Wells AF, et al. - The efficacy, as well as safety of apremilast monotherapy (20 mg or 30 mg), was tested in DMARD-naive patients with active PsA in the PALACE 4 trial. Compared with placebo, significant ACR50 responses [the proportion of patients achieving ≥20% improvement in ACR response criteria (ACR20)] were achieved with both apremilast doses at week 16, along with improvements in secondary efficacy measures (swollen/tender joint counts) and psoriasis assessments. These improvements sustained through week 52. Diarrhoea, nausea, headache and upper respiratory tract infection were common adverse events (AEs); most events were mild or moderate. Both groups suffered comparable serious AEs and AEs leading to discontinuation. Overall, apremilast monotherapy improved PsA signs/symptoms over 52 weeks and was generally well tolerated.

• Randomization of eligible patients (1:1:1) to placebo, apremilast 20 mg twice a day or apremilast 30 mg twice a day was done.
• Rerandomization to apremilast was carried out in placebo patients at week 16 or 24.
• Up to week 52, double-blind apremilast treatment continued and extended up to 4 years.
• The proportion of patients achieving ≥20% improvement in ACR response criteria (ACR20) at week 16 was the primary endpoint; secondary endpoints included the mean change in the HAQ Disability Index (HAQ-DI) score at week 16.

• Data showed that a total of 527 patients with mean disease duration of 3.4 years and high disease activity were randomized and received treatment.
• At week 16, ACR20 response were achieved by more apremilast patients [placebo, 15.9%; 20 mg, 28.0% (P=0.0062); 30 mg, 30.7% (P=0.0010)].
• As per findings, the mean HAQ-DI improvements were -0.17 (20 mg; P=0.0008) and -0.21 (30 mg; P < 0.0001) vs 0.03 (placebo).
• At week 16, both apremilast doses vs placebo showed significant ACR50 responses and improvements in secondary efficacy measures (swollen/tender joint counts) and psoriasis assessments, with sustained improvements through week 52.
• Over 52 weeks, diarrhoea, nausea, headache and upper respiratory tract infection were reported as common adverse events (AEs); most events were mild or moderate.
• Between groups, comparable serious AEs and AEs were reported that led to discontinuation.
• Infrequent and transient laboratory abnormalities were also reported.