November 18, 2015
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Otezla reduced nail and scalp psoriasis severity

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Twice-daily treatment with Otezla significantly reduced the severity of nail and scalp psoriasis among patients with moderate-to-severe psoriasis, according to recently published study results.

Researchers randomly assigned 1,255 patients with moderate-to-severe psoriasis 2:1 to receive Otezla (apremilast, Celgene) 30 mg twice daily or placebo in the phase 3 Efficacy and Safety Trial Evaluating the Effects of Apremilast in Psoriasis (ESTEEM) 1 and 2 trials.

Patients on placebo were switched to apremilast at week 16 through week 32, which was followed by a randomized withdrawal through week 52.

Prioi efficacy analyses were conducted on 844 patients who had nail psoriasis (target Nail Psoriasis Severity Index [NAPSI] score ≥ 1) and/or moderate-to-severe scalp psoriasis (Scalp Physician Global Assessment score ≥ 3).

In the ESTEEM 1 and 2 trials, 66.1% and 64.7% of patients, respectively, had nail psoriasis and 66.7% and 65.5% had moderate-to-severe scalp psoriasis. There was a greater improvement in the NAPSI score among patients treated with apremilast at week 16 compared with patients who received placebo, with a mean percent change of –22.5% vs. +6.5% in ESTEEM 1 (P < .001) and –29% vs. –7.1% in ESTEEM 2 (P = .0052).

Patients treated with apremilast had a greater NAPSI-50 response (50% reduction from baseline in target NAPSI score) vs placebo (P < .0001) and Scalp Physicians Global Assessment score 0 or 1 vs. placebo (P < .0001) at week 16. Patients with a Psoriasis Area and Severity Index response at week 32 generally maintained the improvements through week 52.

“Although the nails and scalp account for a small percentage of the body surface area, psoriasis in these areas can have a disproportionate effect on a patient’s physical and psychosocial function,” the researchers wrote.  “Apremilast, a novel oral therapeutic for patients with moderate-to-severe plaque psoriasis, is an effective option for patients with nail and/or scalp involvement.”  – by Bruce Thiel

Disclosure: Rich reports receiving honoraria/research funding as an advisory board member for Eli Lilly and Company and Sandoz; serving as a consultant for Polichem and as an investigator for AbbVie, Amgen, Celgene Corp., Eli Lilly, Janssen, Merck & Co., Novartis and Pfizer. Please see the full study for a list of other researchers’ relevant financial disclosures.