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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.

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Treat itch below the surface with Otezla 1

ADVANCE:
WHOLE BODY ITCH RESPONSE

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 1,2

OTEZLA DEMONSTRATED SIGNIFICANT IMPROVEMENT IN WHOLE BODY ITCH (WBI)

AT WEEK 16 1,2

ADVANCE: Proportion of patients with improvement in itch [WBI-NRS] through week 16 vs placebo

Itch response comparing Otezla® (apremilast) and placebo

*In patients with WBI-NRS ≥4 at baseline. †P<0.0001.

ESTEEM 1: ITCH 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 4

OTEZLA SHOWED IMPROVEMENT IN MEAN PRURITUS VAS SCORES AT WEEK 16 4

ESTEEM 1: Mean improvement from baseline pruritus VAS scores at week 16

Bar chart of an ESTEEM 1 study that represents pruritus VAS scores at week 16 on Otezla

‡Pruritus was measured on a 100-mm VAS. §Baseline mean pruritus VAS scores (mm): Otezla, 66.2; placebo, 65.2.

SUSTAINED RESULTS IN MEAN PRURITUS VAS SCORES THROUGH 5 YEARS 3

ESTEEM 1: Mean change in baseline pruritus VAS scores through 260 weeks

Line chart of an ESTEEM 1 study that represents the mean change in baseline VAS scores through 260 weeks on Otezla

**FAS. ††Baseline mean pruritus VAS scores (mm): Otezla, 66.2; placebo, 65.2. ‡‡Week 16: secondary endpoint; all other timepoints: exploratory endpoints.
§§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 3
  • Consider open-label extension (OLE) study limitations when interpreting results. The OLE was not blinded, not controlled, and included 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 3
Thumbnail of Otezla 5-year safety data video

5-Year Safety Data Video

WATCH VIDEO

STYLE: SCALP ITCH RESPONSE

STYLE: Evaluated in adult patients with 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% 5

SIGNIFICANT AND RAPID SYMPTOM IMPROVEMENT IN SCALP ITCH AT WEEK 16 WITH ACHIEVEMENT OF RESPONSE AS
EARLY AS 2 WEEKS 3

STYLE: Scalp itch NRS response by timepoint through week 16

Line chart of a STYLE study that represents the proportion of Otezla patients achieving scalp itch NRS response through week 16

***Patients rated their scalp itch on a scale of 0 (no itch) to 10 (worst imaginable itch). Analyses were based on patients in the ITT population with baseline scalp itch NRS score ≥4. †††Scalp itch NRS response was defined as a ≥4-point reduction (improvement) from baseline. At baseline, the mean scalp itch NRS score was 6.7, with scales ranging from 0 to 10. ‡‡‡Due to the MI method used to analyze the data, the n value for patients who achieved response may be in decimals.

Error bars represent 95% confidence interval. 3

Icon of 47 percent number inside a sketched, orange and white circle

of patients taking Otezla achieved a
≥4-point improvement from baseline
in scalp itch NRS scores at week 16
vs placebo (21%) (P<0.0001) 5

Significant improvement
in scalp itch as early as

Graphic of an orange circle with text that reads Significant improvement in scalp itch as early as 2 weeks

Among moderate to severe scalp psoriasis patients in the STYLE clinical trial

SCALP ITCH RESPONSE THROUGH WEEK 32 3

STYLE: Scalp itch NRS response by timepoint through week 32

Line chart of a STYLE study that represents scalp itch 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. 3

§§§Patients rated their scalp itch on a scale of 0 (no itch) to 10 (worst imaginable itch). Analyses were based on patients in the ITT population with baseline scalp itch NRS score ≥4. ****Scalp itch NRS response was defined as a ≥4-point reduction (improvement) from baseline. ††††The placebo-controlled phase by visit (weeks 2, 4, 8, 12, 16) were secondary endpoints; OLE phase by visit (weeks 20, 24, 32) were exploratory endpoints.

Bars represent 2-sided 95% confidence interval. 3

  • 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 3

STYLE: WHOLE BODY ITCH RESPONSE

STYLE: Evaluated in adult patients with 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% 5

SIGNIFICANT IMPROVEMENT IN WHOLE BODY ITCH AT WEEK 16 WITH ACHIEVEMENT OF RESPONSE AS EARLY AS 2 WEEKS 5

STYLE: Whole body itch NRS response by timepoint through week 16

Line chart of a STYLE study that represents the proportion of Otezla patients achieving whole body itch NRS response through week 16

‡‡‡‡Patients rated their whole body itch on a scale of 0 (no itch) to 10 (worst imaginable itch). Analyses were based on patients in the ITT population with baseline whole body NRS score ≥4. At baseline, the mean whole body itch NRS score was 7.2, with the scores ranging from 0 to 10. §§§§Whole body itch NRS response was defined as a ≥4-point reduction (improvement) from baseline. *****Due to the MI method used to analyze the data, the n value for subjects who achieved response may be in decimals.

Error bars represent 95% confidence interval. 3

Icon of 46 percent number inside a sketched, orange and white circle

of patients taking Otezla achieved a
≥4-point improvement from baseline
in WBI-NRS scores at week 16
vs placebo (23%) (P<0.0001) 5

Significant improvement
in whole body itch as early as

Graphic of an orange circle with text that reads Significant improvement in scalp itch as early as 2 weeks

Among moderate to severe scalp psoriasis patients

WHOLE BODY ITCH RESPONSE
THROUGH WEEK 32 3

STYLE: Whole body itch NRS response by timepoint through week 32

Line chart of a STYLE study that represents the whole body itch NRS 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. 3

†††††Patients rated their whole body itch on a scale of 0 (no itch) to 10 (worst imaginable itch). Analyses were based on patients in the ITT population with baseline whole body itch NRS score ≥4. ‡‡‡‡‡WBI-NRS response was defined as a ≥4-point reduction (improvement) from baseline. §§§§§The placebo-controlled phase by visit (weeks 2, 4, 8, 12, 16) were secondary endpoints; OLE phase by visit (weeks 20, 24, 32) were exploratory endpoints.

Bars represent 2-sided 95% confidence interval.3

  • Consider open-label treatment phase study limitations when interpreting results. The 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 3

DISCREET: GENITAL ITCH RESPONSE

DISCREET: Evaluated in adult patients (n=289) with moderate to severe plaque psoriasis and moderate to severe plaque psoriasis of the genital area (modified sPGA-G score ≥3) 1

GENITAL ITCH RESPONSE THROUGH WEEK 16

DISCREET: Proportion of moderate to severe plaque psoriasis patients achieving Genital Psoriasis Itch Numerical Rating Scale (GPI-NRS) response at week 16

Genital itch response comparing Otezla® (apremilast) and placebo
Genital itch response comparing Otezla® (apremilast) and placebo

****** GPI-NRS response is defined as at least a 4-point reduction (improvement) at week 16 in patients with baseline GPI-NRS score ≥4; GPI-NRS scores range from 0 (no) to 10 (worst imaginable).

LIBERATE: ITCH 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 6

ITCH RESPONSE IN BIOLOGIC-NAÏVE PATIENTS 3,6

LIBERATE: Mean change from baseline pruritus VAS scores at week 16

Bar chart of a LIBERATE study representing itch response in biologic-naïve patients at week 16 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. 3,6

††††††Pruritus was measured on a 100-mm VAS. ‡‡‡‡‡‡Baseline mean pruritus VAS scores (mm): Otezla, 62.6; placebo, 62.5.

 

BID, twice daily; BL, baseline; 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; 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; VAS, visual analog scale; WBI-NRS, whole body itch numeric rating scale.

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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

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. Otezla [package insert]. Thousand Oaks, CA: Amgen Inc. 2. Stein Gold L, Papp K, Pariser D, et al. J Am Acad Dermatol. 2022;86(1):77-85. 3. Data on file, Amgen Inc. 4. Papp K, Reich K, Leonardi CL, et al. J Am Acad Dermatol. 2015;73(1):37-49. 5. Van Voorhees AS, Gold LS, Lebwohl M, et al. J Am Acad Dermatol. 2020;83(1):96-103. 6. Reich K, Gooderham M, Green L, et al. J Eur Acad Dermatol Venereol. 2017;31(3):507-517.