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.
Protocol: Randomized, double-blind, multicenter, placebo-controlled trials evaluating the safety and efficacy of apremilast*
Patient population: Adult patients with moderate to severe plaque psoriasis who were candidates for phototherapy or systemic therapy†
Extension phase: Patients entering a long-term extension phase could be treated through 5 years
*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.
On November 21, 2019, Amgen acquired from Celgene Corporation the worldwide rights to Otezla® (apremilast).