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.

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

OTEZLA $0
CO-PAY CARD

*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:

Scan the QR code

Visit otezla.com/copay

Call 1-844-4OTEZLA
(1-844-468-3952)

Otezla was evaluated in a robust clinical development program that 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. ³

Additional Studies: SPROUT

SPROUT was a Phase 3, multicenter, randomized, double-blind, placebo-controlled, parallel group study to assess the efficacy and safety of Otezla in 245 pediatric patients whose ages ranged from 6 to 17 years old, with moderate to severe plaque psoriasis. 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: FOREMOST

FOREMOST is a global randomized, double-blind, placebo-controlled, parallel-group, Phase 4 study that uniquely focused on early oligoarticular PsA. Patients with oligoarticular PsA (>1 but ≤4 tender and swollen joints involved) and early disease (signs and symptoms of PsA ≤5 years’ duration) were randomized 2:1 to receive either Otezla 30 mg BID (n=203) or placebo (n=105) for 24 weeks, stratified based on concomitant medication use, with an early escape at week 16.^11,12

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. ^3,13

BID, twice daily; 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, Stein Gold L, Lebwohl M, et al. J Am Acad Dermatol. 2020;83(1):96-103. 7. Fiorillo L, Becker E, de Lucas R, et al. J Am Acad Dermatol. 2024;90(6):1232-1239. 8. Kavanaugh A, Gladman DD, Edwards CJ, et al. Arthritis Res Ther. 2019;21(1):118. 9. Nash P, Ohson K, Walsh J, et al; ACTIVE Investigators. 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. Mease P, Gladman D, Coates LC, et al. Presented at: ACR/ARHP Annual Meeting; November 10-15, 2023; San Diego, CA. 12. Gossec L, Gladman D, Coates L, et al. Presented at: 32nd Annual Meeting of the European Academy of Dermatology and Venereology (EADV); October 11-14, 2023; Berlin, Germany. 13. 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

Please read the Prescribing Information for instructions on how to administer Otezla.

ADULT DOSING

After an initial 5-day titration period, the maintenance dosage of Otezla is 30 mg twice daily

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

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

Pediatric patients with severe renal impairment:

The maintenance dose of Otezla should be reduced to 30 mg once daily in pediatric patients who weigh at least 50 kg or 20 mg once daily in pediatric patients who weigh 20 kg to <50 kg

• For initial dosage titration, it is recommended that Otezla be titrated using only the AM schedule shown above for the appropriate body weight category and that the PM doses be skipped
• From day 6 on, the dose of Otezla is 30 mg once daily for pediatric patients who weigh at least 50 kg or 20 mg once daily for pediatric patients who weigh 20 kg to <50 kg

With twice-daily dosing, Otezla can be taken once in the morning and once in the evening, as part of your patients’ daily routine

*Creatinine clearance (CLcr) <30 mL/min estimated by the Cockcroft-Gault equation.

PEDIATRIC DOSING

^†Pediatric patients, 6 years of age or older, with moderate to severe plaque psoriasis, and weighing at least 20 kg.

Titration of Otezla is intended to reduce the gastrointestinal symptoms associated with initiation of therapy

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

Reference: 1. Otezla [package insert]. Thousand Oaks, CA: Amgen Inc.