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Guidelines

Guidelines Summary

The American Academy of Dermatology has published guidelines of care for the management of psoriasis and psoriatic arthritis. See the following sections:

Section 1. Overview of psoriasis and guidelines of care for the treatment of psoriasis with biologics^[49]
Section 2. Psoriatic arthritis: overview and guidelines of care for treatment with an emphasis on the biologics^[50]
Section 3. Guidelines of care for the management and treatment of psoriasis with topical therapies^[51]
Section 4. Guidelines of care for the management and treatment of psoriasis with traditional systemic agents^[52]
Section 5. Guidelines of care for the treatment of psoriasis with phototherapy and photochemotherapy^[53]
Section 6. Guidelines of care for the treatment of psoriasis and psoriatic arthritis: Case-based presentations and evidence-based conclusions^[54]

General Clinical Practice Guidelines

Guidelines on the management and treatment of psoriasis with topical and alternative therapies, nonbiologic therapies, phototherapy, and biologic therapies

Guidelines on the management and treatment of psoriasis with topical and alternative therapies, nonbiologic therapies, phototherapy, and biologic therapies were published in February 2021 by the American Academy of Dermatology and the National Psoriasis Foundation in the Journal of the American Academy of Dermatology.^[55]

Topical and alternative treatments

Topical therapies, tools to assess the severity of psoriasis, and alterative/complementary medicines are addressed, as follows:

Topical corticosteroids - Recommended for plaque psoriasis in nonintertriginous areas
Steroid-sparing agents (eg, vitamin D analogs, tazarotene, and calcineurin inhibitors, alone or in combination with steroids) - Confer lower risk of steroid-induced adverse effects; alternate use with steroids is key to long-term management
Other topical agents (eg, salicylic acid, emollients, anthralin, coal tar) - Can be use alone or in combination with topical steroids
Topicals combined with biologic or systemic therapies - Help increase overall efficacy of therapy
Severity measurement tools - Physician’s Global Assessment and body surface area (clinical practice); Psoriasis Area Severity Index (clinical trials); Dermatology Life Quality Index, Psoriasis Symptom Inventory, and pruritus assessment (subjective symptoms and quality of life)
Alternative medicines and complementary therapies (no recommendations, owing to lack of evidence) - Traditional Chinese medicine, herbal therapies (eg, aloe vera, St. John’s wort), diet/dietary supplements (eg, fish oil, vitamin D, turmeric/curcumin, zinc, gluten-free diet), body/mind interventions (eg, hypnosis, stress reduction, meditation)

Nonbiological therapies

Methotrexate - Moderate-to-severe psoriasis in adults
Apremilast - Moderate-to-severe psoriasis in adults
Cyclosporine - Severe, recalcitrant psoriasis; in addition, erythrodermic, generalized pustular psoriasis and/or palmoplantar psoriasis
Acitretin - Monotherapy or combination therapy with PUVA or UVB
Other nonbiologics (not FDA-approved for psoriasis) - Tofacitinib, hydroxyurea, mycophenolate mofetil, azathioprine, leflunomide, tacrolimus, and thioguanine

Phototherapy

Narrowband UVB
Broadband UVB
Targeted UVB - Excimer laser, excimer light, targeted narrowband UVB light
PUVA - Topical, oral, bath
Photodynamic therapy
Grenz ray
Climatotherapy
Visible light
Goeckerman therapy (not a form of phototherapy)
Pulsed dye laser

Biological medications

TNF inhibitors - Etanercept (4/30/2004), infliximab (9/27/2006), adalimumab (1/22/2008), certolizumab (5/27/2018)
IL-12/IL-23 inhibitor - Ustekinumab (9/25/2009)
IL-17 inhibitors - Secukinumab (1/21/2015), ixekizumab (3/22/2016), brodalumab (2/15/2017)
IL-23 inhibitors - Guselkumab (7/13/2017), tildrakizumab (3/21/2018), risankizumab (pending)

Clinical Practice Guidelines on Biologic Therapy for Psoriasis

Guidelines on psoriasis biologic therapy from the British Association of Dermatologists ^[56]

Offer biologic therapy to people with psoriasis who require systemic therapy if methotrexate and cyclosporine have failed; if these agents are not tolerated or are contraindicated; and if the psoriasis has a large impact on physical, psychological, or social functioning (eg, Dermatology Life Quality Index [DLQI] or Children's DLQI score >10 or clinically relevant depressive or anxiety symptoms) and one or more of the following disease severity criteria apply:

Psoriasis is extensive (defined as body surface area [BSA] >10% or PASI ≥10)
Psoriasis is severe at localized sites and associated with significant functional impairment and/or high levels of distress (eg, nail disease or involvement of high-impact and difficult-to-treat sites such as the face, scalp, palms, soles, flexures, and genitals)

Consider biologic therapy earlier in the treatment plan (eg, if methotrexate has failed, is not tolerated, or is contraindicated) in people with psoriasis who fulfill the disease severity criteria and who also have active psoriatic arthritis or who have psoriasis that is persistent (ie, that relapses rapidly, defined as >50% baseline disease severity within 3 mo of completion of any treatment) while not on a therapy that cannot be continued in the long term (eg, narrow-band UVB).

Assess whether the minimal response criteria have been met, which are defined by the following:

Fifty percent or greater reduction in baseline disease severity (eg, PASI 50 response, or percentage BSA where PASI is not applicable) and
Clinically relevant improvement in physical, psychological, or social functioning (eg, ≥4-point improvement in DLQI or resolution of low mood)

Specific agents should be used as follows:

Ustekinumab: Offer ustekinumab as a first-line biologic agent to adults with psoriasis who fulfil the criteria for biologic therapy.
Adalimumab: Offer adalimumab as a first-line biologic agent to adults with psoriasis, particularly when psoriatic arthropathy is a consideration.
Secukinumab: Consider secukinumab as a first-line biologic agent in adults with psoriasis, with or without psoriatic arthritis.
Infliximab: Reserve infliximab for use in people with very severe disease or people in whom other available biologic agents have failed or cannot be used.
Others: Offer adalimumab (age ≥4 y), etanercept (≥6 y), or ustekinumab (≥12 y) to children and young people who fulfill the criteria for biologic therapy.

Advise women of childbearing potential who are starting biologic therapy for psoriasis to use effective contraception and discuss conception plans with the consultant supervising their care. There are no known interactions between biologic therapies and contraceptive methods.

Advise mothers who have received biologic therapy for psoriasis beyond 16 weeks' gestation that their infants should not receive any live vaccinations until they have reached age 6 months (eg, rotavirus and BCG). Do not give live vaccines to people on biologic therapy or to infants (up to age 6 mo) whose mothers have received biologic therapy beyond 16 weeks' gestation. Stop biologic therapy for at least 6 months before giving live vaccines and for 12 months in the case of the shingles (herpes zoster) vaccine. In general, biologic therapy can be started 4 weeks after administration of a live vaccine. Whenever possible, complete all required vaccinations prior to the initiation of biologic therapy, and review vaccination requirements during therapy with reference to the Green Book and the clinical risk category of “immunosuppression.”

Do not use TNF antagonists in people with demyelinating diseases, and review alternative interventions in people who have an affected first-degree relative with demyelinating disease. Stop treatment and seek specialist advice if neurologic symptoms suggestive of demyelinating disease develop during TNF antagonist therapy. Symptoms include loss or reduction of vision in one eye with painful eye movements; double vision; ascending sensory disturbance and/or weakness; problems with balance, unsteadiness, or clumsiness; and altered sensation traveling down the back and sometimes into the limbs when bending the neck forward.

Avoid TNF antagonist therapy in people with severe cardiac failure. Stop TNF antagonist therapy in the event of new or worsening preexisting heart failure and seek specialist advice.

Exercise caution and consult a gastroenterology specialist before using secukinumab or ixekizumab in people with inflammatory bowel disease.

Guidelines on the management and treatment of psoriasis with biologics by the American Academy of Dermatology and the National Psoriasis Foundation ^[57]

TNF-alpha inhibitors

Etanercept recommendations are as follows:

Monotherapy treatment option for adults with moderate-to-severe plaque psoriasis
Recommended starting dose of 50 mg; self-administered SC injection twice weekly for 12 consecutive weeks
Recommended maintenance dose of 50 mg once weekly; 50 mg twice weekly is more efficacious than once weekly and may be required for better disease control in some patients
Recommended as monotherapy option in adults with moderate-to-severe plaque psoriasis affecting the scalp or nails
Can be recommended as monotherapy option for adults with other subtypes (ie, pustular, erythrodermic) of moderate-to-severe plaque psoriasis
Recommended monotherapy option in adults with plaque psoriasis of any severity when associated with significant psoriatic arthritis
Recommended combination treatment option with topicals (eg, high-potency corticosteroids with or without a vitamin D analogue) to augment treatment of moderate-to-severe plaque psoriasis
Recommended combination treatment option with methotrexate for moderate-to-severe plaque psoriasis in adults
May be combined with acitretin, apremilast, cyclosporine, or narrowband ultraviolet phototherapy for moderate-to-severe plaque psoriasis in adults

Infliximab recommendations are as follows:

Monotherapy treatment option for adults with moderate-to-severe plaque psoriasis
Recommended starting dose is an infusion of 5 mg/kg administered at week 0, week 2, and week 6; thereafter, administered every 8 weeks
Recommended to be administered at more frequent intervals (less than q8wk and as frequently as q4wk during maintenance phase) and/or at a higher dose (up to 10 mg/kg) for better disease control in some adults
Recommended as monotherapy option for moderate-to-severe plaque psoriasis affecting the palms and soles (plaque-type palmoplantar psoriasis), nails, or scalp in adults
Can be recommended as monotherapy option in adults with other subtypes (ie, pustular, erythrodermic) of moderate-to-severe plaque psoriasis
Recommended as monotherapy option in adults with plaque psoriasis of any severity when associated with significant psoriatic arthritis; it also inhibits radiographically detected joint damage in psoriatic arthritis
Recommended combination treatment option with topicals (eg, high-potency corticosteroids with or without a vitamin D analogue) to augment treatment of moderate-to-severe plaque psoriasis
May be combined with acitretin, methotrexate, or apremilast for moderate-to-severe plaque psoriasis in adults

Adalimumab recommendations are as follows:

Monotherapy treatment option for adults with moderate-to-severe plaque psoriasis
Recommended starting dose of 80 mg taken as two self-administered SC 40-mg injections, followed by a 40-mg self-administered SC injection 1 week later, followed by 40-mg self-administered SC injections every 2 weeks thereafter
Maintenance dose of 40 mg/wk recommended for better disease control in some patients
Recommended as monotherapy option for adults with moderate-to-severe plaque psoriasis affecting the palms and soles (palmoplantar psoriasis), nails, or scalp
Can be recommended as monotherapy option for adults patients with other subtypes (ie, pustular, erythrodermic) of moderate-to-severe psoriasis
Recommended as monotherapy option in adults with plaque psoriasis of any severity when associated with psoriatic arthritis
Can be recommended combination treatment option with topicals (eg, high-potency corticosteroids with or without a vitamin D analogue) to augment treatment of moderate-to-severe plaque psoriasis
May be combined with acitretin, methotrexate, apremilast, cyclosporine, or narrowband ultraviolet phototherapy for moderate-to-severe plaque psoriasis in adults

Certolizumab has been approved by the FDA for the treatment of plaque psoriasis, psoriatic arthritis, Crohn disease, ankylosing spondylitis, and rheumatoid arthritis. Approved dosing for moderate-to-severe psoriasis is 400 mg (two 200-mg SC injections) every other week. It is likely to possess class characteristics similar to those of other TNF-alpha inhibitors.

Interleukin-12/23 inhibitors

Ustekinumab recommendations are as follows:

Monotherapy treatment option for adults with moderate-to-severe plaque psoriasis
Recommended starting doses: (1) patients weighing 100 kg or less, 45 mg SC initially and 4 weeks later, followed by 45 mg administered SC every 12 weeks; (2) patients weighing more than 100 kg, 90 mg administered SC initially and 4 weeks later, followed by 90 mg administered SC every 12weeks
Recommended alternate dosages are higher doses (90 mg instead of 45 mg in patients weighing ≥100 kg) or with greater frequency (eg, every 8 wk in maintenance phase) if response to standard dosing is inadequate
Can be used as monotherapy option for adults with moderate-to-severe plaque psoriasis affecting the palms and soles (plaque-type palmoplantar psoriasis), nails, or scalp
Can be used as monotherapy option for adults with other subtypes (ie, pustular, erythrodermic) of moderate-to-severe psoriasis; evidence is limited for use in inverse and guttate psoriasis
Recommended as monotherapy option in adults with plaque psoriasis of any severity when associated with psoriatic arthritis
Can be recommended combination treatment option with topicals (eg, high-potency corticosteroids with or without a vitamin D analogue) to augment treatment of moderate-to-severe plaque psoriasis
May be combined with acitretin, methotrexate, apremilast, cyclosporine, or narrowband ultraviolet phototherapy for moderate-to-severe plaque psoriasis in adults

Interleukin-17 inhibitors

Secukinumab recommendations are as follows:

Monotherapy treatment option in adults with moderate-to-severe plaque psoriasis
Recommended starting dose of 300 mg by self-administered SC injection at week 0, week 1, week 2, week 3, and week 4, followed by 300 mg every 4 weeks
Recommended maintenance dose of 300 mg every 4 weeks
Recommended dose of 300 mg is more effective than 150 mg
Can be recommended as monotherapy in adults with moderate-to-severe plaque psoriasis affecting the head and neck (including the scalp) or nails
Recommended as monotherapy option in adults with moderate-to-severe palmoplantar plaque psoriasis
Can be recommended as monotherapy option in adults with moderate-to-severe palmoplantar pustulosis
Can be used as monotherapy in adults with erythrodermic psoriasis
May be used as monotherapy in adults with plaque psoriasis when associated with psoriatic arthritis

Ixekizumab recommendations are as follows:

Monotherapy treatment option for adults with moderate-to-severe plaque psoriasis
Recommended starting dose of 160 mg by self-administered SC injection, followed by 80 mg at week 2, week 4, week 6, week 8, week 10, and week 12
Recommended maintenance dose of 80 mg every 4 weeks
Can be recommended as monotherapy option in adults with moderate-to-severe plaque psoriasis affecting the scalp or nails
Can be recommended as monotherapy option in adults with erythrodermic psoriasis or generalized pustular psoriasis
Recommended as monotherapy option in adults with plaque psoriasis when associated with psoriatic arthritis

Brodalumab recommendations are as follows:

Recommended as monotherapy treatment option in adults with moderate-to-severe plaque psoriasis
Can be used as monotherapy option in adults with generalized pustular psoriasis
Recommended dose of 210 mg by self-administered SC injection at week 0, week 1, and week 2, followed by 210 mg every 2 weeks

Interleukin-23 inhibitors

Guselkumab recommendations are as follows:

Recommended as monotherapy treatment option for adults with moderate-to-severe plaque psoriasis
Recommended dose of 100 mg by self-administered SC injection at week 0 and week 4, followed by every 8 weeks thereafter
Recommended as monotherapy option in adults with scalp, nail, or plaque-type palmoplantar psoriasis

Tildrakizumab recommendations are as follows:

Recommended as monotherapy treatment option in adults with moderate-to-severe plaque psoriasis
Recommended dose of 100 mg given in office by physician-administered SC injection at week 0 and week 4, followed by every 12 weeks thereafter

Risankizumab was approved by the FDA in April 2019. It can be used as monotherapy in adults with moderate-to-severe plaque psoriasis. A suggested dose is 150 mg given by self-administered subcutaneous injections at week 0 and week 4, followed by every 12 weeks.

Clinical Practice Guidelines on Phototherapy for Psoriasis

Guidelines on the m anagement and treatment of psoriasis with phototherapy from the American Academy of Dermatology and the National Psoriasis Foundation ^[58]

Narrowband ultraviolet B phototherapy

Phototherapy using narrowband ultraviolet B (NB-UVB) is recommended as monotherapy for adults with plaque psoriasis.

For adults with generalized plaque psoriasis, the recommended NB-UVB phototherapy starting dose should be based on the minimal erythema dose or it should be determined based on a fixed-dose or skin-phototype protocol.

For adults with generalized plaque psoriasis, a treatment phase of thrice-weekly dosing of NB-UVB phototherapy is recommended.

For adults with psoriasis, treatment with short-term psoralen plus ultraviolet A (PUVA) monotherapy is more effective than NB-UVB.

Owing to its increased safety, higher convenience, and lower cost, NB-UVB is preferred over PUVA monotherapy for psoriasis in adults, even though it is less effective.

In adults with generalized plaque psoriasis, NB-UVB is recommended over broadband ultraviolet B (BB-UVB) monotherapy.

Treatment with NB-UVB monotherapy is recommended for guttate psoriasis patients, regardless of their age.

For appropriate patients with generalized plaque psoriasis, home-based NB-UVB phototherapy is recommended as an alternative to in-office NB-UVB phototherapy.

Treatment with NB-UVB phototherapy is recommended for pregnant patients who have guttate psoriasis or generalized plaque psoriasis.

As a measure to possibly improve efficacy, NB-UVB phototherapy can be safely augmented with concomitant topical therapy using retinoids, vitamin D analogues, and corticosteroids.

Oral retinoids can be combined with NB-UVB phototherapy in appropriate patients with generalized plaque psoriasis if they have not responded adequately to monotherapy.

Owing to an increased risk of developing skin cancer, long-term combination therapy with NB-UVB and cyclosporine is not recommended for adults with generalized plaque psoriasis.

Apremilast combined with NB-UVB phototherapy can be considered for adult patients with generalized plaque psoriasis if they have not responded adequately to monotherapy.

To reduce the risk of genital skin cancer, all patients receiving NB-UVB phototherapy should be provided genital shielding.

To reduce the risk of ocular toxicity, all patients receiving NB-UVB phototherapy should be provided eye protection with goggles.

Owing to the risk of photocarcinogenesis, use caution when administering NB-UVB phototherapy to patients with a history of melanoma or multiple nonmelanoma skin cancers, arsenic intake, or prior exposure to ionizing radiation.

Folate supplementation is recommended for females of childbearing age who are receiving NB-UVB phototherapy.

To maintain the clinical response from NB-UVB phototherapy, maintenance therapy can be considered.

BB-UVB phototherapy

In adults with generalized plaque psoriasis, BB-UVB phototherapy is recommended as monotherapy if NB-UVB is not available.

In adults with generalized plaque psoriasis, BB-UVB monotherapy is considered less efficacious than NB-UVB or oral PUVA monotherapy.

Monotherapy with BB-UVB may be considered for adults with guttate psoriasis.

To reduce the risk of genital skin cancer, all patients being offered BB-UVB phototherapy should be provided with genital shielding.

To reduce the risk of ocular toxicity, all patients receiving BB-UVB phototherapy should be provided eye protection with goggles.

Owing to the risk of photocarcinogenesis, use caution when administering BB-UVB phototherapy to patients with a history of melanoma or multiple nonmelanoma skin cancers, arsenic intake, or prior exposure to ionizing radiation.

Combination therapy with acitretin and BB-UVB can be considered in adults with generalized plaque psoriasis.

Targeted UVB phototherapy

The recommended targeted UVB phototherapy for adults with localized plaque psoriasis (< 10% body surface area), for individual plaque psoriasis lesions, or for patients with more extensive disease includes excimer 308-nm laser, excimer 308-nm light, and targeted NB-UVB 311- to 313-nm light.

For maximal efficacy, the recommended treatment frequency for targeted UVB phototherapy in adults with localized plaque psoriasis is 2-3 times per week, rather than once every 1-2 weeks.

In adults with localized plaque psoriasis, the initial dose of targeted UVB phototherapy is based on the minimal erythema dose or by a fixed-dose or skin-phototype protocol.

For treating localized plaque psoriasis in adults, the most effective targeted UVB phototherapy is excimer 308-nm laser, followed by excimer 308-nm light, followed by localized NB-UVB 311- to 312-nm light.

For adults with plaque psoriasis (including palmoplantar psoriasis), a recommended targeted UVB phototherapy includes excimer 308-nm laser and excimer 308-nm light.

Treatment of plaque psoriasis in adults with excimer 308-nm laser may be combined with topical steroid therapy.

A recommended targeted UVB phototherapy treatment for adults with scalp psoriasis is excimer 308-nm laser.

PUVA therapy

In the treatment of localized plaque psoriasis in adults, particularly those with palmoplantar psoriasis or palmoplantar pustular psoriasis, topical phototherapy with PUVA is deemed superior to NB-UVB 311- to 313-nm light.

A recommended treatment for psoriasis in adults is oral PUVA.

A recommended treatment for moderate-to-severe psoriasis in adults is bath PUVA.

Photodynamic therapy

Photodynamic therapy with either aminolevulinic acid or methyl aminolevulinate is not recommended for adults with localized psoriasis, including the palmoplantar variety or nail psoriasis.

Grenz ray, climatotherapy, visible light, Goeckerman, and pulsed-dye laser therapies

Evidence is insufficient to recommend grenz ray therapy (long-wavelength ionizing radiation) for the treatment of psoriasis.

Sufficient evidence exists to recommend climatotherapy (temporary or permanent relocation geographically) for the treatment of psoriasis.

Evidence is insufficient to recommend the use of visible light (blue or red) as a more effective treatment for psoriasis, except in nail psoriasis.

Sufficient evidence exists to recommend Goeckerman therapy (coal tar in combination with UVB phototherapy) for the treatment of psoriasis.

Pulsed-dye laser can be considered for nail psoriasis.

Medication

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Media Gallery

Plaque psoriasis. Courtesy of University of British Columbia, Department of Dermatology and Skin Science.
Plaque psoriasis. Courtesy of University of British Columbia, Department of Dermatology and Skin Science.
Plaque psoriasis. Photomicrograph of psoriasis. (1) Hyperkeratosis and parakeratosis, (2) neutrophils in the epidermis, (3) thinning of the epidermis overlying the dermal papillae, (4) vessels close to the epidermis, and (5) elongated rete ridges. Courtesy of Richard Crawford, MD, University of British Columbia, Department of Dermatology and Skin Science.

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Author

Harvey Lui, MD, FRCPC Professor and Head, Department of Dermatology and Skin Science, Vancouver General Hospital, University of British Columbia; Medical Director, The Skin Centre, Lions Laser Skin Centre and Psoriasis and Phototherapy Clinic, Vancouver General Hospital

Harvey Lui, MD, FRCPC is a member of the following medical societies: Canadian Medical Association, American Society for Photobiology, Photomedicine Society, European Academy of Dermatology and Venereology, National Psoriasis Foundation, Canadian Dermatology Association, College of Physicians and Surgeons of British Columbia, North American Hair Research Society, Canadian Dermatology Foundation, American Academy of Dermatology, American Society for Laser Medicine and Surgery

Disclosure: Received consulting fee from Astellas for review panel membership; Received consulting fee from Amgen/Wyeth for speaking and teaching; Received honoraria from LEO Pharma for speaking and teaching; Received grant/research funds from LEO Pharma for investigator; Received grant/research funds from Galderma for other.

Coauthor(s)

Adam J Mamelak, MD, FRCPC Attending Physician, Division of Dermatology, The Ottawa Hospital, University of Ottawa

Adam J Mamelak, MD, FRCPC is a member of the following medical societies: American Academy of Dermatology, American College of Mohs Surgery, American Society for Dermatologic Surgery, Canadian Dermatology Association

Disclosure: Nothing to disclose.

Specialty Editor Board

Richard P Vinson, MD Assistant Clinical Professor, Department of Dermatology, Texas Tech University Health Sciences Center, Paul L Foster School of Medicine; Consulting Staff, Mountain View Dermatology, PA

Richard P Vinson, MD is a member of the following medical societies: American Academy of Dermatology, Texas Medical Association, Association of Military Dermatologists, Texas Dermatological Society

Disclosure: Nothing to disclose.

Christen M Mowad, MD Professor, Department of Dermatology, Geisinger Medical Center

Christen M Mowad, MD is a member of the following medical societies: Alpha Omega Alpha, Noah Worcester Dermatological Society, Pennsylvania Academy of Dermatology, American Academy of Dermatology, Phi Beta Kappa

Disclosure: Nothing to disclose.

Chief Editor

Dirk M Elston, MD Professor and Chairman, Department of Dermatology and Dermatologic Surgery, Medical University of South Carolina College of Medicine

Dirk M Elston, MD is a member of the following medical societies: American Academy of Dermatology

Disclosure: Nothing to disclose.

Additional Contributors

Mark G Lebwohl, MD Chairman, Department of Dermatology, Mount Sinai School of Medicine

Mark G Lebwohl, MD is a member of the following medical societies: American Academy of Dermatology

Disclosure: Received none from Amgen for consultant & investigator; Received none from Novartis for consultant & investigator; Received none from Pfizer for consultant & investigator; Received none from Celgene Corporation for consultant & investigator; Received none from Clinuvel for consultant & investigator; Received none from Eli Lilly & Co. for consultant & investigator; Received none from Janssen Ortho Biotech for consultant & investigator; Received none from LEO Pharmaceuticals for consultant & inves.