3 INDICATIONS

3 INDICATIONS Otezla® (apremilast) is indicated for the treatment of adult patients with plaque psoriasis who are candidates for phototherapy or systemic therapy. Read more

Otezla is indicated for the treatment of adult patients with active psoriatic arthritis.

Otezla is indicated for the treatment of adult patients with oral ulcers associated with Behçet's Disease. Read less

Otezla is the first and only oral systemic treatment approved for adult patients with plaque psoriasis across all severities including mild, moderate, or severe 1   Read More

Otezla is the first and only systemic therapy for adult patients with psoriasis across the spectrum of severity 1

Now Approved with bold letters and a check mark in an oval background, representing Otezla as the first and only oral therapy for mild to moderate plaque psoriasis (PsO)

THERE IS NOW AN ORAL TREATMENT OPTION FOR MILD TO MODERATE PLAQUE PSORIASIS PATIENTS — OTEZLA IS NOW APPROVED TO TREAT ALL ADULT PLAQUE PSORIASIS PATIENTS 1

In the ADVANCE clinical trial:

OTEZLA DEMONSTRATED
SIGNIFICANT IMPROVEMENT IN
MILD TO MODERATE PsO 1,2

SIGNIFICANTLY MORE PATIENTS ACHIEVED CLEAR OR ALMOST CLEAR SKIN WITH OTEZLA 1,2

ADVANCE: Otezla demonstrated significantly greater achievement
of sPGA response vs placebo at week 16

as many patients
achieved clearer skin
vs placebo at week 16

Bar chart of the ADVANCE clinical trial in Otezla patients with mild to moderate plaque psoriasis (PsO)

OTEZLA DEMONSTRATED SIGNIFICANT IMPROVEMENT IN DIFFICULT-TO-TREAT MANIFESTATIONS OF MILD TO MODERATE PsO 1-3

OTEZLA SHOWED SIGNIFICANT IMPROVEMENT IN SCALP RESPONSE 1,2,*

ADVANCE: Proportion of patients achieving ScPGA at week 16
Bar chart of the ADVANCE clinical trial in scalp response of Otezla patients with mild to moderate plaque psoriasis (PsO)

*ScPGA score of clear [0] or almost clear [1] with at least a 2-point reduction from baseline.

OTEZLA ALSO DEMONSTRATED SIGNIFICANT AND RAPID SYMPTOM IMPROVEMENT IN WHOLE BODY ITCH 1,2,†

ADVANCE: Improvement from baseline in WBI-NRS response at week 16
Bar chart of the ADVANCE clinical trial in whole body itch of Otezla patients with mild to moderate plaque psoriasis (PsO)

WBI-NRS score reduction of ≥4-points from baseline.

Study design:

ADVANCE was a multicenter, randomized, placebo-controlled, double-blind study of biologic-naïve adults with mild to moderate plaque psoriasis. Patients were randomized 1:1 to receive Otezla® (apremilast) or placebo for a 16-week double-blind phase, followed by a 16-week extension phase (continued Otezla or switched to Otezla) and a 4-week post-treatment observational phase. 1,2

Selected inclusion criteria:

Biologic-naïve adults with chronic, mild to moderate plaque psoriasis (sPGA score 2-3, BSA 2%-15%, PASI score 2-15) whose psoriasis was inadequately controlled with or who were intolerant to ≥1 topical psoriasis therapy. 1,2

ADVERSE EVENTS IN MILD TO MODERATE PLAQUE PSORIASIS PATIENTS WERE CONSISTENT WITH THE ESTABLISHED OTEZLA SAFETY PROFILE FOR MODERATE TO SEVERE PLAQUE PSORIASIS 1

ADVANCE: Treatment-emergent adverse events
(TEAEs) at week 16 2
Table of ADVANCE clinical trial data of Treatment-emergent adverse events (TEAEs) in Otezla patients

DON’T WAIT—TREAT PsO SYSTEMICALLY
FROM THE START 1

BID, twice daily; ITT, intent to treat; PASI, Psoriasis Area and Severity Index; ScPGA, Scalp Physician Global Assessment; sPGA, static Physician Global Assessment; WBI-NRS, Whole Body Itch Numeric Rating Scalp.

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IMPORTANT SAFETY INFORMATION

Contraindications

  • Otezla is contraindicated in patients with a known hypersensitivity to apremilast or to any of the excipients in the formulation

Warnings and Precautions

  • Hypersensitivity Reactions: Hypersensitivity reactions, including angioedema and anaphylaxis, have been reported during postmarketing surveillance. If signs or symptoms of serious hypersensitivity reactions occur, discontinue Otezla and institute appropriate therapy
  • Diarrhea, Nausea, and Vomiting: Cases of severe diarrhea, nausea, and vomiting were associated with the use of Otezla. Most events occurred within the first few weeks of treatment. In some cases, patients were hospitalized. Patients 65 years of age or older and patients taking medications that can lead to volume depletion or hypotension may be at a higher risk of complications from severe diarrhea, nausea, or vomiting. Monitor patients who are more susceptible to complications of diarrhea or vomiting; advise patients to contact their healthcare provider. Consider Otezla dose reduction or suspension if patients develop severe diarrhea, nausea, or vomiting
  • Depression: Carefully weigh the risks and benefits of treatment with Otezla for patients with a history of depression and/or suicidal thoughts/behavior, or in patients who develop such symptoms while on Otezla. Patients, caregivers, and families should be advised of the need to be alert for the emergence or worsening of depression, suicidal thoughts or other mood changes, and they should contact their healthcare provider if such changes occur
    • Plaque Psoriasis: Treatment with Otezla is associated with an increase in depression. During clinical trials in patients with moderate to severe plaque psoriasis, 1.3% (12/920) of patients reported depression compared to 0.4% (2/506) on placebo. Depression was reported as serious in 0.1% (1/1308) of patients exposed to Otezla, compared to none in placebo-treated patients (0/506). Suicidal behavior was observed in 0.1% (1/1308) of patients on Otezla, compared to 0.2% (1/506) on placebo. One patient treated with Otezla attempted suicide; one patient on placebo committed suicide
    • Psoriatic Arthritis: Treatment with Otezla is associated with an increase in depression. During clinical trials, 1.0% (10/998) reported depression or depressed mood compared to 0.8% (4/495) treated with placebo. Suicidal ideation and behavior was observed in 0.2% (3/1441) of patients on Otezla, compared to none in placebo-treated patients. Depression was reported as serious in 0.2% (3/1441) of patients exposed to Otezla, compared to none in placebo-treated patients (0/495). Two patients who received placebo committed suicide compared to none on Otezla
    • Behçet’s Disease: Treatment with Otezla is associated with an increase in depression. During the clinical trial, 1% (1/104) reported depression or depressed mood compared to 1% (1/103) treated with placebo. No instances of suicidal ideation or behavior were reported in patients treated with Otezla or treated with placebo
  • Weight Decrease: Monitor body weight regularly; evaluate unexplained or clinically significant weight loss, and consider discontinuation of Otezla
    • Plaque Psoriasis: Body weight loss of 5-10% occurred in 12% (96/784) of patients with moderate to severe plaque psoriasis treated with Otezla and in 5% (19/382) of patients treated with placebo. Body weight loss of ≥10% occurred in 2% (16/784) of patients treated with Otezla compared to 1% (3/382) of patients treated with placebo
    • Psoriatic Arthritis: Body weight loss of 5-10% was reported in 10% (49/497) of patients taking Otezla and in 3.3% (16/495) of patients taking placebo
    • Behçet’s Disease: Body weight loss of >5% was reported in 4.9% (5/103) of patients taking Otezla and in 3.9% (4/102) of patients taking placebo
  • Drug Interactions: Apremilast exposure was decreased when Otezla was co-administered with rifampin, a strong CYP450 enzyme inducer; loss of Otezla efficacy may occur. Concomitant use of Otezla with CYP450 enzyme inducers (e.g., rifampin, phenobarbital, carbamazepine, phenytoin) is not recommended

Adverse Reactions

  • Plaque Psoriasis: The most common adverse reactions (≥5%) are diarrhea, nausea, upper respiratory tract infection, and headache, including tension headache. Overall, the safety profile of Otezla in patients with mild to moderate plaque psoriasis was consistent with the safety profile previously established in adult patients with moderate to severe plaque psoriasis
  • Psoriatic Arthritis: The most common adverse reactions (≥5%) are diarrhea, nausea, and headache
  • Behçet’s Disease: The most common adverse reactions (≥10%) are diarrhea, nausea, headache, and upper respiratory tract infection

Use in Specific Populations

  • Otezla has not been studied in pregnant women. Advise pregnant women of the potential risk of fetal loss

Please click here for the full Prescribing Information.

INDICATIONS

Otezla® (apremilast) is indicated for the treatment of adult patients with plaque psoriasis who are candidates for phototherapy or systemic therapy.

Otezla is indicated for the treatment of adult patients with active psoriatic arthritis.

Otezla is indicated for the treatment of adult patients with oral ulcers associated with Behçet’s Disease.

References: 1. Otezla [package insert]. Thousand Oaks, CA: Amgen Inc. 2. Stein Gold L, Papp K, Pariser D, et al. J Am Acad Dermatol. Printed online July 31, 2021. doi:10.1016 j.jaad.2021.07.040. 3. Aldredge LM, Higham RC. Manifestations and management of difficult-to-treat psoriasis. JDNA. 2018;10(4):189-197.