Oral Corticosteroid Use In Patients Research Articles

Real-World Effectiveness of Mepolizumab in Patients with Allergic and Non-Allergic Asthma.

Real-world data on mepolizumab in patients with severe asthma and allergic and non-allergic phenotypes are limited. This study investigated the effectiveness of mepolizumab treatment in patients with severe asthma with allergic and non-allergic phenotypes. This retrospective cohort study (GSK ID: 214148) used administrative claims data from the Optum Research Database. Eligible patients were ≥6 years of age with asthma and had ≥2 mepolizumab claims post-index. Index date was the first mepolizumab claim/administration (January 2016-December 2018). Patients were divided into two cohorts: allergic and non-allergic asthma, based on diagnosis codes, medication use and lab test results. Outcomes included the rate of asthma-related exacerbations and oral corticosteroid (OCS) use during the 12 months before (baseline period) and 12 months after (follow-up period) mepolizumab initiation. Study ended in December 2019. Overall, 240 (44.6%) and 298 (55.4%) patients were included in the allergic and non-allergic asthma cohorts, respectively. Mean (standard deviation [SD]) counts of asthma-related exacerbations were significantly reduced from baseline to follow-up in both the allergic and non-allergic asthma cohorts (3.2 [2.5] to 2.1 [2.1], p < 0.001 and 2.5 [2.2] to 1.7 [1.9], p < 0.001, respectively). The mean number of OCS pharmacy claims was significantly decreased by 33.3% and 41.4% from baseline to follow-up in the allergic and non-allergic cohorts, respectively (p < 0.001); mean daily OCS dose significantly decreased by 30.6% and 45.4%, respectively (p < 0.001) as well as the mean number of OCS bursts, which decreased by 44.9% and 41.8%, respectively (p < 0.001). No significant differences were observed between cohorts in reductions in asthma exacerbations, counts of OCS pharmacy claims or OCS bursts (baseline to follow-up). Mepolizumab significantly reduced asthma exacerbations and OCS use in patients with allergic and non-allergic asthma, suggesting that mepolizumab provides real-world benefit in severe asthma irrespective of whether a patient has an allergic phenotype.

Factors Affecting the Ability to Discontinue Oral Corticosteroid Use in Patients with EGPA Treated with Anti-Interleukin-5 Therapy

Introduction: Patients with eosinophilic granulomatosis with polyangiitis (EGPA) and some with severe eosinophilic asthma require continuous long-term oral corticosteroid (OCS) treatment for disease control. The anti-interleukin-5 agent, mepolizumab, has recently become available for the treatment of severe eosinophilic asthma and EGPA, with promising results and safety profiles. The proportion of patients with EGPA who discontinued oral steroids was 18% in the MIRRA trial. To compare patients with EGPA who were able to discontinue steroids with mepolizumab with those who could not. Methods: Twenty patients with EGPA treated with mepolizumab were evaluated at Osaka Habikino Medical Center. The OCS dose, asthma control test score, fractional exhaled nitric oxide levels, peripheral eosinophil count, and spirometric parameters were evaluated before and after treatment. Results: There was a significant reduction in the mean OCS dose from a prednisolone equivalent of 8.88 ± 4.99 mg/day to 3.18 ± 3.47 mg/day (p < 0.001). In this study, 40% of patients discontinued oral steroids. The most common reason for the failure to discontinue steroids in patients was poor asthma control. The percentage of predicted forced expiratory volume in 1 s significantly improved in patients with EGPA who could discontinue steroids after receiving mepolizumab. Conclusion: In this real-world study, treatment with mepolizumab for EGPA was associated with a significant reduction in OCS use; however, poor asthma control was identified as an inhibiting factor for steroid reduction.

CO124 Real-World Reduction of Oral Corticosteroid Use in Patients Treated with Dupilumab and with Moderate-to-Severe Asthma

Dupilumab, a fully human monoclonal antibody, blocks the shared receptor component for interleukin-4/-13, key and central drivers of type 2 inflammation in asthma. Patients with oral corticosteroid (OCS)-dependent severe asthma are at increased risk of OCS-related adverse events. This real-world analysis investigated the reduction in OCS use in patients treated with dupilumab, both overall cohort and with OCS-dependent severe asthma.

REAL-WORLD EFFECTIVENESS OF DUPILUMAB ON ORAL CORTICOSTEROID USE IN PATIENTS WITH MODERATE-TO-SEVERE ASTHMA

<h3>Introduction</h3> Dupilumab, a fully human monoclonal antibody, blocks the shared receptor component for interleukin-4/-13, key and central drivers of type 2 inflammation in asthma. Patients with oral-corticosteroid (OCS)-dependent severe asthma are at increased risk of OCS-related adverse events. In phase 3 VENTURE (NCT02528214), add-on dupilumab 300 mg every 2 weeks vs placebo reduced OCS maintenance dose in patients with OCS-dependent severe asthma. Dupilumab demonstrated an acceptable safety profile. We investigated the real-world effectiveness of dupilumab in reducing OCS use in patients with OCS-dependent severe asthma. <h3>Methods</h3> This retrospective, single-arm study analyzed data from the Avalere Claims database, a large US insurance claims database. Patients diagnosed with moderate-to-severe asthma (GINA 4/5) initiating dupilumab between November 1, 2018, and July 31, 2019, were included. Exclusion criteria were chronic obstructive pulmonary disease (COPD) diagnosis or treatment with another biologic for asthma in the previous year. There were 141 OCS-dependent patients included in this analysis (<b>Table</b>). The proportions of patients with any OCS use, mean annualized cumulative OCS dose, and percentage of patients with ≥90 days of OCS use were assessed pre and post 12 months of dupilumab initiation. <h3>Results</h3> Dupilumab significantly reduced the proportion of patients with any OCS use by 20.6% [<i>P</i>=<0.0001], the mean annualized cumulative OCS dose by 33.4% [<i>P</i>=<0.01], and patients with ≥90 days of OCS-use by 42% [<i>P</i>=<0.0001] in OCS-dependent patients from the 12-month pre baseline to the 12-month follow-up period. <h3>Conclusion</h3> Dupilumab is effective in reducing OCS use in patients with moderate-to-severe OCS-dependent asthma in real-world settings.

THE SUSTAINED OCS-SPARING EFFECT OF MEPOLIZUMAB: RESULTS FROM THE REAL-WORLD REALITI-A STUDY AT 2 YEARS

<h3>Introduction</h3> A main goal of asthma treatment is to reduce or eliminate oral corticosteroid (OCS) use due to their adverse effects. Clinical and real-world studies have reported mepolizumab reduces OCS use in patients with severe eosinophilic asthma (SEA); further evidence of the longer-term OCS-sparing effect of mepolizumab is needed. <h3>Methods</h3> REALITI-A was a 2-year international, prospective study, enrolling patients with asthma, newly prescribed mepolizumab 100 mg subcutaneously at physician's discretion. OCS-related outcomes were assessed at Weeks 53–56 and Weeks 101–104 in patients with baseline (28 days preceding mepolizumab initiation) maintenance OCS (mOCS) use and included: change from baseline in median mOCS dose, including stratification by mOCS dose categories, and proportion discontinuing mOCS. <h3>Results</h3> Of 822 patients treated, 320 (39%) had baseline mOCS use. Median (IQR) mOCS dose reduced from 10.0 (5.0, 14.7) mg/day at baseline (n=297) to 2.5 (0.0, 5.0) mg/day at Weeks 53–56 (n=218) and further to 0.0 (0.0, 5.0) mg/day at Weeks 101–104 (n=168), a 100% reduction. At baseline, 33% of patients (97/297) had a mean mOCS dose range of >10 mg/day, reducing to 10% (21/218) by Weeks 53–56 and 7% (12/168) by Weeks 101–104. In patients with baseline mOCS use, 43% (94/218) of patients discontinued mOCS use by Weeks 53–56, increasing to 57% (95/168) at Weeks 101–104. <h3>Conclusions</h3> During this 2-year real world study, mepolizumab demonstrated sustained and progressive OCS-sparing benefit in SEA, enabling a reduction in the burden associated with mOCS use for these patients.

Is Omalizumab Related to Ear and Labyrinth Disorders? A Disproportionality Analysis Based on a Global Pharmacovigilance Database.

Introduction: Asthma is a chronic disease, characterized by reversible airway obstruction, hypersensitivity reactions, and inflammation. Oral corticosteroids are an important treatment option for patients with severe or steroid-resistant asthma. Biologics for asthma are recommended in patients with severe asthma, owing to their steroid-sparing effect as well as their ability to reduce the severity and aggravation of uncontrolled asthma. Most clinical trials of omalizumab in patients with asthma have suggested its tolerability and safety. However, some studies reported eosinophilic comorbidities in the ear, nose, and throat during omalizumab treatment, particularly eosinophilic otitis media. This study examined the relationship between ear disorders and omalizumab compared with that of other biologics for asthma using a large real-world database. Materials and Methods: Individual case safety reports from the Uppsala Monitoring Centre Vigibase of biologics for asthma (omalizumab, mepolizumab, reslizumab, benralizumab, and dupilumab) up to 29 December 2019, were used. A disproportionality analysis was performed using the proportional reporting ratio (PRR), reporting odds ratio (ROR), and information components (IC). A hierarchy analysis used the Medical Dictionary for Regulatory Activities Terminology. A tree map was generated using R studio version 4.2. Results: In 32,618 omalizumab reports, 714 adverse events (AEs) were detected as signals. Among the 714 signals, seventeen AEs were detected as signals of omalizumab-related ear and labyrinth disorders in 394 reports. Only three AEs (ear pain, ear disorder, and ear discomfort) were detected from mepolizumab. No signal was detected from reslizumab, benralizumab, and dupilumab. Conclusions: Careful monitoring of ear disorders is recommended when omalizumab treatment is started, with decreased oral corticosteroid use in patients with severe asthma. Further studies are necessary to confirm the omalizumab-related signals.

PCR137 Work Productivity and Activity Impairment in Patients with Severe Asthma Treated with Mepolizumab in a Real-World Setting

Severe asthma is associated with substantial productivity loss and activity impairment. In the real-world REALITI-A study, mepolizumab reduced clinically significant exacerbations and oral corticosteroid use in patients with severe asthma. Although mepolizumab improved activity impairment and work productivity in clinical trials, real-world data are limited. This post hoc analysis assessed the real-world impact of mepolizumab treatment on work productivity and daily activity impairment.

Real-World Effectiveness of Reslizumab in Patients With Severe Eosinophilic Asthma – First Initiators and Switchers

Reslizumab, a biologic targeting IL-5, has been shown to reduce asthma exacerbations and maintenance oral corticosteroid use in randomized controlled trials and pre-post studies in patients with severe eosinophilic asthma. However, real-world effectiveness data of reslizumab are scarce, and it is unknown whether reslizumab has added value after switching from another type 2 biologic. To evaluate (1) the real-world effectiveness of reslizumab on severe asthma exacerbations, maintenance oral corticosteroid use, and overall treatment response, both in biologic-naive patients who initiated reslizumab and in those who switched from another type 2 biologic; and (2) physicians' experience with reslizumab treatment. This observational real-world study evaluated data from 134 adults with severe eosinophilic asthma included in the Dutch severe asthma registry (RAPSODI), who initiated reslizumab treatment (4-weekly infusions, 0.3 mg/kg) before April 2020 and had follow-up data for 6 months and greater. Clinical asthma experts completed surveys on their experience with reslizumab treatment. Overall, reslizumab reduced the exacerbation rate (odds ratio [95% CI]= 0.10 [0.05-0.21]; P < .001), oral corticosteroid use (OR [95% CI], 0.2 [0.0-0.5]; P < .001), and maintenance dose (median [CI], 5.0 [0.0-10.0] to 0.0 [0.0-5.0]; P< .001), with comparable results in biologic-naive reslizumab initiators and switchers. The overall response to reslizumab was graded good or excellent in 59.2% of patients. The additive effectiveness of reslizumab after switching from another biologic was reflected in physicians' surveys. Real-world data show that reslizumab reduces severe asthma exacerbations and oral corticosteroid use in patients with severe eosinophilic asthma, both in biologic-naive reslizumab initiators and in those who switched from another type 2 biologic. This additional value of reslizumab was recognized by clinical asthma experts.

PSY26 Healthcare Costs, Resource Utilization, and Adverse Events Associated with Long-term Oral Corticosteroid Use in Patients with Systemic Lupus Erythematosus in the United States

To evaluate costs, healthcare resource utilization (HRU), and oral corticosteroid (OCS)-related adverse events (AEs) associated with OCS use >5 mg/day among patients with systemic lupus erythematosus (SLE) who are long-term OCS users (≥12 months’ continuous use) versus nonusers.

Real-World Reductions in Oral Corticosteroid Use in the USA Following Mepolizumab Therapy for Severe Asthma.

BackgroundPatients with severe asthma often require oral corticosteroid (OCS) treatment. Clinical trials have demonstrated that mepolizumab can reduce OCS dependence, but real-world data are limited.ObjectiveTo evaluate the impact of mepolizumab on OCS use, asthma exacerbations, and asthma exacerbation-related costs in a real-world setting.MethodsThis retrospective cohort study (GSK ID: 209642; HO-19-19597) analyzed data from the MarketScan® Commercial database (identification period: November 2015–September 2017). Patients were ≥12 years old at mepolizumab initiation (index date), had a baseline asthma diagnosis, and received ≥2 mepolizumab administrations in the first 6 months of follow-up. OCS use, asthma exacerbation rate, and asthma exacerbation-related costs were assessed in the 12-months before (baseline) and 12-months after (follow-up) mepolizumab initiation.ResultsMepolizumab was associated with a 14.7% reduction in the proportion of patients with ≥1 OCS claim from baseline to follow-up (93.4% vs 79.7%; P<0.001). The mean numbers of OCS claims/patient and OCS bursts (≥20 mg prednisone equivalents for 3‒28 days) between baseline and follow-up were also reduced by 29.1% (P<0.001) and 36.8% (P<0.001), respectively. Reductions in chronic OCS use were demonstrated during follow-up in patients with baseline mean OCS dose ≥5mg and those with a mean OCS dose ≥10mg 90 days before index; the proportion of patients with no OCS use also increased from 6.6% to 20.3% between baseline and follow-up.ConclusionOur findings demonstrate that mepolizumab therapy is associated with reduced OCS use in patients treated in a real-world setting, potentially mitigating adverse health sequelae caused by OCS use in these patients.

DUPILUMAB IMPROVES PATIENT-REPORTED BREATHING IN ORAL CORTICOSTEROID-DEPENDENT SEVERE ASTHMA

DUPILUMAB IMPROVES PATIENT-REPORTED BREATHING IN ORAL CORTICOSTEROID-DEPENDENT SEVERE ASTHMA

PRS10 COST-UTILITY ANALYSIS OF MEPOLIZUMAB VERSUS BENRALIZUMAB FOR SEVERE EOSINOPHILIC ASTHMA IN THE COLOMBIAN HEALTHCARE SYSTEM

BACKGROUND: Adding mepolizumab to standard treatment with inhaled corticosteroids and controller medications decreases asthma exacerbations and long-term oral corticosteroid use in patients with severe eosinophilic asthma. However, since new biological therapies are available in the Colombian healthcare system, it is necessary to establish their cost-effectiveness to inform local payers and decision-makers. To evaluate the cost-effectiveness of new biologics, mepolizumab and benralizumab, to treat adults with severe eosinophilic asthma in Colombia. A Markovian model was used to determine the incremental cost per quality-adjusted life year (QALY) of mepolizumab plus standard of care (SoC) versus benralizumab plus SoC from the payer’s perspective. In a monthly cycle, patients could transition between five health states (three asthma treatment states, asthma related death, and all-cause mortality) and three types of exacerbation events (exacerbations requiring either OCS burst, emergency department visit or hospitalization). Lifetime horizon was used. A network metanalysis (Busse 2019) was used for efficacy data, and local life tables for death probabilities. Costs were estimated following the methods recommended by the local health technology assessment agency. Costs and benefits were discounted at 5% and expressed in 2018 USD (1 USD = 2,956 COP). At the end of the simulation, mean cost of prevention of exacerbations and long-term oral steroid were $69.22 less per patient in mepolizumab, and mean therapy cost was $6,990.0 less per patient in mepolizumab. Treatment with mepolizumab plus SoC and benralizumab plus SoC resulted in 8.97 and 8.73 QALYs respectively. Findings were consistent in the probabilistic sensitivity analysis. Mepolizumab is a dominating alternative compared with benralizumab in the treatment of adults with severe eosinophilic asthma in Colombia from the payer’s perspective. Funding: GSK (PRJ2813).

Rapid and Consistent Improvements in Morning PEF in Patients with Severe Eosinophilic Asthma Treated with Mepolizumab.

Previous studies showed that mepolizumab significantly reduces exacerbations and oral corticosteroid use in patients with severe eosinophilic asthma. However, early studies reported inconsistent effects on lung function. This study specifically assessed the onset of clinical effect and the relationship of baseline blood eosinophil count of mepolizumab 100mg subcutaneous (SC) administration on morning peak expiratory flow (AM PEF). Post hoc analysis of data from two randomized, double-blind, placebo-controlled studies (MENSA, NCT01691521; MUSCA, NCT02281318) of 4-weekly mepolizumab 100mg versus placebo in patients with severe eosinophilic asthma. Individual study results were generated using a mixed model repeated measures model controlling for multiple covariates and were combined using a fixed effects meta-analysis via inverse-variance weighting. Significant improvements in AM PEF after the first dose of mepolizumab 100mg SC vs. placebo were seen as early as week 1 and continued to improve further with subsequent doses. The mean change in AM PEF was 26L/min in the mepolizumab group compared to 4L/min in the placebo group, p < 0.001. When the population was stratified by blood eosinophil thresholds the mean difference from placebo was 24L/min (≥ 150 cells/µL), 27L/min (≥ 300 cells/µL), and 34L/min (≥ 500 cells/µL), p < 0.001 for all subgroups. The < 150 cells/µL (≥ 300 cells/µL in the previous year) group increased 13L/min, while both 150 to < 300 cells/µL and 300 to < 500 cells/µL ranges demonstrated comparable changes (19L/min and 17L/min), respectively. Our analysis has shown early and consistent improvements in lung function measured by AM PEF using the study enrollment criterion of ≥ 150 eosinophils/µL. We also identified a relationship between baseline blood eosinophils and improvements in AM PEF with mepolizumab in patients with severe eosinophilic asthma. GlaxoSmithKline (study ID 208091).

A Randomized, Double-Blind, Placebo-Controlled Trial of Escitalopram in Patients with Asthma and Major Depressive Disorder

Depression is common in asthma and is associated with poor outcomes. However, antidepressant therapy in depressed patients with asthma has been the topic of little research. This study examined the impact of antidepressant treatment with escitalopram versus placebo on the Hamilton Rating Scale for Depression (HRSD), Inventory of Depressive Symptomatology-Self Report (IDS-SR), Asthma Control Questionnaire (ACQ), and oral corticosteroid use in patients with asthma and major depressive disorder (MDD). Single-site 12-week, randomized, double-blind, placebo-controlled, parallel-group trial of escitalopram (10 mg/d) was conducted in 139 outpatients with asthma and MDD. Randomization was stratified by oral corticosteroid use (≥3 bursts in past 12 months, yes or no) and baseline depressive symptom severity (HRSD score ≥ 20) (higher severity, n= 42) versus less than 3 bursts, HRSD score less than 20, or both (lower severity, n= 97). The primary data analysis was conducted using hierarchical linear modeling Version 7.01 on the higher and lower severity samples and post hoc was conducted on the combined sample. Among the higher severity completers (n= 21), a significant reduction in the ACQ score (P= .04) and oral corticosteroid use (P= .04) was observed with escitalopram. In the combined sample, no significant differences were observed, but a trend toward greater reduction in the IDS-SR score was observed with escitalopram (P= .07). Side effects were comparable across groups. The findings suggest that patients with more severe asthma and depression symptomatology may have a positive response, in terms of both asthma and depressive symptom reduction, to antidepressant treatment.

Reduction in oral corticosteroid use in patients receiving omalizumab for allergic asthma in the real-world setting

BackgroundOral corticosteroids (OCS) are commonly administered in patients with severe persistent allergic asthma. Despite their efficacy, they are associated with a wide variety of adverse events. The eXpeRience registry was set up to investigate real-world outcomes among patients receiving omalizumab for the treatment of uncontrolled allergic asthma. Here, we present the effect of omalizumab treatment on OCS use.MethodseXpeRience was a 2-year, multinational, non-interventional, observational registry of patients receiving omalizumab for uncontrolled allergic asthma. OCS use (proportion of patients on maintenance OCS, mean total daily OCS dose and change in status of OCS therapy) was assessed at baseline, 16 weeks, and 8, 12, 18, and 24 months after the initiation of omalizumab. Response to omalizumab was assessed using the physician’s Global Evaluation of Treatment Effectiveness (GETE) at approximately Week 16. Safety data were also recorded.ResultsA total of 943 patients (mean age, 45 years; female, 64.9%) were enrolled in the registry, 263 of whom were receiving maintenance OCS at baseline. The proportion of patients taking maintenance OCS was markedly lower at Months 12 (16.1%) and 24 (14.2%) than at baseline (28.6%; intent-to-treat population). GETE status was determined in 915 patients receiving omalizumab: 64.2% were responders (excellent or good response), 30.7% were non-responders (moderate, poor or worsening response); 5.1% had no assessment. The frequency of serious adverse events was comparable to that seen in controlled trials of omalizumab.ConclusionsOmalizumab use is associated with an OCS-sparing effect in patients with uncontrolled persistent allergic asthma in the real-world setting.

Reduction in oral corticosteroid use in patients with severe allergic (IgE‐mediated) asthma receiving omalizumab in a real‐world setting

Background Patients with severe allergic asthma (SAA) are often inadequately controlled despite available treatments including high-dose inhaled corticosteroids and longacting b2-agonists. Use of oral corticosteroids (OCS) in SAA patients may not achieve full asthma control, and leads to significant long-term side effects. Omalizumab is a recombinant humanized monoclonal anti-immunoglobulin E (IgE) antibody approved in the European Union as an add-on therapy for patients with SAA. In clinical studies, omalizumab has been shown to reduce OCS use. Here we report the effect of omalizumab treatment on OCS maintenance use for up to 24 months in patients with SAA in the real-world eXpeRience registry.

Reductions In Oral Corticosteroid Use In Patients With Allergic (IgE- Mediated) Asthma Receiving Omalizumab

Reductions In Oral Corticosteroid Use In Patients With Allergic (IgE- Mediated) Asthma Receiving Omalizumab

Improvement of quality of life in patients with concomitant allergic asthma and atopic dermatitis: one year follow-up of omalizumab therapy

ObjectiveAnti IgE treatment with omalizumab is efficacious in the treatment of patients suffering from allergic asthma, improving asthma control and improving quality of life. Furthermore, this approach could be beneficial for patients with concomitant atopic dermatitis. We assessed quality of life and asthma control in atopic patients with allergic asthma and concomitant atopic dermatitis versus those with asthma and without atopic dermatitis treated with omalizumab.MethodsA total of 22 patients with severe allergic asthma were treated with omalizumab for 12 months. 13 patients with allergic asthma without concomitant atopic dermatitis (IgE 212 ± 224 IU/ml) and 9 patients with concomitant allergic asthma and atopic dermatitis (IgE 3,528 ± 2,723 IU/ml) were included. Asthma-related quality of life (AQLQ), atopic dermatitis related quality of life (DLQI), and asthma-related treatment were compared between both groups at baseline and after initiating omalizumab treatment.ResultsDLQI was significantly in favor of omalizumab after 2 months in the atopic dermatitis/asthma group (P = 0.01); AQLQ was improved after 6 months in the asthma group (P = 0.01), while no change was seen in AQLQ in the atopic dermatitis/asthma group (P = 0.12). Omalizumab controlled oral corticosteroid use more effective (P < 0.01) in patients with asthma and atopic dermatitis (in 9/9 cases) compared to patients with asthma alone (9/13). Baseline IgE as well as other factors do not predict response to omalizumab.ConclusionsOmalizumab is effective in improving atopic dermatitis-related quality of life scores and modulates oral corticosteroid use in patients with concomitant asthma and atopic dermatitis in a positive fashion.

Omalizumab reduces oral corticosteroid use in patients with severe allergic asthma: Real-life data

Long-term oral corticosteroid (OCS) therapy is associated with significant burden on patients and healthcare resources; treatments that may help reduce their use are important to improve asthma management. French and German clinicians prescribing omalizumab for >16 weeks to patients with severe persistent allergic asthma collected OCS use data. OCS use was recorded at baseline and at a non-specific time point beyond 16 weeks from initiation of omalizumab. The number of asthma exacerbations (FEV(1) < 60% of personal best, requiring OCS burst and unscheduled doctor/emergency visit or hospitalization) and asthma-related hospitalizations during the 12-months prior to omalizumab treatment and during the observation period were also recorded. Overall, 346 patients were treated with omalizumab for >16 weeks. Of these, 166 (48.0%) were receiving maintenance OCS (France, n = 64; Germany, n = 102). Following omalizumab therapy, 84 (50.6%) patients on OCS at baseline reduced/stopped OCS dose at the time of data collection; 34 (20.5%) stopped and 50 (30.1%) reduced OCS. In all patients receiving maintenance OCS at baseline, mean reduction from baseline in daily OCS dose was 29.6% (7.1 mg prednisolone). In patients who reduced/stopped maintenance OCS, mean reduction from baseline in daily OCS dose was 74.3% (15.4 mg prednisolone). Reductions in exacerbations and hospitalizations were observed from the 12-months prior to baseline in patients at the time of data collection, irrespective of change in OCS dose. European real-life experience demonstrates the OCS-sparing potential of omalizumab in some patients with severe allergic (IgE-mediated) asthma.

Inhaled mometasone furoate reduces oral prednisone usage and improves lung function in severe persistent asthma

The reduction of oral prednisone use by mometasone furoate (MF) delivered by HFA-227 metered dose inhaler (MDI) was examined in oral corticosteroid (OCS)-dependent patients with severe persistent asthma. A 3-month, double-blind, placebo-controlled clinical trial (n=123), followed by a 9-month open-label phase (n=120). The study was conducted at 26 medical centers in the United States. Patients were randomized to treatment with MF-MDI 400 or 800 microg twice-daily (bid) doses, or placebo in the double-blind trial. All patients received MF in the open-label phase. At the endpoint of the double-blind trial, MF-MDI 400 and 800 microg bid reduced the daily OCS dose by 39.4% and 31.1%, respectively, while placebo increased the OCS dose by 107.2% (P<0.01). The OCS requirement was reduced by 50% or more in 63% and 60% of patients treated with MF-MDI 400 and 800 microg bid, respectively, compared with 14% of patients receiving placebo. After 12 weeks, despite prednisone reductions, pulmonary function, asthma symptoms, albuterol use, nocturnal awakenings, and physician-evaluated response to therapy also showed significant improvement with MF-MDI treatment compared with placebo. Further reductions in OCS requirements were achieved with long-term MF-MDI treatment in the open-label phase, with an overall 67% reduction in prednisone usage and 51% of patients completely eliminating prednisone usage by the 1-year time point. MF delivered by HFA-227 MDI significantly reduces daily OCS use compared with placebo and facilitates elimination of OCS use in patients with severe persistent asthma.