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J Rheumatol. 2016 Sep;43(9):1724-34. doi: 10.3899/jrheum.151376. Epub 2016 Jul 15.

A Phase III, Randomized, Controlled Trial of Apremilast in Patients with Psoriatic Arthritis: Results of the PALACE 2 Trial.

Author information

1
From the Research Laboratory and Division of Clinical Rheumatology, University of Genoa, Genoa, Italy; Arthritis and Rheumatology of Georgia, Atlanta, Georgia; Metroplex Clinical Research Center, Dallas, Texas, USA; AP-HP, Hôpital Lariboisière, Rheumatology Department, Université Paris Diderot, Paris, France; University of La Laguna, Hospital Universitario de Canarias, La Laguna, Spain; UZ Gent, Ghent, Belgium; UK National Institute for Health Research (NIHR) Leeds Musculoskeletal Biomedical Research Unit, Leeds Teaching Hospitals Trust and Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, Leeds, UK; Charité - Universitätsmedizin Berlin, Department for Rheumatology and Clinical Immunology, Berlin, Germany; Celgene Corp., Summit, New Jersey, USA; Clinical Research Centre Ltd., Tartu, Estonia.M. Cutolo, MD, University of Genoa; G.E. Myerson, MD, Arthritis and Rheumatology of Georgia; R.M. Fleischmann, MD, Metroplex Clinical Research Center; F. Lioté, MD, AP-HP, Hôpital Lariboisière, Université Paris Diderot; F. Diaz-González, MD, University of La Laguna, Hospital Universitario de Canarias; F. Van den Bosch, MD, UZ Gent; H. Marzo-Ortega, MD, NIHR Leeds Musculoskeletal Biomedical Research Unit, Leeds Teaching Hospitals Trust and Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds; E. Feist, MD, Charité - Universitätsmedizin Berlin; K. Shah, MD, Celgene Corp.; C. Hu, EdM, MS, Celgene Corp.; R.M. Stevens, MD, Celgene Corp.; A. Poder, MD, Clinical Research Centre Ltd. mcutolo@unige.it.
2
From the Research Laboratory and Division of Clinical Rheumatology, University of Genoa, Genoa, Italy; Arthritis and Rheumatology of Georgia, Atlanta, Georgia; Metroplex Clinical Research Center, Dallas, Texas, USA; AP-HP, Hôpital Lariboisière, Rheumatology Department, Université Paris Diderot, Paris, France; University of La Laguna, Hospital Universitario de Canarias, La Laguna, Spain; UZ Gent, Ghent, Belgium; UK National Institute for Health Research (NIHR) Leeds Musculoskeletal Biomedical Research Unit, Leeds Teaching Hospitals Trust and Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, Leeds, UK; Charité - Universitätsmedizin Berlin, Department for Rheumatology and Clinical Immunology, Berlin, Germany; Celgene Corp., Summit, New Jersey, USA; Clinical Research Centre Ltd., Tartu, Estonia.M. Cutolo, MD, University of Genoa; G.E. Myerson, MD, Arthritis and Rheumatology of Georgia; R.M. Fleischmann, MD, Metroplex Clinical Research Center; F. Lioté, MD, AP-HP, Hôpital Lariboisière, Université Paris Diderot; F. Diaz-González, MD, University of La Laguna, Hospital Universitario de Canarias; F. Van den Bosch, MD, UZ Gent; H. Marzo-Ortega, MD, NIHR Leeds Musculoskeletal Biomedical Research Unit, Leeds Teaching Hospitals Trust and Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds; E. Feist, MD, Charité - Universitätsmedizin Berlin; K. Shah, MD, Celgene Corp.; C. Hu, EdM, MS, Celgene Corp.; R.M. Stevens, MD, Celgene Corp.; A. Poder, MD, Clinical Research Centre Ltd.

Abstract

OBJECTIVE:

Apremilast, an oral phosphodiesterase 4 inhibitor, downregulates intracellular inflammatory mediator synthesis by elevating cyclic adenosine monophosphate levels. The PALACE 2 trial evaluated apremilast efficacy and safety in patients with active psoriatic arthritis (PsA) despite prior conventional disease-modifying antirheumatic drugs and/or biologic therapy.

METHODS:

Eligible patients were randomized (1:1:1) to placebo, apremilast 20 mg BID, or apremilast 30 mg BID. At Week 16, patients with swollen and tender joint count improvement < 20% entered early escape, with placebo patients rerandomized (1:1) to apremilast 20 mg BID or 30 mg BID while apremilast patients continued on their initial apremilast dose. At Week 24, patients remaining on placebo were rerandomized to apremilast 20 mg BID or 30 mg BID. The primary endpoint was the proportion of patients achieving > 20% improvement in American College of Rheumatology response criteria (ACR20) at Week 16.

RESULTS:

In the intent-to-treat population (N = 484), ACR20 at Week 16 was achieved by more patients receiving apremilast 20 mg BID [37.4% (p = 0.0002)] and 30 mg BID [32.1% (p = 0.0060)] versus placebo (18.9%). Clinically meaningful improvements in signs and symptoms of PsA, physical function, and psoriasis were observed with apremilast through Week 52. The most common adverse events were diarrhea, nausea, headache, and upper respiratory tract infection. Diarrhea and nausea generally occurred early and usually resolved spontaneously with continued treatment. Laboratory abnormalities were infrequent and transient.

CONCLUSION:

Apremilast demonstrated clinical improvements in PsA for up to 52 weeks, including signs and symptoms, physical function, and psoriasis. No new safety signals were observed. ClinicalTrials.gov identifier: NCT01212757.

KEYWORDS:

APREMILAST; PHASE III CLINICAL TRIAL; PHOSPHODIESTERASE 4 INHIBITOR; PSORIASIS; PSORIATIC ARTHRITIS

PMID:
27422893
DOI:
10.3899/jrheum.151376
[Indexed for MEDLINE]

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