1 Dermatologic and Ophthalmic Drugs Advisory Dermatologic and Ophthalmic Drugs Advisory Committee Committee July 12, 2004 July 12, 2004 Introduction to Introduction to Psoriasis Psoriasis Denise Cook, M.D. Medical Officer Division of Dermatology and Dental Drug Products
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Introduction to Psoriasis Introduction to Psoriasis
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1Dermatologic and Ophthalmic Drugs Advisory Committee Dermatologic and Ophthalmic Drugs Advisory Committee July 12, 2004July 12, 2004
Introduction to PsoriasisIntroduction to PsoriasisIntroduction to PsoriasisIntroduction to Psoriasis
Denise Cook, M.D.Medical Officer
Division of Dermatology and Dental Drug Products
Denise Cook, M.D.Medical Officer
Division of Dermatology and Dental Drug Products
2Dermatologic and Ophthalmic Drugs Advisory Committee Dermatologic and Ophthalmic Drugs Advisory Committee July 12, 2004July 12, 2004
Introduction to PsoriasisIntroduction to PsoriasisIntroduction to PsoriasisIntroduction to Psoriasis
• Prevalence• Genetics and Pathogenesis• Clinical Variants of Psoriasis• State of the Armamentarium
• Prevalence• Genetics and Pathogenesis• Clinical Variants of Psoriasis• State of the Armamentarium
3Dermatologic and Ophthalmic Drugs Advisory Committee Dermatologic and Ophthalmic Drugs Advisory Committee July 12, 2004July 12, 2004
PrevalencePrevalencePrevalencePrevalence
• Psoriasis occurs in 2% of the world’s population
• Prevalence in the U.S may be as high as 4.6%
• Highest in Caucasians• In Africans, African Americans and
Asians between 0.4% and 0.7%
• Psoriasis occurs in 2% of the world’s population
• Prevalence in the U.S may be as high as 4.6%
• Highest in Caucasians• In Africans, African Americans and
Asians between 0.4% and 0.7%
4Dermatologic and Ophthalmic Drugs Advisory Committee Dermatologic and Ophthalmic Drugs Advisory Committee July 12, 2004July 12, 2004
PrevalencePrevalencePrevalencePrevalence
• Equal frequency in males and females
• May occur at any age from infancy to the 10th decade of life
• First signs of psoriasis–Females mean age of 27 years–Males mean age of 29 years
• Equal frequency in males and females
• May occur at any age from infancy to the 10th decade of life
• First signs of psoriasis–Females mean age of 27 years–Males mean age of 29 years
5Dermatologic and Ophthalmic Drugs Advisory Committee Dermatologic and Ophthalmic Drugs Advisory Committee July 12, 2004July 12, 2004
PrevalencePrevalencePrevalencePrevalence
• Two Peaks of Occurrence–One at 20-30 years–One at 50-60 years
• Psoriasis in children–Low – between 0.5 and 1.1% in
children 16 years old and younger–Mean age of onset - between 8 and
12.5 years
• Two Peaks of Occurrence–One at 20-30 years–One at 50-60 years
• Psoriasis in children–Low – between 0.5 and 1.1% in
children 16 years old and younger–Mean age of onset - between 8 and
12.5 years
6Dermatologic and Ophthalmic Drugs Advisory Committee Dermatologic and Ophthalmic Drugs Advisory Committee July 12, 2004July 12, 2004
PrevalencePrevalencePrevalencePrevalence
• Two-thirds of patients have mild disease• One-third have moderate to severe disease• Early onset (prior to age 15)– Associated with more severe disease– More likely to have a positive family history
• Life-long disease– Remitting and relapsing unpredictably– Spontaneous remissions of up to 5 years have
been reported in approximately 5% of patients
• Two-thirds of patients have mild disease• One-third have moderate to severe disease• Early onset (prior to age 15)– Associated with more severe disease– More likely to have a positive family history
• Life-long disease– Remitting and relapsing unpredictably– Spontaneous remissions of up to 5 years have
been reported in approximately 5% of patients
7Dermatologic and Ophthalmic Drugs Advisory Committee Dermatologic and Ophthalmic Drugs Advisory Committee July 12, 2004July 12, 2004
Genetics and PathogenesisGenetics and PathogenesisGenetics and PathogenesisGenetics and Pathogenesis
• Psoriasis and the Immune System– The major histocompatibility complex
• May be widespread – up to 90% BSA• Genitalia involved in up to 30% of patients• Most patients have nail changes– Nail pitting– “Oil Spots”– Involvement of the entire nail bed• Onychodystrophy• Loss of nail plate
• May be widespread – up to 90% BSA• Genitalia involved in up to 30% of patients• Most patients have nail changes– Nail pitting– “Oil Spots”– Involvement of the entire nail bed• Onychodystrophy• Loss of nail plate
18Dermatologic and Ophthalmic Drugs Advisory Committee Dermatologic and Ophthalmic Drugs Advisory Committee July 12, 2004July 12, 2004
20Dermatologic and Ophthalmic Drugs Advisory Committee Dermatologic and Ophthalmic Drugs Advisory Committee July 12, 2004July 12, 2004
Psoriasis of the NailPsoriasis of the NailPsoriasis of the NailPsoriasis of the Nail
21Dermatologic and Ophthalmic Drugs Advisory Committee Dermatologic and Ophthalmic Drugs Advisory Committee July 12, 2004July 12, 2004
Psoriasis of the NailPsoriasis of the NailPsoriasis of the NailPsoriasis of the Nail
22Dermatologic and Ophthalmic Drugs Advisory Committee Dermatologic and Ophthalmic Drugs Advisory Committee July 12, 2004July 12, 2004
Symptoms of Chronic Plaque Symptoms of Chronic Plaque PsoriasisPsoriasis
Symptoms of Chronic Plaque Symptoms of Chronic Plaque PsoriasisPsoriasis
• Pruritus• Pain• Excessive heat loss• Patient Complaints–Unsightliness of the lesions–Low self-esteem–Feelings of being socially outcast–Excessive scale
• Pruritus• Pain• Excessive heat loss• Patient Complaints–Unsightliness of the lesions–Low self-esteem–Feelings of being socially outcast–Excessive scale
23Dermatologic and Ophthalmic Drugs Advisory Committee Dermatologic and Ophthalmic Drugs Advisory Committee July 12, 2004July 12, 2004
• Additional Indications– 0.1% gel - approved for the treatment of
facial acne vulgaris of mild to moderate severity
– 0.1% cream approved as an adjunctive agent for use in the mitigation of facial fine wrinkling, facial mottled hyper- and hypopigmentation, and benign facial lentigines in patients who use comprehensive skin care and sunlight avoidance programs
• Additional Indications– 0.1% gel - approved for the treatment of
facial acne vulgaris of mild to moderate severity
– 0.1% cream approved as an adjunctive agent for use in the mitigation of facial fine wrinkling, facial mottled hyper- and hypopigmentation, and benign facial lentigines in patients who use comprehensive skin care and sunlight avoidance programs
40Dermatologic and Ophthalmic Drugs Advisory Committee Dermatologic and Ophthalmic Drugs Advisory Committee July 12, 2004July 12, 2004
• Nursing mothers• Patients with alcoholism• Alcoholic liver disease• Other chronic liver disease• Patients with overt or laboratory evidence
of immunodeficiency syndromes• Patients who have preexisting blood
dyscrasias
• Nursing mothers• Patients with alcoholism• Alcoholic liver disease• Other chronic liver disease• Patients with overt or laboratory evidence
of immunodeficiency syndromes• Patients who have preexisting blood
dyscrasias
49Dermatologic and Ophthalmic Drugs Advisory Committee Dermatologic and Ophthalmic Drugs Advisory Committee July 12, 2004July 12, 2004
MethotrexateMethotrexateMethotrexateMethotrexate
• Pregnancy Category X drug product– Contraindicated in pregnant women
with psoriasis– Pregnancy must be excluded in women
of childbearing potential– Pregnancy should be avoided if either
partner is receiving MTX during and for a minimum of 3 months after therapy for male patients and for at least one ovulatory cycle after therapy for female patients
• Pregnancy Category X drug product– Contraindicated in pregnant women
with psoriasis– Pregnancy must be excluded in women
of childbearing potential– Pregnancy should be avoided if either
partner is receiving MTX during and for a minimum of 3 months after therapy for male patients and for at least one ovulatory cycle after therapy for female patients
50Dermatologic and Ophthalmic Drugs Advisory Committee Dermatologic and Ophthalmic Drugs Advisory Committee July 12, 2004July 12, 2004
Methotrexate – Side EffectsMethotrexate – Side EffectsMethotrexate – Side EffectsMethotrexate – Side Effects
• Acute or chronic hepatotoxicity• Hepatic cirrhosis• Leukopenia• Thrombocytopenia• Anemia, including aplastic anemia• Rarely, interstitial pneumonitis• Stomatitis• Nausea/vomiting• Alopecia• Photosensitivity• Burning of skin lesions
• Acute or chronic hepatotoxicity• Hepatic cirrhosis• Leukopenia• Thrombocytopenia• Anemia, including aplastic anemia• Rarely, interstitial pneumonitis• Stomatitis• Nausea/vomiting• Alopecia• Photosensitivity• Burning of skin lesions
51Dermatologic and Ophthalmic Drugs Advisory Committee Dermatologic and Ophthalmic Drugs Advisory Committee July 12, 2004July 12, 2004
MethotrexateMethotrexateMethotrexateMethotrexate
• Multiple prescreening tests necessary• Recommendations for hepatic monitoring– Periodic LFTs including serum albumin– Liver biopsy• Pretherapy or shortly thereafter• Cumulative dose of 1.5 grams• After each additional 1.0 to 1.5 grams
• Multiple prescreening tests necessary• Recommendations for hepatic monitoring– Periodic LFTs including serum albumin– Liver biopsy• Pretherapy or shortly thereafter• Cumulative dose of 1.5 grams• After each additional 1.0 to 1.5 grams
52Dermatologic and Ophthalmic Drugs Advisory Committee Dermatologic and Ophthalmic Drugs Advisory Committee July 12, 2004July 12, 2004
• Concomitant PUVA or UVB therapy• Methotrexate or other immunosuppressive
agents• Coal tar or radiation therapy• Patients with abnormal renal function• Patients with uncontrolled hypertension• Patients with malignancies• Nursing mothers
• Concomitant PUVA or UVB therapy• Methotrexate or other immunosuppressive
agents• Coal tar or radiation therapy• Patients with abnormal renal function• Patients with uncontrolled hypertension• Patients with malignancies• Nursing mothers
54Dermatologic and Ophthalmic Drugs Advisory Committee Dermatologic and Ophthalmic Drugs Advisory Committee July 12, 2004July 12, 2004
Neoral – Side EffectsNeoral – Side EffectsNeoral – Side EffectsNeoral – Side Effects