PMID- 28416342
OWN - NLM
STAT- MEDLINE
DCOM- 20170825
LR  - 20220408
IS  - 1097-6787 (Electronic)
IS  - 0190-9622 (Linking)
VI  - 77
IP  - 2
DP  - 2017 Aug
TI  - Long-term safety and tolerability of apremilast in patients with psoriasis: 
      Pooled safety analysis for >/=156 weeks from 2 phase 3, randomized, controlled 
      trials (ESTEEM 1 and 2).
PG  - 310-317.e1
LID - S0190-9622(17)30146-9 [pii]
LID - 10.1016/j.jaad.2017.01.052 [doi]
AB  - BACKGROUND: Randomized, controlled trials demonstrated efficacy and safety of 
      apremilast for moderate-to-severe plaque psoriasis and psoriatic arthritis. 
      OBJECTIVE: Assess long-term safety of oral apremilast in psoriasis patients. 
      METHODS: Safety findings are reported for 0 to >/=156 weeks from the Efficacy and 
      Safety Trial Evaluating the Effects of Apremilast in Psoriasis (ESTEEM) 1 and 2. 
      RESULTS: The 0 to >/=156-week apremilast-exposure period included 1184 patients 
      treated twice daily with apremilast 30 mg (1902.2 patient-years). During 0 to 
      </=52 weeks, the adverse events (AEs) that occurred in >/=5% of patients included 
      diarrhea, nausea, upper respiratory tract infection, nasopharyngitis, tension 
      headache, and headache. From 0 to >/=156 weeks, no new AEs (affecting >/=5% of the 
      population) were reported. AEs, serious AEs, and study drug discontinuations 
      caused by AEs did not increase with long-term exposure. During the 0 to >/=156-week 
      period, the rates of major cardiac events (exposure-adjusted incidence 
      rate [EAIR] 0.5/100 patient-years), malignancies (EAIR 1.2/100 patient-years), 
      depression (EAIR 1.8/100 patient-years), or suicide attempts (EAIR 0.1/100 
      patient-years) did not increase in comparison with the rates found during the 0 
      to </=52-week period. No serious opportunistic infections, reactivation of 
      tuberculosis, or clinically meaningful effects on laboratory measurements were 
      reported. LIMITATIONS: This study had a high dropout rate (21% of patients 
      ongoing >156 weeks); most were unrelated to safety concerns. CONCLUSIONS: 
      Apremilast demonstrated an acceptable safety profile and was generally well 
      tolerated for >/=156 weeks.
CI  - Copyright (c) 2017 American Academy of Dermatology, Inc. Published by Elsevier Inc. 
      All rights reserved.
FAU - Crowley, Jeffrey
AU  - Crowley J
AD  - Bakersfield Dermatology, Bakersfield, California. Electronic address: 
      Crowley415@aol.com.
FAU - Thaci, Diamant
AU  - Thaci D
AD  - Comprehensive Center for Inflammation Medicine, University Hospital 
      Schleswig-Holstein, Campus Lubeck, Germany.
FAU - Joly, Pascal
AU  - Joly P
AD  - Department of Dermatology, Hopital Charles Nicolle, Universite de Rouen, Rouen, 
      France; Institut National de la Sante et de la Recherche Medicale U519, Rouen, 
      France.
FAU - Peris, Ketty
AU  - Peris K
AD  - Catholic University of Rome, Rome, Italy.
FAU - Papp, Kim A
AU  - Papp KA
AD  - Probity Medical Research, Waterloo, Ontario, Canada.
FAU - Goncalves, Joana
AU  - Goncalves J
AD  - Celgene Corporation, Summit, New Jersy.
FAU - Day, Robert M
AU  - Day RM
AD  - Celgene Corporation, Summit, New Jersy.
FAU - Chen, Rongdean
AU  - Chen R
AD  - Celgene Corporation, Summit, New Jersy.
FAU - Shah, Kamal
AU  - Shah K
AD  - Celgene Corporation, Summit, New Jersy.
FAU - Ferrandiz, Carlos
AU  - Ferrandiz C
AD  - Hospital Universitario Germans Trias i Pujol, Badalona, Universidad Autonoma de 
      Barcelona, Barcelona, Spain.
FAU - Cather, Jennifer C
AU  - Cather JC
AD  - Modern Research Associates, Dallas, Texas.
LA  - eng
PT  - Clinical Trial, Phase III
PT  - Journal Article
PT  - Randomized Controlled Trial
DEP - 20170414
PL  - United States
TA  - J Am Acad Dermatol
JT  - Journal of the American Academy of Dermatology
JID - 7907132
RN  - 0 (Anti-Inflammatory Agents, Non-Steroidal)
RN  - 4Z8R6ORS6L (Thalidomide)
RN  - UP7QBP99PN (apremilast)
SB  - IM
MH  - Adult
MH  - Anti-Inflammatory Agents, Non-Steroidal/*adverse effects
MH  - Cardiovascular Diseases/*epidemiology
MH  - Depression/*epidemiology
MH  - Diarrhea/chemically induced
MH  - Female
MH  - Headache/chemically induced
MH  - Humans
MH  - Incidence
MH  - Male
MH  - Middle Aged
MH  - Nasopharyngitis/chemically induced
MH  - Nausea/chemically induced
MH  - Neoplasms/*epidemiology
MH  - Psoriasis/*drug therapy
MH  - Respiratory Tract Infections/chemically induced
MH  - Suicide, Attempted/statistics & numerical data
MH  - Tension-Type Headache/chemically induced
MH  - Thalidomide/adverse effects/*analogs & derivatives
MH  - Time Factors
OTO - NOTNLM
OT  - ESTEEM
OT  - apremilast
OT  - clinical trial
OT  - phosphodiesterase 4 inhibitor
OT  - psoriasis
OT  - psoriatic arthritis
OT  - safety
EDAT- 2017/04/19 06:00
MHDA- 2017/08/26 06:00
CRDT- 2017/04/19 06:00
PHST- 2016/10/27 00:00 [received]
PHST- 2017/01/27 00:00 [revised]
PHST- 2017/01/30 00:00 [accepted]
PHST- 2017/04/19 06:00 [pubmed]
PHST- 2017/08/26 06:00 [medline]
PHST- 2017/04/19 06:00 [entrez]
AID - S0190-9622(17)30146-9 [pii]
AID - 10.1016/j.jaad.2017.01.052 [doi]
PST - ppublish
SO  - J Am Acad Dermatol. 2017 Aug;77(2):310-317.e1. doi: 10.1016/j.jaad.2017.01.052. 
      Epub 2017 Apr 14.