Look at that, a clinical trial for Etanercept for another use sponsored by Pfizer. To me that means that Etanercept as pushed by Dr. Edward Tobinick for stroke does not meet Pfizers' requirements for a clinical study. Of course I may be wrong on that, you'll have to ask Dr. Edward Tobinick yourself if you are thinking of going the perispinal injection route.I can't tell how many cases of Spondyloarthritis occur per year, but I bet it is less that the 800,000 for stroke.
http://www.medpagetoday.com/Rheumatology/Arthritis/48938?
Treatment of axial spondyloarthritis (axSpA) with the biologic agent
etanercept allowed patients to use fewer nonsteroidal anti-inflammatory
drugs (NSAIDs) and alleviated symptoms when compared with placebo,
according to a Pfizer-sponsored SPARSE trial.
The randomized,
double-blind trial is the first to evaluate the NSAID-sparing effect of
an antitumor necrosis factor agent using an NSAID score from the
Assessment of SpondyloArthritis International Society (ASAS) as the
primary endpoint, reported Maxime Dougados, MD, from Paris Descartes University, and colleagues in Arthritis Research and Therapy.
"Additional
studies are required to further evaluate the ASAS-NSAID score as a
meaningful outcome measure," noted the authors, whose results with this
score skirted just shy of reaching clinical significance according to
their predefined definition.
The study included 90 axSpA patients, mean age of 38.9 years, from 19 centers across France.
All patients had active axSpA despite optimal NSAID intake, with a mean disease duration of 5.7 years.
Eligibility
required that patients undergo a 2 to 6 week screening period in which
they discontinued NSAIDs -- only restarting if their symptoms flared
-- with only those patients who flared being admitted into the study.
They
were then randomized to receive either etanercept 50 mg (n=42) or
placebo (n=48) once weekly for 8 weeks along with their regular NSAID
dose, with instructions to taper/discontinue the NSAID over the 8-week
study period.
The primary study outcome was change from baseline to week 8 in the ASAS-NSAID score.
The
ASAS-NSAID score is based on type, dose, and duration of NSAID
treatment, and was calculated using NSAID intake information from
patient diaries.
At baseline, demographic characteristics were
similar between the etanercept and placebo-treated groups, as were
disease characteristics such as ASAS-NSAID, Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), and Bath Ankylosing Spondylitis Functional Index (BASFI) scores.
At
the end of the 8-week treatment period, patients treated with
etanercept were able to reduce their NSAID intake significantly more
than those on placebo, with a mean decrease in ASAS-NSAID score from
baseline of -63.9 compared with -36.6 (P=0.002).
Similarly,
compared with placebo, significantly more etanercept-treated patients
achieved an ASAS-NSAID score of less than 10 (46.2% versus 16.7%; P=0.008) and an ASAS-NSAID score of zero (41.0% versus 14.3%; P=0.013).
The
score difference of 27.3 points between groups was just short of being
considered clinically relevant, according to a predetermined definition
of a 30-point difference.
However, "the between-group differences
in this score observed in primary and secondary and post hoc sensitivity
analyses ... closely approximate the anticipated difference, suggesting
that the study's statistically significant results are also clinically
relevant," the authors stated.
Additionally, conventional clinical
response measures showed that significantly more patients in the
etanercept arm achieved BASDAI50 (39.0% versus 17.8%; P=0.032) and ASAS40 (44.4% versus 21.4%; P=0.028) endpoints compared with placebo-treated patients at week 8, they reported.
"Evaluation
of the safety profile of etanercept was not the main objective of this
study, but no new information was revealed in this area," they added.
Treatment-emergent adverse events (AEs) were reported in 81% of the
etanercept-treated patients and 54% of patients treated with placebo,
with the most common etanercept-related AEs being rhinitis (12%);
asthenia, hypercholesterolemia, injection site hypersensitivity, and
injection site reactions (7% each); and headache, injection site
erythema, and rash.
The authors acknowledged several "noteworthy
weaknesses" of the study including missing information from patient
NSAID diaries, as well as the short duration of the study period. "The
8-week duration was selected as it was considered sufficient to
demonstrate the NSAID-sparing effect of the biologic agent while
limiting the duration of exposure to placebo in patients with this
painful, disabling condition," they wrote. "However, the magnitude of
such treatment effect would likely have been greater in a longer trial."
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