Otezla (apremilast), a new oral treatment for psoriasis, can help clear skin on hard-to-treat areas of the body. According to data presented at the European Academy of Dermatology and Venereology meeting in Amsterdam earlier this month, patients taking Otezla for psoriasis on the scalp, nails, or palms and soles experienced significant improvement on the drug.
Otezla won approval from the Food and Drug Administration (FDA) last month as a psoriasis treatment. In March, the drug was approved for the treatment of psoriatic arthritis.
The data presented at the meeting analyzed findings from the ESTEEM 2 trial, which was a Phase III, randomized placebo-controlled study of Otezla as a treatment for moderate-to-severe plaque psoriasis.
Patients with nail psoriasis enrolled in the trial experienced significantly greater improvement on Otezla than on the placebo, according to the findings. After four months, patients on Otezla experienced an average of 29 percent improvement in their nails, while the placebo group on average experienced 7.1 percent improvement.
At that point, patients who had begun the trial on placebo switched to Otezla. When measurements were taken four months later, the rates of improvement in both groups jumped. Patients who had switched to Otezla now showed 47.6 percent improvement on average, while patients who were on Otezla from the beginning showed an average of 60 percent improvement, the researchers report.
Improvement was evaluated using the Nail Psoriasis Severity Index (NAPSI), which measures symptoms such as nail pitting and discoloration. Eight months after the start of the trial, more than half of patients in both groups experienced a 50 percent improvement in their NAPSI score, also known as NAPSI-50.
Improvements in psoriasis on the palms of the hands and soles of the feet, called palmoplantar psoriasis, and on the scalp were measured using the Physician’s Global Assessment (PGA), which measures severity on a scale of zero to 10, with 10 being the most severe.
Patients with scalp psoriasis experienced significant improvement on Otezla compared to the placebo. After four months, 40.9 percent of patients on Otezla scored zero or one for their scalp PGA, which means that their scalp was clear or almost clear, according to the data. However, only 17.2 percent of patients on placebo achieved this score.
After eight months, 50.7 percent patients who switched to Otezla halfway through the trial achieved clear or almost clear skin. Among patients who stayed on the drug, researchers report that 32.4 percent achieved clear or almost clear skin.
This lower percentage among patients who stayed on the drug could be due to a number of factors, including the possibility that some patients may not have taken the drug consistently, or that the drug could have become less effective in some patients, according to Dr. Jeffrey Crowley of the Bakersfield Dermatology and Skin Cancer Medical Group, the lead author of the study. Crowley is a member of the National Psoriasis Foundation Medical Board.
For patients with palmoplantar psoriasis, Otezla was again significantly more effective than a placebo, according to researchers. After four months, almost two-thirds of patients on Otezla achieved clear or almost clear skin, while less than a third of patients on placebo did. After eight months, 69.2 percent of patients who switched to Otezla achieved clear or almost clear skin. For patients who stayed on the drug, 53.8 percent achieved clear or almost clear skin, the researchers report.
Side effects for patients on Otezla and patients taking the placebo were similar, according to researchers, and, during the first four months of the study, occurred more often in patients taking the placebo. The most common side effects included nausea, diarrhea and the common cold.
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