PURPOSE: Little data exists regarding the duration of treatment with omalizumab and more importantly the natural history of disease once omalizumab is discontinued after adequate treatment. We looked at history of disease in n=9 asthmatics that had received adequate treatment with omalizumab and subsequently did not receive omalizumab for a variety of reasons.
METHODS: Patients with a history of asthma who were treated with omalizumab for at least 6 months and subsequently did not receive omalizumab for at least 3 months were studied in a small pulmonary practice. Time to the first major exacerbation (Emergency Room visit or Inpatient hospitalization) was obtained. Rate of exacerbation before and after discontinuation of drug was obtained and paired t-test statistical analysis was performed.
RESULTS: The time to first exacerbation after the discontinuation of omalizumab was 7.9 weeks + 2.1 (SEM) weeks. The mean number of severe exacerbations per week while the patient was on omalizumab was lower when compared to drug discontinuation and was 0.13 versus 0.73 which was statistically significant (p value= 0.016).
CONCLUSION: Patients in whom omalizumab was discontinued after adequate treatment may relapse unpredictably and must be followed closely to identify severe exacerbations early on as this may facilitate early treatment and prevent catastrophic events.
CLINICAL IMPLICATIONS: Holiday from omalizumab and discontinuing the drug may be risky in patients whose asthma is stable. Further studies must be done to determine criteria for considering drug holiday in patients with asthma being treated with omalizumab.
DISCLOSURE: Mary Zaremba, Consultant fee, speaker bureau, advisory committee, etc. Dr. S. P. Reddy and Mary Lynn Zaremba APRN-BC are on speaker bureau for Genentech. MLZaremba, APRN-BC is on speaker bureau for Novartis.; No Product/Research Disclosure Information