According to a new study data published in Rheumatology, apremilast monotherapy improved symptoms and was generally well-tolerated by patients with psoriatic arthritis (PsA) who were naive to disease-modifying antirheumatic drugs (DMARDs).
The PALACE 4 trial (ClinicalTrials.gov identifier: NCT01307423) was a randomized placebo-controlled study of 527 participants with high disease activity and mean disease duration of 3.4 years. At baseline, patients were randomly assigned to receive placebo, apremilast 20 mg twice a day, or apremilast 30 mg twice a day. At 16 or 24 weeks, patients receiving placebo were re-randomized to apremilast. Double-blind apremilast treatment was continued to 52 weeks. As primary end points, investigators calculated changes in Health Assessment Questionnaire-Disability Index (HAQ-DI) scores and assessed the percentage of patients in each arm achieving ≥20% improvement in American College of Rheumatology (ACR) response criteria (ACR20).
At 16 weeks, 15.9% of patients in the placebo arm achieved ACR20 response compared with 28.0% of patients receiving 20 mg (P =.0062) and 30.7% of patients receiving 30 mg (P =.0010). The mean HAQ-DI improvements in patients receiving apremilast were −0.17 (20 mg; P =.0008) and −0.21 (30 mg; P <.0001) compared with 0.03 in the placebo group. Improvements in secondary efficacy parameters were also higher in the patients receiving apremilast, including swollen joint count, tender joint count, physician global assessments of disease activity, and patient’s self-assessment of pain. HAQ-DI and ACR20 improvements were sustained over the 52-week study period with continued apremilast treatment.
Researchers also assessed adverse events over the 52-week study period to quantify tolerability. Most events were mild or moderate, and serious adverse events were of comparable frequency in the apremilast (1.1%) and placebo (2.8%) arms. Investigators noted that study data collected from a DMARD-naive cohort should be extrapolated to the larger PsA population with care. Still, these study results support the general tolerability and efficacy of apremilast in treating PsA symptoms.
Please refer to the original article for disclosure information.
Wells AF, et al. Apremilast monotherapy in DMARD-naive psoriatic arthritis patients: results of the randomized, placebo-controlled PALACE 4 trial [published online April 4, 2018]. Rheumatology. doi:10.1093/rheumatology/key032