Multiple Sclerosis,
Current treatment of secondary progressive
multiple sclerosis is unsatisfactory in stabilizing or reversing the disabilities
associated with the disease.
Pirfenidone is a new non-peptide
drug which has been shown in vitro and in vivo to decrease synthesis of
Tumor Necrosis Factor-alpha (TNF-a)
and block receptors for TNF-a.
Since TNF-a
seems to be a key cytokine in demyelination, a pilot study of oral pirfenidone
was undertaken in an open-label baseline vs treatment protocol over a 2-year
period in 20 patients.
Fourteen (14/20) patients (70%) remained
in the study for 2 years.
Three (3/20) patients dropped out
early because of gastrointestinal adverse reactions, and another three
patients dropped out for personal reasons after 1 year (not because of
adverse reactions).
The remaining patients did not manifest
any other drug-related adverse reactions and complications.
Improvement or stabilization occurred
in most patients at about 3 months, and it was sustained at 6, 12 and 24
months as evaluated by both primary and secondary outcome measures.
Magnetic resonance imaging failed
to reveal any new lesions.
Thus, pirfenidone appears to offer
protection against the usual slow progression of the disease.
Most patients experienced a distinct
decrease in their neurological disability.
These findings indicate that an extensive
multi-center double blind and placebo controlled trial is warranted.
© 2001 ingenta
October 2001, vol. 7, no. 5,
pp. 305-312(8)
Walker J.E. [1]; Margolin S.B. [2]
*
[1] Board Certified Psychiatry and
Neurology, 12870 Hillcrest, Suite #201, Dallas, Texas 75230, USA [2] Marnac,
Inc., 9400 N. Central Expressway, Suite #305, Dallas, Texas 75231 USA [*]
Correspondence: SB Margolin
Abstract: