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 Lilly Regeneron/Sanofi; Medimetriks Otsuka Galderma Laboratories Novan Valeant PharmaceuIcals DISCLOSURES Lawrence F. Eichenfield, MD Discussion is based on evidence-based recommendations and published or scientifically vetted, well designed studies
What s New in Guidelines
Food Allergy: DefiniIons " Food allergy food intolerance " Food allergy is defined as an adverse health effect arising from a specific immune response that occurs reproducibly on exposure to a given food Boyce JA et al. J Allergy Clin Immunol. 2010 Dec;126(6 Suppl):S1-58
Food Allergy Guidelines suggest that children less than 5 years of age with moderate to severe AD be considered for FA evaluaion for milk, egg, peanut, wheat and soy, if at least one of the following is met: -Persistent AD in spite of opimized management and topical therapy -History of an immediate reacion auer ingesion of Boyce a specific JA et al. J food Allergy Clin Immunol. 2010 Dec;126(6 Suppl):S1-58
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:e1530-8
How common is food allergy? And is IgE tesing reliable? Study of infants with AD: 3-18 mths Pimecrolimus vs. Vehicle, TCS rescue trial) 36 mth trial; up to 33 mth open label phase sige: Baseline, End DB, end OL phase 15.9% had at least 1 food allergy Peanut 6.6%; Cow s milk 4.3%; Egg white 39% PosiJve tests had poor predicjve value! Spergel JM et al. Pediatrics 2015(Dec)136:e1530-8 Silverberg JI, Simpson EL. Pediatr Aller Immunol. 2013;24(5):476 486
Peanut ConsumpIon: Prevents Allergy! NegaIve skin-prick test @ baseline Prevalence of peanut allergy at 60 mths: 13.7% in the avoidance group 1.9% in the consumpion group (P<0.001) IniIally posiive skin prick at baseline: 35.3% avoidance group 10.6% consumpion group Du Toit G, et al. N Engl J Med 2015;372:803-813
New Food Allergy Guideline: NIAID 2017 Addendum to the 2010 guidelines for Diagnosis and Management of Food Allergy IdenIfies infants with severe AD (and/ Severe eczema: defined as persistent or frequently recurring or egg eczema allergy) with typical as group morphology at risk and for distribution, assessed as severe by a health care provider peanut and requiring allergy frequent need for prescriptionstrength topical corticosteroids, TCI, orother antiinflammatory agents despite appropriate use of emollients.
New NIAID Food Allergy Guidelines Recommends that infants with severe eczema, egg allergy or both have introducion of age-appropriate peanut-containing food as early as 4-6 months of age to reduce the risk of peanut allergy Direct referral to allergy or Serum IgE screen (if negaive, feed); if + referral to allergy
Food allergen panel testing or sige for other than peanut: not recommended
Mild to Moderate Eczema Introduce peanut-containing food as early as 4-6 months of age in accordance with family preferences and cultural pracices, to reduce the risk of peanut allergy. Peanut should not be the iniial solid food Peanut introduced at home without an in-office evaluaion. However, the EP recognizes that some caregivers and health care providers may desire an in-office evaluaion
Infants without eczema or food allergy Age-appropriate peanut-containing foods freely introduced in the diet, together with other solid foods, and in accordance with family preferences and cultural pracices.
Guidelines: What are we missing? Crisaborole: Place in therapy Have heard of requirement by insurance of an IGSA score! Dupilimab: Imminent approval? For which paients?
Topical PDE-4: How to use?
How about emerging biologics? Who are our target paients for new systemic therapies Moderate to severe
Dupilimab: inclusion criteria Chronic atopic dermaiis (according to American Academy of Dermatology Consensus Criteria) that has been present for >3 years before screening EASI score of >16 at screening and baseline IGA score of> 3 (on a scale of 0-4, in which 3 is moderate and 4 is severe) at screening and baseline >10% BSA screening and baseline Baseline pruritus numerical raing scale average for maximum itch intensity of >3, based (avg during the 7 days prior)
Dupilimab: inclusion criteria Documented recent history (within 6 months prior to screening) of inadequate response to treatment with topical medicaions, or for whom topical treatments are otherwise medically inadvisable (e.g., because of side effects or safety risks) Inadequate response: failure to achieve and maintain remission or a low disease acivity state (comparable to an IGA score of 0 [indicaing clear] to 2 [indicaing mild] despite treatment with a daily regimen of topical coricosteroids of medium to higher potency (with or without topical calcineurin inhibitors as appropriate), applied for >28 days or for the maximum duraion recommended OR SYSTEMIC THERAPY in PAST 6 MTHS
SEVERITY: Policy: Any statements? InternaIonal Eczema Council SystemaIc and holisic approach to assess severe signs/symptoms of AD and/or impact on quality of life Considering alternate or concomitant diagnoses, avoid trigger factors, opimize topical therapy, ensure paient/caregiver educaion, treat co-existent infecion, consider phototherapy
Diagnosis and Assessment: Diagnosis Caveats Allergic contact dermaiis: alternaive diagnosis and/or exacerbator NutriIonal, metabolic, and immunologic condiions in children and cutaneous T-cell lymphoma in adults Be aware of muliple infecions (bacterial or viral), failure to thrive Eichenfield LF et al, Part 1, JAAD, 2014;70:338-51
Diagnosis and Assessment: What are the Standards? Should query itch, sleep, impact on daily ac.vity, and disease persistence Be Aware and Discuss AssociaIons (as appropriate) ATOPIC: food allergies, asthma, rhiniis/rhinoconjunciviis Sleep disturbance, depression, and other neuropsychiatric condiions Eichenfield LF et al, Part 1, JAAD, 2014;70:338-51
Patch TesIng in Atopics Considered with persistent/recalcitrant disease and/or a history or physical examinaion findings consistent with allergic contact dermaiis Sidbury R et al. Part 4, JAAD 2014;71:1218-33
EducaIonal IntervenIons EducaIonal material: recommended adjunct Discussion of steroid strengths and safety EducaIonal and InstrucIonal materials Wrisen acion plans, Web-sites, Video training modules, Text/Email reinforcers, Apps Sidbury R et al. Part 4, JAAD 2014;71:1218-33
Systemic Therapy: Assessing Need for Systemic Rx Signs scores: (not preferred); EG: IGSA (InvesIgator Global StaIc Assessment);EASI (not so easy!) BSA: 10% + (Psoriasis); not bad for AD, but not so good SCORAD (signs+symptoms): Not so pracical
Systemic Therapy: Assessing Need Recalcitrance: failure to respond to adequate topical therapy; requirement for prolonged use of high potency topical steroids; repeated flares
AD: The PoliIcs Excellent collaboraion amongst dermatologists, allergists Research work, guidelines, clinical collaboraions IniIaIves: CUBE-C (CoaliIon United for Beser Eczema Care) Co-chaired by Allergists! Developed through NaIonal Eczema AssociaIon to create a standardized curriculum on AD TherapeuIc PaIent EducaIon Movement: It s happening (April 8, 2017; San Diego) Access and Cost issues for new medicaions: Much work to do!
Summary: AD EvoluIon/RevoluIon Guidelines will need to be updated! Messaging: ESTABLISH THAT AD can and should be adequately controlled Parallels to asthma treat to no wheeze! Get ready for access work- Advocacy for and with our paients!