Genentech and Biogen Idec
- Administered via intravenous infusion.
- Rituxan is amonoclonal antibody (CD20, from
mouse tissue) that binds to a receptor on the
surface of B cells. These cells are then destroyed
and their levels in the circulation are decreased. It is
approved for use in the treatment ofmany
lymphomas, leukemias, and autoimmune disorders.
- A Phase I/II double-blind study of 80 people with
low-inflammatory SPMS, sponsored by the
National Institute of Neurologic Diseases and
Stroke, is testing Rituxan versus placebo
(RIVITaLISe). The study is still recruiting
participants. The primary outcome measure will
be the progression of brain atrophy after two
years of treatment, unless predetermined analysis
shows that the secondary outcome measures of
MRI and clinical assessment are more reliable
measures of effectiveness than brain atrophy.
- A Phase II trial examined the effect of a single
course of treatment in RRMS, with two infusions
of 1,000 mg each, administered two weeks
apart. At 24 and 48 weeks, the number of active
lesions was reduced by 91 percent and relapses
were reduced by 58 percent.
- The drug was also tested in 30 people with RRMS
who had experienced continued clinical activity
despite treatment with one of the approved
disease-modifying therapies. Participants
received two doses of Rituxan, two weeks apart,
while continuing to take their usual medication.
MRI scans were performed to look for areas of
inflammatory lesions at weeks 4, 12, 16, 18, and
24. Multiple Sclerosis Functional Composite
(MSFC) and EDSS scores were obtained at
baseline and throughout the post-treatment
follow-up to determine changes in function and
mobility. Gadolinium-enhancing lesions were
reduced after treatment with Rituxan; 74 percent
of post-treatment MRI scans were free of
gadolinium-enhancing activity as compared with
26 percent free of gadolinium-enhancing activity
at baseline. Median gadolinium-enhancing
lesions were reduced from 1.0 to 0, and there was
an 88-percent reduction in the mean number of
these lesions. The MSFC improved, while the
EDSS remained stable.
- Serious adverse events have been reported
in Rituxan-treated patients with other
diseases, including Progressive Multifocal
Leukoencephalopathy (PML), an often-fatal
viral infection of the brain (as with Tysabri);
patients must be closely monitored.