oral Tazarotene
None
drug sounds like it might be a good choice for some people. Looks like it
might be pretty safe too. They are shooting for approval the 2nd half of
2003. lets hope..
Read on:
Gel Formulation of Tazarotene Effective in Patients With Psoriasis
IRVINE, Calif., Mar 24, 2003 -- Allergan, Inc. (NYSE:AGN) announced today
the results of its two Phase 3 trials of an oral gel-capsule formulation of
tazarotene in the treatment of moderate to severe psoriasis. The data was
presented by Dr. John Koo, Professor and Vice-Chairman of the University of
San Francisco Department of Dermatology at the 2003 American Academy of
Dermatology meeting in San Francisco, California. The trials were
multi-center, double-blind, randomized, placebo-controlled, safety and
efficacy studies of 12 weeks treatment with oral tazarotene 4.5 mg followed
by 12 weeks post-treatment follow-up.
There were two clinical measures used to evaluate patients in the study,
overall lesional assessment (OLA) and overall global response to treatment.
OLA is an integrated clinical assessment of disease severity. Physicians
were provided with photonumeric guidelines to ensure evaluation consistency
across study sites.
Based on an integrated analysis of the two clinical trials, more than 50%
(53.8%) of patients achieved global treatment success of at least 50%
improvement and 29.7% of patients treated with oral tazarotene achieved at
least 75% improvement compared with 14.9% and 7.4%, respectively, in
patients receiving placebo. These results were significant at p less than
0.001. Also at week 12, 17% of patients treated with oral tazarotene had
clinical success with an OLA of none or minimal psoriasis compared with only
3% treated with placebo (p less than 0.001).
"I'm pleased with the results of these clinical studies and excited about
the possibility that a new retinoid therapy could be available to patients
suffering from psoriasis," said Dr. Koo. "Based on the outstanding results
and the efficacy demonstrated in this trial, oral tazarotene may provide
physicians an exciting new therapy to increase patient results."
Patients were evaluated at baseline and weeks 1, 2, 4, 8 and 12 (the
treatment phase) and weeks 16, 20 and 24 (the post-treatment phase). As is
consistent with retinoid therapy, women of childbearing potential were
required to be on appropriate contraception because of the teratogenic
risks. The primary efficacy endpoint for the trials was the achievement of
clinical success, defined as an OLA of none or minimal disease based on the
6 point OLA score (0=none, 1=minimal, 2=mild, 3=moderate, 4=severe, 5=very
severe disease). In the combined analysis of the two phase 3 trials, 340
patients were treated with oral tazarotene and 350 with placebo. At the
start of the study, patients had a mean OLA score of 3.4 (moderate to
severe) and approximately 29% body surface area affected. The trial results
show that oral tazarotene met the primary efficacy endpoints. These studies
also suggest there may be duration of relief of disease after
discontinuation of treatment.
These results were achieved in the absence of any consistent, clinically
significant changes in laboratory values including serum triglycerides,
total cholesterol, HDL cholesterol, liver function and hematology tests. The
only statistically significant adverse events observed in the
tazarotene-treated patients vs. placebo, with an incidence equal to or
greater than 5%, were cheilitis (66% vs. 17%), dry skin (24% vs. 15%),
headache (19% vs. 12%), arthralgia (17% vs. 8%), myalgia (14% vs. 8%) and
back pain (7% vs. 3%). No treatment-related serious adverse events were
observed. Less than 5% of patients on treatment discontinued the study due
to adverse events.
In these trials, there were no consistent clinically significant changes in
laboratory values. This may be attributable to tazarotene's retinoid
receptor selectivity.
Allergan intends to file for approval with the U.S. Food and Drug
Administration in the second half of 2003. Tazarotene is currently marketed
in the United States as topical formulations under the trade names TAZORACŽ
0.1% and 0.5% and AVAGETM 0.1%.
JXStern
>Gel Formulation of Tazarotene Effective in Patients With Psoriasis
>IRVINE, Calif., Mar 24, 2003 -- Allergan, Inc. (NYSE:AGN) announced today
>the results of its two Phase 3 trials of an oral gel-capsule formulation of
>tazarotene in the treatment of moderate to severe psoriasis.
Well heck maybe it's better systemically than topically?
No, I don't believe it.
The systemic absorption of tazarotene is already pretty high, just
read the insert.
http://www.fda.gov/cder/foi/label/2000/21184lbl.pdf
Hmm, they've updated the insert since I used the stuff way back when.
They claim (a) 2-3% absorbed, (b) this doesn't amount to much even
with test-specific large (topical) doses, (c) in normal doses they can
barely detect any, and (d) DO NOT USE IT IF YOU MIGHT GET PREGNANT.
OK, you guys figure out if this is consistent or not.
My own experience is that using a few small dots of it on the left
leg, resulted in irritation of psoriasis over my whole body.
I am at least gratified to see that the new insert has significant
warnings about UV sensitivity while using Tazorac. Apparently not
everyone sees this effect, but I surely did.
So I remain very skeptical about the promise of this as a systemic
drug, but then again, it might still turn out to work for some people,
and maybe be a better and gentler treatment than the distantly related
Soriatane.
J.