Administration of sugammadex is associated with a dose-related, limited and transient prolongation of APTT and PT(INR) that is unlikely to be of clinical relevance.

Background: Sublingual allergen immunotherapy (SLIT) has been demonstrated to be both clinically efficacious and safe. However, in line with the current regulatory guidance from the European Medicines Agency, allergen immunotherapy (AIT) products must demonstrate their efficacy and safety in pivotal phase III trials for registration. Objective: We sought to investigate the efficacy and safety of sublingual high-dose liquid birch pollen extract (40,000 allergy units native [AUN]/mL) in adults with birch pollen allergy. Methods: A randomized, double-blind, placebo-controlled, parallel-group multicenter trial was conducted in 406 adult patients with moderate-to-severe birch pollen-induced allergic rhinoconjunctivitis with or without mild-to-moderate controlled asthma. Treatment was started 3 to 6 months before the birch pollen season and continued during the season in 40 clinical study centers in 5 European countries. For primary end point assessment, the recommended combined symptom and medication score of the European Academy of Allergy and Clinical Immunology was used. Secondary end points included quality-of-life assessments, immunologic parameters, and safety.Results: Primary efficacy results demonstrated a significant (P < .0001) and clinically relevant (32%) reduction in the combined symptom and medication score compared with placebo after 3 to 6 months of SLIT. Significantly better rhinoconjunctivitis quality-of-life scores (P < .0001) and the patient's own overall assessment of his or her health status, including the visual analog scale score (Euro Quality of Life Visual Analogue Scale; P 5 .0025), were also demonstrated. In total, a good safety profile of SLIT was observed. Conclusion: This study confirmed both the clinical efficacy and safety of a sublingual liquid birch pollen extract in adults with birch pollen allergy in a pivotal phase III trial (EudraCT: ; g ALIAN s.r.o. Ambulancia alergol ogie a klinickej imunol ogie, Bardejov; and h HAL Allergy B.V., Leiden. The results of this study were presented in part as poster presentations at annual congresses of the European Academy of Allergy and Clinical Immunology (EAACI) in Vienna, Austria, June 2016. Sponsored by HAL Allergy B.V., Leiden, The Netherlands. The sponsor also paid for open access of the article (online open publication). Disclosure of potential conflict of interest: O. Pfaar reports grants and personal fees from HAL Allergy B.V. during the conduct of the study; grants and personal fees from ALK-Abell o, Allergopharma, Stallergenes Greer, HAL Allergy BA.; grants and personal fees from Laboratorios LETI/LETI Pharma; personal fees from Novartis Pharma and MEDA Pharma; grants and personal fees from Anergis S.A.; personal fees from Mobile Chamber Experts (a GA 2 LEN Partner), Pohl-Boskamp, and Indoor Biotechnologies; and grants from GlaxoSmithKline all outside the submitted work. C. Bachert reports grants and personal fees from HAL, ALK-Abell o, Stallergenes Greer, Biotech Tools, Novartis Pharma, Mylan, GlaxoSmithKline, Sanofi Aventis, and Ast...

Based on the results of this study of healthy subjects, it can be concluded that sugammadex alone or in combination with rocuronium or vecuronium is not associated with QTc prolongation.

In healthy subjects, treatment with 4 mg/kg and 16 mg/kg sugammadex did not change either anti-Xa activity or APTT to a clinically meaningful extent following pretreatments with enoxaparin or UFH.

The concept of adjuvants or adjuvant systems, used in vaccines, exploit evolutionary relationships associated with how the immune system may initially respond to a foreign antigen or pathogen, thus mimicking natural exposure. This is particularly relevant during the non-specific innate stage of the immune response; as such, the quality of this response may dictate specific adaptive responses and conferred memory/protection to that specific antigen or pathogen. Therefore, adjuvants may optimise this response in the most appropriate way for a specific disease. The most commonly used traditional adjuvants are aluminium salts; however, a biodegradable adjuvant, MCT®, was developed for application in the niche area of allergy immunotherapy (AIT), also in combination with a TLR-4 adjuvant—Monophosphoryl Lipid A (MPL®)—producing the first adjuvant system approach for AIT in the clinic. In the last decade, the use and effectiveness of MCT® across a variety of disease models in the preclinical setting highlight it as a promising platform for adjuvant systems, to help overcome the challenges of modern vaccines. A consequence of bringing together, for the first time, a unified view of MCT® mode-of-action from multiple experiments and adjuvant systems will help facilitate future rational design of vaccines while shaping their success.

Sugammadex 4 mg/kg does not cause clinically relevant QTc interval prolongation versus placebo when combined with propofol or sevoflurane.

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RATIONALE: Poorly-controlled asthma is prevalent in the Medicaid Population. Asthma exacerbations are potentially preventable. Primary care providers lack timely data on asthma control status. Outcomes of predictive models depend on an appropriate system of care. METHODS: Parkland Community Health Plan developed a comprehensive intervention including a risk prediction model to define the risk for asthma ED visits or hospitalizations, monthly patient and provider level risk score reports to network providers including patient-level data on risk scores, integrating point of care decision support alerts in the EHR of the largest PCHP provider, and coordinaton of care between PCHP Disease Management and Case Managers, PCP's, and information technology vendors. RESULTS: The intervention included asthmatic children assigned to 17 PCP's caring for about 50% of PCHP members, The risk prediction model had a good accuracy (C-statistic 0.84). Patients were categorized into four risk score levels. Expected ED visit or hospitalization rate was 20%, 10%, 4%, and 1.4%. After introduction of the EHR alert providers increased prescription of controller medication 50% and controller-to-rescue medication orders 57% compared to the prior year. Asthma related ED visit rates decreased by 30% (from 16% to 11%), hospitalization rates by 43% (from 3.44% to 1.97%), and total costs by 40% (from $1285 to $766 per member per year). The asthma medication ratio increased by 15%, from 0.39 to 0.45. CONCLUSIONS: Combination of a predictive model with a care coordiantion system and EHR alerts for asthma patients in a Medicaid HMO resulted in dramatic improvements in outcomes and cost of care.