3 INDICATIONS

3 INDICATIONS Otezla® (apremilast) is indicated for the treatment of adult patients with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy. Read more

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

ESTEEM Study Design

ESTEEM consists of 2 multicenter, double-blind, placebo-controlled trials of similar design. Patients ≥18 years of age (N=1257) with moderate to severe plaque psoriasis were randomized to placebo (n=419) or Otezla (n=836) given orally twice daily. These studies had a similar design through week 321-3

Study design2,3

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 twice daily or placebo for 16 weeks after a 5-day titration1
  • At week 16, all patients originally assigned to placebo transitioned to Otezla 30 mg twice daily. 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 twice daily at loss of response, but no later than at week 522,3
  • Patients entering a long-term extension phase could be treated through 5 years2,3

Otezla was evaluated in a robust global clinical
development program for plaque psoriasis that
enrolled over 1200 patients1,4

Criteria and endpoints

Selected inclusion criteria1-3:

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

Selected exclusion criteria2,3,5:

  • 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 endpoint2,3:

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

Selected secondary endpoints2,3,5:

  • 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 endpoints5:

  • Percent 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 age1:

  • 46 years (18 to 83 years)

Mean baseline BSA involvement1:

  • 25%

Mean baseline PASI score1:

  • 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 therapy1-3:

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

History of psoriatic arthritis1:

  • 18%

Concomitant psoriasis medications allowed2,3:

  • 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; HIV, human immunodeficiency virus; ESTEEM, Efficacy and Safety Trial Evaluating the Effects of Apremilast in Psoriasis; NAPSI, Nail Psoriasis Severity Index; PASI, Psoriasis Area and Severity Index; 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® (apremilast) is contraindicated in patients with a known hypersensitivity to apremilast or to any of the excipients in the formulation

Warnings and Precautions

  • 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
    • Psoriasis: Treatment with Otezla is associated with an increase in depression. During clinical trials, 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
    • Psoriasis: Body weight loss of 5-10% occurred in 12% (96/784) of patients 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

  • Psoriasis: Adverse reactions reported in ≥5% of patients were (Otezla%, placebo%): diarrhea (17, 6), nausea (17, 7), upper respiratory tract infection (9, 6), tension headache (8, 4), and headache (6, 4)
  • Psoriatic Arthritis: Adverse reactions reported in at least 2% of patients taking Otezla, that occurred at a frequency at least 1% higher than that observed in patients taking placebo, for up to 16 weeks (after the initial 5-day titration), were (Otezla%, placebo%): diarrhea (7.7, 1.6); nausea (8.9, 3.1); headache (5.9, 2.2); upper respiratory tract infection (3.9, 1.8); vomiting (3.2, 0.4); nasopharyngitis (2.6, 1.6); upper abdominal pain (2.0, 0.2)
  • Behçet’s Disease: Adverse reactions reported in ≥5% of patients taking Otezla, that occurred at a frequency at least 1% higher than that observed in patients taking placebo, for up to 12 weeks, were (Otezla%, placebo%): diarrhea (41.3, 20.4); nausea (19.2, 10.7); headache (14.4, 10.7); upper respiratory tract infection (11.5, 4.9); upper abdominal pain (8.7, 1.9); vomiting (8.7, 1.9); back pain (7.7, 5.8); viral upper respiratory tract infection (6.7, 4.9); arthralgia (5.8, 2.9)

Use in Specific Populations

  • Pregnancy: Otezla has not been studied in pregnant women. Advise pregnant women of the potential risk of fetal loss. Consider pregnancy planning and prevention for females of reproductive potential. There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to Otezla during pregnancy. Information about the registry can be obtained by calling 1-877-311-8972 or visiting https://mothertobaby.org/ongoing-study/otezla/
  • Lactation: There are no data on the presence of apremilast or its metabolites in human milk, the effects of apremilast on the breastfed infant, or the effects of the drug on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Otezla and any potential adverse effects on the breastfed child from Otezla or from the underlying maternal condition
  • Renal Impairment: Otezla dosage should be reduced in patients with severe renal impairment (creatinine clearance less than 30 mL/min); for details, see Dosage and Administration, Section 2, in the Full Prescribing Information

Please click here for Full Prescribing Information.

INDICATIONS

Otezla® (apremilast) is indicated for the treatment of adult patients 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.

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.