3 INDICATIONS

3 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. Read more

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. Read less

ESTEEM 1: Nail Response

ESTEEM 1: Evaluated in patients with moderate to severe plaque psoriasis (N=844); age ≥18 years, BSA involvement ≥10%, sPGA ≥3, PASI score ≥121

Otezla demonstrated improvement in nail psoriasis severity response (NAPSI scores) at week 162

ESTEEM 1: Mean percent change from baseline NAPSI score at week 16
Prespecified exploratory endpoint; LOCF; FAS2,*,†

Bar chart of an ESTEEM 1 study that represents the mean percent change in nail psoriasis severity (NAPSI score) at week 16 on Otezla

*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% [558/844]).2,3

Results seen in an Otezla patient

Sustained efficacy with results in nail psoriasis severity response (NAPSI scores) through 5 years2,3

ESTEEM 1: Mean percent change from baseline NAPSI scores through 260 weeks
Exploratory analysis; data as observed2,3,§,**,††,‡‡

Line chart of an ESTEEM 1 study that represents the mean percent change from baseline NAPSI scores through 260 weeks on Otezla

§FAS. **In patients with nail psoriasis at baseline (NAPSI score ≥1; 66% [558/844]). ††Statistical analyses were conducted in a hierarchical manner for efficacy endpoints, including NAPSI score, to control the overall type 1 error rate. ‡‡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 values3
  • Consider open-label extension (OLE) study limitations when interpreting results. The OLE was not blinded, not controlled, and included self-selection bias. Of the 443 patients treated with apremilast from weeks 52 to 260, 26.6% (n=118) discontinued due to lack of efficacy, 22.6% (n=100) withdrew from the study, 8.6% (n=38) discontinued due to an adverse event, and 7.0% (n=31) were lost to follow-up3

LIBERATE: Nail Response

LIBERATE: Evaluated in adult patients with chronic plaque psoriasis for ≥12 months (N=250); PASI score ≥12, BSA involvement ≥10%, sPGA score ≥3, no prior exposure to a biologic therapy4

Nail response in biologic-naïve patients at week 163,4

LIBERATE: Mean percent change from baseline NAPSI scores at week 16
Exploratory endpoint; mITT population; LOCF analysis3,4,§§,***

Bar chart of a LIBERATE study that represents nail response in biologic-naïve patients at week 16 on Otezla

This is an exploratory analysis and has not been adjusted for multiple comparisons. No conclusions of statistical or clinical significance can be drawn.4

§§In patients with a baseline value and at least one post-baseline value. ***Baseline mean NAPSI scores: placebo, 4.14; Otezla, 4.18.

BID, twice daily; BL, baseline; BSA, body surface area; ESTEEM, Efficacy and Safety Trial Evaluating the Effects of Apremilast in Psoriasis; FAS, full analysis set; LOCF, last observation carried forward; mITT, modified intent to treat; NAPSI, Nail Psoriasis Severity Index; PASI, Psoriasis Area and Severity Index; sPGA, static Physician Global Assessment.

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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

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.

References: 1. Otezla [package insert]. Thousand Oaks, CA: Amgen Inc. 2. Data on file, Amgen Inc. 3. Papp K, Reich K, Leonardi CL, et al. J Am Acad Dermatol. 2015;73(1):37-49. 4. Reich K, Gooderham M, Green L, et al. J Eur Acad Dermatol Venereol. 2017;31(3):507-517.