Positive Results Reported from Phase 3 Plaque Psoriasis Trial

By Adam Hochron
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A phase 3 clinical trial for apremilast showed “significant improvements” in patients with mild-to-moderate plaque psoriasis, according to a press release from the manufacturer. 

Top-line data from the ADVANCE trial showed patients given a 30 mg dose of apremilast twice daily showed improvement in Physician’s Global Assessment response compared to placebo. Secondary endpoints after 16 weeks of the trial showed at least 75% improvement in the percent of affected body surface area. Additionally, patients reported a statistically significant change in Psoriasis Area and Severity Index from baseline. 

“Many patients with mild-to-moderate plaque psoriasis who use topical therapies still have challenges managing their psoriasis,” David M. Reese, MD, executive vice president of research and development at Amegn, said in the release. “We look forward to discussions with the FDA about the potential to bring [apremilast], which has already been prescribed to hundreds of thousands of patients with moderate-to-severe psoriasis, to more patients who may need additional therapeutic options.”

The most common adverse events that were reported in at least 5% of patients in either group were diarrhea, headache, nausea, nasopharyngitis, and upper respiratory tract infection. 

The full results from the trial are expected to be presented at an upcoming medical meeting. 

 

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