On November 21, 2019, Amgen acquired from Celgene Corporation the worldwide rights to Otezla® (apremilast).
Moderate to Severe Plaque Psoriasis
In ESTEEM 1, patients were switched to Otezla if they lost their PASI‑75, but no later than at week 52. In ESTEEM 2, patients were switched to Otezla if they lost 50% of the PASI improvement obtained at week 32 compared to baseline, but no later than at week 52.
Doses of Otezla were titrated during the first week of administration.
A responder was defined as a patient achieving ≥PASI-75; a partial responder was defined as a patient achieving PASI‑50 to PASI‑74; a nonresponder was defined as a patient achieving <PASI‑50 in both ESTEEM 1 and ESTEEM 2 at week 32.
At week 32, nonresponders and partial responders (ESTEEM 1) or nonresponders only (ESTEEM 2) had the option of adding topical and/or UVB therapy. The decision could be made at week 32 and was based on the discretion of the investigator.
BID, twice daily; ESTEEM, Efficacy and Safety Trial Evaluating the Effects of Apremilast in Psoriasis; PASI, Psoriasis Area and Severity Index.
BSA, body surface area; HIV, human immunodeficiency virus; ESTEEM, Efficacy and Safety Trial Evaluating the Effects of Apremilast in Psoriasis; NAPSI, Nail Psoriasis Severity Index; PASI, Psoriasis Area and Severity Index; ScPGA, Scalp Physician Global Assessment; sPGA, static Physician Global Assessment; TB, tuberculosis; VAS, visual analog scale.
BSA, body surface area; LIBERATE, Evaluation in a Placebo-Controlled Study of Oral Apremilast and Etanercept in Plaque Psoriasis; PASI, Psoriasis Area and Severity Index; sPGA, static Physician Global Assessment; TB, tuberculosis.
References: 1. Data on file, Amgen Inc. 2. Papp K, Reich K, Leonardi CL, et al. J Am Acad Dermatol. 2015;73(1):37-49. 3. Paul C, Cather J, Gooderham M, et al. Br J Dermatol. 2015;173(6):1387-1399. 4. Otezla [package insert]. Thousand Oaks, CA: Amgen Inc. 5. Reich K, Gooderham M, Green L, et al. J Eur Acad Dermatol Venereol. 2017;31:507-517.
Otezla® (apremitast) is indicated for the treatment of patients with moderate to severe 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.
Warnings and Precautions
Use in Specific Populations