The labeling for Otezla (apremilast; Amgen) has been updated to include safety and efficacy information related to the treatment of patients with moderate to severe plaque psoriasis of the scalp.
The STYLE trial was a double-blind, placebo-controlled study that included 303 patients with moderate to severe plaque psoriasis of the scalp who had a Scalp Physician Global Assessment (ScPGA) score of ≥3, Scalp Surface Area (SSA) involvement of ≥20%, and an inadequate response or intolerance to at least 1 topical therapy for plaque psoriasis of the scalp. Enrolled patients also had moderate to severe plaque psoriasis (body surface area [BSA] involvement of ≥10%, static Physician Global Assessment [sPGA] of ≥3 [moderate or severe disease], and Psoriasis Area and Severity Index [PASI] score ≥12).
Patient demographics included the following:
- Mean age: 46.9 years; 61.7% were men; 75.6% were white
- 76.9% had moderate scalp psoriasis (ScPGA of 3)
- 23.1% had severe scalp psoriasis (ScPGA of 4)
- 71.6% were biologic naive
- 58.8% had failed 1-2 topical therapies
- Mean Whole Body Itch Numeric Rating Scale (NRS) score: 7.2 (range 0 [no itch] to 10 [worst imaginable itch])
- Mean Scalp Itch NRS: 6.7 (range 0 [no itch] to 10 [worst imaginable itch])
- Mean SSA involvement: 60.6%
- Mean BSA involvement: 19.8%
Patients were randomized to receive Otezla 30mg twice daily (n=201) or placebo (n=102) for 16 weeks. The primary end point of the study was the proportion of patients who achieved ScPGA response at Week 16 (defined as ScPGA score of clear  or almost clear  with at least a 2-point reduction from baseline at Week 16). Secondary end points included the proportion of patients with Whole Body Itch NRS response (defined as ≥4-point reduction from baseline) and the proportion of patients with a Scalp Itch NRS response (defined as ≥4-point reduction from baseline).
Results showed that a larger proportion of patients treated with Otezla had ScPGA response compared with placebo (43.3% vs 13.7%; treatment difference: 29.6%; 95% CI, 19.5-39.7). In addition, a greater percentage of Otezla-treated patients had Whole Body Itch NRS response and Scalp Itch NRS response (45.5% and 47.1%, respectively) vs placebo-treated patients (22.5% and 21.1%, respectively).
Otezla, an inhibitor of phosphodiesterase 4, is indicated for the treatment of patients with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy, active psoriatic arthritis, and for oral ulcers associated with Behçet’s disease. It is available in 10mg, 20mg, and 30mg tablets.
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