PMID- 28294430
OWN - NLM
STAT- MEDLINE
DCOM- 20180523
LR  - 20180523
IS  - 1468-3083 (Electronic)
IS  - 0926-9959 (Linking)
VI  - 31
IP  - 9
DP  - 2017 Sep
TI  - Rapid improvements in health-related quality of life and itch with ixekizumab 
      treatment in randomized phase 3 trials: results from UNCOVER-2 and UNCOVER-3.
PG  - 1483-1490
LID - 10.1111/jdv.14211 [doi]
AB  - BACKGROUND: Patients with moderate-to-severe psoriasis report impaired 
      health-related quality of life (HRQoL). OBJECTIVE: To assess speed of onset of 
      ixekizumab-induced clinically relevant improvement in HRQoL. METHODS: This post 
      hoc analysis used pooled data from patients randomized in UNCOVER-2 and 
      UNCOVER-3, and treated with 80 mg ixekizumab every 2 weeks (IXEQ2W), 80 mg 
      ixekizumab every 4 weeks (IXEQ4W), 50 mg etanercept (ETN) twice weekly or placebo 
      (PBO) for 12 weeks. HRQoL and pruritus were assessed using the Dermatology Life 
      Quality Index (DLQI) and Itch Numeric Rating Scale (NRS), respectively. Minimally 
      clinical important differences (MCID) in DLQI and Itch NRS were defined as 
      >/=5-point and >/=4-point improvements from baseline, respectively. Time to response 
      from randomization was estimated using Kaplan-Meier methodology and the log-rank 
      test. Hazard ratios between treatments were calculated using a Cox proportional 
      hazards regression model adjusting for studies. RESULTS: A total of 2570 patients 
      were included: 361 PBO; 740 ETN; 733 IXEQ4W and 736 IXEQ2W. Significantly greater 
      differences in time to DLQI >/=5 point or Itch NRS >/=4 point improvement for IXEQ2W 
      or IXEQ4W compared with ETN and PBO (P < 0.001) were observed. The median time 
      when 50% of patients reached a >/=5-point reduction in DLQI was shorter for 
      ixekizumab-treated patients (2 weeks, both schedules) compared with ETN- 
      (4 weeks) or PBO-treated (>12 weeks) patients. Likewise, the median time when 50% 
      of patients reached a >/=4-point reduction in Itch NRS was shorter for 
      ixekizumab-treated patients (2 weeks, both schedules) compared with ETN- 
      (8 weeks) or PBO-treated (>12 weeks) patients. Significantly more 
      ixekizumab-treated patients were likely to achieve MCIDs in DLQI or itch 
      reduction compared with ETN or PBO after 12 weeks of treatment. CONCLUSION: 
      Ixekizumab-treated patients achieved more rapid improvements both in HRQoL and 
      itch compared with patients treated with ETN and PBO.
CI  - (c) 2017 European Academy of Dermatology and Venereology.
FAU - Leonardi, C L
AU  - Leonardi CL
AD  - Central Dermatology, St Louis, MO, USA.
FAU - Blauvelt, A
AU  - Blauvelt A
AD  - Oregon Medical Research Center, Portland, OR, USA.
FAU - Sofen, H L
AU  - Sofen HL
AD  - Department of Medicine (Dermatology), David Geffen School of Medicine, Los 
      Angeles, CA, USA.
FAU - Gooderham, M
AU  - Gooderham M
AD  - SKiN Centre for Dermatology and Queen's University, Peterborough, ON, Canada.
FAU - Augustin, M
AU  - Augustin M
AD  - Institute for Health Services Research in Dermatology and Nursing, University 
      Medical Center Hamburg, Hamburg, Germany.
FAU - Burge, R
AU  - Burge R
AD  - Eli Lilly and Company, Indianapolis, IN, USA.
AD  - University of Cincinnati, Cincinnati, OH, USA.
FAU - Zhu, B
AU  - Zhu B
AD  - Eli Lilly and Company, Indianapolis, IN, USA.
FAU - Reich, K
AU  - Reich K
AD  - Dermatologikum Hamburg and SCIderm Research Institute, Hamburg, Germany.
LA  - eng
PT  - Clinical Trial, Phase III
PT  - Journal Article
PT  - Randomized Controlled Trial
DEP - 20170628
PL  - England
TA  - J Eur Acad Dermatol Venereol
JT  - Journal of the European Academy of Dermatology and Venereology : JEADV
JID - 9216037
RN  - 0 (Antibodies, Monoclonal, Humanized)
RN  - 0 (Dermatologic Agents)
RN  - 0 (Placebos)
RN  - BTY153760O (ixekizumab)
RN  - OP401G7OJC (Etanercept)
SB  - IM
MH  - Adult
MH  - Antibodies, Monoclonal, Humanized/*therapeutic use
MH  - Dermatologic Agents/*therapeutic use
MH  - Etanercept/therapeutic use
MH  - Female
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Placebos
MH  - Pruritus/*drug therapy/physiopathology
MH  - *Quality of Life
EDAT- 2017/03/16 06:00
MHDA- 2018/05/24 06:00
CRDT- 2017/03/16 06:00
PHST- 2016/09/26 00:00 [received]
PHST- 2017/02/13 00:00 [accepted]
PHST- 2017/03/16 06:00 [pubmed]
PHST- 2018/05/24 06:00 [medline]
PHST- 2017/03/16 06:00 [entrez]
AID - 10.1111/jdv.14211 [doi]
PST - ppublish
SO  - J Eur Acad Dermatol Venereol. 2017 Sep;31(9):1483-1490. doi: 10.1111/jdv.14211. 
      Epub 2017 Jun 28.