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Efficacy

The proven efficacy of Otezla® (apremilast).
  • Primary
    Endpoint
  • PASI
    Scores
  • Scalp Response
    at Week 16
  • Patient
    Photos

Otezla demonstrated a significant increase in PASI-75 response at week 161-3

ESTEEM 1: PASI-75 at week 16 (primary endpoint)1,2

ESTEEM 2: PASI-75 at week 16 (primary endpoint)1,3

Percentage of patients achieving a PASI-75 response in the LIBERATE trial4

LIBERATE: PASI-75 at week 16 (primary endpoint)4,a

a

Modified intent-to-treat population (LOCF).

LIBERATE, Evaluation from a Placebo-controlled Study of Oral Apremilast and Etanercept.

  • A global, phase 3b, placebo-controlled, double-blind, double-dummy study evaluating patients with moderate to severe plaque psoriasis for up to 104 weeks
  • Patients were randomized 1:1:1 to either Otezla® (apremilast) 30 mg (n = 83) twice daily, etanercept 50 mg (n = 83) once weekly, or placebo (n = 84) through week 16. At week 16, all patients crossed over to the Otezla arm
  • Selected inclusion criteria: age ≥18 years; diagnosis of chronic plaque psoriasis for at least 12 months prior to screening; candidate for phototherapy and/or systemic therapy; inadequate response, intolerance, or contraindication to at least one conventional systemic agent; no prior exposure to a biologic for the treatment of psoriatic arthritis or psoriasis
  • Primary endpoint: proportion of patients on Otezla who achieved PASI-75 at week 16 vs placebo

Results seen in Otezla patients3

Individual results may vary.

Baseline

Week 16

ESTEEM 1: PASI-85 result*

Baseline

Week 16

ESTEEM 1: PASI-69 result*

*Actual clinical trial patient.

Selected 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 have been reported 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

Mean PASI scores through week 322,3

a

Results were consistent between ESTEEM 1 and ESTEEM 2.

b

Week 16: secondary endpoint; all other timepoints: exploratory endpoints.

c

Baseline mean PASI scores: Placebo, 19; Otezla, 19; Total, 19.

d

During weeks 16 through 32 (maintenance phase), all patients received Otezla.

e

Causes of patient dropout include adverse events, lack of efficacy, and patient withdrawal.

f

95% confidence interval.

Results seen in Otezla patients3

Individual results may vary.

Baseline

Week 16

ESTEEM 1: PASI-85 result*

Baseline

Week 16

ESTEEM 1: PASI-69 result*

*Actual clinical trial patient.

Selected Safety Information

Warnings and Precautions (cont’d)

  • Depression: 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. Suicidal behavior was observed in 0.1% (1/1308) of patients on Otezla, compared to 0.2% (1/506) on placebo. 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

Scalp response at week 162,3

ESTEEM 1: Proportion of patients with a score of clear or minimal on the Scalp Physician Global Assessment (ScPGA) at week 162,3,a-c

Patients Achieving an ScPGA Score of 0 or 1 (%)

a

FAS; LOCF.

b

Week 16: Prespecified exploratory endpoint. In the planned hierarchical statistical testing sequence for ESTEEM 1 and ESTEEM 2, efficacy analyses preceding ScPGA were statistically significant, allowing for control of the overall type 1 error rate at 0.05 significance level in analysis of ScPGA.

c

Baseline ScPGA ≥3.

Results seen in Otezla patients3

Individual results may vary.

Baseline

Week 16

ESTEEM 1: PASI-63 result*

*Actual clinical trial patient.

Selected Safety Information

Warnings and Precautions (cont'd)

  • Weight Decrease: Monitor body weight regularly; evaluate unexplained or clinically significant weight loss, and consider discontinuation of Otezla. 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. Monitor body weight regularly; evaluate unexplained or clinically significant weight loss, and consider discontinuation of Otezla

Results seen in Otezla patients3

Individual results may vary.

Patient prior to treatment initiation

Baseline

Actual patient results of Otezla® (apremilast) after 16 weeks

Week 16

PASI-76.5 result

Patient prior to treatment initiation

Baseline

Actual patient results of Otezla® (apremilast) after 16 weeks

Week 16

PASI-80 result

Patient prior to treatment initiation

Baseline

Actual patient results of Otezla® (apremilast) after 16 weeks

Week 16

PASI-75 result

Patient prior to treatment initiation

Baseline

Actual patient results of Otezla® (apremilast) after 16 weeks

Week 16

ESTEEM 1: PASI-52 result*

*Actual clinical trial patient.

Selected Safety Information

Warnings and Precautions (cont'd)

  • 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

References: 1. Otezla [package insert]. Summit, NJ: Celgene Corporation. 2. Papp K, Reich K, Leonardi CL, et al. J Am Acad Dermatol. 2015;73(1):37-49. 3. Data on file, Celgene Corporation. 4. Reich K, Gooderham M, Green L, et al. The efficacy and safety of apremilast, etanercept, and placebo, in patients with moderate to severe plaque psoriasis: 52-week results from a phase 3b, randomized, placebo-controlled trial (LIBERATE). J Eur Acad Dermatol Venereol. [Epub ahead of print].

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Indications & Important Safety Information

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