PMID- 21599560
OWN - NLM
STAT- MEDLINE
DCOM- 20110726
LR  - 20151119
IS  - 1532-4303 (Electronic)
IS  - 0277-0903 (Linking)
VI  - 48
IP  - 5
DP  - 2011 Jun
TI  - Changes in total IgE plasma concentration measured at the third month during 
      anti-IgE treatment predict future exacerbation rates in difficult-to-treat atopic 
      asthma: a pilot study.
PG  - 437-41
LID - 10.3109/02770903.2011.578316 [doi]
AB  - In severe, difficult-to-treat atopic asthma with sensitization to perennial 
      allergens, monoclonal antibodies directed against immunoglobulin E (IgE) are 
      recognized to be clinically effective. Omalizumab, a recombinant monoclonal 
      antibody, selectively binds to the high-affinity C-epsilon 3 site of human IgE 
      and inhibits the inflammatory cascade in response to antigenic stimuli. 
      Currently, no indicator is available for predicting patients' responsiveness to 
      long-term omalizumab treatment. This study aims to assess the relationship 
      between early changes in plasma IgE concentration and major outcome variables 
      over a 12-month course of omalizumab. METHODS: Twenty-three nonsmoking, severe 
      asthmatics (14 females; mean age 47.3 years +/- 12.0 SD; mean BMI 25.8 kg/m(2) +/- 
      9.6 SD) sensitized to perennial allergens and unresponsive to high doses of 
      common therapies were evaluated during a 12-month period of omalizumab treatment. 
      Variables included total IgE plasma concentrations, Forced Expiratory Volume 1 
      second (FEV(1)) symptom complaints (Asthma Control Test (ACT) score), number of 
      emergency visits, hospitalizations, and exacerbations. The Wilcoxon signed-rank 
      test was used to compare changes observed after the 1-year omalizumab treatment 
      versus baseline. Statistical modelization was used to determine possible 
      relationships between changes in outcomes after 12 months and early changes in 
      plasma IgE (after 3 months of treatment). RESULTS: The number of emergency 
      visits, hospitalizations, and exacerbations decreased (p < .004, p < .001, and p 
      < .001, respectively) over the 12-months. In contrast, FEV(1) and ACT score 
      substantially increased (both p < .001); the ACT score reaching maximum after 
      only 3 months. The S model showed the best fit and proved the strict relationship 
      between the increase in IgE after 3 months and the exacerbation rate over the 
      1-year survey (threshold value of >/=250 IU/ml, p < .001). The improvement in 
      FEV(1) was independent of the increase in IgE. CONCLUSIONS: When confirmed on a 
      larger population, early changes in IgE may be used as a predictor of future 
      responders to omalizumab in terms of exacerbation rate, thus minimizing the 
      economic burden of anti-IgE therapy.
FAU - Dal Negro, Roberto W
AU  - Dal Negro RW
AD  - Lung Department, Orlandi General Hospital, Bussolengo, Verona, Italy.
FAU - Guerriero, Massimo
AU  - Guerriero M
FAU - Micheletto, Claudio
AU  - Micheletto C
FAU - Tognella, Silvia
AU  - Tognella S
FAU - Visconti, Marilia
AU  - Visconti M
LA  - eng
PT  - Comparative Study
PT  - Journal Article
PL  - England
TA  - J Asthma
JT  - The Journal of asthma : official journal of the Association for the Care of 
      Asthma
JID - 8106454
RN  - 0 (Anti-Asthmatic Agents)
RN  - 0 (Antibodies, Anti-Idiotypic)
RN  - 0 (Antibodies, Monoclonal)
RN  - 0 (Antibodies, Monoclonal, Humanized)
RN  - 2P471X1Z11 (Omalizumab)
RN  - 37341-29-0 (Immunoglobulin E)
SB  - IM
CIN - J Asthma. 2012 Apr;49(3):324-5. PMID: 22316119
MH  - Adult
MH  - Aged
MH  - Anti-Asthmatic Agents/administration & dosage
MH  - Antibodies, Anti-Idiotypic/*administration & dosage
MH  - Antibodies, Monoclonal/*administration & dosage
MH  - Antibodies, Monoclonal, Humanized
MH  - Asthma/blood/*drug therapy/*immunology
MH  - Disease Progression
MH  - Dose-Response Relationship, Drug
MH  - Drug Administration Schedule
MH  - Female
MH  - Follow-Up Studies
MH  - Humans
MH  - Hypersensitivity, Immediate/diagnosis/drug therapy/immunology
MH  - Immunoglobulin E/*blood/drug effects
MH  - Male
MH  - Middle Aged
MH  - Monitoring, Physiologic/methods
MH  - Normal Distribution
MH  - Omalizumab
MH  - Pilot Projects
MH  - Predictive Value of Tests
MH  - Risk Assessment
MH  - Sampling Studies
MH  - Severity of Illness Index
MH  - Spirometry
MH  - Statistics, Nonparametric
MH  - Treatment Outcome
EDAT- 2011/05/24 06:00
MHDA- 2011/07/27 06:00
CRDT- 2011/05/24 06:00
PHST- 2011/05/24 06:00 [entrez]
PHST- 2011/05/24 06:00 [pubmed]
PHST- 2011/07/27 06:00 [medline]
AID - 10.3109/02770903.2011.578316 [doi]
PST - ppublish
SO  - J Asthma. 2011 Jun;48(5):437-41. doi: 10.3109/02770903.2011.578316.