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

Efficacy results seen in actual clinical trial and Otezla patients

Results seen in Otezla patients1

Photo from a female Otezla patient's stomach at baseline
Photo from a female Otezla patient's stomach with PASI-49.7 score at week 16

Actual Otezla® (apremilast) patient.1
Individual results may vary.
*PASI-49.7 response: A 49.7% reduction in a
patient’s PASI score.1

Photo from ESTEEM 1 Study of a male Otezla patient's back at baseline
Photo from ESTEEM 1 Study of a male Otezla patient's back with PASI-52 score at week 16

Actual clinical trial patient from ESTEEM.1
Individual results may vary.
PASI-52 response: A 52% reduction in a patient’s
PASI score.1

Photo from an ESTEEM study of an Otezla patient's calf muscles showing the baseline
Photo from an Otezla patient's calf muscles with PASI-62.5 result at week 16
Photo from an Otezla patient's calf muscles with PASI-72 result at week 32

Actual Otezla patient.1 Individual results may vary.
PASI-62.5 response: A 62.5% reduction in a patient’s
PASI score.1

Photo from ESTEEM 1 Study of an Otezla patient's neck at baseline
Photo from ESTEEM 1 Study of an Otezla patient's neck with PASI-63 score at week 16

Actual clinical trial patient from ESTEEM.1
Individual results may vary.
§PASI-63 response: A 63% reduction in a patient’s
PASI score.1

Photo from ESTEEM 1 Study of an Otezla patient's light skin back at baseline
Photo from ESTEEM 1 Study of an Otezla patient's light skin back with PASI-69 score at week 16

Actual clinical trial patient from ESTEEM1
Individual results may vary.
**PASI-69 response: A 69% reduction in a patient’s
PASI score.1

Photo from an ESTEEM study of an Otezla patient's elbow at baseline
Photo from an ESTEEM study of an Otezla patient's elbow with PASI-70 result at week 16

Actual clinical trial patient from ESTEEM1
Individual results may vary.
††PASI-70 response: A 70% reduction in a patient’s
PASI score.1

Photo from an Otezla patient's knees at baseline
Photo from an Otezla patient's knees with PASI-75 score at week 16

Actual Otezla patient.1 Individual results may vary.
‡‡PASI-75 response: A 75% reduction in a patient’s
PASI score.1

Photo from an Otezla patient's thighs at baseline
Photo from an Otezla patient's thighs with PASI-76.5 result at week 16
Photo from an Otezla patient's thighs with PASI-90 result at week 32

Actual Otezla patient.1 Individual results may vary.
§§PASI-90 response: A 90% reduction in a patient’s
PASI score.1

Photo from an Otezla patient's finger at baseline
Photo from an Otezla patient's 4 fingers at baseline
Photo from an Otezla patient's finger with NAPSI scores at week 16
Photo from an Otezla patient's 4 fingers with NAPSI scores at week 16

Actual Otezla patient.1 Images are not
reflective of NAPSI score.
Individual results may vary.

Photo from an Otezla patient's lower back at baseline
Photo from an Otezla patient's lower back with PASI-80 score at week 16

Actual Otezla patient.1 Individual results may vary.
***PASI-80 response: An 80% reduction in a
patient’s PASI score.1

Photo from an Otezla patient's arm at baseline
Photo from an Otezla patient's arm with PASI-80 score at week 16

Actual Otezla patient.1 Individual results may vary.

Photo from ESTEEM 1 Study of an Otezla patient's legs at baseline
Photo from ESTEEM 1 Study of an Otezla patient's legs with PASI-85 score at week 16

Actual clinical trial patient from ESTEEM.1
Individual results may vary.
†††PASI-85 response: An 85% reduction in a patient’s
PASI score.1

Photo from STYLE Study of a female Otezla patient's ear at baseline
Photo from STYLE Study of an Otezla patient's ear with ScPGA 0 at week 16

Actual clinical trial patient from STYLE.1
Individual results may vary.

Photo from STYLE study of a male Otezla patient's scalp at baseline
Photo from STYLE study of an Otezla patient's scalp with ScPGA score at week 16
Photo from STYLE study of an Otezla patient's scalp with ScPGA score at week 32

Actual clinical trial patient from STYLE.1
Individual results may vary.

Photo from STYLE Study of a male Otezla patient's ear at baseline
Photo from STYLE Study of an Otezla patient's ear with ScPGA 3 at week 16

Actual clinical trial patient from STYLE.1
Individual results may vary.

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; STYLE, Study of the Efficacy and Safety of Apremilast in Subjects With Moderate to Severe Plaque Psoriasis of the Scalp.

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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.

Reference: 1. Data on file, Amgen Inc.