January '02 | briefing | mail | don't say this | flakers' jargon | flaker creativity | articles | other places | archives | send mail | ed dewke | legal stuff | order | search | 2001 Ed Dewke

Crippling Joint Pain After Anti-CD11a Trial
from Lesleigh

Dear Ed:  I find your website very interesting and informative.  I am 33 and have had psoriasis for over 10 years now.  It has been severe for the past 2 years.  I did the anti-cd11a study last year and was one of the few that saw no improvement at all.  It surprised the doctor overseeing the study.  I started to develop joint pain during the study.  In the last month it began to get severe and then in the month after, the pain was all over my body and I was unable to walk. 

I missed more than a month of work, but thanks to a great doctor and the medication I am on, I am feeling much better.  Of course, now I will always have to deal with the psoriatic arthritis. 

I am very concerned that the study drug, anti-cd11a, led to my current condition.  I am concerned that it could happen to other people.  The psoriasis I have is nothing in comparison to the horrific pain I endured just a few months ago.  The swelling and pain were unbearable! 

I would like to chat with anyone who experienced any type of pain while on the anti-cd11a drug study.  It is very important to me to hear from anyone who had any joint pain during or after the study.  I think that Genentech knows more about this problem than they are telling study participants.  It would be greatly appreciated if you could get the word out to others.  You have my permission to post this with my email address.  Thanks! –Lesleigh ([email protected])

*****

Ed’s Response:  Your email was propitiously timed, Lesleigh.  In the November/December issue of the NPF Bulletin, this item: “Genentech, which is moving toward FDA approval for its psoriasis treatment efalizumab (brand name Xanelim) was the first biotechnology company” (page 9, sidebar to “The research pipeline for psoriasis”). Xanelim is the drug growing out of the anti-CD11a trials.  The importance of Genentech being the “first biotechnology company,” is the way this differentiates them from traditional pharmaceutical companies.  In the sidebar from which I drew the quote, it is explained that traditional drugs involve non-living chemicals but new “biologic drugs” involve living sources “such as viruses, animals and people.”

In an earlier report on Genentech’s research (also at NPF’s web site), I read that during their Phase III trial they used 950 test subjects.  You, evidently, were among them.  Also from this report: “[A]nti-cd11a, a humanized monoclonal antibody that is being developed by Genentech and XOMA … blocks the movement of immune system cells (called T cells) from the bloodstream into the skin and the activation of those cells within the skin. T-cell activation is a critical step in the misfired immune response that results in psoriasis.”

While we all want Xanelim to become an important break-through treatment for P, there is no such thing as an unimportant adverse reaction, which you have experienced dramatically.  I hope any readers who participated in the trial and have experienced similar reactions will let us know as well as contact you directly.  Thanks for your report, Lesleigh.  -Ed

Readings from the Archives:
B
ad Rebound After anti-CD11a Trial 
Anti-CD11a Trial Sparked 3-Day Migraine

This Month's Mail | Archives

www.flakehq.com