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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

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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: 760,000+ patients treated globally since 2014 1.3,* PLAQUE PSORIASIS SAFETY PsA SAFETY

A small pill with a big history: 760,000+ 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-Aug 2022; US=approximately 60% 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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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

    Insurance Account Manager

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

    Presentation

    • Plaque psoriasis of the scalp and neck
    • 2% BSA
    • Complains of redness, flaking, and intense itch

    Treatment History

    • Rx shampoo
    • Tried multiple topicals

    Considerations

    • Odor of Rx shampoo
    • Grease residue from topicals
    • Flakes showing on clothing
    • Itch relief

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

    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 MILD PLAQUE PSORIASIS PATIENT WHO HAS TRIED
    MULTIPLE TOPICALS

    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

    Considerations

    • Treatment compliance due to an active lifestyle

    PSORIASIS IS A CHRONIC SYSTEMIC DISEASE THAT MAY BENEFIT
    FROM A SYSTEMIC THERAPY 4

    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 DIFFICULT-TO-TREAT PSORIASIS OF THE NAILS

    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, 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

    ABOUT 50% OF PATIENTS WHO HAVE PLAQUE PSORIASIS ALSO
    HAVE FINGERNAIL INVOLVEMENT     5

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

    Hypothetical patient

Psoriatic Arthritis

  • Noah, hypothetical patient who's newly diagnosed with psoriatic arthritis

    NOAH NEWLY DIAGNOSED WITH PSORIATIC ARTHRITIS

    32 years old

    Restaurant Manager

    Noah is newly diagnosed with PsA and struggling with joint tenderness
    despite treatment with an NSAID

    Presentation

    • Recently diagnosed
    • Total joint count: 4 SJC, 7 TJC, no erosions

    Treatment History

    • Naxopren (NSAID): 500 mg BID

    Considerations

    • Consumes alcohol
    • Seeking a treatment that fits active lifestyle

    PATIENTS AND PHYSICIANS AGREE THAT JOINT TENDERNESS, SORENESS,
    AND PAIN ARE AMONG THE MOST IMPACTFUL ASPECTS OF PSORIATIC DISEASE 6

    Hypothetical patient with joint tenderness in their knee
    Hypothetical psoriatic arthritis patient with soreness and pain in their arms

    Hypothetical patient

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

    AVA COMORBIDITIES AND LOSS OF PHYSICAL FUNCTION

    45 years old

    Executive Assistant

    Ava struggles with physical function loss
    and has comorbidities to consider

    Presentation

    • Total joint count: 6 SJC,
      9 TJC, physical function
      loss as a result of swollen/
      tender joints, no erosion

    Treatment History

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

    Considerations

    • BMI: 34
    • Fatty liver disease

    Improving physical function response should be considered in the treatment of PsA 7

    • Patients with PsA can experience physical function impairment in daily activities, such as dressing/grooming, eating, and walking 8
    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

  • Naomi, hypothetical patient who isn't ready for a biologic treatment

    Naomi DACTYLITIS AND ENTHESITIS, BUT NOT READY
    FOR A BIOLOGIC TREATMENT

    48 years old

    Journalist

    Naomi struggles with dactylitis and enthesitis

    Presentation

    • Total joint count: 9 SJC,
      13 TJC, dactylitis and
      enthesitis flares, no
      erosions

    Treatment History

    • Indomethacin (NSAID):
      150 mg QD
    • Physical therapy

    Considerations

    • Needle-hesitant
    • Treatment and lab-monitoring compliance issues due to work schedule

    The physical impact of PsA is greater in patients with dactylitis or enthesitis 8

    • Dactylitis occurs in up to 53% of patients with PsA 9
    • Enthesitis has been reported in 25% to 78% of patients with PsA 9
    Image of hands with psoriatic arthritis
    Hypothetical patient with dactylitis or enthesitis feeling the physical impact of psoriatic arthritis

    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 10

    • Oral ulcers are the most frequently observed
      manifestation in Behçet’s Disease 11,12
    Oral ulcers inside the mouth area
    Oral ulcers on the tongue

    Hypothetical patient

BSA, body surface area; NSAID, nonsteroidal anti-inflammatory drug; PsA, psoriatic arthritis.

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
  • 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. Van Voorhees AS, Feldman SR, Lebwohl MG, et al. psoriasis.org/the-pocket-guide. Accessed December 8, 2022. 5. Kimmel GW, Lebwohl M. Springer. 2018:1-16. 6. Husni ME, Fernandez A, Hauber B, et al. Arthritis Res Ther. 2018;20(1):102. 7. Cutolo M, Myerson GE, Fleischmann RM, et al. J Rheumatol. 2016;43(9):1724-1734. 8. Kavanaugh A, Helliwell P, Ritchlin CT. Rheumatol Ther. 2016;3(1):91-102. 9. Sakkas LI, Alexiou I, Simopoulou T, et al. Semin Arthritis Rheum. 2013;43(3):325-334. 10. Barnes CG. In: Yazici Y, Yazici H, eds. Behcet's Synrdone. Springer; 20210:7-33. 11. Alpsoy E, Akman. A. Therapy. 2016;3(1)139-151. 12. Alpsoy E, Donmez L, Onder M, et al. Br J Dermatol. 2007;157(5);901-906.