Celgene reports positive results from Phase lll STYLE study of Otezla

10th October 2018 (Last Updated October 10th, 2018 00:00)

Celgene has reported positive results from the STYLE study, a Phase lll trial that examined the efficacy and safety of Otezla (apremilast) for the treatment of patients with moderate to severe plaque psoriasis of the scalp.

Celgene reports positive results from Phase lll STYLE study of Otezla
Nail displaying the characteristic pitting of psoriasis. Credit: Seenms.

Celgene has reported positive results from the STYLE study, a Phase lll trial that examined the efficacy and safety of Otezla (apremilast) for the treatment of patients with moderate-to-severe plaque psoriasis of the scalp.

The results revealed that a twice-daily dose of Otezla at 30mg achieved a highly statistically significant improvement in the primary objective of the Scalp Physician’s Global Assessment (ScPGA) response at week 16 against placebo.

Additionally, the trial achieved statistical significance after meeting the secondary endpoint of the whole body itch numeric rating scale (NRS), which is defined as at least a four-point reduction from baseline, at week 16.

The safety profile was also reported to be similar to the known safety profile of Otezla, and the trial did not report any new safety signals.

"We are encouraged by the significant improvements in this trial and look forward to sharing this data to further enhance the Otezla label."

Treatment-related adverse events occurred in at least 5% of patients in either treatment group. These included diarrhoea, nausea, headache and vomiting.

STYLE is a multi-centre, randomised, placebo-controlled, double-blind trial that enrolled 303 subjects who were randomised in a 2:1 ratio to receive twice-daily doses of Otezla at 30mg or placebo for the first 16 weeks.

Celgene Inflammation and Immunology president Terrie Curran said: “The scalp is the most commonly affected area in moderate-to-severe plaque psoriasis, impacting up to 80% of patients.

“The area is difficult to treat with topical therapies, and clinical data from systemic therapies are limited. We are encouraged by the significant improvements in this trial and look forward to sharing this data to further enhance the Otezla label.”

The Otezla 30mg tablet is an oral small-molecule inhibitor of phosphodiesterase 4 (PDE4).