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Effects of cyclophosphamide on pulmonary function in patients with scleroderma and interstitial lung disease


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#1 janey

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Posted 27 October 2008 - 02:53 PM

Effects of cyclophosphamide on pulmonary function in patients with scleroderma and interstitial lung disease: a systematic review and a meta-analysis of randomized controlled trials and observational prospective cohort studies.

Cyclophosphamide treatment in patients with systemic sclerosis related interstitial lung disease does not result in clinically significant improvement of pulmonary function. (UnBound) C. Nannini. Arthritis Res Ther 2008 Oct 20; 10(5):R124. (Also see: Cyclophosphamide, Clinical Trials, and Pulmonary Fibrosis)

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#2 aka79

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Posted 30 October 2008 - 10:07 AM

I am confused by this news :(

#3 lizzie

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Posted 30 October 2008 - 11:09 AM

Hi Ana, it is confusing! This research was a systematic review of studies that have looked at the effects of cyclophosphamide on ILD. They did a meta-analysis I.e a statistical analysis involving the results of all the studies (9)- this is considered to provide the most reliable evidence of the effectiveness or otherwise of a treatment, more so than the results of individual studies, even though they my have shown a positive effect. I haven't read the actual article yet, or looked at the methods they used but it is published in a reputable journal and will have been subject to scrutiny by other clinicians and researchers before it was published.

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#4 Guest_delk_*

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Posted 30 October 2008 - 11:35 AM

Here's what I don't get. My impression was that the primary goal of the treatment was to prevent worsening of the condition. In the big new clinical trial, I believe I read that a only a small percentage of patients saw any improvement. So it wouldn't be suprising that this analysis showed negative results for improvement. Am I missing something?

#5 janey

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Posted 30 October 2008 - 12:44 PM

I apologize that this is confusing, but I did think that it was quite relevant since so many of us are, have or are considering CYC therapy. Thanks to Lizzie for her great explanation of the review process. Thanks Lizzie!

If you would like to read the full study, click on the "Full Text" tab at the top of the abstract. Then, once it opens, you have to click on "provisional pdf" to get to the study. Following are a couple of excerpts from the study that might help clarify things, or may muddy things up even more. I hope not. One thing to point out is that this review looked at trials that were using either oral or IV cytoxan, so both the results from oral and IV are combined in the conclusion.

What was looked at?
"A total of 16 studies (3 randomized double blind controlled studies and 13 observational studies) were then examined in detail. Five of the 13 bservational studies were excluded due to inadequate length of follow up (less than 12 months) and/or no information on FVC and DLCO as outcome assessments"

Here is the full conclusion from the main report:
"Based on available data, cyclophosphamide treatment in patients with systemic sclerosis related interstitial lung disease does not appear to result in clinically significant improvement of pulmonary function. Since none of the patients included in these studies were selected on the basis of progression of ILD or the time from the SSc related ILD diagnosis, further randomized clinical studies are needed to evaluate whether CYC (or any) therapy might exert a beneficial effect in patients with worsening ILD. It is possible, for example, that patients treated sooner after diagnosis or at earlier stages of SSc related ILD might have a better response to CYC treatment. Based on current understanding, however, SSc related ILD will be only effectively addressed when better understanding of the immunopathophysiology of the disease is understood and treatment options more effective than CYC become available."

As you can see in the full conclusion and if you were to read the report, you'll see there were a lot variables between the various trials that were evaluated. This review took the analyzes of the trials, but could not completely factor in all of the variables. One thing I did notice that I personally feel was significant, was there was no mention of the FVC and DLCO getting worse, so my question would be - Does CYC at least stabilize ILD in SSc?

Clinical trials are still going on so hopefully we'll see more improvements as new drugs and methods are tested. Let's all keep our fingers crossed.

Big Hugs,
Janey Willis
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(Retired) ISN Assistant Webmaster
(Retired) ISN News Director
(Retired) ISN Technical Writer for Training Manuals
International Scleroderma Network (ISN)