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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