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Moderate to Severe Plaque Psoriasis

Efficacy

Results from Otezla® (apremilast) clinical trials
 
Click arrow for more information

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

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

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

Selected Safety Information

Warnings and Precaution (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

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)

Selected Safety Information

Use in Specific Populations (cont’d)

  • 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

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

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

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

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

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

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
Next: PASI Scores

MEAN PASI SCORES THROUGH WEEK 162,4

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

Secondary endpoint; LOCF; FAS

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

LOCF, last observation carried forward.

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
Next: Scalp Response at Week 16

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

Prespecified exploratory endpoint; LOCF; FAS

a

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.

b

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.

Selected Safety Information

Warnings and Precautions

  • 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
Next: Nail Response at Week 16

MEAN PASI SCORES THROUGH WEEK 162,4

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

Secondary endpoint; LOCF; FAS

a

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.

b

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.

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
Next: Pruritus VAS Scores

MEAN PASI SCORES THROUGH WEEK 162,4

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

Secondary endpoint; LOCF; FAS

a

Pruritus was measured on a 100-mm VAS.

b

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

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)
Next: DLQI Scores

CHANGE IN QUALITY OF LIFE AS MEASURED BY DLQI4,5

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

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
Next: 4-year Data

4-YEAR DATA WITH OTEZLA4

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

Exploratory analysis; data as observed

a

FAS.

b

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

c

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 time point
  • Open-label extension 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 weeks4,a-d

Exploratory analysis; data as observed

a

FAS.

b

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

c

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

d

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 time point
  • Open-label extension phase: pooled treatment arms reflect post-hoc analysis

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

Exploratory analysis; data as observed

a

FAS.

b

Baseline ScPGA ≥3.

c

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

d

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 time point
  • Open-label extension phase: pooled treatment arms reflect post-hoc analysis

 

ScPGA, Scalp Physician Global Assessment.

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

Exploratory analysis; data as observed

a

FAS.

b

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

c

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

d

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 time point
  • Open-label extension 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 weeks4,a-d

Exploratory analysis; data as observed

a

FAS.

b

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

c

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

d

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
  • Open-label extension phase: pooled treatment arms reflect post-hoc analysis

 

VAS, visual analog scale.

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

Exploratory analysis; data as observed

a

FAS.

b

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

c

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

d

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 time point
  • Open-label extension 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.

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
Next: LIBERATE: Biologic-naïve

EFFICACY IN BIOLOGIC-NAÏVE PATIENTS4,6

LIBERATE®: PASI-75 at week 166,a

Primary endpoint; LOCF; mITT

a

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 164,6,a

Prespecified exploratory analysis; LOCF; mITT

a

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

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

Prespecified exploratory analysis; LOCF; mITT

a

Baseline ScPGA ≥3.

 


ScPGA, Scalp Physician Global Assessment.

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

Prespecified exploratory analysis; LOCF; mITT

a

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

b

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 164,6,a,b

Prespecified exploratory analysis; LOCF; 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.

 


BL, baseline; VAS, visual analog scale.

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

Secondary endpoint; LOCF; mITT

a

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.

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
Next: Paitent Photos

Results seen in Otezla patients4

Individual results may vary.

Actual patient PASI-52 result with Otezla® (apremilast) at baseline

Baseline

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

Week 16

ESTEEM 1: PASI-52 result*

Actual patient PASI-69 result with Otezla® (apremilast) at baseline

Baseline

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

Week 16

ESTEEM 1: PASI-69 result*

Actual patient PASI-75 result with Otezla® (apremilast) at baseline

Baseline

Actual patient PASI-75 result with Otezla® (apremilast) after 16 weeks

Week 16

PASI-75 result

Actual patient PASI-76.5 result with Otezla® (apremilast) at baseline

Baseline

Actual patient PASI-76.5 result with Otezla® (apremilast) after 16 weeks

Week 16

PASI-76.5 result

Actual patient PASI-80 result with Otezla® (apremilast) at baseline

Baseline

Actual patient PASI-80 result with Otezla® (apremilast) after 16 weeks

Week 16

PASI-80 result

Actual patient PASI-85 result with Otezla® (apremilast) at baseline

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

Baseline

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

Week 16

ESTEEM 1: PASI-63 result*

*Actual clinical trial patient.

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

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
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.

INDICATIONS & IMPORTANT SAFETY INFORMATION

INDICATIONS

Otezla® (apremitast) is indicated for the treatment of 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% (1/1 308) of patients exposed to Otezla, compared to none in placebo-treated patients (0/506). Suicidal behavior was observed in 0.1%(1/1 308) of patients on Otezla, compared to 0.2% (1/506) on placebo. One patient treated with Otezia 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% (3/1 441) of patients on Otezla, compared to none in placebo-treated patients. Depression was reported as serious in 0.2% (3/1 441) 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
    • Behcet’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% (1 9/382) 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 ¡n 3.9% (4/102) of patients taking placebo
  • Drug Interactions: Apremilast exposure was decreased when Otezla was co-administered with rilampin, a strong CYP4SO enzyme inducer; loss of Otezla efficacy may occur. Concomitant use of Otezla with CYP45O enzyme inducers (e.g., rifampin. phenobarbital, carbamazepine, phenytoin) is not recommended

Adverse Reactions

  • Psoriasis: Adverse reactions reported in ≥5% of patients were (Otezla%, ptacebo%): 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 (east 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 (2M, 0.2)
  • Behçet’s Disease: Adverse reactions reported in 5% of patients taking Otezta, 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://mothertoaby.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 breastleeding should be considered along with the mother’s clinical need for Otezla and any potential adverse effects on the breastled 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/mm); 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® (apremitast) is indicated for the treatment of 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% (1/1 308) of patients exposed to Otezla, compared to none in placebo-treated patients (0/506). Suicidal behavior was observed in 0.1%(1/1 308) of patients on Otezla, compared to 0.2% (1/506) on placebo. One patient treated with Otezia 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% (3/1 441) oF patients on Otezla, compared to none in placebo-treated patients. Depression was reported as serious in 0.2% (3/1 441) 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
    • Behcet’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% (1 9/382) 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 ¡n 3.9% (4/102) of patients taking placebo
  • Drug Interactions: Apremilast exposure was decreased when Otezla was co-administered with rilampin, a strong CYP4SO enzyme inducer; loss of Otezla efficacy may occur. Concomitant use of Otezla with CYP45O enzyme inducers (e.g., rifampin. phenobarbital, carbamazepine, phenytoin) is not recommended

Adverse Reactions

  • Psoriasis: Adverse reactions reported in ≥5% of patients were (Otezla%, ptacebo%): 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 (east 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 (2M, 0.2)
  • Behçet’s Disease: Adverse reactions reported in 5% of patients taking Otezta, 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 letal 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 breastleeding should be considered along with the mother’s clinical need for Otezla and any potential adverse effects on the breastled 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/mm); for details, see Dosage and Administration, Section 2, in the Full Prescribing Information

Please click here for Full Prescribing Information.