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Xolair reduced the rate of hospital emergency visits by 44% in
patients with inadequately controlled asthma.
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Results of a clinical study presented at a leading
international medical congress show that Xolair? (omalizumab)
halved the rate of severe asthma exacerbations and reduced
the rate of hospital emergency visits by 44% in patients
with inadequately controlled severe persistent asthma, who
are at high risk of life-threatening attacks.(1) Xolair also
significantly improved patients' asthma-related quality of
life, according to data from the same study presented at the
centenary congress of the American Thoracic Society this
week.(2)
Xolair is a first-in-class therapy that is given by injection
every two or four weeks and blocks the action of IgE, the antibody
responsible for triggering the cascade of allergic symptoms in
patients with diseases such as allergic
asthma. It offers a novel
therapeutic approach to the control of
asthma symptoms such as
wheezing and shortness
of breath, even in the most difficult-to-treat patients whose
condition remains poorly-controlled despite receiving the best
available therapy.
A total of 419 such patients, aged 12-75, were recruited for a
double-blind, placebo-controlled, parallel-group, multicenter study
called INNOVATE to assess the effect of add-on Xolair therapy on the
rate of severe asthma
exacerbations and emergency visits.(1) The participants all had
reduced lung function
and a recent history of clinically significant exacerbations,
despite receiving step 4 therapy as defined in the GINA guidelines,
including high-dose inhaled
corticosteroids,
long-acting
beta2-agonists and other controller medication (including oral
corticosteroids)
if required.
Severe exacerbations halved
The severe exacerbation rate (i.e. where lung function measured
by PEF or FEV1 was
less than 60% of personal best, requiring systemic
corticosteroids)
and the rate of emergency visits (i.e. hospital admissions,
emergency room visits and unscheduled doctor's visits) were
calculated during the treatment phase. Results showed that add-on
Xolair therapy significantly reduced both the severe exacerbation
rate (0.24 vs 0.48, p=0.002) and emergency visit rate (0.24 vs 0.43,
p=0.038) compared with placebo. The authors concluded: "Omalizumab
should be considered as add-on therapy for patients with
inadequately controlled severe persistent
asthma who have a
significant unmet need despite best available therapy."
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The rate of clinically significant
asthma exacerbations (i.e.
those requiring rescue systemic corticosteroid therapy) was
significantly reduced by 26% (p = 0.043), when adjusted for an
observed imbalance in asthma
exacerbation history prior to randomization into the trial. Without
taking this baseline imbalance into account, a similar magnitude of
effect was seen (i.e. a 19% reduction) but this did not reach
statistical significance.(3)
Around 300 million people in the world have
asthma,(4) of whom an
estimated 15 million suffer from severe persistent disease.(5) Their
health and quality of daily life are severely affected, and
asthma is estimated to cause
more than 180,000 deaths worldwide each year.(6) Until now there
have been few additional therapeutic options available for these
patients.
A further analysis of data from the INNOVATE study evaluated the
impact of Xolair treatment on patients' quality of life, measured by
the Asthma QoL Questionnaire (AQLQ) (i.e. individual domains,
overall score and clinically meaningful ≥0.5-point improvement).(2)
Add-on Xolair therapy produced significantly greater improvements
than placebo for each individual AQLQ domain (p0.002) and overall
score (p<0.001). In addition, a significantly greater proportion of
patients receiving Xolair achieved a clinically meaningful
≥0.5-point improvement from baseline in their AQLQ score than
patients receiving placebo (60.8% vs 47.8%, p=0.008).
Well-tolerated in children
Another study presented at the ATS congress evaluated the
long-term safety and tolerability of Xolair in children aged 6-12
years at entry, who were eligible to join a three-year multicenter,
open-label extension on completion of a one-year clinical trial
(28-week double-blind core trial and 24-week open-label
extension).(7)
The percentage of patients who experienced adverse events (AEs)
in the core trial was similar in the Xolair and placebo groups
(89.3%, n=201 and 87.2%, n=95 respectively). Of the 309 patients who
entered the 24-week extension of the core trial, 244 (79.0%)
experienced an AE. A total of 188 patients continued into the
three-year extension, of whom 103 completed the study. Of the 85
patients who discontinued, the majority withdrew consent due to
study duration and maintaining study commitments.
Xolair was generally well-tolerated and most AEs were mild to
moderate in severity. When evaluated by 28-week increments, the
incidence of AEs was generally comparable or lower than that seen in
the 28-week core trial. No AEs suggestive of immunological reactions
were reported. Overall, there were 13 AEs that investigators
suspected were drug-related. There were eight serious AEs of which
only one (dyspnea)
was considered to be drug-related. No evidence of clinically
significant changes in vital signs,
spirometry or
laboratory parameters, including platelets, were observed following
Xolair treatment.
Xolair was launched in the US in
July 2003, and is also approved in Australia, Brazil, Canada,
Dominican Republic, Guatemala, Israel, New Zealand and Venezuela. It
has been developed under an agreement between Novartis Pharma AG,
Genentech, Inc., and Tanox, Inc. The European Medicines Agency (EMEA)
is due to announce its decision on Xolair approval later this year.
References
- Korenblat P, Levy R, Slavin R, Hedgecock S, Fox H, Surrey K,
Reisner C. Add-on omalizumab therapy significantly reduces
severe asthma exacerbations and emergency visits in patients
with inadequately controlled severe persistent asthma despite
GINA 2002 step 4 therapy: INNOVATE. ATS, May 2005.
- Matz J, Melamed I, Ledford D, Hedgecock S, Fox H, Surrey K,
Reisner C. Add-on omalizumab therapy significantly improves
quality of life in patients with inadequately controlled severe
persistent asthma despite GINA 2002 step 4 treatment: INNOVATE.
ATS, May 2005.
- Humbert M et al. Benefits of omalizumab as add-on therapy in
patients with severe persistent asthma who are inadequately
controlled despite best available therapy (GINA 2002 step 4
treatment): INNOVATE. Allergy Mar 2005
- GINA. The Global Burden of Asthma Report 2004.
- American Thoracic Society. Proceedings of the ATS workshop
on refractory asthma. Current understanding, recommendations,
and unanswered questions. Am J Respir Crit Care Med
2000;162:2341?2351.
- World Health Organization
- Milgrom H, Miller SD, Lanier BQ, Fowler-Taylor A, Chen H,
Gupta N. Long-term omalizumab therapy is well tolerated in
children with moderate-to-severe IgE-mediated asthma. ATS, May
2005.
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