Thursday, 14 Nov 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.

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

Add new comment

More Like This

Most Psoriatics Go on Biologics

A cohort study of 97 patients with psoriatic arthritis (PsA) examined the prescribing practices in PsA, and found biologics are commonly initiated as the primary mode of therapy in outpatients with PsA. However, treatment modifications can be made regarding patients who are managed with apremilast alone.

Year in Review - Psoriatic Arthritis 2019

Major new insights into the treatment of psoriatic arthritis dominated the headlines during the past year, with a head-to-head trial comparing IL-17A inhibition with tumor necrosis factor blockade, another study considering whether methotrexate can improve outcomes with anti-TNF therapy in PsA, and an investigation into the effects of biologic therapy on bone.

EXCEED Study: Cosentyx Equals Humira in Psoriatic Arthritis

Novartis has announced the results of the EXCEED trial that pitted its IL-17 inhibitor, Cosentyx (secukinumab - SEC) against Humira (adalimumab - ADA) in patients with active psoriatic arthritis. The trial demonstrated that SEC was not non-inferior to ADA, but failed to meet its primary endpoint of superiority over ADA as far as drug efficacy.

Rinvoq (upadacitinib) Effective in Psoriatic Arthritis

Yesterday, AbbVie reported the top-line study results showing the efficacy of Rinvoq (upadacitinib - UPAD) adult patients with active psoriatic arthritis who previously had an inadequate response to a biologic DMARD.

Comorbidity Worsens Axial Spondyloarthritis

Comorbidities are common in patients with axial spondyloarthropathy (axSpA), and a recent study has shown that multimorbidity, the coexistence of 2 or more conditions, is associated with more severe disease than those without comorbidities.