PURPOSE: In patients with difficult to control asthma who meet established criteria, Omalizumab has been shown in multiple trials to be an effective treatment option. Inclusion criteria for these trials typically requires documentation of at least 12% reversibility. Studies to determine the efficacy of Omalizumab in asthmatics without documented reversibility have not been done. In an attempt to enforce “evidenced-based” practice patterns, some managed care organizations (MCOs) are restricting the use of Omalizumab to asthmatics with documented reversibility, despite the fact that many of these patients are already on one or more controller agents.
METHODS: The records of 38 consecutive patients treated with Omalizumab at a pulmonary and allergy specialty practice were reviewed to determine the relationship between reversibility and outcome. All patients met the accepted criteria for this treatment. Reversibility was defined as 12% or more improvement in FEV-1 on any spirometry prior to the first dose of Omalizumab, independent of whether or not the patient was on controller medication(s). Outcome was determined by the global assessment of the treating physician; “much better”, “better”, “slightly better” or “no better”. Those assessed as “much better” or “better” were classified as responders and those assessed as “slightly better” or “no better” were considered nonresponders.
RESULTS: Patients were followed for a mean of 39 months prior to the first dose of Omalizumab. 17 patients had documented reversibility and 20 were irreversible. Records of bronchodilator testing were not available in 1 patient. Overall 58% of patients receiving Omalizumab were classified as responders. In those with documented reversibility, the response rate was 59% and in those without reversibility the response rate was 55%.
CONCLUSION: Response to Omalizumab can not be predicted based on prior documentation of reversibility in patients otherwise meeting the criteria for this treatment.
CLINICAL IMPLICATIONS: The presence of reversibility on spirometry should not be used as a criteria in determining eligibility for Omalizumab treatment by MCOs since this practice deprives a significant number of asthmatics from receiving potentially effective therapy.
DISCLOSURE: Robert Sussman, No Product/Research Disclosure Information; Grant monies (from industry related sources) Clinical research: Glaxo, BI, Intermune, Actelion, Novartis, Astra-Zeneca, Altana, Dey; Consultant fee, speaker bureau, advisory committee, etc. Speakers bureau: Glaxo, BI, Novartis, Genetec, Pfizer, Schering, Oscient, Sepracor