PMID- 28391657
OWN - NLM
STAT- MEDLINE
DCOM- 20180430
LR  - 20181113
IS  - 1346-8138 (Electronic)
IS  - 0385-2407 (Print)
IS  - 0385-2407 (Linking)
VI  - 44
IP  - 8
DP  - 2017 Aug
TI  - Apremilast, an oral phosphodiesterase 4 inhibitor, in the treatment of Japanese 
      patients with moderate to severe plaque psoriasis: Efficacy, safety and 
      tolerability results from a phase 2b randomized controlled trial.
PG  - 873-884
LID - 10.1111/1346-8138.13829 [doi]
AB  - Apremilast, an oral, small-molecule phosphodiesterase 4 inhibitor, works 
      intracellularly within immune cells to regulate inflammatory mediators. This 
      phase 2b randomized, placebo-controlled study evaluated efficacy and safety of 
      apremilast among Japanese patients with moderate to severe plaque psoriasis. In 
      total, 254 patients were randomized to placebo, apremilast 20 mg b.i.d. 
      (apremilast 20) or apremilast 30 mg b.i.d. (apremilast 30) through week 16; 
      thereafter, all placebo patients were re-randomized to apremilast 20 or 30 
      through week 68. Efficacy assessments included achievement of 75% or more 
      reduction from baseline in Psoriasis Area and Severity Index score (PASI-75; 
      primary) and achievement of static Physician Global Assessment (sPGA; secondary) 
      score of 0 (clear) or 1 (minimal) at week 16. Safety was assessed through week 
      68. At week 16, PASI-75 response rates were 7.1% (placebo), 23.5% (apremilast 20; 
      P = 0.0032 vs placebo) and 28.2% (apremilast 30; P = 0.0003 vs placebo); sPGA 
      response rates (score of 0 or 1) were 8.8% (placebo), 23.9% (apremilast 20; P = 
      0.0165 vs placebo) and 29.6% (apremilast 30; P = 0.0020 vs placebo). Responses 
      were maintained with apremilast through week 68. Most common adverse events (AEs) 
      with placebo, apremilast 20 and apremilast 30 (0-16 weeks) were nasopharyngitis 
      (8.3%, 11.8%, 11.8%), diarrhea (1.2%, 8.2%, 9.4%), and abdominal discomfort 
      (1.2%, 1.2%, 7.1%), respectively. Exposure-adjusted incidence of these AEs did 
      not increase with continued apremilast treatment (up to 68 weeks). Apremilast 
      demonstrated efficacy and safety in Japanese patients with moderate to severe 
      plaque psoriasis through 68 weeks that was generally consistent with prior 
      studies.
CI  - (c) 2017 The Authors. The Journal of Dermatology published by John Wiley & Sons 
      Australia, Ltd on behalf of Japanese Dermatological Association.
FAU - Ohtsuki, Mamitaro
AU  - Ohtsuki M
AD  - Jichi Medical University, Shimotsuke, Japan.
FAU - Okubo, Yukari
AU  - Okubo Y
AD  - Tokyo Medical University, Tokyo, Japan.
FAU - Komine, Mayumi
AU  - Komine M
AD  - Jichi Medical University, Shimotsuke, Japan.
FAU - Imafuku, Shinichi
AU  - Imafuku S
AD  - Fukuoka University, Fukuoka, Japan.
FAU - Day, Robert M
AU  - Day RM
AD  - Celgene Corporation, Summit, New Jersey, USA.
FAU - Chen, Peng
AU  - Chen P
AD  - Celgene Corporation, Summit, New Jersey, USA.
FAU - Petric, Rosemary
AU  - Petric R
AD  - Celgene Corporation, Summit, New Jersey, USA.
FAU - Maroli, Allan
AU  - Maroli A
AD  - Celgene Corporation, Summit, New Jersey, USA.
FAU - Nemoto, Osamu
AU  - Nemoto O
AD  - Kojinkai Sapporo Skin Clinic, Sapporo, Japan.
LA  - eng
PT  - Clinical Trial, Phase II
PT  - Journal Article
PT  - Randomized Controlled Trial
DEP - 20170409
PL  - England
TA  - J Dermatol
JT  - The Journal of dermatology
JID - 7600545
RN  - 0 (Anti-Inflammatory Agents, Non-Steroidal)
RN  - 0 (Phosphodiesterase 4 Inhibitors)
RN  - 0 (Placebos)
RN  - 4Z8R6ORS6L (Thalidomide)
RN  - UP7QBP99PN (apremilast)
SB  - IM
MH  - Administration, Oral
MH  - Adult
MH  - Anti-Inflammatory Agents, Non-Steroidal/pharmacology/*therapeutic use
MH  - Diarrhea/chemically induced/epidemiology
MH  - Dose-Response Relationship, Drug
MH  - Double-Blind Method
MH  - Female
MH  - Humans
MH  - Incidence
MH  - Japan
MH  - Male
MH  - Middle Aged
MH  - Nasopharyngitis/chemically induced/epidemiology
MH  - Phosphodiesterase 4 Inhibitors/pharmacology/*therapeutic use
MH  - Placebos
MH  - Psoriasis/*drug therapy/pathology
MH  - Severity of Illness Index
MH  - Thalidomide/*analogs & derivatives/pharmacology/therapeutic use
MH  - Treatment Outcome
PMC - PMC5573969
OTO - NOTNLM
OT  - Psoriasis Area and Severity Index
OT  - apremilast
OT  - phosphodiesterase 4
OT  - phosphodiesterase 4 inhibitor
OT  - psoriasis
EDAT- 2017/04/10 06:00
MHDA- 2018/05/01 06:00
PMCR- 2017/08/29
CRDT- 2017/04/10 06:00
PHST- 2017/01/16 00:00 [received]
PHST- 2017/02/06 00:00 [accepted]
PHST- 2017/04/10 06:00 [pubmed]
PHST- 2018/05/01 06:00 [medline]
PHST- 2017/04/10 06:00 [entrez]
PHST- 2017/08/29 00:00 [pmc-release]
AID - JDE13829 [pii]
AID - 10.1111/1346-8138.13829 [doi]
PST - ppublish
SO  - J Dermatol. 2017 Aug;44(8):873-884. doi: 10.1111/1346-8138.13829. Epub 2017 Apr 
      9.