OTEZLA: 4 INDICATIONSOtezla® (apremilast)/Otezla XR™ (apremilast) is indicated for the treatment of adult patients with plaque psoriasis who are candidates for phototherapy or systemic therapy.Read more
OTEZLA: 4 INDICATIONS
Otezla® (apremilast)/Otezla XR™ (apremilast) is indicated for the treatment of adult patients with plaque psoriasis who are candidates for phototherapy or systemic therapy.
Otezla is indicated for the treatment of pediatric patients 6 years of age and older and weighing at least 20 kg with moderate to severe plaque
psoriasis who are candidates for phototherapy or systemic therapy.
Otezla XR is indicated for the treatment of pediatric patients 6 years of age and older and weighing at least 50 kg with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy.
Otezla is indicated for the treatment of adult patients and pediatric patients 6 years of age and older and weighing at least 20 kg with active psoriatic arthritis.
Otezla XR is indicated for the treatment of adult patients and pediatric patients 6 years of age and older and weighing at least 50 kg with active psoriatic arthritis.
Otezla/Otezla XR is indicated for the treatment of adult patients with oral ulcers associated with Behçet’s Disease.
*Estimates of patients treated reflect global data since launch (Apr 2014-Mar 2023; US=59% of
data). Calculations based on observed drug utilization parameters and number of units distributed. Utilization patterns change over time to best represent current
markets.
FDA, U.S. Food and Drug Administration; PsA, psoriatic arthritis; TB, tuberculosis.
References: 1. Otezla [package insert]. Thousand Oaks, CA: Amgen Inc. 2. Data
on file, Amgen Inc. 3. Otezla® (apremilast) FDA approval letter. March 21, 2014.
ADVANCE: Evaluated in patients with mild to moderate plaque psoriasis (N=595); age ≥18 years, sPGA score 2-3, BSA involvement 2%-15%, PASI score 2-15 1,2
OTEZLA DEMONSTRATED SIGNIFICANT IMPROVEMENT IN WHOLE BODY ITCH (WBI) AT WEEK 16 1,2
ADVANCE: Proportion of patients with improvement in itch
(WBI-NRS)
through week 16 vs placebo
Analyses at week 2 are exploratory and have not been adjusted for multiple comparisons. No statistical or clinical conclusions can be drawn.
*In patients with WBI-NRS ≥4 at baseline.
ESTEEM 1: ITCH RESPONSE
ESTEEM 1: Evaluated in patients with moderate to severe plaque psoriasis (N=844); age ≥18 years, BSA involvement ≥10%, sPGA ≥3, PASI score ≥12 4
OTEZLA SHOWED IMPROVEMENT IN MEAN PRURITUS VAS SCORES AT WEEK 16 4
ESTEEM 1: Mean improvement from baseline pruritus VAS scores at week 16
†Pruritus was measured on a 100-mm VAS. ‡Baseline mean pruritus VAS scores (mm): Otezla, 66.2; placebo, 65.2.
SUSTAINED RESULTS IN MEAN PRURITUS VAS SCORES THROUGH 5 YEARS 3
ESTEEM 1: Mean change in baseline pruritus VAS scores through 260 weeks
§FAS. **Baseline mean pruritus VAS scores (mm): Otezla, 66.2; placebo, 65.2. ††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 values 3
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-up 3
5-Year Safety Data Video
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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% 5
Significant AND RAPID SYMPTOM improvement in SCALP itch at week 16 with achievement of response as early as 2 weeks 3
STYLE: Scalp itch NRS response by timepoint 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
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) 5
Significant improvement
in scalp itch as early as
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% 5
SIGNIFICANT IMPROVEMENT IN WHOLE BODY ITCH AT WEEK 16 WITH ACHIEVEMENT OF RESPONSE AS
EARLY AS 2 WEEKS 5
STYLE: Whole body itch NRS response by timepoint 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 scores 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
of patients taking Otezla achieved a ≥4-point improvement from baseline
in WBI-NRS scores at week 16
vs placebo (23%) (P<0.0001) 5
Significant improvement
in scalp itch as early as
DISCREET: GENITAL ITCH RESPONSE
DISCREET: Evaluated in adult patients (n=289) with moderate to severe plaque psoriasis and moderate to severe plaque psoriasis of the genital area (modified sPGA-G score ≥3) 1
GENITAL ITCH RESPONSE THROUGH WEEK 16
DISCREET: Proportion of moderate to severe plaque psoriasis patients achieving Genital Psoriasis Itch Numerical Rating Scale (GPI-NRS) response at week 16
This is an exploratory analysis and has not been adjusted for multiple comparisons. No conclusions of statistical or clinical significance can be drawn. 3,6
††††GPI-NRS response is defined as at least a 4-point reduction (improvement) at week 16 in patients with baseline GPI-NRS score ≥4; GPI-NRS scores range from 0 (no) to 10 (worst imaginable).
BID, twice daily; BL, baseline; BSA, body surface area; FAS, full analysis set; ITT, intent to treat; MI, multiple imputation; NRS, numeric rating scale; PASI, Psoriasis Area and Severity Index; PASI-75, a 75% reduction in a patient's PASI score; ScPGA, Scalp Physician Global Assessment; SE, standard error; sPGA, static Physician Global Assessment; sPGA-G, static Physician Global Assessment of Genitalia; SSA, scalp surface area; VAS, visual analog scale; WBI-NRS, whole body itch numeric rating scale.
Otezla/OTEZLA XR is contraindicated in patients with a known hypersensitivity to apremilast or to any of the excipients in the formulation
Warnings and Precautions
Hypersensitivity: Hypersensitivity reactions, including angioedema and anaphylaxis, have been reported during postmarketing surveillance. If signs or symptoms of serious hypersensitivity reactions occur, discontinue Otezla/OTEZLA XR and institute appropriate therapy
IMPORTANT SAFETY INFORMATION
Contraindications
Otezla/Otezla XR is contraindicated in patients with a known hypersensitivity to apremilast or to any of the excipients in the formulation
Warnings and Precautions
Hypersensitivity: Hypersensitivity reactions, including angioedema and anaphylaxis, have been reported during postmarketing surveillance. If signs or symptoms of serious hypersensitivity reactions occur, discontinue Otezla/Otezla XR and institute appropriate therapy
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/Otezla XR dose reduction or suspension if patients develop severe diarrhea, nausea, or vomiting
Depression: Carefully weigh the risks and benefits of treatment with Otezla/Otezla XR for patients with a history of depression and/or suicidal thoughts/behavior, or in patients who develop such symptoms while on Otezla/Otezla XR. 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
Plaque Psoriasis: Treatment with Otezla is associated with an increase in depression. During clinical trials in adult patients with moderate to severe plaque psoriasis, 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 in adult patients, 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/Otezla XR
Plaque Psoriasis: Body weight loss of 5-10% occurred in 12% (96/784) of adult patients with moderate to severe plaque psoriasis treated with Otezla and in 5% (19/382) of patients treated with placebo. Body weight loss of ≥10% occurred in 2% (16/784) of adult patients treated with Otezla compared to 1% (3/382) of patients treated with placebo. Body weight loss of 5%-10% occurred in 12% (19/163) of pediatric patients with moderate to severe plaque psoriasis treated with Otezla compared to 2.5% (2/80) with placebo. Body weight loss of ≥10% occurred in 1% (1/163) of pediatric patients treated with Otezla twice daily compared to 0% (0/80) of patients with placebo. Closely monitor growth (height and weight) in Otezla/Otezla XR-treated pediatric patients. Pediatric patients who are not growing or gaining weight as expected may need to have their treatment interrupted
Psoriatic Arthritis: Body weight loss of 5-10% was reported in 10% (49/497) of adult 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 co-administered with rifampin, a strong CYP450 enzyme inducer; loss of Otezla/Otezla XR efficacy may occur. Concomitant use of Otezla/Otezla XR with CYP450 enzyme inducers (e.g., rifampin, phenobarbital, carbamazepine, phenytoin) is not recommended
Adverse Reactions
Plaque Psoriasis: The most common adverse reactions (≥5%) are diarrhea, nausea, upper respiratory tract infection, and headache, including tension headache. Overall, the safety profile of Otezla in adult patients with mild to moderate plaque psoriasis and pediatric patients with moderate to severe plaque psoriasis was consistent with the safety profile established in adult patients with moderate to severe plaque psoriasis
Psoriatic Arthritis: The most common adverse reactions (≥5%) are diarrhea, nausea, and headache
Behçet’s Disease: The most common adverse reactions (≥10%) are diarrhea, nausea, headache, and upper respiratory tract infection
Use in Specific Populations
Advise pregnant women of the potential risk of fetal loss
INDICATIONS
Otezla/Otezla XR is indicated for the treatment of adult patients with plaque psoriasis who are candidates for phototherapy or systemic therapy
Otezla is indicated for the treatment of pediatric patients 6 years of age and older and weighing at least 20 kg with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy
Otezla XR is indicated for the treatment of pediatric patients 6 years of age and older and weighing at least 50 kg with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy
Otezla is indicated for the treatment of adult patients and pediatric patients 6 years of age and older and weighing at least 20 kg with active psoriatic arthritis
Otezla XR is indicated for the treatment of adult patients and pediatric patients 6 years of age and older and weighing at least 50 kg with active psoriatic arthritis
Otezla/Otezla XR is indicated for the treatment of adult patients with oral ulcers associated with Behçet’s Disease
Please click here for the full Prescribing Information.
References: 1. Otezla [package insert]. Thousand Oaks, CA: Amgen Inc. 2. Stein Gold L, Papp K, Pariser D, et al. J Am Acad Dermatol. 2022;86(1):77-85. 3. Data on file, Amgen; 2022. 4. Papp K, Reich K, Leonardi CL, et al. J Am Acad Dermatol. 2015;73(1):37-49. 5. Van Voorhees AS, Gold LS, Lebwohl M, et al. J Am Acad Dermatol. 2020;83(1):96-103. 6. Reich K, Gooderham M, Green L, et al. J Eur Acad Dermatol Venereol. 2017;31(3):507-517.
