introduction to psoriasis introduction to psoriasis

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

Introduction to PsoriasisIntroduction to PsoriasisIntroduction to PsoriasisIntroduction to Psoriasis

• Prevalence• Genetics and Pathogenesis• Clinical Variants of Psoriasis• State of the Armamentarium

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%

• 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

• 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

• 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

Genetics and PathogenesisGenetics and PathogenesisGenetics 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

• 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

Psoriasis as a Systemic DiseasePsoriasis as a Systemic DiseasePsoriasis as a Systemic DiseasePsoriasis as a Systemic Disease

• Koebner Phenomenon• Elevated ESR• Increased uric acid levels → gout• Mild anemia• Elevated α2-macroglobulin• Elevated IgA levels • Increased quantities of Immune

Complexes

• Koebner Phenomenon• Elevated ESR• Increased uric acid levels → gout• Mild anemia• Elevated α2-macroglobulin• Elevated IgA levels • Increased quantities of Immune

Complexes

Psoriasis as a Systemic DiseasePsoriasis as a Systemic DiseasePsoriasis 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

• Psoriatic arthropathy• Aggravation of psoriasis by systemic

factors–Medication–Focal infections–Stress

• Life-threatening forms of psoriasis

Clinical Variants of PsoriasisClinical Variants of PsoriasisClinical Variants of PsoriasisClinical Variants of Psoriasis

Characteristic Lesion of PsoriasisCharacteristic Lesion of PsoriasisCharacteristic 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

• Sharply demarcated erythematous plaque with micaceous silvery white scale

• Histopathology–Thickening of the epidermis–Tortuous and dilated blood vessels– Inflammatory infiltrate primarily of

lymphocytes

Psoriatic PlaquePsoriatic PlaquePsoriatic PlaquePsoriatic Plaque

Severity of DiseaseSeverity of DiseaseSeverity of DiseaseSeverity of Disease

• Three Cardinal Signs of Psoriatic Lesions–Plaque elevation–Erythema–Scale

• Body Surface Area

• Three Cardinal Signs of Psoriatic Lesions–Plaque elevation–Erythema–Scale

• Body Surface Area

Chronic Plaque PsoriasisChronic Plaque PsoriasisChronic 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

• 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

Widespread Chronic Plaque Widespread Chronic Plaque PsoriasisPsoriasis

Chronic PsoriasisChronic PsoriasisChronic PsoriasisChronic Psoriasis

Psoriasis of the NailPsoriasis of the NailPsoriasis of the NailPsoriasis of the Nail

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

Guttate PsoriasisGuttate PsoriasisGuttate 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

• 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

Guttate PsoriasisGuttate PsoriasisGuttate PsoriasisGuttate Psoriasis

Life–Threatening Forms of Life–Threatening Forms of PsoriasisPsoriasis

• Generalized Pustular Psoriasis• Erythrodermic Psoriasis• Generalized Pustular Psoriasis• Erythrodermic Psoriasis

Generalized Pustular PsoriasisGeneralized Pustular PsoriasisGeneralized 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

• 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

• Cause is obscure• Triggering Factors– Infection– Pregnancy– Lithium– Hypocalcemia secondary to

hypoalbuminemia– Irritant contact dermatitis–Withdrawal of glucocorticosteroids,

primarily systemic

• Cause is obscure• Triggering Factors– Infection– Pregnancy– Lithium– Hypocalcemia secondary to

hypoalbuminemia– Irritant contact dermatitis–Withdrawal of glucocorticosteroids,

primarily systemic

Erythrodermic PsoriasisErythrodermic PsoriasisErythrodermic 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

• 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

• Triggering Factors–Systemic Infection–Withdrawal of high potency topical

or oral steroids–Withdrawal of Methotrexate–Phototoxicity– Irritant contact dermatitis

• Triggering Factors–Systemic Infection–Withdrawal of high potency topical

or oral steroids–Withdrawal of Methotrexate–Phototoxicity– Irritant contact dermatitis

State of the ArmamentariumState of the ArmamentariumState 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

• 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

State of the ArmamentariumState of the ArmamentariumState of the ArmamentariumState of the Armamentarium

• Therapies–Topical Corticosteroids–Topical Vitamin D3 Analogues–Topical Retinoids–Photo(chemo)therapy–Systemic Therapies•Oral• Parenteral

Topical CorticosteroidsTopical CorticosteroidsTopical 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

• 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

Topical CorticosteroidsTopical CorticosteroidsTopical 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

• 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

Topical Vitamin DTopical Vitamin D33 Analogues AnaloguesTopical Vitamin DTopical Vitamin D33 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

• 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

Topical Vitamin DTopical Vitamin D33 Analogues AnaloguesTopical Vitamin DTopical Vitamin D33 Analogues Analogues

• Side Effects–Cutaneous•Burning• Stinging• Pruritus• Skin irritation• Tingling of the skin

Topical RetinoidsTopical RetinoidsTopical 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

• 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

Topical Tazarotene Topical Tazarotene 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

• 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

Topical Tazarotene (con’t)Topical Tazarotene (con’t)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

• 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

Photo(chemo)therapyPhoto(chemo)therapyPhoto(chemo)therapyPhoto(chemo)therapy

• Two types of phototherapy–Ultraviolet B (UVB)–Ultraviolet A + psoralen (PUVA)

UVBUVBUVBUVB

• 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

• 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

PUVAPUVAPUVAPUVA

• 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

• 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

PUVAPUVAPUVAPUVA

• 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

• 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

Contraindications to PUVAContraindications to PUVAContraindications 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

• 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

Systemic TherapiesSystemic TherapiesSystemic TherapiesSystemic Therapies

• Oral–Methotrexate –Neoral (cyclosporine)–Soriatane (acitretin)

• Parenteral–Amevive (alefacept)–Raptiva (efalizimab)–Enbrel (etanercept)

• Oral–Methotrexate –Neoral (cyclosporine)–Soriatane (acitretin)

• Parenteral–Amevive (alefacept)–Raptiva (efalizimab)–Enbrel (etanercept)

MethotrexateMethotrexateMethotrexateMethotrexate

• Folic acid antagonist• Usually reserved for severe,

recalcitrant, disabling psoriasis• Maximum improvement can be

expected after 8 -12 weeks

• Folic acid antagonist• Usually reserved for severe,

recalcitrant, disabling psoriasis• Maximum improvement can be

expected after 8 -12 weeks

Contraindications - MethotrexateContraindications - MethotrexateContraindications - 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

• 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

• 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

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

• 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

NeoralNeoralNeoralNeoral

• Potent Immunosuppressive• Adult, non-immunocompromised

patients with severe, recalcitrant plaque psoriasis

• Maximum efficacy achieved at 16 weeks of therapy

• Potent Immunosuppressive• Adult, non-immunocompromised

patients with severe, recalcitrant plaque psoriasis

• Maximum efficacy achieved at 16 weeks of therapy

Contraindications - NeoralContraindications - NeoralContraindications - 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

• 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

Neoral – Side EffectsNeoral – Side EffectsNeoral – Side EffectsNeoral – Side Effects

• Possibility of Irreversible renal damage• Hypertension• Headache• Hypertriglyceridemia• Hirsutism/hypertrichosis• Paresthesia/hyperesthesia• Influenza-like symptoms• Nausea/vomiting• Diarrhea• Lethargy• Arthralgia

NeoralNeoralNeoralNeoral

• Multiple prescreening tests are required

• Tests must continue throughout treatment with dosage adjustment as necessary to prevent end-organ damage

• Multiple prescreening tests are required

• Tests must continue throughout treatment with dosage adjustment as necessary to prevent end-organ damage

SoriataneSoriataneSoriataneSoriatane

• Oral retinoid approved for the treatment of severe psoriasis in adults

• Significant improvement can be achieved with 8 weeks of therapy

• Oral retinoid approved for the treatment of severe psoriasis in adults

• Significant improvement can be achieved with 8 weeks of therapy

Soriatane - ContraindicationsSoriatane - ContraindicationsSoriatane - 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

• 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

• 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

• 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

Soriatane – Side EffectsSoriatane – Side EffectsSoriatane – Side EffectsSoriatane – Side Effects

• Those associated with retinoid therapy– Cheilitis– Alopecia– Skin peeling– Dry skin– Pruritus– Rhinitis– Xeropthalmia– Arthralgia

Soriatane – Side EffectsSoriatane – Side EffectsSoriatane – 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

• 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

• Multiple prescreening tests must be obtained

• Continued monitoring throughout therapy necessary with possible dosage adjustment

• Multiple prescreening tests must be obtained

• Continued monitoring throughout therapy necessary with possible dosage adjustment

Parenteral TherapyParenteral TherapyAmeviveAmevive

• Immunosuppressive dimeric fusion protein–Extracellular CD2-binding portion

of the human leukocyte function antigen-3 (LFA-3)–Linked to the Fc portion of human

• Immunosuppressive dimeric fusion protein–Extracellular CD2-binding portion

of the human leukocyte function antigen-3 (LFA-3)–Linked to the Fc portion of human

AmeviveAmeviveAmeviveAmevive

• 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

• 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

Amevive – Side EffectsAmevive – Side EffectsAmevive – 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

• 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

Amevive – Side EffectsAmevive – Side EffectsAmevive – 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

• Lymphopenia• Increase risk of malignancies– Skin cancer – BCC and SCC– Lymphoma

• Serious infections requiring hospitalization

• Risk of reactivation of chronic, latent infections

• Hypersensitivity reactions

introduction to psoriasis introduction to psoriasis

chronic psoriasis

years psoriasis

prevalence psoriasis

severe psoriasis

pathogenesis psoriasis

guttate psoriasis

psoriasis prevalence

pustular psoriasis cause

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