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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

Read less

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: 760,000+ patients treated globally since 2014 1.3,* PLAQUE PSORIASIS SAFETY PsA SAFETY

A small pill with a big history: 760,000+ 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-Aug 2022; US=approximately 60% 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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PATIENTS WITH PLAQUE PSORIASIS COULD BENEFIT FROM A DIFFERENT APPROACH 1

PSORIASIS AFFECTS MORE THAN 8 MILLION PEOPLE IN THE UNITED STATES 2

85%-90% of them have plaque psoriasis 3

MILD PSORIASIS CAN FEEL ANYTHING BUT MILD FOR PATIENTS 1
>50% icon

of patients with mild to moderate disease perceived their severity to be worse than their affected BSA in the UPLIFT survey 4,*,†

Only 29% icon

of patients with mild to moderate disease reported their severity as “mild” while on topical therapy 5,‡

74% icon

of patients with BSA ≤3 had psoriasis in 1 or more special areas, like scalp and nails, in the UPLIFT survey 4,*

85% icon

of patients with mild-to-moderate plaque psoriasis reported feeling “embarrassed or self-conscious because of their skin” 5,‡

~50% icon

of plaque psoriasis patients have cycled through 4 or more topicals and have not used a systemic
therapy 6,§,**

Plaque psoriasis on darker skin tone

PATIENTS WITH DARKER SKIN TONES ARE MORE LIKELY TO HAVE UNDIAGNOSED PSORIASIS. PLAQUES MAY BE THICKER, PURPLE IN COLOR, AND HAVE MORE SCALING. 7

*UPLIFT was a multinational online survey conducted from March 2 to June 3, 2020, including adult patients (≥18 years of age) who reported that they had been diagnosed with PsO and/or PsA by a healthcare professional. 1006 patients were surveyed in the United States. †In the UPLIFT survey, mild disease was defined as with ≤3 palms of affected area and moderate disease was defined as 4-10 palms of affected area. ‡An online US cross-sectional survey among 175 adult patients on prescription topicals for mild to moderate psoriasis (≤10% BSA). §Claims data derived from Symphony Health Solutions includes PsO patients (Aug 2014–Jul 2018) on a topical with no prior systemic therapy, with ≥2 PsO diagnoses (Jan 2007–2018). Eligibility criteria includes patients who are active within the 4-year look-back period (Aug 2014–Jul 2018). **47% of patients in claims data analysis.

PATIENTS WITH PSORIASIS HAVE SYSTEMIC INFLAMMATION REGARDLESS OF DISEASE SEVERITY. 1,8

Plaque psoriasis can manifest in multiple ways

Patient with plaque psoriasis on the torso

Skin

  • Flaking, scaling, and itching of nonscalp areas were among the most frequently reported symptoms in psoriasis 9
  • Despite the number of treatment options, patients with psoriasis often struggle to get clearer skin 10
Plaque psoriasis patient with plaque on scalp

Scalp

  • Scalp psoriasis is characterized by red thickened plaques along the hairline, on the forehead, ears, or on the back of the neck 11
  • Up to 80% of patients who have plaque psoriasis also have scalp involvement 11
Patient's hand with fingernail psoriasis

Nail

  • About 50% of all patients with psoriasis will have fingernail involvement 2
  • Nail psoriasis can manifest in several different ways in plaque psoriasis, including pitting and red spots, and is a difficult condition to treat 12,13
Arm with irritation from itching due to plaque psoriasis

Itch

  • Psoriasis is a systemic disease that can extend beyond the surface of the skin, and patients may require a systemic treatment 12
  • 5X the proportion of patients vs dermatologists cite itching as the most important factor contributing to disease severity (38% vs 7%) 14
Plaque psoriasis of the genital area

Genital

  • ~46% of psoriasis patients have not discussed their genital psoriasis with a physician due to embarrassment 2
  • More than 2 out of 3 patients with genital psoriasis are undertreated, having never applied treatment to their genital regions 15

DESPITE ITS PREVALENCE, PSORIASIS IS OFTEN UNDERTREATED. PLAQUE PSORIASIS IS A SYSTEMIC DISEASE THAT MAY BENEFIT FROM A SYSTEMIC THERAPY. 1,16

WHEN TREATING YOUR PATIENTS WITH PLAQUE PSORIASIS, ARE YOU LOOKING FOR SIGNS OF PSORIATIC ARTHRITIS?

~30% icon

OF PEOPLE WITH PSORIASIS DEVELOP PSORIATIC ARTHRITIS 17

Learn more about psoriatic arthritis

BSA, body surface area; PsA, psoriatic arthritis; PsO, plaque psoriasis.

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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
  • 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. Van Voorhees A, Feldman S, Lebwohl M, et al. The Psoriasis and Psoriatic Arthritis Pocket Guide. psoriasis.org/the-pocket-guide. Accessed December 7, 2022. 2. National Psoriasis Foundation. psoriasis.org. Accessed December 7, 2022. 3. Nestle F, Kaplan D, Barker J. N Engl J Med. 2009;361:496-609. 4. Lebwohl M, Ogdie A, Merola JF, et al. Abstract presented at: 2021 Maui Derm for Dermatologists; January 25-29, 2020; Maui, HI. 5. Gupta S, Garbarini S, Nazareth T, et al. Dermatol Ther. 2021;1-19. 6. Data on file, Amgen Inc. 7. Kaufman BP, Alexis AF. Am J Clin Dermatol. 2018;19(3):405-423. 8. Schafer P. Biochem Pharmacol. 2012;83(12):1583-1590. 9. Pariser D, Schenkel B, Carter C, et al. J Dermatolog Treat. 2016;27(1):19-26. 10. Mrowietz U, Kragballe K, Reich K, et al. Arch Dermatol Res. 2011;303(1):1-10. 11. Blakely K, Gooderham M. Psoriasis (Auckl). 2016;6:33-40. 12. Kimmel GW, Lebwohl M. Evidence-based Psoriasis: Diagnosis and Treatment. Springer; 2018:1-6. 13. Pasch MC. Drugs. 2016;76(6):675-705. 14. Van de Kerkhof PC, Reich K, Kavanaugh A, et al. J Eur Acad Dermatol Venereol. 2015;29(10):2002-2010. 15. Merola J, Qureshi A, Husni M. Dermatol Ther. 2018;31(3):e12589. 16. Kim WB, Jerome D, Yeung J. Can Fam Physician. 2017;63(4):278-285. 17. Lebwohl MG, Kavanaugh A, Armstrong AW, Van Voorhees AS. Am J Clin Dermatol. 2016;17(1):87-97.