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

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

^§Based on IQVIA licensed data: Jan 2018 - Jul 2021 Longitudinal Prescription (LRx) Data and Medical Claims (Dx) Data, reflecting estimates of real-world activity. Study information maintained by Amgen. LRx Data covers retail, traditional/specialty mail order, and long-term claims. Dx data captures US physicians. Patient classified as systemic-naïve if not previously on systemic therapy for the past 12 months, had any claim for a branded systemic, and had at least one psoriasis diagnosis.

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

REAL RESULTS

seen in Otezla patients

BASELINE

WEEK 16

PASI-75 result ^‡‡

BASELINE

WEEK 16

PASI-70 result ^§§

Actual clinical trial patient from ESTEEM. ³ Individual results may vary.

^‡‡PASI-75 response: A 75% reduction in a patient's PASI score. ³ ^§§PASI-70 Response: A 70% reduction in a patient's PASI score. ³

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

The most common AEs leading to discontinuation of Otezla in the ADVANCE trial were diarrhea (1.3%), nausea (0.7%) and vomiting (0.3%) ³
The most common AEs leading to discontinuation for patients taking Otezla in the ESTEEM trials were nausea (1.6%), diarrhea (1.0%), and headache (0.8%) ⁸
The majority of patients reporting nausea and diarrhea in the ESTEEM trials did so within the first 2 weeks; the events tended to resolve over time with continued dosing ⁸

Note: Direct comparisons cannot be made between ADVANCE and ESTEEM trials.

***Investigators in ADVANCE were not trained to differentiate between tension headache and headache.

AEs, adverse effects; NA, not applicable; URTI, upper respiratory tract infection.

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

Emily

MILD TO MODERATE PATIENT WITH SCALP INVOLVEMENT

48 years old
Insurance Account Manager

Presentation:

Plaque psoriasis of the scalp and neck
2% BSA
Complains of redness, flaking, and intense itch

Treatment History:

Rx shampoo
Failed multiple topicals

Patient Considerations:

Odor of Rx shampoo
Grease residue from topicals
Flakes showing on clothing
Itch relief

Hypothetical patient.

Emily brushing scalp psoriasis flakes from her shoulder

Ivan

MILD TO MODERATE PATIENT

37 years old
Teacher and Coach

Presentation:

Plaque psoriasis on hands, arms, and abdomen
5% BSA
Complains of purple flakey patches and gray scales

Treatment History:

Failed multiple topicals

Patient Considerations:

Has found topicals to be messy and time consuming
Challenges with symptom improvement with current treatments
Struggles to cover up plaques

Hypothetical patient.

Photo of plaque psoriasis along the elbow and arm

Chris

MODERATE TO SEVERE PATIENT

40 years old
Electrician

Presentation:

Plaque psoriasis of the scalp, arms (elbow), and back
8% BSA
Complains of visible itchy plaques and flaking

Treatment History:

Failed numerous treatments, including topicals

Patient Considerations:

Compliance to treatment due to active lifestyle

Hypothetical patient.

Photo of plaque psoriasis on back and shoulder

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

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.

Study Design

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?