#107 - URGENT INFORMATION about Rituxan (rituximab) & Lupus! PLEASE READ

Medscape Alerts

Off-Label Use of Rituxan Linked to Fatal Leukoencephalopathy
Yael WaknineInformation from Industry

December 19, 2006 — The US Food and Drug Administration (FDA) is warning healthcare professionals regarding the risk for progressive multifocal leukoencephalopathy (PML) in patients receiving rituximab intravenous infusion (Rituxan, made by Genentech, Inc, and Biogen Idec, Inc) for the treatment of systemic lupus erythematosus (SLE), an off-label indication.

The warning was based on 2 fatal cases of PML in patients with SLE receiving rituximab, according to an alert sent today from MedWatch, the FDA's safety information and adverse event reporting program. The drug manufacturers estimate that approximately 10,000 patients with SLE have received rituximab therapy.

PML is a rare and frequently fatal demyelinating disease of the central nervous system that primarily affects patients whose immune systems are compromised by disease or medical treatments. It is caused by reactivation of the JC virus, which remains latent in up to 80% of healthy adults. There are no known effective treatments for PML.

The first death occurred during March 2006 in a woman aged 70 years with a history of lupus nephritis and hemolytic anemia. She had received prior treatment with cyclophosphamide, azathioprine, and long-term corticosteroid therapy. After receiving multiple infusions of rituximab (4 in 2004 and 2 in 2005), she developed vertigo, tongue biting, and difficulty walking. Magnetic resonance imaging (MRI) revealed multiple brain lesions, and brain autopsy showed characteristics of PML.

The second death, in July 2006, involved a woman aged 45 years with a 24-year history of SLE and prior treatment with cyclophosphamide and intravenous methylprednisolone. After receiving 3 courses of rituximab from 2002 to 2005, she developed neurologic signs and symptoms. MRI revealed multiple brain lesions, and tests of cerebrospinal fluid were positive for JC virus.

Because rituximab targets CD20-positive lymphocytes, its use is associated with an increased vulnerability to infection regardless of the indication. Postmarketing reports of serious viral illness have included 23 confirmed cases of PML in patients with lymphoid malignancies either during treatment or as long as 1 year after the last dose. The FDA notes that the majority of affected patients had also received other immunosuppressive drugs.

Healthcare professionals are advised to maintain a high index of suspicion for PML in patients receiving rituximab therapy, particularly those who develop new neurologic signs or symptoms.

Patients receiving rituximab therapy should be advised to promptly contact their healthcare professional if they develop any major changes in vision, balance/coordination, or experience disorientation/confusion.

Rituximab intravenous infusion is approved for use in combination with methotrexate to reduce signs and symptoms of moderately to severely active rheumatoid arthritis in adults who have had an inadequate response to one or more tumor necrosis factor–alpha inhibitor therapies.

It is also indicated for use with cyclophosphamide, vincristine, and prednisolone chemotherapy in the first-line treatment of follicular, CD20-positive B-cell non-Hodgkin's lymphoma (NHL), and for the treatment of low-grade NHL in patients with stable disease who achieve a partial or complete response to first-line treatment with CVP chemotherapy.

In addition, rituximab can be used for the treatment of patients with relapsed or refractory low-grade or follicular CD20-positive B-cell NHL, and for the first-line treatment of CD20-positive diffuse large B-cell non-Hodgkin's lymphoma in combination with cyclophosphamide, doxorubicin, vincristine, and prednisone or other anthracycline-based chemotherapy regimens.

Adverse events potentially related to rituximab therapy, including PML, should be reported to the FDA's MedWatch reporting program by phone at 1-800-FDA-1088, by fax at 1-800-FDA-0178, online at http://www.fda.gov/medwatch, or by mail to 5600 Fishers Lane, Rockville, MD 20852-9787.


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Yael Waknine is a freelance writer for Medscape.
Medscape Medical News 2006. © 2006 Medscape
Tags: rituxan, lupus, rituximab

#106 - Holiday Greetings from the Lupus Research Foundation

I received the following e-mail from the S.L.E. LUPUS FOUNDATION:

A Holiday Message from the S.L.E. Lupus Foundation:

Dear Loretta,

For more than 35 years, the S.L.E. Lupus Foundation has worked tirelessly to unlock the mysteries of lupus. In the last year alone, the Foundation, along with its research partner, the Lupus Research Institute (LRI), has made substantial progress and sponsored key discoveries—findings that may well lead to desperately needed new treatments.

Click here to watch a video and see how the S.L.E. Lupus Foundation is bringing hope to the nearly 1.5 million Americans living with lupus. The video highlights recent breakthroughs in the search for new treatments. (Or, if you prefer, visit our website here to read about the Foundation’s groundbreaking New Investigator Program, the largest of its kind in the country.)

In October, with the S.L.E. Lupus Foundation’s assistance, the LRI awarded 15 new national research grants—$100,000 each for the next three years. We need your help once again to fund this pioneering work.

Join Us in the Fight Against Lupus Today.With every day that passes and every dollar raised, we get one step closer to finding a cure. Join us in the fight against lupus; together we can truly make a difference.

Click here to make a secure online donation now »

For an added way to support the cause while you search the web, log on to www.goodsearch.org and select the S.L.E. Lupus Foundation. Every time you use this search engine, you'll be helping in the fight against lupus.

Thank you so much for your commitment and best wishes to you and your family in this holiday season.

Sincerely, Peggy Dowd

Executive Director

S.L.E. Lupus Foundation
email: lupus@lupusny.org
phone: 212.685.4118
web: http://www.LupusNY.org

#105 - Thank You Tyra Banks!

I have not been writing much about the lupus lately.

Actually, I have been trying to run as far away from lupus as humanly possible.

The problem is, that Ms. Lupus follows me wherever I go.

And she also has managed to keep me from running.

She has forced me into bed rest for 18 to 20 hours per day.

I find it really hard to avoid depression when the lupus gets this bad.

So today I am looking over a huge pile of laundry that is going to take me hours to fold (I have to work very slowly because of the fatigue and shakiness)... and the television is running (because I get so lonely during the day being cooped up at home)...

and of all things I am watching the Tyra Banks Show.

The Tyra Banks Show

And I don't even know why.

I kept telling myself I don't like that show.

I am totally hooked on Tyra's other show America's Next Top Model, and every season I hate myself for that.

I think I am being frivilous, that maybe I should be reading a book or doing something else during that weekly hour I spend with ANTM.

But, here's the thing... very early into the run of this show (it is now on Season 7)... the show featured a beautiful young lady (Mercedes) who happens to have systemic lupus.

The show addressed the issue very well, and I will tell you this...

seeing a beautiful model battling with lupus was extremely validating.

Many of us with lupus do not look sick.

We don't look like drop dead gorgeous models either...

but, we really do not look sick.

Maybe this should be a relief, but the thing is when you have such a serious health condition...

it is really hard to interact with people because they do not SEE what you are dealing with.

Out of sight, out of mind.

Those of us with an invisible illness like lupus often hear:

"Gee, you don't look sick."

I am sure that some well meaning people mean that as a compliment, but what many of us with lupus hear is:

"You are a hypochondriac."

"You are a faker."

"You really aren't that sick."

What people do not realize is that systemic lupus is very, very hard to diagnose.

Many people wait YEARS for a diagnosis.

Years and years of being invalidated...

of being challenged for feeling ill...

of being told it's all in the head.

So any dismissive remark is magnified one thousand fold.

"Gee, you don't look sick..." hurts a lot.

It reverberates all the years of being ignored, beaten down by the medical system that was supposed to help, and all the family/friends who did not offer support and believe us prior to diagnosis.

So...

there I was in front of the t.v. today...

feeling worn down to the nubbin and seeing an 18 year young lady with lupus on the Tyra Banks show.

THANK YOU TYRA!

And even better, she did a special clip of a daughter and her father. The father has lupus and knows his life span has been significantly shortened.

He didn't look sick either.

So, now I am starting to really, really like this Tyra Banks.

I want her to do MORE of this kind of television.

About educating people, about helping others, about the injuries caused by angry hurtful words.

Less with that hoochie mama show stuff, and more substance.

Yes, please, Ms. Tyra...

RESOURCES:

But You Don't Look Sick?


Mercedes Scelba-Shorte: Information from Answers.com

Mercedes Joins Tomiko As LFA Spokesperson