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4 INDICATIONSOtezla® (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 pediatric patients 6 years of age and older and weighing at least 20 kg with moderate to severe 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.
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Oral Ulcers in Behçet’s Disease
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Study Design
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Overview Adverse Reactions Through Week 16 Pediatric: Adverse Reactions Adverse Reactions Weeks 16 to 32 Adverse Reactions Through 5 Years Adverse Events of Special Interest Laboratory Parameters
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Plaque Psoriasis Psoriatic Arthritis Oral Ulcers in Behçet's Disease
Mechanism of Disease (MOD) Otezla MOA
Dosing

First and only oral therapy approved for mild, moderate, and severe plaque psoriasis, and active PsA SEE THE DATA

First and only oral therapy approved for mild, moderate, and severe plaque psoriasis, and active PsA

SEE THE DATA REFERENCES

No lab monitoring. No TB or baseline blood panel tests. No planning around live vaccines 1 START TODAY WITHOUT DELAY

No lab monitoring. No TB or baseline blood panel tests. No planning around live vaccines 1

 START TODAY WITHOUT DELAY REFERENCES

A small pill with a big history: 1 million+ patients treated globally since 2014 1-3,* PsO SAFETY PsA SAFETY

A small pill with a big history: 1 million+ patients treated globally since 2014 1-3,*

PsO SAFETY PsA SAFETY REFERENCES & FOOTNOTE
REFERENCES REFERENCES & FOOTNOTE

*Estimates of patients treated reflect global data since launch (Apr 2014-Mar 2023; US=59% of data). Calculations based on observed drug utilization parameters and number of units distributed. Utilization patterns change over time to best represent current markets.

FDA, U.S. Food and Drug Administration; PsA, psoriatic arthritis; TB, tuberculosis.

References: 1. Otezla [package insert]. Thousand Oaks, CA: Amgen Inc. 2. Data on file, Amgen Inc. 3. Otezla® (apremilast) FDA approval letter. March 21, 2014.

LIBERATE STUDY DESIGN

LIBERATE was a global, Phase 3b, placebo-controlled, double-blind, double-dummy study evaluating 250 patients with moderate to severe plaque psoriasis for up to 104 weeks 1

Study Design 1

Timeline chart that represents LIBERATE study design results to treat plaque psoriasis in Otezla patients through 52 weeks

*Starting at week 32, all nonresponders (<PASI-50) had the option of adding topical therapies and/or ultraviolet light B phototherapy to their treatment regimen. †Screening up to 35 days before randomization. ‡For patients randomized to apremilast, doses were titrated over the first week of treatment. §At week 16, all placebo and biologic control arm patients were switched to open-label apremilast 30 mg BID through week 104.

  • Patients were randomized 1:1:1 to either Otezla 30 mg (n=83) BID, biologic control arm (n=83) once weekly, or placebo (n=84) through week 16. At week 16, all patients crossed over to the Otezla arm 1
  • This study was not designed for apremilast vs biologic control arm comparisons 1
 

Criteria and endpoints

Selected inclusion criteria 1:

  • Chronic moderate or severe plaque psoriasis for ≥12 months
  • PASI score ≥12
  • BSA involvement ≥10%
  • sPGA score ≥3 (moderate to severe)
  • Inadequate response, intolerance, or contraindication to ≥1 conventional systemic agent for treatment of plaque psoriasis
  • Candidates for phototherapy or systemic therapy
  • No prior exposure to a biologic therapy for plaque psoriasis or psoriatic arthritis

Selected exclusion criteria 1:

  • Prior failure of >3 systemic agents for treatment of plaque psoriasis
  • History of known demyelinating diseases such as multiple sclerosis or optic neuritis or history of/or concurrent congestive heart failure, including medically controlled, asymptomatic, congestive heart failure
  • Other clinically significant or major uncontrolled disease
  • Serious infection
  • Latent, active, or history of incompletely treated TB

Primary endpoint 1:

  • Proportion of patients treated with apremilast or placebo who achieved PASI-75 at week 16

Patient demographics

Mean age 1:

  • Otezla, 46 years; placebo, 43 years; biologic control arm, 47 years

Mean baseline BSA involvement 1:

  • Otezla, 27%; placebo, 27%; biologic control arm, 28%

Mean baseline PASI score 1:

  • Otezla, 19.3; placebo, 19.4; biologic control arm, 20.3

Concomitant plaque psoriasis medications allowed 1:

  • Low-potency topical corticosteroids as background therapy for treatment of face, axillae, and groin
  • Coal tar shampoo and/or salicylic acid scalp preparations for scalp lesions
  • All were permitted except within 24 hours before study visits
 

BID, twice daily; BSA, body surface area; PASI,Psoriasis Area and Severity Index; sPGA, static Physician Global Assessment;TB, tuberculosis; UVB, ultraviolet light B.

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IMPORTANT SAFETY INFORMATION 

Contraindications

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

Warnings and Precautions

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

IMPORTANT SAFETY INFORMATION

Contraindications

  • Otezla® (apremilast) 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 adult 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 adult 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 adult patients treated with Otezla compared to 1% (3/382) of patients treated with placebo. Body weight loss of 5%-10% occurred in 12% (19/163) of pediatric patients with moderate to severe plaque psoriasis treated with Otezla compared to 2.5% (2/80) with placebo. Body weight loss of ≥ 10% occurred in 1% (1/163) of pediatric patients treated with Otezla twice daily compared to 0% (0/80) of patients with placebo. Closely monitor growth (height and weight) in Otezla-treated pediatric patients. Pediatric patients who are not growing or gaining weight as expected may need to have their treatment interrupted
    • 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 adult patients with mild to moderate plaque psoriasis and pediatric patients with moderate to severe plaque psoriasis was consistent with the safety profile 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® is indicated for the treatment of:

  • Adult patients with plaque psoriasis who are candidates for phototherapy or systemic therapy
  • Pediatric patients 6 years of age and older and weighing at least 20 kg with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy
  • Adult patients with active psoriatic arthritis
  • Adult patients with oral ulcers associated with Behçet’s Disease

Reference: 1. Reich K, Gooderham M, Green L, et al. J Eur Acad Dermatol Venereol. 2017;31(3):507-517.