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

Otezla showed improvement in mean pruritus VAS scores at week 162

ESTEEM 1: Mean improvement from baseline pruritus VAS scores at week 16
Secondary endpoint; LOCF; FAS2,*,†

Bar chart of an ESTEEM 1 study that represents pruritus VAS scores at week 16 on Otezla

*Pruritus was measured on a 100-mm VAS. Baseline mean pruritus VAS scores (mm): placebo, 65.2; Otezla, 66.2.

Sustained efficacy with results in mean pruritus VAS scores through 5 years3

ESTEEM 1: Mean change in baseline VAS scores through 260 weeks
Exploratory analysis; data as observed3,‡,§,**,††

Line chart of an ESTEEM 1 study that represents the mean change in baseline VAS scores through 260 weeks on Otezla

FAS. §Baseline mean pruritus VAS scores (mm): placebo, 65.2; Otezla, 66.2. **Week 16: secondary endpoint; all other timepoints: 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 values3
  • Consider open-label extension (OLE) study limitations when interpreting results. The OLE is not blinded, not controlled, and includes 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

STYLE: Scalp Itch Response

STYLE: Evaluated in adult patients with moderate to severe plaque psoriasis of the scalp (N=303); age ≥18 years, BSA involvement ≥10%, sPGA score ≥3, PASI score ≥12, ScPGA score ≥3, SSA ≥20%4

Significant improvement in scalp itch at week 16 with achievement of response as early as 2 weeks4

STYLE: Scalp itch NRS response by timepoint through week 16
Secondary endpoint; ITT population; MI analysis2,3,‡‡,§§,***

Line chart of a STYLE study that represents the proportion of Otezla patients achieving scalp itch NRS response through week 16

‡‡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.3

47% of patients
taking Otezla achieved a

≥4-point improvement
from baseline

in scalp itch NRS scores at
week 16
vs placebo (21%) (P<0.0001)4

Significant improvement
in scalp itch
as early as

2
weeks1,3

Among moderate to severe scalp psoriasis patients in the STYLE clinical trial

Scalp itch response through week 323

STYLE: Scalp itch NRS response by timepoint through week 32
ITT population; NRI analysis3,†††,‡‡‡,§§§

Line chart of a STYLE study that represents scalp itch by timepoint through week 32 on Otezla

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.3

†††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 (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.3

  • Consider open-label treatment phase study limitations when interpreting results. The open-label extension (OLE) was not blinded, not controlled, and included inherent self-selection bias. Overall, a total of 33 patients (13.3%) discontinued during the study, of which 6 patients (2.4%) discontinued due to adverse events3

STYLE: Whole Body Itch Response

STYLE: Evaluated in adult patients with moderate to severe plaque psoriasis of the scalp (N=303); age ≥18 years, BSA involvement ≥10%, sPGA score ≥3, PASI score ≥12, ScPGA score ≥3, SSA ≥20%4

Significant improvement in whole body itch at week 16 with achievement of response as early as 2 weeks4

STYLE: Whole body itch NRS response by timepoint through week 16
Secondary endpoint; ITT population; MI analysis1,3,****,††††,‡‡‡‡

Line chart of a STYLE study that represents the proportion of Otezla patients achieving whole body itch NRS response through week 16

****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.3

46% of patients
taking Otezla achieved a

≥4-point improvement
from baseline

in whole body itch NRS scores at
week 16
vs placebo (23%) (P<0.0001)3,4

Significant improvement
in whole body itch
as early as

2
weeks1,3

Among moderate to severe scalp psoriasis patients

Whole body itch response through week 323

STYLE: Whole body itch NRS response by timepoint through week 32
ITT population; NRI analysis3,§§§§,*****,†††††

Line chart of a STYLE study that represents the whole body itch NRS response by timepoint through week 32 on Otezla

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.3

§§§§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.3

  • Consider open-label treatment phase study limitations when interpreting results. The OLE was not blinded, not controlled, and included inherent self-selection bias. Overall, a total of 33 patients (13.3%) discontinued during the study, of which 6 patients (2.4%) discontinued due to adverse events3

LIBERATE: Itch 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 therapy5

Itch response in biologic-naïve patients3,5

LIBERATE: Mean change from baseline pruritus VAS scores at week 16
Exploratory endpoint; mITT population; LOCF analysis3,5,‡‡‡‡‡,§§§§§

Bar chart of a LIBERATE study representing itch 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.3,5

‡‡‡‡‡Pruritus was measured on a 100-mm VAS.§§§§§Baseline mean pruritus VAS scores (mm): placebo, 62.5; Otezla, 62.6.

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; ITT, intent to treat; LOCF, last observation carried forward; MI, multiple imputation; NRI, nonresponder imputation; NRS, numeric rating scale; PASI, Psoriasis Area and Severity Index; ScPGA, Scalp Physician Global Assessment; SE, standard error; sPGA, static Physician Global Assessment; SSA, scalp surface area; STYLE, Study of the Efficacy and Safety of Apremilast in Subjects With Moderate to Severe Plaque Psoriasis of the Scalp; VAS, visual analog scale.

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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. Papp K, Reich K, Leonardi CL, et al. J Am Acad Dermatol. 2015;73(1):37-49. 2. Otezla [package insert]. Thousand Oaks, CA: Amgen Inc. 3. Data on file, Amgen Inc. 4. Van Voorhees AS, Gold LS, Lebwohl M, et al. J Am Acad Dermatol. 2020;83(1):96-103. 5. Reich K, Gooderham M, Green L, et al. J Eur Acad Dermatol Venereol. 2017;31(3):507-517.