Hi Marc,
Quote:
Rituxan can indeed be prescribed off label for MS. It is in trials for both RRMS and PPMS, but that does not disqualify its use off label for either of those two conditions.
I stand corrected, as indeed it is used off label.Quote:
As for the instances of PML seen in Rituxan, the actual number is 23 out of a total treated patient population in excess of 500,000, the vast majority of whom were severely immunocompromised lymphoma patients
According to Medscape alerts, with regard to the two patients that died from PML, the first patient had only six doses of Rituxin, and the second patient had only three doses of Rituxin.
In the small phase II Rituxin study, 104 patients with relapsing-remitting MS were randomly assigned to either placebo or to a single course of Rituxan, delivered in two IV infusions two weeks apart...The proportion of patients who had relapses during the study was 34.3% on the placebo versus 14.5% for patients on Rituxan This difference translated into a 58% reduction in relapses for Rituxan (Note: After 48 weeks, 20 percent of the 69 Rituxan recipients had suffered a relapse...in other words, the drug was not as good at preventing relapses, but was still much better than the 35 patients who received the placebo and had a relapse rate of 40 percent).
The second study, designed to look at the safety of the drug, showed that 26 of 28 people were able to complete the 48-week study, in which they received two infusions of Rituxan two weeks apart and then another course six months later.
Tysabri data from thousands of MS patients treated, showed in clinical trials for all forms of relapsing MS, that there was a 67% reduction in relapses, not 58%.
Additionally, patients who received Rituxan showed a 91 percent relative reduction in lesions vs. patients who received placebo, whereas, the AFFIRM investigators reported that there were 92% fewer gadolinium-enhancing lesions and 83% fewer new or enlarging T2-hyperintensities on MRI in the Tysabri group versus the placebo group.
My main concern is that, based on the new results, doctors may begin using the drug on their MS patients even though it has not been approved for that use. Because Rituxan is not approved by the FDA for use in treating MS, the current study was relatively small and was a Phase II study, which means that it is preliminary but gives reason to proceed with further trials that will be larger and more definitive and more carefully designed to look for potential long-term safety & efficacy data, and as well as adverse events data.
Rituxan is an expensive medication and its lack of FDA approval for MS would likely make insurance coverage or other reimbursement difficult. The lack of Phase III data will also make many physicians reluctant to prescribe it, however, this would be a personal decision and I agree that all choices regarding any medication used to treat our disease should absolutely be a personal decision.
I do hope and pray that the Rituxan studies/trials for PPMS yield great results for many of us, and I hope Marc that you are somehow able to qualify for one of the studies. I believe that it is always good to have a great variety of medications available to us to effectively treat our disease.
All my best,
Lauren 
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