STUDY DESIGNS

CLINICAL TRIAL PROGRAMS

OTEZLA has been studied in over 4,000 patients with psoriasis and psoriatic arthritis worldwide¹

ESTEEM, Efficacy and Safety Trial Evaluating the Effects of Apremilast in Psoriasis; LIBERATE, Evaluation in a Placebo-Controlled Study of Oral Apremilast and Etanercept in Plaque Psoriasis.

^aDoses of apremilast were titrated during the first week of administration.

^bA responder was defined as a patient achieving ≥PASI-75 in both ESTEEM 1 and ESTEEM 2 at week 32.

^cAt week 32, nonresponders and partial responders (ESTEEM 1) or nonresponders (ESTEEM 2) had the option of adding topical and/or UVB therapy. The decisions could be made at week 32 only but did not need to be initiated at that visit.

^*The use of low-potency topical corticosteroids on the face, axillae, and groin, coal tar shampoo and/or salicylic acid scalp preparations was permitted throughout the studies. In addition, at week 32, subjects who did not achieve a PASI-75 response in ESTEEM 1 or a PASI-50 response in ESTEEM 2 were permitted to use topical psoriasis therapies and/or phototherapy in addition to OTEZLA 30 mg BID.

^†BSA ≥10%, sPGA ≥3, PASI score ≥12.

BID, twice daily; BSA, body surface area; ESTEEM, Efficacy and Safety Trial Evaluating the Effects of Apremilast in Psoriasis; PASI, Psoriasis Area and Severity Index; sPGA, static Physician Global Assessment; UVB, ultraviolet-B.

^*OTEZLA 30 mg (n = 83), etanercept 50 mg (n = 83), or placebo (n = 84).

^†Primary endpoint: Proportion of patients on OTEZLA who achieved PASI-75 at week 16 vs placebo.

^‡Patient population also included inadequate response, intolerance, or contraindication to at least one conventional systemic agent and no prior exposure to a biologic for the treatment of psoriatic arthritis or psoriasis.

References:

Data on file, Amgen Inc.

Papp K, Reich K, Leonardi CL, et al. Apremilast, an oral phosphodiesterase 4 (PDE4) inhibitor, in patients with moderate to severe plaque psoriasis: results of a phase III, randomized, controlled trial (Efficacy and Safety Trial Evaluating the Effects of Apremilast in Psoriasis [ESTEEM] 1). J Am Acad Dermatol. 2015;73:37-49.

Rich P, Gooderham M, Bachelez H, et al. Apremilast, an oral phosphodiesterase 4 inhibitor, in patients with difficult-to-treat nail and scalp psoriasis: results of 2 phase III randomized, controlled trials (ESTEEM 1 and ESTEEM 2). JAAD. 2015;74(1):134-142.

Reich K, Gooderham M, Bewley A, et al. Safety and efficacy of apremilast through 104 weeks in patients with moderate to severe psoriasis who continued on apremilast or switched from etanercept treatment: findings from the LIBERATE study. J Eur Acad Dermatol Venereol. 2018;32(3):397-402.

STUDY DESIGNS

CLINICAL TRIAL PROGRAMS

OTEZLA has been studied in over 4,000 patients with psoriasis and psoriatic arthritis worldwide1

References:

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OTEZLA has been studied in over 4,000 patients with psoriasis and psoriatic arthritis worldwide¹