Treatment of psoriatic arthritis in a phase 3 randomised, placebo-controlled trial with apremilast, an oral phosphodiesterase 4 inhibitor

Arthur F Kavanaugh, Philip J Mease, Juan Jesus Gomez-Reino, Adewale O Adebajo, Jurgen Wollenhaupt, Dafna D Gladman, Eric Lespessailles, Stephen Hall, Marla Hochfeld, ChiaChi Hu, Douglas Hough, Randall M Stevens, Georg Schett

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Abstract

Apremilast, an oral phosphodiesterase 4 inhibitor, regulates inflammatory mediators. Psoriatic Arthritis Long-term Assessment of Clinical Efficacy 1 (PALACE 1) compared apremilast with placebo in patients with active psoriatic arthritis despite prior traditional disease-modifying antirheumatic drug (DMARD) and/or biologic therapy. Methods: In the 24-week, placebo-controlled phase of PALACE 1, patients (N=504) were randomised (1:1:1) to placebo, apremilast 20 mg twice a day (BID) or apremilast 30 mg BID. At week 16, patients without =20 reduction in swollen and tender joint counts were required to be re-randomised equally to either apremilast dose if initially randomised to placebo or remained on their initial apremilast dose. Patients on background concurrent DMARDs continued stable doses (methotrexate, leflunomide and/or sulfasalazine). Primary outcome was the proportion of patients achieving 20 improvement in modified American College of Rheumatology response criteria (ACR20) at week 16. Results: At week 16, significantly more apremilast 20 mg BID (31 ) and 30 mg BID (40 ) patients achieved ACR20 versus placebo (19 ) (p
Original languageEnglish
Pages (from-to)1020 - 1026
Number of pages7
JournalAnnals of the Rheumatic Diseases
Volume73
Issue number6
DOIs
Publication statusPublished - 2014

Cite this

Kavanaugh, A. F., Mease, P. J., Gomez-Reino, J. J., Adebajo, A. O., Wollenhaupt, J., Gladman, D. D., Lespessailles, E., Hall, S., Hochfeld, M., Hu, C., Hough, D., Stevens, R. M., & Schett, G. (2014). Treatment of psoriatic arthritis in a phase 3 randomised, placebo-controlled trial with apremilast, an oral phosphodiesterase 4 inhibitor. Annals of the Rheumatic Diseases, 73(6), 1020 - 1026. https://doi.org/10.1136/annrheumdis-2013-205056