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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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Otezla is the first and only oral therapy approved across all severities of adult plaque psoriasis SEE THE DATA

ESTEEM STUDY DESIGN

ESTEEM consists of 2 multicenter, double-blind, placebo-controlled trials of similar design. Patients aged ≥18 years (N=1257) with moderate to severe plaque psoriasis were randomized to Otezla (n=836) or placebo (n=419) given orally BID. These studies had a similar design through week 32 1,3

Study Design 2,3

Timeline chart that represents the ESTEEM 1 and ESTEEM 2 study designs to treat plaque psoriasis in Otezla patients through 52 weeks

In ESTEEM 1, patients were switched to Otezla if they lost their PASI-75, but no later than at week 52.2 In ESTEEM 2, patients were switched to Otezla if they lost 50% of the PASI improvement obtained at week 32 compared to baseline, but no later than at week 52.

*Doses of Otezla were titrated during the first week of administration. †A responder was defined as a patient achieving ≥PASI-75; a partial responder was defined as a patient achieving PASI-50 to PASI-74; a nonresponder was defined as a patient achieving <PASI-50 in both ESTEEM 1 and ESTEEM 2 at week 32. ‡At week 32, nonresponders and partial responders (ESTEEM 1) or nonresponders only (ESTEEM 2) had the option of adding topical and/or UVB therapy. The decision could be made at week 32 and was based on the discretion of the investigator.

  • Evaluated in 2 multicenter, double-blind, placebo-controlled trials of similar design. Patients with moderate to severe plaque psoriasis (N=1257) were randomized 2:1 to Otezla 30 mg BID or placebo for 16 weeks after a 5-day titration 1
  • At week 16, all patients originally assigned to placebo transitioned to Otezla 30 mg BID. At week 32, some patients originally randomized to Otezla were, based on clinical response, re-randomized to Otezla or placebo. Those re-randomized to placebo restarted Otezla 30 mg BID at loss of response, but no later than at week 52 2,3
  • Patients entering a long-term extension phase could be treated through 5 years 2,3

OTEZLA WAS EVALUATED IN A ROBUST GLOBAL CLINICAL DEVELOPMENT PROGRAM FOR
PLAQUE PSORIASIS THAT ENROLLED OVER 1200 PATIENTS 1,4

Criteria and endpoints

Selected inclusion criteria 1-3:

  • BSA involvement ≥10%
  • sPGA ≥3 (moderate or severe disease)
  • PASI score ≥12
  • Candidates for phototherapy or systemic therapy

Selected exclusion criteria 2,3,5:

  • Active TB or incompletely treated TB; however, there was no requirement for latent TB screening
  • Hepatitis B or hepatitis C positive at screening
  • History of HIV

Primary endpoint 2,3:

  • The proportion of patients who achieved PASI-75 at week 16

Selected secondary endpoints 2,3,5:

  • Proportion of patients who achieved sPGA score of clear (0) or almost clear (1) with at least a 2-point reduction from baseline at week 16
  • Change from baseline in pruritus VAS at week 16

Selected exploratory endpoints 5:

  • Percentage change from baseline in NAPSI scores at week 16
  • Proportion of patients with scalp psoriasis with improvement of ScPGA scores to 0 (clear) and 1 (minimal) at week 16

Patient demographics

Median age 1:

  • 46 years (18 to 83 years)

Mean baseline BSA involvement 1:

  • 25%

Mean baseline PASI score 1:

  • 19

Proportion of patients with baseline sPGA score 3 (moderate) 1:

  • 70%

Proportion of patients with baseline sPGA score 4 (severe) 1:

  • 30%

Prior psoriasis therapy 1-3:

  • Phototherapy: 30%
  • Systemic therapy: 54%
    • Conventional systemic therapy: 37%
    • Biologic therapy: 30%
    • No prior phototherapy, conventional systemic therapy, or biologics: 35%

History of PsA 1:

  • 18%

Concomitant plaque psoriasis medications allowed 2,3:

  • Low-potency topical corticosteroids for face, axillae, and groin psoriatic lesions
  • Coal tar shampoo and/or salicylic acid preparations for scalp lesions
  • All the above permitted except within 24 hours before each study visit
 

BID, twice daily; BSA, body surface area; NAPSI, Nail Psoriasis Severity Index; PASI, Psoriasis Area and Severity Index; PsA, psoriatic arthritis; ScPGA, Scalp Physician Global Assessment; sPGA, static Physician Global Assessment; TB, tuberculosis; UVB, ultraviolet light B; VAS, visual analog scale.

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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. Otezla [package insert]. Thousand Oaks, CA: Amgen Inc. 2. Papp K, Reich K, Leonardi CL, et al. J Am Acad Dermatol. 2015;73(1):37-49. 3. Paul C, Cather J, Gooderham M, et al. Br J Dermatol. 2015;173(6):1387-1399. 4. Reich K, Gooderham M, Green L, et al. J Eur Acad Dermatol Venereol. 2017;31(3):507-517. 5. Data on file, Amgen Inc.