Otezla Systemic Treatment for Plaque Psoriasis | Otezla® (apremilast) Healthcare Professional Site

ADVANCE CLINICAL DEVELOPMENT PROGRAM

Pivotal Study: ADVANCE was a multicenter, randomized, placebo-controlled, double-blind study. Biologic-naïve adults with mild to moderate plaque psoriasis (N=595) were randomized 1:1 to receive Otezla or placebo for a 16-week phase, followed by a 16-week extension phase and a 4-week post-treatment observation phase. ^8,9

Selected inclusion criteria: Biologic-naïve adults with chronic mild to moderate plaque psoriasis (sPGA score 2-3, BSA 2%-15%, PASI score 2-15) whose psoriasis was inadequately controlled with or who were intolerant to ≥1 topical psoriasis therapy ^8,9

Please click here for full study design.

BSA, body surface area; PASI, Psoriasis Area and Severity Index; sPGA, static Physician Global Assessment.

ESTEEM CLINICAL DEVELOPMENT PROGRAM

Pivotal Studies: ESTEEM 1 and ESTEEM 2 were 2 multicenter, double-blind, placebo-controlled trials of similar design. Patients aged ≥18 years with moderate to severe plaque psoriasis (N=1257) were randomized 2:1 to Otezla 30 mg BID (n=836) or placebo (n=419) for 16 weeks after a week-long titration. ^8,10,11

Selected inclusion criteria: Adults with chronic moderate to severe plaque psoriasis (BSA ≥10%, sPGA score ≥3, PASI score ≥12) who were candidates for phototherapy or systemic therapy ⁸

Please click here for full study design.

BID, twice daily.

In mild to moderate plaque psoriasis

SIGNIFICANTLY MORE PATIENTS ACHIEVED
CLEAR OR ALMOST CLEAR SKIN WITH OTEZLA ^8,9

5x as many otezla patients achived clearer skin vs placebo at week16

ADVANCE: Otezla demonstrated significantly greater achievement of sPGA response vs placebo at week 16

Bar chart of ADVANCE clearer skin data at 16 weeks

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 ^8,9

**sPGA response was defined as the percentage of patients who achieved sPGA score of 0 (clear) or 1 (almost clear) and a ≥2-point reduction from baseline.

ITT, intent to treat.

In mild to moderate plaque psoriasis

OTEZLA DEMONSTRATED SIGNIFICANT IMPROVEMENT
IN SCALP RESPONSE ^8,9

2x the proportion of patients taking otezla achieved scalp PGA response vs placebo at week16

ADVANCE: Percentage of patients achieving ScPGA response at week 16

Bar chart of ADVANCE scalp response data at 16 weeks

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 ^8,9

^††In patients with ScPGA ≥2 at baseline.

ScPGA, Scalp Physician Global Assessment.

In moderate to severe plaque psoriasis

PATIENTS ACHIEVED 75% CLEARER SKIN WITH OTEZLA ^8,10

6x as many patients taking otezla achieved PASI-75 response at week16 vs placebo

ESTEEM 1: Percentage of patients who achieved a 75% reduction in their PASI score (PASI-75 response) at week 16

Bar chart of ESTEEM 1 PASI-75 results at 16 weeks

ESTEEM 2: Significant improvement in PASl-75 with Otezla 29% (n=274) vs placebo 6% (n=137) at week 16; P<0.0001 (primary endpoint) ^8,10,11
Results were consistent between ESTEEM 1 and ESTEEM 2 ⁸
ESTEEM: Evaluated in patients with moderate to severe plaque psoriasis (N=1257); age ≥18 years, BSA involvement ≥10%, sPGA score ≥3, PASI score ≥12 ^8,9

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.

Study Design

Study Design

How Otezla Works

Dosing

JUMP TO:

WHEN YOUR PATIENT'S SKIN LOOKS LIKE THIS, WHAT DO YOU DO?

of them have plaque psoriasis 2

of patients with plaque psoriasisare under a PCP's care 3,*

Plaque psoriasis manifests as red, raised, well-circumscribed, scaly patches, but the appearance can differ depending on the skin tone 4,5

LIGHTER SKIN

Reddish pink color and silvery-white scales 4,5

DARKER SKIN

Purple or violet color, thicker plaques, and more scaling 5

Psoriasis can extend beyond the surface of the skin and patients may require a systemic treatment 6,7

THERE IS AN ORAL THERAPY THAT TREATS SYSTEMICALLY FROM THE START 8

Otezla is indicated for the treatment of adult patients with plaque psoriasis who are candidates for phototherapy or systemic therapy 8

ADVANCE CLINICAL DEVELOPMENT PROGRAM

ESTEEM CLINICAL DEVELOPMENT PROGRAM

In mild to moderate plaque psoriasis

SIGNIFICANTLY MORE PATIENTS ACHIEVED CLEAR OR ALMOST CLEAR SKIN WITH OTEZLA 8,9

ADVANCE: Otezla demonstrated significantly greater achievement of sPGA response vs placebo at week 16

In mild to moderate plaque psoriasis

OTEZLA DEMONSTRATED SIGNIFICANT IMPROVEMENT IN SCALP RESPONSE 8,9

ADVANCE: Percentage of patients achieving ScPGA response at week 16

In moderate to severe plaque psoriasis

PATIENTS ACHIEVED 75% CLEARER SKIN WITH OTEZLA 8,10

ESTEEM 1: Percentage of patients who achieved a 75% reduction in their PASI score (PASI-75 response) at week 16

REAL RESULTS

Significant improvements in DIFFICULT-TO-TREAT places like scalp psoriasis are possible with a systemic treatment like Otezla 6,7,8,12

Explore results in other manifestations

Otezla has an established safety profile in a range of patients with plaque psoriasis across multiple trials 8,13

Select adverse events reported in ≥2% of patients in any treatment group through week 16 8,9

ADVERSE EVENTS IN MILD TO MODERATE PLAQUE PSORIASIS PATIENTS WERE CONSISTENT WITH THE ESTABLISHED OTEZLA SAFETY PROFILE FOR MODERATE TO SEVERE PLAQUE PSORIASIS. 8-11

Appropriate

patients with Plaque psoriasismay be in your waiting room

Take a look at Emily, Ivan, and Chris who have tried topicals and still have challenges with their plaque psoriasis

Emily

MILD TO MODERATE PATIENT WITH SCALP INVOLVEMENT

48 years oldInsurance Account Manager

Presentation:

Treatment History:

Patient Considerations:

Ivan

MILD TO MODERATE PATIENT

37 years oldTeacher and Coach

Presentation:

Treatment History:

Patient Considerations:

Chris

MODERATE TO SEVERE PATIENT

40 years oldElectrician

Presentation:

Treatment History:

Patient Considerations:

When your adult patients with plaque psoriasis have tried prescription topicals,

DON'T WAIT — TREAT plaque psoriasis SYSTEMICALLY FROM THE START WITH OTEZLA 8

Ready to get your patients started on something other than another topical?

IMPORTANT SAFETY INFORMATION

IMPORTANT SAFETY INFORMATION

INDICATIONS

WHEN YOUR
PATIENT'S SKIN
LOOKS
LIKE THIS,
WHAT DO YOU DO?

of them have plaque
psoriasis ²

of patients with
plaque psoriasis
are under a PCP's care ^3,*

Plaque psoriasis manifests as red, raised, well-circumscribed,
scaly patches, but the appearance can differ depending on the skin tone ^4,5

Reddish pink color and silvery-white scales ^4,5

Purple or violet color, thicker plaques, and more scaling ⁵

Psoriasis can extend beyond the surface of the skin and patients may require a systemic treatment ^6,7

THERE IS AN ORAL THERAPY THAT TREATS SYSTEMICALLY FROM THE START ⁸

Otezla is indicated for the treatment of adult
patients with plaque psoriasis
who are candidates for phototherapy or systemic therapy ⁸

SIGNIFICANTLY MORE PATIENTS ACHIEVED
CLEAR OR ALMOST CLEAR SKIN WITH OTEZLA ^8,9

OTEZLA DEMONSTRATED SIGNIFICANT IMPROVEMENT
IN SCALP RESPONSE ^8,9

PATIENTS ACHIEVED 75% CLEARER SKIN WITH OTEZLA ^8,10

Significant improvements in DIFFICULT-TO-TREAT places like scalp psoriasis are possible with a systemic treatment like Otezla ^6,7,8,12

Explore results in other
manifestations

Otezla has an established safety profile in a range of patients with plaque psoriasis across multiple trials ^8,13

Select adverse events reported in ≥2% of patients in any treatment group through week 16 ^8,9

ADVERSE EVENTS IN MILD TO MODERATE PLAQUE PSORIASIS PATIENTS WERE CONSISTENT WITH THE ESTABLISHED OTEZLA SAFETY PROFILE FOR MODERATE TO SEVERE PLAQUE PSORIASIS. ^8-11

patients with
Plaque psoriasis
may be in your waiting room

Take a look at Emily, Ivan, and Chris who have tried topicals and
still have challenges with their plaque psoriasis

48 years old
Insurance Account Manager

37 years old
Teacher and Coach

40 years old
Electrician

DON'T WAIT — TREAT plaque psoriasis SYSTEMICALLY FROM THE START WITH OTEZLA ⁸

Ready to get your patients
started on something other than another topical?