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Otezla® (apremilast) Patient Profiles in PsO, PsA, and BD
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3 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 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

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 ACTIVE
Psoriatic Arthritis
Overview ACR20 Response Joint Tenderness and Swelling Dactylitis Enthesitis Fatigue Pain Physical Function cDAPSA
Psoriatic Arthritis
Overview Adverse Reactions Through Week 16 Adverse Reactions Through 5 Years ACTIVE Adverse Events of Special Interest Laboratory Parameters
Plaque Psoriasis
Why Systemic Therapy? About Plaque Psoriasis
Plaque Psoriasis
Overview ADVANCE ESTEEM STYLE DISCREET LIBERATE
Plaque Psoriasis
Overview Mild to Moderate
Plaque Psoriasis PASI-75 Response Mean PASI Response Scalp Response Nail Response Itch Response Genital Response Patient Photo Library
Plaque Psoriasis
Overview Adverse Reactions Through Week 16 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 Formulary Access Co-Pay and Patient Support
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: 840,000+ patients treated globally since 2014 1.3,* PLAQUE PSORIASIS SAFETY PsA SAFETY

A small pill with a big history: 840,000+ patients treated globally since 2014 1.3,*

PLAQUE PSORIASIS SAFETY PsA SAFETY REFERENCES & FOOTNOTE
REFERENCES REFERENCES & FOOTNOTE

*Estimates of patients treated reflect global data since launch (Apr 2014-Mar 2023; US=58% 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
    • Was recently diagnosed with psoriatic arthritis
    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

  • Mike, hypothetical patient newly diagnosed with psoriatic arthritis

    MIKE NEWLY DIAGNOSED WITH PSORIATIC ARTHRITIS. ALSO
    STRUGGLES WITH PLAQUE PSORIASIS DESPITE
    TOPICAL TREATMENT

    45 years old

    Engineer

    Mike was diagnosed with PsA 6 months ago and is struggling with joint tenderness despite treatment with an NSAID

    Presentation

    • 3 SJC, 3 TJC
    • Joint pain in the knees and hands

    Treatment History

    • OTC NSAIDs
    • Tried multiple topicals for plaque psoriasis

    Considerations

    • Seeking a treatment that fits active lifestyle
    • Plaque psoriasis with nail involvement

    Patients and physicians agree that joint tenderness, soreness, and pain are among the most impactful aspects of psoriatic disease 7

    Foot with soreness and pain from psoriatic arthritis
    Hands with joint tenderness from psoriatic arthritis

    Hypothetical patient

  • Ava, hypothetical patient with comorbidities and loss of physical function

    AVA CHALLENGED WITH LOSS OF PHYSICAL FUNCTION

    45 years old

    Executive Assistant

    Ava suffers with physical function loss and has comorbidities to consider

    Presentation

    • 11 SJC, 20 TJC
    • Physical function loss as a result of swollen joints and knee pain

    Treatment History

    • Celecoxib (NSAID): 200 mg BID
    • Physical therapy

    Considerations

    • Obesity
    • Fatty liver disease
    • Physical function loss impacts work and day-to-day activities at home
    • Needle-hesitant

    Improving physical function response should be considered in the treatment of PsA 8

    • Patients with PsA can experience physical function impairment in daily activities, such as dressing/grooming, eating, and walking 9
    Hypothetical patient with psoriatic arthritis with physical function loss in their knees
    Hypothetical patient with psoriatic arthritis with physical function loss in their hands

    Hypothetical patient

  • David, hypothetical patient with dactylitis and enthesitis

    DAVID SUFFERS WITH DACTYLITIS AND ENTHESITIS
    DESPITE TREATMENT WITH METHOTREXATE

    52 years old

    Data Analyst

    David battles dactylitis and enthesitis

    Presentation

    • 11 SJC, 21 TJC
    • Dactylitis and enthesitis, elbow pain
    • Physical function loss associated with joint pain

    Treatment History

    • MTX 15 mg/week

    Considerations

    • Difficulty complying with lab monitoring
    • Frustrated with current treatment (MTX) due to side effects
    • Has hypertension

    The physical impact of PsA is greater in patients with dactylitis or enthesitis 9

    • Dactylitis occurs in up to 53% of patients with PsA 10
    • Enthesitis has been reported in 25% to 78% of patients with PsA 10
    Knee experiencing physical impact of psoriatic arthritis with dactylitis or enthesitis
    Elbow experiencing physical impact of psoriatic arthritis with dactylitis or enthesitis

    Hypothetical patient

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 11

    • Oral ulcers are the most frequently observed manifestation in Behçet’s Disease 12,13
    Oral ulcers inside the mouth area
    Oral ulcers on the tongue

    Hypothetical patient

BID, twice daily; BSA, body surface area; MTX, methotrexate; NSAID, nonsteroidal anti-inflammatory drug; OTC, over-the-counter; PsA, psoriatic arthritis; PsO, plaque psoriasis; SJC, swollen joint count; TJC, tender joint count.

Accordion icon

IMPORTANT SAFETY INFORMATION 

Contraindications

Otezla 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

IMPORTANT SAFETY INFORMATION

Contraindications

  • Otezla 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 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 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
    • 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 patients with mild to moderate plaque psoriasis was consistent with the safety profile previously 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® (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 adult patients with active psoriatic arthritis.

Otezla is indicated for the treatment of 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;66:33-40. 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. psoriasis.org/the-pocket-guide. Accessed August 22, 2023. 6. Kimmel GW, Lebwohl M. Psoriasis: Overview and Diagnosis. In: Evidence-Based Psoriasis. Updates in Clinical Dermatology . 2018;1-16. 7. Husni ME, Fernandez A, Hauber B, et al. Arthritis Res Ther. 2018;20(1):102. 8. Cutolo M, Myerson GE, Fleischmann RM, et al. J Rheumatol. 2016;43(9):1724-1734. 9. Kavanaugh A, Helliwell P, Ritchlin CT. Rheumatol Ther. 2016;3(1):91-102. 10. Sakkas LI, Alexiou I, Simopoulou T, et al. Semin Arthritis Rheum. 2013;43(3):325-334. 11. Barnes CG. In: Yazici Y, Yazici H, eds. Behcet’s Syndrome. Springer. 2010:7-33. 12. Alpsoy E, Akman A. Therapy. 2016;3(1)139-151. 13. Alpsoy E, Donmez L, Onder M, et al. Br J Dermatol. 2007;157(5);901-906.