CAMPATH® Shows Promise in the Treatment of
MS
Results of several pilot studies with the drug Campath
(alemtuzumab) were presented at the annual American
Academy of Neurology (AAN) meeting in Honolulu on
April 1, 2003. Professor Alastair Compston, chairman
of neurology at Addenbrooke’s Hospital in Cambridge,
England, gave the presentation on Campath’s
effects on MS, which he and his colleagues have been
studying for more than 10 years.
According to a press release from ILEX™ Oncology
Inc. (marketers of Campath), Professor Compston reports
that a five-day course of Campath suppressed disease
activity for a “prolonged period” in 36
individuals with secondary-progressive MS (SPMS).
In a separate study, 17 individuals with early, active
relapsing-remitting MS (RRMS) who had no progression
or severe disability, experienced a nearly complete
reduction in annualized relapse rate. Disability
did not increase in any of the 17 RRMS participants.
In an abstract from the AAN meeting, Campath is
described as a humanized monoclonal antibody that
depletes T-cells. Campath is given annually, via
five intravenous infusions, one per day for five
consecutive days. This is a potent anti-cancer drug;
for this reason, steroids are given during the treatment
period to reduce the risk of a flare-up in symptoms.
According to the abstract, disability continued
to progress in the 36 SPMS patients receiving Campath.
They did, however, experience a suppressed relapse
rate for a mean average of seven years. While it
has been reported to strongly suppress inflammatory
activity in SPMS, Campath does not appear to affect
established progression, axonal degeneration (nerve
cell death), and cerebral atrophy (permanent damage
within the brain).
Participants with RRMS saw a reduction in relapse
rate from a mean average of three relapses per year
to point-one (.1, or one-tenth of one relapse) per
year. In the following year, only one of the 22 treated
individuals with RRMS experienced a relapse. The
mean average of progression improved, starting with
an increase in disability of two-point-four (2.4)
Kurtzke Expanded Disability Status Scale (EDSS) points
in the year prior to treatment, to a point-five (.5)
EDSS point reduction in disability (in other words,
participants had less disability after one year in
the study compared to when they began).
Similar to the present approved treatments for MS,
using Campath very early in the course of this disease
may prove to be the time when this drug is the most
effective in terms of reducing inflammation, as well
as potentially preventing early cell death and the
onset of progression. This theory has yet to be proven,
however, and additional study results are needed
before Campath’s effectiveness in treating MS
can be confirmed.
Graves’ disease developed in approximately
one-third of the patients. (Graves’ disease
is a treatable thyroid condition, and with the knowledge
that this is a potential consequence of the medication,
clinicians may now be proactive by looking for and
providing treatment at the first sign of subclinical
Graves’ disease activity.) No significant adverse
effects relating to infection were reported. Rash
and itchiness were reported as side effects, which
subsided through the use of an antihistamine such
as Benadryl®.
Ilex has begun a three-year, phase II study comparing
low-dose and high-dose Campath treatments to high-dose
Rebif treatments in 150 patients with early, active
RRMS. This study is being conducted at approximately
35 sites in the United States and Europe. Some of
the sites in this country have yet to recruit participants.
To be eligible, individuals must have early RRMS
(less than three years) and have never been on any
immunotherapy for MS other than steroids, along with
meeting the other inclusion and exclusion criteria.
For more information about this study, please refer
to www.ilexonc.com/ CAMMS223.htm for a listing of
entry criteria and specific study locations. Information
may also be found at www.clinicaltrials.gov.
Anyone without access to the internet may call MSAA’s
Helpline at (800) 532-7667
for assistance.
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