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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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Otezla is the first and only oral therapy approved across all severities of adult plaque psoriasis SEE THE DATA

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 of the scalp (N=303); age ≥18 years, BSA involvement ≥10%, sPGA score ≥3, PASI score ≥12, ScPGA score ≥3, SSA ≥20% 3

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Otezla is the first and only oral therapy 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).

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

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.

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 4,6

ESTEEM 1: Proportion of patients with ScPGA score of clear or minimal 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

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

ESTEEM 1: Proportion of patients with ScPGA score of clear or minimal 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

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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 7

SCALP RESPONSE IN BIOLOGIC-NAÏVE PATIENTS AT WEEK 16 7

LIBERATE: Patients with ScPGA score of clear or minimal 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.

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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. 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. Papp K, Reich K, Leonardi CL, et al. J Am Acad Dermatol. 2015;73(1):37-49. 7. Reich K, Gooderham M, Green L, et al. J Eur Acad Dermatol Venereol. 2017;31(3):507-517.