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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

  • Depression: Treatment with Otezla is associated with an increase in adverse reactions of depression. During clinical trials, 1.3% (12/920) of patients treated with Otezla reported depression compared to 0.4% (2/506) on placebo; 0.1% (1/1308) of Otezla patients discontinued treatment due to depression compared with none on placebo (0/506). 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.

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)

  • 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: 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. Monitor body weight regularly; evaluate unexplained or clinically significant weight loss, and consider discontinuation of Otezla
  • 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 (eg, rifampin, phenobarbital, carbamazepine, phenytoin) is not recommended

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.

References: 1. Otezla [package insert]. Summit, NJ: Celgene Corporation; 2015. 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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