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Background Chronic spontaneous urticaria (CSU) is a relatively common skin disease associated with hives and angio-oedema. Eosinophils play a role in CSU pathogenesis. Benralizumab, an anti-interleukin-5 receptor-α monoclonal antibody, has been shown to induce nearly complete depletion of eosinophils. Objectives To determine the clinical efficacy and safety of benralizumab in patients with CSU who were symptomatic despite H1 antihistamine treatment. Methods The 24-week, randomized, double-blind, placebo-controlled, phase IIb portion of the ARROYO trial enrolled adult patients with CSU who were currently on H1 antihistamine treatment. Patients were randomized to one of five treatment groups according to benralizumab dose and regimen for a 24-week treatment period. The primary endpoint was change from baseline in Itch Severity Score (ISS)7 at week 12. The key secondary endpoint was change from baseline in Urticaria Activity Score (UAS)7 at week 12. Additional secondary endpoints included other metrics to assess CSU at week 24, blood eosinophil levels, and pharmacokinetics and immunogenicity assessments. Exploratory subgroup analyses were conducted to explore responses according to demographics, clinical features and biomarkers. Safety was assessed in all treatment groups. Results Of 155 patients, 59 were randomized to benralizumab 30 mg, 56 to benralizumab 60 mg and 40 to placebo. Baseline and disease characteristics were consistent with what was expected for patients with CSU. There were no significant differences in change from baseline in ISS7 score at week 12 between benralizumab and placebo [benralizumab 30 mg vs. placebo, least-squares mean difference −1.01, 95% confidence interval (CI) −3.28 to 1.26; benralizumab 60 mg vs. placebo, least-squares mean difference –1.79, 95% CI –4.09 to 0.50] nor in change from baseline in UAS7 score at week 12 between benralizumab and placebo (benralizumab 30 mg vs. placebo, P = 0.407; benralizumab 60 mg vs. placebo, P = 0.082). Depletion of blood eosinophil levels was observed at week 24 in patients treated with benralizumab. All other secondary endpoints and exploratory/subgroup analyses indicated no significant differences between benralizumab and placebo. Safety results were consistent with the known profile of benralizumab. Conclusions Although benralizumab resulted in near-complete depletion of blood eosinophils, there was no clinical benefit over placebo. [ABSTRACT FROM AUTHOR]

Background: Adults with traumatic brain injuries (TBI) frequently experience cognitive, emotional, physical and communication deficits that require long‐term rehabilitation and community support. Although access to rehabilitation services is linked to positive outcomes, there can be barriers to accessing community rehabilitation related to system navigation, referral processes, funding, resource allocation and communications required to ensure access. Aims: This study aimed to identify barriers to accessing insurer funding for rehabilitation and healthcare services, for adults with TBI injured in motor vehicle collisions (MVCs). Methods: We used a co‐design approach to collaborate with persons with lived experience to design a survey of adults who sustained a TBI in an MVC. The survey examined access to insurer funding for rehabilitation services and was disseminated through brain injury networks in Ontario, Canada. Results: Respondents (n = 148) identified multiple barriers to accessing rehabilitation services through insurer funding, including delays of more than 2 years (49%), mandatory duplicative assessments (64%) and invasion of privacy (55%). Speech‐language therapy and neuropsychological services were denied most frequently. Negative experiences included insurers' poor understanding of TBI symptoms, denials of services despite medical evidence demonstrating need and unsupportive insurer interactions. Although 70% of respondents reported cognitive‐communication difficulties, accommodations were rarely provided. Respondents identified supports that would improve insurer and healthcare communications and rehabilitation access. Conclusion & Implications: The insurance claims process had many barriers for adults with TBI, limiting their access to rehabilitation services. Barriers were exacerbated by communication deficits. These findings indicate a role for Speech‐language therapists in education, advocacy and communication supports during the insurance process specifically as well as rehabilitation access processes in general. WHAT THIS PAPER ADDS: What is already known on this subject: There is extensive documentation of the long‐term rehabilitation needs of individuals with traumatic brain injury (TBI) and their challenges in accessing rehabilitation services over the long term. It is also well known that many individuals with TBI have cognitive and communication deficits that affect their interactions in the community, including with healthcare providers, and that SLTs can train communication partners to provide communication supports to individuals with TBI in these communication contexts. What this study adds: This study adds important information about barriers to accessing rehabilitation, including barriers to accessing SLT services in the community. We asked individuals with TBI about challenges to accessing auto insurance funding for private community services, and their responses illustrate the broader challenges individuals with TBI face in communicating their deficits, conveying service needs, educating and convincing service administrators and self‐advocating. The results also highlight the critical role that communication plays in healthcare access interactions, from completing forms to reviewing reports and funding decisions, to managing telephone calls, writing emails and explaining to assessors. What are the clinical implications of this work?: This study shows the lived experience of individuals with TBI in overcoming barriers to accessing community rehabilitation. The results show that best practices in intervention should include evaluating rehabilitation access, which is a critical step in patient‐centred care. Evaluation of rehabilitation access includes evaluating referral and navigation, resource allocation and healthcare communications, and ensuring accountability at each step, regardless of model of service delivery or funding source. Finally, these findings show the critical role of speech‐language therapists in educating, advocating and supporting communications with funding sources, administrators and other healthcare providers. [ABSTRACT FROM AUTHOR]