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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.

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How do you evaluate patients for psoriatic arthritis?

EARLY DETECTION AND DIAGNOSIS OF PSORIATIC ARTHRITIS ARE IMPORTANT FOR INITIATING TIMELY, APPROPRIATE TREATMENT 1,2


Explore the numbers

PLAQUE PSORIASIS IS A KEY DOMAIN OF PsA AND CAN HELP WITH DIAGNOSIS 3

SKIN PLAQUES

Patient with skin plaque due to psoriatic arthritis

~85%

of patients with psoriatic arthritis develop psoriasis before experiencing joint symptoms 3

SCALP PSORIASIS

Patient with scalp psoriasis at risk for psoriatic arthritis

70% to 90%

of patients with psoriatic arthritis may present with scalp psoriasis 4,5

The risk of psoriatic arthritis in patients with psoriasis can be ~4x higher for patients with scalp involvement 6,*

NAIL PSORIASIS

Patient's fingers with nail psoriasis at risk of psoriatic arthritis

Up to 80%

of patients with psoriatic arthritis showed signs of nail psoriasis 7

The presence of nail psoriasis can help clinicians with diagnosing psoriatic arthritis 8

*Plaque psoriasis diagnoses were validated through a medical-record analysis of 1,633 patients. Incident and clinically recognized patients with PsA were classified according to CASPAR. Cox proportional hazards models were used to identify predictors of PsA within the plaque psoriasis cohort.

PsA IS MORE THAN JOINTS 9

Image of a swollen foot due to psoriatic arthritis
Patient's fingers with joint tenderness and swelling from psoriatic arthritis
Patient with swollen fingers from psoriatic arthritis

Joint tenderness and swelling

  • 68% of patients with psoriatic arthritis have peripheral arthritis (tender and swollen joint count >0) 10
  • Patients and physicians agree that joint tenderness, soreness, and pain are among the most common aspects of psoriatic disease 11

Dactylitis

  • Dactylitis occurs in up to 53% of patients with psoriatic arthritis 12
  • The physical impact of psoriatic arthritis is greater in patients with dactylitis 9

Enthesitis

  • Enthesitis has been reported in up to 78% of patients with psoriatic arthritis 12
  • The physical impact of psoriatic arthritis is greater in patients with enthesitis 9

Axial symptoms

  • About 25% to 70% of patients with psoriatic arthritis have axial involvement and experience inflammatory back pain and stiffness, along with spinal involvement on imaging 13
  • The characterization of axial psoriatic arthritis is not fully understood. Therefore, further examination of the characteristics in patients with axial involvement is necessary to determine the proper course of treatment 14

Fatigue

  • Fatigue is a common symptom of psoriatic arthritis, with 49.5% of patients experiencing at least moderate fatigue and 28.7% experiencing severe fatigue 15
  • Fatigue is a key component of the overall impact of psoriatic arthritis on patients 15

Pain

  • 89% of patients with psoriatic arthritis report experiencing joint pain 16
  • 45% of patients listed joint pain/swelling as the most important factor leading to disease severity 16

CASPAR, Classification of Psoriatic Arthritis; PsA, psoriatic arthritis.

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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

References: 1. Mease PJ, Armstrong AW. Drugs. 2014;74(4):423-441. 2. Arthritis Foundation. arthritis.org. Accessed December 6, 2022. 3. National Psoriasis Foundation. psoriasis.org. Accessed December 8, 2022. 4. Yang Q, Qu L, Tian H, et al. J Eur Acad Dermatol Venereal. 2011;25(12):1409-1414. 5. Spelman L, Su JC, Fernandez-Peñas P, et al. J Eur Acad Dermatol Venereal. 2015:29(11):2184-2191. 6. Wilson FC, Icen M, Crowson CS, et al. Arthritis Rheum. 2009; 61(2):233-239. 7. Sobolewski P, Walecka I, Oopytalska K. Reumatologia. 2017;55(3):131-135. 8. Gottlieb A, Korman NK, Gordon KB, et al. J Am Acad Dermatol. 2008;58(51):851-864. 9. Kavanaugh A, Helliwell P, Ritchlin CT. Rheumatol Ther. 2016;3(1):91-102. 10. Ogdie A, Shin D, Choi H, et al. Ann Rheum Dis. 2019. doi:10.1136/annrheumdis-2019-eular.4991 11. Husni ME, Fernandez A, Hauber B, et al. Arthritis Res Ther. 2018;20(1):102. 12. Sakkas LI, Alexiou I, Simopoulou T, et al. Arthritis Rheum. 2013;43(3):325-334. 13. Gottlieb AB, Merola JF. J Am Acad Dermatol. 2021;84(1):92-101. 14. Coates LC, Kavanaugh A, Mease PJ, et al. Arthritis Rheumatol. 2016;68(5):1060-1071. 15. Husted JA, Tom BD, Schentag CT, et al. Ann Rheum Dis. 2009;68(10):1553-1558. 16. Lebwohl MG, Bachelez H, Barker J, et al. J Am Acad Dermatol. 2014;70(5):871-881.