A randomized multicenter study evaluating Xolair persistence of response after long-term therapy

Area of Science:

• Allergy and Immunology
• Pulmonology
• Clinical Pharmacology

Background:

• Limited data exist on the long-term efficacy and persistence of response for asthma therapies like omalizumab.
• Clinicians require evidence to guide decisions on continuing or discontinuing long-term omalizumab treatment for patients with persistent asthma.

Purpose of the Study:

• To evaluate the benefits and persistence of response in patients continuing or withdrawing from long-term omalizumab treatment.
• To assess the impact of omalizumab discontinuation on asthma exacerbations and control.

Main Methods:

• The Xolair Persistency Of Response After Long-Term Therapy (XPORT) study was a randomized, double-blind, placebo-controlled withdrawal trial.
• Patients with moderate-to-severe persistent asthma on long-term omalizumab were randomized to continue omalizumab or switch to placebo for 1 year.
• Primary outcome was protocol-defined severe asthma exacerbation; secondary outcomes included time to exacerbation and changes in asthma control scores.

Main Results:

• Significantly more patients continuing omalizumab (67%) experienced no severe exacerbations compared to the placebo group (47.7%), a 40.1% relative difference.
• Patients on omalizumab showed significantly better asthma control, with improved Asthma Control Test and Asthma Control Questionnaire scores.
• Omalizumab discontinuation led to increased free IgE and basophil IgE receptor expression, with no new safety concerns identified.

Conclusions:

• Continuation of omalizumab following long-term treatment provides sustained clinical benefits for patients with moderate-to-severe persistent asthma.
• Omalizumab therapy effectively reduces the risk of severe asthma exacerbations and enhances symptom control.
• The findings support the ongoing use of omalizumab for maintaining asthma control in selected patients.