Otezla is the first and only oral therapy approved across all severities of adult plaque psoriasis SEE NEW DATA
*According to PCPs, based on a survey of 150 patients (78 suspected and 72 diagnosed with plaque psoriasis) seen over a 6-month time period.
PCP, primary care physician.
Nearly 50% of plaque psoriasis patients have cycled through 4 or more topicals and have not used a systemic therapy 3,†,‡
†Claims data derived from Symphony Health Solutions includes plaque psoriasis patients (Aug 2014-Jul 2018) on a topical with no prior systemic therapy, with ≥2 plaque psoriasis diagnoses (Jan 2007-Jul 2018). Eligibility criteria includes patients who are active within the 4-year look-back period (Aug 2014-Jul 2018). ‡47% of patients in claims data analysis.
§Based on IQVIA licensed data: Jan 2018 - Jul 2021 Longitudinal Prescription (LRx) Data and Medical Claims (Dx) Data, reflecting estimates of real-world activity. Study information maintained by Amgen. LRx Data covers retail, traditional/specialty mail order, and long-term claims. Dx data captures US physicians. Patient classified as systemic-naïve if not previously on systemic therapy for the past 12 months, had any claim for a branded systemic, and had at least one psoriasis diagnosis.
Pivotal Study: ADVANCE was a multicenter, randomized, placebo-controlled, double-blind study. Biologic-naïve adults with mild to moderate plaque psoriasis (N=595) were randomized 1:1 to receive Otezla or placebo for a 16-week phase, followed by a 16-week extension phase and a 4-week post-treatment observation phase. 8,9
Please click here for full study design.
BSA, body surface area; PASI, Psoriasis Area and Severity Index; sPGA, static Physician Global Assessment.
Pivotal Studies: ESTEEM 1 and ESTEEM 2 were 2 multicenter, double-blind, placebo-controlled trials of similar design. Patients aged ≥18 years with moderate to severe plaque psoriasis (N=1257) were randomized 2:1 to Otezla 30 mg BID (n=836) or placebo (n=419) for 16 weeks after a week-long titration. 8,10,11
Please click here for full study design.
BID, twice daily.
**sPGA response was defined as the percentage of patients who achieved sPGA score of 0 (clear) or 1 (almost clear) and a ≥2-point reduction from baseline.
ITT, intent to treat.
††In patients with ScPGA ≥2 at baseline.
ScPGA, Scalp Physician Global Assessment.
seen in Otezla patients
Actual clinical trial patient from ESTEEM. 3 Individual results may vary.
‡‡PASI-75 response: A 75% reduction in a patient's PASI score. 3 §§PASI-70 Response: A 70% reduction in a patient's PASI score. 3
Note: Direct comparisons cannot be made between ADVANCE and ESTEEM trials.
***Investigators in ADVANCE were not trained to differentiate between tension headache and headache.
AEs, adverse effects; NA, not applicable; URTI, upper respiratory tract infection.
Warnings and Precautions
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. National Psoriasis Foundation. psoriasis.org. Accessed November 20, 2021. 2. Nestle FO, Kaplan DH, Barker J. N Engl J Med. 2009;361(5):496-509. 3. Data on file, Amgen Inc. 4. Kim WB, Jerome D, Yeung J. Can Fam Physician. 2017;63(4):278-285. 5. Kaufman BP, Alexis AF. Am J Clin Dermatol. 2018;19(3):405-423. 6. Schafer PH, Parton A, Capone L, et al. Cell Signal. 2014;26(9):2016-2029. 7. Van Voorhees AS, Feldman SR, Lebwohl MG, Mandelin A, Ritchlin C. psoriasis.org/the-pocket-guide. Accessed November 20, 2021. 8. Otezla [package insert]. Thousand Oaks, CA; Amgen Inc. 9. Stein Gold L, Papp K, Pariser D, et al. J Am Acad Dermatol. 2022;86(1):77-85. 10. Papp K, Reich K, Leonardi CL, et al. J Am Acad Dermatol. 2015;73(1):37-49. 11. Paul C, Cather J, Gooderham M, et al. Br J Dermatol. 2015;173(6):1387-1399. 12. Aldredge LM, Higham RC. JDNA. 2018;10(4):189-197. 13. Reich K, Gooderham M, Green L, et al. J Eur Acad Dermatol Venereol. 2017;31(3):507-517.