Rituximab add-on therapy for relapsing MS had 3rd case of PML with use for rheumatoid arthritis

MS Resource Centre; Rituximab/Rituxan

June of this year saw Rituximab's 52-week phase II trial a success for relapsing forms of multiple sclerosis (MS) as use with standard injectible therapies such Rebrif or Copaxone.

The results showed lesions reduced with 74% of patients treated afterwords being free of activity.

This is, of course, good news, but there are ripples of worry over a few things that have not really been talked of yet:

1.) They only used 30 MS patients for the clinical trial and,

2.) Cases of PML with Rituxan use on rheumatoid arthritis now and problems with another biologic drug, Tysabri.

Progressive multifocal leukoencephalopathy (PML) causes inflammation in the brain and it has been seen as fatal in half of those who contract this disease.  It's caused by a reactivation of the JC virus that is found in about 70 to 90 percent of the population (click here for more information about the JC virus and here for more regarding PML).

The other biologic drugs out there that are targeting immune system factors such as Tysabri and Raptiva, that have been linked to PML, were both removed from the market.  Tysabri was brought back with strict risk evaluations and although there have been more reports of PML regarding the use of Tysabri, they are now lower statistically than before the pulling of it.

This 3rd report of PML involving a 73 year old woman who had received two doses of ritximab in February of 2009 is now coming out.  Her symptoms developed four to six months later and a letter sent out by Genentech, the manufacturer, does not indicate whether she has survived.

Genentech reported an approximate number of 100,000 patients with rheumatoid arthritis received rituximab which would put the risk of getting PML lower than those who do Tysabri therapy.

Which is where Rick Yasime from Lima, Ohio likes to get involved, "I've been doing Tysabri since November of 2008 and I knew the risks.  I've talked to so many people here and online about PML and over and over again, I hear how the risks are so low as to getting it and yet our risks are higher of having MS mess us up so where does that put us?  To me, MS messed up my life to the point where I was heading straight to a wheelchair and a bed, so, for me personally, Tysabri and PML were worth the risk."

Mr. Yasime has said he will tell people with MS that each and every treatment is a very personal choice and regardless of what others may feel, "You have to do what you think is good for your health as long as you do your homework on the risks."

“Physicians should consider PML in any patient being treated with Rituxan who presents with new onset neurologic manifestations,” Genentech’s letter said. “Consultation with a neurologist, brain MRI, and lumbar puncture should be considered as clinically indicated."

Sources:  Multiple Sclerosis Resource Centre, www.msrc.co.uk/index.cfm/fuseaction/show/pageid/1394; Discuss Pharmacy Copyright 2010 Discuss Pharmacy; Neurology. 2010 Jun 8;74(23):1860-7. & Pubmed PMID: 20530322

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