PMID- 15571425
OWN - NLM
STAT- MEDLINE
DCOM- 20050316
LR  - 20181025
IS  - 1173-8804 (Print)
IS  - 1173-8804 (Linking)
VI  - 18
IP  - 6
DP  - 2004
TI  - Spotlight on omalizumab in allergic asthma.
PG  - 415-8
AB  - Omalizumab (Xolair) is a humanized monoclonal antibody used in the treatment of 
      adolescent and adult patients with moderate to severe allergic asthma 
      inadequately controlled with inhaled corticosteroids (ICS). It selectively binds 
      to circulating immunoglobulin E (IgE) and, thereby, prevents binding of IgE to 
      mast cells and other effector cells. Without surface-bound IgE, these cells are 
      unable to recognize allergens, thus preventing cellular activation by antigens 
      and the subsequent allergic/asthmatic symptoms. Omalizumab decreases free serum 
      IgE levels in a dose-dependent manner, reduces IgE receptor density on effector 
      cells, and significantly improves airway inflammation parameters. Omalizumab is 
      slowly absorbed after subcutaneous administration, and mean elimination half-life 
      is 26 days, thus allowing infrequent administration of the drug. Omalizumab 
      dosage is determined by bodyweight and pretreatment serum total IgE levels. 
      Patients treated with subcutaneous omalizumab in clinical trials received a 
      dosage that was approximately equal to 0.016 mg/kg/IgE (IU/mL) per 4 weeks. Thus, 
      patients received 150 or 300 mg every 4 weeks, or 225, 300, or 375 mg every 2 
      weeks. In adults and adolescents (> or = 12 years of age) with moderate to severe 
      allergic asthma, subcutaneous administration of omalizumab as add-on therapy with 
      ICS improved the number of asthma exacerbations, rescue medication use, asthma 
      symptom scores, and quality-of-life (QOL) scores compared with placebo during 28- 
      and 32-week double-blind trials. In addition, concomitant ICS use was 
      significantly decreased in patients receiving omalizumab, and in the two largest 
      double-blind trials approximately 40% of omalizumab recipients completely 
      withdrew from ICS therapy while maintaining effective asthma control. In general, 
      results of extension studies showed that the beneficial effects of omalizumab 
      were maintained over a total period of 52 weeks. Omalizumab was well tolerated as 
      add-on therapy with ICS during treatment for up to 52 weeks. Common adverse 
      events in clinical trials included injection site reaction, viral infection, 
      upper respiratory tract infection, sinusitis, headache, and pharyngitis, although 
      the incidence of adverse events with omalizumab was similar to that with placebo. 
      In conclusion, omalizumab, as add-on therapy with ICS, is an effective and well 
      tolerated agent for the treatment of moderate to severe allergic asthma in 
      adolescents and adults. In addition to its symptomatic and QOL benefits, 
      omalizumab therapy allows ICS dosage reduction or discontinuation of ICS in many 
      patients. Comparisons of omalizumab with other asthma therapies have yet to be 
      conducted; however, clinical efficacy and tolerability data indicate that 
      omalizumab is a valuable option in the treatment of allergic asthma.
FAU - Bang, Lynne M
AU  - Bang LM
AD  - Adis International Limited, 770 Township Line Road, Yardley, PA 19047, USA.
FAU - Plosker, Greg L
AU  - Plosker GL
LA  - eng
PT  - Journal Article
PT  - Review
PL  - New Zealand
TA  - BioDrugs
JT  - BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy
JID - 9705305
RN  - 0 (Anti-Asthmatic Agents)
RN  - 0 (Antibodies, Anti-Idiotypic)
RN  - 0 (Antibodies, Monoclonal)
RN  - 0 (Antibodies, Monoclonal, Humanized)
RN  - 2P471X1Z11 (Omalizumab)
SB  - IM
MH  - Adult
MH  - Anti-Asthmatic Agents/administration & dosage/adverse 
      effects/pharmacokinetics/*therapeutic use
MH  - Antibodies, Anti-Idiotypic
MH  - Antibodies, Monoclonal/administration & dosage/adverse 
      effects/pharmacokinetics/*therapeutic use
MH  - Antibodies, Monoclonal, Humanized
MH  - Asthma/*drug therapy/etiology
MH  - Child
MH  - Clinical Trials as Topic
MH  - Humans
MH  - Hypersensitivity/*complications
MH  - Omalizumab
MH  - Randomized Controlled Trials as Topic
RF  - 23
EDAT- 2004/12/02 09:00
MHDA- 2005/03/17 09:00
CRDT- 2004/12/02 09:00
PHST- 2004/12/02 09:00 [pubmed]
PHST- 2005/03/17 09:00 [medline]
PHST- 2004/12/02 09:00 [entrez]
AID - 1867 [pii]
AID - 10.2165/00063030-200418060-00007 [doi]
PST - ppublish
SO  - BioDrugs. 2004;18(6):415-8. doi: 10.2165/00063030-200418060-00007.