Psoriasis

[Supplied: 10, 25mg capsule]

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. ]

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

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)

Supplied: 0.005% ointment /cream/ solution.

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.

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%

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

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

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.

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).