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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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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 ACTIVE Safety Adverse Events of Special Interest Laboratory Parameters
Plaque Psoriasis
Why Systemic Therapy? About Plaque Psoriasis Patient Stories
Plaque Psoriasis
Overview ADVANCE ESTEEM SPROUT STYLE DISCREET LIBERATE
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 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
Resources Overview Downloadable Resources Patient Profiles Billing and Coding Video Hub FAQs
Start Today Co-Pay and Patient Support Coverage
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.

OTEZLA MECHANISM OF ACTION (MOA)

OTEZLA IS AN ORAL, SYSTEMIC, PDE4 INHIBITOR WITH A DISTINCT MOA THAT WORKS
INTRACELLULARLY AND IMPACTS MULTIPLE INFLAMMATORY MEDIATORS 1,2

Dial down multiple inflammatory drivers with Otezla, an immunomodulator 2-8

Visual representation of the mechanism of action of Otezla that elevates cAMP levels and believed to indirectly modulate production of inflammatory mediators

*Visual representation based on preclinical evidence. 9 These analyses were exploratory and not designed to detect changes in biomarker levels or the relationship between biomarker change and clinical outcome. 9

STEPS

Number 1 in a circle

Otezla inhibits the enzyme PDE4 within an inflammatory cell 2

Number 2 in a circle

This inhibition increases cAMP levels 2

Number 3 in a circle

As a result, Otezla is thought to indirectly modulate production of inflammatory mediators 2

*Visual representation based on preclinical evidence. 9 These analyses were exploratory and not designed to detect changes in biomarker levels or the relationship between biomarker change and clinical outcome. 9

  • The specific mechanism(s) by which apremilast exerts its therapeutic action is not well defined 1
  • PDE4 has been shown to degrade cAMP to AMP in inflammatory cells, which may modulate the expression of
    pro-inflammatory and
    anti-inflammatory mediators 2,4
  • Exploratory biomarker substudies evaluated 47 biomarkers, some of which are relevant in the pathophysiology of psoriatic disease. In the PALACE 1 substudy, an increase in anti-inflammatory mediators such as IL-10 and a decrease in pro-inflammatory mediators such as IL-12, IL-17A, IL-23, and TNF-α were observed. †,‡ In the ESTEEM 2 substudy, a decrease in pro-inflammatory mediators such as IL-17F, IL-17A, IL-22, and TNF-α were
    observed 3,4,6,§

†Based on PALACE 1 substudy (n=150; blood plasma samples at baseline and at weeks 4, 16, 24, and 40) using a validated multiplexed immunoassay. ‡Prior exposure to a biologic was higher in the biomarker subset compared to the full patient population (49% vs 24%). §Based on ESTEEM 2 substudy (n=130; blood plasma samples at baseline and at weeks 4, 16, 32, 36, 40, and 44) using a validated multiplex immunoassay.

OTEZLA MOA VIDEOS

Otezla inhibits PDE4 intracellularly and has anti-inflammatory properties 1,2

​

MOA IN PLAQUE PSORIASIS

See how Otezla may work in plaque psoriasis

The specific mechanism(s) by which apremilast exerts its therapeutic action in patients with psoriasis is not well defined. 1

​

VIDEO TRANSCRIPT

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Mechanism of Action in Plaque Psoriasis

INDICATION

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

Please see additional Safety Information later in this video.

Plaque psoriasis appears on the skin as raised, red patches covered with a silvery buildup of dead skin cells. Plaque psoriasis most commonly appears on the knees, fingernails, elbows, lower back, and scalp. Data from cell and animal studies indicates that the immune cell releases pro-inflammatory cytokines that can then activate other cells. The activated cells recruit more cells to the site of the disease creating a chronic cycle of inflammation. Recent research has identified important signaling molecules within immune cells. One such molecule is phosphodiesterase 4 or PDE4, an intracellular enzyme that degrades cyclic AMP into its inactive form, AMP in inflammatory cells. A treatment for plaque psoriasis, apremilast, an inhibitor of PDE4 is indicated for the treatment of adult patients with plaque psoriasis. Apremilast is an oral small-molecule inhibitor of PDE4. The specific mechanisms by which apremilast exerts its therapeutic action is not well defined. Through this targeted inhibition, apremilast elevates intracellular cAMP levels, which is thought to decrease levels of some pro-inflammatory mediators and increase the production of certain anti-inflammatory mediators.

IMPORTANT SAFETY INFORMATION

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.

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.

Weight Decrease: Monitor body weight regularly; evaluate unexplained or clinically significant weight loss and consider discontinuation of Otezla. 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.

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

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.

Use in Specific Populations

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

Please see the Full Prescribing Information for Otezla provided on Otezlapro.com

​

MOA IN PsA

See how Otezla may work in psoriatic arthritis

The specific mechanism(s) by which apremilast exerts its therapeutic action in patients with PsA is not well defined. 1

​

VIDEO TRANSCRIPT

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Otezla is an Oral Treatment Option for Psoriatic Arthritis Patients

INDICATION

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

IMPORTANT SAFETY INFORMATION

Contraindications

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

Please see additional Important Safety Information later in this video.

Psoriatic arthritis is an inflammatory disease which develops in up to 30 percent of people that experience psoriasis.

Psoriatic arthritis typically affects the peripheral and distal joints of the fingers and toes, but can sometimes affect the spine and sacroiliac area. Data from cell and animal studies indicates that the immune cell releases pro-inflammatory cytokines that can then activate other cells. The activated cells recruit more cells to the site of the disease, creating a chronic cycle of inflammation. Recent research has identified important signaling molecules within immune cells. One such molecule is phosphodiesterase 4 or PDE4, an intracellular enzyme that degrades cyclic AMP into its inactive form AMP in inflammatory cells. A treatment for psoriatic arthritis apremilast, an inhibitor of PDE4 is indicated for the treatment of adult patients with active psoriatic arthritis. Apremilast is an oral small molecule inhibitor of PDE4. The specific mechanisms by which apremilast exerts its therapeutic action in psoriatic arthritis patients is not well defined. Through this targeted inhibition, apremilast, elevates intercellular cAMP levels, which is thought to decrease levels of some pro-inflammatory mediators and increase the production of certain anti-inflammatory mediators.

IMPORTANT SAFETY INFORMATION

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.

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.

Weight Decrease: Monitor body weight regularly; evaluate unexplained or clinically significant weight loss, and consider discontinuation of Otezla. 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.

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

The most common adverse reactions (≥5%) are diarrhea, nausea, and headache.

Use in Specific Populations

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

Please see the Full Prescribing Information for Otezla provided on OtezlaPro.com

AMP, adenosine monophosphate; cAMP, cyclic adenosine monophosphate; IL, interleukin; PASI, Psoriasis Area and Severity Index; PDE4, phosphodiesterase 4; PsA, psoriatic arthritis; TNF, tumor necrosis factor.

Accordion icon

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

References: 1. Otezla [package insert]. Thousand Oaks, CA: Amgen Inc. 2. Schafer PH, Parton A, Capone L, et al. Cell Signal. 2014;26(9):2016-2029. 3. Schafer PH, Chen P, Fang L, Wang A, Chopra R. J Immunol Res. 2015;2015:906349. 4. Schafer P. Biochem Pharmacol. 2012;83(12):1583-1590. 5. Gottlieb AB, Matheson RT, Menter A, et al. J Drugs Dermatol. 2013;12(8):888-897. 6. Garcet S, Nograles K, Correa da Rosa J, Schafer PH, Krueger JG. J Allergy Clin Immunol. 2018;142(3):1010-1013. 7. Maloney N, Zhao J, Tegtmeyer K, et al. J Dermatolog Treat. 2020;1-17. 8. Medical Dictionary. https://medical-dictionary.thefreedictionary.com/immunomodulation. Accessed January 10, 2023. 9. Data on file, Amgen Inc.