Oral apremilast in the treatment of active psoriatic arthritis: Results of a multicenter, randomized, double-blind, placebo-controlled study
Arthritis & Rheumatism, 06/27/2012
Schett G et al. – Both apremilast 20 mg BID and 40 mg QD demonstrated efficacy versus placebo and were generally well–tolerated in active psoriatic arthritis (PsA). The balance of efficacy, tolerability, and safety supports further study of apremilast in PsA.Methods
- This phase 2, multi–center, randomized, double–blind, placebo–controlled study included a 12–week treatment phase, with subjects receiving placebo, apremilast 20 mg BID, or apremilast 40 mg QD; a 12–week treatment–extension phase, with placebo subjects re–randomized to apremilast; and a 4–week observational phase after treatment cessation.
- The primary endpoint was the proportion of subjects achieving American College of Rheumatology criteria for 20% improvement (ACR20) at week 12.
- Safety assessments included adverse events (AEs), physical examinations, vital signs, laboratory parameters, and electrocardiograms.
- Of 204 subjects randomized, 165 completed the treatment phase.
- At the end of the treatment phase (week 12), 43.5% of subjects receiving apremilast 20 mg BID (P<0.001) and 35.8% receiving 40 mg QD (P=0.002) achieved an ACR20 versus 11.8% receiving placebo.
- At the end of the treatment–extension phase (week 24), >40% of subjects in each group (apremilast 20 mg BID, apremilast 40 mg QD, placebo subjects re–randomized to apremilast) achieved an ACR20.
- Most subjects in the treatment (84.3%) and treatment–extension (68.3%) phases reported ≥1 AEs.
- Diarrhea, headache, nausea, fatigue, and nasopharyngitis were reported most frequently; most events were mild/moderate.
- No clinically relevant laboratory or electrocardiographic abnormalities were reported.