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Apremilast monotherapy in DMARD-naive psoriatic arthritis patients: results of the randomized, placebo-controlled PALACE 4 trial

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Wells AF1, Edwards CJ2, Kivitz AJ3, Bird P4, Nguyen D5, Paris M5, Teng L5, Aelion JA6. Rheumatology (Oxford). 2018 Apr 4. doi: 10.1093/rheumatology/key032. [Epub ahead of print]

Abstract

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1 Rheumatology and Immunotherapy Center, Franklin, WI, USA.

2 NIHR Wellcome Trust Clinical Research Facility, University Hospital Southampton, Southampton, UK.

3 Altoona Center for Clinical Research, Duncansville, PA, USA.

4 Combined Rheumatology Practice, Kogarah, NSW, Australia.

5 Celgene Corporation, Summit, NJ.

6 West Tennessee Research Institute, Jackson, TN, USA.

Abstract

OBJECTIVES: The PALACE 4 trial evaluated apremilast monotherapy in patients with active PsA who were DMARD-naive.

METHODS: Eligible patients were randomized (1:1:1) to placebo, apremilast 20 mg twice a day or apremilast 30 mg twice a day. At week 16 or 24, placebo patients were rerandomized to apremilast. Double-blind apremilast treatment continued to week 52, with extension up to 4 years. The primary endpoint was the proportion of patients achieving ⩾20% improvement in ACR response criteria (ACR20) at week 16; secondary endpoints included the mean change in the HAQ Disability Index (HAQ-DI) score at week 16.

RESULTS: A total of 527 patients with mean disease duration of 3.4 years and high disease activity were randomized and received treatment. More apremilast patients achieved ACR20 response at week 16 [placebo, 15.9%; 20 mg, 28.0% (P = 0.0062); 30 mg, 30.7% (P = 0.0010)]. The mean HAQ-DI improvements were -0.17 (20 mg; P = 0.0008) and -0.21 (30 mg; P < 0.0001) vs 0.03 (placebo). Both apremilast doses showed significant ACR50 responses vs placebo at week 16 and improvements in secondary efficacy measures (swollen/tender joint counts) and psoriasis assessments, with sustained improvements through week 52. Common adverse events (AEs) over 52 weeks were diarrhoea, nausea, headache and upper respiratory tract infection; most events were mild or moderate. Serious AEs and AEs leading to discontinuation were comparable between groups. Laboratory abnormalities were infrequent and transient.

CONCLUSIONS: In DMARD-naive patients, apremilast monotherapy improved PsA signs/symptoms over 52 weeks and was generally well tolerated.

TRIAL REGISTRATION: ClinicalTrials.gov (http://clinicaltrials.gov), NCT01307423.