Anti IgE therapy is the ultimate therapeutic option for severe atopic conditions, not controlled by conventional treatment. Its efficacy and safety was described in several peer reviewed publications.
Here we report on the events temporally related to the administration of almost four hundred doses of the only monoclonal Anti IgE antibody approved in our country for the treatment of severe asthma.
Methods:
Descriptive retrospective analysis of clinical charts of patients receiving omalizumab because of Severe Uncontrolled Asthma, considering those events presented in the 72 hours after administration of it, which was not present before the procedure or as a concomitant condition of the patient.
Vital signs, respiratory and cardiovascular evaluation, and dermatological inspection were performed in the hour after administration of corresponding doses. Patients having any kind of complain were evaluated in unscheduled visits.
Results: 384 doses of 150 mg omalizumab were given to from April 2007 to June 2011, to nine severe asthmatic patients. One of them received treatment for over four years, and two for over three years.
| YES | NO |
| Local erythema and edema: 0.78%-mild | Muscle pain: 1%-moderate |
| Nausea: 0.26%-moderate | Bruises: 0.52%-mild |
| Sinusal Tachycardia: 0.26%-moderate | Headache: 0.26%-mild |
| Ear pain: 0.26%-mild | |
Conclusions:
Our records from patients receiving omalizumab have not registered severe adverse events in almost four hundred doses given. The moderate adverse events of nausea and tachycardia resulted in discontinuation of treatment in this unique patient.
Overall, omalizumab demonstrated a very acceptable safety profile in our patients.
Funded by Fundación Ayre (Salta), Fundación LIBRA (Córdoba), CIMeR (U.C.Córdoba), Argentina