PMID- 29635379
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20200306
IS  - 1462-0332 (Electronic)
IS  - 1462-0324 (Print)
IS  - 1462-0324 (Linking)
VI  - 57
IP  - 7
DP  - 2018 Jul 1
TI  - Apremilast monotherapy in DMARD-naive psoriatic arthritis patients: results of 
      the randomized, placebo-controlled PALACE 4 trial.
PG  - 1253-1263
LID - 10.1093/rheumatology/key032 [doi]
AB  - 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.
CI  - (c) The Author(s) 2018. Published by Oxford University Press on behalf of the 
      British Society for Rheumatology.
FAU - Wells, Alvin F
AU  - Wells AF
AD  - Rheumatology and Immunotherapy Center, Franklin, WI, USA.
FAU - Edwards, Christopher J
AU  - Edwards CJ
AD  - NIHR Wellcome Trust Clinical Research Facility, University Hospital Southampton, 
      Southampton, UK.
FAU - Kivitz, Alan J
AU  - Kivitz AJ
AD  - Altoona Center for Clinical Research, Duncansville, PA, USA.
FAU - Bird, Paul
AU  - Bird P
AD  - Combined Rheumatology Practice, Kogarah, NSW, Australia.
FAU - Nguyen, Dianne
AU  - Nguyen D
AD  - Celgene Corporation, Summit, NJ, USA.
FAU - Paris, Maria
AU  - Paris M
AD  - Celgene Corporation, Summit, NJ, USA.
FAU - Teng, Lichen
AU  - Teng L
AD  - Celgene Corporation, Summit, NJ, USA.
FAU - Aelion, Jacob A
AU  - Aelion JA
AD  - West Tennessee Research Institute, Jackson, TN, USA.
LA  - eng
SI  - ClinicalTrials.gov/NCT01307423
PT  - Journal Article
PL  - England
TA  - Rheumatology (Oxford)
JT  - Rheumatology (Oxford, England)
JID - 100883501
SB  - IM
PMC - PMC6014136
OTO - NOTNLM
OT  - apremilast
OT  - monotherapy
OT  - phase III clinical trial
OT  - phosphodiesterase 4 inhibitor
OT  - psoriatic arthritis
EDAT- 2018/04/11 06:00
MHDA- 2018/04/11 06:01
PMCR- 2018/04/04
CRDT- 2018/04/11 06:00
PHST- 2017/06/19 00:00 [received]
PHST- 2018/01/26 00:00 [revised]
PHST- 2018/04/11 06:00 [pubmed]
PHST- 2018/04/11 06:01 [medline]
PHST- 2018/04/11 06:00 [entrez]
PHST- 2018/04/04 00:00 [pmc-release]
AID - 4960028 [pii]
AID - key032 [pii]
AID - 10.1093/rheumatology/key032 [doi]
PST - ppublish
SO  - Rheumatology (Oxford). 2018 Jul 1;57(7):1253-1263. doi: 
      10.1093/rheumatology/key032.