FAQs

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 Amgen® SupportPlus at
1-844-4OTEZLA (1-844-468-3952).

Otezla prescriptions can be filled at any specialty pharmacy.
However, some payers may mandate a specialty pharmacy for Otezla.

Specialty pharmacies may furnish patient support by providing:

• Guidance to patients whose insurance programs cover Otezla and to those who lack health insurance
• Suggestions and service to stay on track with medications
• Assistance locating co-pay support programs and other financial support, such as the Otezla Co-Pay Card * Program

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 Amgen® SupportPlus
at 1-844-4OTEZLA (1-844-468-3952).

Enrolling in the $0 Co-Pay Card * Program may help eligible commercially insured patients start their Otezla prescription without delay

*Eligibility criteria and program maximums apply. See AmgenSupportPlus.com/copay-terms for full Terms and Conditions.

3 SIMPLE WAYS FOR PATIENTS TO ENROLL IN THE CO-PAY PROGRAM:

For more information, call
1-844-4OTEZLA (1-844-468-3952)

The Otezla clinical development program began in 2010. Patients in the long-term open-label extension phase of the ESTEEM and PALACE clinical trials were followed for up to 5 years. ^1,2

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

Plaque Psoriasis

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 plaque psoriasis and moderate to severe plaque psoriasis of the genital area. ⁷

Psoriatic Arthritis

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

Oral Ulcers in Behçet’s Disease

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 is an oral PDE4 inhibitor with a distinct MOA ^1,2

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.

Otezla is an oral medication ¹

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 twice daily ¹

This titration is intended to reduce the gastrointestinal symptoms associated with initiation of therapy ¹

• Otezla can be administered without regard to meals ¹
• Patients should not crush, split, or chew the tablet ¹

The dosage of Otezla should be reduced to 30 mg once daily in patients with severe renal impairment ^1,*

• For initial dosage titration, it is recommended that Otezla be titrated using only the AM schedule shown above and the PM doses be skipped ¹
• From day 6 on, the dose of Otezla is 30 mg once daily 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.