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Omalizumab improves asthma in long term therapy

Peter Kardos, Hassan Alakmeh, Christian Franke, Maryam Aalamian-Mattheis
European Respiratory Journal 2012 40: P748; DOI:
Peter Kardos
1Pneumologie, Zentrum für Allergologie, Pneumologie und Schlafmedizin am Maingau Krankenhaus, Frankfurt, Germany
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Hassan Alakmeh
2Innere Medizin, Praxis Dr.med. Hassan Alakmeh, Backnang, Germany
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Christian Franke
3Pneumologie, Gemeinschaftspraxis Dres. Franke, Sonneberg, Germany
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Maryam Aalamian-Mattheis
4Clinical Research Critical Care, Novartis Pharma GmbH, Nuremberg, Germany
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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.

  • Quality of life
  • Asthma - management
  • Longitudinal study
  • © 2012 ERS
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Omalizumab improves asthma in long term therapy
Peter Kardos, Hassan Alakmeh, Christian Franke, Maryam Aalamian-Mattheis
European Respiratory Journal Sep 2012, 40 (Suppl 56) P748;

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Omalizumab improves asthma in long term therapy
Peter Kardos, Hassan Alakmeh, Christian Franke, Maryam Aalamian-Mattheis
European Respiratory Journal Sep 2012, 40 (Suppl 56) P748;
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