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

Plaque Psoriasis
4 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-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.
Hypothetical patient
Paula
Presentation:
Treatment History:
Patient Considerations:
Hypothetical patient
PALACE 1-3 studied DMARD-experienced patients
PALACE 1-3 Study design: Multicenter, randomized, double-blind, placebo-controlled Phase 3 trials. Adult patients with active PsA were randomized 1:1:1 to receive either Otezla 30 mg BID, Otezla 20 mg BID, or a placebo for 24 weeks 1
PALACE 1-3 Primary endpoint: In PALACE 1, Otezla significantly improved ACR20 response vs placebo: 38%, Otezla (n=168) vs 19% placebo (n=168), with or without DMARDs, at week 16; P=0.0001 (nonresponder imputation; FAS). Consistent results were seen with PALACE 2 and 3 1,2
PALACE 4 studied DMARD-naïve patients, like Paula
PALACE 4 Study design: Phase 3 multicenter, randomized, double-blind, placebo-controlled, parallel-group study of 527 DMARD-naïve adult patients with active psoriatic arthritis 3,4
Primary endpoint:
Nearly 2x the ACR20 response rate at 16 weeks with Otezla 30 mg BID (31%, n=176) vs placebo (16%, n=176, P=0.001) 4,*
*Primary endpoint; nonresponder imputation; FAS.
cDAPSA Disease Activity Score 5,6,†
The cDAPSA composite score places patients into one of four disease activity levels 5
cDAPSA Disease Activity Levels
†cDAPSA is calculated as a composite score based on SJC, TJC, PAP, and PtGA with possible scores ranging from 0-154. ‡Clinical remission does not mean drug‑ free remission or complete absence of disease.
Post-hoc analysis is exploratory and has not been adjusted for multiple comparisons. No conclusions of statistical or clinical significance can be drawn.
PALACE 1-3: DMARD-experienced patients (post-hoc analysis; MI) 5,††
– 37% achieved treatment targets by week 16
§cDAPSA is calculated as a composite score based on SJC, TJC, PAP, and PtGA with possible scores ranging from 0-154. **The post-hoc analyses included patients from the PALACE 1-3 and 4 clinical trials receiving Otezla 30 mg BID who had undergone randomization at baseline and had cDAPSA components available to calculate responses (PALACE 1-3, n=494; PALACE 4, n=175). ††Includes randomized patients who received Otezla 30 mg BID at baseline and had available cDAPSA components at baseline (PALACE 1-3, n=494; PALACE 4, n=175). ‡‡Clinical remission does not mean drug-free remission or complete absence of disease. §§REM or LDA.
In PALACE 1-3
***Not included in the cDAPSA treatment target calculation.
Post-hoc analysis is exploratory and has not been adjusted for multiple comparisons. No conclusions of statistical or clinical significance can be drawn.
ACR, American College of Rheumatology; BID, twice daily; BMI, body mass index; cDAPSA, clinical Disease Activity Index for Psoriatic Arthritis; CRP, C-reactive protein; DMARD, disease-modifying antirheumatic drug; FAS, full analysis set; MASES, Maastricht Ankylosing Spondylitis Enthesitis Score; MI, multiple imputation; NSAID, nonsteroidal anti-inflammatory drug; PAP, Patient Assessment of Pain; PASI, Psoriasis Area and Severity Index; PsA, psoriatic arthritis; PtGA, Patient Global Assessment of Disease Activity; SJC, swollen joint count; TJC, tender joint count; VAS, visual analog scale.
Contraindications
Otezla® (apremilast) is contraindicated in patients with a known hypersensitivity to apremilast or to any of the excipients in the formulationWarnings and Precautions
Hypersensitivity reactions, including angioedema and anaphylaxis, have been reported during postmarketing surveillance. If signs or symptoms of serious hypersensitivity reactions occur, discontinue Otezla and institute appropriate therapyContraindications
Warnings and Precautions
Adverse Reactions
Use in Specific Populations
Otezla is indicated for the treatment of:
Please click here for the full Prescribing Information.