PALACE 4 results support apremilast for DMARD-naïve patients with PsA
medwireNews: Phase III trial findings suggest that treatment with the phosphodiesterase 4 inhibitor apremilast is beneficial for patients with psoriatic arthritis (PsA) who have not received prior treatment with conventional or biologic DMARDs.
The first three PALACE (Psoriatic Arthritis Long-term Assessment of Clinical Efficacy) studies demonstrated the benefits of apremilast in patients with active PsA and an inadequate response to DMARD treatment, whereas “PALACE 4 assessed apremilast use earlier in the treatment algorithm,” say Alvin Wells (Rheumatology and Immunotherapy Center, Franklin, Wisconsin, USA) and colleagues.
As reported in Rheumatology, the PALACE 4 investigators randomly assigned 527 patients with a mean disease duration of 3.4 years to receive treatment with oral apremilast 20 mg or 30 mg twice daily, or to receive placebo. A second randomization to one of the apremilast groups was performed for the placebo-treated patients, at week 16 for those who did not have at least a 20% improvement in swollen and tender joint counts at this timepoint or at week 24 for the remaining participants.
At the 16-week follow-up, patients in the apremilast 20 mg and 30 mg groups were significantly more likely to achieve a 20% or greater improvement in ACR criteria (ACR20 response) than those given placebo, at corresponding rates of 28.0% and 30.7% versus 15.9%.
Apremilast-treated patients also experienced significantly greater improvements in physical functioning over 16 weeks of treatment, with mean decreases in Health Assessment Questionnaire Disability Index scores of 0.17 and 0.21 points in the 20 mg and 30 mg groups, respectively, compared with an average increase of 0.03 points for patients treated with placebo.
Moreover, patients given either dose of apremilast had significantly higher ACR50 response rates at week 16 than those in the placebo group, as well as greater improvements in swollen and tender joint counts, physician-assessed disease activity, and patient-reported pain. Improvements were maintained with continuous apremilast treatment until the 1-year follow-up.
In all, 49.7% of patients in the 20 mg group, 56.6% of those in the 30 mg group, and 41.5% of placebo-treated patients experienced adverse events (AEs) over 24 weeks of treatment. The most frequently reported AEs were nausea, diarrhea, headache, and upper respiratory tract infection.
Wells and colleagues report that the majority of AEs were mild or moderate in severity, and apremilast was “generally well tolerated up to 52 weeks.”
They add that the drug had “no clinically meaningful effects on laboratory measurements,” in contrast to many conventional PsA therapies that require ongoing laboratory monitoring for safety concerns.
And the team concludes that apremilast may be “a therapeutic option for patients with active PsA whose systemic treatment choices may be limited by efficacy, frequent laboratory safety requirements and tolerability.”
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