PMID- 18657960
OWN - NLM
STAT- MEDLINE
DCOM- 20090506
LR  - 20151119
IS  - 1532-3064 (Electronic)
IS  - 0954-6111 (Linking)
VI  - 102
IP  - 10
DP  - 2008 Oct
TI  - Effectiveness of omalizumab in patients with inadequately controlled severe 
      persistent allergic asthma: an open-label study.
PG  - 1371-8
LID - 10.1016/j.rmed.2008.06.002 [doi]
AB  - BACKGROUND: In a 1-year, randomized, open-label study in patients with 
      moderate-to-severe allergic (immunoglobulin E (IgE)-mediated) asthma, adding 
      omalizumab to best standard care (BSC) significantly improved efficacy outcomes 
      compared with BSC alone (control). We assessed the efficacy of omalizumab in the 
      subgroup of patients with inadequately controlled severe persistent allergic 
      asthma despite high-dose inhaled corticosteroids (ICS) plus a long-acting 
      beta(2)-agonist (LABA), which reflects the European Union (EU) label population. 
      METHODS: Efficacy outcomes included annual asthma exacerbation rate, annual 
      asthma deterioration-related incident (ADRI) rate, % predicted forced expiratory 
      volume in 1 s (FEV(1)), asthma symptoms (Wasserfallen score) and quality of life 
      (Mini Asthma Quality of Life Questionnaire (Mini-AQLQ)), which were compared in 
      the omalizumab and control groups. Outcomes were also determined for 
      omalizumab-treated patients judged to have responded to therapy (> or = 0.5-point 
      improvement in Mini-AQLQ overall score at 27 weeks). RESULTS: In total, 164 
      patients (omalizumab, n=115; control, n=49) were receiving high-dose ICS plus a 
      LABA. Annual asthma exacerbation rate was significantly reduced by 59% in the 
      omalizumab group vs. control (1.26 vs. 3.06; P<0.001). ADRI rate was 
      significantly reduced by 40% in the omalizumab group compared with control (5.61 
      vs. 9.40; P<0.05). Significant improvements were also seen in % predicted FEV(1) 
      (71% vs. 60%; P<0.001), change from baseline in asthma symptom scores (-6.7 vs. 
      0.5; P<0.05) and Mini-AQLQ overall score (1.32 vs. 0.17; P<0.001). In 
      omalizumab-treated patients, 71/102 (70%) were judged to have responded to 
      therapy. In these Mini-AQLQ-assessed responders, exacerbation rate was reduced by 
      64% vs. control (1.12 vs. 3.06; P<0.001), ADRI rate was reduced by 50% vs. 
      control (4.71 vs. 9.40; P<0.01). Percent predicted FEV(1) (73% vs. 60%; P<0.001), 
      change from baseline in asthma symptom scores (-8.1 vs. 0.5; P<0.001) and 
      Mini-AQLQ overall score (1.81 vs. 0.17; P<0.001) were also further significantly 
      improved vs. control. CONCLUSIONS: Adding omalizumab to BSC is efficacious in 
      patients with inadequately controlled severe persistent allergic asthma despite 
      high-dose ICS plus a LABA (EU label population), with further efficacy observed 
      in patients judged to have responded to therapy which may more accurately 
      illustrate the actual benefit of omalizumab therapy in clinical practice. The 
      naturalistic setting of this study confirms the benefits observed in double-blind 
      randomized clinical trials.
FAU - Niven, R
AU  - Niven R
AD  - North West Lung Centre, Wythenshawe Hospital, Southmoor Road, Manchester, M23 
      9LT, UK. robert.niven@smuht.nwest.nhs.uk
FAU - Chung, K F
AU  - Chung KF
FAU - Panahloo, Z
AU  - Panahloo Z
FAU - Blogg, M
AU  - Blogg M
FAU - Ayre, G
AU  - Ayre G
LA  - eng
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20080726
PL  - England
TA  - Respir Med
JT  - Respiratory medicine
JID - 8908438
RN  - 0 (Adrenergic beta-Agonists)
RN  - 0 (Anti-Asthmatic Agents)
RN  - 0 (Antibodies, Anti-Idiotypic)
RN  - 0 (Antibodies, Monoclonal)
RN  - 0 (Antibodies, Monoclonal, Humanized)
RN  - 0 (Glucocorticoids)
RN  - 2P471X1Z11 (Omalizumab)
RN  - 37341-29-0 (Immunoglobulin E)
SB  - IM
MH  - Adolescent
MH  - Adrenergic beta-Agonists/therapeutic use
MH  - Adult
MH  - Aged
MH  - Analysis of Variance
MH  - Anti-Asthmatic Agents/*therapeutic use
MH  - Antibodies, Anti-Idiotypic
MH  - Antibodies, Monoclonal/*therapeutic use
MH  - Antibodies, Monoclonal, Humanized
MH  - Asthma/*drug therapy/immunology/physiopathology
MH  - Child
MH  - Drug Therapy, Combination
MH  - European Union
MH  - Female
MH  - Forced Expiratory Volume
MH  - Glucocorticoids/therapeutic use
MH  - Humans
MH  - Hypersensitivity/*drug therapy/immunology/physiopathology
MH  - Immunoglobulin E/immunology
MH  - Lung/physiopathology
MH  - Male
MH  - Middle Aged
MH  - Omalizumab
MH  - Regression Analysis
MH  - Treatment Outcome
EDAT- 2008/07/29 09:00
MHDA- 2009/05/07 09:00
CRDT- 2008/07/29 09:00
PHST- 2007/09/28 00:00 [received]
PHST- 2008/05/29 00:00 [revised]
PHST- 2008/06/04 00:00 [accepted]
PHST- 2008/07/29 09:00 [pubmed]
PHST- 2009/05/07 09:00 [medline]
PHST- 2008/07/29 09:00 [entrez]
AID - S0954-6111(08)00203-5 [pii]
AID - 10.1016/j.rmed.2008.06.002 [doi]
PST - ppublish
SO  - Respir Med. 2008 Oct;102(10):1371-8. doi: 10.1016/j.rmed.2008.06.002. Epub 2008 
      Jul 26.