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4 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 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 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.
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Plaque Psoriasis Psoriatic Arthritis Oral Ulcers in Behçet's Disease
Oral Ulcers in Behçet’s Disease
About Behçet's Disease Oral Ulcers in BD
Oral Ulcers in Behçet’s Disease
Clinical Response of Oral Ulcers Oral Ulcers: Pain Results Oral Ulcers: Complete Response Oral Ulcers: Maintenance of Response Oral Ulcers: Daily Average
Oral Ulcers in Behçet’s Disease
Study Design
Oral Ulcers in Behçet’s Disease
RELIEF Safety Laboratory Parameters
Psoriatic Arthritis
About Psoriatic Arthritis
Psoriatic Arthritis
Overview PALACE 1-3 PALACE 4 FORMOST ACTIVE
Psoriatic Arthritis
Overview ACR20 Response Oligoarticular PsA Joint Tenderness and Swelling Dactylitis Enthesitis Fatigue Pain Physical Function cDAPSA
Psoriatic Arthritis
Overview Adverse Reactions Through Week 16 Adverse Reactions Through 5 Years FOREMOST Safety Tolerability ACTIVE Safety Adverse Events of Special Interest Laboratory Parameters
Plaque Psoriasis
Why Systemic Therapy? About Plaque Psoriasis Patient Stories
Plaque Psoriasis
Study Design
Plaque Psoriasis
Overview Mild to Moderate
Plaque Psoriasis PASI-75 Response Mean PASI Response Pediatric Response Scalp Response Nail Response Itch Response Genital Response Patient Photo Library Real-World Data
Plaque Psoriasis
Overview Mild to Moderate Plaque PsO Moderate to Severe Plaque PsO Pediatric
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Plaque Psoriasis Psoriatic Arthritis Oral Ulcers in Behçet's Disease
How Otezla Works
Dosing

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.

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IN THE TREATMENT OF PsA, CONSIDER
OTEZLA® (APREMILAST) FROM DIAGNOSIS

Otezla may be a great place to start your patients with active psoriatic arthritis

PALACE 1-3 study design: Phase 3, multicenter, randomized, double-blind, placebo-controlled trials of similar design for 1493 adult patients with active psoriatic arthritis. 1,2

PALACE 4 study design: Phase 3, multicenter, randomized, double-blind, placebo-controlled, parallel-group study of 527 DMARD-naïve adult patients with active psoriatic arthritis. 2,3

FOREMOST study design: Phase 4, multicenter, randomized, double-blind, placebo-controlled, parallel-group study. Patients with oligoarticular PsA (>1 but ≤4 tender and swollen joint count) and early disease (signs and symptoms of PsA ≤5 years’ duration) were randomized 2:1 to receive either Otezla 30 mg BID (n=203) or placebo (n=105) for 24 weeks, stratified based on concomitant medication use, with an early escape at week 16. 4,5

ACTIVE study design: Phase 3b, multicenter, randomized, double-blind, placebo-controlled, parallel-group study of 219 adult patients with active psoriatic arthritis who were biologic-naïve. 6

OTEZLA HAS DATA ACROSS MULTIPLE DOMAINS
OF PSORIATIC ARTHRITIS

Human body with multiple boxes that pinpoint the locations of manifestations from psoriatic arthritis ACR20 cDAPSA JOINT TENDERNESS AND SWELLING DACTYLITIS PHYSICAL FUNCTION FATIGUE PAIN Oligoarticular PsA ENTHESITIS ABOUT PSORIATIC ARTHRITIS
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Multidisciplinary Care Videos

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ACR20

Explore ACR20 responses at week 16 and through 5 years (PALACE 1-4) 1,3,7-9

PALACE 1-3 primary endpoints 7-9

  • Otezla significantly improved ACR20 response vs placebo at week 16
  • PALACE 1: 38% vs 19%, Otezla 30 mg BID (n=168) vs placebo (n=168) (P=0.0001)
  • PALACE 2: 32% vs 19%, Otezla 30 mg BID (n=162) vs placebo (n=159) (P< />
  • PALACE 3: 41% vs 18%, Otezla 30 mg BID (n=167) vs placebo (n=169) (P≤0.0001)

PALACE 4 primary endpoint 3

  • PALACE 4: 31% vs 16%, Otezla 30 mg BID (n=176) vs placebo (n=176) (P=0.001)

ACTIVE primary endpoint 6

  • ACTIVE: 38% vs 20%, Otezla 30 mg BID (n=110) vs placebo (n=109) (P=0.004)
See More

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additional endpoints
Image of Otezla messaging as the only oral therapy indicated for plaque psoriasis and psoriatic arthritis

The only oral therapy approved for all severities of adult plaque psoriasis and psoriatic arthritis

Watch Dr. Troum's experience prescribing Otezla® (apremilast)

“A Major Impact”:Hear Dr. Troum’s Experience Prescribing Otezla

WATCH VIDEO
Cindy, a real Otezla® (apremilast) patient shares her story

Check out Cindy, a real Otezla patient, and her journey with Otezla

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ACR, American College of Rheumatology; BID, twice daily; cDAPSA, clinical Disease Activity Index for Psoriatic Arthritis; DMARD, disease-modifying antirheumatic drug; FACIT-F, Functional Assessment of Chronic Illness Therapy—Fatigue; FAS, full analysis set; HAQ-DI, Health Assessment Questionnaire—Disability Index; MCID, minimal clinically important difference; MDA-Joints, minimal disease activity-joints; MI, multiple imputation; PsA, psoriatic arthritis; SJC, swollen joint count; TJC, tender joint count.

 
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IMPORTANT SAFETY INFORMATION 

Contraindications

Otezla® (apremilast) is contraindicated in patients with a known hypersensitivity to apremilast or to any of the excipients in the formulation

Warnings and Precautions

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® (apremilast) 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 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, 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 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-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 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 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

  • Otezla has not been studied in pregnant women. Advise pregnant women of the potential risk of fetal loss

INDICATIONS

Otezla is indicated for the treatment of:

  • Adult patients with plaque psoriasis who are candidates for phototherapy or systemic therapy
  • 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
  • Adult patients with active psoriatic arthritis
  • Adult patients with oral ulcers associated with Behçet’s Disease

Please click here for the full Prescribing Information.

References: 1. Otezla [package insert]. Thousand Oaks, CA: Amgen Inc. 2. Kavanaugh A, Gladman DD, Edwards CJ, et al. Arthritis Res Ther. 2019;21(1):118. 3. Wells AF, Edwards CJ, Kivitz AJ, et al. Rheumatology (Oxford). 2018;57(7):1253-1263. 4. Gossec L, Gladman D, Coates L, et al. Presented at: 32nd Annual Meeting of the European Academy of Dermatology and Venereology (EADV); October 11-14, 2023; Berlin, Germany. 5. Mease P, Gladman D, Coates LC, et al. Presented at: ACR/ARHP Annual Meeting; November 10-15, 2023; San Diego, CA. 6. Nash P, Ohson K, Walsh J, et al; ACTIVE Investigators. Ann Rheum Dis. 2018;77(5):690-698. 7. Data on file, Amgen; 2018. 8. Cutolo M, Myerson GE, Fleischmann RM, et al. J Rheumatol. 2016;43(9):1724-1734. 9. Edwards CJ, Blanco FJ, Crowley J, et al. Ann Rheum Dis. 2016;75(6):1065-1073. 10. Gossec L, Coates LC, Gladman DD, et al. Ann Rheum Dis. 2024;83(11):1480-1488.