Amgen Reports Positive Phase 3 Results for Otezla in Genital Psoriasis, Addressing Unmet Needs in 63% of Psoriasis Patients

Recently, Amgen announced positive results from a Phase 3 clinical trial of apremilast tablets (brand name: Otezla). The trial results showed that in adult patients with moderate to severe genital psoriasis and moderate to severe plaque psoriasis, treatment with 30 mg of Otezla for 16 weeks led to significant improvements in genital psoriasis compared to placebo.

Psoriasis is a chronic, inflammatory skin condition with symptoms including red plaques covered with silver scales, dryness, cracking, bleeding, and thickened, pitted, or ridged nails. For patients with more severe symptoms, psoriasis significantly impacts their lives. According to statistics provided in the press release, there are 125 million people worldwide living with psoriasis. Among them, approximately 80% have plaque psoriasis, and up to 63% of psoriasis patients will experience outbreaks in the genital area during the course of the disease. Although drug development in this field has made progress over the past decade, patient survey data indicates that 30% of psoriasis patients still do not receive adequate treatment.

Otezla is an oral selective phosphodiesterase 4 (PDE4) inhibitor initially developed by Celgene, a subsidiary of Bristol-Myers Squibb (BMS). Inhibition of PDE4 leads to increased intracellular cAMP levels, which researchers believe indirectly modulates the production of inflammatory mediators. The drug has been approved by the U.S. FDA for three indications: treatment of patients with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy; adult patients with active psoriatic arthritis; and adult patients with Behçet's disease-related oral ulcers. Last year, Amgen acquired the development and commercialization rights for this drug from Celgene.

This Phase 3 trial enrolled 289 patients, with the primary endpoint being the proportion of patients achieving complete or almost complete clearance of skin symptoms, as assessed by the sPGA-G score for evaluating genital psoriasis skin symptoms at Week 16, with at least a 2-point improvement from baseline.

In addition, compared to the placebo group, Otezla group showed clinically significant improvement in the Genital Psoriasis Itch Numeric Rating Scale (GPI-NRS) response at week 16, as well as other psoriasis symptom indicators. The types and incidence of adverse events observed were consistent with the known safety profile of Otezla. The most commonly reported adverse events (occurring in at least 5% of patients) in either treatment group were diarrhea, headache, nausea, and nasopharyngitis.

References:

[1] Amgen Announces Positive Top-Line Results From Otezla® (apremilast) Phase 3 DISCREET Study In Moderate To Severe Genital Psoriasis. Retrieved December 1, 2021, from https://www.amgen.com/newsroom/press-releases/2021/12/amgen-announces-positive-topline-results-from-otezla-apremilast-phase-3-discreet-study-in-moderate-to-severe-genital-psoriasis

(Original text has been abridged)

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