First and only oral therapy approved for mild, moderate, and severe plaque psoriasis, and active PsA SEE THE DATA

Plaque Psoriasis
3 INDICATIONS Otezla® (apremilast) is indicated for the treatment of adult patients with plaque psoriasis who are candidates for phototherapy or systemic therapy. Read more
*Estimates of patients treated reflect global data since launch (Apr 2014-Aug 2022; US=approximately 60% 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.
*In patients with WBI-NRS ≥4 at baseline. WBI-NRS score reduction of ≥4 points from baseline.
†Pruritus was measured on a 100-mm VAS. ‡Baseline mean pruritus VAS scores (mm): Otezla, 66.2; placebo, 65.2.
§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.
§§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. 4
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
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. 4
‡‡‡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. 4
††††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. 4
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 whole body itch as early as
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. 4
*****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. †††††WBI-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.4
§§§§§ 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).
This is an exploratory analysis and has not been adjusted for multiple comparisons. No conclusions of statistical or clinical significance can be drawn. 4,7
******Pruritus was measured on a 100-mm VAS. ††††††Baseline mean pruritus VAS scores (mm): Otezla, 62.6; placebo, 62.5.
BID, twice daily; BL, baseline; BSA, body surface area; FAS, full analysis set; ITT, intent to treat; LOCF, last observation carried forward; MI, multiple imputation; mITT, modified intent to treat; 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; VAS, visual analog scale; WBI-NRS, whole body itch numeric rating scale.
Contraindications
Warnings and Precautions
Adverse Reactions
Use in Specific Populations
Please click here for the full Prescribing Information.
Otezla® (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 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. Stein Gold L, Papp K, Pariser D, et al. J Am Acad Dermatol. 2022;86(1):77-85. 3. Papp K, Reich K, Leonardi CL, et al. J Am Acad Dermatol. 2015;73(1):37-49. 4. Data on file, Amgen Inc. 5. Van Voorhees AS, Gold LS, Lebwohl M, et al. J Am Acad Dermatol. 2020;83(1):96-103. 6. Merola F, Parish L, Guenther L, et al. Abstract presented at: the 31st Annual Meeting of the European Academy of Dermatology and Venereology (EADV); September 7-10, 2022. 7. Reich K, Gooderham M, Green L, et al. J Eur Acad Dermatol Venereol. 2017;31(3):507-517.