AAD consensus statement on psoriasis therapies*

FROM

THE

ACADEMY

AAD consensus statement on psoriasis therapies* Summit Planning Group: Jeffrey P. Callen, MD, Gerald G. Krueger, MD, Mark Lebwohl, MD, Elizabeth I. McBurney, MD, Philip Mease, MD, Alan Menter, MD, Amy S. Paller, MD, David M. Pariser, MD, Michael Weinblatt, MD, and Gail Zimmerman

T

his statement was developed as part of the Psoriasis Therapies Educational Summit meeting that took place in Louisville, Kentucky, November 2 and 3, 2002. The statement was developed to fill the gap between the existing Guidelines of Care document that was developed by the American Academy of Dermatology (AAD) in 1991 and its formal revision that will be developed with the use of “evidence-based” methods over the next several years. It is to be used to guide evaluation and treatment plans for patients with psoriasis and psoriatic arthritis until a new “evidence-based set of guidelines” is published. This statement should be supplemented by some excellent publications that have been recently developed by the National Psoriasis Foundation, a co-sponsor of the Summit meeting (see Suggested readings at the end of this article). This statement was developed by a subset of the attendees, led by Gerald D. Weinstein, MD, and Craig A. Elmets, MD, and subsequently has been sent for review and comment to all Summit attendees, AAD members, and members of the Ad Hoc Task Force: Psoriasis Education Initiative and the Psoriasis Therapies Educational Summit Work Group. It is not the intention here to be inclusive of all the therapies that have ever been utilized, but rather to

*A listing of all summit participants may be found at the end of this article. This document is the work product of The Psoriasis Therapies Educational Summit meeting that was held in Louisville, Ky, November 2-3, 2002. The Breakout group responsible for this document was chaired by Gerald D. Weinstein, MD, and cochaired by Craig A. Elmets, MD. Other members of this group included Irwin M. Braverman, MD, David E. Cohen, MD, Alice B. Gottlieb, MD, PhD, Richard G. B. Langley, MD, Craig L. Leonardi, MD, Alan Menter, MD, Seth J. Orlow, MD, PhD, and Guy F. Webster, MD, PhD. A first draft was presented to the entire group and the document was then circulated for comments. Reprint requests: American Academy of Dermatology, PO Box 4014, Schaumburg, IL 60168-4014. Published online August 21, 2003. J Am Acad Dermatol 2003;49:897-9. Copyright © 2003 by the American Academy of Dermatology, Inc. 0190-9622/2003/$30.00 ⫹ 0 doi:10.1067/S0190-9622(03)01870-X

use the expert opinion of those in attendance to formulate a strategy for use by practitioners. I. Diagnosis of psoriasis and psoriatic arthritis: A. Dermatologic history and physical examination: The diagnosis of psoriatic arthritis may be difficult to make. If the diagnosis is in question, collaboration with a rheumatologist may be helpful. B. Skin biopsy may be helpful. C. Identify potential precipitating causes such as drugs, stress, environment, coincidental related diseases (HIV infection or other infections, drug hypersensitivity reactions, chemical or biologic trauma) D. Laboratory tests—rheumatoid factor, C-reactive protein, erythrocyte sedimentation rate II. The therapy(ies) selected by the patient with the advice of their physician must take into account the following aspects: A. The type of psoriasis present in the patient 1. Plaque (80%-90% of patients with psoriasis) 2. Guttate psoriasis 3. Pustular psoriasis—localized versus generalized 4. Erythrodermic psoriasis 5. Palmar-plantar psoriasis 6. Psoriatic arthritis 7. Scalp psoriasis 8. Nail psoriasis 9. Inverse psoriasis B. Location of lesions: face, ears, hands, feet, genitalia and intertriginous areas, scalp, nails, trunk, extremities C. Severity of the lesions: thickness, redness, scaling D. Extent of disease, body surface area (BSA) estimates; Psoriasis Area and Severity Index (PASI) score E. Age of the patient F. Symptoms: pain, pruritus, other G. Response to previous therapies H. Accessibility to dermatologist, hospital, ultraviolet light facilities 897

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I. Therapies available to treating physician and physician preferences J. Economic factors relating to therapy options: eg, cost/benefit ratios, potential for third-party insurers to approve the plan for treatment K. Quality of life considerations: ability to perform daily activities, employability, interpersonal relationships L. Co-morbid disease/states including childbearing potential, pregnancy, desire to impregnate, liver disease, hepatitis C or HIV infection, hypertension, and alcohol intake III. Categorize into mild, moderate, or severe types A. Severity is a qualitative decision, hinging on measures of disease activity, resistance to prior therapy, and psychosocial considerations. B. Assignment of severity is based on overall judgment as determined by history, examination, and consideration of the factors above. (see II above) C. “Mild” disease, based on limited body surface area involvement, may still warrant phototherapy or systemic therapy, if not responsive to topicals or if there is disruption of daily activities and/or employment. IV. Categorize as moderate to severe disease: A. Patients needing more aggressive therapies B. BSA should not generally be used to determine which therapy to select. Patients with psoriasis of the palms, soles, head and neck, or genitalia, or with more than 5% BSA involvement may be considered to have moderate to severe disease. C. Moderate and severe disease overlap and even limited disease can be considered moderate for the purposes of selecting a therapy. D. Patients with psoriatic arthritis may have limited skin disease but require more aggressive systemic therapies. V. Therapies available: A. Plaque disease 1. Limited disease: Topical therapies a. Corticosteroids: variety of strengths, vehicles, intralesional, tape (Note: The selection of an agent depends on the location of the lesion and its severity.) b. Retinoids: tazarotene c. Vitamin D derivatives: calcipotriene d. Anthralin e. Tar preparations f. Keratolytic agents: salicylic acid, lactic acid, urea g. Lubrication products h. Combinations or sequential uses of above agents

J AM ACAD DERMATOL NOVEMBER 2003

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2. Moderate to severe psoriasis a. Phototherapy (UVB with or without topicals, with or without oral retinoids), home, office, day care center, narrowband UVB, targeted phototherapy (in rare instances patients and their physician may consider tanning bed facilities as well) b. Photochemotherapy with psoralen and UVA light (PUVA) (with or without oral retinoids) c. Methotrexate (oral, subcutaneous, or intramuscular) d. Cyclosporine (oral) e. Oral retinoids: acitretin and tazarotene* f. Etanercept (subcutaneous)*,† g. Alefacept (intramuscular or intravenous push)‡ h. Efalizumab (subcutaneous)* i. Infliximab (intravenous 2- to 3-hour infusion)* j. Combinations of above including topicals Pustular psoriasis 1. Oral retinoids: Isotretinoin or acitretin (depends on sex/age of the patient) 2. Methotrexate 3. Cyclosporine 4. Phototherapy 5. Immunobiologics may be effective 6. Hospitalization 7. Combinations Guttate psoriasis 1. Phototherapy (with or without tar) or photochemotherapy 2. Topical therapies 3. Systemic therapies as needed Erythrodermic/generalized psoriasis 1. Hospitalization 2. Cyclosporine 3. Methotrexate 4. Oral retinoids with or without phototherapy or photochemotherapy 5. Combinations Psoriatic arthritis 1. Aspirin, nonsteroidal anti-inflammatory drugs for mild disease

*Not yet approved by the Food and Drug Administration (FDA) for psoriasis. † Approved for psoriatic arthritis. ‡ Approved by the FDA for psoriasis.

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2. Sulfasalazine (more useful for joint disease than for skin disease)* 3. Methotrexate,* cyclosporine,* or azathioprine* 4. Etanercept: May prevent progression of joint disease. 5. Infliximab* VI. General treatment principles A. Goals of therapy 1. Durable remission is realistic with available therapies and occurs in perhaps as many as 40% of patients. 2. “Substantial” improvement— complete clearing is possible. 3. Maintenance therapy after initial improvement 4. To minimize significant side effects B. Methods to achieve goals of therapy 1. Monotherapy— use of a single agent 2. Combinations may improve effectiveness and allow some of the therapies that are associated with potential toxicity to be utilized at lower doses. Consider “benefit/ cost/effectiveness/safety” equation when selecting among the various therapies to combine with one another. 3. Rotational therapy: The use of therapies for a specified period (often 1-2 years) after which an alternative therapy is utilized. This strategy may minimize the long-term toxicity associated with any given therapy and decrease resistance to that therapy. 4. Sequential therapy—the use of stronger, but potentially more toxic agents to “clear” the psoriasis initially, followed by the use of a “weaker,” less toxic agent to maintain control. VII. Other issues A. For purposes of FDA approval of a new drug, the goal for studies has been a 75% improvement in the PASI score from baseline that is significantly better than placebo. However, recognize that the PASI score is an imperfect measure of the true response to therapy, and it is not reflective of the natural course of the disease. The real effectiveness for patients is judged by both the individual and physician using different scoring systems. In the future the PASI 75 should not be used as the sole criterion for regulatory agency drug approval. B. Treatment decisions should include qualityof-life considerations in selecting optimal therapies. *Not approved by the FDA for psoriatic arthritis.

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C. The dermatologist has an important role in the recognition and management of psoriatic arthritis since skin disease precedes joint involvement in the great majority of patients by up to 10 years. This may result in prevention of joint damage and/or progression of disability. However, care for the patient with psoriatic arthritis may involve collaboration with a rheumatologist, physical therapist, occupational therapist, and other health professionals. Summit participants: Elizabeth A. Abel, MD, William Abramovits, MD, Jerry Bagel, MD, Diane R. Baker, MD, David R. Bickers, MD, Andrew Blauvelt, MD, Irwin M. Braverman, MD, Mary R. Buchness, MD, Ivor Caro, MD, Fred F. Castrow II, MD, Daniel Clegg, MD, David E. Cohen, MD, MPH, Raymond L. Cornelison, Jr, MD, John J. Cush, MD, Lynn A. Drake, MD, Craig A. Elmets, MD, Marc I. Epstein, MD, Steven R. Feldman, MD, David Fiorentino, MD, PhD, Nicole Furfaro, BSN, MSN, ARNP, Dafna Gladman, MD, Bernard S. Goffe, MD, Kenneth B. Gordon, MD, Alice B. Gottlieb, MD, PhD, Francisco A. Kerdel, MD, Marisa Klein-Gitelman, MD, MPH, John Y. M. Koo, MD, Neil J. Korman, MD, PhD, James G. Krueger, MD, Richard G. B. Langley, MD, Craig L. Leonardi, MD, Marie Macor, RN, Molly Marshall, Pamela Morgan, RN, Warwick L. Morison, MD, Seth J. Orlow, MD, PhD, Elektra J. Papadopoulos, MD, Kim A. Papp, MD, PhD, Ross E. Petty, MD, PhD, Nicola Ries, Robert L. Rietschel, MD, Henry H. Roenigk, Jr, MD, Eric M. Ruderman, MD, Daniel N. Sauder, MD, Jeffrey N. Siegel, MD, Linda F. Stein, MD, Stephen P. Stone, MD, Bill Taggert, Bruce H. Thiers, MD, Guy F. Webster, MD, PhD, Gerald D. Weinstein, MD SUGGESTED READINGS Gladman DD. Psoriatic arthritis. Rheum Clin North Am 1998;24:82944. Krueger GG, Feldman SR, Camisa C, Duvic M, Elder JT, Gottlieb AB, et al. Two considerations for patients with psoriasis and their clinicians: what defines mild, moderate, and severe psoriasis? what constitutes a clinically significant improvement when treating psoriasis? J Am Acad Dermatol 2000;43:281-5. Lebwohl M, Feldman SR, Koo JYM, Menter A. Psoriasis: treatment options and patient management. Portland (OR): National Psoriasis Foundation; 2002. Mease PJ. Psoriatic arthritis/psoriasis. In: Smolen JS, Lipsky PE, editors. Targeted therapies in rheumatology. London: Martin Dunitz; 2003. p. 525-48. Menter A, editor. Psoriasis for the clinician: a new therapeutics era (“the Biologics”) beckons. J Am Acad Dermatol 2003;49(Suppl): S39-142. Menter A, Bagel J, Feldman SR. Practice management considerations for biologic therapies. Portland (OR): National Psoriasis Foundation; 2002. Weinstein GD, Gottlieb AB. Therapy for moderate-severe psoriasis. Portland (OR): National Psoriasis Foundation; 2003.