Friday, 23 Aug 2019

You are here

PALACE 3 Study: Apremilast Shows 52 Wk. Efficacy in Active Psoriatic Arthritis

Apremilast, a novel phosphodiesterase 4 (PDE4) inhibiting conversion of cyclic AMP to AMP, was approved for treatment of psoriatic arthritis (PsA) after showing its efficacy in 16 weeks PALACE 1, 2, and 3 trials in 2014.

This report describes the results of the first 52 weeks of PALACE 3, a randomized, controlled, phase 3 trial that included 505 PsA patients with psoriatic skin involvement.  All patients in the study met the Classification Criteria for Psoriatic Arthritis (CASPAR) and had ≥three swollen and ≥three tender joints. Prior treatment with conventional DMARDs and/or biologics was mandatory. Patients were also required to have active skin disease with ≥one plaque psoriasis skin lesion >2 cm in size.

At week 16, ACR 20 responses were superior to placebo (18%) in those receiving 20 mg bid (28%, p=0.0295) or 30 mg bid (41%, p<0.0001). This effect was sustained at week 52, with 56% of patients receiving apremilast 20 mg and 63% receiving apremilast 30 mg achieving an ACR20 response.

Despite low entry PASI scores (< 8), PASI-75 responses were significantly better in apremilast 20 mg and 30 mg patients versus placebo (placebo: 8%; 30 mg: 21%, p=0.0098; 20 mg: 20%, p=0.0215 at week 16).  PASI50 (49% and 55%) were seen in apremilast 20mg and 30 mg groups respectively and at week 52 the PASI75 was 29% and 39%, respectively.

Enthesitis score (MASES) did not reach statistical significance with mean changes of −0.9 for apremilast 20 mg, −1.1 for apremilast 30 mg and −0.7 for placebo at week 24.  

In terms of safety, no new safety signals were reported. Main side effects were diarrhoea, nausea, headache and upper respiratory tract infection. All side effects were mild or moderate in severity.

Study concluded that apremilast shows significant and sustained efficacy in following PsA domains: ACR20 response, changes in HAQ-DI, mean and mean per cent change in TJC, mean change in SJC, dactylitis count, and DAS-28 (CRP), achievement of DAS-28 (CRP) <2.6, physician's and patient's global assessments of disease activity, and skin involvement.

The author has no conflicts of interest to disclose related to this subject

Add new comment

More Like This

Skyrizi Outduels Humira in Psoriasis

A head-to-head trial has shown that risankizumab was significantly superior to adalimumab in providing skin clearance (PASI90) in patients with moderate-to-severe plaque psoriasis, with no difference in safety signals between the two agents.

Biologic Therapy Improves Psoriasis and Reduces CV Inflammation

Psoriasis confers a significant risk of comorbidity, but is psoriasis associated with increased coronary inflammation and is this risk attenuated by biologic therapy? JAMA Cardiology has published a cohort study of 134 consecutive patients with moderate to severe psoriasis, showing that biologic therapy was associated with a significant decrease in coronary inflammation as assessed by perivascular fat attenuation index, a marker of coronary inflammation associated with cardiovascular outcomes. Patients not receiving biologic therapy had no change in perivascular fat attenuation index at 1 year.

Joint Surgery Rates Remain High in Psoriatic Arthritis

The incidence rate of joint surgery among patients with psoriatic arthritis (PsA) has remained persistently high, double that of the general population, according to a new Danish cohort study.

Fatigue is Driven by Inflammation, Pain, and Chronicity in Psoriatic Arthritis

Correlates with fatigue were assessed in psoriatic arthritis (PsA) patients in the DANBIO registry and found to be associated with  clinical inflammatory factors, disease duration, and chronic pain.

A toital of 2062 PsA patients in the Danish nationwide registry DANBIO were studied by cross-sectional survey from December 2013 to June 2014.

CAM Use is Common in Psoriasis

The July issue of the Journal of the American Academy of Dermatology reports that patients with psoriasis are frequent users of complementary and alternative medicines (CAMs) largely because of disatisfaction with traditional medications.

The National Psoriasis Foundation commissioned a survey of patients on CAMs use and patients' perceptions.

The survey was sent to 100,927 NPF members and 219 completed it.