Total Corticosteroid Research Articles

Results of omalizumab treatment in chronic eosinophilic pneumonia: Real-life data.

Recurrences occur when corticosteroid therapy is discontinued or reduced during the treatment of chronic eosinophilic pneumonia (CEP). The probability of recurrence is once in 50% of patients and twice or more in 25%. In such instances, new treatment options are deemed necessary. This study aims to assess the efficacy of omalizumab treatment as a steroid-sparing drug in patients with CEP. The clinical features of patients treated with omalizumab for recurrent CEP were evaluated retrospectively before and after treatment. All data from patients and diagnoses were reviewed. The effects of treatment on recurrence rate, oral corticosteroid (OCS) use and lung functions, peripheral eosinophil values, and symptom scores were evaluated. Radiological regression was also evaluated. In the final analysis, we included ten patients with a median follow-up of 22 months after initiation of omalizumab. During this follow-up period, the results were associated with a significant reduction in the number of asthma attacks per year, the number of CEP relapses, the rate of hospitalization, the amount of corticosteroids consumed daily, and the total corticosteroid dose. In addition, improvement was observed in the symptom scores and lung functions of the patients. Systemic steroids were completely discontinued in two patients receiving omalizumab treatment. In other patients, the mean steroid dose was reduced by 77.2 percent in the first year of omalizumab treatment and 82 percent in the second year, respectively. Nevertheless, there was no elevation in peripheral eosinophil count, and radiological regression was observed. Omalizumab can be an effective treatment for CEP and can be used as a steroid-sparing agent.

Change in systemic steroid use and surgery rate in patients with inflammatory bowel disease: a Japanese real-world database analysis

BackgroundCorticosteroids are recommended only for induction of remission in inflammatory bowel disease (IBD), including ulcerative colitis (UC) and Crohn’s disease (CD). This study aimed to evaluate the change in pharmacologic treatment use, particularly systemic corticosteroids, over approximately 30 years, and the impact of biologics on IBD treatment since their appearance in the 2000s.MethodsThis retrospective study conducted in Japan used data from the Phoenix cohort database (January 1990 to March 2021). Patients with disease onset at age ≥ 10 years who received treatment for UC or CD between January 1990 and March 2021 were included. Outcome measures were change in IBD treatments used, total cumulative corticosteroid doses, initial corticosteroid dose, duration of corticosteroid treatment, and surgery rate.ResultsA total of 1066 and 579 patients with UC and CD, respectively, were included. In UC, the rate of corticosteroid use as initial treatment was relatively stable regardless of the year of disease onset; however, in CD, its rate decreased in patients who had disease onset after 2006 (before 2006: 14.3–27.8% vs. after 2006: 6.6–10.5%). Compared with patients with disease onset before biologics became available, cumulative corticosteroid doses in both UC and CD, and the surgery rate in CD only, were lower in those with disease onset after biologics became available.ConclusionsSince biologics became available, corticosteroid use appears to have decreased, with more appropriate use. Furthermore, use of biologics may reduce surgery rates, particularly in patients with CD. UMIN Clinical Trials Registry; UMIN000035384.

A Fully Decentralized Randomized Controlled Study of As-Needed Albuterol-Budesonide Fixed-Dose Inhaler in Mild Asthma: The BATURA Study Design.

Decentralized clinical trials, where trial-related activities occur at locations other than traditional clinical sites(eg participant homes, local healthcare facilities), have the potential to improve trial access for people for whom time and/or distance constraints may impede participation. Albuterol-budesonide 180/160 µg pressurized metered-dose inhaler (pMDI) is FDA approved for the as-needed treatment or prevention of bronchoconstriction and to reduce the risk of exacerbations in patients with asthma 18 years or older. BATURA (NCT05505734) is a fully decentralized study, investigating as-needed albuterol-budesonide in participants with mild asthma. BATURA is a fully decentralized, phase 3b, randomized, double-blind, event-driven exacerbation study conducted in the United States. Participants aged ≥12 years using as-needed short-acting β2-agonist (SABA), alone or with low-dose inhaled corticosteroid or leukotriene receptor antagonist maintenance, are randomized 1:1 to as-needed albuterol-budesonide 180/160 µg or albuterol 180 µg pMDI for up to 52 weeks (minimum 12 weeks). Participants continue their current maintenance therapy, if applicable. Participants must have used SABA for ≥2 days in the 2 weeks pre-enrollment and have an Asthma Impairment Risk Questionnaire score ≥2 at screening and randomization. All trial-related visits, including screening and consent, are conducted virtually, with study medication shipped directly to each participant's residence. The primary objective is to evaluate the efficacy of as-needed albuterol-budesonide versus albuterol on severe asthma exacerbation risk, measured by time-to-first severe asthma exacerbation (primary endpoint). Secondary endpoints include annualized rate of severe asthma exacerbation and total systemic corticosteroid exposure. Study medication use is captured via a Hailie sensor attached to the study medication pMDI. The intended sample size is 2500 participants. BATURA evaluates as-needed albuterol-budesonide in participants with mild asthma. The decentralized study model enables the trial to move out of research sites into participant homes, reducing participant burden and improving access.

Real-world effectiveness of dupilumab in patients with asthma: Findings from the US ADVANTAGE study

BackgroundDupilumab is approved as an add-on maintenance therapy for patients (≥6 years) with moderate-to-severe asthma. Better understanding of real-world effectiveness is needed. ObjectiveTo characterize the real-world effectiveness of dupilumab in asthma management. MethodsThis retrospective study included patients (≥12 years of age) diagnosed with asthma, initiating dupilumab between November 2018 and September 2020. The study used a US electronic medical record database (TriNetX Dataworks, Cambridge, Massachusetts). Asthma exacerbation rates before and after the initiation of dupilumab were analyzed using generalized estimating equations models with Poisson probabilistic link to estimate incidence rate ratios (IRRs). Sensitivity analyses were conducted based on previous exacerbation data, eosinophil levels, history of atopic dermatitis or chronic rhinosinusitis with nasal polyps, previous use of biologics, and presence of SARS-CoV-2 (COVID-19). ResultsA total of 2400 patients initiating dupilumab met all study criteria. After initiation of dupilumab, risk of asthma exacerbation was reduced by 44% (IRR, 0.56; 95% CI, 0.47-0.57; P = <0.0001) and systemic corticosteroid prescriptions by 48% (IRR, 0.52; 95% CI, 0.48, 0.56; P = <0.0001) compared with those before initiation of dupilumab. Adjustment for COVID-19 showed a greater reduction in asthma exacerbations (IRR, 0.50; 95% CI, 0.45-0.55; P = <0.0001). ConclusionCurrent real-world efficacy evidence indicates that dupilumab reduces asthma exacerbations and total systemic corticosteroid prescriptions in clinical practice. The effectiveness of dupilumab was observed independent of exacerbation history, eosinophil levels, or COVID-19 impact.

Mepolizumab Reduces Systemic Corticosteroid Use in Chronic Rhinosinusitis With Nasal Polyps

Systemic corticosteroids (SCSs) are associated with short- and long-term adverse effects. To assess mepolizumab efficacy according to prior SCS use and characterize mepolizumab's SCS-sparing capabilities, in patients with severe chronic rhinosinusitis with nasal polyps. In the randomized, double-blind, phase IIISYNAPSE trial (NCT03085797), adults with severe chronic rhinosinusitis with nasal polyps eligible for repeat sinus surgery despite standard of care treatment received mepolizumab (100 mg subcutaneously) or placebo every 4 weeks for 52 weeks. The impact of prior SCS courses (0/1/>1) on mepolizumab versus placebo treatment responses (changes from baseline in total endoscopic nasal polyp [week 52], nasal obstruction visual analog scale [weeks 49-52], and 22-item Sino-Nasal Outcome Test total [week 52] scores) was analyzed post hoc. To characterize mepolizumab's SCS-sparing capabilities, time-to-first SCS course for nasal polyps (prespecified) and total prednisolone-equivalent oral corticosteroid dose by patient baseline characteristics (post hoc, in patients with ≥1 SCS course during SYNAPSE) were assessed up to week52. Mepolizumab versus placebo improved treatment responses, irrespective of prior SCS use. By week 52, the probability of requiring SCSs for nasal polyps (Kaplan-Meier estimate [95% CI]) was lower with mepolizumab (25.4% [20.0-32.1]) versus placebo (37.5% [31.1-44.6]). In patients requiring 1 or more dose of SCSs, total (mean ± SD mg/y) prednisolone-equivalent oral corticosteroid dose was lower with mepolizumab (438.9 ± 350.40) versus placebo (505.2 ± 455.091), overall and irrespective of prior sinus surgeries, blood eosinophil count, or comorbidities. Mepolizumab is associated with clinical benefits in patients with severe chronic rhinosinusitis with nasal polyps regardless of prior SCS use and has an SCS-sparing effect.

The factors predicting development of serious infections in ANCA-associated vasculitis.

Anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis (AAV) is a rare autoimmune disease usually involving small vessels and progressing with necrotizing inflammation. Treatment requires long-term use of immunosuppressive agents to inhibit disease activity. Serious infections (SIs) are a common complication in AAV. The aim of this study was to identify the risk factors for serious infections which required hospitalization in patients with AAV. In this retrospective cohort study., we included 84 patients admitted to the Ankara University Faculty of Medicine in the last 10 years with a diagnosis of AAV. In 42 (50%) of 84 patients followed up with the diagnosis of AAV, an infection requiring hospitalization was identified. The patients' total corticosteroid dose, use of pulse steroids, induction regimen, levels of C-reactive protein (CRP) and the presence of pulmonary and renopulmonary involvement were found to be associated with the frequency of infection (p=0.015, p=0.016, p=0.010, p=0.03, p= 0.026 and p=0.029, respectively). In multivariable analysis, it was found that renopulmonary involvement (p=0.002, HR=4.95, 95% CI= 1.804-13.605), age of over 65 (p=0.049, HR=3.37, 95% CI=1.004-11.369) and high CRP levels (p=0.043, HR=1.006, 95% CI=1.000-1.011) constituted independent predictors of serious infection risk. The frequency of infection is known to be increased in ANCA-associated vasculitis. Our study showed that renopulmonary involvement, age and elevated CRP levels on admission are independent risk factors of infection.

Management of Inflammatory Bowel Disease Using E-Health Technologies: A Systematic Review and Meta-Analysis.

Technological advances have provided innovative, adaptive, and responsive models of care for inflammatory bowel diseases (IBD). We conducted a systematic review to compare e-health interventions with standard care in management of IBD. We searched electronic databases for randomized controlled trials (RCT) comparing e-health interventions to standard care for patients with IBD. Effect measures were standardized mean difference (SMD), odds ratio (OR) or rate ratio (RR), calculated using the inverse variance or Mantel-Haenszel statistical method and random-effects models. Version 2 of the Cochrane tool was used to assess the risk of bias. The certainty of evidence was appraised with the GRADE framework. Fourteen RCTs (n=3111; 1754-e-health & 1357-controls) were identified. The difference in disease activity scores (SMD 0.09, 95% CI: -0.09-0.28) and clinical remission (OR 1.12, 95% CI: 0.78-1.61) between e-health interventions and standard care were not statistically significant. Higher QoL (SMD 0.20, 95% CI: 0.05-0.35) and IBD knowledge (SMD 0.23, 95% CI: 0.10-0.36) scores were noted in the e-health group, while self-efficacy levels (SMD -0.09, 95% CI: -0.22-0.05) were comparable. E-health patients had fewer office (RR 0.85, 95% CI: 0.78-0.93) and emergency (RR 0.70, 95% CI: 0.51- 0.95) visits, with no statistically significant difference in endoscopic procedures, total healthcare encounters, corticosteroid use, and IBD related hospitalization or surgery. The trials were judged to be high risk of bias or have some concerns for disease remission. The certainty of evidence was moderate or low. E-health technologies may have a role in value-based care in IBD.

Shear Wave Elastography-Correlated Dose Modifying: Can We Reduce Corticosteroid Doses in Idiopathic Granulomatous Mastitis Treatment? Preliminary Results

Idiopathic granulomatous mastitis (IGM) is a chronic inflammatory breast disease treated with local and systemic corticosteroids. This study aims to evaluate the efficacy of reducing corticosteroids doses in IGM cases based on shear wave elastography (SWE) tissue stiffness measurements. This prospective study included IGM patients who received systemic or local corticosteroids between January 2020 and September 2022. A 20% or more reduction in tissue elasticity values (kPa) was considered a positive response to treatment in the study group, and the corticosteroids dose was reduced. The control group was dosed routinely. All patients were followed for 2 years to compare treatment efficacy, duration, total corticosteroids dose, recurrence, and side effects. There were 12 patients (9 local/3 systemic corticosteroids) in the study group and 24 patients (17 local/7 systemic corticosteroids) in the control group. Ten (83.4%) out of 12 patients in the study group were successfully treated by reducing corticosteroid doses with follow-up, and 2 (16.6%) out of 12 patients were reverted to the initial treatment protocol due to an increase in elasticity values during the follow-up. Nevertheless, successful treatment results were obtained in these two patients without reducing the corticosteroid dose. When compared to the control group, the median corticosteroid dose in the study group was significantly lower in patients using both local (p < 0.01) and systemic (p < 0.01) corticosteroids. A significant negative correlation was found between the rate of decrease in elasticity values and the median dose of corticosteroids (r = -0.649, p < 0.05) and the median treatment time (r = -0.751, p < 0.01). Side effects due to corticosteroids were found to be significantly lower in the study group (p < 0.05). According to our first and preliminary results, the SWE-correlated dose-modifying technique may reduce corticosteroid doses and side effects without significantly compromising treatment efficacy.

Albuterol-budesonide Fixed-dose Combination (FDC) Inhaler As-needed Reduces Progression from Symptomatic Deterioration to Severe Exacerbation in Patients with Moderate-to-severe Asthma: Analysis from MANDALA

Short-acting β2-agonists (SABAs) treat symptoms, but not the underlying inflammation. A “window of opportunity” may exist to prevent severe exacerbations if symptoms and inflammation are treated concomitantly, as advocated by GINA and NAEPP. In the Phase 3 MANDALA study (NCT03769090), as-needed albuterol-budesonide 180/160μg FDC significantly reduced severe exacerbation risk by 27%, annualized severe exacerbation rate by 24%, and annualized total systemic corticosteroid exposure mean was reduced by 33% versus albuterol.

P773 Extended induction in the True North open-label extension study: clinical outcomes of ~2 years of ozanimod treatment

Abstract Background Ozanimod is approved in the EU, US, and other countries for the treatment of moderately to severely active ulcerative colitis in adults. In the phase 3, 52-week, double-blind True North (TN) study, Week 10 clinical nonresponders to ozanimod could enter the open-label extension (OLE) to continue treatment. Previous analysis showed that approximately 50% of Week 10 nonresponders achieved symptomatic clinical response with extended induction during the OLE in as early as 5 weeks. The current analysis evaluated long-term clinical and symptomatic endpoints up to 2 years in this delayed responder subgroup. Methods Efficacy data were analysed for TN Week 10 ozanimod nonresponders who subsequently received open-label ozanimod in the OLE, both by whole subgroup and original study arms (double-blind [Cohort 1] and open-label ozanimod [Cohort 2]) (data cutoff: January 10, 2022). Endpoints included symptomatic clinical response, symptomatic clinical remission, total Mayo score, clinical response, clinical remission, and corticosteroid (CS)-free remission up to OLE Week 94 (104 weeks of continuous ozanimod treatment). Data were evaluated using observed case (OC) and nonresponder imputation (NRI) analyses. Results A total of 226 nonresponders at TN Week 10 entered the OLE (Cohort 1, n=150; Cohort 2, n=76). Males comprised 67% of this subgroup, and mean (SD) age was 39.6 (13.6) years. Symptomatic clinical response (Figure 1), symptomatic clinical remission, and reduction in partial Mayo scores were observed as early as OLE Week 5 and were maintained through OLE Week 94. Minimal change in total Mayo score was observed from TN Week 0 (baseline) to TN Week 10 (OLE Week 0), but significant reductions from baseline occurred by OLE Week 46 (–4.2 [2.7]) and OLE Week 94 (–5.3 [2.6]). Overall, 62% of patients achieved clinical response, 26% achieved clinical remission, and 24% achieved CS-free remission at OLE Week 46; these increased to 74%, 35%, and 33%, respectively, by OLE Week 94 in the OC analysis (Figure 2). Data were similar between Cohorts 1 and 2. Conclusion Symptomatic response in ozanimod nonresponders was observed as early as 5 weeks after extended induction with ozanimod. Delayed response to ozanimod was maintained for up to 2 years as demonstrated by both symptomatic and objective endpoints. Even in those with delayed initial response, efficacy of ozanimod was durable.

Clinical Characteristics of Patients with Probable Coronavirus Disease 2019-associated Pulmonary Aspergillosis at a Tertiary Care Hospital in the Republic of Korea: A Case Series

Background: Coronavirus disease 2019 (COVID-19)-associated pulmonary aspergillosis (CAPA) is a life-threatening invasive fungal infection in critically ill patients with COVID-19. However, only a few studies have reported CAPA in the Republic of Korea. Objective: To describe clinical characteristics of CAPA in patients at a tertiary care hospital in the Republic of Korea. Methods: This retrospective, observational consecutive case series study was conducted by reviewing the electronic medical records of patients who developed CAPA at Seoul National University Hospital from January 1, 2020, to August 31, 2021. CAPA was defined by European Confederation of Medical Mycology/International Society for Human and Animal Mycology (ECMM/ISHAM) consensus criteria. Patient demographics, comorbidities, corticosteroid use, clinical presentation, treatment, and outcomes were investigated. Results: Eleven patients were diagnosed with probable CAPA according to the ECMM/ISHAM criteria. One patient had classical host factor for invasive pulmonary aspergillosis before admission. All patients received corticosteroid therapy before CAPA diagnosis. The mean total corticosteroid administered before CAPA diagnosis was 220 mg of dexamethasone equivalent dose (range, 80~572 mg), and the mean duration of steroid therapy was 15 days (range, 4~34 days). The median time from intensive care unit admission to CAPA diagnosis was 12 days (range, 5~36 days). All individuals showed aggravation on chest X-rays. Ten patients were diagnosed with positive serum galactomannan (GM), and one was diagnosed with positive GM in a bronchoalveolar lavage specimen. Of the 11 patients, 8 received voriconazole-based antifungal therapy for a median of 30.5 days. Only two patients survived after antifungal treatment. Conclusion: These cases illustrate CAPA complicated in critically ill COVID-19 patients. The challenges in diagnosis and poor outcomes of CAPA emphasize the clinical suspicion and needs for further investigation.

Kidney Disease After Allogeneic Hematopoietic Stem Cell Transplantation Is Associated With Decreased Physical Function

Allogeneic hematopoietic stem cell transplantation (allo-HSCT) has improved outcomes and prognosis, but it has many complications and is associated with impaired physical function. To solve this problem, it is necessary to further analyze the factors that cause the decline in physical function. In the present study, we hypothesized that kidney disease following allo-HSCT would be associated with impaired physical function, in addition to conventional factors, and tested this hypothesis retrospectively. Thirty-one patients who underwent allo-HSCT at the Department of Hematology in our hospital from January 2016 to October 2021 were included in the analysis. Correlation analysis and stepwise multiple regression analysis with change in 30-second sit to stand test (Δ30-s STS) as the dependent variable were performed to identify predictors of physical function decline from pretransplant to discharge. The mean age of participants was 43.9 years (SD=11.8), the mean time from transplant to discharge was 103.1 days (SD=35.0), and approximately 30% of patients had kidney disease following allo-HSCT. All patients were ambulatory and independent at discharge, but 30-s STS was significantly reduced (P < .001). Among various factors, age (β=-0.464, P < .05), total corticosteroid dose (β=-0.380, P < .05), and kidney disease after allo-HSCT (β=-0.307, P < .05) were the independent predictors of Δ30-s STS (R2=0.592, adjusted R2=0.547, F=13.072, P < .01). Kidney disease after allo-HSCT is one of the factors that may contribute to poor physical function, and patients who experience this condition may require additional follow-up to improve physical function.

Clinical impact and a prognostic marker of early rituximab treatment after rituximab reimbursement in Korean pemphigus patients.

Pemphigus is an autoimmune mucocutaneous blistering disease caused by autoantibodies against desmogleins. Rituximab effectively treats pemphigus by inducing remission and rapidly reducing corticosteroid dosage. In Korea, the high cost of rituximab had been a burden until the National Health Insurance began to cover 90% of rituximab costs via reimbursement for severe pemphigus patients. We analyzed 214 patients with pemphigus who were treated with their first round of rituximab. The time to initiate rituximab and the time to partial remission under minimal therapy (PRMT) were both significantly shorter after the rituximab reimbursement policy. The total steroid intake for PRMT and complete remission (CR) was less in patients who were diagnosed after the reimbursement. The interrupted time series (ITS) model, a novel analysis method to evaluate the effects of an intervention, showed a decrease in total systemic corticosteroid intake until PRMT after reimbursement began. In peripheral blood mononuclear cells from patients with pemphigus vulgaris, the relative frequencies of desmoglein 3-specific CD11c+CD27−IgD− atypical memory B cells positively correlated with the periods from disease onset to rituximab treatment and to PRMT and the total systemic corticosteroid intake until PRMT. We found that early rituximab therapy, induced by the reimbursement policy, shortened the disease course and reduced the total corticosteroid use by pemphigus patients. The decreased frequency of circulating desmoglein-specific atypical memory B cells can be used as a surrogate marker for a good prognosis after rituximab.

Comparison of the efficacy and cost-effectiveness of an immunologically targeted low-dose rituximab protocol with the conventional rheumatoid arthritis protocol in severe pemphigus.

Various dosing protocols of rituximab have been used in pemphigus. B-cell repopulation following rituximab treatment can be considered a forerunner of clinical relapse. Immunologically guided dosing may remove the need for fixed timepoint maintenance dosing, hence being more cost-effective and perhaps safer. To compare the overall efficacy and cost-effectiveness of a low-dose rituximab regimen (500 mg, 2 weeks apart) with immunologically guided, ultralow-dose (200 mg) top-up infusions on immunological relapse vs. the use of a rheumatoid arthritis (RA) protocol with rituximab 500 mg repeat infusion to treat clinical relapse in severe pemphigus, over a 1-year period, METHODS: In total, 23 patients with severe pemphigus were randomized into Group A (RA protocol: 1000 mg given as two doses, 2 weeks apart) and Group B (low-dose rituximab 500 mg given as two doses, 2 weeks apart). Both groups also received short-term oral corticosteroids, and underwent clinical and immunological (3-monthly flow cytometry assessments of B-cell subtypes) monitoring. Group A received a top-up dose of rituximab 500 mg upon clinical relapse, while Group B received an ultralow top-up dose (200 mg) following detection of B-cell repopulation, which was intended to prevent clinical relapse. Outcome parameters [complete remission off treatment (CROT), relapse (clinical and immunological), total corticosteroid dose and direct cost of therapy] were compared. The mean ± SD time to CROT (Group A, 27.1 ± 1.6 weeks; Group B, 26 ± 1.2 weeks, P = 0.09) and the cumulative prednisolone dose (P = 0.28) were comparable between the two groups. In Group A, 3 of 9 (33.3%) patients had clinical relapse (mean ± SD time of 9.3 ± 0.4 months). In Group B, B-cell repopulation was seen in 10 of 11 (90.9%) patients within a mean time of 8.4 ± 2.4 months, and a single top-up dose of 200 mg successfully prevented clinical relapse. The overall cost of therapy was 37.4% cheaper in Group B. An immunologically guided low-dose rituximab regimen can be an equally effective but more affordable alternative to conventional rituximab regimens in pemphigus.

171 International survey: Effects of cumulative exposure to corticosteroids in patients with eczema, including topical steroid withdrawal syndrome (TSWS)

Patients with eczema have a lifetime of exposure to corticosteroids (topical (TCS), oral (OCS), inhaled, nasal sprays etc). The survey examined cumulative effects of corticosteroid exposure, sociodemographic characteristics, disease attributes, history of eczema treatment, and experience and knowledge of topical steroid withdrawal syndrome (TSWS). Surveyed total lifetime corticosteroid use of all types. 91% reported TCS use with an average duration of 15.3 years, applying 1-2 times daily, for 15-30 days a month, on an average body surface area (BSA) of 24%.

Comparison between oral pentoxifylline + corticosteroid and oral corticosteroid alone for severe erythema nodosum leprosum

Background: Severe erythema nodosum leprosum (ENL) is common but difficult to treat. Long term use of systemic corticosteroid causes side effects. This study compares the use of a combination of pentoxifylline + oral corticosteroids with a single oral corticosteroid in leprosy patients with severe ENL reactions. Parameters measured include skin RSA score, systemic RSA, total corticosteroid dose, resolution time of skin lesions, improvement of pain VAS and treatment side effects. Methods: 29 subjects with severe ENL reactions are allocated randomly into two groups which receive oral pentoxifylline + methylprednisolone, and oral placebo + methylprednisolone for 12 weeks. The starting dose of pentoxifylline are 400 mg thrice daily for 4 weeks, tapered to 400 mg daily every 4 weeks. Methylprednisolone is based on WHO guideline. Results: In the end, the median of cutaneous RSA score in pentoxifylline vs placebo group is 4 (0-5) vs 3 (0- 5). The median of systemic RSA score in pentoxifylline vs placebo group is 0 (0-6) vs 0 (0-5). The median of total corticosteroid doses in pentoxifylline vs placebo group is 156 (120-200) mg vs 136 (96-200) mg. The median of resolution time in pentoxifylline vs placebo group is 6 (0-12) weeks vs 6 (0-12) weeks. The median of change of pain VAS score in pentoxifylline vs placebo group is 5 (0-6) vs 3 (-3-6). No statistically significant difference (p&gt;0,05) are found in all parameters, including side effects. Conclusion: Combination of oral pentoxifylline + corticosteroid is not proven to be more effective. Both are safe. Keywords: combination, corticosteroid, erythema nodosum leprosum, pentoxifylline

Combination fixed-dose β agonist and steroid inhaler as required for adults or children with mild asthma: a Cochrane systematic review

BackgroundIn people with mild asthma poor adherence to regular therapy is common and increases the risk of exacerbations, morbidity and mortality. The use of fixed-dose combination inhalers containing an inhaled...

Use of Tocilizumab in hospitalized patients during the first wave of the COVID-19 pandemic

Introduction: The aim of this study was to characterize the use of tocilizumab in a hospital.&#x0D; Method: Retrospective cohort study including adult SARS-CoV-2 infected inpatients with moderately severe infection (PaO2/FiO2 &lt; 300). ORs for mortality and treatment success were calculated.&#x0D; Results: The tocilizumab group (n=18), presented 5 days of symptoms vs 7 days in the untreated group (n=71). Minimum PaO2/FiO2 was 147.5 (95%CI: 116.7 to 194.0) vs 255.6 (95%CI: 320.7 to 452.4) (p=0.01).&#x0D; No significant differences were found between the two groups concerning survival (OR=1.22; 95%CI: 0.38 to 3.92), nor treatment success (OR=0.46; 95%CI: 0.16 to 1.33). After adjusting for age, sex and total corticosteroid dose, OR for success was 0.18 (95%CI: 0.03 to 0.96), while mortality was not significant.&#x0D; Conclusions: The use of tocilizumab in moderately severe hospitalized patients could decrease the hyperinflammatory state preventing disease progression.

Changes in prescription pain medication and intra-articular corticosteroid utilization after intra-articular bio-fermentation derived hyaluronic acid use in patients undergoing multimodal pain management

Background Multiple interventions may be used to treat symptomatic knee osteoarthritis (OA), but concerns have been raised about the safety and efficacy of some therapies. Clinical trials have shown that hyaluronic acid (HA) can provide pain relief up to 6 months and possibly to 12 months, while real-world data has shown that pain medication and intra-articular corticosteroid (CS) injection utilization are reduced within 6 months after HA. Objective To examine changes in prescription pain medication and CS utilization during 1 year after multimodal therapy that included high molecular weight, bio-fermentation derived HA (Bio-HA) use for knee OA. Methods Commercial and Medicare Supplemental claims data (IBM MarketScan Research Databases) (1 January 2012, through 31 December 2018) was used to identify unilateral Bio-HA patients using multimodal therapy (any combination of CS injection, opioids, and non-opioid pain medication). Monthly therapy utilization was compared in the 12 months after Bio-HA therapy initiation to the 4-month intra-multimodal period. Results A total of 13,999 patients underwent Bio-HA therapy with concurrent multimodal therapy. The number of filled opioid prescriptions decreased from 2,913.0/month to 2,861.5/month after Bio-HA, with a reduction in mean monthly prescriptions from 0.60 to 0.43 per user (p < 0.001). A number of opioid days supplied also decreased from 48,914/month to 39,730/month, with a decrease from 10.1/month to 6.0/month per user (p < 0.001). Bio-HA patients had prescription pain medication-free days for 71% of the time post-multimodal period compared to 53% during the intra-multimodal period (p < 0.001). The proportion of patients with CS injections after Bio-HA decreased from 53.8% to 29.6% (p < 0.001). Total monthly CS injections decreased from 2,292 to 663. Conclusions Our data suggest that high molecular weight Bio-HA, as part of multimodal therapy, may be effective in providing longer-term pain relief with the reduction in pain therapy (CS injections and opioids) and increase in prescription pain medication-free days.

Real-world benefits of biologics for asthma: Exacerbation events and systemic corticosteroid use

BackgroundStudies have shown the efficacy of asthma biologics in real-world settings, confirming the generalizability of randomized controlled trial (RCT) results, but studies on more than one biologic are scarce. Accordingly, little is known about the different background characteristics in users of asthma biologics. This study aimed to describe the backgrounds of asthma patients using biologics (omalizumab, mepolizumab, benralizumab, and dupilumab) and examine the effectiveness of these biologics for reducing asthma exacerbations and total systemic corticosteroid doses. MethodsWe conducted a retrospective cohort study using self-controlled methods to evaluate the association between the use of biologics and reduction in exacerbations and hospitalizations using a large-scale health insurance claims database in Japan. ResultsOf 355 continuously treated asthma patients using biologics, 119, 82, 69, and 85 patients were assigned to the omalizumab, mepolizumab, benralizumab, and dupilumab groups, respectively. The baseline characteristics differed among users of biologics. The incidence ratios of exacerbations and hospitalizations during biologics use were 0.68 (95% confidence interval, 0.62–0.74) and 0.65 (0.55–0.77) compared with the period before biologics use. The total systemic corticosteroid dose equivalent to prednisolone per person-year was reduced from a median of 600 [interquartile range, 90–1713] mg to 164 [0–1010] mg (P < .001). Similar results were obtained for individual biologics with a few exceptions. ConclusionsThe background characteristics of biologics users differed in a real-world setting. Our results confirmed findings from RCTs demonstrating that each biologic (omalizumab, mepolizumab, benralizumab, and dupilumab) is associated with decreased exacerbation numbers and corticosteroid-sparing effects, even outside of the controlled settings of RCTs.