Close window icon

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.
Read less
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.

JUMP TO:

OTEZLA PATIENT PROFILES

Your patients may be ready for an oral systemic therapy—keep an eye out for patients like these in your practice

Plaque Psoriasis

  • Emily, hypothetical patient with plaque psoriasis of the scalp

    Emily PLAQUE PSORIASIS PATIENT WITH SCALP INVOLVEMENT

    48 years old

    Account Manager

    Emily has prominent scalp psoriasis and intense itch, which can be
    difficult to treat with topicals alone 1,2

    Presentation

    • Limited skin involvement with scalp psoriasis, flaking, and itch
    • 2% BSA
    • Complains of redness, flaking, and intense itch

    Treatment History

    • Rx shampoo
    • Tried multiple topicals and frustrated with messy application

    Considerations

    • Grease residue from topicals
    • Flakes showing on clothing
    • Itch relief
    scalp-psoriasis

    UP TO 80% OF PATIENTS WHO HAVE PLAQUE PSORIASIS ALSO HAVE SCALP INVOLVEMENT 3

    ~76% of patients with limited skin involvement had unresolved scalp psoriasis despite topical therapy 2,*

    PATIENTS WITH SCALP PSORIASIS ARE AT A ~4X HIGHER RISK OF DEVELOPING PSORIATIC ARTHRITIS 2,4,†

    *Based on a real-world study of 304 adult systemic-naïve patients with mild to moderate (BSA ≤ 10%) plaque psoriasis from a survey of physicians; patients still affected by scalp psoriasis (n=120/158). Data were drawn from the 2017 to 2018 Adelphi Psoriasis Disease Specific Programme. Most patients were receiving a generic topical steroid formulation at the time of consultation (72.7%, n=221); 23.4% (n=71) were receiving a generic topical non-steroid formulation, and 24.7% (n=75) were receiving advanced/branded topical products with multiple active formulations. †In a population-based setting, among 1633 patients first diagnosed with plaque psoriasis, 97 subjects were diagnosed with psoriatic arthritis according to the CASPAR criteria. Cox proportional hazard models were used to identify predictors of psoriatic arthritis within the psoriasis cohort.

    Hypothetical patient with scalp psoriasis
    Hypothetical patient with plaque psoriasis with an intense itch

    Hypothetical patient

  • Chris, hypothetical mild plaque psoriasis patient who is ready for an oral medication

    CHRIS HAS DIFFICULTY WITH TOPICAL TREATMENT

    40 years old

    Electrician

    Your patients like Chris might be ready for a systemic treatment

    Presentation

    • Plaque psoriasis of the arms (elbow) and back
    • 3% BSA
    • Complains of visible itchy plaques and flaking

    Treatment History

    • Tried multiple topicals and frustrated due to application
    • Reports nonadherence to topical therapy due to busy lifestyle and concerns about staining clothes

    Considerations

    • Nervous about trying any treatment that has not been on the market for at least a few years

    Psoriasis is a chronic systemic disease that may benefit from a systemic therapy 5

    Hypothetical patient with plaque psoriasis on their elbow and back
    Hypothetical patient with plaque psoriasis on their back

    Hypothetical patient

  • Ivan, hypothetical patient with plaque psoriasis on nails

    IVAN STRUGGLES WITH BOTH PLAQUE PSORIASIS
    AND PSORIATIC ARTHRITIS

    37 years old

    Teacher and Coach

    Your patients, like Ivan, might be struggling to get results with topicals
    that are challenging to apply

    Presentation

    • Plaque psoriasis on nails, hands, arms, and abdomen
    • 5% BSA
    • Complains of purple flakey patches and gray scales

    Treatment History

    • Tried multiple topicals

    Considerations

    • Has found topicals to be messy and time consuming
    • Challenges with symptom improvement with current treatments
    • Struggles to cover up plaques
    nail psoriasis

    About 50% of patients who have plaque psoriasis also have fingernail involvement 6

    92% of patients with limited skin involvement had nail psoriasis that persisted despite topical therapy 2,*

    Patients with nail psoriasis are at a ~3x higher risk of developing psoriatic arthritis 4,†

    *Based on a real-world study of 304 adult systemic-naïve patients with mild to moderate (BSA ≤ 10%) plaque psoriasis from a survey of physicians; patients still affected by nail psoriasis (n=24/26). Data were drawn from the 2017 to 2018 Adelphi Psoriasis Disease Specific Programme. Most patients were receiving a generic topical steroid formulation at the time of consultation (72.7%, n=221); 23.4% (n=71) were receiving a generic topical non-steroid formulation, and 24.7% (n=75) were receiving advanced/branded topical products with multiple active formulations. †In a population-based setting, among 1633 patients first diagnosed with plaque psoriasis, 97 subjects were diagnosed with psoriatic arthritis according to the CASPAR criteria. Cox proportional hazard models were used to identify predictors of psoriatic arthritis within the psoriasis cohort.

    Plaque psoriasis on darker skin tone
    Darker skin tone hand with plaque psoriasis on skin and nails

    Hypothetical patient

Psoriatic Arthritis

  • Fred, hypothetical patient with joint tenderness from psoriatic arthritis

    FREDSTRUGGLING WITH JOINT TENDERNESS DESPITE
    TREATMENT WITH AN NSAID

    34 years old

    Presentation

    • Total joint count: 2 SJC, 3 TJC
    • Physical function loss as a
      result of swollen/tender joints

    Treatment History

    • Naproxen (NSAID): Dose increased to 500 mg BID

    Patient Considerations

    • Seeking treatment that fits
      within his active lifestyle
    Swollen, tender finger joints
    Loss of physical function in hands
  • Paula, hypothetical patient with psoriatic arthritis

    PAULA PsA AND STRUGGLES WITH LOSS OF PHYSICAL
    FUNCTION ASSOCIATED WITH TENDER AND
    SWOLLEN JOINTS

    51 years old

    Presentation

    • Total joint count: 6 SJC, 9 TJC
    • Dactylitis and enthesitis

    Treatment History

    • Celecoxib (NSAID): Dose increased to 200 mg BID
    • Physical therapy

    Patient Considerations

    • BMI: 30
    Swollen heel
    Swollen toes

Oral Ulcers in Behçet’s Disease

  • Joseph, hypothetical patient with oral ulcers in Behçet's disease

    JOSEPH RECURRENT ORAL ULCERS

    37 years old

    Chef

    Joseph suffers from pain associated with his recurrent oral ulcers

    Presentation

    • Total ulcer count: 4 (1 major type, 3 minor type)

    Treatment History

    • Failed colchicine (2 mg/day)
    • Topical treatments (triamcinolone acetonide, dexamethasone) used for oral ulcer pain had limited success

    Considerations

    • Pain from oral ulcers associated with Behçet’s Disease

    98% of patients experience oral ulcers 7

    • Oral ulcers are the most frequently observed manifestation in Behçet’s Disease 8,9
    Oral ulcers inside the mouth area
    Oral ulcers on the tongue

    Hypothetical patient

 

BID, twice daily; BMI, body mass index; BSA, body surface area; CASPAR, Classification of Psoriatic Arthritis; NSAID, nonsteroidal anti-inflammatory drug; PsA, psoriatic arthritis; SJC, swollen joint count; TJC, tender joint count.

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. Aldredge LM, Higham RC. JDNA. 2018;10(4):189-197. 2. Kaplan D, Hetherington J, Lucas J, et al. J Dermatolog Treat. 2022;33(6):2844-2852. 3. Blakely K, Gooderham M. Psoriasis (Auckl). 2016;6:33-40. 4. Wilson FC, Icen M, Crowson CS, et al. Arthritis Rheum. 2009;61(2):233-239. 5. Van Voorhees AS, Feldman SR, Lebwohl MG, et al. The Psoriasis and Psoriatic Arthritis Pocket Guide. psoriasis.org/the-pocket-guide. Accessed February 1, 2024. 6. Kimmel GW, Lebwohl M. Psoriasis: overview and diagnosis. In: Bhutani T, Liao W, Nakamura M, eds. Evidence-based Psoriasis: Diagnosis and Treatment. Springer; 2018:1-6. 7. Barnes CG. History and diagnosis. In: Yazici Y, Yazici H, eds. Behçet’s Syndrome. Springer; 2010:7-33. 8. Alpsoy E, Akman A. Therapy. 2016;3(1):139-151. 9. Alpsoy E, Donmez L, Onder M, et al. Br J Dermatol. 2007;157(5):901-906.