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Efficacy and safety of apremilast in patients with mild to moderate plaque psoriasis: Results of a phase 3, multicenter, randomized, double-blind, placebo-controlled trial

Journal of the American Academy of Dermatology Aug 06, 2021

Gold LS, Papp K, Pariser D, et al. - In this phase 3, double-blind, placebo-controlled study, apremilast showed efficacy in mild-to-moderate psoriasis and was found to be safe, according to the drug's established safety profile.

  • A total of 595 patients were randomly assigned (apremilast: 297; placebo: 298).

  • The primary endpoint was met, with a significantly higher static Physician Global Assessment response rate observed in the apremilast group compared with the placebo group at Week 16.

  • All secondary endpoints were met (achievement of BSA-75 [33.0% vs 7.4%], BSA ≤ 3% [61.0% vs 22.9%], ≥ 4-point reduction in Whole Body Itch NRS [43.2% vs 18.6%], Scalp PGA 0 or 1 and ≥ 2-point reduction [44.0% vs 16.6%], and changes from baseline in BSA, PASI, and DLQI).

  • Consistent with previous research, the most commonly reported adverse events (5%) with apremilast were diarrhea, headache, nausea, nasopharyngitis, and upper respiratory tract infection.

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