First and only oral therapy approved for mild, moderate, and severe plaque psoriasis, and active PsA SEE THE DATA
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.
Amgen Inc. continually works to expand the number and location of insurance plans that cover the cost of Otezla. Please reach out to your Otezla sales representative for more information on local coverage.
For benefit verification and additional support, call Otezla SupportPlus® at
1-844-4OTEZLA (1-844-468-3952).
Specialty pharmacies may furnish patient support by providing:
Unless a specific specialty pharmacy is mandated by the patient’s payer, Otezla can be filled at any specialty pharmacy of your choice.
You can also find a grid that captures major payers and their mandated or preferred specialty pharmacy, however there are exceptions and carve-outs. For benefit verification and additional support, call Otezla SupportPlus®
at 1-844-4OTEZLA (1-844-468-3952).
*The Otezla Co-Pay Card is for eligible commercially insured patients. Terms, conditions, and program maximums apply. Other restrictions may apply. Click here for full Terms and Conditions. This program is not open to patients receiving prescription reimbursement under any federal, state, or government-funded healthcare program. Not valid where prohibited by law. Patients who are not eligible can call 1-844-4OTEZLA (1-844-468-3952) to discuss further financial support opportunities. †If the patient's health plan requires a prior authorization, or if patient experiences a delay in obtaining approval for Otezla, patients can qualify for the Bridge to Commercial Coverage Offer and receive Otezla free for up to 12 months while pursuing approval from their health plans. No purchase necessary. Click here for full Terms and Conditions.
Otezla is covered by most health plans in the US, including commercial, Medicare, and Medicaid.
Amgen Inc. continually works to expand the number and location of insurance plans that cover the cost of Otezla.
Please reach out to your Otezla sales representative for more information on local coverage.
While pursuing coverage, commercially insured patients can enroll in the combined
Otezla Co-Pay Card * and Bridge Program † to start and stay on Otezla as prescribed for as little as $0.
*The Otezla Co-Pay Card is for eligible commercially insured patients. Terms, conditions, and program maximums apply. Other restrictions may apply. Click here for full Terms and Conditions. This program is not open to patients receiving prescription reimbursement under any federal, state, or government-funded healthcare program. Not valid where prohibited by law. Patients who are not eligible can call 1-844-4OTEZLA (1-844-468-3952) to discuss further financial support opportunities. †If the patient’s health plan requires a prior authorization or if patient experiences a delay in obtaining approval for Otezla, patients can qualify for the Bridge to Commercial Coverage Offer and receive Otezla free for up to 12 months while pursuing approval from their health plans. No purchase necessary. Click here for full Terms and Conditions.
The Start Today page also includes an overview of the 3 simple steps to get appropriate patients started on Otezla and other available resources.
For more information, call
1-844-4OTEZLA (1-844-468-3952)
The safety and efficacy of Otezla in moderate to severe plaque psoriasis clinical trials were assessed in 1257 subjects in 2 multicenter, randomized, double-blind, placebo-controlled trials (Studies PSOR-1 and PSOR-2). In mild to moderate plaque psoriasis, the safety and efficacy of Otezla were evaluated in 595 subjects in a multicenter, randomized, placebo-controlled, double-blind study. In PsA clinical trials, the safety and efficacy of Otezla were evaluated in 1493 adult patients with active PsA in 3 multicenter, randomized, double-blind, placebo-controlled trials (Studies PsA-1, PsA-2, and PsA-3). 3
Otezla was evaluated in a robust global clinical development program. 3-5
Pivotal Study: ADVANCE
ADVANCE was a multicenter, randomized, placebo-controlled, double-blind study of biologic-naïve adults with mild to moderate plaque psoriasis. 3
Pivotal Studies: ESTEEM 1 and ESTEEM 2
ESTEEM 1 and ESTEEM 2 were 2 large, pivotal, Phase 3, randomized, placebo-controlled studies evaluating apremilast in patients with a diagnosis of moderate to severe plaque psoriasis for at least 12 months prior to screening, and who were also candidates for phototherapy and/or systemic therapy. 1-3
Additional Studies: LIBERATE
LIBERATE was a global, Phase 3b, placebo-controlled, double-blind, double-dummy study that evaluated use of apremilast in biologic-naïve patients with moderate to severe plaque psoriasis for up to 104 weeks. 4
Additional Studies: STYLE
STYLE was a Phase 3, multicenter, randomized, double-blind, placebo-controlled study of 303 adult moderate to severe plaque psoriasis patients with moderate to severe plaque psoriasis of the scalp. 6
Additional Studies: DISCREET
DISCREET was a Phase 3, multicenter, randomized, placebo-controlled, double-blind study of 289 adult patients with moderate to severe genital psoriasis and moderate to severe plaque psoriasis. 7
In multiple clinical trials, Otezla has been evaluated in more than 1400 patients with psoriatic arthritis. 8-10
Pivotal Studies: PALACE 1-3
PALACE 1, PALACE 2, and PALACE 3 were 3 pivotal, Phase 3, multicenter, randomized, double-blind, placebo-controlled studies in patients with active PsA, despite prior or current DMARD therapy. 3,8
Additional Studies: PALACE 4
PALACE 4 was a Phase 3, multicenter, randomized, double-blind, placebo-controlled, parallel-group study of 527 csDMARD-naïve and biologic-naïve adult patients with active PsA. 10
Additional Studies: ACTIVE
ACTIVE was a global, Phase 3b, multicenter, randomized, double-blind, placebo-controlled, parallel-group
study evaluating apremilast monotherapy in adult patients with active PsA who were biologic naïve for up
to 104 weeks. 9
Otezla was evaluated in adult patients with Behçet’s Disease (BD) with active oral ulcers. 3
Pivotal Study: RELIEF
Otezla was evaluated in a Phase 3, multicenter, randomized, double-blind, placebo-controlled trial of 207 adult patients with BD and active oral ulcers. 3,11
csDMARD, conventional synthetic disease-modifying antirheumatic drug; DMARD, disease-modifying antirheumatic drug; PsA, psoriatic arthritis.
References: 1. Papp K, Reich K, Leonardi CL, et al. J Am Acad Dermatol. 2015;73(1):37-49. 2. Paul C, Cather J, Gooderham M, et al. Br J Dermatol. 2015;173(6):1387-1399. 3. Otezla [package insert]. Thousand Oaks, CA: Amgen Inc. 4. Reich K, Gooderham M, Green L, et al. J Eur Acad Dermatol Venereol. 2017;31(3):507-517. 5. Stein Gold L, Papp K, Pariser D, et al. J Am Acad Dermatol. 2022;86(1):77-85. 6. Van Voorhees AS, Gold LS, Lebwohl M, et al. J Am Acad Dermatol. 2020;83(1):96-103. 7. 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. 8. Kavanaugh A, Gladman DD, Edwards CJ, et al. Arthritis Res Ther. 2019;21(1):118. 9. Nash P, Ohson K, Walsh J, et a Ann Rheum Dis. 2018;77(5):690-698. 10. Wells AF, Edwards CJ, Kivitz AJ, et al. Rheumatology (Oxford). 2018;57(7):1253-1263. 11. Hatemi G, Mahr A, Ishigatsubo Y, et al. N Engl J Med. 2019;381(20):1918-1928.
Otezla works by inhibiting phosphodiesterase 4 (PDE4) intracellularly and has anti-inflammatory properties. By elevating cyclic adenosine monophosphate (cAMP) levels, Otezla is thought to indirectly modulate production of pro-inflammatory and anti-inflammatory mediators. 1,2
PDE4 and cAMP
Learn more about the role of PDE4 and cAMP in controlling inflammation. 3
Otezla MOA
Learn how Otezla’s inhibition of PDE4 within cells is thought to affect the production of inflammatory mediators. 3
The specific mechanism(s) by which apremilast exerts its therapeutic action in patients is not well defined. 1
References: 1. Otezla [package insert]. Thousand Oaks, CA: Amgen Inc. 2. Schafer PH, Parton A, Capone L, et al. Cell Signal. 2014;26(9):2016-2029. 3. Schafer PH, Parton A, Gandhi AK, et al. Br J Pharmacol. 2010;159(4):842-855.
*Amgen, the marketer of Otezla, has entered into a fee-for-service arrangement with CoverMyMeds to provide a more simplified ePA experience after you have chosen to prescribe Otezla. CoverMyMeds is a registered trademark of CoverMyMeds LLC. All rights reserved.
Resource Center
The Resource Center includes multiple resources to support you.
If you have questions related to the Otezla initiation process, please call Otezla SupportPlus® at
1-844-4OTEZLA (1-844-468-3952) 8AM–8PM ET, Monday – Friday.
Financial Support
The Otezla SupportPlus program offers multiple resources for you and your patients, including insurance and reimbursement support. Financial support options are available to patients who face a wide variety of insurance scenarios:
Click here to learn more or contact Otezla SupportPlus at 1-844-4OTEZLA (1-844-468-3952) to discuss which financial support program may be appropriate for your patients.
Please read the Prescribing Information for instructions on how to administer Otezla.
Dosing
After an initial 5-day titration period, the maintenance dosage of Otezla is 30 mg BID. 1
This titration is intended to reduce the gastrointestinal symptoms associated with initiation of therapy 1
The dosage of Otezla should be reduced to 30 mg once daily in patients with severe renal impairment 1,*
With twice-daily dosing, Otezla can be taken once in the morning and once in the evening, as part of your patients' daily routine 1
*Creatinine clearance (CLcr) <30 mL/min estimated by the Cockcroft-Gault equation.
Reference: 1. Otezla [package insert]. Thousand Oaks, CA: Amgen Inc.
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.