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Otezla® (apremilast) logo
The FDA approves new data for Otezla® (apremilast) Learn more about this treatment option for your patients
EXPLORE

Moderate to Severe Plaque Psoriasis

Safety

Safety data from Otezla® (apremilast) clinical trials
 
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ESTEEM: ADVERSE REACTIONS THROUGH WEEK 161

ESTEEM: Adverse reactions reported in ≥1% of patients on Otezla and with greater frequency than in subjects on placebo; up to day 112 (week 16)1,a

 
Placebo(n = 506) n (%)
Otezla 30 mg BID (n = 920) n (%)
Adverse reaction
Diarrhea 32 (6) 160 (17)
Nausea 35 (7) 155 (17)
Upper respiratory tract infection 31 (6) 84 (9)
Tension headache 21 (4) 75 (8)
Headache 19 (4) 55 (6)
Abdominal painb 11 (2) 39 (4)
Vomiting 8 (2) 35 (4)
Fatigue 9 (2) 29 (3)
Dyspepsia 6 (1) 29 (3)
Decreased appetite 5 (1) 26 (3)
Insomnia 4 (1) 21 (2)
Back pain 4 (1) 20 (2)
Migraine 5 (1) 19 (2)
Frequent bowel movements 1 (0) 17 (2)
Depression 2 (0) 12 (1)
Bronchitis 2 (0) 12 (1)
Tooth abcess 0 (0) 10 (1)
Folliculitis 0 (0) 9 (1)
Sinus headache 0 (0) 9 (1)
a

The safety of Otezla was assessed in 1426 subjects in 3 randomized, double-blind, placebo-controlled trials (including the ESTEEM studies).

b

Two subjects treated with Otezla experienced serious adverse reaction of abdominal pain.

  • Discontinuation of treatment due to any adverse reaction was 6.1% for patients taking Otezla and 4.1% for placebo1
  • The most common adverse reactions leading to discontinuation for patients taking Otezla were nausea (1.6%), diarrhea (1.0%), headache (0.8%)1

The majority of patients reporting nausea and diarrhea did so within the first 2 weeks; the events tended to resolve over time with continued dosing2

  • Postmarketing reports of severe diarrhea, nausea, and vomiting have been associated with the use of Otezla. In some cases patients were hospitalized. Monitor patients who are more susceptible to complications of diarrhea or vomiting1
 

BID, twice daily; ESTEEM, Efficacy and Safety Trial Evaluating the Effects of Apremilast in Psoriasis; LIBERATE, Evaluation in a Placebo-Controlled Study of Oral Apremilast and Etanercept in Plaque Psoriasis.

STYLE: Adverse reactions through week 161

STYLE: Most common adverse reactions reported in ≥ 5% of patients on Otezla and with greater
frequency than in patients on placebo through week 16 1,2

 
Placebo(n = 102) n (%)
Otezla 30 mg BID (n = 200) n (%)
Adverse reaction
Diarrhea 11 (11) 61 (31)
Nausea 6 (6) 43 (22)
Headache 5 (5) 24 (12)
Vomiting 2 (2) 11 (6)

Otezla was evaluated in a Phase 3, multicenter, randomized, placebo-controlled study in adults with moderate to severe plaque psoriasis of the scalp. A total of 302 patients were randomized to receive Otezla 30 mg BID or placebo.

  • Discontinuation rates due to gastrointestinal adverse reactions in patients who received Otezla 30 mg BID vs placebo, respectively1:
    • Diarrhea: 3% vs 0%
    • Nausea: 1.5% vs 1%
    • Vomiting: 1.5% vs 0%

Discontinuation of treatment due to any adverse event during the 16-week placebo-controlled period was 6% for patients taking Otezla and 3% for placebo1

LIBERATE: Adverse reactions through week 163

LIBERATE: Adverse reactions reported in ≥5%
of patients in any treatment group (weeks 0 to 16)3

 
Placebo(n = 84) n (%)
Otezla 30 mg BID (n = 83) n (%)
Adverse reaction
Headache 3 (3.6) 11 (13.3)
Nausea 1 (1.2) 9 (10.8)
Diarrhea 3 (3.6) 9 (10.8)
Upper respiratory tract infection 2 (2.4) 6 (7.2)
Tension headache 4 (4.8) 5 (6.0)
Nasopharyngitis 8 (9.5) 4 (4.8)
  • Discontinuation of treatment due to adverse reactions was 3.6% for Otezla and 2.4% for placebo3

The long-term safety profile of Otezla was consistent through 2 years of exposure in
patients with moderate to severe plaque psoriasis who continued on Otezla from baseline
within the LIBERATE study4

Next: STYLE Adverse Reactions Through Week 32

STYLE: ADVERSE REACTIONS WEEKS 16 TO 32

STYLE: Adverse events reported in ≥2% of patients in any treatment
group during weeks 16 to 321,a Open-label Extension Phase

 
Placebo/Otezla 30 mg BID (N=84) n (%)
Otezla 30 mg BID/
Otezla 30 mg BID (N=163) n (%)
Adverse reactions
Nausea 8 (9.5) 6 (3.7)
Nasopharyngitis 0 5 (3.1)
Urinary tract infection 2 (2.4) 5 (3.1)
Diarrhea 14 (16.7) 4 (2.5)
Back pain 0 4 (2.5)
a
a

Includes all patients who received Otezla during the time interval relative to the start of Otezla administration.

  • Discontinuation of treatment due to any adverse reaction during weeks 16 to 32 (open-label extension phase) was 2.5% for patients taking Otezla/Otezla 30 mg BID and 1.2% for placebo/Otezla 30 mg BID1
 

BID, twice daily.

Next: ESTEEM Adverse Reactions Through Week 260/5 Years

ESTEEM: ADVERSE REACTIONS THROUGH WEEK 260

ESTEEM: Adverse reactions reported
in >5% of patients
in any treatment group
on Otezla through week 2602,a

a

Includes all patients in the ESTEEM trials who received Otezla during the time interval relative to the start of Otezla administration.

  • Discontinuation due to adverse reactions occurred at 7.6% during weeks 0 to ≤52, 3.7% during weeks >52 to ≤104, 3.5% during weeks >104 to ≤156, and 3.8% during weeks >156 to ≤208, and 1.9% during weeks >208 to ≤2602
  • The long-term safety profile of Otezla was consistent through 5 years of exposure in clinical studies of patients with moderate to severe plaque psoriasis2

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

Next: Additional Safety

ESTEEM®: ADVERSE REACTIONS OF SPECIAL INTEREST2

Adverse reactions of special interest2,a

Exposure-adjusted incidence rate/100 patient-yearsb

 
Placebo (n = 418)
Otezla 30 mg BID(n = 1184)
Major adverse cardiac events
Events 0.9 0.5
Malignancies
Hematologic 0.0 0.0
Skin (excluding melanoma) 0.9 1.1
Skin (including melanoma) 0.9 0.4
Infections
Non-opportunistic serious 1.7 1.0
Opportunistic (systemic) 0.0 0.0
Reactivation of tuberculosis (TB)c 0.0 0.0
a

The placebo group includes data from weeks 0 to 16. For the Otezla group, all data for subjects exposed to Otezla are included regardless of when the Otezla exposure started.

b

Exposure-adjusted incidence rate/100 patient-years is 100 times the number (n) of patients reporting the event divided by patient-years (up to the first event start date for patients reporting the event).

c

Patients with a history of active or incompletely treated TB were excluded from the trials. There was no requirement for latent TB screening. The trials included 9 patients with a history of either latent TB, pulmonary TB, disseminated TB, or a positive tuberculin test or QuantiFERON®-TB Gold.

In the pooled safety data for the phase 3 studies, 2 patients reported positive QuantiFERON®-TB Gold test results; both were in ESTEEM 1. Both patient cases were sent for adjudication. One was adjudicated as latent TB; it is unknown whether the patient had latent TB prior to study enrollment. Both patients were treated prophylactically with TB therapy.

 

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

Next: Laboratory Parameters

ESTEEM®: Laboratory parameters2

Selected marked abnormalities in laboratory parameters (weeks 0 to 16, pooled placebo-controlled safety population)2

 
Placebo(n = 418) (%)
Otezla 30 mg BID(n = 832) (%)
Chemistry
ALT >3x ULN0.20.1
AST >3x ULN0.70.2
Bilirubin >1.8x ULN0.20.2
Creatinine >1.7x ULN0.00.1
Cholesterol >7.8 mmol/La2.10.8
Urate, male >590 μmol/L; female >480 μmol/L5.03.4
Hemoglobin A1c >9%0.50.5
Hematology
Hemoglobin, male <10.5 g/dL; female <8.5 g/dL0.70.2
Lymphocytes <0.8 x 109/L3.01.1
Neutrophils <1.0 x 109/L0.00.0
Platelets <75 x 109/L0.00.0
a

Did not have to be drawn when patient was fasting. ALT, alanine aminotransferase; AST, aspartate aminotransferase; BID, twice daily; ESTEEM, Efficacy and Safety Trial Evaluating the Effects of Apremilast in Psoriasis; ULN, upper limit of normal.

The Full Prescribing Information for Otezla has no requirement for routine laboratory monitoring1

Next: Dosing

References: 1. Otezla [package insert]. Thousand Oaks, CA: Amgen Inc. 2. Van Voorhees AS, 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. Reich K, Gooderham M, Green L, et al. J Eur Acad Dermatol Venereol. 2017;31(3):507-517. 4. Data on file, Amgen Inc.

Reference: 1. Data on file, Amgen Inc.

References: 1. Otezla [package insert]. Thousand Oaks, CA: Amgen Inc. 2. Data on file, Amgen Inc. 3. Reich K, Gooderham M, Green L, et al. J Eur Acad Dermatol Venereol. 2017;31(3):507-517. 4. Crowley J, Thaçi D, Joly P, et al. J Am Acad Dermatol. 2017;77(2):310-317. 5. Reich K, Gooderham M, Bewley A, et al. J Eur Acad Dermatol Venereol. 2018;32(3):397-402. 6. Van Voorhees AS, Gold LS, Lebwohl M, et al. J Am Acad Dermatol. 2020. doi:10.1016/j.jaad.2020.01.072.

References: 1. Otezla [package insert]. Thousand Oaks, CA: Amgen Inc. 2. Data on file, Amgen Inc. 3. Reich K, Gooderham M, Green L, et al. J Eur Acad Dermatol Venereol. 2017;31(3):507-517. 4. Crowley J, Thaçi D, Joly P, et al. J Am Acad Dermatol. 2017;77(2):310-317. 5. Reich K, Gooderham M, Bewley A, et al. J Eur Acad Dermatol Venereol. 2018;32(3):397-402. 6. Van Voorhees AS, 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. Journal of the American Academy of Dermatology (2020), doi:10.1016/j.jaad.2020.01.072.

References: 1. Otezla [package insert]. Thousand Oaks, CA: Amgen Inc. 2. Data on file, Amgen Inc. 3. Reich K, Gooderham M, Green L, et al. J Eur Acad Dermatol Venereol. 2017;31(3):507-517. 4. Crowley J, Thaçi D, Joly P, et al. J Am Acad Dermatol. 2017;77(2):310-317. 5. Reich K, Gooderham M, Bewley A, et al. J Eur Acad Dermatol Venereol. 2018;32(3):397-402. 6. Van Voorhees AS, 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. Journal of the American Academy of Dermatology (2020), doi:10.1016/j.jaad.2020.01.072.

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

Please click here for Full Prescribing Information.