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

Kavanaugh A, Mease PJ, Gomez-Reino JJ, Adebajo AO, Wollenhaupt J, Gladman DD, Lespessailles E, Hall S, Hochfeld M, Hu C, Hough D, Stevens RM, Schett G (2014)

Publication Type: Journal article

Publication year: 2014

Journal

Annals of the Rheumatic Diseases BMJ Publishing Group

Publisher: BMJ Publishing Group

Book Volume: 73

Pages Range: 1020-6

Journal Issue: 6

DOI: 10.1136/annrheumdis-2013-205056

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.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.At week 16, significantly more apremilast 20 mg BID (31%) and 30 mg BID (40%) patients achieved ACR20 versus placebo (19%) (p<0.001). Significant improvements in key secondary measures (physical function, psoriasis) were evident with both apremilast doses versus placebo. Across outcome measures, the 30-mg group generally had higher and more consistent response rates, although statistical comparison was not conducted. The most common adverse events were gastrointestinal and generally occurred early, were self-limiting and infrequently led to discontinuation. No imbalance in major adverse cardiac events, serious or opportunistic infections, malignancies or laboratory abnormalities was observed.Apremilast was effective in the treatment of psoriatic arthritis, improving signs and symptoms and physical function. Apremilast demonstrated an acceptable safety profile and was generally well tolerated.NCT01172938.

Authors with CRIS profile

Georg Schett Lehrstuhl für Innere Medizin III

Involved external institutions

University of California, San Diego US United States (USA) (US) Swedish Medical Center US United States (USA) (US) Complejo Hospitalario Universitario de Santiago de Compostela ES Spain (ES) University of Sheffield GB United Kingdom (GB) Schön Klinik Hamburg Eilbek DE Germany (DE) University of Toronto CA Canada (CA) University of Orléans / Université d'Orléans FR France (FR) Monash University AU Australia (AU) Celgene Corporation US United States (USA) (US)

How to cite

APA:

Kavanaugh, A., Mease, P.J., Gomez-Reino, J.J., Adebajo, A.O., Wollenhaupt, J., Gladman, D.D.,... 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), 1020-6. https://doi.org/10.1136/annrheumdis-2013-205056

MLA:

Kavanaugh, Arthur, et al. "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 (2014): 1020-6.

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