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Efficacy Overview | Otezla® (apremilast) for PsO
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3 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. Read less

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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 ACTIVE
Psoriatic Arthritis
Overview ACR20 Response Joint Tenderness and Swelling Dactylitis Enthesitis Fatigue Pain Physical Function cDAPSA
Psoriatic Arthritis
Overview Adverse Reactions Through Week 16 Adverse Reactions Through 5 Years ACTIVE Adverse Events of Special Interest Laboratory Parameters
Plaque Psoriasis
Why Systemic Therapy? About Plaque Psoriasis
Plaque Psoriasis
Overview ADVANCE ESTEEM STYLE DISCREET LIBERATE
Plaque Psoriasis
Overview Mild to Moderate
Plaque Psoriasis PASI-75 Response Mean PASI Response Scalp Response Nail Response Itch Response Genital Response Patient Photo Library
Plaque Psoriasis
Overview Adverse Reactions Through Week 16 Adverse Reactions Weeks 16 to 32 Adverse Reactions Through 5 Years Adverse Events of Special Interest Laboratory Parameters
Resources Overview Downloadable Resources Patient Profiles Billing and Coding Video Hub FAQs
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Mechanism of Disease (MOD) Otezla MOA
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: 840,000+ patients treated globally since 2014 1.3,* PLAQUE PSORIASIS SAFETY PsA SAFETY

A small pill with a big history: 840,000+ patients treated globally since 2014 1.3,*

PLAQUE PSORIASIS SAFETY PsA SAFETY REFERENCES & FOOTNOTE
REFERENCES REFERENCES & FOOTNOTE

*Estimates of patients treated reflect global data since launch (Apr 2014-Mar 2023; US=58% 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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OTEZLA® (APREMILAST) EFFICACY IN PLAQUE PSORIASIS

Otezla showed results across multiple endpoints at week 16 in patients with mild to moderate and moderate to severe plaque psoriasis 1,2

ADVANCE study design: A multicenter, randomized, placebo-controlled, double-blind study of 595 biologic-naïve adults with mild to moderate plaque psoriasis. 1,3

ESTEEM 1 & 2 study designs: Two multicenter, double-blind, placebo-controlled trials of similar design for 1257 adult patients with moderate to severe plaque psoriasis. 1,4,5

STYLE study design: Phase 3, multicenter, randomized, double-blind, placebo-controlled study of 303 adult moderate to severe plaque psoriasis patients with moderate to severe plaque psoriasis of the scalp. 1

DISCREET study design: Phase 3, multicenter, randomized, placebo-controlled, double-blind study of 289 adult patients with moderate to severe plaque psoriasis and moderate to severe plaque psoriasis of the genital area. 1

LIBERATE study design: Global, randomized, Phase 3b, placebo-controlled, double-blind, double-dummy study of 250 biologic-naïve patients with moderate to severe plaque psoriasis. 2

OTEZLA HAS BEEN STUDIED ACROSS ALL SEVERITIES OF
ADULT PLAQUE PSORIASIS AND IN ACTIVE PSORIATIC ARTHRITIS

TREAT MULTIPLE MANIFESTATIONS OF
PLAQUE PSORIASIS WITH OTEZLA 1,3,4,6

Otezla® (apremilast) is indicated to treat mild to moderate, and moderate to severe plaque psoriasis PsO Skin sPGA Data Skin BSA-75 Data Skin PASI-75 Data Skin Mean PASI Data SCALP Data SCALP Data Nail Data NAIL Data ITCH Data ITCH Data GENITAL Data Otezla® (apremilast) is indicated to treat mild to moderate, and moderate to severe plaque psoriasis PsO Skin sPGA Data Skin BSA-75 Data SCALP Data Nail Data ITCH Data Skin PASI-75 Data Skin Mean PASI Data SCALP Data NAIL Data ITCH Data GENITAL Data

OTEZLA IS ALSO APPROVED
TO TREAT ACTIVE
PSORIATIC ARTHRITIS 1

Otezla® (apremilast) is indicated to treat active psoriatic arthritis PsA
Indicated for patients with active PsA 1

*Efficacy of Otezla in nail psoriasis was studied in the ADVANCE clinical trial for patients with mild to moderate plaque psoriasis. Analysis is exploratory and has not been adjusted for multiple comparisons. No conclusions of statistical or clinical significance can be drawn.

STUDY RESULTS: MILD TO MODERATE PLAQUE PSORIASIS:

  • In ADVANCE, 22% of patients taking Otezla (n=297) achieved an sPGA score of 0 (clear) or 1 (almost clear) and a ≥2-point reduction from baseline vs 4% with placebo (n=298) at week 16 (P<0.0001; primary endpoint; ITT population) 1,3

STUDY RESULTS: MODERATE TO SEVERE PLAQUE PSORIASIS:

  • In ESTEEM 1, 33% of patients taking Otezla (n=562) achieved PASI-75 response vs 5% with placebo (n=282) at week 16 (P<0.0001; primary endpoint) 1,4
  • In ESTEEM 2, 29% of patients taking Otezla (n=274) achieved PASI-75 response vs 6% with placebo (n=137) at week 16 (P<0.001; primary endpoint) 5
  • In STYLE, 43% of patients taking Otezla (n=201) achieved a significant improvement in ScPGA response vs 14% with placebo (n=102) at week 16 (P<0.0001; primary endpoint; ITT population; MI analysis) 7
  • In DISCREET, 40% of patients taking Otezla (n=143) achieved significant improvement in modified sPGA-G response, vs 20% with placebo (n=146) at week 16 (P=0.0003; primary endpoint) 1,6
  • In LIBERATE, 40% of patients taking Otezla (n=83) achieved PASI-75 response vs 12% with placebo (n=84) at week 16 (P<0.0001; primary endpoint) 2
About Plaque Psoriasis
Why Systemic Therapy?
Thumbnail image for video of the Mechanism of Action in Plaque Psoriasis

Dermatology and
Multidisciplinary Care Videos

WATCH VIDEOS
Image of Otezla messaging as the number one prescribed systemic treatment for patients starting treatment for psoriasis

Otezla is the #1 prescribed brand for psoriasis patients starting systemic treatment 6,†

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 active psoriatic
arthritis

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

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

WATCH VIDEO

†Based on IQVIA licensed data: Jan 2018 – May 2022 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.

BSA, body surface area; ITT, intent to treat; MI, multiple imputation; PASI, Psoriasis Area and Severity Index; ScPGA, Scalp Physician Global Assessment; sPGA, static Physician Global Assessment.

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PSORIASIS AFFECTS MORE THAN 8 MILLION PEOPLE IN THE US

85%-90% OF THEM HAVE PLAQUE PSORIASIS 1,2

Image of plaque psoriasis which is characterized by flaking, scaling and itching of non-scalp areas

Skin

  • Flaking, scaling, and itching of non-scalp areas were among the most frequently reported symptoms in psoriasis 3
  • Despite the number of treatment options, patients with psoriasis often struggle to get clearer skin 4
Image of scalp psoriasis which is characterized by red, thickened plaques along the hairline, on the forehead, ears, or on the back of the neck

Scalp

  • Scalp psoriasis is characterized by red, thickened plaques along the hairline, on the forehead, ears, or on the back of the neck 5
  • Up to 80% of patients who have plaque psoriasis also have scalp involvement 5
Image of nail psoriasis, which can manifest in several different ways in plaque psoriasis, including pitting and red spots, and is a difficult condition to treat

Nail

  • About 50% of all patients with psoriasis will have fingernail involvement 1
  • Nail psoriasis can manifest in several different ways in plaque psoriasis, including pitting and red spots, and is a difficult condition to treat 6,7
Image of plaque psoriasis which is a systemic disease that can extend beyond the surface of the skin

Itch

  • Psoriasis is a systemic disease that can extend beyond the surface of the skin, and patients may require a systemic treatment 6
  • 5X the proportion of patients vs dermatologists cite itching as the most important factor contributing to disease severity (38% vs 7%) 8

In your patients with plaque psoriasis, are you looking out for joint symptoms?

Icon of approximately 30 percent number

OF PEOPLE WITH PSORIASIS
DEVELOP PSORIATIC ARTHRITIS 9

DESPITE ITS PREVALENCE, PSORIASIS IS OFTEN UNDERTREATED.
PLAQUE PSORIASIS IS A SYSTEMIC DISEASE THAT MAY BENEFIT
FROM A SYSTEMIC THERAPY. 10,11

Back to Efficacy Overview

References: 1. National Psoriasis Foundation. psoriasis.org. Accessed February 21, 2021. 2. Nestle FO, Kaplan DH, Barker J. N Engl J Med. 2009;361(5):496-509. 3. Pariser D, Schenkel B, Carter C, et al. J Dermatolog Treat. 2016;27(1):19-26. 4. Mrowietz U, Kragballe K, Reich K, et al. Arch Dermatol Res. 2011;303(1):1-10. 5. Blakely K, Gooderham M. Psoriasis (Auckl). 2016;6:33-40. 6. Kimmel GW, Lebwohl M. Evidence-based Psoriasis: Diagnosis and Treatment. Springer; 2018:1-6. 7. Pasch MC. Drugs. 2016;76(6):675-705. 8. Van de Kerkhof PC, Reich K, Kavanaugh A, et al. J Eur Acad Dermatol Venereol. 2015;29(10):2002-2010. 9. Lebwohl MG, Kavanaugh A, Armstrong AW, Van Voorhees AS. Am J Clin Dermatol. 2016;17(1):87-97. 10. Kim WB, Jerome D, Yeung J. Can Fam Physician. 2017;63(4):278-285. 11. Van Voorhees AS, Feldman SR, Lebwohl MG, Mandelin A, Ritchlin C. The Psoriasis and Psoriatic Arthritis Pocket Guide. psoriasis.org/the-pocket-guide. Accessed July 19, 2021.

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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.

References: 1. Otezla [package insert]. Thousand Oaks, CA: Amgen Inc. 2. Reich K, Gooderham M, Green L, et al. J Eur Acad Dermatol Venereol. 2017;31(3):507-517. 3. Stein Gold L, Papp K, Pariser D, et al. J Am Acad Dermatol. 2022;86(1):77-85. 4. Papp K, Reich K, Leonardi CL, et al. J Am Acad Dermatol. 2015;73(1):37-49. 5. Paul C, Cather J, Gooderham M, et al. Br J Dermatol. 2015;173(6):1387-1399. 6. Data on file, Amgen Inc. 7. Van Voorhees AS, Gold LS, Lebwohl M, et al. J Am Acad Dermatol. 2020;83(1):96-103.