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Efficacy

Results from Otezla® (apremilast) clinical trials
  • PASI-75 
    Response
  • PASI
    Scores
  • Scalp Response
    at Week 16
  • Nail Response
    at Week 16
  • Pruritus VAS Scores
  • DLQI Scores
  • LIBERATE: Biologic-Naïve
  • 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

Response Rate (%)

P < 0.0001

ESTEEM 2: PASI-75 at week 16 (primary endpoint)1,3,4

Response Rate (%)

P < 0.0001

BID, twice daily.

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 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

Mean PASI scores through week 322,3

ESTEEM 1®: Mean percent improvement in PASI scores at week 162,3,a-d

Exploratory analysis; data as observed

a

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

b

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

c

At week 16, patients receiving placebo were switched to Otezla.

d

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

e

95% confidence interval.

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

Prespecified exploratory endpoint


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

P < 0.0001

Results were consistent between ESTEEM 1 and ESTEEM 2.2,4

a

FAS; LOCF.

b

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.

FAS, full analysis set; LOCF, last observation carried forward.

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

Nail response at week 162

ESTEEM® 1: Mean percent change in NAPSI score at week 162,a-c

Prespecified exploratory endpoint

P < 0.0001
a

FAS; LOCF.

b

In the planned hierarchical statistical testing sequence for ESTEEM, efficacy analyses preceding NAPSI were statistically significant, allowing for control of the overall type 1 error rate at 0.05 significance level in analysis of NAPSI.

c

In patients with nail psoriasis at baseline (NAPSI score ≥1; 66.1% [558/844]).

NAPSI, Nail Psoriasis Severity Index.

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

Mean pruritus VAS scores through week 322,3

ESTEEM® 1: Mean improvement in baseline pruritus VAS scores at week 162,3,a-e

Exploratory analysis; data as observed

a

Pruritus was measured on a 100-mm VAS.

b

At week 16, patients receiving placebo were switched to Otezla.

c

Baseline mean pruritus VAS scores (mm): Placebo, 65.2; Otezla, 66.2.

d

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

e

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

f

95% confidence interval.

BL, baseline; VAS, visual analogue scale.

Selected Safety Information

Adverse Reactions

  • 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)

Change in quality of life as measured by DLQI3,5

ESTEEM® 1: Mean improvement in baseline DLQI score at week 163,5,a-d

Exploratory analysis; data as observed

a

At week 16, patients receiving placebo were switched to Otezla.

b

Baseline mean DLQI scores: Placebo, 12.1; Otezla, 12.7.

c

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

d

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

e

95% confidence interval.

DLQI, Dermatology Life Quality Index.

  • Otezla achieved significant improvement in DLQI at week 165
    • At week 16, patients taking Otezla 30 mg BID achieved a greater reduction in DLQI score than patients taking placebo (-6.6 vs -2.1 respectively; P < 0.0001; LOCF)
  • The DLQI is a 10-item questionnaire assessing the impact of skin disease on health-related quality of life (HRQoL). Total score ranges from 0 to 30; higher scores indicate poor quality of life and scores of 11 to 20 indicate a large impact of skin disease on HRQoL. The minimal clinically important difference (MCID) in the DLQI is a decrease of 5.0 points from baseline

Selected Safety Information

Use in Specific Populations

  • Pregnancy and Nursing Mothers: Otezla is Pregnancy Category C; it has not been studied in pregnant women. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. It is not known whether apremilast or its metabolites are present in human milk. Caution should be exercised when Otezla is administered to a nursing woman

Efficacy in biologic-naïve patients6

LIBERATE: PASI-75 at week 16 (primary endpoint)6,a

Response Rate (%)

P < 0.0001
a

mITT; LOCF.

Patients were randomized and received one dose of study drug and had both baseline PASI and at least one post-treatment PASI evaluation.

LIBERATE, Evaluation from a Placebo-controlled Study of Oral Apremilast and Etanercept in Plaque Psoriasis; mITT, modified intent-to-treat.

LIBERATE: Mean percent change in PASI scores at week 163,6,a

Exploratory analysis; data as observed: mITT

a

Baseline mean PASI scores: Placebo, 19.4; Otezla, 19.3

b

95% confidence interval.

LIBERATE: Mean change in baseline pruritus VAS scores3,6,a,b

Exploratory analysis; data as observed: mITT

a

Pruritus was measured on a 100-mm VAS.

b

Baseline mean pruritus VAS scores (mm): Placebo, 62.5; Otezla, 62.6.

c

95% confidence interval.

LIBERATE: Mean improvement in baseline DLQI score at week 163,6,a

Secondary endpoint; data as observed; mITT

a

Baseline DLQI scores: Placebo, 11.4; Otezla, 13.6.

b

95% confidence interval.

  • 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 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
  • The most common adverse reactions in ≥5% of patients were nausea, diarrhea, upper respiratory tract infection, nasopharyngitis, tension headache, and headache. Discontinuation of treatment due to adverse reactions was 3.6% for Otezla and 2.4% for placebo6
  • The DLQI is a 10-item questionnaire assessing the impact of skin disease on health-related quality of life (HRQoL). Total score ranges from 0 to 30; higher scores indicate poorer quality of life and scores of 11 to 20 indicate a large impact of skin disease on HRQoL. The minimal clinically important difference (MCID) in the DLQI is a decrease of 5.0 points from baseline

Selected Safety Information

Use in Specific Populations (cont’d)

  • 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

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

ESTEEM® 1: PASI-52 result*

Patient prior to treatment initiation

Baseline

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

Week 16

ESTEEM 1: PASI-69 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

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

ESTEEM 1: PASI-85 result*

Baseline

Week 16

ESTEEM 1: PASI-63 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

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. Paul C, Cather J, Gooderham M, et al. Br J Dermatol. 2015;173:1387-1399. 5. Thaçi D, Kimball A, Foley P, et al. J Eur Acad Dermatol Venereol. 2017;31(3):498-506. 6. Reich K, Gooderham M, Green L, et al. J Eur Acad Dermatol Venereol. 2017;31:507-517.

Indications & Important Safety Information

Please click here for Full Prescribing Information.

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Reference: 1. Data on file, Celgene Corporation.
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