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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.

JUMP TO:

With Otezla, scalp symptoms don’t have to be difficult to treat 1,2

STYLE: ScPGA RESPONSE

STYLE: Evaluated in adult patients with moderate to severe plaque psoriasis and moderate to severe plaque psoriasis of the scalp (N=303); age ≥18 years, BSA involvement ≥10%, sPGA score ≥3, PASI score ≥12, ScPGA score ≥3, SSA ≥20% 3

badge 1st

Otezla is the first oral medication with data in the label for adult patients with scalp psoriasis

 

OTEZLA SIGNIFICANTLY IMPROVED SCALP (ScPGA) RESPONSE AT WEEK 16 2-4

Graphic of orange circle with text that reads 3x as many Otezla patients achieved scalp improvement at week 16 vs placebo

STYLE: Proportion of patients achieving ScPGA response at week 16

Graphic of orange circle with text that reads 3x as many Otezla patients achieved scalp improvement at week 16 vs placebo
Bar chart of a STYLE study for scalp itch patients that represents the proportion achieving ScPGA response by week 16 on Otezla

*ScPGA is evaluated on a 5-point scale (0 [clear], 1 [almost clear], 2 [mild], 3 [moderate], 4 [severe]), assessing the severity of erythema, scaling, and plaque elevation. †ScPGA response was defined as the proportion of patients achieving ScPGA response score of 0 (clear) or 1 (almost clear) with at least a
2-point reduction from baseline (Otezla 43% vs placebo 14%; P<0.0001).

See Scalp Itch NRS
Response at Week 16
See WBI-NRS
at Week 16
Video about the STYLE clinical trial study design and primary enbpoint of Otezla® (apremilast)

STYLE Data Video

WATCH VIDEOS

RESULTS SEEN IN OTEZLA PATIENTS

BASELINE
WEEK 16
ScPGA: 0
3-point improvement
in ScPGA score

Actual clinical trial patient from STYLE. 4
Individual results may vary.

BASELINE
WEEK 16
ScPGA: 2
1-point improvement in ScPGA score

Actual clinical trial patient from STYLE. 4
Individual results may vary.

BASELINE
WEEK 16
ScPGA: 3
1-point improvement in ScPGA score

Actual clinical trial patient from STYLE. 4
Individual results may vary.

Thumbnail of plaque psoriasis STYLE results at week 16 on the ear of a femaie Otezla patient
Thumbnail of plaque psoriasis STYLE results at week 16 on the scalp of a male Otezla patient
Thumbnail of plaque psoriasis STYLE results at week 16 on the ear of a male Otezla patient
Explore Extended Patient Photo Library

SCALP (ScPGA) RESPONSE
THROUGH WEEK 32 4

STYLE: ScPGA response by timepoint through week 32

Line chart of a STYLE study that represents the scalp itch ScPGA response by timepoint through week 32 on Otezla

Note: For each timepoint in a treatment arm, n = number of observed responded patients, N = total number of patients, and response rate (%) was calculated as 100*n/N. For assessments before week 16, N includes all randomized patients. For assessments after week 16, N includes only patients who entered the OLE phase. 4

‡ScPGA is evaluated on a 5-point scale (0 [clear], 1 [almost clear], 2 [mild], 3 [moderate], 4 [severe]), assessing the severity of erythema, scaling, and plaque elevation. §ScPGA response was defined as the proportion of patients achieving ScPGA response score of 0 (clear) or 1 (almost clear) with at least a
2-point reduction from baseline.

Bars represent 2-sided 95% confidence interval. 4

  • Consider open-label treatment phase study limitations when interpreting results. The open-label extension (OLE) was not blinded, not controlled, and included inherent self-selection bias. Overall, a total of 33 patients (13.3%) discontinued during the study, of which 6 patients (2.4%) discontinued due to adverse events 4

OTEZLA SHOWED SIGNIFICANT IMPROVEMENT IN SCALP PSORIASIS THROUGH WEEK 32 4

ADVANCE: ScPGA WEEK 16

ADVANCE: Evaluated in patients with mild to moderate plaque psoriasis (N=595); age ≥18 years, sPGA score 2-3,
BSA involvement 2%-15%, PASI score 2-15 2,5

IN MILD TO MODERATE PLAQUE PSORIASIS OTEZLA DEMONSTRATED
SIGNIFICANT IMPROVEMENT IN SCALP RESPONSE 2,5

ADVANCE: Proportion of patients achieving ScPGA response at week 16

Bar chart of the Otezla ADVANCE clinical trial for mild to moderate plaque psoriasis in scalp

**In patients with ScPGA ≥2 at baseline. ScPGA score of clear [0] or almost clear [1] with at least a 2-point reduction from baseline.

Emily, hypothetical patient with plaque psoriasis of the scalpEmily, hypothetical patient with plaque psoriasis of the scalp

For patients like Emily, scalp psoriasis and itch might be difficult to treat with topicals alone 1,6

Not actual patients

ESTEEM 1: ScPGA RESPONSE

ESTEEM 1: Evaluated in patients with moderate to severe plaque psoriasis (N=844); age ≥18 years, BSA involvement ≥10%, sPGA ≥3, PASI score ≥12 2

IMPROVEMENT IN SCALP (ScPGA) RESPONSE AT WEEK 16 4,7

ESTEEM 1: Proportion of patients with an ScPGA score of clear (0) or minimal (1) at week 16

Bar chart of an ESTEEM 1 study that represents the proportion of patients with a ScPGA score of clear or minimal at week 16 on Otezla

††In the planned hierarchical statistical testing sequence for ESTEEM, efficacy analyses preceding ScPGA were statistically significant, allowing for control of the overall type 1 error rate at 0.05 significance level in analysis of ScPGA. ‡‡Baseline ScPGA ≥3.

RESULTS SEEN IN OTEZLA PATIENTS

BASELINE
WEEK 16
ESTEEM 1: PASI-63 result§§

Actual clinical trial patient from ESTEEM. 4 Individual results may vary.
§§PASI-63 response: A 63% reduction in a patient's PASI score. 4

Explore Extended Patient Photo Library

SUSTAINED RESULTS IN SCALP RESPONSE (ScPGA SCORES) THROUGH
5 YEARS 4

ESTEEM 1: Proportion of patients with an ScPGA score of clear (0) or minimal (1) through 260 weeks

Line chart of an ESTEEM 1 study that represents the proportion of patients with ScPGA score of clear or minimal through 260 weeks on Otezla

***FAS. †††Baseline ScPGA ≥3. ‡‡‡Statistical analyses were conducted in a hierarchical manner for efficacy endpoints, including ScPGA score, to control the overall type 1 error rate. §§§Randomized treatment withdrawal phase (weeks 32 to 52) where additional psoriasis therapies, including topicals and/or phototherapy, could have been added to PASI-75 nonresponders. Please see study design for additional information.

  • Data are presented "as observed" with no imputation for missing values 4
  • Consider open-label extension (OLE) study limitations when interpreting results. The OLE is not blinded, not controlled, and includes self-selection bias. Of the 443 patients treated with apremilast from weeks 52 to 260, 26.6% (n=118) discontinued due to lack of efficacy, 22.6% (n=100) withdrew from the study, 8.6% (n=38) discontinued due to an adverse event, and 7.0% (n=31) were lost to follow-up 4
Thumbnail of Otezla 5-year safety data video

5-Year Safety Data Video

WATCH VIDEO

LIBERATE: SCALP RESPONSE

LIBERATE: Evaluated in adult patients with chronic moderate to severe plaque psoriasis for ≥12 months (N=250); PASI score ≥12, BSA involvement ≥10%, sPGA score ≥3, no prior exposure to a biologic therapy 8

SCALP RESPONSE IN BIOLOGIC-NAÏVE PATIENTS AT WEEK 16 8

LIBERATE: Patients with ScPGA score of clear (0) or minimal (1) at week 16

Bar chart of a LIBERATE study representing scalp response in biologic-naïve patients on Otezla

This is an exploratory analysis and has not been adjusted for multiple comparisons. No conclusions of statistical or clinical significance can be drawn. 4

****Baseline ScPGA ≥3.

 

BID, twice daily; BSA, body surface area; FAS, full analysis set; ITT, intent to treat; LOCF, last observation carried forward; MI, multiple imputation; mITT, modified intent to treat; NRI, nonresponder imputation; NRS, numeric rating scale; PASI, Psoriasis Area and Severity Index; ScPGA, Scalp Physician Global Assessment; SE, standard error; sPGA, static Physician Global Assessment; SSA, scalp surface area; WBI-NRS, whole body itch numeric rating scale.

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. Otezla [package insert]. Thousand Oaks, CA: Amgen Inc. 3. Van Voorhees AS, Gold LS, Lebwohl M, et al. J Am Acad Dermatol. 2020;83(1):96-103. 4. Data on file, Amgen Inc. 5. Stein Gold L, Papp K, Pariser D, et al. J Am Acad Dermatol. 2022;86(1):77-85. 6. Kaplan D, et al.
J Dermatol Treat. 2022;33(6):2844-2852. 7. Papp K, Reich K, Leonardi CL, et al. J Am Acad Dermatol.
2015;73(1):37-49. 8. Reich K, Gooderham M, Green L, et al. J Eur Acad Dermatol Venereol. 2017;31(3):507-517.