Faculty Information ECZEMA: THE ITCH THAT RASHES A CONTINUING EDUCATION WEBINAR Speaker Celia Lu, Pharm.D, BCACP Assistant Clinical Professor St. John s University College of Pharmacy & Health Sciences Nissa Mazzola, Pharm.D, CDE Assistant Clinical Professor St. John s University College of Pharmacy & Health Sciences Moderator Maryjo Dixon, RPh Sr. Director of Scientific Affairs Pharmacy Times Office of Continuing Professional Education Disclosures and COI Resolution Celia Lu, Pharm.D, BCACP and Nissa Mazzola, Pharm.D, CDE, have no relevant financial relationships with commercial interests to disclose. Pharmacy Times Office of Continuing Professional Education Planning Staff: Dave Heckard, Maryjo Dixon, RPh, and Donna Fausak have no financial relationships with commercial interests to disclose. An anonymous peer reviewer has been used as part of content validation and conflict resolution. The peer reviewer has no relevant financial relationships with commercial interests to disclose. The content of this webinar may include information regarding the use of products that may be inconsistent with, or outside the approved labeling for, these products in the United States. Pharmacists should note that the use of these products outside current approved labeling is considered experimental and are advised to consult the prescribing information for these products. Pharmacy Accreditation Pharmacy Times Office of Continuing Professional Education is accredited by the Accreditation Council for Pharmacy Education (ACPE) as a provider of continuing pharmacy education. This activity is approved for 1.0 contact hour (0.1 CEU) under the ACPE universal activity number 0290-0000-15-112-L01-P. The activity is available for CE credit through January 29, 2015. Type of Activity: Knowledge This activity is supported by an educational grant from Bayer HealthCare Pharmaceuticals, Inc. How to Receive Credit for Live CE Webinars To be eligible for CE credit, each participant must use a computer to log onto the webinar using the assigned link sent to them in their confirmation email. This link is unique to each participant and can not be shared. All participants must view the webinar in its entirety. If you cannot see this slide, you need to log onto this webinar in order to receive credit. All participants must request their credit by within 2 weeks of this live broadcast (before February 12, 2015). How to Receive Credit for Live Webinars CE credit for this live webinar will be available 48 hours after the webinar concludes Directions: 1. Go to our website www.pharmacytimes.org and log in 2. Click on the MY CE tab. This will take you to your course history page 3. Under the Manage My CE section, you will see this webinar listed 4. Click on the session that you attended and complete the activity evaluation 5. Your statement of credit will be available once you have submitted an evaluation form or Wait for an email from Pharmacy Times Office of CPE containing a link to the evaluation form and certificate. 1
Questions? Contact us For the Live Q&A Session Please send all questions or comments concerning this webinar to: CEINFO@pharmacytimes.com, the official email of Pharmacy Times Office of CPE. Send your discussion questions to CEINFO@pharmacytimes.com All emails sent to this address will be answered within 24 hours in the order that they are received. Objectives ECZEMA: THE ITCH THAT RASHES Celia Lu, PharmD, BCACP Assistant Clinical Professor St. John s University College of Pharmacy & Health Sciences January 29, 2015 Nissa Mazzola, PharmD, CDE Assistant Clinical Professor St. John s University College of Pharmacy & Health Sciences Review the pathophysiology and environmental factors that exacerbate atopic dermatitis (eczema) List the characteristics of patients that are at high risk for atopic dermatitis Identify skin care and moisturizing products and other non-pharmacologic recommendations for patients with atopic dermatitis Discuss products and methods for the treatment of atopic dermatitis and the respective adverse effects Pre-Test Question 4 - Case Pre-assessment Audience Polling Questions Patient JD is a 25 yo M with atopic dermatitis who comes to the PCP office complaining of persistent itching in the flexural areas of the knees and elbows. The affected areas appear erythematous, excoriated, and lichenified. He reports that the symptoms are worse during extreme weather changes and also when he sweats during exercise. He has tried showering and using lotion, but this has not helped to relieve his symptoms. 2
Also know as eczema Atopic Dermatitis Chronic, relapsing, inflammatory skin disease Affected areas: Face, scalp, and extensor surfaces in infants and children Flexural surfaces in adults Onset typically during childhood Most common during 3-6 months of age 90% by 5 years of age Prevalence of childhood eczema in US is 10.7% May persist into adult years Kay J, et al. J Am Acad Dermatol. 1994;30:35-9 Shaw TE, et al. J Invest Dermatol. 2011;131:67-73 Features of Atopic Dermatitis Photos released with permission from Nissa Mazzola, PharmD, CDE Clinical features include pruritus and xerosis Stages: Acute/subacute: Erythematous, excoriated papules with exudate Chronic: Thickened plaques and/or skin markings (lichenification) Atopic Dermatitis Severity Assessed as Mild, Moderate, or Severe Intensity of symptoms Extent of affected areas Most common severity scales SCORAD (SCORing Atopic Dermatitis) EASI (Eczema Area and Severity Index) SASSAD (Six Area, Six Sign Atopic Dermatitis) Scales are mainly used in clinical trials, not in practice Atopic Dermatitis and Quality of Life Negative impact on quality of life Can affect performance at work or school May decrease self-esteem Associated with Sleep disturbances Depression Anxiety Behavior disorders, including ADHD Eichenfield LF, et al. J Am Acad Dermatol. 2014;70:338-51 European Task Force on Atopic Dermatitis. Dermatology. 1993;186:23-31 Lewis-Jones S. Int J Clin Pract. 2006;60:984-92 Yaghmaie P, et al. J Allergy Clin Immunol. 2013;131:428-33 Pathophysiology of Atopic Dermatitis Causes are not fully understood Develops in the presence of offending agents Involves genetic factors that result in Skin barrier defects Immune dysregulation Disruption in the normal skin barrier Due to mutation in FLG (filaggrin) gene Leads to water loss Decreases protection from irritants Increases risk for staphylococcal and viral infections Pathophysiology Itch-Scratch Cycle Itching leads to scratching Defective skin barrier weakens further Irritants activate inflammatory response Effects of immune system lead to increased itching TSLP = Thymic stromal lymphopoietin IL = Interleukin DC = Dendritic cell Th2 = T-helper cell (type 2) Image source: Reprinted from with permission from Elsevier 3
Heat Sweating Stress/Anxiety Infections Soaps and detergents Wool fibers Food allergens Environmental Triggers Risk Factors for Atopic Dermatitis Strong association Personal or family history of atopic diseases FLG gene mutation Possible association Race Living in urban areas Unclear or limited data Gender Socioeconomic status Exposure to pets, infections, or antibiotics Eichenfield LF, et al. J Am Acad Dermatol. 2014;70:338-51 Wen HJ, et al. Br J Dermatol. 2009;161:1166-72 Shaw TE, et al. J Invest Dermatol. 2011;131:67-73 Schmitt J, et al. Pediatr Allergy Immunol. 2010;21:292-300 Effect of Pregnancy/Lactation Practices No evidence-based dietary recommendations for prevention Probiotics during pregnancy and/or infancy may risk High-risk infants may benefit from breastfeeding or hydrolyzed formula Not shown to reduce child s risk of developing an atopic disease: Avoiding dietary allergens during pregnancy or lactation Delaying introduction of solid foods Atopic Dermatitis Treatment Avoid triggers Skin hydration Restoration of the skin barrier Management of skin inflammation Goals of therapy Improve quality of life Prevent infectious complications and flare-ups Minimize medication side effects Eichenfield LF, et al. J Am Acad Dermatol. 2014;70:338-51 Pelucchi C, et al. Epidemiology. 2012;23:402-14 Greer FR, et al. Pediatrics. 2008;121:183-91 Non-Pharmacologic Management American Academy of Dermatology 2014 Guidelines Intervention Recommendation Strength Moisturizers Should be an essential part of treatment A Bathing practices No standard for frequency/duration of bathing May use non-soap cleansers Adding bath oils not recommended C C C Topical Moisturizers Essential for mild to severe disease Helps skin retain water and relieve dryness caused by defects in the skin barrier Shown to reduce disease severity, pruritus, erythema, fissuring, and lichenification Can reduce need for anti-inflammatory treatments (eg, topical corticosteroids) Wet-wrap therapy May use (with or without a topical corticosteroid) for patients with moderatesevere atopic dermatitis Table adapted from B Grimalt R, et al. Dermatology. 2007;214:61-7 4
Components of Topical Moisturizers Ingredient Function Examples Emollients Lubricate and soften skin Glycol Glyceryl stearate Soy sterols Occlusive agents Form protective layer to reduce water loss Petrolatum Dimethicone Mineral oil Humectants Attract and retain water Glycerol Lactic acid Urea New class of topical moisturizers available Prescription emollient devices contain components aimed to restore specific defects in skin barrier OTC Moisturizers OTC Brand Name Aquaphor Ointment Eucerin Cream Examples of Moisturizers Main Ingredient(s) Petrolatum 41%, water Petrolatum, mineral oil, mineral wax AmLactin Lotion Ammonium lactate 12% Prescription Emollient Devices/Barrier Repair Creams Rx Brand Name Atopiclair Cream EpiCeram Cream Main Ingredient(s) Glycyrrhetinic acid, hyaluronic acid Ceramide, fatty acids, cholesterol Benner KW. Atopic dermatitis and dry skin. In: Krinsky DL, ed. Handbook of Nonprescription Drugs: An Interactive Approach to Self-Care. 18 th ed. Washington, D.C: American Pharmacists Association; 2015. Atopiclair [package insert]. Bristol,TN: Graceway Pharmaceuticals,LLC; 2009. EpiCeram [package insert]. South Plainfield, NJ: PuraCap Pharmaceutical LLC; 2014. Topical Moisturizer Selection Creams, ointments, oils, gels, and lotions Ointments more occlusive Creams better tolerated Generally well tolerated No product superior to another Counseling points Avoid those with perfumes, fragrances, preservatives Apply liberally to dry skin areas Apply a few times a day every day or more if still dry Bathing Practices May help remove crust, irritants, and allergens Helps hydrate skin Suggested duration and frequency May bathe up to once a day for 5-10 minutes in warm water May use soak and smear technique if patient is on topical anti-inflammatory agents May use non-soap cleansers that are hypoallergenic, fragrance-free, neutral to low ph Apply moisturizer right after bathing to prevent water loss Wet-Wrap Therapy May be used in severe flares Helps with the following Improving hydration Preventing scratching Improving penetration of topical product Disadvantages Increased cost Time spent with application Wet-Wrap Therapy Instructions Apply topical medication and/or moisturizer Cover with a layer of wet gauze or bandage Apply dry layer of gauze or bandage over the wet layer Wear for a few hours to up to 24 hours Use for up to 2 weeks Not recommended on infected lesions 5
Topical Pharmacologic Management American Academy of Dermatology 2014 Guidelines Intervention Topical corticosteroids (TCS) Topical calcineurin inhibitors (TCI) Recommendation Use when moisturizers and skin care measures fail Maintenance: Use intermittently to prevent flares Steroid-sparing agent for acute and chronic disease Maintenance: Use intermittently to prevent flares Topical Corticosteroids (TCS) First-line anti-inflammatory treatment for flares and chronic maintenance Choice of potency depends on disease severity, affected area, and age Use lowest potency needed to relieve symptoms Available as ointments, creams, and lotions Ointments are more potent and occlusive; have less preservatives Table adapted from Hoare C, et al. Health Technol Assess. 2000;4:1-191 TCS Potencies Potency Ratings of TCS Low Potency High Potency Skin area Safe for thin areas of skin Avoid in thin areas or under occlusion May be used in thicker areas Use in children Safe Avoid Duration May be used long term Avoid use >3 weeks Potency Class 1:Superpotent Class 2: Potent Class 3: Upper Mid-Strength Class 4: Mid-Strength Class 5: Lower Mid-Strength Class 6: Mild Class 7: Least Potent Example (Augmented) Betamethasone dipropionate 0.05% ointment (Augmented) Betamethasone dipropionate 0.05% cream Betamethasone dipropionate 0.05% ointment Fluticasone propionate 0.005% ointment Mometasone furoate 0.1% cream Triamcinolone acetonide 0.1% cream Triamcinolone acetonide 0.025% ointment Desonide 0.05% cream Hydrocortisone 1%, 2.5% cream Ference JD, et al. American Family Physician. 2009;79(2):135-140 Table adapted from: Jacob SE, et al. J Am Acad Dermatol. 2006;54:723-7 Counseling points Applying TCS Apply thin layer on affected areas Then apply thick layer of moisturizer to non-affected areas For flare-ups Apply twice daily up to several weeks Then switch to using moisturizer alone Or switch to once- to twice-weekly application Short courses of mid- or high-potency corticosteroids may be used for more severe flare-ups Thomas KS, et al. BMJ. 2002;324:768 Fingertip Unit Application Method Area of the body Fingertip unit* required for one application (g) Weight of ointment required for one application (g) Weight of ointment required for an adult male to treat twice daily for one week (g) Face and neck 2.5 1.25 17.5 Trunk (front or back) 7 3.5 49 One arm 3 1.5 21 One hand (one side) 0.5 0.25 3.5 One leg 6 3 42 One foot 2 1 *One fingertip unit = amount that can be squeezed from the fingertip to the first crease of the finger (approximately 0.5 g) Table adapted with permission from: Ference JD, et al. Am Fam Physician. 2009;79:135-40 Long CC, et al. Clin Exp Dermatol. 1991;16:444-7 6
Concerns with TCS Use Local adverse effects Skin atrophy Striae Acne Telangiectasia Risk increases with higher potency corticosteroid Systemic effect: adrenal suppression Extended, continuous use may increase risk Steroid phobia may result in poor compliance TCS Adverse Effects Steroid abuse in a patient with atopic dermatitis Higher potency used as result of tachyphylaxis Effects Generalized facial erythema Patchy hyperpigmentation on the forehead Increased atrophy and wrinkles around the eyes Image source: Reprinted from Hengge UR, et al. J Am Acad Dermatol. 2006;54:1-15 with permission from American Academy of Dermatology Topical Calcineurin Inhibitors (TCI) May use if TCS fail or not tolerated Greater improvement with tacrolimus 0.1% vs. fluticasone 0.005% ointment in adults with facial atopic dermatitis Second-line anti-inflammatory agent due to risks Adverse effects Most common: burning, stinging, pruritus Black box warning: rare cases of malignancy No skin atrophy, so preferred for sensitive skin areas Greater efficacy combined with TCS than TCS alone Drug Name Tacrolimus (Protopic) Pimecrolimus (Elidel) Dosage Form Available TCI Strength Ointment 0.03% 0.1% Indication Second-line therapy for treatment of moderate to severe atopic dermatitis - 0.03% for children aged 2 to 15 years - Patients >15 years of age may use either strength Cream 1% Second-line therapy for treatment of mild to moderate atopic dermatitis Doss N, et al. Br J Dermatol. 2009;161:427-34 Hebert AA, et al. Cutis. 2006;78:357-63 Protopic [package insert]. Northbrook, IL: Astellas Pharma US, Inc.; 2012 Elidel [package insert]. Bridgewater, NJ: Valeant Pharmaceuticals North America LLC; 2014 TCI Counseling Points Apply thin layer to affected skin twice a day Use the smallest amount necessary to relieve symptoms Avoid long-term continuous use Limit sun exposure Do not cover with bandages Do not bathe/shower after application Moisturizers can be applied after use Protopic [package insert]. Northbrook, IL: Astellas Pharma US, Inc.; 2012 Elidel [package insert]. Bridgewater, NJ: Valeant Pharmaceuticals North America LLC; 2014 Other Topical Treatments Topical antimicrobials and antiseptics 2010 Cochrane review: lack of evidence supporting their use Bleach baths with intranasal topical mupirocin may help in moderate to severe cases with frequent bacterial infections Topical antihistamines Not recommended due to lack of utility Adverse effects: stinging, burning, contact dermatitis Topical coal tar derivatives Few trials showing efficacy in atopic dermatitis Topical phosphodiesterase inhibitors New class of anti-inflammatory treatments undergoing clinical trials Bath-Hextall FJ, et al. Br J Dermatol. 2010;163:12-26 7
Systemic Pharmacologic Management American Academy of Dermatology 2014 Guidelines Intervention Recommendation Phototherapy Use as second-line treatment Systemic immunomodulatory agents Use if symptoms uncontrolled after phototherapy and topical therapy No formal recommendations regarding dosing, duration of therapy, and monitoring Systemic steroids Avoid except for acute, severe flares Table adapted from Sidbury R, et al. J Am Acad Dermatol. 2014;71:327-49 Systemic Immunomodulatory Agents Drug Name Use Adverse Effects Cyclosporine Azathioprine Methotrexate Mycophenolate mofetil Interferon gamma Off-label for refractory disease Off-label for refractory disease Off-label for refractory disease Off-label for refractory disease (Alternative agent) Off-label for refractory disease (Alternative agent) Sidbury R, et al. J Am Acad Dermatol. 2014;71:327-49 Roekevisch E, et al. J Allergy Clin Immunol. 2014;133:429-38 Infection, nephrotoxicity, hypertension, tremor, headache Nausea, vomiting, headache, elevated liver function tests, leukopenia Nausea, ulcerative stomatitis, bone marrow suppression Nausea, vomiting, hematologic disorders Fever, nausea, vomiting, myalgia Other Systemic Agents Systemic corticosteroids for severe flares Rebound flares and worsened severity when stopped May require tapering Systemic antibiotics and antiviral agents may be used for infections Short-term use of oral antihistamine may help reduce itching and associated sleep loss Not recommended due to lack of evidence Omalizumab Oral calcineurin inhibitors Sidbury R, et al. J Am Acad Dermatol. 2014;71:327-49 Schmitt J, et al. Br J Dermatol. 2010;162:661-8 Heil PM, et al. J Dtsch Dermatol Ges. 2010;8:990-8 Phototherapy May be combined with moisturizers and TCS Multiple forms of phototherapy available Ultraviolet A1 (UVA1) and narrowband ultraviolet B (NB-UVB) both showed improved SASSAD scores in crossover study Adverse effects Common: local erythema, pruritus, burning, stinging Less common: skin cancer, skin eruptions, folliculitis, herpes simplex virus reactivation Sidbury R, et al. J Am Acad Dermatol. 2014;71:327-49 Gambichler T, et al. Br J Dermatol. 2009;160:652-8 Avoid triggers Preventative Measures Consider food allergy evaluation for children <5 years of age with moderate to severe disease if Atopic dermatitis persists despite optimal treatment History of immediate food reaction Education and psychological interventions Cognitive therapy and stress management programs may help reduce itching Preventative Measures (continued) Limited evidence to support use of Probiotics/prebiotics Fish oil, evening primrose oil, zinc, vitamin supplements House dust mite covers Specific laundering practices Specialized clothing fabrics Chinese herbal therapy Sidbury R, et al. J Am Acad Dermatol. 2014;71:1218-33 Sidbury R, et al. J Am Acad Dermatol. 2014;71:1218-33 8
Summary Environmental and genetic factors lead to skin barrier disruption and immune dysregulation Avoid triggers Moisturize TCS and TCI are effective for treatment and prevention Systemic treatments, including immunomodulatory agents and phototherapy, may be used for refractory disease despite potentially serious adverse effects Additional Resources American Academy of Allergy, Asthma and Immunology Website: http://www.aaaai.org/ American College of Allergy, Asthma and Immunology Website: http://www.acaai.org/ American Academy of Dermatology Website: https://www.aad.org/ National Eczema Association Website: http://nationaleczema.org/ National Institute of Allergy and Infectious Diseases Website: http://www.niaid.nih.gov/ Post-Test Question 4 - Case Post-activity Audience Polling Questions Patient JD is a 25 yo M with atopic dermatitis who comes to his PCP office complaining of persistent itching in the flexural areas of the knees and elbows. The affected areas appear erythematous, excoriated, and lichenified. He reports that the symptoms are worse during extreme weather changes and also when he sweats during exercise. He has tried showering and using lotion but this has not helped to relieve his symptoms. Question and Answer Session For the Live Q&A Session Send your discussion questions to CEINFO@pharmacytimes.com 9
How to Receive Credit for Live Webinars CE credit for this live webinar will be available 48 hours after the webinar concludes Directions: 1. Go to our website www.pharmacytimes.org and log in 2. Click on the MY CE tab. This will take you to your course history page 3. Under the Manage My CE section, you will see this webinar listed 4. Click on the session that you attended and complete the activity evaluation 5. Your statement of credit will be available once you have submitted an evaluation form or Wait for an email from Pharmacy Times Office of CPE containing a link to the evaluation form and certificate. Questions? Contact us Please send all questions or comments concerning this webinar to: CEINFO@pharmacytimes.com, the official email of Pharmacy Times Office of CPE. All emails sent to this address will be answered within 24 hours in the order that they are received. NOTE: You must submit your evaluation form by February 5, 2015 in order to receive CE credit. For the Live Q&A Session Send your discussion questions to CEINFO@pharmacytimes.com Thank you! We hope you enjoyed the webinar. Pharmacy Times Office of CPE is a leader in education for retail, specialty, managed care, and health-system pharmacists. Visit us at www.pharmacytimes.org for continuing education at its best! 10