The FDA has approved a label update for secukinumab (Cosentyx, Novartis) that includes data on treating moderate-to-severe scalp psoriasis, a difficult-to-treat form of the disease that affects approximately half of all psoriasis patients. The label update is based on the results of a dedicated phase 3 scalp psoriasis trial.
Secukinumab is the first interleukin-17A (IL-17A) antagonist approved to treat moderate-to-severe plaque psoriasis. Scalp psoriasis can be challenging to treat with topical agents or phototherapy due to the presence of hair and other factors, Novartis notes.
The randomized, double-blind, placebo-controlled scalp study evaluated the efficacy and safety of secukinumab in 102 patients with moderate-to-severe scalp psoriasis. Eligible patients were equally randomized to either subcutaneous secukinumab 300 mg or placebo at weeks 0, 1, 2, and 3, then every four weeks for 12 weeks.
At week 12, patients in the placebo group who did not achieve at least a 90% improvement from baseline in the Psoriasis Scalp Severity Index (PSSI) score were switched to secukinumab 300 mg at weeks 12, 13, 14, 15, 16, and 20 (study completion was 24 weeks).
The primary endpoint was the proportion of patients who achieved a PSSI 90 response at week 12. The key secondary objective was Investigator's Global Assessment modified 2011 (IGA) 0 (clear) or 1 (almost clear) response (for the scalp only) at week 12. The proportion of patients achieving an IGA scalp-only score of 0 or 1 (clear or almost clear) were 56.9% and 5.9% for secukinumab and the placebo groups, respectively.
Secukinumab, launched in 2015, is the first and only fully-human IL-17A antagonist approved to treat moderate-to-severe plaque psoriasis, psoriatic arthritis, and ankylosing spondylitis.
Source: Novartis; February 6, 2018.