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

Otezla was 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

STYLE: Proportion of patients achieving ScPGA response at week 16

Bar chart of a STYLE study for scalp itch patients that represents the proportion achieving ScPGA response by week 16 on Otezla

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

*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 VIDEO

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

For patients like Emily, scalp psoriasis and itch might be difficult to treat with topicals alone ^5,6

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

5-Year Safety Data Video

WATCH VIDEO

BID, twice daily; BSA, body surface area; FAS, full analysis set; ITT, intent to treat; MI, multiple imputation; NRS, numeric rating scale; PASI, Psoriasis Area and Severity Index; PASI-75, a 75% reduction in a patient's PASI score; ScPGA, Scalp Physician Global Assessment; sPGA, static Physician Global Assessment; SSA, scalp surface area; WBI-NRS, whole body itch numeric rating scale.

Pediatric Response

Nail Response

IMPORTANT SAFETY INFORMATION

Contraindications

Otezla/OTEZLA XR 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/OTEZLA XR and institute appropriate therapy

IMPORTANT SAFETY INFORMATION

Contraindications

Otezla/Otezla XR 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/Otezla
XR 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/Otezla XR
dose reduction or suspension if patients develop severe diarrhea, nausea, or vomiting
Depression: Carefully weigh the risks and benefits of treatment with Otezla/Otezla XR for patients with a history of depression and/or suicidal thoughts/behavior, or in patients who develop such symptoms while on Otezla/Otezla XR. 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 in adult patients, 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/Otezla XR
- 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/Otezla XR-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 adult 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 co-administered with rifampin, a strong CYP450 enzyme inducer; loss of Otezla/Otezla XR efficacy may occur. Concomitant use of Otezla/Otezla XR 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

Advise pregnant women of the potential risk of fetal loss

INDICATIONS

Otezla/Otezla XR 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 XR is indicated for the treatment of pediatric patients 6 years of age and older and weighing at least 50 kg with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy
Otezla is indicated for the treatment of adult patients and pediatric patients 6 years of age and older and weighing at least 20 kg with active psoriatic arthritis
Otezla XR is indicated for the treatment of adult patients and pediatric patients 6 years of age and older and weighing at least 50 kg with active psoriatic arthritis
Otezla/Otezla XR is indicated for the treatment of adult patients with oral ulcers associated with Behçet’s Disease

Please click here for the full Prescribing Information.

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, Stein Gold L, Lebwohl M, et al. J Am Acad Dermatol. 2020;83(1):96-103. 4. Data on file, Amgen; 2021. 5. Stein Gold L, Papp K, Pariser D, et al. J Am Acad Dermatol. 2022;86(1):77-85. 6. Kaplan D, Hetherington J, Lucas J, 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.

Study Design

Study Design

How Otezla Works

Dosing

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

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

STYLE: Proportion of patients achieving ScPGA response at week 16

STYLE Data Video

RESULTS SEEN IN OTEZLA 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

RESULTS SEEN IN OTEZLA PATIENTS

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

5-Year Safety Data Video

IMPORTANT SAFETY INFORMATION

IMPORTANT SAFETY INFORMATION

INDICATIONS

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

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

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

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

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