AUGUST 30, 2004
VOLUME 1 NO. 15
 

 


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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