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Colegio de Medicina Interna de México.

2022, Number 5

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Med Int Mex 2022; 38 (5)

Pharmacovigilance of omalizumab in a cohort of 30 patients with severe asthma

Herrera-García JC, Villarreal-Portillo DA, Vera-Guerrero LS, Palacios-Rosas E, Castro-Pastrana LI

Language: Spanish
References: 38
Page: 977-989
PDF size: 242.53 Kb.


ABSTRACT

Objectivoes: To analyze the adverse reactions of omalizumab in a Mexican cohort and to establish the possible association between their occurrence and the variables gender, age, dose, frequency and duration of treatment.
Materials and Methods: A retrospective observational pharmacovigilance study was conducted where the records of patients with severe asthma treated with omalizumab were analyzed from January 2016 to July 2018. Adverse reactions were characterized using the MedDRA terminology, the CTCAE Criteria for Adverse Events, the Naranjo algorithm and the Mexican pharmacovigilance regulations. The estimated risk of adverse reaction for the cohort and the correlation between the occurrence of adverse reactions and possible risk factors were determined.
Results: Thirty patients with severe asthma were studied, 24 were women, aged between 20 and 77 years, average weight 69.7 ± 11.4 kg, average initial IgE of 250.7 ± 146.6 IU/mL, with duration of treatment from 4 to 120 weeks and doses between 150-600 mg in a single administration. The estimated risk of adverse reaction was of 33.3%. Influenza like illness was the most prevalent adverse reaction. Nine patients with adverse reactions had hypertension as a comorbidity. An association was found between receiving omalizumab every 2 weeks and presenting adverse reactions ( p = 0.028).
Conclusions:Our results support the safety of omalizumab in severe asthma and add useful evidence for updating guidelines and protocols.


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