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

STYLE Study Design

STYLE is a Phase 3, multicenter, randomized, double-blind, placebo-controlled study of 303 adult moderate to severe plaque psoriasis
patients with moderate to severe scalp psoriasis1

Study design1-3

Timeline chart that represents STYLE study design for moderate to severe scalp psoriasiss

*Screening up to 35 days before randomization. All doses were titrated over the first week of treatment. At week 16, all placebo patients were switched to open-label apremilast 30 mg BID (with dose titration) through week 32.

  • Patients were randomized 2:1 to receive either Otezla (n=201) 30 mg BID or placebo (n=102) BID for week 16 (placebo-controlled phase)2,3
    • Randomization was stratified by baseline ScPGA score (3 [moderate] or 4 [severe]) to ensure balance between treatment arms
    • At week 16, patients in the placebo arm were switched to Otezla 30 mg BID; patients initiated on Otezla continued with Otezla 30 mg BID until week 32 (weeks 16 to 32 open-label extension phase)

Criteria and endpoints

Selected inclusion criteria1-3:

  • Adults ≥18 years of age
  • With moderate to severe plaque psoriasis (PASI ≥12, BSA ≥10%, sPGA ≥3)
  • With moderate to severe plaque psoriasis of the scalp (ScPGA ≥3, SSA ≥20%)
  • Inadequate response or intolerance to ≥1 topical therapy for plaque psoriasis of the scalp
  • Candidate for phototherapy and/or systemic therapy for either body or scalp psoriasis lesions

Selected exclusion criteria3:

  • Active TB or history of incompletely treated TB
  • Hepatitis B or C positive at screening
  • History of HIV

Primary endpoint1,2:

  • Proportion of patients who achieved ScPGA response at week 16 (defined as ScPGA score of clear [0] or almost clear [1]) with at least a 2-point reduction from baseline

Secondary endpoint1,2:

  • Proportion of patients with whole body itch NRS response (defined as a ≥4-point reduction from baseline) and the proportion of subjects with a scalp itch NRS response (defined as a ≥4-point reduction from baseline)

Patient demographics

Mean age3:

  • 46.9 years (range 19 to 84 years)

Sex3:

  • Male, 62%

Race3:

  • White, 76%

Baseline disease characteristics1,3:

  • Proportion of patients with baseline ScPGA score 3 (moderate scalp psoriasis): 77%
  • Proportion of patients with baseline ScPGA score 4 (severe scalp psoriasis): 23%
  • Mean duration of plaque psoriasis: 15.36 years
  • Mean baseline-affected SSA: 61%
  • Mean baseline BSA involvement: 20%
  • Mean scalp itch NRS score at baseline: 6.7 (range 0-10)
  • Mean whole body itch NRS score at baseline: 7.2 (range 0-10)

Scalp psoriasis treatment history1:

  • Biologic-naïve: 72%
  • Failed on 1 to 2 topicals or shampoo treatments: 59%

Concomitant psoriasis therapy3:

  • For scalp lesions: nonmedicated shampoos
  • For body lesions: unmedicated emollients

BID, twice daily; BSA, body surface area; NRS, numeric rating scale; PASI, Psoriasis Area and Severity Index; ScPGA, Scalp Physician Global Assessment; sPGA, static Physician Global Assessment; SSA, scalp surface area; STYLE, Study of the Efficacy and Safety of Apremilast in Subjects With Moderate to Severe Plaque Psoriasis of the Scalp; TB, tuberculosis.

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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. Van Voorhees AS, Gold LS, Lebwohl M, et al. J Am Acad Dermatol. 2020;83(1):96-103. 3. Data on file, Amgen Inc.