Efficacy and safety of reslizumab in the treatment of eosinophilic granulomatosis with polyangiitis.

BACKGROUND: Eosinophilic granulomatosis with polyangiitis (EGPA), a rare vasculitis with substantial morbidity, is characterized by asthma, eosinophilia, sinusitis, pulmonary infiltrates, neuropathy, positivity for antineutrophil cytoplasmic antibody, and multiorgan vasculitis. Although treatment options previously included corticosteroids and immunosuppressants, anti-interleukin 5 therapies have gained interest in EGPA treatment. Mepolizumab was approved for and recently benralizumab was found to have safety and efficacy in EGPA. OBJECTIVE: To determine the safety and efficacy of reslizumab in EGPA. METHODS: In this open-label, pilot study, we evaluated the safety and efficacy of intravenous reslizumab (3 mg/kg) in EGPA in 10 subjects. Oral corticosteroid dose, adverse events, exacerbations, symptom control, disease activity, blood markers, and lung function were evaluated before, during, and after 7 monthly reslizumab treatments. RESULTS: Reslizumab was tolerated and resulted in a significant reduction in daily oral corticosteroid (P < .05). Of the 10 subjects, 3 experienced an EGPA exacerbation during the treatment. One had a severe adverse event, requiring removal from the study. CONCLUSION: Yielding similar results to other anti-interleukin 5 biologic medications, reslizumab is generally a safe and effective treatment for EGPA that warrants further study. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02947945.

Benralizumab as a Steroid-Sparing Treatment Option in Eosinophilic Granulomatosis with Polyangiitis.

BACKGROUND: Eosinophilic granulomatosis with polyangiitis (EGPA) is a vasculitis associated with significant morbidity and mortality that has historically been treated with systemic corticosteroids and immunosuppressants. The IL-5 antagonist mepolizumab was Food and Drug Administration approved in 2017 after demonstrating safety and efficacy in EGPA. We hypothesized that benralizumab, an IL-5 receptor antagonist approved for eosinophilic asthma, would demonstrate safety and efficacy in EGPA. OBJECTIVES: To determine the safety and efficacy of benralizumab in EGPA as measured by reduction in oral corticosteroid dose and EGPA exacerbations. METHODS: We conducted a prospective 40-week open-label pilot study of benralizumab 30 mg administered subcutaneously in 10 patients with EGPA. Adverse events, oral corticosteroid dosing, exacerbations, and lung function were evaluated before, during, and after benralizumab treatment. Paired tests and tests derived from longitudinal models were used to compare outcome variables between phases or visits. RESULTS: Benralizumab was well tolerated and resulted in reduction of median corticosteroid dose from 15 mg at the start to 2 mg at the end of treatment. Geometric mean corticosteroid dose was reduced from 11.6 mg during pretreatment to 6.3 mg during treatment phase. Five patients were able to achieve a dose of 0 mg. Mean annualized exacerbation rate was lowest during the treatment (1.5) compared with the pre- and posttreatment phases (4.6, P = .008 for treatment vs pre- and postphases combined). CONCLUSIONS: Benralizumab was well tolerated, facilitated oral corticosteroid reduction, and reduced exacerbations in EGPA. Larger controlled trials are warranted to further evaluate the role of benralizumab in EGPA.

Simulating Teamwork for Better Decision Making in Pediatric Emergency Medical Services.

Emergency Medical Services (EMS) are an essential component of health systems and are critical to the provision of pediatric emergency care. Challenges in this setting include fast pace, need for advanced teamwork, situational awareness and limited resources. The purpose of this study was to identify human factors-related obstacles during care delivery by EMS teams that could lead to inefficiencies and patient safety issues. We examined video recordings of 24 simulations of EMS teams (paramedics and EMTs) who were providing care to pediatric patients. Two reviewers documented a total of 262 efficiency and patient safety issues in 4.25 hours of videos. These issues were grouped into 28 categories. Reviewers also documented 19 decision support opportunities. These issues and decision support opportunities can inform the design of clinical decision support systems that can improve EMS related patient outcomes.