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Intro

Approximately one percent of the population is affected by psoriasis. The typical clinical findings of erythema and scaling are the result of hyperproliferation and abnormal differentiation of the epidermis, plus inflammatory cell infiltrates and vascular changes.

Acitretin - soriatane ® 

Drug Category: Retinoid-Like Compound. Individualization of dosage is required to achieve maximum therapeutic response while minimizing side effects.
Dosing (Adults) : ( treatment of severe psoriasis) Therapy should be initiated at 25 or 50 mg per day, given as a single dose with the main meal. Maintenance doses of 25 to 50 mg per day may be given after initial response to treatment. In general, therapy should be terminated when lesions have resolved sufficiently. Relapses may be treated as outlined for initial therapy.

[Supplied: 10, 25mg capsule]

Alefacept -  amevive ® 

CLINICAL PHARMACOLOGY
AMEVIVE® interferes with lymphocyte activation by specifically binding to the lymphocyte antigen, CD2, and inhibiting LFA-3/CD2 interaction. Activation of T lymphocytes involving the interaction between LFA-3 on antigen-presenting cells and CD2 on T lymphocytes plays a role in the pathophysiology of chronic plaque psoriasis. The majority of T lymphocytes in psoriatic lesions are of the memory effector phenotype characterized by the presence of the CD45RO marker1, express activation markers (e.g., CD25, CD69) and release inflammatory cytokines, such as interferon γ.

AMEVIVE® also causes a reduction in subsets of CD2+ T lymphocytes (primarily CD45RO+), presumably by bridging between CD2 on target lymphocytes and immunoglobulin Fc receptors on cytotoxic cells, such as natural killer cells. Treatment with AMEVIVE® results in a reduction in circulating total CD4+ and CD8+ T lymphocyte counts. CD2 is also expressed at low levels on the surface of natural killer cells and certain bone marrow B lymphocytes. Therefore, the potential exists for AMEVIVE® to affect the activation and numbers of cells other than T lymphocytes. In clinical studies of AMEVIVE®, minor changes in the numbers of circulating cells other than T lymphocytes have been observed.

Dosing (adults): 7.5 mg IV weekly or 15 mg IM have been effective in plaque psoriasis. Optimal doses/schedules remain to be established. Usual duration of treatment is 12 weeks. Second course: A second course of treatment may be initiated at least 12 weeks after completion of the initial course of treatment, provided CD4+ T-lymphocyte counts are within the normal range.

Monitoring: CD4+ T-lymphocyte counts should be monitored before initiation of treatment and weekly during therapy. Dosing should be withheld if CD4+ counts are <250 cells/µL, and dosing should be permanently discontinued if CD4+ lymphocyte counts remain at <250 cell/µL for longer than 1 month.

[Supplied: Injection (powder for reconstitution): 7.5mg, 15 mg. ]

Anthralin  -  drithocreme ® 

Synthetic tar derivative.
Dosing
: Apply once daily at bedtime, covered with dressing, and removed after 8 to 24 hours. Therapy is usually initiated with 0.1% topical cream, ointment, or paste, gradually increasing concentrations to an optimal response level within acceptable patient skin irritation limits. Alternatively, a short-contact regimen that uses higher initial concentrations of anthralin (1% to 3%) may be applied for 5 to 60 minutes. Anthralin concentrations are increased every 3 to 4 days until patient intolerance occurs. Therapy continues until psoriatic plaques clear. Maintenance therapy is infrequently used.

Supplied: [ointment, cream: 0.1, 0.25, 0.5, 1%].

Betamethasone dipropionate - sernivo™ spray 

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Drug UPDATES:  SERNIVO™ (betamethasone dipropionate) Spray, for 0.05% for topical use
[Drug information  /  PDF]  
Package insert - Dosing:  Click (+) next to Dosage and Administration section (drug info link)

Initial U.S. Approval:  2016

Mechanism of Action:
Corticosteroids play a role in cellular signaling, immune function, inflammation, and protein regulation; however, the precise mechanism of action of SERNIVO Spray in psoriasis is unknown.

INDICATIONS AND USAGE:
SERNIVO Spray is a corticosteroid indicated for the treatment of mild to moderate plaque psoriasis in patients 18 years of age or older.

DOSAGE AND ADMINISTRATION:
Apply to the affected skin areas twice daily. Rub in gently. (2)
Use SERNIVO Spray for up to 4 weeks and not beyond. (2)
Discontinue treatment when control is achieved. (2)
Do not use if atrophy is present at the treatment site. (2)
Do not use with occlusive dressings unless directed by a physician. (2)
Avoid use on the face, scalp, axilla, groin, or other intertriginous areas. (2)
Not for oral, ophthalmic, or intravaginal use. (2)

HOW SUPPLIED:
DOSAGE FORMS AND STRENGTHS
Spray: 0.05% (equivalent to 0.5 mg betamethasone/g)

Calcipotriene  -  dovonex ® 

Synthetic vitamin D3 derivative.
Indicated for the treatment of plaque psoriasis.
Dosing:  Apply twice daily.

Supplied: 0.005% ointment /cream/ solution.

Efalizumab -  raptiva ® 

NO LONGER AVAILABLE IN U.S.

Mechanism of Action
RAPTIVA binds to CD11a, the α subunit of leukocyte function antigen-1 (LFA-1), which is expressed on all leukocytes, and decreases cell surface expression of CD11a. RAPTIVA inhibits the binding of LFA-1 to intercellular adhesion molecule-1 (ICAM-1), thereby inhibiting the adhesion of leukocytes to other cell types. Interaction between LFA-1 and ICAM-1 contributes to the initiation and maintenance of multiple processes, including activation of T lymphocytes, adhesion of T lymphocytes to endothelial cells, and migration of T lymphocytes to sites of inflammation including psoriatic skin. Lymphocyte activation and trafficking to skin play a role in the pathophysiology of chronic plaque psoriasis. In psoriatic skin, ICAM-1 cell surface expression is upregulated on endothelium and keratinocytes. CD11a is also expressed on the surface of B lymphocytes, monocytes, neutrophils, natural killer cells, and other leukocytes. Therefore, the potential exists for RAPTIVA to affect the activation, adhesion, migration, and numbers of cells other than T lymphocytes.

Dosing (adults): Tx of psoriasis: 0.7 mg/kg SQ initially, followed by weekly dose of 1 mg/kg (maximum: 200 mg/dose).

Supplied: Injection (powder for reconstitution): provides 125 mg/1.25 ml after dilution.

Tazarotene  -  tazorac ® 

Retinoid.
Psoriasis: The mechanism of tazarotene action in psoriasis is not defined. Topical tazarotene blocks induction of mouse epidermal ornithine decarboxylase (ODC) activity, which is associated with cell proliferation and hyperplasia. In cell culture and in vitro models of skin, tazarotene suppresses expression of MRP8, a marker of inflammation present in the epidermis of psoriasis patients at high levels. In human keratinocyte cultures, it inhibits cornified envelope formation, whose build-up is an element of the psoriatic scale. Tazarotene also induces the expression of a gene which may be a growth suppressor in human keratinocytes and which may inhibit epidermal hyperproliferation in treated plaques. However, the clinical significance of these findings is unknown.

Acne: The mechanism of tazarotene action in acne vulgaris is not defined. However, the basis of tazarotene's therapeutic effect in acne may be due to its anti-hyperproliferative, normalizing-of-differentiation and anti-inflammatory effects. Tazarotene inhibited corneocyte accumulation in rhino mouse skin and cross-linked envelope formation in cultured human keratinocytes. The clinical significance of these findings is unknown.


Psoriasis: Apply a thin film to lesions at bedtime (no more than 20% of body surface area). Avoid application to unaffected skin. ACNE: apply a thin film to dry skin once a day in the evening.

Supplied: gel: 0.05, 0.1%

Ustekinumab -stelara® 

INDICATIONS AND USAGE
STELARA® is a human interleukin-12 and -23 antagonist indicated for the treatment of adult patients (18 years or older) with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy.

DOSAGE AND ADMINISTRATION
STELARA® is administered by subcutaneous injection.

For patients weighing ≤100 kg (220 lbs), the recommended dose is 45 mg initially and 4 weeks later, followed by 45 mg every 12 weeks.

For patients weighing >100 kg (220 lbs), the recommended dose is 90 mg initially and 4 weeks later, followed by 90 mg every 12 weeks.

DOSAGE FORMS AND STRENGTHS
Injection: 45 mg/0.5 mL in a single-use prefilled syringe
Injection: 90 mg/1 mL in a single-use prefilled syringe
Injection: 45 mg/0.5 mL in a single-use vial
Injection: 90 mg/1 mL in a single-use vial

Brodalumab - siliq™ injection 

Drug UPDATES:  SILIQ™ (brodalumab) injection
[Drug information  /  PDF]     REVIEW PACKAGE INSERT FOR POSSIBLE UPDATES
PACKAGE INSERT -Dosing:  Click (+) next to Dosage and Administration section (drug info link)
BOXED WARNING
WARNING: SUICIDAL IDEATION AND BEHAVIOR
Suicidal ideation and behavior, including completed suicides, have occurred in patients treated with SILIQ. Prior to prescribing SILIQ, weigh the potential risks and benefits in patients with a history of depression and/or suicidal ideation or behavior. Patients with new or worsening suicidal ideation and behavior should be referred to a mental health professional, as appropriate. Advise patients and caregivers to seek medical attention for manifestations of suicidal ideation or behavior, new onset or worsening depression, anxiety, or other mood changes [see Warnings and Precautions (5.1)].

Because of the observed suicidal behavior in subjects treated with SILIQ, SILIQ is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the SILIQ REMS Program

Initial U.S. Approval:  2017

Mechanism of Action:
Brodalumab is a human monoclonal IgG2 antibody that selectively binds to human IL-17RA and inhibits its interactions with cytokines IL-17A, IL-17F, IL-17C, IL-17A/F heterodimer and IL-25. IL-17RA is a protein expressed on the cell surface and is a required component of receptor complexes utilized by multiple IL-17 family cytokines. Blocking IL-17RA inhibits IL-17 cytokine-induced responses including the release of pro-inflammatory cytokines and chemokines.

INDICATIONS AND USAGE:
SILIQ is a human interleukin-17 receptor A (IL-17RA) antagonist indicated for the treatment of moderate to severe plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy and have failed to respond or have lost response to other systemic therapies.

DOSAGE AND ADMINISTRATION:
Administer 210 mg of SILIQ by subcutaneous injection at Weeks 0, 1, and 2 followed by 210 mg every 2 weeks.
See package insert for additional instructions - PDF

HOW SUPPLIED:

Injection: 210 mg/1.5 mL solution in a single-dose prefilled syringe

Ixekizumab - taltz™ injection 

ledDrug UPDATESTALTZ™ (ixekizumab) injection
[Drug information  /  PDF]  
Package insert - Dosing:  Click (+) next to Dosage and Administration section (drug info link)

Initial U.S. Approval:  2016

Mechanism of Action:
Ixekizumab is a humanized IgG4 monoclonal antibody that selectively binds with the interleukin 17A (IL-17A) cytokine and inhibits its interaction with the IL-17 receptor. IL-17A is a naturally occurring cytokine that is involved in normal inflammatory and immune responses. Ixekizumab inhibits the release of proinflammatory cytokines and chemokines.

INDICATIONS AND USAGE:
TALTZ™ is a humanized interleukin-17A antagonist indicated for the treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy.

DOSAGE AND ADMINISTRATION
Administer by subcutaneous injection.
Recommended dose is 160 mg (two 80 mg injections) at Week 0, followed by 80 mg at Weeks 2, 4, 6, 8, 10, and 12, then 80 mg every 4 weeks.

HOW SUPPLIED:
DOSAGE FORMS AND STRENGTHS
Autoinjector
Injection: 80 mg/mL solution in a single-dose prefilled autoinjector. (3)

Prefilled Syringe
Injection: 80 mg/mL solution in a single-dose prefilled syringe.

Secukinumab injection - cosentyx ® 

Drug UPDATES: COSENTYX ®- secukinumab injection
[Drug information  /  PDFled   Click link for the latest monograph
Dosing:  Click (+) next to Dosage and Administration section (drug info link)

Initial U.S. Approval:  2015

Mechanism of Action: Secukinumab is a human IgG1 monoclonal antibody that selectively binds to the interleukin-17A (IL-17A) cytokine and inhibits its interaction with the IL-17 receptor. IL-17A is a naturally occurring cytokine that is involved in normal inflammatory and immune responses. Secukinumab inhibits the release of proinflammatory cytokines and chemokines.

INDICATIONS AND USAGE:  
1.1 Plaque Psoriasis
COSENTYX® is indicated for the treatment of moderate to severe plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy.

1.2 Psoriatic Arthritis
COSENTYX is indicated for the treatment of adult patients with active psoriatic arthritis.

1.3 Ankylosing Spondylitis
COSENTYX is indicated for the treatment of adult patients with active ankylosing spondylitis.

HOW SUPPLIED:
Injection: 150 mg/mL solution in a single-use Sensoready pen.
Injection: 150 mg/mL solution in a single-use prefilled syringe.
For Injection: 150 mg, lyophilized powder in a single-use vial for reconstitution (for healthcare professional use only).

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Reference(s)

National Institutes of Health, U.S. National Library of Medicine, DailyMed Database.
Provides access to the latest drug monographs submitted to the Food and Drug Administration (FDA). Please review the latest applicable package insert for additional information and possible updates.  A local search option of this data can be found here.

Psoriasis

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