New Therapies for Asthma
|
|
- Merryl Goodwin
- 5 years ago
- Views:
Transcription
1 New Therapies for Asthma Tracy Bridges, MD Speaker Disclosure: Dr. Bridges participates in speaker bureaus for Teva, Genetech & Astra Zeneca. Objectives: Discuss the use of LAMA s for Asthma Detail the use of biologics to target IgE Describe the use of biologics to target IL5, IL4, IL13 What has happened in Asthma Pharmacology in the last few years? Tracy Bridges, MD Allergy and Asthma Clinics of Georgia Georgia Pollens Clinical Research What s new in Inhaled Therapy for Asthma? In NHLBI Guidelines for treatment of asthma, Inhaled Corticosteroids (ICS) and Inhaled Corticosteroids PLUS Long Acting Beta Agonists (ICS+LABA) are integrally positioned at in the guidelines for treatment of asthma. Inhaled Corticosteroids are Cornerstone Therapies for Asthma in the NHLBI Guidelines 1
2 Traditional ICS available for years Fluticasone propionate BID (HFA/DISKUS) Mometasone furoate BID/QD(HFA/Twisthaler) Budesonide BID/QD (Flexhaler/Respules) Beclomethasone dipropionate BID (HFA) Ciclesonide BID (HFA) Flunisolide BID (HFA) Recent ICS NEW Flunisolide (80 mcg) HFA in MDI with Built in Spacer to be used BID for maintenance therapy for asthma Age 6 12: 1 2 puffs BID Age >12: 2 4 puffs BID Fluticasone Furoate (100 and 200 mcg) Dry Powder Inhaler Age 12 and above: 1 puff QD Benefits: improved lung function and decreased albuterol use Benefits of ICS Flunisolide HFA Benefits Primary Endpoints: Improvement in FEV1 vs. Placebo at dose of 160 mcg and 320 mcg BID Secondary Endpoints: AM Peak Flow, AM and PM asthma sx., Nocturnal Awakenings, PRN SABA use 2
3 Fluticasone furoate Fluticasone Furoate Benefits Primary Endpoints: Statistical change in trough FEV1 from baseline to end of study (Weeks 12 or24) [100 mcg 146ml 186ml improvement] & [200 mcg 284 ml improvement] Special Note: Studies including Fluticasone Furoate 200 mcg QD and Fluticasone Propionate 500 mcg BID demonstrate improvements in FEV1 = 328ml and 258ml RESPECTIVELY Implication: Fluticasone furoate 200 mcg is as good or better than Fluticasone propionate 500 mcg BID Warning and Precautions Local Infections Acute Asthma Episodes Immunosupression Transfer from Systemic Corticosteroids Adrenal Supression Reductions in Bone Mineral Density Effects on Growth Glaucoma and Cataracts Traditional ICS + LABA: Fluticasone + Salmeterol BID HFA and DPI Mometasone + Formoterol BID HFA Budesonide + Formoterol BID HFA 3
4 Recent ICS+LABA Fluticasone Furoate + Vilanterol DPI 100/25 and 200/25 (18 and above) Sig: 1 puff once daily Fluticasone Propionate + Salmeterol Breath Actuated Dry Powder BID Supporting Clinical Information Fluticasone Furoate + Vilanterol RDB 12 week study (n=1039), FF+V 100/25 QD vs FF 100 QD: FEV1: FF+V 100/ ml > FF 100 RESCUE FREE DAYS: FF+V 100/ % > FF 100 SYMPTOM FREE DAYS: FF+V 100/25 7.8%>FF100 RDB week study (n=2019), FF+V 100/25 QD vs FF 100 QD: RISK OF EXACERBATION: : FF+V 100/25 DECREASED 20% VS FF100 Long Acting Muscarinic Antagonist (LAMA) Tiotropium Bromide was approved in 2003 for treatment of COPD Clinical studies in treating asthma has shown efficacy such that Tiotropium Bromide was approved in 2016 for the treatment of asthma in patients aged 12 and above, and in early and above. Tiotropium dosing 1.25 mcg 2 puffs once daily (total dose 2.5 mcg) 4
5 Differences between Beta Agonists (LABA/SABA) & Muscarinic Antagonists (SAMA/LAMA) Effect of Beta Agonist in Airway: LABA/SABA stimulate bronchodilation Effect of Anti Muscarinic in Airway: SAMA (ipratropium) and LAMA (tiotropium) works via cholinergic pathway to block bronchoconstriction How do LAMAs benefit Asthma? Improve Lung Function (FEV1 and PEF) Improve Quality of Life Reduce Exacerbations Note: All Tiotropium Asthma Trials were conducted on a background of ICS therapy!! Tiotropium may be used with ICS+LABA Tiotropium Warning and Precautions Not for acute use Not a Rescue! Immediate Hypersensitivity Reactions (hives,angioedema, anaphylaxis, itching) Paradoxical Bronchospasm Worsening of Narrow Angle Glaucoma Worsening of Urinary Retention Renal Impairment renal excretion watch for anticholinergic side effects with CrCl <60ml/min 5
6 Tiotropium Clinical Trials :PI all asthma TIO trials done on background of ICS Dose Selection Trials 4 8 weeks: 256 adults/105 adolescents/101 peds 0 3 hour post dose improvement in FEV1 vs placebo ADULTS 2.5 mcg QD 128 ml improvement ADOLESCENTS 2.5 mcg QD 57 ml improvement PEDIATRICS 2.5 mcg QD 104 ml improvement Trial #2 Tiotropium PI Asthma:Effects on FEV1 Medium Dose ICS+TIO, ICS+Salmeterol, ICS+PBO ICS + Tx Peak FEV1 change Mean Trough FEV1 change Mean Tiotropium 2.5 mcg 290 ml 240 ml 150 ml 190 ml Salmeterol 100 mcg 270 ml 210 ml 90 ml 120 ml Placebo 50 ml 30 ml Package Insert Tiotropium Bromide Inhalation Spray for Oral Inhalation Tiotropium PI: Effect on Asthma Exacerbations # of patients with at least 1 event, n (%) Tiotropium 2.5 mcg N=259 Placebo N=256 Tiotropium 2.5 mcg N=256 Placebo N=253 9 (3.5%) 24 (9.1% 13 (5.1%) 19 (7.5%) Rate of asthma exacerbations per patient yr. Mean rate of events Comparison to % Placebo, RR (0.20, 0.51) (0.46,1.08) 30% Time to first asthma exacerbation Comparison to Placebo, RR 0.37 (0.17,0.80) TRIAL 2 TRIAL (0.33,1.34) 6
7 Tiotropium Adolescent Patients 12 17: Effects of LAMA vs. PBO added to ICS+LABA Peak FEV1 (0 3 Week 12 Change from Baseline ICS+LABA+ LAMA= 550 ml ICS+LABA+ Placebo= 438 ml Difference = 110 ml (p=0.0457,[95% CI: 2,220 ml) NOTE: 83% of patients in trial were on medium to high dose ICS+LABA Biologic Therapy for Asthma! Until 2015, no Biologic Therapy had been approved for treatment of asthma in over a decade. Omalizumab, a monoclonal antibody directed against IgE the allergy antibody was approved in the early 2000 s for individuals > 12 year of age based on the primary endpoint of FDA mandated clinical trials of REDUCTION in ASTHMA EXACERBATIONS In 2015, Omalizumab was approved for treatment of children age 6 and above Why block IgE? IgE or the allergy antibody is present in low levels in the blood as compared to IgG,A,M If one is allergic, they have specific IgE antibodies to allergens such as Dust Mites, Weeds, Trees, Grasses, Molds, etc. The tendency to be allergic is common in patients with Asthma such that 70 80% of asthmatics are allergic to something. 7
8 Role of IgE in Asthma Studies have clearly shown that the higher the serum IgE level, the greater the probability of asthma Therefore, if elevated IgE levels are common in asthma patients and a large % of asthmatics are allergic, blocking the allergy antibody (IgE) leads to improvement in asthma. Omalizumab: Pediatric Indication Age Weeks while maintaining ICS for 24 weeks, and allowing adjustment of ICS for the next 28 weeks Omalizumab 0.78 rate of asthma attacks vs 1.36 rate of asthma attacks control 43% reduction in asthma exacerabations Enter IL5 Inhibitors Since late 2015, 3 monoclonal antibody therapies that block IL5 have been approved to treat Severe Persistent Asthmatics with Eosinophilic Phenotypes 8
9 To understand role of IL 5 inhibitors..knowledge of Eosinophils critical! Eosinophils are WBC s that comprise a small % of WBC #. Along with other circumstances (parasites/malignancy), eosinophils are commonly seen in respiratory tissues that are inflammed e.g.allergy Eosinophils can be found in large numbers in nasal secretions, nasal polyps, sputum and bronchial biopsies from asthmatics, inflammed skin, etc. IL5 eosinophils IL5 is a cytokine that is produced by key inflammatory cells that has a variety of effects on eosinophils Maturation and expulsion of eos from BM Recruitment of eos from blood into sites of inflammation Prolongation of survival and activation of eos in tissues IL 5 is the major cytokine responsible for growth and differentiation, 1-5* recruitment, activation, and survival of eosinophils 2 6* *Multiple cell types, including eosinophils, and chemical mediators are involved in inflammation 6 9
10 IL5 Inhibitors Approved IL5 inhibitors for Subcutaneous or IV administration: Mepolizumab 100 mg SC q 4 weeks age 12 and up approved 2015 Reslizumab 3mg/kg IV q 4 weeks age 18 and up approved 2016 Benralizumab 8 mg SC q 4 weeks x 3 months, and then q 8 weeks thereafter approved late 2017 Eosinophil effects in tissue Eos co migrate with other inflammatory cells into the lung tissue Eos degranulate releasing cytotoxic granules locally including the following: Major Basic Protein Eosinophilic Cationic Protein Eosinophil Peroxidase Eos richly produce a litany of cytokines and chemokines that perpetuate airway inflammation What do IL5 inhibitors do? By blocking either IL5 (mepolizumab and reslizumab) or the IL5 receptor, eosinophil levels in the blood drop dramatically to largely undetectable levels within hours of administration and remain low for many days after the last infusion.. Tissue eosinophil levels drop to low levels as well presumably reducing the toxic effects of eosinophils on surrounding tissues. 10
11 Mepolizumab Humanized monoclonal antibody (IgG1) Binds IL5 cytokine blocking the binding of IL5 to receptor but does not block receptor SC one size fits all dosing 100 mg SC Eosinophil requirement > 300 Mepolizumab: Rate of Exacerbations Treatment Rate Difference Rate Ratio Trial 1 Mepolizumab 75 mg IV (n=153) Placebo (n=155) (0.39,0.69) 48% Trial 2 Mepolizumab 100 mg SC (n=194) Placebo (n=191) ( ) % Reslizumab Monoclonal antibody that binds IL 5 Similar in MOA to Mepolizumab Dosing is IV and weight based 3 mg/kgoffering tailored dosing Eosinophil requirement >400 11
12 Reslizumab Reduced Overall Exacerbations (Including Those Requiring OCS or Hospitalization 1,2 ) Reslizumab Reduced Asthma Exacerbations a (Primary Endpoint) by More than Half Asthma Exacerbation Rate % fewer events 0.86 Study II Castro M, Zangrilli J, Wechsler ME, et al. Lancet Respir Med May;3(5): Study I (3082; n=245) results showed 50% fewer exacerbations in patients taking Reslizumab (P<.0001) Study II (3083; n=232) results showed 59% fewer exacerbations in patients taking Reslizumab (P<.0001) Reslizumab reduced exacerbations requiring corticosteroids by 55% and 61% (Study I, II respectively) Reslizumab reduced exacerbations requiring hospitalization or ER visit by 34% and 31% (Study I, II respectively) a Rate Ratio (95% CI): Study I: 0.5 (0.37, 0.67); Study II: 0.41 (0.28, 0.59). 34 Lung Function Improved Significantly Over 16 Weeks 1,2 160 ml Change in FEV 1 Over 16 Weeks (Study III/3081) Reslizumab 160 ml 1. CINQAIR Prescribing Information. Horsham, PA: Teva Pharmaceuticals, LLC; May Bjermer L, Lemiere C, Maspero J, et al. Chest Oct;150(4): Benralizumab Humanized monoclonal antibody (IgG1) Binds to alpha subunit of IL5 receptor (IL 5Ra) blocking the effects of IL5 IL5 receptor is expressed on surface of eosinophils & basophils Binding of Benralizumab to IL5 receptors leads to apoptosis or programmed cell death of eosinophils and basophils 12
13 Benralizumab : Clinical Data Reduction in Eosinophils: Noted within 24 hours after dosing In Trials 1&2, SC Benra reduced blood eosinophils to a median absolute blood eos count of 0 cells/ul noted at 4 weeks of treatment & maintained throughout treatment Benralizumab: Rate of Exacerbations Treatment Rate Difference Rate Ratio Trial 1 Benralizumab (n=267) Placebo (n=267) Trial 2 Benralizumab (n=239) Placebo (n=248) Benralizumab : Daily Oral Steroid Reduction Median percent REDUCTION in daily OCS in clinical trials was as follows 75% Benralizumb (95% CI 60 88) 25% Placebo (95% CI 0 33) 13
14 Benralizumab: Change in FEV1 Trial Difference from Placebo in Mean Change from Pre Bronchodilator Baseline FEV1, ml (95% CI) ml (68 249) ml (28 204) ml (33 258) Bronchial Thermoplasty A procedure done through a bronchoscope in which a specially designed catheter delivers thermal energy to the airway wall in a controlled manner to reduce excessive airway smooth muscle Reducing excessive Airway Smooth Muscle (ASM) decreases the ability of airways to constrict thereby reducing the frequency of asthma attacks BT Logistics BT is a non drug procedure for Severe Persistent Asthma in patients 18 yo and greater not controlled with ICS+LABA Procedure performed in 3 outpatient procedure visits each treating a different area of the lungs approx. 3 weeks apart 14
15 BT Benefits and Risks One year follow up 32% reduction in asthma attacks 84% reduction in ER visits 73% reduction in hospitalizations 66% reduction in days lost from work/school Risks of BT In the peri procedure period, expected increase /worsening of asthma sx Increased symptoms last for 1 7 days after procedure 3.4% possibility (per procedure) of hospitalization for management of asthma sx 15
Cinqair (reslizumab injection for intravenous use)
Cinqair (reslizumab injection for intravenous use) Policy Number: 5.02.522 Last Review: 04/2018 Origination: 04/2016 Next Review: 04/2019 Policy Blue Cross and Blue Shield of Kansas City (Blue KC) will
More informationAsthma Management Updates: A Focus on Long-acting Muscarinic Antagonists and Intermittent Inhaled Corticosteroid Dosing
Asthma Management Updates: A Focus on Long-acting Muscarinic Antagonists and Intermittent Inhaled Corticosteroid Dosing Diana M. Sobieraj, PharmD, BCPS Assistant Professor University of Connecticut School
More informationGlobal Initiative for Asthma (GINA) What s new in GINA 2016?
Global Initiative for Asthma (GINA) What s new in GINA 2016? GINA Global Strategy for Asthma Management and Prevention GINA: A Brief History Established in 1993 Collaboration between NHLBI and WHO Multiple
More information12/18/2017. Disclosures. Asthma Management Updates: A Focus on Long-acting Muscarinic Antagonists and Intermittent Inhaled Corticosteroid Dosing
Asthma Management Updates: A Focus on Long-acting Muscarinic Antagonists and Intermittent Inhaled Corticosteroid Dosing Diana M. Sobieraj, PharmD, BCPS Assistant Professor University of Connecticut School
More informationAsthma Upate 2018: What s New Since the 2007 Asthma Guidelines of NAEPP?
10:50-11:50am Asthma Update 2018: What s New Since the 2007 National Asthma Guidelines? SPEAKER Christopher H. Fanta, MD Disclosures The following relationships exist related to this presentation: Christopher
More informationMeeting the Challenges of Asthma
Presenter Disclosure Information 11:05 11:45am Meeting the Challenge of Asthma SPEAKER Christopher Fanta, MD The following relationships exist related to this presentation: Christopher Fanta, MD: No financial
More informationBiologic Agents in the treatment of Severe Asthma
Biologic Agents in the treatment of Severe Asthma Daniel L Maxwell, D.O., FACOI, FAASM Clinical Assistant Professor of Medicine Michigan State University College of Osteopathic Medicine College of Human
More informationbenralizumab (Fasenra )
Applies to all products administered or underwritten by Blue Cross and Blue Shield of Louisiana and its subsidiary, HMO Louisiana, Inc.(collectively referred to as the Company ), unless otherwise provided
More informationCynthia S. Kelly, M.D. Professor of Pediatrics Eastern Virginia Medical School Division Director Allergy Children s Hospital of The King s Daughters
Cynthia S. Kelly, M.D. Professor of Pediatrics Eastern Virginia Medical School Division Director Allergy Children s Hospital of The King s Daughters Disclosures Speakers bureau of Novartis and Genentech
More informationGINA. At-A-Glance Asthma Management Reference. for adults, adolescents and children 6 11 years. Updated 2017
GINA At-A-Glance Asthma Management Reference for adults, adolescents and children 6 11 years Updated 2017 This resource should be used in conjunction with the Global Strategy for Asthma Management and
More informationLearning the Asthma Guidelines by Case Studies
Learning the Asthma Guidelines by Case Studies Timothy Craig, DO Professor of Medicine and Pediatrics Distinguished Educator Penn State University Hershey Medical Center Objectives 1. Learn the Asthma
More informationImproving Outcomes in the Management & Treatment of Asthma. April 21, Spring Managed Care Forum
Improving Outcomes in the Management & Treatment of Asthma April 21, 2016 2016 Spring Managed Care Forum David M. Mannino, M.D. Professor Department of Preventive Medicine and Environmental Health University
More informationNucala (mepolizumab injection for subcutaneous use)
Nucala (mepolizumab injection for subcutaneous use) Policy Number: 5.01.612 Last Review: 01/2018 Origination: 02/2016 Next Review: 02/2019 Policy Blue Cross and Blue Shield of Kansas City (Blue KC) will
More informationAsthma Therapy 2017 JOSHUA S. JACOBS, M.D.
Asthma Therapy 2017 JOSHUA S. JACOBS, M.D. BACKGROUND-PREVALENCE Asthma is one of the most common chronic diseases worldwide with an estimated 300 million affected individuals Prevalence is increasing
More informationInformation for Parents and Young People on New and Emerging Treatments in Asthma
Information for Parents and Young People on New and Emerging Treatments in Asthma Asthma continues to be a very common condition that causes a lot of distress to children and their families. For some it
More informationUsing Inhaled Corticosteroids as Needed for Asthma: giving patients relief or leaving them breathless?
Using Inhaled Corticosteroids as Needed for Asthma: giving patients relief or leaving them breathless? Lindsay Thomas, Pharm.D. PGY2 Ambulatory Care Resident Department of Pharmacotherapy and Pharmacy
More informationBrooke L. Gildon, Pharm.D., BCPS, BCPPS, AE C
Brooke L. Gildon, Pharm.D., BCPS, BCPPS, AE C Associate Professor of Pharmacy Practice Southwestern Oklahoma State University College of Pharmacy Oklahoma Society of Health System Pharmacists Annual Meeting
More informationUPDATE ON ASTHMA MEDICATIONS INCLUDING BIOLOGICS FOR SEVERE PERSISTENT ASTHMA JOAN O LEAR FNP AE- C KENWOOD ALLERGY AND ASTHMA CENTER
JOAN O LEAR FNP AE- C KENWOOD ALLERGY AND ASTHMA CENTER UPDATE ON ASTHMA MEDICATIONS INCLUDING BIOLOGICS FOR SEVERE PERSISTENT ASTHMA OBJECTIVES Describe Describe asthma medications that have been added
More informationreslizumab (Cinqair )
Applies to all products administered or underwritten by Blue Cross and Blue Shield of Louisiana and its subsidiary, HMO Louisiana, Inc.(collectively referred to as the Company ), unless otherwise provided
More informationTreatment Responses. Ronald Dahl, Aarhus University Hospital, Denmark
Asthma and COPD: Are They a Spectrum Treatment Responses Ronald Dahl, Aarhus University Hospital, Denmark Pharmacological Treatments Bronchodilators Inhaled short-acting β -Agonist (rescue) Inhaled short-acting
More informationAsthma Update I have no professional or personal financial conflicts of interest to disclose.
Asthma Update 2018 Disclosures Jennifer W. McCallister, MD, FACP, FCCP Associate Professor Division of Pulmonary, Critical Care, and Sleep Medicine The Ohio State University Wexner Medical Center I have
More informationAsthma Update Jennifer W. McCallister, MD, FACP, FCCP
Asthma Update 2018 Jennifer W. McCallister, MD, FACP, FCCP Associate Professor Division of Pulmonary, Critical Care, and Sleep Medicine The Ohio State University Wexner Medical Center Disclosures I have
More informationCigna Drug and Biologic Coverage Policy
Cigna Drug and Biologic Coverage Policy Subject Interleukin (IL)-5 Antagonists: Mepolizumab and Reslizumab Table of Contents Coverage Policy... 1 General Background... 3 Coding/Billing Information... 5
More informationRobert Kruklitis, MD, PhD Chief, Pulmonary Medicine Lehigh Valley Health Network
Robert Kruklitis, MD, PhD Chief, Pulmonary Medicine Lehigh Valley Health Network Robert.kruklitis@lvh.com Correlation of a Asthma pathophyisology with basic science Asthma (Physiology) Bronchodilators
More informationDrug Prior Authorization Guideline NUCALA (mepolizumab)
Drug Prior Authorization Guideline MB9914 Covered Service: Prior Authorization Required: Additional Information: Yes when meets criteria below Yes as shown below Restricted to Pulmonology, Allergy, and
More informationQuestion I was one of the first dry power devices available in the US Flovent, Serevent and Advair are all available in this device
What Device am I Class Side Effects History Potpourri Monitoring Tools 10 10 10 10 10 20 20 20 20 20 30 30 30 30 30 40 40 40 40 40 50 50 50 50 50 WHAT KIND OF DEVICE AM I? I was one of the first dry power
More informationTreatment Options for Complicated/Severe Asthma. Henry J. Kanarek, MD Kanarek Allergy Asthma Immunology
Treatment Options for Complicated/Severe Asthma Henry J. Kanarek, MD Kanarek Allergy Asthma Immunology www.kallergy.com 913-451-8555 Asthma Epidemiology World Health Organization, Asthma is one of the
More informationSupplementary materials
Supplementary materials Table S1 Patient comorbidities by diagnosis Total Asthma n (%) 5348 (148.4) COPD n (%) 4563 (143.4) ACOS n (%) 469 (197.9) No other comorbidities 95 (26.4) 614 (19.3) 27 (11.4)
More informationAsthma and Vocal Cord Dysfunction
Asthma and Vocal Cord Dysfunction Amy L. Marks DO, FACOP Pediatric Allergy and Immunology Assistant Professor of Pediatrics Oakland University William Beaumont School of Medicine Objectives: Understanding
More informationAerospan (flunisolide)
STRENGTH DOSAGE FORM ROUTE GPID 80mcg/actuation HFA aerosol inhaler w/ Inhaled 35718 8.9 g/canister adapter MANUFACTURER Meda Pharmaceuticals INDICATION Aerospan Inhalation Aerosol is indicated for the
More informationRespiratory Health. Asthma and COPD
Respiratory Health Asthma and COPD Definition of asthma Working definition by AAH 2014: Chronic lung disease Can be controlled not cured Large variation in lung function Large variation in respiratory
More informationBronchial asthma. MUDr. Mojmír Račanský Odd. Alergologie a klinické imunologie FNOL Ústav Imunologie LF UPOL
Bronchial asthma MUDr. Mojmír Račanský Odd. Alergologie a klinické imunologie FNOL Ústav Imunologie LF UPOL DEFINITION ASTHMA BRONCHIALE = Asthma is a chronic inflammatory disorder of the airways in which
More informationAsthma Description. Asthma is a disease that affects the lungs defined as a chronic inflammatory disorder of the airways.
Asthma Asthma Description Asthma is a disease that affects the lungs defined as a chronic inflammatory disorder of the airways. Symptoms of asthma In susceptible individuals, this inflammation causes recurrent
More informationBiologics in asthma Are we turning the corner? Roland Buhl Pulmonary Department Mainz University Hospital
Biologics in asthma Are we turning the corner? Roland Buhl Pulmonary Department Mainz University Hospital Biologics in asthma - are we turning the corner? Allergic asthma anti - IgE Allergic airway inflammation
More informationThe Acute & Maintenance Treatment of Asthma via Aerosolized Medications
The Acute & Maintenance Treatment of Asthma via Aerosolized Medications Douglas S. Gardenhire, EdD, RRT-NPS, FAARC Associate Professor and Chairman Department of Respiratory Therapy Objectives Define Asthma.
More informationAsthma in Day to Day Practice
Asthma in Day to Day Practice VIJAY.K.VANAM Financial relationships: Disclosures Employed at Mercy Medical Center, Mason City. Nonfinancial relationships: I receive no financial gain from any pharmaceutical
More informationClinical Implications of Asthma Phenotypes. Michael Schatz, MD, MS Department of Allergy
Clinical Implications of Asthma Phenotypes Michael Schatz, MD, MS Department of Allergy Definition of Phenotype The observable properties of an organism that are produced by the interaction of the genotype
More informationPOCKET GUIDE FOR ASTHMA MANAGEMENT AND PREVENTION
POCKET GUIDE FOR ASTHMA MANAGEMENT AND PREVENTION (for Adults and Children Older than 5 Years) A Pocket Guide for Health Professionals Updated 2018 BASED ON THE GLOBAL STRATEGY FOR ASTHMA MANAGEMENT AND
More informationChoosing an inhaler for COPD made simple. Dr Simon Hart Castle Hill Hospital
Choosing an inhaler for COPD made simple Dr Simon Hart Castle Hill Hospital 1 Declaration of interests I have received speaker fees, sponsorship to attend conferences, and funding for research from companies
More informationIs reslizumab effective in improving quality of life and asthma control in adolescent and adult patients with poorly controlled eosinophilic asthma?
Philadelphia College of Osteopathic Medicine DigitalCommons@PCOM PCOM Physician Assistant Studies Student Scholarship Student Dissertations, Theses and Papers 2018 Is reslizumab effective in improving
More informationMANAGING ASTHMA. Nancy Davis, RRT, AE-C
MANAGING ASTHMA Nancy Davis, RRT, AE-C What is asthma? Asthma is a chronic respiratory disease characterized by episodes or attacks of inflammation and narrowing of small airways in response to asthma
More informationSponsor. Generic drug name. Trial indication(s) Protocol number. Protocol title. Clinical trial phase. Study Start/End Dates.
Sponsor Novartis Generic drug name Fluticasone propionate Trial indication(s) Moderate-severe bronchial asthma Protocol number CQAE397A2202 Protocol title A randomized open label study to assess the utility
More informationAsthma Management in Pregnancy HEATHER HOWE, MD UNIVERSITY OF UTAH PULMONARY DIVISION
Asthma Management in Pregnancy HEATHER HOWE, MD UNIVERSITY OF UTAH PULMONARY DIVISION Asthma Management in Pregnancy Effects of asthma on pregnancy outcomes Effects of pregnancy on asthma control Management
More informationFoundations of Pharmacology
Pharmacologic Management of Asthma Objectives: 1. Review the physiological basis for asthma therapy 2. Discuss the differences between SABA and LABA 3. Discuss the role of inhaled and oral systemic corticosteroids
More informationOmalizumab (Xolair ) ( Genentech, Inc., Novartis Pharmaceuticals Corp.) September Indication
( Genentech, Inc., Novartis Pharmaceuticals Corp.) September 2003 Indication The FDA recently approved Omalizumab on June 20, 2003 for adults and adolescents (12 years of age and above) with moderate to
More informationDo We Need Biologics in Pediatric Asthma Management?
Do We Need Biologics in Pediatric Asthma Management? Ting Fan LEUNG, MBChB, MD, FRCPCH, FAAAAI Professor and Chairman Department of Paediatrics The Chinese University of Hong Kong Asthma and Allergy by
More informationBiologic Therapy in the Management of Asthma. Nabeel Farooqui, MD
Biologic Therapy in the Management of Asthma Nabeel Farooqui, MD None Disclosures Objectives Define severe asthma phenotypes and endotypes Describe the role of biologics in asthma management Review pivotal
More informationDifficult Asthma Assessment: A systematic approach
Difficult Asthma Assessment: A systematic approach Dr Naghmeh Radhakrishna Respiratory, Sleep & Allergy Physician Allergy, Asthma & Clinical Immunology Service The Alfred Hospital Melbourne, Australia
More informationSEVERE ASTHMA - EVIDENCE TABLES APPENDIX 1
Section 2: Biomarkers Biomarkers to predict response to biologic therapies and macrolides Summary of randomized controlled trials Cut-offs Cut-off selection Study Design N Drug Predictive ability to identify
More informationSearching for Targets to Control Asthma
Searching for Targets to Control Asthma Timothy Craig Distinguished Educator Professor Medicine and Pediatrics Penn State University Hershey, PA, USA Inflammation and Remodeling in Asthma The most important
More informationMedications Affecting The Respiratory System
Medications Affecting The Respiratory System Overview Asthma is a chronic inflammatory disorder of the airways. It is an intermittent and reversible airflow obstruction that affects the bronchioles. The
More informationDual-Controller Asthma Therapy: Rationale and Clinical Benefits
B/1 Dual-Controller Asthma Therapy: Rationale and Clinical Benefits MODULE B The 1997 National Heart, Lung, and Blood Institute (NHLBI) Expert Panel guidelines on asthma management recommend a 4-step approach
More informationPharmacy Management Drug Policy
SUBJECT: : Nucala (mepolizumab), Cinqair (reslizumab), & Fasenra (benralizumab) POLICY NUMBER: Pharmacy-62 EFFECTIVE DATE: 12/15 LAST REVIEW DATE: 3/5/2018 If the member s subscriber contract excludes
More informationPediatric Asthma: Pharmacotherapy. Joseph Spahn, MD Children s Hospital Colorado & University of Colorado Medical School Aurora, Colorado
Pediatric Asthma: Pharmacotherapy Joseph Spahn, MD Children s Hospital Colorado & University of Colorado Medical School Aurora, Colorado Pediatric Asthma: Pharmacotherapy Disclosures/Conflicts of Interest:
More informationThree s Company - The role of triple therapy in chronic obstructive pulmonary disease (COPD)
Three s Company - The role of triple therapy in chronic obstructive pulmonary disease (COPD) Zahava Picado, PharmD PGY1 Pharmacy Practice Resident Central Texas Veterans Healthcare System Temple, TX October
More informationCOPD: A Renewed Focus. Disclosures
COPD: A Renewed Focus Heath Latham, MD Assistant Professor Division of Pulmonary and Critical Care Medicine Disclosures No Business Interests No Consulting No Speakers Bureau No Off Label Use to Discuss
More informationPharmacist Objectives. Pulmonary Update. Outline. Technician Objectives. GOLD Guidelines. COPD Diagnosis 9/22/2017
Pharmacist Objectives Pulmonary Update Patty Marshik, PharmD Associate Professor University of New Mexico College of Pharmacy pmarshik@salud.unm.edu Discuss the new Global Initiative for Chronic Obstructive
More informationAmanda Hess, MMS, PA-C President-Elect, AAPA-AAI Arizona Asthma and Allergy Institute Scottsdale, AZ
Amanda Hess, MMS, PA-C President-Elect, AAPA-AAI Arizona Asthma and Allergy Institute Scottsdale, AZ Financial Disclosures Advanced Practiced Advisory Board for Circassia Learning Objectives 1. Briefly
More informationDrug Class Monograph
Drug Class Monograph Class: Inhaled Corticosteroids Drugs: Aerospan (flunisolide), Advair Diskus, Advair HFA (fluticasone/salmeterol), Alvesco (ciclesonide), Arnuity Ellipta (fluticasone furoate), Asmanex
More informationTHE PROMISE OF NEW AND NOVEL DRUGS. Pyng Lee Respiratory & Critical Care Medicine National University Hospital
THE PROMISE OF NEW AND NOVEL DRUGS Pyng Lee Respiratory & Critical Care Medicine National University Hospital Pyng_lee@nuhs.edu.sg Asthma Prevalence, Morbidity, Mortality 235 million suffer from asthma
More informationUS max daily dose i Food and Drug Administration [2]
APPENDIX 2 etable 1. Regulatory limits on total daily dose for asthma medications Drugs Canadian max daily dose i Health Canada [1] US max daily dose i Food and Drug Administration [2] European max daily
More informationThe Pharmacist s Role in Managing Severe Asthma. This activity is supported by an educational grant from Genentech. Educational Objectives
The Pharmacist s Role in Managing Severe Asthma Jennifer M. Malinowski, PharmD, RPh Assistant Dean, Academic Affairs Associate Professor, Pharmacy Practice Wilkes University School of Pharmacy Wilkes-Barre,
More informationMEDICAL COVERAGE GUIDELINES ORIGINAL EFFECTIVE DATE: 07/05/18 SECTION: DRUGS LAST REVIEW DATE: LAST CRITERIA REVISION DATE: ARCHIVE DATE:
CINQAIR (reslizumab) Non-Discrimination Statement and Multi-Language Interpreter Services information are located at the end of this document. Coverage for services, procedures, medical devices and drugs
More informationStudy designs and PD/Clinical endpoints to demonstrate therapeutic equivalence: European Views
IPAC-RS/University of Florida Study designs and PD/Clinical endpoints to demonstrate therapeutic equivalence: European Views 20 th March 2014 Dr. Alfredo García - Arieta Head of the Service of Generic
More informationThree better than 1 or 2?
Three better than 1 or 2? DISCLOSURE Pam McLean-Veysey, Team Leader Drug Evaluation Unit DEU funded by the Drug Evaluation Alliance of NS. (DEANS). DEU prepares Drug Evaluation Reports for the Atlantic
More informationNew and Novel Medications for Respiratory Care
New and Novel Medications for Respiratory Care JASON MOORE, PHARM.D. BCCCP CLINICAL STAFF PHARMACIST STORMONT-VAIL HEALTH Objectives Quick overview of the newest FDA-approved repiratory-related medications
More informationPreschool Asthma What you need to know in 10 minutes
Preschool Asthma What you need to know in 10 minutes Alan Kaplan MD CCFP(EM) FCFP Family Physician Airways Group of Canada Respiratory Medicine section CFPC Faculty/Presenter Disclosure Faculty: Alan Kaplan
More informationFerris State University College of Pharmacy MPA CE Symposium 2016 Paul Thill, PharmD, BCPS
Ferris State University College of Pharmacy MPA CE Symposium 2016 Paul Thill, PharmD, BCPS Objectives Categorize the new asthma and COPD inhalers in to existing or newly created categories Discuss the
More informationAsthma in Pregnancy. Asthma. Chronic Airway Inflammation. Objective Measures of Airflow. Peak exp. flow rate (PEFR)
Chronic Airway Inflammation Asthma in Pregnancy Robin Field, MD Maternal Fetal Medicine Kaiser Permanente San Francisco Asthma Chronic airway inflammation increased airway responsiveness to a variety of
More information2/4/2019 STEROIDS: THE GOOD, THE BAD AND THE UGLY! CONFLICT OF INTEREST, DISCLOSURES AND CONFESSIONS OUTLINE MICHAEL ZACHARISEN, MD.
STEROIDS: THE GOOD, THE BAD AND THE UGLY! MICHAEL ZACHARISEN, MD. CONFLICT OF INTEREST, DISCLOSURES AND CONFESSIONS Conflict of interest: None Disclosures: I prescribe steroids and have for 31 years I
More informationDiagnosis and Management of Asthma
Supporting Evidence: Diagnosis and Management of Asthma The subdivision of this section is: Appendix B Tables Copyright 2016 by 1 Eleventh Edition/December 2016 Appendix B Asthma Summary Tables Class:
More informationMedical Policy An independent licensee of the Blue Cross Blue Shield Association
Xolair (omalizumab) Page 1 of 15 Medical Policy An independent licensee of the Blue Cross Blue Shield Association Title: Xolair (omalizumab) Prime Therapeutics will review Prior Authorization requests.
More informationAsthma Hetereogeneity, Phenotypes and Endotypes Choosing the Right Biologic for your Patient
Asthma Hetereogeneity, Phenotypes and Endotypes Choosing the Right Biologic for your Patient Mario Castro MD, MPH Asthma & Airway Translational Research Unit Washington University School of Medicine St.
More informationAsthma and Its Many Unmet Needs: Directions for Novel Therapeutic Approaches
Asthma and Its Many Unmet Needs: Directions for Novel Therapeutic Approaches William W. Busse,, M.D. University of Wisconsin School of Medicine and Public Health Madison, WI, USA Disclosure Slide Employment
More informationSafety of β2-agonists in asthma
Safety of β2-agonists in asthma Sanjeeva Dissanayake IPAC-RS/UF Orlando Inhalation Conference March 20, 2014 Overview Origin of concerns Mechanistic hypotheses Large scale clinical datasets Interpretation
More informationSevere Asthma & Exacerbations: Dawn of a New Era?
Severe Asthma & Exacerbations: Dawn of a New Era? Christophe von Garnier Department of Pulmonary Medicine Syndromes, Phenotypes & Endotypes Asthma Syndrome Variable symptoms, expiratory airflow limitation,
More informationTRELEGY ELLIPTA (fluticasone-umeclidinium-vilanterol) aerosol powder
TRELEGY ELLIPTA (fluticasone-umeclidinium-vilanterol) aerosol powder Coverage for services, procedures, medical devices and drugs are dependent upon benefit eligibility as outlined in the member's specific
More informationCoverage Criteria: Express Scripts, Inc. monograph dated 03/03/2010
BENEFIT DESCRIPTION AND LIMITATIONS OF COVERAGE ITEM: PRODUCT LINES: COVERED UNDER: DESCRIPTION: CPT/HCPCS Code: Company Supplying: Setting: Xolair (omalizumab) Commercial HMO/PPO/CDHP HMO/PPO/CDHP: Rx
More informationWirral COPD Prescribing Guidelines
Wirral COPD Prescribing Guidelines (To be read in conjunction with the Wirral COPD Supplementary Information) STEP 1: Assess symptoms COPD Assessment Test (CAT) [Link for CAT-test Online] is a patient-completed
More informationCOPD: Preventable and Treatable. Lecture Outline. Diagnosis of COPD. COPD: Defining Terms
COPD: Preventable and Treatable Christopher H. Fanta, M.D. Partners Asthma Center Pulmonary and Critical Care Division Brigham and Women s Hospital Harvard Medical School Lecture Outline I. Diagnosis and
More informationOn completion of this chapter you should be able to: discuss the stepwise approach to the pharmacological management of asthma in children
7 Asthma Asthma is a common disease in children and its incidence has been increasing in recent years. Between 10-15% of children have been diagnosed with asthma. It is therefore a condition that pharmacists
More informationDR REBECCA THOMAS CONSULTANT RESPIRATORY PHYSICIAN YORK DISTRICT HOSPITAL
DR REBECCA THOMAS CONSULTANT RESPIRATORY PHYSICIAN YORK DISTRICT HOSPITAL Definition Guidelines contact complicated definitions Central to this is Presence of symptoms Variable airflow obstruction Diagnosis
More informationDisclosure. Case. Objectives. Case Continued. Inhalers. Asthma: A GINA Update to the NAEPP 2007 Guidelines 1/20/2015
Disclosure Asthma: A GINA Update to the NAEPP 2007 Guidelines Robert (RC) Hellinga, Pharm.D. PGY 1 Pharmacy Resident Wolfson Children s Hospital/Baptist Health I do not have a vested interest in or affiliation
More informationObjectives. Asthma in Primary Care. Definition. Epidemiology. Pathophysiology
Objectives Asthma in Primary Care Jed Grant, PA-C Program Director, SJVC PA Program Staff PA, AMCH Emergency Department Apply the NAEPP guideline measures of severity and control including current impairment
More informationWho can get most benefit
Who can get most benefit from tiotropium in asthma? Y-M. Oh Asan Medical Center Univ. of Ulsan College of Medicine Seoul, Korea Tiotripium for Asthma 1 New in GINA 2015 Add-on tiotropium by soft-mist inhaler
More informationVA/DoD Clinical Practice Guideline Management of COPD Pocket Guide
VA/DoD Clinical Practice Guideline Management of COPD Pocket Guide MODULE A: MAAGEMET OF COPD 1 2 Patient with suspected or confirmed COPD presents to primary care [ A ] See sidebar A Perform brief clinical
More informationXOLAIR (omalizumab) Prior Authorization
MP9309 Covered Service: Prior Authorization Required: Additional Information: Yes when meets criteria below Yes as shown below May only be prescribed by Allergy, Pulmonary, Immunology or Dermatology specialists
More informationPrescribing guidelines: Management of COPD in Primary Care
Prescribing guidelines: Management of COPD in Primary Care Establish diagnosis of COPD in patients 35 years with appropriate symptoms with history, examination and spirometry (FEV1/FVC ratio < 70%) Establish
More informationAsthma training. Mike Levin Division of Asthma and Allergy Red Cross Hospital
Asthma training Mike Levin Division of Asthma and Allergy Red Cross Hospital Introduction Physiology Diagnosis Severity Treatment Control Stage 3 of guidelines Acute asthma Drug delivery Conclusion Overview
More informationFASENRA (benralizumab)
FASENRA (benralizumab) Non-Discrimination Statement and Multi-Language Interpreter Services information are located at the end of this document. Coverage for services, procedures, medical devices and drugs
More informationWhat s new in Asthma? Dr Alexandra Nanzer-Kelly Consultant Respiratory Physician Royal Brompton and Harefield Hospitals
What s new in Asthma? Dr Alexandra Nanzer-Kelly Consultant Respiratory Physician Royal Brompton and Harefield Hospitals Asthma is an inflammatory disease Relaxed smooth muscles Air trapped in alveoli Tightened
More informationASTHMA PRESCRIBING GUIDELINES FOR ADULTS AND CHILDREN OVER 12
North Hampshire CCG Asthma Prescribing Guidelines June 2015 ASTHMA PRESCRIBING GUIDELINES FOR ADULTS AND CHILDREN OVER 12 These guidelines are based on the British Thoracic Society (BTS) and Scottish Intercollegiate
More informationUp in FLAMES: Stable Chronic Obstructive Pulmonary Disease (COPD) Management. Colleen Sakon, PharmD BCPS September 27, 2018
Up in FLAMES: Stable Chronic Obstructive Pulmonary Disease (COPD) Management Colleen Sakon, PharmD BCPS September 27, 2018 Disclosures I have no actual or potential conflicts of interest 2 Objectives Summarize
More informationPredicting, Preventing and Managing Asthma Exacerbations. Heather Zar Department of Paediatrics & Child Health University of Cape Town South Africa
Predicting, Preventing and Managing Asthma Exacerbations Heather Zar Department of Paediatrics & Child Health University of Cape Town South Africa Asthma exacerbations Predicting exacerbation recognising
More informationAsthma Treatment Update: 2018
Asthma Treatment Update: 2018 John B. Cox MD Clinical Professor Division of Pulmonary, Critical Care, Allergy and Sleep Medicine Medical University of South Carolina Disclosures I have no conflicts and
More informationPosition within the Organisation
ASTHMA TREATMENT GUIDELINES Document Description Document Type Service Application Guidelines All healthcare professionals(hcps) caring for patients with asthma Version 4.0 Ratification date September
More informationMedical Policy An independent licensee of the Blue Cross Blue Shield Association
Xolair (omalizumab) Page 1 of 15 Medical Policy An independent licensee of the Blue Cross Blue Shield Association Title: Xolair (omalizumab) Prime Therapeutics will review Prior Authorization requests.
More informationEffective Date: 4/27/2016 Version: 1.0 Approval By: CCC Clinical Delivery Steering Planned Review Date: 4/27/2017
Protocol Title: Adult Asthma Protocol Effective Date: 4/27/2016 Version: 1.0 Approval By: CCC Clinical Delivery Steering Planned Review Date: 4/27/2017 1 Purpose & Objective This protocol provides evidence-based
More informationGetting Asthma treatment right. Dr David Cremonesini Specialist Pediatrician American Hospital
Getting Asthma treatment right Dr David Cremonesini Specialist Pediatrician American Hospital cdavid@ahdubai.com } Consultant Paediatrician from UK of 5.5 years } Speciality in Allergy / Asthma (PG Certificate)
More informationChallenges in Meeting International Requirements for Clinical Bioequivalence of Inhaled Drug Products
Challenges in Meeting International Requirements for Clinical Bioequivalence of Inhaled Drug Products Tushar Shah, M.D. Sr. VP, Global Respiratory Research and Development TEVA Pharmaceuticals 1 Presentation
More information