Introduction to Psoriasis Introduction to Psoriasis

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Dermatologic and Ophthalmic Drugs Advisory Committee Dermatologic and Ophthalmic Drugs Advisory Committee
July 12, 2004July 12, 2004
Introduction to PsoriasisIntroduction to Psoriasis
Denise Cook, M.D.
Medical Officer
Division of Dermatology and Dental
Drug Products

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Dermatologic and Ophthalmic Drugs Advisory Committee Dermatologic and Ophthalmic Drugs Advisory Committee
July 12, 2004July 12, 2004
Introduction to PsoriasisIntroduction to Psoriasis
•Prevalence
•Genetics and Pathogenesis
•Clinical Variants of Psoriasis
•State of the Armamentarium

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Dermatologic and Ophthalmic Drugs Advisory Committee Dermatologic and Ophthalmic Drugs Advisory Committee
July 12, 2004July 12, 2004
PrevalencePrevalence
•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%

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Dermatologic and Ophthalmic Drugs Advisory Committee Dermatologic and Ophthalmic Drugs Advisory Committee
July 12, 2004July 12, 2004
PrevalencePrevalence
•Equal frequency in males and
females
•May occur at any age from infancy to
the 10
th
decade of life
•First signs of psoriasis
–Females mean age of 27 years
–Males mean age of 29 years

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Dermatologic and Ophthalmic Drugs Advisory Committee Dermatologic and Ophthalmic Drugs Advisory Committee
July 12, 2004July 12, 2004
PrevalencePrevalence
•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

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Dermatologic and Ophthalmic Drugs Advisory Committee Dermatologic and Ophthalmic Drugs Advisory Committee
July 12, 2004July 12, 2004
PrevalencePrevalence
•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

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Dermatologic and Ophthalmic Drugs Advisory Committee Dermatologic and Ophthalmic Drugs Advisory Committee
July 12, 2004July 12, 2004
Genetics and PathogenesisGenetics and Pathogenesis
•Psoriasis and the Immune System
–The major histocompatibility complex
(MHC)
•Short arm of chromosome 6
–Histocompatibility Antigens (HLA)
•HLA-Cw6
•HLA-B13, -B17, -B37, -Bw16
–T-lymphocyte-mediated mechanism

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Dermatologic and Ophthalmic Drugs Advisory Committee Dermatologic and Ophthalmic Drugs Advisory Committee
July 12, 2004July 12, 2004
Psoriasis as a Systemic DiseasePsoriasis as a Systemic Disease
•Koebner Phenomenon
•Elevated ESR
•Increased uric acid levels → gout
•Mild anemia
•Elevated α
2
-macroglobulin
•Elevated IgA levels
•Increased quantities of Immune
Complexes

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Dermatologic and Ophthalmic Drugs Advisory Committee Dermatologic and Ophthalmic Drugs Advisory Committee
July 12, 2004July 12, 2004
Psoriasis as a Systemic DiseasePsoriasis as a Systemic Disease
•Psoriatic arthropathy
•Aggravation of psoriasis by systemic
factors
–Medication
–Focal infections
–Stress
•Life-threatening forms of psoriasis

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Dermatologic and Ophthalmic Drugs Advisory Committee Dermatologic and Ophthalmic Drugs Advisory Committee
July 12, 2004July 12, 2004
Clinical Variants of PsoriasisClinical Variants of Psoriasis

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Dermatologic and Ophthalmic Drugs Advisory Committee Dermatologic and Ophthalmic Drugs Advisory Committee
July 12, 2004July 12, 2004
Characteristic Lesion of PsoriasisCharacteristic Lesion of Psoriasis
•Sharply demarcated erythematous
plaque with micaceous silvery white
scale
•Histopathology
–Thickening of the epidermis
–Tortuous and dilated blood vessels
–Inflammatory infiltrate primarily of
lymphocytes

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Dermatologic and Ophthalmic Drugs Advisory Committee Dermatologic and Ophthalmic Drugs Advisory Committee
July 12, 2004July 12, 2004
Psoriatic PlaquePsoriatic Plaque

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Dermatologic and Ophthalmic Drugs Advisory Committee Dermatologic and Ophthalmic Drugs Advisory Committee
July 12, 2004July 12, 2004
Severity of DiseaseSeverity of Disease
•Three Cardinal Signs of Psoriatic
Lesions
–Plaque elevation
–Erythema
–Scale
•Body Surface Area

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Dermatologic and Ophthalmic Drugs Advisory Committee Dermatologic and Ophthalmic Drugs Advisory Committee
July 12, 2004July 12, 2004
Chronic Plaque PsoriasisChronic Plaque Psoriasis
•Most Common Variant
•Plaques may be as large as 20 cm
•Symmetrical disease
•Sites of Predilection
–Elbows
–Knees
–Presacrum
–Scalp
–Hands and Feet

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Dermatologic and Ophthalmic Drugs Advisory Committee Dermatologic and Ophthalmic Drugs Advisory Committee
July 12, 2004July 12, 2004
Chronic Plaque PsoriasisChronic Plaque Psoriasis

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Dermatologic and Ophthalmic Drugs Advisory Committee Dermatologic and Ophthalmic Drugs Advisory Committee
July 12, 2004July 12, 2004
Chronic Plaque PsoriasisChronic Plaque Psoriasis

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Dermatologic and Ophthalmic Drugs Advisory Committee Dermatologic and Ophthalmic Drugs Advisory Committee
July 12, 2004July 12, 2004
Chronic Plaque PsoriasisChronic Plaque Psoriasis
•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

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Dermatologic and Ophthalmic Drugs Advisory Committee Dermatologic and Ophthalmic Drugs Advisory Committee
July 12, 2004July 12, 2004
Widespread Chronic Plaque Widespread Chronic Plaque
PsoriasisPsoriasis

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Dermatologic and Ophthalmic Drugs Advisory Committee Dermatologic and Ophthalmic Drugs Advisory Committee
July 12, 2004July 12, 2004
Chronic PsoriasisChronic Psoriasis

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Dermatologic and Ophthalmic Drugs Advisory Committee Dermatologic and Ophthalmic Drugs Advisory Committee
July 12, 2004July 12, 2004
Psoriasis of the NailPsoriasis of the Nail

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Dermatologic and Ophthalmic Drugs Advisory Committee Dermatologic and Ophthalmic Drugs Advisory Committee
July 12, 2004July 12, 2004
Psoriasis of the NailPsoriasis of the Nail

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Dermatologic 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
•Pruritus
•Pain
•Excessive heat loss
•Patient Complaints
–Unsightliness of the lesions
–Low self-esteem
–Feelings of being socially outcast
–Excessive scale

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Dermatologic and Ophthalmic Drugs Advisory Committee Dermatologic and Ophthalmic Drugs Advisory Committee
July 12, 2004July 12, 2004
Guttate PsoriasisGuttate Psoriasis
•Characterized by numerous 0.5 to 1.5
cm papules and plaques
•Early age of onset
•Most common form in children
•Streptococcal throat infection often a
trigger
•Spontaneous remissions in children
•Often chronic in adults

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Dermatologic and Ophthalmic Drugs Advisory Committee Dermatologic and Ophthalmic Drugs Advisory Committee
July 12, 2004July 12, 2004
Guttate PsoriasisGuttate Psoriasis

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Dermatologic and Ophthalmic Drugs Advisory Committee Dermatologic and Ophthalmic Drugs Advisory Committee
July 12, 2004July 12, 2004
Life–Threatening Forms of Life–Threatening Forms of
PsoriasisPsoriasis
•Generalized Pustular Psoriasis
•Erythrodermic Psoriasis

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Dermatologic and Ophthalmic Drugs Advisory Committee Dermatologic and Ophthalmic Drugs Advisory Committee
July 12, 2004July 12, 2004
Generalized Pustular PsoriasisGeneralized Pustular Psoriasis
•Unusual manifestation of psoriasis
•Can have a gradual or an acute onset
•Characterized by waves of pustules on
erythematous skin often after short
episodes of fever of 39˚ to 40˚C
•Weight loss
•Muscle Weakness
•Hypocalcemia
•Leukocytosis
•Elevated ESR

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Dermatologic and Ophthalmic Drugs Advisory Committee Dermatologic and Ophthalmic Drugs Advisory Committee
July 12, 2004July 12, 2004
Generalized Pustular PsoriasisGeneralized Pustular Psoriasis
•Cause is obscure
•Triggering Factors
–Infection
–Pregnancy
–Lithium
–Hypocalcemia secondary to
hypoalbuminemia
–Irritant contact dermatitis
–Withdrawal of glucocorticosteroids,
primarily systemic

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Dermatologic and Ophthalmic Drugs Advisory Committee Dermatologic and Ophthalmic Drugs Advisory Committee
July 12, 2004July 12, 2004
Generalized Pustular PsoriasisGeneralized Pustular Psoriasis

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Dermatologic and Ophthalmic Drugs Advisory Committee Dermatologic and Ophthalmic Drugs Advisory Committee
July 12, 2004July 12, 2004
Erythrodermic PsoriasisErythrodermic Psoriasis
•Classic lesion is lost
•Entire skin surface becomes
markedly erythematous with
desquamative scaling.
•Often only clues to underlying
psoriasis are the nail changes and
usually facial sparing

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Dermatologic and Ophthalmic Drugs Advisory Committee Dermatologic and Ophthalmic Drugs Advisory Committee
July 12, 2004July 12, 2004
Erythrodermic PsoriasisErythrodermic Psoriasis
•Triggering Factors
–Systemic Infection
–Withdrawal of high potency topical
or oral steroids
–Withdrawal of Methotrexate
–Phototoxicity
–Irritant contact dermatitis

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Dermatologic and Ophthalmic Drugs Advisory Committee Dermatologic and Ophthalmic Drugs Advisory Committee
July 12, 2004July 12, 2004
Erythrodermic PsoriasisErythrodermic Psoriasis

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Dermatologic and Ophthalmic Drugs Advisory Committee Dermatologic and Ophthalmic Drugs Advisory Committee
July 12, 2004July 12, 2004
State of the ArmamentariumState of the Armamentarium
•Wide range of therapies for the
treatment of moderate to severe
psoriasis
•None induce a permanent remission
•All have side effects that can place
limits on their use

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Dermatologic and Ophthalmic Drugs Advisory Committee Dermatologic and Ophthalmic Drugs Advisory Committee
July 12, 2004July 12, 2004
State of the ArmamentariumState of the Armamentarium
•Therapies
–Topical Corticosteroids
–Topical Vitamin D
3
Analogues
–Topical Retinoids
–Photo(chemo)therapy
–Systemic Therapies
•Oral
•Parenteral

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Dermatologic and Ophthalmic Drugs Advisory Committee Dermatologic and Ophthalmic Drugs Advisory Committee
July 12, 2004July 12, 2004
Topical CorticosteroidsTopical Corticosteroids
•High potency and Super potent topical
steroids
•These include
–Fluocinonide family (cream, ointment,
gel)
–Betamethasone dipropionate cream
–Clobetasol propionate family (cream,
ointment, gel, foam, lotion)
–Diflorasone diacetate ointment
–Betamethasone dipropionate ointment

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Dermatologic and Ophthalmic Drugs Advisory Committee Dermatologic and Ophthalmic Drugs Advisory Committee
July 12, 2004July 12, 2004
Topical CorticosteroidsTopical Corticosteroids
•Side effects associated with use
–Skin atrophy
–Burning and stinging
–Suppression of the hypothalamic-
pituitary-adrenal (HPA) axis
•This may occur after 2 weeks of
use with certain topical
corticosteroids

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Dermatologic and Ophthalmic Drugs Advisory Committee Dermatologic and Ophthalmic Drugs Advisory Committee
July 12, 2004July 12, 2004
Topical Vitamin DTopical Vitamin D
33 Analogues Analogues
•Prototype for this group is
calcipotriene
•3 formulations – cream, ointment,
and scalp solution
•Former two are approved for plaque
psoriasis
•Latter for moderate to severe
psoriasis of the scalp

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Dermatologic and Ophthalmic Drugs Advisory Committee Dermatologic and Ophthalmic Drugs Advisory Committee
July 12, 2004July 12, 2004
Topical Vitamin DTopical Vitamin D
33 Analogues Analogues
•Side Effects
–Cutaneous
•Burning
•Stinging
•Pruritus
•Skin irritation
•Tingling of the skin

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Dermatologic and Ophthalmic Drugs Advisory Committee Dermatologic and Ophthalmic Drugs Advisory Committee
July 12, 2004July 12, 2004
Topical RetinoidsTopical Retinoids
•Tazarotene Gel and Cream
–Available in two strengths
•0.05% and 0.1%
–Side Effects
•Pruritus
•Burning/Stinging
•Erythema
•Worsening of psoriasis
•Irritation
•Skin pain
•Hypertriglyceridemia

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Dermatologic and Ophthalmic Drugs Advisory Committee Dermatologic and Ophthalmic Drugs Advisory Committee
July 12, 2004July 12, 2004
Topical Tazarotene Topical Tazarotene
•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

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Dermatologic and Ophthalmic Drugs Advisory Committee Dermatologic and Ophthalmic Drugs Advisory Committee
July 12, 2004July 12, 2004
Topical Tazarotene (con’t)Topical Tazarotene (con’t)
•Both products are pregnancy category X
•Are contraindicated in women who are or
may become pregnant
•Requirements before and during therapy
–A negative pregnancy test 2 weeks prior
–Therapy initiated during a normal
menses
–Women of childbearing potential should
use adequate birth control

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Dermatologic and Ophthalmic Drugs Advisory Committee Dermatologic and Ophthalmic Drugs Advisory Committee
July 12, 2004July 12, 2004
Photo(chemo)therapyPhoto(chemo)therapy
•Two types of phototherapy
–Ultraviolet B (UVB)
–Ultraviolet A + psoralen (PUVA)

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Dermatologic and Ophthalmic Drugs Advisory Committee Dermatologic and Ophthalmic Drugs Advisory Committee
July 12, 2004July 12, 2004
UVBUVB
•Two types
–Broadband UVB
–Narrowband UVB (311-313 nm)
•Treatment is time consuming
–2-3 visits/week for several months
•Side effect – possibility of
experiencing an acute sunburn
reaction

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Dermatologic and Ophthalmic Drugs Advisory Committee Dermatologic and Ophthalmic Drugs Advisory Committee
July 12, 2004July 12, 2004
PUVAPUVA
•Consists of ingestion of or topical treatment with
a psoralen followed by UVA
•Usually reserved for severe, recalcitrant,
disabling psoriasis
•Time consuming – 2-3 visits/wk; at least 6 weeks
•Precautions
–Patients must be protected from further UV
light for 24 hours post treatment
–With oral psoralen, wrap around UV-blocking
glasses must be worn for 24 hours post
treatment

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Dermatologic and Ophthalmic Drugs Advisory Committee Dermatologic and Ophthalmic Drugs Advisory Committee
July 12, 2004July 12, 2004
PUVAPUVA
•Side effects with oral psoralen
–Nausea
–Dizziness
–Headache
•Side effects with PUVA
–Early
•Pruritus
–Late
•Skin damage
•Increased risk for skin cancer, particularly
squamous cell (SCC) and after 200 - 250
treatments, increased risk for melanoma

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Dermatologic and Ophthalmic Drugs Advisory Committee Dermatologic and Ophthalmic Drugs Advisory Committee
July 12, 2004July 12, 2004
Contraindications to PUVAContraindications to PUVA
•Patients less than 12 years of age
•Patients with a history of light
sensitive disease states
•Patients with, or with a history of
melanoma
•Patients with invasive SCC
•Patients with aphakia

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Dermatologic and Ophthalmic Drugs Advisory Committee Dermatologic and Ophthalmic Drugs Advisory Committee
July 12, 2004July 12, 2004
Systemic TherapiesSystemic Therapies
•Oral
–Methotrexate
–Neoral (cyclosporine)
–Soriatane (acitretin)
•Parenteral
–Amevive (alefacept)
–Raptiva (efalizimab)
–Enbrel (etanercept)

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Dermatologic and Ophthalmic Drugs Advisory Committee Dermatologic and Ophthalmic Drugs Advisory Committee
July 12, 2004July 12, 2004
MethotrexateMethotrexate
•Folic acid antagonist
•Usually reserved for severe,
recalcitrant, disabling psoriasis
•Maximum improvement can be
expected after 8 -12 weeks

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Dermatologic and Ophthalmic Drugs Advisory Committee Dermatologic and Ophthalmic Drugs Advisory Committee
July 12, 2004July 12, 2004
Contraindications - MethotrexateContraindications - Methotrexate
•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

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Dermatologic and Ophthalmic Drugs Advisory Committee Dermatologic and Ophthalmic Drugs Advisory Committee
July 12, 2004July 12, 2004
MethotrexateMethotrexate
•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

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Dermatologic and Ophthalmic Drugs Advisory Committee Dermatologic and Ophthalmic Drugs Advisory Committee
July 12, 2004July 12, 2004
Methotrexate – 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

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Dermatologic and Ophthalmic Drugs Advisory Committee Dermatologic and Ophthalmic Drugs Advisory Committee
July 12, 2004July 12, 2004
MethotrexateMethotrexate
•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

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Dermatologic and Ophthalmic Drugs Advisory Committee Dermatologic and Ophthalmic Drugs Advisory Committee
July 12, 2004July 12, 2004
NeoralNeoral
•Potent Immunosuppressive
•Adult, non-immunocompromised
patients with severe, recalcitrant
plaque psoriasis
•Maximum efficacy achieved at 16
weeks of therapy

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Dermatologic and Ophthalmic Drugs Advisory Committee Dermatologic and Ophthalmic Drugs Advisory Committee
July 12, 2004July 12, 2004
Contraindications - NeoralContraindications - Neoral
•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

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Dermatologic and Ophthalmic Drugs Advisory Committee Dermatologic and Ophthalmic Drugs Advisory Committee
July 12, 2004July 12, 2004
Neoral – Side EffectsNeoral – Side Effects
•Possibility of Irreversible renal damage
•Hypertension
•Headache
•Hypertriglyceridemia
•Hirsutism/hypertrichosis
•Paresthesia/hyperesthesia
•Influenza-like symptoms
•Nausea/vomiting
•Diarrhea
•Lethargy
•Arthralgia

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Dermatologic and Ophthalmic Drugs Advisory Committee Dermatologic and Ophthalmic Drugs Advisory Committee
July 12, 2004July 12, 2004
NeoralNeoral
•Multiple prescreening tests are
required
•Tests must continue throughout
treatment with dosage adjustment as
necessary to prevent end-organ
damage

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Dermatologic and Ophthalmic Drugs Advisory Committee Dermatologic and Ophthalmic Drugs Advisory Committee
July 12, 2004July 12, 2004
SoriataneSoriatane
•Oral retinoid approved for the
treatment of severe psoriasis in
adults
•Significant improvement can be
achieved with 8 weeks of therapy

57. 57
Dermatologic and Ophthalmic Drugs Advisory Committee Dermatologic and Ophthalmic Drugs Advisory Committee
July 12, 2004July 12, 2004
Soriatane - ContraindicationsSoriatane - Contraindications
•Patients with severely impaired liver
or kidney function
•Patients with chronic abnormally
elevated blood lipid values
•Patients who are taking methotrexate
•Ethanol use when on therapy and for
2 months following therapy in female
patients

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Dermatologic and Ophthalmic Drugs Advisory Committee Dermatologic and Ophthalmic Drugs Advisory Committee
July 12, 2004July 12, 2004
SoriataneSoriatane
•Pregnancy Category X drug product
as it is a human teratogen
•Contraindicated in pregnant females
or those who intend to become
pregnant during therapy or any time
up to three years post therapy

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Dermatologic and Ophthalmic Drugs Advisory Committee Dermatologic and Ophthalmic Drugs Advisory Committee
July 12, 2004July 12, 2004
Soriatane – Side EffectsSoriatane – Side Effects
•Those associated with retinoid therapy
–Cheilitis
–Alopecia
–Skin peeling
–Dry skin
–Pruritus
–Rhinitis
–Xeropthalmia
–Arthralgia

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Dermatologic and Ophthalmic Drugs Advisory Committee Dermatologic and Ophthalmic Drugs Advisory Committee
July 12, 2004July 12, 2004
Soriatane – Side EffectsSoriatane – Side Effects
•Laboratory Abnormalities
–Hypertriglyceridemia (66%)
–Decreased HDL (40%)
–Hypercholesterolemia (33%)
–Elevated liver function tests (33%)
–Elevated alkaline phosphatase (10-25%)
–Hyperglycemia (10-25%)
–Elevated CPK (10-25%)
•Hepatitis and jaundice occurred in < 1% of
patients in clinical trials on Soriatane

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Dermatologic and Ophthalmic Drugs Advisory Committee Dermatologic and Ophthalmic Drugs Advisory Committee
July 12, 2004July 12, 2004
SoriataneSoriatane
•Multiple prescreening tests must be
obtained
•Continued monitoring throughout
therapy necessary with possible
dosage adjustment

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Dermatologic and Ophthalmic Drugs Advisory Committee Dermatologic and Ophthalmic Drugs Advisory Committee
July 12, 2004July 12, 2004
Parenteral TherapyParenteral Therapy
AmeviveAmevive
•Immunosuppressive dimeric fusion
protein
–Extracellular CD2-binding portion
of the human leukocyte function
antigen-3 (LFA-3)
–Linked to the Fc portion of human
IgG1

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Dermatologic and Ophthalmic Drugs Advisory Committee Dermatologic and Ophthalmic Drugs Advisory Committee
July 12, 2004July 12, 2004
AmeviveAmevive
•Indicated for the treatment of adult
patients with moderate to severe
chronic plaque psoriasis
•With 12 weeks of therapy, a disease
state of clear or almost clear was
achieved by 11% (via IV) and 14%
(via IM) of patients, respectively

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Dermatologic and Ophthalmic Drugs Advisory Committee Dermatologic and Ophthalmic Drugs Advisory Committee
July 12, 2004July 12, 2004
Amevive – Side EffectsAmevive – Side Effects
•Dose dependent reduction in
circulating CD4+ and CD8+ T
lymphocytes
–Should not be administered to
patients with low CD4+ counts
–CD4+ counts must be monitored
before and weekly throughout
therapy

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Dermatologic and Ophthalmic Drugs Advisory Committee Dermatologic and Ophthalmic Drugs Advisory Committee
July 12, 2004July 12, 2004
Amevive – Side EffectsAmevive – Side Effects
•Lymphopenia
•Increase risk of malignancies
–Skin cancer – BCC and SCC
–Lymphoma
•Serious infections requiring
hospitalization
•Risk of reactivation of chronic, latent
infections
•Hypersensitivity reactions