Message #143 From:
TheMachine Date: May 31, 2009 03:24:08 PM
BIIB Stock News : Subset Data from Two Randomized Phase 3 Trials Show TYSABRI® Significantly Improves Health-Related Quality of Life for Crohn’s Disease Patients with Prior Exposure or Inadequate Response to Anti-TNFα Therapy
Elan Corporation, plc (NYSE: ELN) and Biogen Idec (NASDAQ: BIIB) shared
data today that TYSABRI® (natalizumab) improved health
related quality of life (QOL) in Crohn’s Disease (CD) patients who had
previously been exposed to or failed anti-TNFα therapy versus placebo.
These results were obtained from subset analyses of the Phase 3 ENACT-2
(Evaluation of Natalizumab as Continuous Therapy) and ENCORE (Efficacy
of Natalizumab in Crohn’s Disease Response and Remission) trials and
were presented today at Digestive Disease Week in Chicago.
QOL was measured using the patient-reported, disease-specific
Inflammatory Bowel Disease Questionnaire (IBDQ), which measures bowel
function, emotional function, systemic function, and social function.
The Short-form 36 (SF-36), a general measure of QOL including physical
function, bodily pain, general health, social function, mental health
and vitality, was also used. In the 12-week ENCORE induction trial,
patients receiving TYSABRI (n=89) who had failed previous anti-TNFα
therapy achieved statistically significant improvements compared with
those receiving placebo (n=83) on the total IBDQ scale and the two
summary scales of the SF-36, the Physical Component Summary and the
Mental Component Summary.
In the ENACT-2 maintenance trial, patients classified as responders to
TYSABRI and who had an inadequate response to anti-TNFα therapy (n=32)
had total IBDQ scores above 170, a level consistent with remission,
throughout the length of the trial. These levels were significantly
higher than placebo (n=40) at all measurements (P<0.05 at weeks 24, 36,
48, and 60). In addition, at week 60 of therapy, there was no clinically
meaningful difference (i.e. <5 points) between patients receiving
TYSABRI and the general population on seven of the eight individual
scales of the SF-36. While the ability to improve the QOL of patients
who have failed previous anti-TNFα therapy is important, a larger
clinical question is whether these improvements can be sustained during
long-term therapy.
Brian Feagan, M.D., of the Robarts Research Institute at the University
of Western Ontario, and first author of a manuscript published in the American
Journal of Gastrointerology1 detailing the effects of
TYSABRI on the full sample of patients in ENACT-2, said these data
showed a similar impact. “In the more difficult-to-treat subsets of
patients studied here, TYSABRI helped patients with moderate to severe
CD achieve and maintain a considerably improved QOL as measured by the
IBDQ and the SF-36 as compared with placebo,” Dr. Feagan said.
“TYSABRI is an important treatment option for patients with this
debilitating disease who have failed anti-TNFα therapies,” stated Elan
President Carlos V. Paya, MD, PhD.
“Quality of life is an important measure of how CD patients feel in
their day-to-day lives,” said Michael Panzara, MD, MPH, vice president,
chief medical officer of neurology, Biogen Idec.
1 Feagan BG, Sandborn WJ, Hass S, et al. (2007).
Health-Related Quality of Life During Natalizumab Maintenance Therapy
for Crohn’s Disease. Am J Gastroenterol, 102:2737–2746. doi:
10.1111/j.1572-0241.2007.01508.x
About ENCORE and ENACT-2
Data from the ENCORE trial showed that TYSABRI induced response and
remission among patients with moderately to severely active CD, and
objective evidence of inflammation, as measured by elevated C-reactive
protein.
After 12 weeks of therapy, 60% of TYSABRI-treated patients attained
response, compared to 44% of placebo treated patients, and 48% of
patients showed a response at both weeks 8 and 12, compared to 32% of
placebo treated patients (p<0.005 for both). Among the patients who had
inadequate response to prior treatment with inhibitors of TNFα, 38%
achieved a response at weeks 8 and 12.
ENACT-2 presented maintenance data for an additional year of TYSABRI
therapy among patients with an initial response to TYSABRI, after 3
months in ENACT-1. Of patients with response in ENACT-1, sustained
response during ENACT-2 was seen in 61% of patients treated with TYSABRI
at every visit through an additional 6 months of therapy, compared to
29% for placebo. This treatment difference was also sustained through 12
months of additional therapy (54% vs. 20%). Remission was maintained at
every visit with an additional 6 months or 12 months of TYSABRI in 45%
and 40% of patients, respectively, compared to 26% and 15% of placebo
treated patients (p<0.005 at 6 months). Among the patients that had
previously failed anti-TNFα therapy, response and remission was
sustained at every visit through an additional 6 months of TYSABRI in
52% and 30% of patients, respectively. Given the requirement to
discontinue chronic steroids, among the subset of patients(n=65) on
steroids and in whom a clinical response was achieved, approximately
two-thirds were able to discontinue steroids within 10 weeks of
beginning to taper steroids. Although permitted in the clinical trials,
combination therapy with immunosuppressants is not recommended.
About Crohn's Disease (CD)
An estimated 500,000 people in the United States have CD, a chronic and
progressive inflammatory disease of the gastrointestinal tract, which
commonly affects both men and women. CD can have a devastating impact on
the lifestyle of patients, many of whom are young and active. Currently
there is no medical or surgical cure for CD. Many patients fail to
respond to current therapies, including biological therapies such as
agents that inhibit tumor necrosis factor alpha (TNFα). Due to this
failure of current therapies in CD, therapies that have alternate
biological targets provide patients and physicians with therapeutic
options.
The disease usually causes diarrhea and cramping abdominal pain, often
associated with fever, and at times rectal bleeding. Loss of appetite
and weight loss also may occur. Complications include narrowing of the
intestine, obstruction, abscesses, and fistulas (abnormal channels
connecting the intestine and other organs, including the skin), and
malnutrition. Most patients eventually require surgery, which has both
risks and potential short- and long-term complications.
About TYSABRI®
TYSABRI is a treatment approved for relapsing forms of MS in the U.S.
and relapsing-remitting MS in the European Union. According to data that
have been published in the New England Journal of Medicine, after two
years, TYSABRI treatment led to a 68 percent relative reduction
(p<0.001) in the annualized relapse rate compared with placebo and
reduced the relative risk of disability progression by 42-54 percent
(p<0.001).
In early 2008, TYSABRI was approved in the U.S. to induce and maintain
clinical response and remission in adult patients with moderately to
severely active Crohn's disease (CD) with evidence of inflammation who
have had an inadequate response to, or are unable to tolerate,
conventional CD therapies and inhibitors of TNF-alpha. According to the
US full prescribing information, among patients who responded to TYSABRI
in a clinical trial, 54 percent sustained their response through the one
year visit compared to 20 percent of patients receiving placebo, for a
treatment difference of 34%.
TYSABRI increases the risk of progressive multifocal leukoencephalopathy
(PML), an opportunistic viral infection of the brain that usually leads
to death or severe disability. Cases of PML have been reported in
patients taking TYSABRI who were recently or concomitantly treated with
immunomodulators or immunosuppressants, as well as in patients receiving
TYSABRI as monotherapy. Other serious adverse events that have occurred
in TYSABRI-treated patients included hypersensitivity reactions (e.g.,
anaphylaxis) and infections. Serious opportunistic and other atypical
infections have been observed in TYSABRI-treated patients, some of whom
were receiving concurrent immunosuppressants. Herpes infections were
slightly more common in patients treated with TYSABRI. In MS and CD
clinical trials, the incidence and rate of other serious adverse events,
including serious infections, were similar in patients receiving TYSABRI
and those receiving placebo. Common adverse events reported in
TYSABRI-treated MS patients include headache, fatigue, infusion
reactions, urinary tract infections, joint and limb pain and rash. Other
common adverse events reported in TYSABRI-treated CD patients include
respiratory tract infections and nausea. Clinically significant liver
injury has been reported in patients treated with TYSABRI in the
post-marketing setting.
TYSABRI is approved in more than 40 countries.
For more information about TYSABRI please visit www.tysabri.com,
ww.biogenidec.com or www.elan.com
or call 1-800-456-2255.
About Elan
Elan Corporation, plc is a neuroscience-based biotechnology company
committed to making a difference in the lives of patients and their
families by bringing innovations in science to fill significant unmet
medical needs. Elan shares trade on the New York, London and Dublin
Stock Exchanges. For additional information about the company, please
visit www.elan.com.
About Biogen Idec
Biogen Idec creates new standards of care in therapeutic areas with high
unmet medical needs. Founded in 1978, Biogen Idec is a global leader in
the discovery, development, manufacturing, and commercialization of
innovative therapies. Patients in more than 90 countries benefit from
Biogen Idec's significant products that address diseases such as
lymphoma, multiple sclerosis, and rheumatoid arthritis. For product
labeling, press releases and additional information about the company,
please visit www.biogenidec.com.
Safe Harbor/Forward-Looking Statements
This press release contains forward-looking statements regarding
TYSABRI. These statements are based on the companies' current beliefs
and expectations. The commercial potential of TYSABRI is subject to a
number of risks and uncertainties. Factors which could cause actual
results to differ materially from the companies' current expectations
include the risk that we may be unable to adequately address concerns or
questions raised by the FDA or other regulatory authorities, that
concerns may arise from additional data, that the incidence and/or risk
of PML or other opportunistic infections in patients treated with
TYSABRI may be higher than observed in clinical trials, that the
companies may encounter other unexpected hurdles, or that new therapies
for MS with better efficacy or safety profiles or more convenient
methods of administration are introduced into the market. Drug
development and commercialization involves a high degree of risk.
For more detailed information on the risks and uncertainties associated
with the companies' drug development and other activities, see the
periodic and current reports that Elan has filed with the Securities and
Exchange Commission. The companies assume no obligation to update any
forward-looking statements, whether as a result of new information,
future events or otherwise.
