RT Journal Article
SR Electronic
T1 Evaluating omalizumab persistency of response after long-term therapy (XPORT)
JF European Respiratory Journal
JO Eur Respir J
FD European Respiratory Society
SP P3485
VO 44
IS Suppl 58
A1 William Busse
A1 Benjamin Trazskoma
A1 Theodore Omachi
A1 Janice Canvin
A1 Karin Rosén
A1 Bradley Chipps
A1 Allan Luskin
A1 Paul Solari
YR 2014
UL http://erj.ersjournals.com/content/44/Suppl_58/P3485.abstract
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 Many patients withdrawn from OMA also remained exacerbation free at 1 year.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.