PMID- 22806399
OWN - NLM
STAT- MEDLINE
DCOM- 20130116
LR  - 20220409
IS  - 1529-0131 (Electronic)
IS  - 0004-3591 (Linking)
VI  - 64
IP  - 10
DP  - 2012 Oct
TI  - Oral apremilast in the treatment of active psoriatic arthritis: results of a 
      multicenter, randomized, double-blind, placebo-controlled study.
PG  - 3156-67
LID - 10.1002/art.34627 [doi]
AB  - OBJECTIVE: To evaluate the efficacy and safety of apremilast, a novel, orally 
      available small molecule that specifically targets phosphodiesterase 4, in the 
      treatment of active psoriatic arthritis (PsA). METHODS: This phase II, 
      multicenter, randomized, double-blind, placebo-controlled study included the 
      following: a 12-week treatment phase, with patients receiving placebo, apremilast 
      20 mg twice per day, or apremilast 40 mg once per day; a 12-week 
      treatment-extension phase, with patients in the placebo group re-randomized to 
      receive apremilast; and a 4-week observational phase after treatment cessation. 
      The primary end point was the proportion of patients achieving the American 
      College of Rheumatology criteria for 20% improvement (ACR20) at week 12. Safety 
      assessments included adverse events (AEs), physical examinations, vital signs, 
      laboratory parameters, and electrocardiograms. RESULTS: Of the 204 patients with 
      PsA who were randomized to a treatment group, 165 completed the treatment phase. 
      At the end of the treatment phase (week 12), 43.5% of patients receiving 
      apremilast 20 mg twice per day (P < 0.001) and 35.8% of those receiving 40 mg 
      once per day (P = 0.002) achieved an ACR20 response, compared with 11.8% of those 
      receiving placebo. At the end of the treatment-extension phase (week 24), >40% of 
      patients in each group (patients receiving apremilast 20 mg twice per day, 
      patients receiving apremilast 40 mg once per day, and patients in the placebo 
      group re-randomized to receive apremilast) achieved the ACR20 level of 
      improvement. Most patients in the treatment phase (84.3%) and treatment-extension 
      phase (68.3%) reported >/= 1 AE. Diarrhea, headache, nausea, fatigue, and 
      nasopharyngitis were reported most frequently; most events were mild or moderate. 
      No clinically relevant laboratory or electrocardiographic abnormalities were 
      reported. CONCLUSION: Treatment with apremilast at a dosage of 20 mg twice per 
      day or 40 mg once per day demonstrated efficacy in comparison with placebo and 
      was generally well tolerated in patients with active PsA. The balance of 
      efficacy, tolerability, and safety supports further study of apremilast in PsA.
CI  - Copyright (c) 2012 by the American College of Rheumatology.
FAU - Schett, Georg
AU  - Schett G
AD  - University of Erlangen-Nuremberg, Erlangen, Germany. georg.schett@uk-erlangen.de
FAU - Wollenhaupt, Jurgen
AU  - Wollenhaupt J
FAU - Papp, Kim
AU  - Papp K
FAU - Joos, Rik
AU  - Joos R
FAU - Rodrigues, Jude F
AU  - Rodrigues JF
FAU - Vessey, Adele R
AU  - Vessey AR
FAU - Hu, ChiaChi
AU  - Hu C
FAU - Stevens, Randall
AU  - Stevens R
FAU - de Vlam, Kurt L
AU  - de Vlam KL
LA  - eng
SI  - ClinicalTrials.gov/NCT00456092
PT  - Clinical Trial, Phase II
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
PL  - United States
TA  - Arthritis Rheum
JT  - Arthritis and rheumatism
JID - 0370605
RN  - 0 (Antirheumatic Agents)
RN  - 4Z8R6ORS6L (Thalidomide)
RN  - UP7QBP99PN (apremilast)
RN  - YL5FZ2Y5U1 (Methotrexate)
SB  - IM
MH  - Administration, Oral
MH  - Antirheumatic Agents/administration & dosage/*therapeutic use
MH  - Arthritis, Psoriatic/*drug therapy
MH  - Dose-Response Relationship, Drug
MH  - Double-Blind Method
MH  - Drug Therapy, Combination
MH  - Female
MH  - Humans
MH  - Male
MH  - Methotrexate/administration & dosage/therapeutic use
MH  - Middle Aged
MH  - Thalidomide/administration & dosage/*analogs & derivatives/therapeutic use
MH  - Treatment Outcome
EDAT- 2012/07/19 06:00
MHDA- 2013/01/17 06:00
CRDT- 2012/07/19 06:00
PHST- 2012/07/19 06:00 [entrez]
PHST- 2012/07/19 06:00 [pubmed]
PHST- 2013/01/17 06:00 [medline]
AID - 10.1002/art.34627 [doi]
PST - ppublish
SO  - Arthritis Rheum. 2012 Oct;64(10):3156-67. doi: 10.1002/art.34627.