PMID- 28573683
OWN - NLM
STAT- MEDLINE
DCOM- 20180619
LR  - 20220330
IS  - 1468-3083 (Electronic)
IS  - 0926-9959 (Print)
IS  - 0926-9959 (Linking)
VI  - 31
IP  - 10
DP  - 2017 Oct
TI  - Omalizumab substantially improves dermatology-related quality of life in patients 
      with chronic spontaneous urticaria.
PG  - 1715-1721
LID - 10.1111/jdv.14384 [doi]
AB  - BACKGROUND: Chronic spontaneous/idiopathic urticaria (CSU/CIU) has substantial 
      detrimental effects on health-related quality of life (HRQoL) with an effect 
      comparable to or worse than many other skin diseases. OBJECTIVE: To assess the 
      effect of omalizumab on CSU patients' HRQoL, measured by the Dermatology Life 
      Quality Index (DLQI) in three phase III studies ASTERIA I, ASTERIA II and 
      GLACIAL. METHODS: A post hoc analysis examined changes in DLQI scores, 
      distribution of patients across DLQI bands and the proportion reaching minimal 
      clinically important difference (MCID) following omalizumab vs. placebo. RESULTS: 
      Omalizumab 300 mg significantly improved total DLQI scores vs. placebo, with a 
      mean decrease from baseline to week 12 of -10.3 vs. -6.1 (P < 0.0001) in ASTERIA 
      I, -10.2 vs. -6.1 (P = 0.0004) in ASTERIA II and -9.7 vs. -5.1 (P < 0.0001) in 
      GLACIAL. A significant shift from high disease impact on life at baseline towards 
      less impact at week 12 was seen with omalizumab 300 mg vs. placebo (P < 0.001; 
      all studies). The proportion of patients where change in mean total DLQI score 
      from baseline to week 12 reached an MCID of >/=4 was 74.1%, 76.0% and 77.2% in 
      ASTERIA I, II and GLACIAL, respectively (P < 0.01; all studies). LIMITATIONS: 
      Maximum duration of omalizumab treatment was 24 weeks. CONCLUSION: This 
      additional analysis assessed the impact of CSU and benefit of treatment with 
      omalizumab by exploring different facets of DLQI data by treatment arm at 
      multiple assessment points. The original aspects of analysis included applying 
      the concept of the recently validated score for the MCID of the DLQI, changes in 
      DLQI domain scores and in the distribution of subjects based on validated total 
      DLQI score bands. It showed consistently that omalizumab provides significant and 
      clinically relevant improvements in many aspects of HRQoL that are important to 
      patients with CSU. These results contribute to a better understanding of the 
      impact of CSU and its treatment on patients and can support clinical 
      decision-making in routine medical practice.
CI  - (c) 2017 The Authors. Journal of the European Academy of Dermatology and 
      Venereology published by John Wiley & Sons Ltd on behalf of European Academy of 
      Dermatology and Venereology.
FAU - Finlay, A Y
AU  - Finlay AY
AD  - Department of Dermatology and Wound Healing, Cardiff University School of 
      Medicine, Cardiff University, Cardiff, UK.
FAU - Kaplan, A P
AU  - Kaplan AP
AD  - Medical University of South Carolina, Charleston, SC, USA.
FAU - Beck, L A
AU  - Beck LA
AD  - Department of Dermatology, University of Rochester Medical Center, Rochester, NY, 
      USA.
FAU - Antonova, E N
AU  - Antonova EN
AD  - Genentech, Inc., South San Francisco, CA, USA.
FAU - Balp, M-M
AU  - Balp MM
AD  - Novartis Pharma AG, Basel, Switzerland.
FAU - Zazzali, J
AU  - Zazzali J
AD  - Genentech, Inc., South San Francisco, CA, USA.
FAU - Khalil, S
AU  - Khalil S
AD  - Novartis Pharma AG, Basel, Switzerland.
FAU - Maurer, M
AU  - Maurer M
AD  - Department of Dermatology and Allergy, Charite - Universitatsmedizin Berlin, 
      Berlin, Germany.
LA  - eng
PT  - Clinical Trial, Phase III
PT  - Journal Article
PT  - Randomized Controlled Trial
DEP - 20170719
PL  - England
TA  - J Eur Acad Dermatol Venereol
JT  - Journal of the European Academy of Dermatology and Venereology : JEADV
JID - 9216037
RN  - 0 (Anti-Allergic Agents)
RN  - 0 (Placebos)
RN  - 2P471X1Z11 (Omalizumab)
SB  - IM
MH  - Adolescent
MH  - Adult
MH  - Aged
MH  - Anti-Allergic Agents/*therapeutic use
MH  - Child
MH  - Chronic Disease
MH  - Double-Blind Method
MH  - Female
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Omalizumab/*therapeutic use
MH  - Placebos
MH  - *Quality of Life
MH  - Urticaria/*drug therapy/physiopathology
MH  - Young Adult
PMC - PMC5697571
EDAT- 2017/06/03 06:00
MHDA- 2018/06/21 06:00
PMCR- 2017/11/21
CRDT- 2017/06/03 06:00
PHST- 2017/03/07 00:00 [received]
PHST- 2017/05/09 00:00 [accepted]
PHST- 2017/06/03 06:00 [pubmed]
PHST- 2018/06/21 06:00 [medline]
PHST- 2017/06/03 06:00 [entrez]
PHST- 2017/11/21 00:00 [pmc-release]
AID - JDV14384 [pii]
AID - 10.1111/jdv.14384 [doi]
PST - ppublish
SO  - J Eur Acad Dermatol Venereol. 2017 Oct;31(10):1715-1721. doi: 10.1111/jdv.14384. 
      Epub 2017 Jul 19.