OTEZLA:
4 INDICATIONSOtezla^® (apremilast)/Otezla XR^™ (apremilast) is indicated for the treatment of adult patients with plaque psoriasis who are candidates for phototherapy or systemic therapy.Read more

OTEZLA:
4 INDICATIONS

Otezla® (apremilast)/Otezla XR™ (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 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.

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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.

ADVANCE STUDY DESIGN

ADVANCE was a multicenter, randomized, placebo-controlled, double-blind study of 595 biologic-naïve adults with mild to moderate plaque psoriasis ^1,2

Patients were randomized 1:1 to receive Otezla or placebo for a 16-week double-blind phase, followed by a 16-week extension phase (continued Otezla or switched to Otezla) and a 4-week post-treatment observational phase ^1,2

FOR THE 31% OF PATIENTS AT BASELINE WITH MILD DISEASE, RESPONSE, AS DEFINED BY THE PRIMARY ENDPOINT, COULD ONLY BE ACHIEVED WITH AN sPGA SCORE OF 0 (CLEAR) ²

Criteria and endpoints

Selected inclusion criteria: ^1,2

Biologic-naïve adults
Chronic mild to moderate plaque psoriasis (sPGA score 2-3, BSA 2%-15%, PASI score 2-15)
Inadequate control with or who were intolerant to ≥1 topical plaque psoriasis therapy

Selected exclusion criteria: ¹

Current or planned concurrent use of other plaque psoriasis therapies that may have a possible effect on psoriasis

Primary endpoint: ²

Proportion of patients with sPGA score of 0 (clear) or 1 (almost clear) and ≥2-point reduction from baseline at week 16

Secondary endpoints: ^1,2

BSA-75 response at week 16
Response in scalp plaque psoriasis by week 16 as measured by ScPGA response
Itch improvement by week 16 as measured by WBI-NRS response

Patient demographics

Median age: ¹

48.7 years

Sex: ¹

Male: 54.6%

Duration: ¹

Mean duration of plaque psoriasis:
16.9 years

Baseline disease characteristics: ¹

Body mass index, mean (SD), kg/m²:
31.1 (7.1)
sPGA score, n (%)
- 2 (mild): 182 (30.6)
- 3 (moderate): 413 (69.4)
BSA percentage, mean (SD): 6.4 (3.4)
PASI score, mean (SD): 6.5 (2.9)
WBI-NRS score, mean (SD): 6.2 (2.5)
ScPGA score ≥2, n (%): 411 (69.1)

Concomitant medications allowed: ²

For body lesions: Unmedicated emollients
For scalp lesions: Nonmedicated shampoos

BID, twice daily; BSA, body surface area; PASI, Psoriasis Area and Severity Index; ScPGA, Scalp Physician’s Global Assessment; SD, standard deviation; sPGA, static Physician’s Global Assessment; WBI-NRS, whole body itch numeric rating scale.

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. Stein Gold L, Papp K, Pariser D, et al. J Am Acad Dermatol. 2022;86(1):77-85. 2. Otezla [package insert]. Thousand Oaks, CA: Amgen Inc.

Study Design

Study Design

How Otezla Works

Dosing

ADVANCE STUDY DESIGN

ADVANCE was a multicenter, randomized, placebo-controlled, double-blind study of 595 biologic-naïve adults with mild to moderate plaque psoriasis 1,2

FOR THE 31% OF PATIENTS AT BASELINE WITH MILD DISEASE, RESPONSE, AS DEFINED BY THE PRIMARY ENDPOINT, COULD ONLY BE ACHIEVED WITH AN sPGA SCORE OF 0 (CLEAR) 2

Criteria and endpoints

Selected inclusion criteria: 1,2

Selected exclusion criteria: 1

Primary endpoint: 2

Secondary endpoints: 1,2

Patient demographics

Median age: 1

Sex: 1

Duration: 1

Baseline disease characteristics: 1

Concomitant medications allowed: 2

IMPORTANT SAFETY INFORMATION

IMPORTANT SAFETY INFORMATION

INDICATIONS

ADVANCE was a multicenter, randomized, placebo-controlled, double-blind study of 595 biologic-naïve adults with mild to moderate plaque psoriasis ^1,2

FOR THE 31% OF PATIENTS AT BASELINE WITH MILD DISEASE, RESPONSE, AS DEFINED BY THE PRIMARY ENDPOINT, COULD ONLY BE ACHIEVED WITH AN sPGA SCORE OF 0 (CLEAR) ²

Selected inclusion criteria: ^1,2

Selected exclusion criteria: ¹

Primary endpoint: ²

Secondary endpoints: ^1,2

Median age: ¹

Sex: ¹

Duration: ¹

Baseline disease characteristics: ¹

Concomitant medications allowed: ²