PT - JOURNAL ARTICLE AU - William Busse AU - Benjamin Trazskoma AU - Theodore Omachi AU - Janice Canvin AU - Karin Rosén AU - Bradley Chipps AU - Allan Luskin AU - Paul Solari TI - Evaluating omalizumab persistency of response after long-term therapy (XPORT) DP - 2014 Sep 01 TA - European Respiratory Journal PG - P3485 VI - 44 IP - Suppl 58 4099 - http://erj.ersjournals.com/content/44/Suppl_58/P3485.short 4100 - http://erj.ersjournals.com/content/44/Suppl_58/P3485.full SO - Eur Respir J2014 Sep 01; 44 AB - Introduction: This study evaluated persistency of response to omalizumab (OMA, Xolair®) in patients continuing or withdrawing from therapy after ≥5 years.Methods: This was a 1 year, double-blind, placebo-controlled withdrawal study of patients with moderate-to-severe persistent asthma receiving OMA for ≥5 years. Patients were randomized (stratified by baseline inhaled corticosteroid use, baseline asthma control, OMA dosing interval, study site) to continue OMA (same dose) or switch to placebo. Primary efficacy analysis was persistency of response (proportion of patients without a protocol-defined asthma exacerbation).Results: Patients were randomized to OMA continuation (n=88) or withdrawal to placebo (n=88). Baseline characteristics were similar. Persistency (no protocol-defined exacerbation) was significantly higher in the OMA continuation group (67.0% [95%CI 57.2%, 76.9%]) vs placebo (47.7% [95%CI 37.3%, 58.2%]). Symptom control was significantly better in the OMA continuation group: OMA mean (SD) change from baseline to week 52 Asthma Control Test -1.16 (4.14) vs placebo -2.88 (5.38), P=0.0188 and Asthma Control Questionnaire OMA 0.22 (0.66) vs placebo 0.63 (1.13), P=0.0039. Time to first protocol-defined exacerbation was longer in the OMA continuation group vs the placebo group (HR:0.49 [CI: 0.28, 0.86]). The incidence of adverse events and serious adverse events was similar.Conclusions: Continuation of OMA treatment resulted in persistency of response as evidenced by better maintenance of symptom control and lower exacerbation risk. Many patients withdrawn from OMA also remained exacerbation free at 1 year. Future research is required to characterize this subgroup of patients.