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ALL ABOUT OMALIZUMAB
I'm writing in regards to
the article "Omalizumab:
Uh, I'm a little slow" (Vol 1 No 10, page 27). I
disapprove of the article title and the comment that
the drug "may only become effective after months of
apparently useless treatment." As the introductory message
to clinicians faced with the challenge of difficult-to-treat
asthma, the author should have highlighted the efficacy
of omalizumab rather than its onset of action. What's
relevant to the physician is that, as add-on therapy,
this drug reduced the incidence of asthma exacerbations
by half, significantly improved asthma symptoms, respiratory
function and asthma-related quality of life in patients
with moderate to severe uncontrolled asthma. What's
also important is the fact that patients most likely
to achieve the greatest benefit from omalizumab therapy
can now easily be identified.
Indeed, "two-thirds of the treatment
group showed an improvement in symptoms, so did half
of the placebo arm." We're all aware that participation
in a clinical study allows optimizing management of
a disease and often has beneficial effects on its own.
This is particularly true of asthma where poor patient
adherence to therapy is well recognized. Regarding omalizumab
phase III studies, one should bear in mind that the
placebo group response is actually the response in the
optimal conditions and monitoring of a clinical trial.
Omalizumab, on the other hand, requires a frequency
of administration that maintains optimized management
and increased compliance. I recently read an article
in the June edition of Allergy that highlighted
the efficacy of omalizumab in asthmatic patients using
the best standard of care (all available concomitant
therapy), which reflected omalizumab's efficacy in a
real-life situation. Once again, the results indicated
that patients on omalizumab were able to significantly
reduce exacerbations, symptoms scores, need for rescue
medications and FEV1.
As one of the Canadian investigators
of a Novartis sponsored clinical trial on their drug
Xolair (omalizumab), I had the opportunity to follow
many patients treated with this drug. The results that
I observed in these high-risk patents were remarkable.
For example, one woman prior to treatment with omalizumab
was on prednisone 15mg/day, fluticasone 1500mg/day and
salbutamol 800mg/day. She hasn't needed anything apart
from omalizumab for the past three years with only occasional
use of fluticasone for rescue medication. Another female
subject, also on zero inhaled corticosteroids for some
time now, feels so much improvement that she can't believe
the difference this medication has made in her quality
of life. She even walks up seven flights of stairs to
my office for appointments, something she would never
have contemplated prior to the research study.
Dr William H Yang
Allergy & Asthma Research Centre,
Executive Director
Toronto, ON
The research paper, which appeared
in the April issue of Chest, did not question the efficacy
of the drug. It warned instead that treatment not be
ended prematurely. After 12 weeks, 87% of patients had
responded favourably. ? Ed
AH,
REFRESHING
I enjoy your refreshing approach to medical reporting.
I especially enjoyed the article on the Iron woman ("Behind
every Ironman
is an iron woman", No 14 Vol 1, page 1).
Dr Christopher
Kwiatkowski
Huntsville, ON
MORE
MEDICAL MISTAKES
Considering that a jumbo jet full of Canadians die every
week from medical errors I think an article on or review
of the book Internal Bleeding ? the definitive
Book on medical errors ? would be important. Thanks.
Love the paper!
Dr TM Quigg
Collingwood, ON
We actually did cover this topic
in a recent issue, "Klutz
like a knife" (No 13 Vol 1, page 1). We agree that
this is an important topic and will definitely consider
reviewing the book you mentioned. ? Ed
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