GINA: Newly designed website

Juan Carlos Ivancevich Thursday, 24 January 2019 15:51

“GINA is proud to announce the launch a newly designed website with a clean, modern layout and content that focuses on our mission to increase awareness of asthma among health professionals, health authorities, and the general public.”

https://ginasthma.org/welcome-to-our-new-website/

EuroQol (EQ-5D-5L) Validity in Assessing the Quality of Life in Adults With Asthma: Cross-Sectional Study

Juan Carlos Ivancevich Thursday, 24 January 2019 00:13

Original Paper 

Gimena Hernandez1,2,3, MD, MPH Olatz Garin1,3,4, MPH, PhD Alexandra L Dima5, PhD Angels Pont1,3, BSc Marc Martí Pastor1,2,3, MD, MPH Jordi Alonso1,3,4, MD, PhD Eric Van Ganse5,6, MD, PhD Laurent Laforest6, MD, PhD Marijn de Bruin7, PhD Karina Mayoral1,2, MPH Vicky Serra-Sutton3,8, PhD Montse Ferrer1,2,3, MD, PhD ASTRO-LAB Group

1Health Services Research Group, Hospital del Mar Medical Research Institute, Barcelona, Spain

2Department of Paediatrics, Obstetrics and Gynaecology and Preventive Medicine, Universitat Autònoma de Barcelona, Barcelona, Spain

3Centro de Investigación Biomédica en Red de Epidemiología y Salud Pública, Madrid, Spain

4Experimental and Health Sciences, Pompeu Fabra University, Barcelona, Spain

5Health Services and Performance Research, Université Claude Bernard Lyon 1, Lyon, France

6Pharmaco-Epidemiology Lyon, Lyon, France

7Institute of Applied Health Sciences, University of Aberdeen, Scotland, United Kingdom

8Agència de Qualitat i Avaluació Sanitàries de Catalunya, Barcelona, Spain

Corresponding Author:

Montse Ferrer, MD, PhD

Health Services Research Group

ABSTRACT

Background: The EuroQol-5 Dimension (EQ-5D), developed in 1990, is a most widely used generic tool to measure the health-related quality of life (HRQoL) and considered suitable for patients with asthma. In 2009, the EuroQol Group developed a new EQ-5D version to overcome limitations related to its consistently reported high ceiling effect. To enhance the sensitivity for assessing the HRQoL in further patient populations, the number of responses of EQ-5D was increased from 3 to 5 levels (EQ-5D-5L). Moreover, the availability of well-defined requirements for its Web-based administration allows EQ-5D-5L use to monitor the HRQoL in electronic health (eHealth) programs. No study has evaluated the metric properties of the new EQ-5D-5L in patients with asthma yet.

Objective: This study aims to examine the distribution, construct validity, and reliability of the new EQ-5D-5L questionnaire administered online to adults with asthma.

Methods: We evaluated patients with asthma (age: 18-40 years) from a primary care setting in France and England, who self-completed the EQ-5D-5L questionnaire online. The inclusion criteria were persistent asthma defined as >6 months of prescribed inhaled corticosteroids and long-acting beta-agonists or inhaled corticosteroids alone during the 12 months prior to inclusion. The EQ-5D index was obtained by applying the English preference value set for the new EQ-5D-5L and the French 3L-5L crosswalk value set. Both value sets produced single preference-based indices ranging from 1 (best health state) to negative values (health states valued as worse than death), where 0=death, allowing the calculation of quality-adjusted life years. Responses to dimensions and index distribution, including ceiling and floor effects, were examined. The construct validity was assessed by comparing the means of known groups by analyses of variance and calculation of effect sizes.

Results: Of 312 patients answering the baseline Web-based survey, 290 completed the EQ-5D-5L (93%). The floor effect was null, and the ceiling effect was 26.5% (74/279). The mean EQ-5D-5L index was 0.88 (SD 0.14) with the English value set and 0.83 (SD 0.19) with the French 3L-5L crosswalk value set. In both indices, large effect sizes were observed for known groups defined by the Asthma Control Questionnaire (1.06 and 1.04, P<.001). Differences between extreme groups defined by chronic conditions (P=.002 and P=.003 for the English value set and French 3L-5L crosswalk value set, respectively), short-acting beta-agonists (SABAs) canisters in the last 12 months (P=.02 and P=.03), or SABA use during the previous 4 weeks (P=.03 and P=.01) were of moderate magnitude with effect sizes around 0.5.

Conclusions: The new EQ-5D-5L questionnaire has an acceptable ceiling effect, a good construct validity based on the discriminant ability for distinguishing among health-related known groups, and high reliability, supporting its adequacy for assessing the HRQoL in patients with asthma. EQ-5D-5L completion by most Web-based respondents supports the feasibility of this administration form.

J Med Internet Res 2019;21(1):e10178                  PDF

A phase I, randomized, observer-blinded, single and multiple ascending-dose study to investigate the safety, pharmacokinetics, and immunogenicity of BITS7201A, a bispecific antibody targeting IL-13 and IL-17, in healthy volunteers

Juan Carlos Ivancevich Tuesday, 08 January 2019 13:02

BMC Pulmonary Medicine

Research article, Open Access, Open Peer Review
Tracy L. StatonKun PengRyan OwenDavid F. ChoyChristopher R. CabanskiAlice FongFlavia BrunsteinKathila R. Alatsis and Hubert Chen Email author
Contributed equally

Open Peer Review reports

Abstract

Background

Inhibition of interleukin (IL)-13, a Type 2 inflammatory mediator in asthma, improves lung function and reduces exacerbations; however, more effective therapies are needed. A subset of asthma patients also exhibits elevated IL-17, which is associated with greater disease severity, neutrophilic inflammation, and steroid resistance. BITS7201A is a novel, humanized bispecific antibody that binds and neutralizes both IL-13 and IL-17.

Methods

Safety, pharmacokinetics, and immunogenicity of BITS7201A were evaluated in a phase 1 study. Part A was a single ascending-dose design with 5 cohorts: 30-, 90-, and 300-mg subcutaneous (SC), and 300- and 750-mg intravenous (IV). Part B was a multiple ascending-dose design with 3 cohorts: 150-, 300-, and 600-mg SC every 4 weeks × 3 doses. Both parts enrolled approximately 8 healthy volunteers into each cohort (6 active: 2 placebo). Part B included an additional cohort of patients with mild asthma (600-mg SC).

Results

Forty-one subjects (31 active, 10 placebo) and 26 subjects (20 active, 6 placebo) were enrolled into Parts A and B, respectively. The cohort with mild asthma patients was terminated after enrollment of a single patient. No deaths, serious adverse events, or dose-limiting adverse events occurred. In Part A, 12 active (39%) and 5 placebo subjects (50%), and in Part B, 6 active (30%) and 3 placebo subjects (50%) experienced at least 1 treatment-emergent adverse event (TEAE). The most common AEs were fatigue (n = 3) and influenza-like illness (n = 2). One injection-site reaction was reported. Two subjects with elevated blood eosinophil counts at baseline had transient elevations in blood eosinophils (≥Grade 2, > 1500 cells/μL). In Parts A and B, 16 of 30 (53%) and 16 of 17 (94%) active subjects, respectively, tested positive for anti-drug antibodies (ADAs). No anaphylaxis or hypersensitivity events occurred. BITS7201A exhibited single- and multiple-dose pharmacokinetic characteristics consistent with an IgG monoclonal antibody; exposure generally increased dose-proportionally. Postdose elevations of the serum pharmacodynamic biomarkers, IL-17AA and IL-17FF, occurred, confirming target engagement.

Conclusions

BITS7201A was well tolerated, but was associated with a high incidence of ADA formation.

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Diagnosis and Management of Difficult-to-treat and Severe Asthma in adolescent and adult patients

Juan Carlos Ivancevich Thursday, 17 January 2019 15:18

“GINA has added an important addition to the resources that we offer to assist practitioners treating patients with asthma. A new Pocket Guide, “Diagnosis and Management of Difficult-to-treat and Severe Asthma in adolescent and adult patients””

Bronchial Thermoplasty: A Decade of Experience: State of the Art

Juan Carlos Ivancevich Monday, 31 December 2018 11:18

 Abstract

Bronchial thermoplasty (BT) delivers targeted radiofrequency energy to bronchial airway walls and results in the partial ablation of the airway smooth muscle that is responsible for bronchoconstriction. It is approved for the treatment of severe persistent asthma. Multiple, large clinical trials including a recent “real-world” study demonstrate significant improvements in asthma-related quality of life, reduction in asthma exacerbations, emergency department visits, and hospitalizations after BT that is sustained out to 5 years. In this article, we review the state of the art of BT treatment in severe persistent asthma and share a decade of BT research and clinical experience. We share our personal experience and introduce the three “I”s (identification, implementation, and intense follow-up) that we believe promote successful patient outcomes and help build a successful BT program.

PDF (1 MB)

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Editor: Juan C. Ivancevich, MD

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