Efficacy

Results from Otezla^® (apremilast) clinical trials

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ESTEEM: PASI-75 Response
ESTEEM: PASI Scores
ESTEEM: Scalp Response at Week 16
ESTEEM: Nail Response at Week 16
ESTEEM: Pruritus VAS Scores
ESTEEM: DLQI Scores
ESTEEM: 4-year Data
STYLE: ScPGA Response
STYLE: Scalp Itch NRS
STYLE: Whole Body Itch NRS
LIBERATE: Biologic-naïve
Patient Photos

OTEZLA DEMONSTRATED A SIGNIFICANT INCREASE IN PASI-75 RESPONSE AT WEEK 16^1-3

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

33%

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

29%

BID, twice daily; ESTEEM, Efficacy and Safety Trial Evaluating the Effects of Apremilast in Psoriasis; PASI, Psoriasis Area and Severity Index.

Next: PASI Scores

MEAN PASI SCORES THROUGH WEEK 16^2,4

ESTEEM 1: Mean percent improvement in PASI scores at week 16^2,4,a

Secondary endpoint; LOCF; FAS

aBaseline mean PASI scores: Placebo, 19; Otezla, 19.

LOCF, last observation carried forward.

Next: Scalp Response at Week 16

SCALP RESPONSE AT WEEK 16^2,4

ESTEEM 1: Proportion of patients with a ScPGA score of clear or minimal at week 16^2,4,a,b

Prespecified exploratory endpoint; LOCF; FAS

In the planned hierarchical statistical testing sequence for ESTEEM, 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.

Baseline ScPGA ≥3.

BID, twice daily; ESTEEM, Efficacy and Safety Trial Evaluating the Effects of Apremilast in Psoriasis; FAS, full analysis set; LOCF, last observation carried forward; ScPGA, Scalp Physician Global Assessment.

Next: Nail Response at Week 16

NAIL RESPONSE AT WEEK 16^2,4

ESTEEM 1: Mean percent change in nail psoriasis severity (NAPSI score) at week 16^2,a,b

Prespecified exploratory endpoint; LOCF; FAS

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.

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

BID, twice daily; BL, baseline; ESTEEM, Efficacy and Safety Trial Evaluating the Effects of Apremilast in Psoriasis; FAS, full analysis set; LOCF, last observation carried forward; NAPSI, Nail Psoriasis Severity Index.

Next: Pruritus VAS Scores

MEAN PRURITUS VAS SCORES AT WEEK 16^2,4

ESTEEM 1: Mean improvement from baseline pruritus VAS scores at week 16^2,4,a,b

Secondary endpoint; LOCF; FAS

Pruritus was measured on a 100-mm VAS.

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

VAS, visual analog scale.

Next: DLQI Scores

CHANGE IN QUALITY OF LIFE AS MEASURED BY DLQI^4,5

ESTEEM 1: Mean improvement from baseline DLQI scores at week 16^4,5,a

Secondary endpoint; LOCF; FAS

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

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 baseline⁵

Next: 4-year Data

4-YEAR DATA WITH OTEZLA⁴

ESTEEM 1: PASI-75 response through 208 weeks^4,a-c

Exploratory analysis; data as observed

Consider open-label extension (OLE) study limitations when interpreting results. The OLE is not blinded, not controlled, and includes inherent self-selection bias.

FAS.

Week 16: primary endpoint; all other time points: exploratory endpoints.

Randomized treatment withdrawal phase (weeks 32 to 52) where additional psoriasis therapies, including topicals and/or phototherapy, could have been added to PASI‑75 nonresponders. Please see study design for additional information.

Data are presented “as observed” with no imputation for missing values; causes of patient dropout include lack of efficacy, withdrawal by subject, adverse events, and loss to follow-up, which may increase patient response at each timepoint
OLE phase: pooled treatment arms reflect post-hoc analysis

BID, twice daily; ESTEEM, Efficacy and Safety Trial Evaluating the Effects of Apremilast in Psoriasis; FAS, full analysis set; PASI, Psoriasis Area and Severity Index.

ESTEEM 1: Mean percent change in PASI scores through 208 weeks^4,a-d

Exploratory analysis; data as observed

Consider OLE study limitations when interpreting results. The OLE is not blinded, not controlled, and includes inherent self-selection bias.

FAS.

Week 16: secondary endpoint; all other time points: exploratory endpoints.

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

Data are presented “as observed” with no imputation for missing values; causes of patient dropout include lack of efficacy, withdrawal by subject, adverse events, and loss to follow-up, which may increase patient response at each time point
OLE phase: pooled treatment arms reflect post-hoc analysis

ESTEEM 1: Proportion of patients with ScPGA score of clear or minimal through 208 weeks^4,a-d

Exploratory analysis; data as observed

Consider OLE study limitations when interpreting results. The OLE is not blinded, not controlled, and includes inherent self-selection bias.

FAS.

Baseline ScPGA ≥3.

Statistical analyses were conducted in a hierarchical manner for efficacy endpoints, including ScPGA score, to control the overall type 1 error rate.

Data are presented “as observed” with no imputation for missing values; causes of patient dropout include lack of efficacy, withdrawal by subject, adverse events, and loss to follow-up, which may increase patient response at each time point
OLE phase: pooled treatment arms reflect post-hoc analysis

ScPGA, Scalp Physician Global Assessment.

ESTEEM 1: Mean percent change from baseline NAPSI scores through 208 weeks^4,a-d

Exploratory analysis; data as observed

Consider OLE study limitations when interpreting results. The OLE is not blinded, not controlled, and includes inherent self-selection bias.

FAS.

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

Statistical analyses were conducted in a hierarchical manner for efficacy endpoints, including NAPSI score, to control the overall type 1 error rate.

Data are presented “as observed” with no imputation for missing values; causes of patient dropout include lack of efficacy, withdrawal by subject, adverse events, and loss to follow-up, which may increase patient response at each time point
OLE phase: pooled treatment arms reflect post-hoc analysis

BL, baseline; NAPSI, Nail Psoriasis Severity Index.

ESTEEM 1: Mean change in baseline VAS scores through 208 weeks^4,a-d

Exploratory analysis; data as observed

Consider OLE study limitations when interpreting results. The OLE is not blinded, not controlled, and includes inherent self-selection bias.

FAS.

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

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

Data are presented “as observed” with no imputation for missing values; causes of patient dropout include lack of efficacy, withdrawal by subject, adverse events, and loss to follow-up, which may increase patient response at each timepoint
OLE phase: pooled treatment arms reflect post-hoc analysis

VAS, visual analog scale.

ESTEEM 1: Mean change from baseline DLQI scores through 208 weeks^4,a-d

Exploratory analysis; data as observed

Consider OLE study limitations when interpreting results. The OLE is not blinded, not controlled, and includes inherent self-selection bias.

FAS.

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

Week 16: secondary endpoint; all other time points: exploratory endpoints.

Data are presented “as observed” with no imputation for missing values; causes of patient dropout include lack of efficacy, withdrawal by subject, adverse events, and loss to follow-up, which may increase patient response at each time point
OLE phase: pooled treatment arms reflect post-hoc analysis
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 baseline⁵

DLQI, Dermatology Life Quality Index.

Next: STYLE ScPGA Response

THE ONLY ORAL THERAPY WITH DATA IN THE LABEL FOR ADULTS WITH MODERATE TO SEVERE SCALP PSORIASIS¹
OTEZLA SIGNIFICANTLY IMPROVED ScPGA RESPONSE AT WEEK 16^1,2

STYLE: Proportion of patients achieving ScPGA response at week 16^1,2,a,b

Primary endpoint; ITT population; Ml analysis

ScPGA is evaluated on a 5-point scale (0 [clear], 1 [almost clear], 2 [mild], 3 [moderate], 4 [severe]), assessing the severity of erythema, scaling, and plaque elevation.

ScPGA response was defined as the proportion of patients achieving ScPGA response score of 0 (clear) or 1 (almost clear) with at least a 2-point reduction from baseline (Otezla 43.3% vs placebo 13.7%; P<0.0001).

3x-callout

See Scalp Itch NRS Response and Whole Body Itch NRS Response at week 16

ScPGA RESPONSE THROUGH WEEK 32³

STYLE: ScPGA response by timepoint through week 32^3,a,b

Exploratory analysis; ITT population; NRI analysis

Consider open-label extension (OLE) study limitations when interpreting results. The OLE study was not blinded, not controlled, and included inherent self-selection bias for remaining in the trial.

Note: For each timepoint in a treatment arm, n = number of observed responded patients, N = total number of patients, and response rate (%) was calculated as 100*n/N. For assessments before week 16, N includes all randomized patients. For assessments after week 16, N includes only patients who entered the OLE phase.

ScPGA is evaluated on a 5-point scale (0 [clear], 1 [almost clear], 2 [mild], 3 [moderate], 4. [severe]), assessing the severity of erythema, scaling, and plaque elevation.

ScPGA response was defined as the proportion of patients achieving ScPGA response score of 0 (clear) or 1 (almost clear) with at least a 2-point reduction from baseline.

Bars represent 2-sided 95% confidence interval.

BID, twice daily; ITT, intent to treat; MI, multiple imputation; NRI, nonresponder imputation; ScPGA, Scalp Physician Global Assessment; SE, standard error.

Next: Scalp Itch Response

OTEZLA DEMONSTRATED SIGNIFICANT IMPROVEMENT IN SCALP ITCH AT WEEK 16 WITH SIGNIFICANT ACHIEVEMENT OF RESPONSE AS EARLY AS WEEK 2^1,2

STYLE: Proportion (±SE) of patients achieving scalp itch NRS response through week 16^1,2,a-c

Secondary endpoint; ITT population; MI analysis

style-proportion-patients-scalp-itch-week-16

26.1% of patients achieved a ≥4-point improvement from baseline in scalp itch NRS vs placebo (11.5%) at 2 weeks; P=0.0025

Patients rated their scalp itch on a scale of 0 (no itch) to 10 (worst imaginable itch).

Analyses were based on patients in the ITT population with baseline scalp itch NRS score ≥4.

Scalp itch NRS response was defined as a ≥4-point reduction (improvement) from baseline. At baseline, the mean scalp itch NRS score was 6.7, with scales ranging from 0 to 10.

Due to the MI method used to analyze the data, the n value for patients who achieved response may be in decimals.

Error bars represent 95% confidence interval.

Scalp itch response through Week 32³

STYLE: Proportion (± SE) of patients achieving scalp itch NRS response through week 32^3,a-d

ITT population; NRI analysis

style-proportion-achieving-scalp-itch-nrs-week-32

Consider open-label extension (OLE) study limitations when interpreting results. The OLE study was not blinded, not controlled, and included inherent self-selection bias for remaining in the trial.

Patients rated their scalp itch on a scale of 0 (no itch) to 10 (worst imaginable itch). Analyses were based on patients in the ITT population with baseline scalp itch NRS score ≥4.

Scalp itch NRS response was defined as a ≥4-point reduction (improvement) from baseline.

The placebo-controlled phase by visit (week 2, 4, 8, 12, 16) were secondary endpoints; OLE phase by visit (weeks 20, 24, 32) were exploratory endpoints.

Bars represent 2-sided 95% confidence interval.

BID, twice daily; ITT, intent to treat; MI, multiple imputation; NRI, nonresponder imputation; NRS, numeric rating scale; SE, standard error.

Next: Whole Body Itch Response

OTEZLA DEMONSTRATED SIGNIFICANT IMPROVEMENT IN WHOLE BODY ITCH AT WEEK 16 WITH SIGNIFICANT ACHIEVEMENT OF RESPONSE AS EARLY AS WEEK 2^1,2

STYLE: Proportion (± SE) of patients achieving whole body itch NRS response through week 16^1,2,a-c

Secondary endpoint; ITT population; MI analysis

style-proportion-achieving-whole-body-nrs-week-16

20.5 % of patients achieved a ≥4-point improvement from baseline in whole body itch NRS vs placebo (3.5 %) at 2 weeks; P<0.0001

Patients rated their whole body itch on a scale of 0 (no itch) to 10 (worst imaginable itch). Analyses were based on patients in the ITT population with baseline whole body NRS score ≥4. At baseline, the mean whole body itch NRS score was 7.2, with the scales ranging from 0 to 10.

Whole body itch NRS response was defined as a ≥4-point reduction (improvement) from baseline.

Due to the MI method used to analyze the data, the n value for subjects who achieved response may be in decimals.

Error bars represent 95% confidence interval.

Whole body itch response through Week 32³

STYLE: Proportion (± SE) of patients achieving whole body itch NRS response through week 32^3,a-c

ITT population; NRI analysis

style-proportion-achieving-whole-body-nrs-week-32

Consider open-label extension (OLE) study limitations when interpreting results. The OLE study was not blinded, not controlled, and included inherent self-selection bias for remaining in the trial.

Patients rated their whole body itch on a scale of 0 (no itch) to 10 (worst imaginable itch). Analyses were based on patients in the ITT population with baseline whole body itch NRS score ≥4.

Whole body itch NRS response was defined as a ≥4-point reduction (improvement) from baseline.

The placebo-controlled phase by visit (weeks 2, 4, 8, 12, 16) were secondary endpoints; OLE phase by visit (weeks 20, 24, 32) were exploratory endpoints.

Bars represent 2-sided 95% confidence interval.

BID, twice daily; ITT, intent to treat; MI, multiple imputation; NRI, nonresponder imputation; NRS, numeric rating scale; SE, standard error.

Next: LIBERATE: Biologic-naïve

EFFICACY IN BIOLOGIC-NAÏVE PATIENTS^4,6

LIBERATE^®: PASI-75 at week 16^6,a

Primary endpoint; LOCF; mITT

Patients were randomized and received ≥1 dose of study drug and had both baseline PASI and at least one post-treatment PASI evaluation.

LIBERATE, Evaluation in a Placebo-Controlled Study of Oral Apremilast and Etanercept in Plaque Psoriasis; LOCF, last observation carried forward; mITT, modified intent-to-treat; PASI, Psoriasis Area and Severity Index.

In LIBERATE:

The most common adverse reactions in ≥5% of patients were nausea, diarrhea, upper respiratory tract infection, nasopharyngitis, tension headache, and headache⁶
Discontinuation of treatment due to adverse reactions was 3.6% for Otezla and 2.4% for placebo⁶

LIBERATE study design⁶

Program:

Global, phase 3b, placebo-controlled, double-blind, double-dummy study
250 adult patients with moderate to severe plaque psoriasis
Click here to see full study design for more information

LIBERATE: Mean percent change from baseline PASI scores at week 16^4,6,a

Prespecified exploratory analysis; LOCF; mITT

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

LIBERATE: Patients with a ScGPA score of "clear" or "minimal" at week 16^4,6,a

Prespecified exploratory analysis; LOCF; mITT

Baseline ScPGA ≥3.

ScPGA, Scalp Physician Global Assessment.

LIBERATE: Mean percent change from baseline NAPSI score at week 16^4,6,a,b

Prespecified exploratory analysis; LOCF; mITT

In patients with a baseline value and at least one post-baseline value.

Baseline mean NAPSI scores: Placebo, 4.14; Otezla, 4.18.

BL, baseline; NAPSI, Nail Psoriasis Severity Index.

LIBERATE: Mean change from baseline pruritus VAS scores at week 16^4,6,a,b

Prespecified exploratory analysis; LOCF; mITT

Pruritus was measured on a 100-mm VAS.

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

95% confidence interval.

BL, baseline; VAS, visual analog scale.

LIBERATE: Mean improvement from baseline DLQI scores at week 16^4,6,a

Secondary endpoint; LOCF; mITT

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

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 baseline⁵

DLQI, Dermatology Life Quality Index.

Next: Patient Photos

Results seen in Otezla patients¹

Individual results may vary.

Baseline

Actual patient PASI-52 result with Otezla® (apremilast) after 16 weeks

Week 16

ESTEEM 1: PASI-52 result*

Baseline

Actual patient PASI-69 result with Otezla® (apremilast) after 16 weeks

Week 16

ESTEEM 1: PASI-69 result*

Baseline

Week 16

PASI-75 result

Baseline

Week 16

PASI-76.5 result

Baseline

Week 16

PASI-80 result

Baseline

Actual patient PASI-85 result with Otezla® (apremilast) after 16 weeks

Week 16

ESTEEM 1: PASI-85 result*

Actual patient PASI-63 result with Otezla® (apremilast) at baseline

ESTEEM^® 1: Baseline

Actual patient PASI-63 result with Otezla® (apremilast) after 16 weeks

Week 16

ESTEEM 1: PASI-63 result*

STYLE: Baseline

Week 16

STYLE: ScPGA 0^†
3-point improvement in ScPGA score

STYLE: Baseline

Week 16

STYLE: ScPGA 3^†
1-point improvement in ScPGA score

*Actual clinical trial patient. Individual results may vary.

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

ESTEEM, Efficacy and Safety Trial Evaluating the Effects of Apremilast in Psoriasis; PASI, Psoriasis Area and Severity Index.

STYLE: Efficacy and Safety of Apremilast in Patients with Moderate to Severe Plaque Psoriasis of the Scalp; ScPGA, scalp physician global assessment.

Next: Safety

References: 1. Otezla [package insert]. Thousand Oaks, CA: Amgen Inc. 2. Papp K, Reich K, Leonardi CL, et al. J Am Acad Dermatol. 2015;73(1):37-49. 3. Paul C, Cather J, Gooderham M, et al. Br J Dermatol. 2015;173(6):1387-1399. 4. Data on file, Amgen Inc. 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(3):507-517.

References: 1. Otezla [package insert]. Thousand Oaks, CA: Amgen Inc. 2. Van Voorhees A, Gold LS, Lebwohl M, et al. Efficacy and safety of apremilast in patients with moderate to severe plaque psoriasis of the scalp: results of a phase 3b, multicenter, randomized, placebo-controlled, double-blind study. J Am Acad Dermatol. 2020. doi:10.1016/j.jaad.2020.01.072 3. Data on file, Amgen Inc.

Reference: 1. Data on file, Amgen Inc.

INDICATIONS & IMPORTANT SAFETY 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.

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 & IMPORTANT SAFETY 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.

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

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The FDA approves new data for otezla® (apremilast)

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Efficacy

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)1,3,4

MEAN PASI SCORES THROUGH WEEK 162,4

ESTEEM 1: Mean percent improvement in PASI scores at week 162,4,a

SCALP RESPONSE AT WEEK 162,4

ESTEEM 1: Proportion of patients with a ScPGA score of clear or minimal at week 162,4,a,b

NAIL RESPONSE AT WEEK 162,4

ESTEEM 1: Mean percent change in nail psoriasis severity (NAPSI score) at week 162,a,b

MEAN PRURITUS VAS SCORES AT WEEK 162,4

ESTEEM 1: Mean improvement from baseline pruritus VAS scores at week 162,4,a,b

CHANGE IN QUALITY OF LIFE AS MEASURED BY DLQI4,5

ESTEEM 1: Mean improvement from baseline DLQI scores at week 164,5,a

4-YEAR DATA WITH OTEZLA4

ESTEEM 1: PASI-75 response through 208 weeks4,a-c

ESTEEM 1: Mean percent change in PASI scores through 208 weeks4,a-d

ESTEEM 1: Proportion of patients with ScPGA score of clear or minimal through 208 weeks4,a-d

ESTEEM 1: Mean percent change from baseline NAPSI scores through 208 weeks4,a-d

ESTEEM 1: Mean change in baseline VAS scores through 208 weeks4,a-d

ESTEEM 1: Mean change from baseline DLQI scores through 208 weeks4,a-d

THE ONLY ORAL THERAPY WITH DATA IN THE LABEL FOR ADULTS WITH MODERATE TO SEVERE SCALP PSORIASIS1 OTEZLA SIGNIFICANTLY IMPROVED ScPGA RESPONSE AT WEEK 161,2

STYLE: Proportion of patients achieving ScPGA response at week 161,2,a,b

ScPGA RESPONSE THROUGH WEEK 323

STYLE: ScPGA response by timepoint through week 323,a,b

OTEZLA DEMONSTRATED SIGNIFICANT IMPROVEMENT IN SCALP ITCH AT WEEK 16 WITH SIGNIFICANT ACHIEVEMENT OF RESPONSE AS EARLY AS WEEK 21,2

STYLE: Proportion (±SE) of patients achieving scalp itch NRS response through week 161,2,a-c

Scalp itch response through Week 323

STYLE: Proportion (± SE) of patients achieving scalp itch NRS response through week 323,a-d

OTEZLA DEMONSTRATED SIGNIFICANT IMPROVEMENT IN WHOLE BODY ITCH AT WEEK 16 WITH SIGNIFICANT ACHIEVEMENT OF RESPONSE AS EARLY AS WEEK 21,2

STYLE: Proportion (± SE) of patients achieving whole body itch NRS response through week 161,2,a-c

Whole body itch response through Week 323

STYLE: Proportion (± SE) of patients achieving whole body itch NRS response through week 323,a-c

EFFICACY IN BIOLOGIC-NAÏVE PATIENTS4,6

LIBERATE®: PASI-75 at week 166,a

LIBERATE study design6

Program:

LIBERATE: Mean percent change from baseline PASI scores at week 164,6,a

LIBERATE: Patients with a ScGPA score of "clear" or "minimal" at week 164,6,a

LIBERATE: Mean percent change from baseline NAPSI score at week 164,6,a,b

LIBERATE: Mean change from baseline pruritus VAS scores at week 164,6,a,b

LIBERATE: Mean improvement from baseline DLQI scores at week 164,6,a

Results seen in Otezla patients1

Individual results may vary.

Baseline

Week 16

ESTEEM 1: PASI-52 result*

Baseline

Week 16

ESTEEM 1: PASI-69 result*

Baseline

Week 16

PASI-75 result

Baseline

Week 16

PASI-76.5 result

Baseline

Week 16

PASI-80 result

Baseline

Week 16

ESTEEM 1: PASI-85 result*

ESTEEM® 1: Baseline

Week 16

ESTEEM 1: PASI-63 result*

STYLE: Baseline

Week 16

STYLE: ScPGA 0† 3-point improvement in ScPGA score

STYLE: Baseline

Week 16

STYLE: ScPGA 3† 1-point improvement in ScPGA score

INDICATIONS & IMPORTANT SAFETY INFORMATION

INDICATIONS

IMPORTANT SAFETY INFORMATION

INDICATIONS & IMPORTANT SAFETY INFORMATION

INDICATIONS

The FDA approves new data
for otezla^® (apremilast)

OTEZLA DEMONSTRATED A SIGNIFICANT INCREASE IN PASI-75 RESPONSE AT WEEK 16^1-3

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

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

MEAN PASI SCORES THROUGH WEEK 16^2,4

ESTEEM 1: Mean percent improvement in PASI scores at week 16^2,4,a

SCALP RESPONSE AT WEEK 16^2,4

ESTEEM 1: Proportion of patients with a ScPGA score of clear or minimal at week 16^2,4,a,b

NAIL RESPONSE AT WEEK 16^2,4

ESTEEM 1: Mean percent change in nail psoriasis severity (NAPSI score) at week 16^2,a,b

MEAN PRURITUS VAS SCORES AT WEEK 16^2,4

ESTEEM 1: Mean improvement from baseline pruritus VAS scores at week 16^2,4,a,b

CHANGE IN QUALITY OF LIFE AS MEASURED BY DLQI^4,5

ESTEEM 1: Mean improvement from baseline DLQI scores at week 16^4,5,a

4-YEAR DATA WITH OTEZLA⁴

ESTEEM 1: PASI-75 response through 208 weeks^4,a-c

ESTEEM 1: Mean percent change in PASI scores through 208 weeks^4,a-d

ESTEEM 1: Proportion of patients with ScPGA score of clear or minimal through 208 weeks^4,a-d

ESTEEM 1: Mean percent change from baseline NAPSI scores through 208 weeks^4,a-d

ESTEEM 1: Mean change in baseline VAS scores through 208 weeks^4,a-d

ESTEEM 1: Mean change from baseline DLQI scores through 208 weeks^4,a-d

THE ONLY ORAL THERAPY WITH DATA IN THE LABEL FOR ADULTS WITH MODERATE TO SEVERE SCALP PSORIASIS¹
OTEZLA SIGNIFICANTLY IMPROVED ScPGA RESPONSE AT WEEK 16^1,2

STYLE: Proportion of patients achieving ScPGA response at week 16^1,2,a,b

ScPGA RESPONSE THROUGH WEEK 32³

STYLE: ScPGA response by timepoint through week 32^3,a,b

OTEZLA DEMONSTRATED SIGNIFICANT IMPROVEMENT IN SCALP ITCH AT WEEK 16 WITH SIGNIFICANT ACHIEVEMENT OF RESPONSE AS EARLY AS WEEK 2^1,2

STYLE: Proportion (±SE) of patients achieving scalp itch NRS response through week 16^1,2,a-c

Scalp itch response through Week 32³

STYLE: Proportion (± SE) of patients achieving scalp itch NRS response through week 32^3,a-d

OTEZLA DEMONSTRATED SIGNIFICANT IMPROVEMENT IN WHOLE BODY ITCH AT WEEK 16 WITH SIGNIFICANT ACHIEVEMENT OF RESPONSE AS EARLY AS WEEK 2^1,2

STYLE: Proportion (± SE) of patients achieving whole body itch NRS response through week 16^1,2,a-c

Whole body itch response through Week 32³

STYLE: Proportion (± SE) of patients achieving whole body itch NRS response through week 32^3,a-c

EFFICACY IN BIOLOGIC-NAÏVE PATIENTS^4,6

LIBERATE^®: PASI-75 at week 16^6,a

LIBERATE study design⁶

LIBERATE: Mean percent change from baseline PASI scores at week 16^4,6,a

LIBERATE: Patients with a ScGPA score of "clear" or "minimal" at week 16^4,6,a

LIBERATE: Mean percent change from baseline NAPSI score at week 16^4,6,a,b

LIBERATE: Mean change from baseline pruritus VAS scores at week 16^4,6,a,b

LIBERATE: Mean improvement from baseline DLQI scores at week 16^4,6,a

Results seen in Otezla patients¹

ESTEEM^® 1: Baseline

STYLE: ScPGA 0^†
3-point improvement in ScPGA score

STYLE: ScPGA 3^†
1-point improvement in ScPGA score