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4 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 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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Plaque Psoriasis Psoriatic Arthritis Oral Ulcers in Behçet's Disease
Oral Ulcers in Behçet’s Disease
About Behçet's Disease Oral Ulcers in BD
Oral Ulcers in Behçet’s Disease
Clinical Response of Oral Ulcers Oral Ulcers: Pain Results Oral Ulcers: Complete Response Oral Ulcers: Maintenance of Response Oral Ulcers: Daily Average
Oral Ulcers in Behçet’s Disease
Study Design
Oral Ulcers in Behçet’s Disease
RELIEF Safety Laboratory Parameters
Psoriatic Arthritis
About Psoriatic Arthritis
Psoriatic Arthritis
Overview PALACE 1-3 PALACE 4 FORMOST ACTIVE
Psoriatic Arthritis
Overview ACR20 Response Oligoarticular PsA Joint Tenderness and Swelling Dactylitis Enthesitis Fatigue Pain Physical Function cDAPSA
Psoriatic Arthritis
Overview Adverse Reactions Through Week 16 Adverse Reactions Through 5 Years FOREMOST Safety Tolerability ACTIVE Safety Adverse Events of Special Interest Laboratory Parameters
Plaque Psoriasis
Why Systemic Therapy? About Plaque Psoriasis Patient Stories
Plaque Psoriasis
Study Design
Plaque Psoriasis
Overview Mild to Moderate
Plaque Psoriasis PASI-75 Response Mean PASI Response Pediatric Response Scalp Response Nail Response Itch Response Genital Response Patient Photo Library Real-World Data
Plaque Psoriasis
Overview Mild to Moderate Plaque PsO Moderate to Severe Plaque PsO Pediatric
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Plaque Psoriasis Psoriatic Arthritis Oral Ulcers in Behçet's Disease
How Otezla Works
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.

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IN MODERATE TO SEVERE PLAQUE PsO, OTEZLA
HAS ESTABLISHED SAFETY OVER 5 YEARS 1

Explore results across trials

ESTEEM: WEEK 16 SAFETY

Adverse reactions through week 16 in patients with moderate to severe plaque psoriasis 2

AN ESTABLISHED SAFETY PROFILE IN MODERATE TO SEVERE PATIENTS THROUGH WEEK 16 2

ESTEEM: Adverse reactions reported in ≥1% of subjects on Otezla
and with greater frequency than in subjects on placebo through week 16 2,*

Chart 2 of Otezla safety in plaque psoriasis at Week 16

*The safety of Otezla was assessed in 1426 subjects in 3 randomized, double-blind, placebo-controlled trials (including the ESTEEM studies). †Two subjects treated with Otezla experienced a serious adverse reaction of abdominal pain.

  • Discontinuation of treatment due to any adverse reaction was 6.1% for patients taking Otezla and 4.1% for placebo 2
  • The most common adverse reactions leading to discontinuation for patients taking Otezla were nausea (1.6%), diarrhea (1.0%), headache (0.8%) 2

STYLE: WEEK 16 SAFETY

Adverse reactions through week 16 in moderate to severe scalp psoriasis 2,3

AN ESTABLISHED SAFETY PROFILE IN SCALP PSORIASIS THROUGH WEEK 16 2,3

STYLE: Most common adverse reactions reported in ≥5% of patients on Otezla
and with greater frequency than in patients on placebo through week 16 2,3,‡

Otezla® (apremilast) safety in patients with moderate to severe scalp psoriasis at Week 16

‡Otezla was evaluated in a Phase 3, multicenter, randomized, placebo-controlled study in adults with moderate to severe plaque psoriasis of the scalp. A total of 302 patients were randomized to receive Otezla 30 mg BID or placebo.

  • Discontinuation rates due to gastrointestinal adverse reactions in patients who received Otezla 30 mg BID vs placebo, respectively:2,3
    • Diarrhea: 3% vs 0%
    • Nausea: 1.5% vs 1%
    • Vomiting: 1.5% vs 0%

DISCREET: WEEK 16 SAFETY

Adverse reactions through week 16 in patients with moderate to severe plaque psoriasis and moderate to severe plaque psoriasis of the genital area 4,5

AN ESTABLISHED SAFETY PROFILE THROUGH WEEK 16 4,5

DISCREET: Most common TEAEs through week 16 4,5,§

Otezla® (apremilast) safety in patients with moderate to severe plaque psoriasis and genital psoriasis at Week 16
Otezla® (apremilast) safety in patients with moderate to severe plaque psoriasis and genital psoriasis at Week 16

§Each subject is counted once for each applicable specific TEAE. Subject incidence is 100 times the number (n) of subjects reporting the event divided by N. **Patient years=39.8. ††Patient years=41.2.

  • The most commonly reported adverse events that occurred in ≥5% of patients in either treatment group were diarrhea, headache, nausea, and nasopharyngitis 4,5

IN ESTEEM, THE LONG-TERM SAFETY PROFILE OF OTEZLA WAS CONSISTENT THROUGH 5 YEARS OF EXPOSURE

ESTEEM 1 & 2: Adverse reactions reported in >5% of patients in any
treatment group on Otezla through week 260

IN ESTEEM, the long-term safety profile of otezla was consistent through 5 years of exposure

‡‡Includes all patients in the ESTEEM trials who received Otezla during the time interval relative to the start of Otezla administration.

  • Discontinuation due to adverse reactions occurred at 7.6% during weeks 0 to ≤52, 3.7% during weeks >52 to ≤104, 3.5% during weeks >104 to ≤156, 3.8% during weeks >156 to ≤208, and 1.9% during weeks >208 to ≤260 7
Video about the STYLE clinical trial study design and primary enbpoint of Otezla® (apremilast)

5-Year Safety Data Video

WATCH VIDEO

OTEZLA HAS DATA THROUGH 5 YEARS IN ADVERSE EVENTS OF SPECIAL INTEREST

ESTEEM 1 & 2: Adverse events of special interest through week 16 and through 5 years 8,§§

IN ESTEEM, the long-term safety profile of otezla was consistent through 5 years of exposure

§§EAIR/100 PY is the exposure-adjusted incident rate per 100 patient years. ***In the Otezla 30 mg BID group, events included acute myocardial infarction (AMI).8

OTEZLA HAS AN ESTABLISHED SAFETY PROFILE YOU’VE COME TO TRUST

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Boxed Warning 2

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increased incidence of MACE or serious infections through week 16 vs placebo, with data available through 5 years 8,†††

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initial or routine lab monitoring 2

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tests, including for TB or baseline blood panels 2

The warnings and precautions for Otezla include: 2
  • Hypersensitivity
  • Diarrhea, nausea, and vomiting
  • Depression
  • Weight decrease
  • Drug interactions

†††Increased exposure to Otezla did not contribute to an increase in incidence rates of MACE or serious infections compared to placebo at week 16.

BID, twice daily; PsO, plaque psoriasis; TB, tuberculosis.

PLEASE SEE THE IMPORTANT SAFETY INFORMATION AND PRESCRIBING
INFORMATION FOR ADDITIONAL DETAILS.

OTEZLA LABORATORY PARAMETERS THROUGH WEEK 16

ESTEEM 1 & 2: Selected laboratory parameters through week 16 in the pooled,
placebo-controlled safety population 9

IN ESTEEM, the long-term safety profile of otezla was consistent through 5 years of exposure

‡‡‡n/m=Number of subjects with at least 1 occurrence of the abnormality/number of subjects with a baseline value and at least 1 postbaseline value for criteria requiring baseline or number of subjects with at least 1 postbaseline value for criteria not requiring baseline. Subject incidence is 100 times n divided by m. §§§Blood did not have to be drawn when patient was fasting. 10

A1c, glycosylated hemoglobin; ALT, alanine aminotransferase; AST, aspartate transferase; ULN, upper limit of normal.

Otezla has no requirement for initial or ongoing lab monitoring 2

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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

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

Please click here for the full Prescribing Information.

References: 1. Data on file, Amgen; 2022. 2. Otezla [package insert]. Thousand Oaks, CA: Amgen Inc. 3. Van Voorhees AS, Stein Gold L, Lebwohl M, et al. J Am Acad Dermatol. 2020;83(1):96-103. 4. Data on file, Amgen; April 2022. 5. Merola JF, Parish LC, Guenther L, et al. J Am Acad Dermatol. 2024;90(3):485-493. 6. Data on file, Amgen; [1]; 2020. 7. Data on file, Amgen; [2]; 2020. 8. Data on file, Amgen; August 2022. 9. Data on file, Amgen; December 2020. 10. Data on file, Amgen; 2013.