Omalizumab improves asthma in long term therapy

Abstract

Introduction:

X-TEND, a multi-center, non-interventional study on omalizumab (Xolair®), is a long-term follow-up examination on patients who participated in prior non-interventional omalizumab studies X-CLUSIVE and X-PERTISE.

Study objectives have been (i) examination of drug utilisation over several years, (ii) evaluation of changes in the course of disease, quality of life (QoL) and allergen sensitivity, (iii) assessment of long-term efficacy and tolerability of omalizumab therapy in real life.

Methods:

Following data were collected under daily routine specialist care conditions:

• Mini AQLQ

• Number of asthma exacerbations in the past 12 months

• FEV₁

• Frequency of application, dosage, therapy interruptions and discontinuation

• Tolerability assessment based on analysis of adverse events

Results:

Data from 106 patients were analyzed. Mean observation period of omalizumab treatment was 5.0 ± 0.54 years. At the visit of X-TEND, 50% were still on omalizumab. Mean treatment duration was 1253 ± 618 days (= 3.4 years). Mean FEV₁ improved from 1.9 ± 0.7 L to 2.3 ± 0.99 L (p<0.001). The median number of severe asthma exacerbations during the last 12 months was 0 per patient vs. 3 as assessed prior to initiation of omalizumab therapy. QoL scores improved in Mini AQLQ from 3.0 ± 0.79 (at the beginning of X-PERTISE) to 4.9 ± 1.52 (p<0.001) (at the visit of X-TEND). In patients still on treatment with omalizumab mean QoL was 5.4 ± 1.28, whereas patients who discontinued reported 4.4 ± 1.67 (p=0.037).

Conclusion:

In this real-life observation in patients who were approximately 1253 days on omalizumab treatment, we observed an improvement in asthma exacerbations, quality of life and FEV₁.