PMID- 22443408
OWN - NLM
STAT- MEDLINE
DCOM- 20120904
LR  - 20220330
IS  - 1532-4303 (Electronic)
IS  - 0277-0903 (Linking)
VI  - 49
IP  - 4
DP  - 2012 May
TI  - Omalizumab therapy in severe asthma: experience from the Spanish registry--some 
      new approaches.
PG  - 416-22
LID - 10.3109/02770903.2012.668255 [doi]
AB  - OBJECTIVE: The efficacy of omalizumab in severe asthma has been widely 
      demonstrated. The main objective of this study was to evaluate the efficacy and 
      tolerability of omalizumab in a real-life setting in Spain, particularly in those 
      patients with immunoglobulin E (IgE) levels out of range. METHODS: Totally 266 
      uncontrolled severe asthma patients receiving high-dose inhaled corticosteroids 
      (ICSs) plus long-acting beta2-agonist (LABA) were recruited. Main efficacy outcomes 
      were asthma exacerbation rate (AER), asthma control test (ACT), and global 
      evaluation of treatment effectiveness (GETE). RESULTS: AER was reduced from 3.6 
      (3.6) in previous year to 0.67 (1.2) at 4 months (p < .05) and to 1.04 (1.8) at 2 
      years (p < .05). ACT increased significantly from 14.3 (4.7) at baseline to 18.4 
      (4.4) at 4 months (p < .05) and to 20.3 (4.0) (p < .05) at 2 years. After 4 
      months, 74.6% of patients had reached a good or excellent rate on the GETE scale 
      (p < .05). This rate continued increasing up to 81.6% at 2 years. These efficacy 
      results were similar for patients with "off-label" IgE > 700 IU/ml. At follow-up, 
      maintenance treatment with oral steroids was discontinued in a considerable 
      number of patients: from 89 to 19 (p < .05). Omalizumab was discontinued because 
      of lack of efficacy only in 28/266 (10.5%) patients. Overall, 30 patients (11.4%) 
      reported adverse events. Severe adverse events were not observed. CONCLUSION: 
      This real-life study confirms that omalizumab is very efficacious and very well 
      tolerated in patients with uncontrolled severe asthma. Results did not vary in 
      the subgroup of patients with IgE levels >700 IU/ml.
FAU - Vennera, Maria Del Carmen
AU  - Vennera Mdel C
AD  - Department of Pneumology and Respiratory Allergy, Hospital Clinic, Universitat de 
      Barcelona, Barcelona, Spain. mvennera@hotmail.com, cvennera@clinic.ub.es
FAU - Perez De Llano, Luis
AU  - Perez De Llano L
FAU - Bardagi, Santiago
AU  - Bardagi S
FAU - Ausin, Pilar
AU  - Ausin P
FAU - Sanjuas, Carles
AU  - Sanjuas C
FAU - Gonzalez, Hector
AU  - Gonzalez H
FAU - Gullon, Jose A
AU  - Gullon JA
FAU - Martinez-Moragon, Eva
AU  - Martinez-Moragon E
FAU - Carretero, Jose A
AU  - Carretero JA
FAU - Vera, Elisabet
AU  - Vera E
FAU - Medina, Juan F
AU  - Medina JF
FAU - Alvarez, Francisco J
AU  - Alvarez FJ
FAU - Entrenas, Luis M
AU  - Entrenas LM
FAU - Padilla, Alicia
AU  - Padilla A
FAU - Irigaray, Rosa
AU  - Irigaray R
FAU - Picado, Cesar
AU  - Picado C
CN  - Spanish Registry
LA  - eng
PT  - Journal Article
DEP - 20120323
PL  - England
TA  - J Asthma
JT  - The Journal of asthma : official journal of the Association for the Care of 
      Asthma
JID - 8106454
RN  - 0 (Adrenal Cortex Hormones)
RN  - 0 (Adrenergic beta-Agonists)
RN  - 0 (Anti-Asthmatic Agents)
RN  - 0 (Antibodies, Anti-Idiotypic)
RN  - 0 (Antibodies, Monoclonal, Humanized)
RN  - 2P471X1Z11 (Omalizumab)
RN  - 37341-29-0 (Immunoglobulin E)
SB  - IM
MH  - Adrenal Cortex Hormones/therapeutic use
MH  - Adrenergic beta-Agonists/therapeutic use
MH  - Adult
MH  - Anti-Asthmatic Agents/adverse effects/*therapeutic use
MH  - Antibodies, Anti-Idiotypic/adverse effects/*therapeutic use
MH  - Antibodies, Monoclonal, Humanized/adverse effects/*therapeutic use
MH  - Asthma/blood/*drug therapy
MH  - Female
MH  - Humans
MH  - Immunoglobulin E/blood
MH  - Male
MH  - Middle Aged
MH  - Omalizumab
MH  - Product Surveillance, Postmarketing
MH  - Severity of Illness Index
MH  - Smoking/epidemiology
MH  - Spain/epidemiology
FIR - Martinez, Carlos
IR  - Martinez C
FIR - Sabadell, Carlos
IR  - Sabadell C
FIR - Celorrio, Nuria
IR  - Celorrio N
FIR - Blanco-Aparicio, Marina
IR  - Blanco-Aparicio M
FIR - Munoz, Mariana
IR  - Munoz M
FIR - Tatay, Frederic
IR  - Tatay F
FIR - Canete, Concepcion
IR  - Canete C
FIR - Borderias, Luis
IR  - Borderias L
FIR - Pellicer, Concha
IR  - Pellicer C
FIR - Zamarro, Soledad
IR  - Zamarro S
FIR - Larco, Jose I
IR  - Larco JI
FIR - Bazus, Teresa
IR  - Bazus T
FIR - Munoz, Xavier
IR  - Munoz X
FIR - Sobrevia, Maria T
IR  - Sobrevia MT
FIR - Pascual, Silvia
IR  - Pascual S
FIR - Urrutia, Isabel
IR  - Urrutia I
FIR - Marin, Alejandra
IR  - Marin A
FIR - Abeijon, Benedicta
IR  - Abeijon B
FIR - Almonacid, Carlos
IR  - Almonacid C
FIR - Serrano, Jose
IR  - Serrano J
EDAT- 2012/03/27 06:00
MHDA- 2012/09/05 06:00
CRDT- 2012/03/27 06:00
PHST- 2012/03/27 06:00 [entrez]
PHST- 2012/03/27 06:00 [pubmed]
PHST- 2012/09/05 06:00 [medline]
AID - 10.3109/02770903.2012.668255 [doi]
PST - ppublish
SO  - J Asthma. 2012 May;49(4):416-22. doi: 10.3109/02770903.2012.668255. Epub 2012 Mar 
      23.