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3 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. Read less

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Otezla is the first and only oral therapy approved across all severities of adult plaque psoriasis SEE NEW DATA

ADVANCE: MILD TO MODERATE PLAQUE PSORIASIS

New Data with bold letters on a blue background, representing Otezla as the first and only oral therapy for mild to moderate plaque psoriasis

ADVANCE: Evaluated in patients with mild to moderate plaque psoriasis (N=595); age ≥18 years, sPGA score 2-3, BSA involvement 2%-15%, PASI score 2-15 1,2

 

ADVANCE: SKIN DATA, sPGA

IN MILD TO MODERATE PLAQUE PSORIASIS, SIGNIFICANTLY MORE PATIENTS ACHIEVED CLEAR OR
ALMOST CLEAR SKIN WITH OTEZLA
 1,2

Greater than 5x icon that represents the patients taking Otezla achieving clearer skin vs placebo at week 16

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

Greater than 5x icon that represents the patients taking Otezla achieving clearer skin vs placebo at week 16
Bar chart of the Otezla ADVANCE clinical trial for mild to moderate plaque psoriasis primary endpoint

CLEARER SKIN STARTS BENEATH THE SURFACE

*sPGA response was defined as the percentage of patients who achieved sPGA score of 0 (clear) or 1 (almost clear) and ≥2-point reduction from baseline. 2

ADVANCE: SKIN DATA, BSA-75

IN MILD TO MODERATE PLAQUE PSORIASIS PATIENTS ACHIEVED 75% CLEARER SKIN WITH OTEZLA 2

Greater than 4x icon that represents the patients taking Otezla achieving a 75% BSA response at week 16 vs placebo

ADVANCE: Otezla demonstrated significantly greater achievement
of BSA-75 response vs placebo at week 16

Greater than 4x icon that represents the patients taking Otezla achieving a 75% BSA response at week 16 vs placebo
Bar chart of the Otezla ADVANCE clinical trial for mild to moderate plaque psoriasis in skin

CLEARER SKIN STARTS FROM WITHIN

 

ADVANCE: SCALP DATA

OTEZLA DEMONSTRATED SIGNIFICANT IMPROVEMENT IN SCALP RESPONSE 1,2

ADVANCE: Proportion of patients achieving ScPGA at week 16

Bar chart of the Otezla ADVANCE clinical trial for mild to moderate plaque psoriasis in scalp

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

ADVANCE: ITCH DATA

OTEZLA DEMONSTRATED SIGNIFICANT SYMPTOM IMPROVEMENT IN WHOLE BODY ITCH (WBI) 1,2

ADVANCE: Improvement from baseline in WBI-NRS response at week 16

Bar chart of the Otezla ADVANCE clinical trial for mild to moderate plaque psoriasis in whole body itch

In patients with WBI-NRS ≥4 at baseline. WBI-NRS score reduction of ≥4 points from baseline.

ADVANCE: NAIL DATA

PATIENTS ACHIEVED IMPROVEMENT IN NAIL RESPONSE 3

ADVANCE: Proportion of patients achieving NAPSI response at week 16

Bar chart of the Otezla ADVANCE clinical trial for mild to moderate plaque psoriasis in nails

§In patients with NAPSI score >0 at baseline. **Analysis is exploratory and has not been adjusted for multiple comparisons. No conclusions of statistical significance can be drawn.

IN THE ADVANCE CLINICAL TRIAL, PATIENTS TAKING OTEZLA SHOWED IMPROVEMENT IN CLEARER SKIN AND IN DIFFICULT-TO-TREAT MANIFESTATIONS OF MILD TO MODERATE PLAQUE PSORIASIS 1,2

BID, twice daily; BSA, body surface area; ITT, intent to treat; NAPSI, Nail Psoriasis Severity Index; PASI, Psoriasis Area and Severity Index; ScPGA, Scalp Physician Global Assessment; sPGA, static Physician Global Assessment; WBI, whole body itch; WBI-NRS, whole body itch numeric rating scale.

Accordion icon

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: 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. 2022;86(1):77-85. 3. Data on file, Amgen Inc.