Real life study of three years omalizumab in patients with difficult-to-control asthma.
BACKGROUND
Even though there are multiple options for the treatment of asthma, there still exists a fair group of patients with difficult-to-control asthma. We describe for the first time the real-world effects of three-year omalizumab treatment on patients with difficult-to-control asthma, seen in a social security hospital in a Latin American country.


METHODS
Difficult-to-control asthmatic patients from the out-patient clinic of a regional hospital were recruited to receive a three-year omalizumab course. Efficacy parameters were asthma control test (ACT) score; FEV1; daily beclomethasone maintenance dose; and unplanned visits for asthma exacerbations (emergency room (ER), hospitalisations, intensive care).


RESULTS
52 patients were recruited, 47 completed the three-year treatment (42 female, 15-67 years, mean age 43.5). Comparing efficacy parameters of the year before omalizumab with the 3rd year of omalizumab: mean ACT improved from 12.4 to 20.5, mean FEV1 from 66.3% (standard deviation (SD) 19.1%) to 88.4% (SD 16.2%) of predicted, while mean beclomethasone dose reduced from 1750 to 766 mcg/day and there was a significant reduction in patients experiencing ER visits (from 95% to 19%, p<0.0001), hospitalisation (38% to 2%, p<0.0001) and intensive care (4% to 0, NS). Five patients discontinued omalizumab, two because of an adverse event (anaphylaxis, severe headache, both resolved without sequelae).


CONCLUSIONS
Omalizumab improved most clinical parameters of Mexican patients with difficult-to-control asthma. Especially the rates of ER visits and hospitalisation were significantly reduced, thus reducing costs. Omalizumab was generally well tolerated.
Department of Allergy and Clinical Immunology, H.R. Lic. Adolfo López Mateos, ISSSTE, Mexico City, Mexico. Electronic address: drlopeztiro@gmail.com.
J Jesús
JJ
López Tiro
Department of Allergy and Clinical Immunology, H.R. Lic. Adolfo López Mateos, ISSSTE, Mexico City, Mexico.
E Angélica Contreras
EA
Contreras
Department of Allergy and Clinical Immunology, H.R. Lic. Adolfo López Mateos, ISSSTE, Mexico City, Mexico.
M Elena Ramírez
ME
del Pozo
Department of Allergy and Clinical Immunology, H.R. Lic. Adolfo López Mateos, ISSSTE, Mexico City, Mexico.
J
J
Gómez Vera
Allergy Staff, Hospital Medica Sur, Mexico City, Mexico.
D
D
Larenas Linnemann
D000293:Adolescent; D000328:Adult; D000368:Aged; D018927:Anti-Asthmatic Agents / Q000627:therapeutic use*; D001249:Asthma / Q000188:drug therapy*; D001507:Beclomethasone / Q000627:therapeutic use; D018450:Disease Progression; D004632:Emergency Medical Services; D005260:Female; D006801:Humans; D007073:Immunoglobulin E / Q000276:immunology; D008297:Male; D008800:Mexico; D008875:Middle Aged; D000069444:Omalizumab / Q000627:therapeutic use*; D012129:Respiratory Function Tests; D013997:Time Factors; D055815:Young Adult
D018927:Anti-Asthmatic Agents; D000069444:Omalizumab; D007073:Immunoglobulin E; D001507:Beclomethasone
Anti-IgE; Asthma exacerbation; Asthmatic crisis; Biological; Difficult-to-control asthma; Emergency room; Hospitalisation; Omalizumab; Severe asthma