EMS, there is an opportunity for earlier corticosteroid administration. Most EMS agencies carry intravenous (IV) corticosteroids; yet given the challenges and low rates of EMS pediatric IV placement, oral corticosteroids (OCS) are a logical alternative. However, previous single-agency studies showed low adoption of OCS. Therefore, qualitative study of OCS implementation by EMS is warranted. Methods: This study’s objective was to explore uptake and implementation of OCS for pediatric asthma treatment through semi-structured interviews and focus groups with EMS clinicians. We thematically coded and analyzed transcripts using the domains and constructs of the Consolidated Framework for Implementation Research (CFIR) to identify barriers and facilitators that most strongly influenced OCS implementation and adoption by EMS clinicians. Results: We conducted five focus groups with a total of ten EMS clinicians from four EMS systems: one urban region with multiple agencies that hosted two focus groups, one suburban agency, one rural agency, and a mixed rural/suburban agency. Of the 36 CFIR constructs, 31 were addressed in the interviews. Most constructs coded were in the CFIR domains of the inner setting and characteristics of individuals, indicating that EMS agency factors as well as EMS clinician characteristics were impactful for implementation. Barriers to OCS adoption included unfamiliarity and inexperience with pediatric patients and pediatric dosing, and lack of knowledge of the benefits of corticosteroids. Facilitators included friendly competition with colleagues, having a pediatric medical director, and feedback from receiving EDs on patient outcomes. Conclusion: This qualitative focus group study of OCS implementation by EMS clinicians for the treatment of pediatric asthma found many barriers and facilitators that mapped to the structure of EMS agencies and characteristics of individual EMS clinicians. To fully implement this evidence-based intervention for pediatric asthma, more education on the intervention is required, and EMS clinicians will benefit from further pediatric training.

An asthma collaboration to reduce childhood asthma disparities on the Navajo Nation: Trial protocol for the Community Asthma Program

Navajo children disproportionately experience poor asthma outcomes. Following a one-year community engagement period with key stakeholders from the Navajo Nation, the Community Asthma Program (CAP) was created using evidenced based programs with the goal of reducing asthma disparities among Navajo children. CAP is being evaluated with a six-year, multi-site step-wedge design in three Navajo communities: Tuba City, Chinle and Fort Defiance, Arizona. The primary outcome is asthma exacerbations defined as use of systemic oral corticosteroids, asthma hospitalizations, asthma related ED visits, and ICU admissions. Asthma exacerbations will be measured using data from the electronic medical records of the three community health care centers. Secondary outcomes include will changes in asthma-related events and asthma control. The RE-AIM (Reach and representativeness, 2)Effectiveness, 3) Adoption, 4) Implementation, and 5) Maintenance) framework is being used to guide the implementation evaluation which includes iterative collection and analysis of process data to identify facilitators and barriers, describe relevant organizational contexts, and inform strategies for dissemination. The CAP intervention requires community engagement and participation, building community capacity, incorporating evidenced-based guidelines and practices while ensuring program strategies actively involve Navajo community members during all steps of the intervention. The outcome of this trial will allow us to determine the effectiveness of a multi-component, community-focused intervention to improve asthma in a tribal community.

Acute exacerbations of chronic rhinosinusitis: The current state of knowledge.

ObjectivesAcute exacerbations of chronic rhinosinusitis (AECRS) are distinct from baseline symptomatology related to chronic rhinosinusitis (CRS). In this review, we seek to examine the literature on AECRS to synthesize the definition, epidemiology, pathophysiology, treatment, and impact of AECRS on CRS patients.MethodsA comprehensive narrative review of the scientific literature, identified by searching PubMed from inception through April 2022, was performed.ResultsAECRS is defined in consensus guidelines as a worsening of chronic sinus disease symptomatology, with a return to baseline, typically after intervention with systemic antibiotics and/or corticosteroids. The working definition used across the literature, however, is broad and heterogeneous. The pathophysiology of AECRS is incompletely understood but is hypothesized to include an interplay of environmental and patient‐specific factors. AECRS have been found to have a negative impact on quality‐of‐life measures, independent of baseline CRS symptomatology, and impact how patients and physicians view overall disease control. Treatment for AECRS includes oral antibiotics and systemic corticosteroids, although their efficacy for AECRS is unclear. Appropriate use of medical and surgical treatment for CRS can reduce the frequency of AECRS.ConclusionsAECRS are a distinct entity in CRS patients and should be independently assessed when evaluating patients for CRS control. The efficacy of systemic medication usage for AECRS is currently unclear, but appropriate medical management of baseline CRS can reduce the frequency of AECRS. More research is needed to further understand this phenomenon, including a more precise and prospective definition, defined epidemiology, and how to appropriately treat.Level of Evidence5

Oral Tofacitinib and Systemic Corticosteroids, Alone or in Combination, in Patients With Moderate-to-Severe Alopecia Areata: A Retrospective Study.

IntroductionAlopecia areata (AA) is an autoimmune hair loss mediated by CD8 + T cells. Treatment for moderate-to-severe AA is still challenging. Janus kinase inhibitors, such as tofacitinib, have been recently investigated as a promising treatment option for AA. Evidence on the combination use of oral tofacitinib and systemic corticosteroids (SCs) for AA is still lacking.ObjectiveTo compare the efficacy and safety of monotherapy of oral tofacitinib and SCs, as well as their combination in patients with moderate-to-severe AA.MethodsPatients with moderate-to-severe AA, who have been treated with at least 3 months of monotherapy of tofacitinib or SCs, or in their combination, were included in this study. The efficacy and adverse events of these treatments were retrospectively analyzed.ResultsSixty-one patients with moderate-to-severe AA were included in this study. There were 12 (66.7%) of 18 patients in the SCs group, 12 (60.0%) of 20 patients in the tofacitinib group, and 18 (78.3%) of 23 patients achieved SALT50, with no significant difference among the three groups. The ratio of patients who achieved SALT50 was significantly higher in patients with a short duration of current hair loss episode (≤2 years) than in those with a duration of current hair loss episode (>2 years) in all the three groups. There were 66.7% patients in the SCs group, 35.0% patients in the tofacitinib group, and 56.5% patients in the combined group that showed adverse effects.ConclusionTofacitinib was an effective treatment for patients with moderate-to-severe AA, and it was more tolerated than SCs. A combination of tofacitinib and SCs may have higher efficacy than SCs alone. Efficacy significantly decreased in patients with a current episode of disease for more than 2 years.

SUCCESSFUL NON-OPERATIVE TREATMENT IN MICROCYSTIC LYMPHATIC MALFORMATION OF THE TONGUE: A CASE REPORT

Background: Microcystic lymphatic malformation (MLM) is an abnormal congenital growth of lymphatic vessels. It may occur in any part of the human body, with 75 % cases found in the head and neck, including in oral cavity. This case report aimed to describe a case of MLM in a child who was successfully treated non-operatively with antibiotics and corticosteroid. Case Report: A 4-year-old child came to Oral Medicine Clinic of Dr. Hasan Sadikin General Hospital, Bandung, with a chief complaint lesions of the tongue since a year ago, accompanied by bleeding in the affected areas but not pain. Patient gave history of recurrent episodes of the symptoms since 7 months old. Result : Ultrasonography was performed and diagnosis of microcystic lymphatic malformation was established. Systemic oral corticosteroid, antibiotics, and multivitamins were given and the lesions showed significant improvement after 2-weeks treatment. Conclusion: Therapy of MLM with antibiotics and systemic oral corticosteroid significantly improved patient’s condition, and ultrasonography may be used as a diagnostic modality in MLM diagnosis.

Use of systemic therapies in adults with atopic dermatitis: 12-month results from the European prospective observational study in patients eligible for systemic therapy for atopic dermatitis (EUROSTAD)

Background The European Prospective Observational Study in Patients Eligible for Systemic Therapy for Atopic Dermatitis (EUROSTAD) is an ongoing observational study aiming to describe characteristics of patients with atopic dermatitis (AD) treated with systemic therapy over time and the management of their disease in a real-world setting. Methods Data from patients enrolled in EUROSTAD between March 2017 and April 2019 were analyzed for systemic therapy use and treatment change over 12 months. Results 288 patients reported taking systemic medications; 42.7% received cyclosporine, 35.3% dupilumab, 28.1% methotrexate, 25.4% oral corticosteroids, 6.8% azathioprine, 6.1% injectable corticosteroids, and 3.4% mycophenolate. The median duration of treatment was 1.1 months for oral systemic corticosteroids, 3.2 months for injectable corticosteroids, 4.8 months for cyclosporine, 7.3 months for methotrexate, and 14.9 months for dupilumab. The most frequent reasons for stopping treatment included lack of efficacy, patient decision, adverse events, and disease well controlled. Conclusion The 12-month interim EUROSTAD study analysis highlights the current trends and outcomes of systemic treatments for moderate-to-severe AD. Among all systemic treatments for AD, dupilumab was the least likely to be discontinued, whereas cyclosporine and corticosteroids, whilst effective, were primarily limited to episodic flare management consistent with treatment guidelines.

Intratympanic corticosteroid as salvage therapy in treatment of idiopathic sudden sensorineural hearing loss: A systematic review and meta-analysis

BackgroundThe standard treatment of idiopathic sudden sensorineural hearing loss (ISSNHL) constitutes of systemic oral corticosteroid. Although oral corticosteroid might revert the acute deafness, some patients with ISSNHL display a more treatment refractory course. For these patients, corticosteroid installed directly into the middle ear has become a more frequent treatment, due to the potential benefits of a high, local concentration compared to a systemic administration. As such, for patients being refractory to standard treatment, intratympanic injection of a high dosage of corticosteroid as salvage therapy may be beneficial. ObjectivesTo evaluate the efficacy of intratympanic corticosteroid (ITC) as a salvage treatment of ISSNHL. MethodsA systematic literature search was performed in relevant databases. Both randomized trials and observational studies were considered for inclusion. The risk of bias was evaluated using the Cochrane risk of bias tool (randomized trials) or ROBINS-I tool (observational studies). Meta-analysis was performed to investigate the improvement of PTA (dB) and number of patients displaying recovery following salvage ITC injections. Occurrence of serious side effects was investigated. Finally, the certainty of the evidence was evaluated using the GRADE approach. ResultsEleven relevant studies were identified (4 randomized trials and 7 observational studies). Both observational and randomized trials showed that salvage ITC significantly increased the number of patients displaying recovery. No serious adverse events were identified in any of the included studies. The certainty of evidence ranged from moderate to very low, due to risk of bias, imprecision, and heterogeneity. ConclusionCollectively, our findings indicate that salvage ITC treatment may be a beneficial and safe treatment for patients with sudden hearing loss, who otherwise are refractory to standard treatment approaches. However, the evidence level indicates need for a cautious interpretation of especially the magnitude of effect and thus the extrapolation on how much the individual may improve from this treatment. Furthermore, it remains to be investigated whether treatment outcomes may vary across different patient groups presenting with ISSNHL. This potential variation in treatment response should be kept in mind, when counselling the patient. Trial registration numberThe protocol is registered in PROSPERO. Registration number: CRD42019130586.

Nonselective Beta-Blockers for the Efficacious Healing of Ulcerated Infantile Hemangiomas in Unusual Locations of Two Female Infants

Infantile hemangiomas (IHs) are the most common vascular soft-tissue tumors of newborns and early childhood with a prevalence rate of approximately 4%-5% in infancy. Most of the IHs regress spontaneously after initial proliferation. Ulceration is one of the most common complications seen in IHs, which heal poorly without treatment. The prevalence of IHs is three times more in females compared to males. The most common location of IH is head and neck with the least being in extremities Oral propranolol and systemic corticosteroids are used as first-line therapy in the treatment. Topical timolol has been used as an alternative to counteract the long-term side effects of the prior modalities. In this study, we are reporting and presenting case reports of two female infants with ulcerated IH who were treated with oral propranolol and topical timolol, respectively, and comparing the efficacy of one over the other. we observed fast and efficacious healing with oral propranolol when used with proper monitoring, as compared to topical timolol, although the latter is more commonly used as it is safer with fewer potential side effects.

Comparison of low dose oral Methotrexate vs Systemic Corticosteroids for treatment of Oral Lichen Planus

Background: Oral Lichen Planus (OLP) is a relatively common chronic inflammatory mucocutaneous disorder. WHO considers OLP a premalignant lesion. This makes management of OLP important to avoid its malignant transformation. Corticosteroids are considered as the first-line of treatment. Different other treatment modalities are also in use for OLP. But there is no statistically significant data available for a particular therapy. The recent evidences suggest methotrexate may effectively be used in low dose in the treatment of OLP. Aim: To compare the frequency of complete resolution of mucosal lesions of oral lichen planus with low dose oral methotrexate versus systemic corticosteroids. Methods: It was a randomized control trial conducted at Oral &amp; Maxillofacial Surgery Department, King Edward Medical University/Mayo Hospital Lahore in six months. A sample of 60 patients was divided into two sub groups namely Group -A (methotrexate) and Group - B (corticosteroid) using lottery method. More than 75% resolution of mucosal lesions clinically was considered as complete resolution at the end of 8th week. Results: The mean age of the patients was 44.55±12.38 years. On 8th week, frequency of complete resolution of mucosal lesions was 73.3% in Group A and 60% in Group B with an insignificant difference (p-value&lt;0.05). Conclusion: Methotrexate group A showed more complete resolution of mucosal lesions than corticosteroid group B with insignificant statistical difference. Keywords: Oral Lichen Planus, Mucosal lesions, Malignant transformation, Methotrexate, Corticosteroids

Efficacy and safety of tetracyclines for pemphigoid: a systematic review and meta-analysis.

The aim of this review was to evaluate the efficacy and safety of tetracyclines for treatment of pemphigoid. We searched PubMed, EMBASE, Ovid, Web of Science, and the Cochrane Library for studies involving pemphigoid patients treated with tetracyclines published in English before 29 February 2020. References of included studies were also screened to widen the scope of the literature search. Data regarding predefined clinical outcomes of 341 patients from 77 studies were extracted and analyzed. A meta-analysis was conducted on the basis of 4 studies including 2 randomized controlled trials and 2 comparative studies. The patients had a mean age of 74.60 ± 13.18years, 45.4% were males, and 54.6% were females. There were 185 patients with mild-to-moderate and 143 patients with severe disease. The average initial doses were 1.62 ± 0.39g/day for tetracycline, 0.20 ± 0.01g/day for doxycycline, and 0.11 ± 0.05g/day for minocycline. The average time on tetracyclines was 3.74 ± 5.99months, and 261 (81.3%) patients reported partial or complete remission. Relapses occurred in 72 (28.3%) cases. Adverse effects were experienced by 130 (41.9%) patients. The pooled ORs for short-term effectiveness, relapse, adverse effects, and 1-year survival in patients treated with oral tetracyclines vs. systemic corticosteroids were 0.40 (95% CI, 0.22-0.76), 0.69 (95% CI, 0.44-1.10), 0.47 (95% CI, 0.27-0.82) and 2.02 (95% CI, 1.16-3.50), respectively. Compared to doxycycline and minocycline, tetracycline was significantly associated with better treatment outcomes and fewer adverse effects (p < 0.05). This review revealed tetracyclines' efficacy and safety in pemphigoid treatment and may offer support for clinical use of tetracyclines in pemphigoid.

PRS47 Management of Severe Asthma in Portugal: Insights from a Delphi Panel

To characterize the asthmatic patients in GINA 5 in the Portuguese National Health System, in terms of resource use by disease control and level of exacerbation, % OCS-dependent and % comorbidities. The study was conducted using a modified Delphi panel, composed of 6 reference physicians (pneumologists and immunoallergologists), that follow approximately 1870 asthmatic patients per year. GINA was used to define disease severity. Disease control was defined based on ACT score. A descriptive analysis was performed for the key variables. Based on panel results, severe asthma (GINA 5) represent 3% and 27% of the total adolescent (12-17 years old) and adult asthmatic patients follow by the physicians, respectively. Severe asthmatic patients are usually managed with a combined therapy of high doses of inhaled corticosteroids (ICS)/long-acting beta-2 agonists (LABA). Several options are usually added as a third drug in all patients for symptom relief. Despite the available therapies, 17% of patients are still systemic oral corticosteroids (OCS)-dependent. Regarding resource consumption: the share of controlled/uncontrolled patients attending each type of medical appointment is similar, however, uncontrolled patients need, on average, more appointments per year. The same was true when analyzing the consumption of exams. During exacerbations (moderate/severe), uncontrolled patients have additional consumption of resources, with most patients having to take antibiotics and OCS, while some even need hospitalization. Finally, when analyzing comorbidities, approximately 74% of severe asthma patients suffer from chronic rhinosinusitis, 34% from chronic rhinosinusitis with severe nasal polyposis, 19% from moderate-to-severe atopic dermatitis and 13% from food allergy. Severe asthma represents a great resource consumption. This fact is even more relevant in uncontrolled patients, namely due to moderate/severe exacerbations. Therapeutically there are still a relevant proportion of patients OCS-dependent, which is associated with many potential complications. Even with existing therapies, there remains an unmet need, especially in patients OCS-dependent.