PMID- 31077258
OWN - NLM
STAT- MEDLINE
DCOM- 20200527
LR  - 20200527
IS  - 1478-6362 (Electronic)
IS  - 1478-6354 (Print)
IS  - 1478-6354 (Linking)
VI  - 21
IP  - 1
DP  - 2019 May 10
TI  - Long-term experience with apremilast in patients with psoriatic arthritis: 5-year 
      results from a PALACE 1-3 pooled analysis.
PG  - 118
LID - 10.1186/s13075-019-1901-3 [doi]
LID - 118
AB  - BACKGROUND: The efficacy and safety of apremilast were assessed in patients with 
      psoriatic arthritis (PsA) in three phase III clinical trials with similar designs 
      (PALACE 1, 2, and 3). METHODS: Following a 24-week, randomized (1:1:1 to 
      apremilast 30 mg twice daily, 20 mg twice daily, or placebo), double-blind phase 
      and a 28-week blinded active treatment phase, patients could receive apremilast 
      in open-label extension studies for an additional 4 years. Eligible adult 
      patients had active PsA for >/= 6 months and three or more swollen joints and three 
      or more tender joints despite prior treatment with disease-modifying 
      anti-rheumatic drugs. RESULTS: A total of 1493 randomized patients received one 
      or more doses of study medication (placebo: n = 496; apremilast 30 mg twice 
      daily: n = 497; apremilast 20 mg twice daily: n = 500). In patients continuing 
      apremilast treatment, response was sustained without new safety issues. At week 
      260, 67.2% of remaining patients achieved an ACR20 response, and 44.4% and 27.4% 
      achieved ACR50 and ACR70 responses, respectively. Among patients with baseline 
      enthesitis and dactylitis, 62.4% achieved a Maastricht Ankylosing Spondylitis 
      Enthesitis Score of 0 and 80.9% achieved a dactylitis count of 0, respectively. 
      In patients who had >/= 3% baseline psoriasis body surface area involvement, 43.6% 
      achieved >/= 75% reduction from the baseline Psoriasis Area and Severity Index 
      scores. The most commonly reported adverse events (AEs) were diarrhea, nausea, 
      headache, upper respiratory tract infection, and nasopharyngitis, with most 
      diarrhea and nausea AEs occurring within the first 2 weeks of treatment and 
      usually resolving within 4 weeks. Reported rates of depression during the study 
      were low (</= 1.8%). The majority of patients maintained their weight within 5% of 
      baseline during the study. No new safety concerns or increases in the incidence 
      or severity of AEs were observed over the long term. CONCLUSIONS: Apremilast 
      maintained clinical benefit and a favorable safety profile for up to 5 years 
      among patients with PsA. TRIAL REGISTRATION: ClinicalTrials.gov NCT01172938 , 
      NCT01212757 , NCT01212770.
FAU - Kavanaugh, Arthur
AU  - Kavanaugh A
AD  - School of Medicine, University of California San Diego, 9500 Gilman Drive, La 
      Jolla, CA, 92037, USA. akavanaugh@ucsd.edu.
FAU - Gladman, Dafna D
AU  - Gladman DD
AD  - Division of Rheumatology, Krembil Research Institute, Toronto Western Hospital, 
      University of Toronto, Toronto, Ontario, Canada.
FAU - Edwards, Christopher J
AU  - Edwards CJ
AD  - NIHR Wellcome Trust Clinical Research Facility, University Hospital Southampton, 
      Southampton, UK.
FAU - Schett, Georg
AU  - Schett G
AD  - Friedrich-Alexander-Universitat Erlangen-Nurnberg und Universitatsklinikum 
      Erlangen, Erlangen, Germany.
FAU - Guerette, Benoit
AU  - Guerette B
AD  - Celgene Corporation, Summit, NJ, USA.
FAU - Delev, Nikolay
AU  - Delev N
AD  - Celgene Corporation, Summit, NJ, USA.
FAU - Teng, Lichen
AU  - Teng L
AD  - Celgene Corporation, Summit, NJ, USA.
FAU - Paris, Maria
AU  - Paris M
AD  - Celgene Corporation, Summit, NJ, USA.
FAU - Mease, Philip J
AU  - Mease PJ
AD  - Rheumatology Clinical Research Division, Swedish Medical Center/Providence St. 
      Joseph Health and University of Washington, Seattle, WA, USA.
LA  - eng
SI  - ClinicalTrials.gov/NCT01172938
SI  - ClinicalTrials.gov/NCT01212757
SI  - ClinicalTrials.gov/NCT01212770
PT  - Clinical Trial, Phase III
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20190510
PL  - England
TA  - Arthritis Res Ther
JT  - Arthritis research & therapy
JID - 101154438
RN  - 0 (Anti-Inflammatory Agents, Non-Steroidal)
RN  - 4Z8R6ORS6L (Thalidomide)
RN  - UP7QBP99PN (apremilast)
SB  - IM
MH  - Adult
MH  - Anti-Inflammatory Agents, Non-Steroidal/*therapeutic use
MH  - Arthritis, Psoriatic/*drug therapy
MH  - Double-Blind Method
MH  - Female
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Thalidomide/*analogs & derivatives/therapeutic use
MH  - Time
MH  - Treatment Outcome
PMC - PMC6509758
OTO - NOTNLM
OT  - Apremilast
OT  - Drug safety
OT  - Psoriatic arthritis
OT  - Treatment efficacy
COIS- ETHICS APPROVAL AND CONSENT TO PARTICIPATE: The institutional review boards from 
      each participating medical center approved the study protocol for each of the 
      three studies. All patients provided written informed consent before any 
      study-related procedures were conducted. CONSENT FOR PUBLICATION: Not applicable. 
      COMPETING INTERESTS: AK has received grant/research support from Abbott, Amgen, 
      AstraZeneca, BMS, Celgene Corporation, Centocor-Janssen, Pfizer, Roche, and UCB. 
      DDG has received grant/research support from and served as a consultant for 
      AbbVie, Amgen, BMS, Celgene Corporation, Gilead, Janssen, Novartis, Pfizer, and 
      UCB. CJE has received grant/research support from and served as a consultant for 
      AbbVie, BMS, Celgene Corporation, Janssen, Pfizer, Roche, Samsung, Sanofi, and 
      UCB. GS has received grant/research support from and served as a consultant for 
      Abbott, Celgene Corporation, Roche, and UCB. BG, ND, LT, and MP are employees of 
      Celgene Corporation. PJM has received grant/research support from and served as a 
      consultant for Abbott, Amgen, Biogen Idec, BMS, Celgene Corporation, Eli Lilly, 
      Genentech, Janssen, Novartis, Pfizer, and UCB, and has served on speakers bureaus 
      for Abbott, Amgen, Biogen Idec, BMS, Eli Lilly, Genentech, Janssen, Pfizer, and 
      UCB. PUBLISHER'S NOTE: Springer Nature remains neutral with regard to 
      jurisdictional claims in published maps and institutional affiliations.
EDAT- 2019/05/12 06:00
MHDA- 2020/05/28 06:00
PMCR- 2019/05/10
CRDT- 2019/05/12 06:00
PHST- 2018/12/12 00:00 [received]
PHST- 2019/04/18 00:00 [accepted]
PHST- 2019/05/12 06:00 [entrez]
PHST- 2019/05/12 06:00 [pubmed]
PHST- 2020/05/28 06:00 [medline]
PHST- 2019/05/10 00:00 [pmc-release]
AID - 10.1186/s13075-019-1901-3 [pii]
AID - 1901 [pii]
AID - 10.1186/s13075-019-1901-3 [doi]
PST - epublish
SO  - Arthritis Res Ther. 2019 May 10;21(1):118. doi: 10.1186/s13075-019-1901-3.