Improvement of Disease Activity in Patients with PsA with Apremilast

Boston—The results of a recent study indicated that apremilast demonstrated clinically meaningful improvements in psoriatic arthritis (PsA) disease activity measures that were sustained with continual treatment for 52 weeks. Improvements were evident for both joint- and skin-related signs and symptoms of PsA.
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The study’s results were presented at the ACR/ARHP meeting during a poster session titled Apremilast, an Oral Phosphodiesterase 4 Inhibitor, Is Associated With Long-term (52-Week) Improvement in Measures of Disease Activity in Patients With Psoriatic Arthritis: Results From 3 Phase 3, Randomized, Controlled Trials.

The PALACE [Psoriatic Arthritis Long-term Assessment of Clinical Efficacy] clinical trial program consisted of 3 phase 3, multicenter, randomized, double-blind, placebo-controlled studies that compared the efficacy and safety of apremilast with placebo in patients with active PsA despite prior conventional disease-modifying antirheumatic drug (DMARD) use or biologics use. The current study examined the impact of apremilast on PsA disease activity in patients enrolled in the PALACE study who had received treatment for up to 52 weeks.

Patients were included if they had PsA duration ≥6 months, had ≥3 swollen and ≥3 tender joints despite past or current DMARD use, had used prior conventional DMARDs and/or biologics, and had ≥1 plaque psoriasis lesion of ≥2 cm.

In this study, eligible patients were randomized to receive placebo, apremilast 20 mg twice daily, or apremilast 30 mg twice daily. Patients originally randomized to receive placebo and whose swollen joint count and tender joint count had not improved by ≥20% at week 16 were considered nonresponders and were required to be rerandomized to apremilast 20 mg or 30 mg. At week 24, all participants still taking placebo were also rerandomized to receive apremilast 20 mg or 30 mg.

The study’s primary end point was the proportion of patients achieving modified American College of Rheumatology (ACR) 20 response criteria at week 16. Additional secondary end points were examined at weeks 16, 24, and 52, including:

• Disease Activity Score using C-reactive protein (DAS28-CRP) mean change from baseline
• European League Against Rheumatism good or moderate response
• Maastricht Ankylosing Spondylitis Enthesitis Score
• Dactylitis count
• Psoriasis Area and Severity Index score reduction of 75% from baseline

A total of 504 (PALACE 1), 484 (PALACE 2), and 505 (PALACE 3) participants were randomized for study inclusion.

At week 16, significantly more patients receiving apremilast 20 mg (PALACE 1: 30.4%, P<.05; PALACE 2: 37.4%, P≤.005; PALACE 3: 28.4%, P<.05) and apremilast 30 mg (PALACE 1: 38.1%, P≤.0001; PALACE 2: 32.1%, P<.05; PALACE 3: 40.7%, P≤.0001) achieved a modified ACR20 response compared with placebo (PALACE 1: 19%; PALACE 2: 18.9%; PALACE 3: 18.3%).

Among the 3 PALACE study groups, in the patients initially randomized to receive apremilast 20 mg, a modified ACR20 response was achieved at week 52 by 63%, 52.9%, and 56% of patients, respectively. Among the 3 PALACE study groups, in the patients initially randomized to receive apremilast 30 mg, a modified ACR20 response was achieved at week 52 by 54.6%, 52.6%, and 63% of patients, respectively.

In addition, at 16 weeks, patients receiving apremilast 20 mg and 30 mg had significantly greater improvements in DAS28-CRP scores compared with placebo. DAS28-CRP improvement and DAS28-CRP <2.6 response were sustained over 52 weeks of treatment among patients initially randomized to either dose of apremilast.

The most commonly reported adverse events occurring in patients treated with apremilast for up to 24 weeks were diarrhea, nausea, and headache.—Kerri Fitzgerald

The studies were sponsored by Celgene Corporation.