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A phase 3 randomized study of apremilast, an oral phosphodiesterase 4 inhibitor, for active ankylosing spondylitis

The Journal of Rheumatology Aug 05, 2021

Taylor PC, van der Heijde D, Landewé R, et al. - Apremilast treatment was not identified as clinically beneficial in patients with active ankylosing spondylitis (AS). Apremilast was identified as safe and tolerable in line with its known profile.

  • In this phase 3, multicenter, double-blind, placebo-controlled study, 490 patients with active AS were randomized (placebo: n = 164; apremilast 20 mg twice daily: n = 163; apremilast 30 mg twice daily: n = 163).

  • The primary endpoint of Assessment of the Spondyloarthritis international Society 20 (ASAS20) response at Week 16 was not met.

  • Diarrhea, nasopharyngitis, upper respiratory infection, and nausea were the most frequently reported adverse events through Week 104.

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