Pediatric Inflammatory Skin Disease Update. Inflammatory Skin Diseases. Factors influencing development of atopic dermatitis.
|
|
- Homer Wright
- 5 years ago
- Views:
Transcription
1 Pediatric Inflammatory Skin Disease Update Lawrence F. Eichenfield, M.D. Professor of Dermatology and Pediatrics Rady Children s Hospital, San Diego University of California, San Diego Disclosure Lawrence F. Eichenfield, M.D. Investigator/Consultant Anacor/Pfizer, Genentech, Regeneron/Sanofi; Medimetriks; Otsuka No equity interest Discussion is based on evidence-based recommendations and published, well designed studies Inflammatory Skin Diseases Inflammatory skin diseases have a tremendous impact over a lifetime for affected individuals Insights into pathogenesis are driving new therapies Clinical intervention studies provide the basis for improved disease management Comorbidities are being recognized and impact on approaches to patient care US prevalence by state: 2003 National Survey of Children's Health (n=102,353 children aged 0 17) Overall prevalence in children aged 0 17 years: 10.7%, ranging from % between regions Percent with Eczema Less than More than 11.5 Shaw TE et al. J Invest Dermatol. 2011;131(1): Factors influencing development of atopic dermatitis 1
2 Baby Skin: Leaky Skin Predicts AD! 1903 infants enrolled Skin barrier function at 2days; 2 mths 1300 infants genotyped FLG mutations AD at 6 mths: 18.7% AD at 12 mths: 15.53% INCREASED TEWL DAY 2: PREDICTIVE of AD Even independent of parent AD, FLG status Lowest quartile TEWL: Less risk of AD Kelleher M et al. J Allergy Clin Immunol 2015 Emollient from birth: atopic dermatitis prevention Randomized controlled UA and UK: 124 neonates at high risk for atopic dermatitis. Full-body emollient therapy at least once per day starting within 3 weeks of birth. Parents in the control arm were asked to use no emollients. The primary feasibility outcome was the percentage of families willing to be randomized. The primary clinical outcome was the cumulative incidence of atopic dermatitis at 6 months, as assessed by a trained investigator. Simpson EL et al. J All Clin Immunol 2014;134:4: Emollient from birth: atopic dermatitis prevention 42% percent families agreed to be randomized Statistically significant protective effect Relative risk reduction of AD: 50% (relative risk, 0.50; 95% CI, ; P =.017). No emollient-related adverse events and no differences in adverse events between groups. If confirmed in larger trials, emollient therapy from: simple and low-cost intervention that could reduce the global burden of allergic diseases Wait. Is atopic dermatitis from barrier dysfunction, or altered immunologic responses? Simpson EL et al. J All Clin Immunol 2014;134:4: Good and Bad News: GET READY TO LEARN SOME IMMUNOLOGY! New therapeutic agents have novel targets and newer research techniques will dissect immune response to traditional and new agents SIMPLIFICATION AD is a disease of barrier dysfunction and Th2 driven inflammation 2
3 Therapies Targeting Type 2 Immune Pathways Allergens Itch/ Infection Scratch Cycle Therapies Targeting Type 2 Signaling Pathways expression of skin barrier proteins and AMPs Mediates pruritis Epidermis Key: 1 Anti-TSLP MEDI9929/AMG157 IL-4 2 TSLP 1 IL Dual Anti-IL-4/IL-13 Dupilumab IL-13 3 B-cell 3 Anti-IL-13 Lebrikizumab Tralokinumab DC ThO IL-4 * 2 IL-4 IL Anti-IgE Omalizumab Ligelitumab MEDI4212 XmAb7195 Th2 IgE 4 Eosinophil Basophil Mast cell Dermis 5 Anti-IL-31/Anti-IL-31 Nemolizumab BMS IL-4 IL-31 IL-13 IL-5 IL-5 6 CRTH2 Antagonist Fevipiprant OC 459 BB IL-4 2 PGD2 IL-13 3 Granule release PGD2 / granule release expression of endothelial adhesion molecules PGD2P 6 Blood vessel Definition of Abbreviations: AMP: Antimicrobial Peptide CRTH2: Chemoattractant Receptor-Homologous Molecule Expressed on Th2 Cells, DP2 DC: Dendritic Cell IgE: Immunoglobulin E IL-: Interleukin PGD2: Prostaglandin D2 Th: T-Helper TSLP: Thymic Stromal Lymphopoeitin (Am J Clin Dermatol Oct;17(5):425) (Am J Clin Dermatol Oct;17(5):425) New Therapies Role of Phosphodiesterase (PDE) Hanifin et al. reported increased PDE activity and decreased intracellular camp levels in peripheral blood leukocytes of patients with atopic dermatitis PDE inhibitors increase intracellular camp levels and reduce cytokine and mediator release Role of Phosphodiesterase (PDE) Hanifin et al. reported increased PDE activity and decreased intracellular camp levels in peripheral blood leukocytes of patients with atopic dermatitis PDE inhibitors increase intracellular camp levels and reduce cytokine and mediator release PDE-4 Inhibitor treated AD Atopic Dermatitis Associated Inflammation by Inhibiting PDE4 AMP, adenosine monophosphate; AD, atopic dermatitis; camp, cyclic adenosine monophosphate; PDE4, phosphodiesterase 4. Freund YR et al. FEBS Lett. 2012;586: Dastidar SG et al. Curr Opin Investig Drugs. 2007;8: Baumer W et al. Inflamm Allergy Drug Targets. 2007;6: Jimenez JL et al. J Pharmacol Exp Ther. 2001;299(2): Chan SC et al. J Invest Dermatol. 1993;100(5): Grewe S et al. J Allergy Clin Immunol. 1982;70(6): Heskel NS et al. J Am Acad Dermatol. 1984;11(3): Butler JM et al. J Allergy Clin Immunol. 1983;71(5): Hanifin JM. J Dermatol Sci. 1990;1(1): 1-6. Hanifin JM et al. J Invest Dermatol. 1996;107(1):
4 Boron-based PDE4 Inhibitor Crisaborole Integration of boron ring into cyclic structure: stability, effective target binding capacity/selectivity, Found naturally in high concentrations in foods Low molecular weight facilitates penetration through human skin and access to target cells Boron-based topical PDE4 inhibitor Crisaborole Topical Ointment, 2%: PK Study Adolescents with Atopic Dermatitis: Open Label Phase 2a Study July/August 2016 Tom WL et al. Pediatric Dermatology Volume 33, Issue 2, pages , 18 JAN 2016 DOI: /pde Crisaborole Topical Ointment, 2% in Patients Ages 2 to 17 Years with Atopic Dermatitis: A Phase 1b Open Label Crisaborole 2% Ointment Phase 3 Tom Wl et al. Pediatric Dermatology Volume 33, Issue 4, pages , 18 MAY 2016 DOI: /pde Two multi-center, double-blind, vehicle-controlled U.S. studies Over 750 patients 2 years and older Mild-to-moderate atopic dermatitis affecting >5% body surface area Patients were randomized 2:1 (crisaborole:vehicle) and treated BID for 28 days OUTCOMES: ISGA (Investigator Static Global Assessment SUCCESS: Clear or Almost Clear with >2-grade improvement from baseline) at Day 29 CLEAR or ALMOST CLEAR (with or w/o> 2 grade improvement) TIME TO SUCCESS 4
5 Crisaborole 2% Ointment Phase 3 Primary Endpoint DAY 29 AD-301 (crisaborole / vehicle*) N=503 / 256 AD-302 (crisaborole / vehicle*) N=513 / 250 % in ISGA Success (score of 0 (clear) or 1 (almost clear) with a minimum 2-grade improvement) Secondary Endpoints % in ISGA Clear/Almost Clear (0 or 1) 32.8% / 25.4% (p=0.038) 51.7% / 40.6% (p=0.005) 31.4% / 18% (p<0.001) 48.5% / 29.7% (p<0.001) Time to success in ISGA: Crisaborole achieved success earlier than vehicle-treated patients (p<0.001) Crisaborole 2% Ointment Phase 3 * Crisaborole 2%: Long Term Safety Open-label 48 wk safety study (after phase 3) AD severity every 4 weeks ISGA scale Treated with 4-week cycles of crisaborole as needed Safety measures: local tolerability, adverse events (AEs), serious adverse events (SAEs), clinical laboratory results, vital signs, and physical examinations 517 patients: Treatment-emergent SAES: 10.2% AD, application-site pain, 1.2% AS-infection * 9 SAEs: Not considered treatment related No atrophy, telangiectasia, hypopigmentation Eichenfield LF et al ESPD What don t we know Comparative efficacy Neither head to head, nor by objective scores Cost-efficiency Effect on regions (eg face) Under age 2 Long term safety (but oral PDE-4 s exist) 5
6 OpA-15406: IGA Success Back to Basics : Successful response was defined as an IGA score of 0 or 1 with at least a 2-grade reduction from baseline.. Hanifin JM, Ellis CN et al. Journal of the American Academy of Dermatology, Volume 75, Issue 2, 2016, 297 European treatment of severe AE in children: TREAT survey Treatment of severe AE Taskforce Survey: collect data on current systemic agent prescribing practices First line agents Cyclosporin: 43% Oral Corticosteroids: 30.7% Azathioprine: 21.7% Second line agents: Cyclosporin: 33.6%; Third line agent: MTX: 26.2% Proudfoot LE et al. Br J Dermatol 2013:169: st Line 2 nd Line 3 rd Line RESULTS 86.5% Initiate Systemic Therapy for severe AD CYC MTX MYCO AZA CORT OTHER 45.2% 29.6% 13% 7% 5.2% % 31.3% 30.4% 20% % 19.1% 24.3% 33% 1.7% 4.5%* *Dapsone, referral, IVIG, either methotrexate or azathioprine, two week intensive topical therapy regimen Totri et al. TREATUS&Canada JAAD (in press) Factors that Discourage Use of Systemic Agents Side effect profile: (82.6%) Suspected risks of long term toxicity: (81.7%) ADVOCACY: A success story! Given the high unmet need for effective and safe therapies in atopic dermatitis in children, pediatric studies with systemic therapies should be initiated as soon as possible in the drug development process, as long as there are no safety signals that would raise particular concern in pediatric age patients. Endorsed by: PeDRA, AAD, SPD, SID, AAD-ERG AD, NEA-SAC, IEC, ACDS * n(% 6
7 Systemic Therapy in Atopic Dermatitis Get ready for the revolution Dupilumab Anti-interleukin-4receptor (IL-4R) α antibody Inhibits IL-4 and IL-13 singalling by inhibiting both IL-4 type 1 and 2 receptors on various immune cells Administered subcutaneously Randomized, double-blind, placebo-controlled phase 3 studies of dupilumab in adults with moderate to severe AD Primary endpoint: % achieving IGA of 0/1 at 16 weeks n=1,379 adults with moderate-severe AD Trial Dose % % change achieving EASI IGA SOLO-1 SOLO-2 300mg q1wk 300mg q2wk 300mg q1wk 37% vs. 10%; 38% vs. 10%; 36% vs. 8.5%; 36% vs. 8.5%; 72% vs. 38%; 72% vs. 38%; 69% vs. 31%; 67% vs. 31%; EASI % vs. 15% 51% vs. 15% 48% vs. 12% 300mg 44% vs. 12% q2wk Accessed 31 August Dupilimab: Phase 3 Data 37 and 36 % dupilumab 300 mg q wk 38 and 36 % dupilumab 300 mg q 2 weeks, achieved clearing or near-clear (IGA 0 or 1) 10 and 8.5 % with placebo (p <0.0001). EASI improvement: 72 and 69 % 300 mg q wk 72 and 67 percent 300 mg q 2 weeks, 38 and 31 percent for placebo (p =<0.0001) EASI 75: 52.5;48 % 300 mg weekly, 51; 44 % 300 q every 2 weeks 15; 12 percent with placebo (p <0.0001) NOTE: Released online (not peer reviewed) How common is food allergy in children with AD? Older figures: 30-50% Mild to moderate AD: ABOUT 15-16% Spergel JM et al. Pediatrics 2015(Dec)136:e Spergel JM et al. Pediatrics 2015(Dec)136:e
8 Peanut Consumption and Allergy 640 infants 4 mths-11 mths, with: severe eczema, egg allergy or both Randomized based on preexisting sensitivity to peanut extract (skin-prick test) to: CONSUME or AVOID Peanuts Du Toit G., Roberts G, et al. N Engl J Med 2015;372: Peanut Consumption and Allergy Negative skin-prick test Prevalence of peanut allergy at 60 mths: 13.7% in the avoidance group 1.9% in the consumption group (P<0.001) Initially positive test results: 35.3% avoidance group 10.6% consumption group Du Toit G, et al. N Engl J Med 2015;372: New Guideline in the Works: NIAID 2016 Addendum to the 2010 guidelines for Diagnosis and Management of Food Allergy Identifies infants with severe AD (and/or egg allergy) as group at risk for peanut allergy Severe eczema is defined as persistent or frequently recurring eczema with typical morphology and distribution, assessed as severe by a health care provider and requiring frequent need for prescription-strength topical corticosteroids, calcineurin inhibitors or other antiinflammatory agents despite appropriate use of emollients. Recommends that infants with severe eczema, egg allergy or both have introduction of age-appropriate peanut-containing food as early as 4-6 months of age to reduce the risk of peanut allergy. Consider referral to allergy for skin prick testing for peanut, or IgE screen, with referral if positive Skin prick testing: Negative, low level: EARLY FEEDING Medium positive: OBSERVED FEEDING ACNE: New Treatments! Novel nitric oxide based therapy Topical hormonal therapy (cortexalone) New topical retinoid Lipid-changing topicals (targeting sebum) Recently approved: Dapsone 7.5% gel q day Lortscher D, Admani S Eichenfield LF. J Drugs Dermatol 2016;15:670 8
9 Hormonal Contraceptives and Acne At the time of initial on line consultation for acne, each of 2147 consecutive patients using hormonal contraception provided assessment contraceptive affect on acne Depot injections, subdermal implants, and hormonal intrauterine devices worsened acne COC hierarchy: drospirenone (most helpful)>norgestimate & desogestrel> levonorgestrel & norethrindone Triphasic progestin dosage had positive effect No distinct effect from estrogen dosage variation Lortscher D, Admani S, Satur N, Eichenfield LF. JDD 2016;15:670 PSORIASIS INFLAMMATION MATTERS, IN WAYS WE ARE JUST FIGURING OUT Pediatric Psoriasis: Cardiovascular Risks? Case-control: 50 ped psor/50 age-matched controls Obesity or overweight: 50% (vs 32% of controls) Fasting insulin levels: statistically higher! Psoriasis pts: More ALT, AST, fasting lipid abnormalities than controls At least one marker CV risk: 44 % vs 28% ctrls DIFFERENCES: HDL size; Cholesterol buffering capacity (Independent of obesity) Tom WL et al. JID 2015 Sep30 Characterization of Lipoprotein Composition and Function in Pediatric Psoriasis Reveals a More Atherogenic Profile DECREASED Cholesterol efflux capacity (proportionate to severity) 73 HDL: smaller size (p=0.06) with decreased number of large, beneficial HDL particles (5.3 +/- 3.0 vs /- 2.7; p=0.02) Tom WL et al. J Invest Dermatol 2016:136:67-73 Pediatric Psoriasis: Comorbidity Screening Guidelines Cardiovascular risks ASHD, dyslipidemia, metabolic syndrome Obesity Arthritis Psychologic/psychiatric disorders Depression, anxiety National Psoriasis Foundation/PeDRA Pediatric Psoriasis CSI Project: Comorbidity Screening 9
10 Psoriasis in Children: Systemic Therapy Finally some movement towards approval of systemic agents! Summary: Evolving perspectives on atopic dermatitis, acne and psoriasis Rapidly evolving therapy But it is a long and arduous route to approval of new therapies! And then.we have to figure out how they work in practice! 10
Lawrence F. Eichenfield, M.D.
What s New in Pediatric Dermatology Lawrence F. Eichenfield, M.D. Professor of Dermatology and Pediatrics Rady Children s Hospital, San Diego University of California, San Diego Disclosure Lawrence F.
More informationAtopic Dermatitis Guidelines: What s New?
Atopic Dermatitis Guidelines: What s New? Lawrence F. Eichenfield, M.D. Professor of Dermatology and Pediatrics University of California, San Diego Rady Children s Hospital, San Diego Anacor/Pfizer Genentech
More informationAn Update on Topical Therapy for Atopic Dermatitis
An Update on Topical Therapy for Atopic Dermatitis Amy S. Paller, M.D. Professor and Chair of Dermatology Professor of Pediatrics Northwestern University Feinberg School of Medicine Chicago, Illinois Disclosures
More informationBiologic Therapies for Atopic Dermatitis and Beyond
Biologic Therapies for Atopic Dermatitis and Beyond Jonathan Corren, M.D. Departments of Medicine and Pediatrics, David Geffen School of Medicine at UCLA Disclosures Genentech - research Medimmune/AZ -
More informationMarch 9, 2015 From: The Pediatric Dermatology Research Alliance (PeDRA)
Web: www.pedraresearch.org From: The Pediatric Dermatology Research Alliance (PeDRA) To: Jennifer Shepherd, Center for Drug Evaluation and Research Food and Drug Administration, 10903 New Hampshire Ave.,
More informationPositioning New Treatments for Atopic Dermatitis in Our Practice Parameter
40 th Annual Pulmonary and Allergy Update Positioning New Treatments for Atopic Dermatitis in Our Practice Parameter Mark Boguniewicz, MD Professor, Division of Allergy-Immunology Department of Pediatrics
More informationOverview. Atopic Dermatitis. Overview. 1. Genes and pathogenesis 2. Natural history and disease course 3. Comorbidities 4. Treatments 5.
Overview Atopic Dermatitis Albert C. Yan, MD, FAAP, FAAD Children s Hospital of Philadelphia Perelman School of Medicine at the University of Pennsylvania 1. Genes and pathogenesis 2. Natural history and
More informationAtopic Dermatitis: Emerging therapies. Melinda Gooderham MSc MD FRCPC
Atopic Dermatitis: Emerging therapies Melinda Gooderham MSc MD FRCPC SKiN Centre for Dermatology, Peterborough Assistant Professor, Queen s University, Kingston ON Investigator, Probity Medical Research,
More informationAssessing the Current Treatment of Atopic Dermatitis: Unmet Needs
Transcript Details This is a transcript of a continuing medical education (CME) activity accessible on the ReachMD network. Additional media formats for the activity and full activity details (including
More informationNovel Insights in Atopic Dermatitis: Pathways, Biomarkers, and Phenotypes for a Targeted Approach Transcript
Novel Insights in Atopic Dermatitis: Pathways, Biomarkers, and Phenotypes for a Targeted Approach Transcript Title Slide Welcome to the CME-certified program: Novel Insights in Atopic Dermatitis; Pathways,
More informationLearning Objectives 10/26/2017. New Treatments in Atopic Dermatitis
New Treatments in Atopic Dermatitis Lynda C. Schneider, MD Professor of Pediatrics, Harvard Medical School Boston Children s Hospital lynda.schneider@childrens.harvard.edu Disclosures: Lynda Schneider,
More informationWhat s New in Atopic Dermatitis?
What s New in Atopic Dermatitis? SMITA AWASTHI, MD ASSISTANT CLINICAL PROFESSOR, DEPT. OF DERMATOLOGY AND PEDIATRICS UNIVERSITY OF CALIFORNIA, DAVIS Disclosures No financial disclosures relevant to this
More informationCENTENE PHARMACY AND THERAPEUTICS NEW DRUG REVIEW 3Q17 July August
BRAND NAME Dupixent GENERIC NAME dupilumab MANUFACTURER Regeneron DATE OF APPROVAL March 28, 2017 PRODUCT LAUNCH DATE First week of April 2017 REVIEW TYPE Review type 1 (RT1): New Drug Review Full review
More informationItchy babies: Current treatment guidelines for atopic dermatitis
Itchy babies: Current treatment guidelines for atopic dermatitis Rachel Laarman, MD Helen DeVos Children s Hospital Grand Rapids, MI Photo cred: www.dermatologytimes.modernmedicine.com I have no disclosures
More informationEucrisa. Eucrisa (crisaborole) Description
Federal Employee Program 1310 G Street, N.W. Washington, D.C. 20005 202.942.1000 Fax 202.942.1125 5.90.25 Subject: Eucrisa Page: 1 of 6 Last Review Date: September 15, 2017 Eucrisa Description Eucrisa
More informationThe Skinny of the Immune System
The Skinny of the Immune System Robert Hostoffer, DO, FACOP, FAAP Associate Professor of Pediatrics Case Western Reserve University, Cleveland, Ohio Overview 1. Immune system of the skin 2. Immune Players
More informationRecent insights into atopic dermatitis and implications for management of infectious complications
Mark Boguniewicz, MD Professor, Division of Allergy-Immunology Department of Pediatrics National Jewish Health and University of Colorado School of Medicine Denver, Colorado USA Recent insights into atopic
More informationEucrisa. Eucrisa (crisaborole) Description
Federal Employee Program 1310 G Street, N.W. Washington, D.C. 20005 202.942.1000 Fax 202.942.1125 Subject: Eucrisa Page: 1 of 7 Last Review Date: June 22, 2018 Eucrisa Description Eucrisa (crisaborole)
More informationLessons Learned from the International Eczema Council (IEC)
Lessons Learned from the International Eczema Council (IEC) Amy S. Paller, MD Northwestern University Feinberg School of Medicine American Academy of Dermatology meeting F046 February 17, 2017 No conflicts
More informationA Yardstick for Managing Patients with Atopic Dermatitis
AAIFNA 2018 Symposium A Yardstick for Managing Patients with Atopic Dermatitis Mark Boguniewicz, MD Professor, Division of Allergy-Immunology Department of Pediatrics National Jewish Health and University
More informationThe Role of Allergen Immunotherapy and Biologicals in the Treatment of Atopic Dermatitis
The Role of Allergen Immunotherapy and Biologicals in the Treatment of Atopic Dermatitis John Oppenheimer MD Div Allergy and Immunology UMDNJ-Rutgers Potential Conflicts of Interest Consultant GSK, Teva,
More informationExpert Analysis of Emerging Atopic Dermatitis Therapy Studies. A CE/CME Activity
Expert Analysis of Emerging Atopic Dermatitis Therapy Studies Overview A CE/CME Activity Lawrence F. Eichenfield, MD, and Jonathan I. Silverberg, MD, PhD, MPH, provide their perspectives on the clinical
More informationAtopic Dermatitis: Therapeutic Challenges
Atopic Dermatitis: Therapeutic Challenges PDA August 14, 2009 Jon Hanifin OHSU, Portland Dominant Concepts in Atopic Dermatitis Allergy / Immunology Era: 1915-2006 The Epidermal Era: 2006---- Barrier dysfunction
More informationPNW EPC Drug Effectiveness Review Project Summary Report Atopic Dermatitis New Drug Evaluation: Dupilumab
Copyright 2012 Oregon State University. All Rights Reserved Drug Use Research & Management Program Oregon State University, 500 Summer Street NE, E35 Salem, Oregon 97301-1079 Phone 503-947-5220 Fax 503-947-1119
More informationPNW EPC Drug Effectiveness Review Project Summary Report Atopic Dermatitis New Drug Evaluation: Dupilumab
Copyright 2012 Oregon State University. All Rights Reserved Drug Use Research & Management Program Oregon State University, 500 Summer Street NE, E35 Salem, Oregon 97301-1079 Phone 503-947-5220 Fax 503-947-1119
More informationBeacon Hospital Annual Study Morning Treatment of Atopic Dermatitis (Eczema) in Primary Care
Beacon Hospital Annual Study Morning Treatment of Atopic Dermatitis (Eczema) in Primary Care Alan D. Irvine MD DSc Lecture overview What causes AD How to get optimise results in primary care Eczema and
More informationMedication Policy Manual. Topic: Dupixent, dupilumab Date of Origin: March 10, Committee Approval: March 10, 2017 Next Review Date: May 2018
Independent licensees of the Blue Cross and Blue Shield Association Medication Policy Manual Policy No: dru493 Topic: Dupixent, dupilumab Date of Origin: March 10, 2017 Committee Approval: March 10, 2017
More informationSee Important Reminder at the end of this policy for important regulatory and legal information.
Clinical Policy: (Dupixent) Reference Number: CP.HNMC.208 Effective Date: 04.11.17 Last Review Date: 11.17 Line of Business: Medicaid Medi-Cal Revision Log See Important Reminder at the end of this policy
More informationUnitedHealthcare Pharmacy Clinical Pharmacy Programs
UnitedHealthcare Pharmacy Clinical Pharmacy Programs Program Number 2017 P 2116-3 Program Prior Authorization/Medical Necessity Medications Dupixent (dupilumab) P&T Approval Date 1/2017, 5/2017, 7/2017
More informationThe safety and effectiveness of Dupixent in pediatric patients have not been established (1).
Federal Employee Program 1310 G Street, N.W. Washington, D.C. 20005 202.942.1000 Fax 202.942.1125 5.90.30 Subject: Dupixent Page: 1 of 6 Last Review Date: September 15, 2017 Dupixent Description Dupixent
More informationNote: AD stands for Atopic Dermatitis. Page numbers in italics indicate figures. Page numbers followed by a t indicate tables.
index Note: AD stands for Atopic Dermatitis. Page numbers in italics indicate figures. Page numbers followed by a t indicate tables. Adolescent-onset AD, 67, 70, 71 ADSI (AD Severity ), 101 Adult-onset
More informationNovan Provides Update on SB414 Inflammatory Skin Disease Development Program
Novan Provides Update on SB414 Inflammatory Skin Disease Development Program SB414 Nitric Oxide-Releasing Cream Safe and Well-Tolerated in Psoriasis Phase 1b Trial Preclinical Data with SB414 Targeting
More informationPersistent food allergy might present a more challenging situation. Patients with the persistent form of food allergy are likely to have a less
Iride Dello Iacono Food allergy is an increasingly prevalent problem in westernized countries, and there is an unmet medical need for an effective form of therapy. A number of therapeutic strategies are
More informationPediatric Dermatology. Dra. Ana Batalla
Pediatric Dermatology Dra. Ana Batalla Special aspects of skin in neonates and infants Prof. Dr. Regina Fölster-Holst. Kiel - Germany. Vernix caseosa facilitates the development of stratum corneum Functions
More informationipad Increasing Nickel Exposure in Children
ipad Increasing Nickel Exposure in Children abstract We discuss allergic contact dermatitis to the ipad to highlight a potential source of nickel exposure in children. Pediatrics 2014;134:e580 e582 AUTHORS:
More informationWhat s Topical About Topicals?
What s Topical About Topicals? Megha M. Tollefson, MD Associate Professor of Dermatology and Pediatrics July 29, 2017 2015 MFMER 3513105-1 Disclosures None 2015 MFMER 3513105-2 Outline Topical steroids
More informationDupilumab and Crisaborole for Atopic Dermatitis: Effectiveness, Value, and Value-Based Price Benchmarks
Dupilumab and Crisaborole for Atopic Dermatitis: Effectiveness, Value, and Value-Based Price Benchmarks Draft Background and Scope November 7, 2016 Background: Atopic dermatitis (eczema) is a chronic/chronically-relapsing
More informationNovan Announces Promising Clinical Results with SB414
Novan Announces Promising Clinical Results with SB414 In the recently completed Phase 1b trial for atopic dermatitis, clinical efficacy measures were highly correlated with critical and disease-relevant
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 informationApproach to eczema. Hugo Van Bever Department of Pediatrics NUHS - Singapore
Approach to eczema Hugo Van Bever Department of Pediatrics NUHS - Singapore APAPARI workshop, Yangon, October 30, 2016 Eczema in children 1. Atopic dermatitis 2. Constitutional eczema 3. Contact dermatitis
More informationManagement of Chronic Idiopathic Urticaria
9/3/216 Management of Chronic Idiopathic Urticaria Brian Berman, M.D., Ph.D. Professor Emeritus of Dermatology and Dermatologic Surgery, University of Miami Co-Director Center for Clinical and Cosmetic
More information2/25/17. Translating the Evidence: Allergy vs. Dermatology. How can they disagree?! Bias: It doesn t come out in the wash. wash. Precision Medicine
Translating the Evidence: Allergy vs. Dermatology Peter A. Lio, MD, FAAD Assistant Professor Clinical Dermatology & Pediatrics Northwestern University Feinberg School of Medicine How can they disagree?!
More informationWYNNIS L. TOM, MD: And I m Dr. Wynnis Tom. I m Associate Professor of Dermatology and Pediatrics at the University of California, San Diego.
LEARNING OBJECTIVES At the conclusion of this activity, participants should be better able to: Assess the severity of atopic dermatitis (AD) and its impact on the patient Evaluate treatment efficacy Design
More informationDupixent (dupilumab)
Dupixent (dupilumab) Line(s) of Business: HMO; PPO; QUEST Integration Effective Date: TBD POLICY A. INDICATIONS The indications below including FDA-approved indications and compendial uses are considered
More informationContact Dermatitis In Atopic Patients
Contact Dermatitis In Atopic Patients Jenny Murase, MD Palo Alto Foundation Medical Group Director of Patch Testing University of California, San Francisco Associate Clinical Professor Disclosures Consultant
More informationTopical Doxepin Prior Authorization with Quantity Limit Program Summary
Topical Doxepin Prior Authorization with Quantity Limit Program Summary FDA APPROVED INDICATIONS DOSAGE 1-3 Agent(s) Indication(s) Dosage & Administration Doxepin 5% cream Prudoxin (doxepin) cream 5% KS_PS_Topical_Doxepin_PAQL_ProgSum_AR1018
More informationDISCLOSURES WHAT S NEW AND EXCITING FROM JAAD
WHAT S NEW AND EXCITING FROM JAAD Bruce H. Thiers, MD, Editor, JAAD Professor, Medical University of South Carolina Department of Dermatology and Dermatologic Surgery DISCLOSURES PFIZER VALEANT EFFECT
More informationSystemic treatment for moderate-to-severe atopic dermatitis? A systematic review and recommendation
Systemic treatment for moderate-to-severe atopic dermatitis? A systematic review and recommendation Jochen Schmitt Centre for evidence-based healthcare, Universitätsklinikum Carl Gustav Carus, Technische
More informationAtopic Eczema with detail on how to apply wet wraps
Atopic Eczema with detail on how to apply wet wraps Dr Carol Hlela Consultant Dermatologist Head of Unit, Department of Dermatology, Paediatrics Red Cross Children s Hospital, UCT Red Cross War Memorial
More informationAnti-IL-33 (ANB020) Program
Anti-IL-33 (ANB020) Program Phase 2a Peanut Allergy Clinical Trial Interim Data Update March 26 th 2018 NASDAQ: ANAB Safe Harbor Statement This presentation and the accompanying oral presentation contain
More informationHelp! What s the Answer? FRM F027 - Translating Evidence into Practice: Atopic Dermatitis Guidelines
Help! What s the Answer? FRM F027 - Translating Evidence into Practice: Atopic Dermatitis Guidelines Christine T. Lauren, M.D. Assistant Professor of Dermatology and Pediatrics Columbia University, New
More informationMolecular mechanisms in atopic eczema - why do they ma6er in the clinic?
Molecular mechanisms in atopic eczema - why do they ma6er in the clinic? Sara Brown Professor of Molecular & Gene0c Dermatology Wellcome Trust Senior Fellow in Clinical Research Professor of Molecular
More informationUpdate on emollients
Update on emollients Amal Mhanna, MD Pediatric Dermatologist Clemenceau Medical Center Disclosure: I was a member of an advisory board y for J&J and received honoraria. Emollients and moisturizers are
More informationProof-of-Concept Phase-2a Clinical Trial of ANB020 (Anti-IL-33 Antibody) in the Treatment of Moderate-to-Severe Adult Atopic Dermatitis
Proof-of-Concept Phase-2a Clinical Trial of ANB020 (Anti-IL-33 Antibody) in the Treatment of Moderate-to-Severe Adult Atopic Dermatitis Professor Graham Ogg University of Oxford United Kingdom American
More informationLearning Teams - Biologic Integration. p. 01
Learning Teams - Biologic Integration p. 01 p. 02 Expanding our portfolio to include both biologics and topicals... The NME Innovation Pipeline features 3 biologics, which are all at very different stages
More informationBiologics in Asthma: Present and Future
Biologics in Asthma: Present and Future Flavia Hoyte, MD Associate Professor of Medicine Fellowship Training Program Director Division of Allergy and Immunology National Jewish Health and University of
More informationReview of Evidence for Dietary Influences on Atopic Dermatitis Sarah Mohajeri, MD, MPH, Sabrina A. Newman, MD Skin Therapy Letter.
www.medscape.com Review of Evidence for Dietary Influences on Atopic Dermatitis Sarah Mohajeri, MD, MPH, Sabrina A. Newman, MD Skin Therapy Letter. 2014;19(4) Abstract and Introduction Abstract Atopic
More informationHeld in conjunction with AMCP Managed Care & Specialty Pharmacy Annual Meeting Jointly provided by
Jointly provided by This activity is supported by independent educational grants from Sanofi Genzyme and Regeneron Pharmaceuticals Held in conjunction with AMCP Managed Care & Specialty Pharmacy Annual
More informationThe Burden of Atopic Dermatitis: from Population to Bedside
The Burden of Atopic Dermatitis: from Population to Bedside S028 AAD Annual Meeting March 2, 2019 Research and institutional funding Sanofi Regeneron Disclosures Consultant Honoraria Sanofi Astellas Canada
More informationHot topics in Pediatric Dermatology. Yvonne Chiu, MD
Hot topics in Pediatric Dermatology Yvonne Chiu, MD Hot Topics for Pediatric Dermatology Yvonne Chiu, MD WDS Summer Meeting July 21, 2012 Disclosure Statement I, Yvonne Chiu, MD, do not have any relevant
More informationWhat is atopic dermatitis?
What is atopic dermatitis? Complex inflammatory skin disorder intense pruritus cutaneous hyperreactivity immune dysregulation Chronic with exacerbations and remissions Affects all ages, but more common
More informationAnti-IgE: beyond asthma
Anti-IgE: beyond asthma Yehia El-Gamal, MD, PhD, FAAAAI Professor of Pediatrics Pediatric Allergy and Immunology Unit Children s Hospital, Ain Shams University Member, WAO Board of Directors Disclosure
More informationPresented by: Adelaide A Hebert, MD UTHealth McGovern Medical School, Houston, TX
Evaluation of the Efficacy, Safety and Tolerability of 4% Once-Daily in Subjects with Moderate to Severe Acne Vulgaris Treated Topically for Up to 52 Weeks A Hebert, J Del Rosso, M Rico, R Woolson, E de
More informationCurrent and Future Prospects for the Treatment of Food Allergy
Current and Future Prospects for the Treatment of Food Allergy Robert A. Wood, MD Professor of Pediatrics and International Health Director, Pediatric Allergy and Immunology Director, Pediatric Clinical
More informationAtopic Dermatitis and Topical Antipsoriatics
Atopic Dermatitis and Topical Antipsoriatics Goal(s): Restrict dermatological drugs only for funded OHP diagnoses. Moderate/severe psoriasis and moderate/severe atopic dermatitis treatments are funded
More informationBrian S. Kim, MD, MTR, FAAD
What s New In the Pathophysiology of Itch? Brian S. Kim, MD, MTR, FAAD Assistant Professor of Dermatology, Anesthesiology, and Pathology and Immunology Co-Director, Center for the Study of Itch Itch is
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 informationVitamina D: un ormone multifunzione
Vitamina D: un ormone multifunzione Introduction And Infections Diego Peroni Clinica Pediatrica Universita di Ferrara Food Allergy Asthma Conclusions diego.peroni@unife.it Holick, M. F. J. Clin. Invest.
More informationProof-of-Concept Phase-2a Clinical Trial of ANB020 (Anti-IL-33 Antibody) in the Treatment of Moderate-to-Severe Adult Atopic Dermatitis
Proof-of-Concept Phase-2a Clinical Trial of ANB020 (Anti-IL-33 Antibody) in the Treatment of Moderate-to-Severe Adult Atopic Dermatitis Professor Graham Ogg University of Oxford United Kingdom European
More informationNIH Public Access Author Manuscript J Invest Dermatol. Author manuscript; available in PMC 2014 April 01.
NIH Public Access Author Manuscript Published in final edited form as: J Invest Dermatol. 2013 October ; 133(10): 2311 2314. doi:10.1038/jid.2013.239. Mechanisms of contact sensitization offer insights
More informationTopical Immunomodulator Step Therapy Program
Topical Immunomodulator Step Therapy Program Policy Number: 5.01.557 Last Review: 8/2017 Origination: 7/2013 Next Review: 8/2018 Policy Blue Cross and Blue Shield of Kansas City (Blue KC) BCBSKC will provide
More information20/11/55. Food Allergy and Atopic Dermatitis. Outline of Talk - 1. Outline of talk - 2
Food Allergy and Atopic Dermatitis Pakit Vichyanond, MD Department of Pediatrics Faculty of Medicine Siriraj Hospital Mahidol University, Bangkok, Thailand Outline of Talk - 1 Frequency of food sensitization
More informationFood allergies and eczema
Department of Dermatology Food allergies and eczema Information for parents and carers Eczema, also known as atopic eczema or atopic dermatitis, is a skin condition that causes inflammation and irritation.
More informationUPDATES IN ATOPIC DERMATITIS
UPDATES IN ATOPIC DERMATITIS Amanda Hess, MMS, PA-C President-Elect, AAPA-AAI Arizona Asthma and Allergy Institute, Scottsdale, AZ LEARNING OBJECTIVES Discuss epidemiology, risk factors, and causes of
More informationDupilumab and Crisaborole for Atopic Dermatitis: Effectiveness and Value
Dupilumab and Crisaborole for Atopic Dermatitis: Effectiveness and Value Evidence Report May 12, 2017 Prepared for Institute for Clinical and Economic Review, 2017 ICER Staff David M. Rind, MD, MSc Chief
More informationD E R M A T O L O G Y
We customize individual prescriptions for the specific needs of our patients. F E B R U A R Y 2 0 1 3 I N S I D E T H I S I S S U E : Psoriasis Vulgaris 2 Atopic Dermatitis 3 P R E S C R I P T I O N C
More informationWYNNIS L. TOM, MD: And I m Dr. Wynnis Tom. I m Associate Professor of Dermatology and Pediatrics at the University of California, San Diego.
LEARNING OBJECTIVE At the conclusion of this activity, participants should be better able to: Answer common patient questions about the course of atopic dermatitis (AD) and effective strategies for treating
More informationTHINGS CLINICIANS AND CONSUMERS SHOULD QUESTION. Developed by the Australasian Society of Clinical Immunology and Allergy
THINGS CLINICIANS AND CONSUMERS SHOULD QUESTION Developed by the Australasian Society of Clinical Immunology and Allergy 1 Don t use antihistamines to treat anaphylaxis prompt administration of adrenaline
More informationWhat to do when patch testing is negative?
What to do when patch testing is negative? Christen M. Mowad MD Clinical Professor of Dermatology Geisinger Medical Center Danville, PA 17821 cmowad@geisinger.edu I have no disclosures. What to do when
More informationUpdate on systemic therapies and emerging treatments How do I choose a systemic agent?
Update on systemic therapies and emerging treatments How do I choose a systemic agent? Amy S. Paller, M.D. Walter J. Hamlin Professor and Chair of Dermatology Professor of Pediatrics Northwestern University
More informationHow immunology informs the design of immunotherapeutics.
How immunology informs the design of immunotherapeutics. Stephen R Durham Allergy and Clinical Immunology, Royal Brompton Hospital and Imperial College London WAO Cancun Mon Dec 5 th 2011 How immunology
More informationPsoriasis and the metabolic syndrome
Psoriasis and the metabolic syndrome MD, PhD James G. Krueger 1 Inflammation as a foundation of metabolic dysregulation and cardiovascular disease risk Diseases of systemic immune activation and inflammation,
More informationInflammation in the clinic
Inflammation in the clinic Stephen T. Holgate MRC Clinical Professor of Immunopharmacology ILSI Europe Workshop, Seville, May 14-15 2012 The immune system acts in four general ways to ensure host defence
More informationSarcoidosis Case. Robert P. Baughman Interstitial Lung Disease and Sarcoidosis Clinic University of Cincinnati, USA. WASOG: educational material
Sarcoidosis Case Robert P. Baughman Interstitial Lung Disease and Sarcoidosis Clinic University of Cincinnati, USA WASOG: educational material Sarcoidosis Case patient is a Caucasian male age 46 was diagnosed
More informationPsoriasiform Dermatitis in Children: Calling in the Troops
Psoriasiform Dermatitis in Children: Calling in the Troops Markus Boos, MD PhD Attending Physician, Dermatology Seattle Children s Hospital Assistant Professor of Pediatrics, University of Washington School
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 informationComparative efficacy of topical mometasone furoate 0.1% cream vs topical tacrolimus 0.03% ointment in the treatment of atopic dermatitis
Original Article Comparative efficacy of topical mometasone furoate 0.1% cream vs topical tacrolimus 0.03% ointment in the treatment of atopic dermatitis Md Alauddin Khan *, Lubna Khondker **, Dilshad
More informationUpdates. Updates. Crisaborole 2% Ointment. New Therapies! 9/14/17. Dermatology Update 2017 Pediatric Dermatology NEW THERAPIES. July July 2017
Dermatology Update 2017 Pediatric Dermatology Melinda Jen, MD Director of Dermatologic Surgery Director of Pigmented Lesion Clinic Assistant Professor of Pediatrics and Dermatology Children s Hospital
More informationClinical Policy: Dupilumab (Dupixent) Reference Number: ERX.SPA.49 Effective Date:
Clinical Policy: (Dupixent) Reference Number: ERX.SPA.49 Effective Date: 06.01.17 Last Review Date: 02.19 Revision Log See Important Reminder at the end of this policy for important regulatory and legal
More informationDupilumab for treating adults with moderate to severe atopic dermatitis [ID1048]
Dupilumab for treating adults with moderate to severe atopic dermatitis [ID1048] Thank you for agreeing to give us your organisation s views on this technology and its possible use in the NHS. You can
More informationThe Treatment Toolbox for Severe Pediatric Psoriasis
The Treatment Toolbox for Severe Pediatric Psoriasis Dr. Kim A. Papp, MD, PhD, FRCPC, FAAD K Papp Clinical Research and Probity Medical Research Objectives: Treating severe pediatric psoriasis 1. Challenges
More informationNIH Public Access Author Manuscript J Invest Dermatol. Author manuscript; available in PMC 2015 February 01.
NIH Public Access Author Manuscript Published in final edited form as: J Invest Dermatol. 2014 August ; 134(8): 2071 2074. doi:10.1038/jid.2014.141. A possible role for IL-17A in establishing Th2 inflammation
More informationRELEVANT DISCLOSURES. Consultant for Galderma Research grant from Ceragenix Investigator on Novartis study Research grant from Celgene
Novel Therapeutics in Atopic Dermatitis Eric Simpson, MD,MCR Associate Professor, Dermatology Oregon Health & Science University RELEVANT DISCLOSURES Consultant for Galderma Research grant from Ceragenix
More information5007 Seminar Advanced Therapeutics: Managing Severe & Refractory Eczema. Part 1. Keys to Adherence: Simplify regimen & Educate
5007 Seminar Advanced Therapeutics: Managing Severe & Refractory Eczema Luz Fonacier, MD Professor of Clinical Medicine State University of New York at Stony Brook Head of Allergy & Training Program Director
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 information7/25/2016. Use of Epinephrine in the Community. Knowledge Amongst Paramedics. Knowledge Amongst Paramedics survey of 3479 paramedics
Recognition & Management of Anaphylaxis in the Community S. Shahzad Mustafa, MD, FAAAAI Disclosures Speaker s bureau Genentech, Teva Consultant Genentech, Teva Outline Knowledge gap Definition Pathophysiology
More informationPotent and Selective CRTh2 Antagonists are Efficacious in Models of Asthma, Allergic Rhinitis and Atopic Dermatitis
Potent and Selective CRTh2 Antagonists are Efficacious in Models of Asthma, Allergic Rhinitis and Atopic Dermatitis Laura L. Carter, Yoshi Shiraishi, Yooseob Shin, Laurence Burgess, Christine Eberhardt,
More informationSafety, PK and PD of ARRY-502, a CRTh2 Antagonist, in Healthy Subjects with a History of Seasonal Allergies
Safety, PK and PD of ARRY502, a CRTh2 Antagonist, in Healthy Subjects with a History of Seasonal Allergies L. Burgess*, L. Anderson, C. Nugent, N. Klopfenstein, C. Eberhardt, L. Carter, C. Kass, S. RojasCaro,
More informationDupilumab and Crisaborole for Atopic Dermatitis: Effectiveness and Value. Public Meeting May 25, 2017
Dupilumab and Crisaborole for Atopic Dermatitis: Effectiveness and Value Public Meeting May 25, 2017 Welcome and Introduction Midwest Comparative Effectiveness Public Advisory Council (CEPAC) The Institute
More informationMedical Policy An independent licensee of the Blue Cross Blue Shield Association
Topical Doxepin Page 1 of 5 Medical Policy An independent licensee of the Blue Cross Blue Shield Association Title: Topical Doxepin Prime Therapeutics will review Prior Authorization requests Prior Authorization
More information