Efficacy and safety of different doses of apremilast in mild to-moderate psoriasis: A randomized controlled study

Abstract: OBJECTIVES: Apremilast, proven to be effective against psoriasis, has many side effects at the standard dose of 30 mg, impacting adherence. Hence, we aimed to compare the lower doses (10 mg and 20 mg) to the 30 mg apremilast dose. Primary objectives were to compare psoriasis area and severity index (PASI) 75 response and adverse events (AEs) in apremilast 30 mg versus 20 mg, and 30 mg versus 10 mg from baseline to 16 th week. METHODS: In this randomized, active-controlled trial, 124 patients with mild to moderate psoriasis were randomized (1:1:1 ratio) to apremilast 10 mg, 20 mg, or 30 mg twice daily for 16 weeks. Efficacy parameters were evaluated at 16 th week, and safety was monitored every 2 weeks. RESULTS: At week 16, PASI 75 response was comparable between apremilast 30 mg (31.7%) and 20 mg (28.6%) ( P = 0.756), but significantly higher than 10 mg (9.8%) ( P = 0.014). Apremilast 30 mg and 20 mg demonstrated comparable static physician global assessment 0/1 responses (39% vs. 31%, P = 0.441), whereas 30 mg significantly outperformed 10 mg (12.2%, P = 0.005). Common AEs observed in all groups were nausea and headache. Apremilast 30 mg exhibited significantly more AEs than 20 mg ( P = 0.023) and 10 mg ( P = 0.001). CONCLUSION: Apremilast 20 mg demonstrated comparable efficacy with significantly fewer side effects than the 30 mg dose in mild-to-moderate psoriasis, while apremilast 10 mg showed no significant improvement in efficacy compared to the 30 mg dose.