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4 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 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
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Oral Ulcers in Behçet’s Disease
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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 Tolerability ACTIVE Safety Adverse Events of Special Interest Laboratory Parameters
Plaque Psoriasis
Why Systemic Therapy? About Plaque Psoriasis Patient Stories
Plaque Psoriasis
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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 Mild to Moderate Plaque PsO Moderate to Severe Plaque PsO Pediatric
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Plaque Psoriasis Psoriatic Arthritis Oral Ulcers in Behçet's Disease
How Otezla Works
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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PSORIASIS AFFECTS MORE THAN 8 MILLION
PEOPLE IN THE UNITED STATES 1

Plaque psoriasis can manifest in multiple ways:
Patient with plaque psoriasis on the torso

Skin

  • Flaking, scaling, and itching of nonscalp areas were among the most frequently reported symptoms in psoriasis 2
  • Despite the number of treatment options, patients with psoriasis often struggle to get clearer skin 3
Plaque psoriasis patient with plaque on scalp

Scalp

  • Scalp psoriasis is characterized by red thickened plaques along the hairline, on the forehead, ears, or on the back of the neck 4
  • Up to 80% of patients who have plaque psoriasis also have scalp involvement 4

“When going for a haircut, I always feel like I need to warn people: ‘I have plaque psoriasis on my scalp.’”

—Genine, an actual patient compensated for her time

Arm with irritation from itching due to plaque psoriasis

Itch

  • 60%-96% of psoriasis patients experience itch 5
  • Patients consider itching to be the biggest contributor to disease severity at 5X the rate that dermatologists do (38% vs 7%) 6

“You try to be mindful about not touching your scalp, but it's really hard because it is really uncomfortable and itchy.”

—Genine, an actual patient compensated for her time

Patient's hand with fingernail psoriasis

Nail

  • About 50% of all patients with psoriasis will have fingernail involvement 1
  • Nail psoriasis can manifest in several different ways in plaque psoriasis, including pitting and red spots, and is a difficult condition to treat 7,8
genital_area

Genital Area

  • ~46% of plaque psoriasis patients have not discussed their genital area psoriasis with a physician due to embarrassment 1
  • More than 2 out of 3 patients with psoriasis of the genital area are undertreated, having never applied treatment to their genital regions 9
Plaque psoriasis on darker skin tone

PATIENTS WITH DARKER SKIN TONES ARE MORE LIKELY TO HAVE UNDIAGNOSED PSORIASIS.

Plaques may be thicker, purple in color, and have more scaling. 10

REGARDLESS OF WHERE PLAQUE PsO MANIFESTS, IT IS OFTEN MORE THAN SKIN DEEP FOR PATIENTS 11,12

85

of patients with mild to moderate plaque psoriasis reported feeling “embarrassed or self-conscious because of their skin” 13,*

50

of patients with mild to moderate disease perceived their severity to be worse than their affected BSA in the UPLIFT survey 14,†,‡

56

of psoriasis patients on therapy have cycled through 3 or more topicals and have not used an advanced therapy 15,§

RISK FACTORS OF DEVELOPING PSORIATIC ARTHRITIS INCLUDE:

Scalp Psoriasis:
Nail Psoriasis:
40

of patients with psoriasis are at risk of developing psoriatic arthritis 16

Scalp Psoriasis:
4x

higher risk of developing psoriatic arthritis compared to patients without scalp involvement 17,**

Nail Psoriasis:
3x

higher risk of developing psoriatic arthritis compared to patients without nail involvement 17,**

*According to a US cross-sectional survey conducted among 175 adult systemic-naïve patients with mild to moderate plaque psoriasis (BSA ≤10%). †Based on the UPLIFT survey, a multinational online survey conducted from March 2 to June 3, 2020, including adult patients (≥18 years of age) who reported that they had been diagnosed with plaque psoriasis and/or psoriatic arthritis by a healthcare professional. 1006 patients were surveyed in the United States. ‡In the UPLIFT survey, mild disease was defined as ≤3 palms of affected area and moderate disease was defined as 4-10 palms of affected area. §Data based on active psoriasis patients on therapy between June 2023 to May 2024. Analysis is based on IQVIA Longitudinal Access and Adjudication Dataset (LAAD) claims. IQVIA LAAD is an open claim data source and does not have 100% patient capture. Additionally, the stability rules minimize patient capture changes within the dataset. Advanced therapies included biologic, pre-biologic, and systemic treatments. **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.

BSA, body surface area; CASPAR, Classification of Psoriatic Arthritis; PsO, plaque psoriasis.

Plaque psoriasis is a systemic disease that may benefit from a systemic therapy. 11

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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

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

Please click here for the full Prescribing Information.

References: 1. National Psoriasis Foundation. Psoriasis statistics. psoriasis.org/psoriasis-statistics/ Accessed March 28, 2025. 2. Pariser D, Schenkel B, Carter C, et al; Psoriasis Patient Interview Study Group. J Dermatolog Treat. 2016;27(1):19-26. 3. Mrowietz U, Kragballe K, Reich K, et al. Arch Dermatol Res. 2011;303(1):1-10. 4. Blakely K, Gooderham M. Psoriasis (Auckl). 2016;6:33-40. 5. Strober BE, van der Walt JM, Armstrong AW, et al. Dermatol Ther (Heidelb). 2019;9(1):5-18. 6. Van de Kerkhof PCM, Reich K, Kavanaugh A, et al. J Eur Acad Dermatol Venereol. 2015;29(10):2002-2010. 7. 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. 8. Pasch MC. Drugs. 2016;76(6):675-705. 9. Merola JF, Qureshi A, Husni ME. Dermatol Ther. 2018;31(3):e12589. 10. Kaufman BP, Alexis AF. Am J Clin Dermatol. 2018;19(3):405-423. 11. Bhutani T, Haberman R, Khattri S, et al. The Psoriasis and Psoriatic Arthritis Pocket Guide. psoriasis.org/the-pocket-guide/. 12. Schafer PH, Parton A, Capone L, et al. Cell Signal. 2014;26(9):2016-2029. 13. Gupta S, Garbarini S, Nazareth T, et al. Dermatol Ther (Heidelb). 2021;11(6):2057‑2075. 14. Lebwohl M, Ogdie A, Merola JF, et al. Presented at: 2021 Maui Derm for Dermatologists; January 25-29, 2020; Maui, HI. 15. Data on file, Amgen; May 2024. 16. Mease PJ, Armstrong AW. Drugs. 2014;74(4):423-441. 17. Wilson FC, Icen M, Crowson CS, et al. Arthritis Rheum. 2009;61(2):233-239.