Shire Presents Results of Five Lialda (mesalamine) Analyses at ACG 2009 Annual Scientific Meeting
SAN DIEGO, Oct. 26 /PRNewswire-FirstCall/ -- Shire plc , the
global specialty biopharmaceutical company, presented the results
of three 5-aminosalicylic acid (5-ASA) persistency analyses at ACG
2009 Annual Scientific Meeting, evaluating persistency of
Lialda® (mesalamine), Asacol® (mesalamine), Pentasa®
(mesalamine) (250mg and 500mg), balsalazide [combined results from
generic balsalazide disodium and Colazal® (balsalazide
disodium)], and Dipentum® (olsalazine sodium) (500mg).
Additionally, on October 27, 2009, Shire will present results of a
Lialda patient experience survey as well as the results of a study
that evaluated the impact of oral 5-ASAs on all-cause health care
utilization and costs among ulcerative colitis (UC) patients with
active disease.
"Persistency plays a significant role in the management of UC,
and this data shows us just how challenging adherence can be for UC
patients," said Roger Adsett, senior vice president of Shire's GI
business unit. "The results of the Lialda and 5-ASA persistency
analyses will provide insights as to how UC patients manage their
mesalamine prescription refills."
Lialda is an FDA-approved, once-daily oral medication for the
induction of remission in patients with active, mild to moderate
UC. The safety and effectiveness of Lialda beyond eight weeks have
not been established.
Factors Affecting Persistence with Mesalamine Therapy: Results
from a Large Pharmacy Database
Poster Presentation: October 25, 2009, San Diego Convention
Center (#293)
Results of a long-term persistency analysis showed that after 18
months of treatment, 13 percent of Lialda patients (n=6,170) were
persistent (continuing). Also, 5 percent of Asacol patients
(n=25,887), 6 percent (250mg) and 10 percent (500mg) of Pentasa
patients (n=7,218), 6 percent of balsalazide [combined results from
generic balsalazide disodium and Colazal] patients (n=4,557), and 6
percent (500mg) of Dipentum patients (n=359) were persistent
(continuing).
The database analysis evaluated the persistency of UC patients
who filled a prescription for the aforementioned 5-ASAs between
March and September 2007. Persistency is defined as the proportion
of patients who remained on their prescribed therapy over an
extended period of time. Continuing patients were defined as those
who refilled their prescription within a period of up to twice the
duration of the prescription that preceded the refill. This
database analysis was neither designed nor intended to compare the
safety and efficacy of the 5-ASA products and no such conclusions
can be drawn from its results.
Lialda is an FDA-approved, once-daily oral medication for the
induction of remission in patients with active, mild to moderate
UC. The safety and effectiveness of Lialda beyond eight weeks have
not been established.
Persistence with Mesalamine Therapy: Long-term Results in
Patients Persistent with Therapy at Outset
Poster Presentation: October 25, 2009, San Diego Convention
Center (#290)
Results of a long-term persistency analysis showed that among
continuing and restart patients who were persistent (continuing)
after three months of therapy, the persistency rates at 12 and 18
months were as follows: Lialda patients (n=3,687) were 47 and 35
percent persistent (continuing), respectively; Asacol patients
(n=10,727) were 34 and 25 percent persistent (continuing); Pentasa
patients who took 250mg (n=555) were 33 and 23 percent persistent
(continuing), and Pentasa patients who took 500mg (n=2,331) were 34
and 25 percent persistent (continuing); balsalazide patients
(n=1,972) were 34 and 24 percent persistent (continuing) [combined
results from generic balsalazide disodium and Colazal]; and
Dipentum patients (500mg) (n=126) were 36 and 27 percent persistent
(continuing). A total of 19,398 patients were identified as
persistent (continuing) patients after three months of therapy and
were included in this analysis.
Persistent (continuing) patients were defined as those who
refilled their prescription within a period of up to twice the
duration of the prescription that preceded the refill. Restart
patients were defined as those who refilled their prescription
after the grace period of twice the duration of their prescription
had elapsed. Refill records for patients who were considered
persistent (continuing) over the initial 3 months of treatment were
analyzed at 12 and 18 months. This database analysis was neither
designed nor intended to compare the safety and efficacy of the
5-ASA products and no such conclusions can be drawn from its
results.
Lialda is an FDA-approved, once-daily oral medication for the
induction of remission in patients with active, mild to moderate
UC. The safety and effectiveness of Lialda beyond eight weeks have
not been established.
Continuing Persistence with Mesalamine Therapy: Results from
Patients Persistent with Long-term Therapy
Poster Presentation: October 25, 2009, San Diego Convention
Center (#292)
A long-term persistency analysis evaluated patients who were
persistent (continuing) at month 12 and followed them for an
additional six months. At month 18, results showed 66 percent were
persistent (continuing) with Lialda (n=1,247), 58 percent with
Asacol (n=2,384), 49 percent with Pentasa (250mg) (n=122) and 59
percent with Pentasa (500mg) (n=542), 59 percent with balsalazide
(n=445), and 56 percent with Dipentum (500 mg) (n=36).
Persistent (continuing) patients were defined as those who
refilled their prescription within a period of up to twice the
duration of the prescription that preceded the refill. In total,
4,776 patients were identified as being persistent (continuing)
with mesalamine therapy over 12 months and were included in this
analysis. This database analysis was neither designed nor intended
to compare the safety and efficacy of the 5-ASA products and no
such conclusions can be drawn from its results.
Lialda is an FDA-approved, once-daily oral medication for the
induction of remission in patients with active, mild to moderate
UC. The safety and effectiveness of Lialda beyond eight weeks have
not been established.
Preliminary Outcomes from a Patient Experience Program on
Ulcerative Colitis Treatment with Lialda® (mesalamine)
Poster Presentation: October 27, 2009, San Diego Convention
Center (#1123)
Results of a patient experience survey showed that patients
reported that their adherence to Lialda was 88 percent. Of the 319
patients initiating Lialda therapy who were invited to participate
in the survey, 110 patients completed the baseline and 60-day
surveys. Patient self-assessment revealed that both symptom
severity and interference with daily activities were reduced
following treatment with Lialda.
Patients were surveyed using a secure Web site or automated
telephone system, where they completed a questionnaire on perceived
symptom severity, self-assessed disruption to daily activities,
prior UC medication and treatment satisfaction, at baseline and at
approximately 30 and 60 days post-baseline. Patients were also
questioned about their understanding of UC and management of the
disease.
The Impact of Oral 5-ASA Adherence on All-Cause Health Care
Costs among Ulcerative Colitis Patients
Poster Presentation: October 27, 2009, San Diego Convention
Center (#1105)
Results of a database analysis showed that adherence with 5-ASAs
for UC patients reduces total all-cause health care utilization and
associated costs. Adherent patients had significantly lower mean
all-cause total costs compared to non-adherent patients ($11,331
vs. $15,177, P<.05). Although mean pharmacy costs for adherent
patients were almost twice as much as those of non-adherent
patients ($4,450 vs. $2,794, P<.05), costs were offset by
significant reductions in all other costs sectors. Adherent
patients had fewer inpatient hospitalizations on average (0.32 vs.
0.46, P<.05), shorter length of stay (8.4 vs. 12.1 days,
P<.05), and significantly lower mean inpatient costs ($2,793 vs.
$7,019, P<.05). The mean costs associated with Emergency
Department visits ($76 vs. $134, P<.05) and other outpatient
ancillary services ($3,092 vs. $4,231, P<.05) also were
significantly lower.
Insurance claims from the PharMetrics Integrated Outcomes
Database were analyzed. Patients who were 18 or older with greater
than or equal to 1 claims for a UC diagnosis (ICD-9 556.xx) between
June 1997 and August 2005, with greater than or equal to 30 days of
oral 5-ASA treatment and greater than or equal to 1 corticosteroid
prescription (proxy for active disease) within 12 months following
5-ASA initiation (n=1,693) were identified for the study. Patients
had continuous enrollment for greater than or equal to 6 months
prior to and greater than or equal to 12 months following 5-ASA
initiation.
Cumulative exposure to oral 5-ASAs over a 12-month period was
calculated using the Medication Possession Ratio (MPR), defined as
total 5-ASA days supplied during the period divided by 365 days.
Patients with an MPR of at least 0.80 were classified as adherent.
All-cause resource utilization and costs were computed over the
12-month follow-up period and compared between adherent and
non-adherent patients.
About Lialda Important Safety Information
Lialda tablets are indicated for the induction of remission in
patients with active, mild to moderate ulcerative colitis. Safety
and effectiveness of Lialda beyond 8 weeks have not been
established.
Lialda is contraindicated in patients with hypersensitivity to
salicylates (including mesalamine) or to any of the components of
Lialda. Caution should be exercised when treating patients with
pyloric stenosis or those allergic to sulfasalazine. Mesalamine has
been associated with an acute intolerance syndrome (3 percent of
patients in clinical trials with mesalamine or sulfasalazine) that
may be difficult to distinguish from a flare of inflammatory bowel
disease. If acute intolerance syndrome is suspected, prompt
withdrawal is required. Mesalamine-induced cardiac hypersensitivity
reactions (myocarditis and pericarditis) have been reported.
Reports of renal impairment have been associated with mesalamine
medications. In patients with renal impairment, caution should be
exercised, and Lialda should be used only if the benefits outweigh
the risks. No information is available for patients with hepatic
impairment.
Lialda is generally well tolerated. The majority of adverse
events in the double-blind, placebo-controlled trials were mild or
moderate in severity. In clinical trials (N=535), the most common
treatment-related adverse events with Lialda 2.4 g/day, 4.8 g/day
and placebo were headache (5.6 percent, 3.4 percent and 0.6
percent, respectively) and flatulence (4 percent, 2.8 percent and
2.8 percent, respectively). Pancreatitis occurred in less than 1
percent of patients during clinical trials and resulted in
discontinuation of therapy with Lialda.
Additional information about Lialda and Full Prescribing
Information are available at Lialda.com.
For further information, please contact:
Media Blythe Bertolo (GolinHarris) +1 312 729 4463
Matthew Cabrey (Shire) +1 484 595 8248
Notes to editors
SHIRE PLC
Shire's strategic goal is to become the leading specialty
biopharmaceutical company that focuses on meeting the needs of the
specialist physician. Shire focuses its business on attention
deficit hyperactivity disorder (ADHD), human genetic therapies
(HGT) and gastrointestinal (GI) diseases as well as opportunities
in other therapeutic areas to the extent they arise through
acquisitions. Shire's in-licensing, merger and acquisition efforts
are focused on products in specialist markets with strong
intellectual property protection and global rights. Shire believes
that a carefully selected and balanced portfolio of products with
strategically aligned and relatively small-scale sales forces will
deliver strong results.
For further information on Shire, please visit the Company's
website: www.shire.com.
"SAFE HARBOR" STATEMENT UNDER THE PRIVATE SECURITIES LITIGATION
REFORM ACT OF 1995
Statements included herein that are not historical facts are
forward-looking statements. Such forward-looking statements involve
a number of risks and uncertainties and are subject to change at
any time. In the event such risks or uncertainties materialize, the
Company's results could be materially adversely affected. The risks
and uncertainties include, but are not limited to, risks associated
with: the inherent uncertainty of research, development, approval,
reimbursement, manufacturing and commercialization of the Company's
Specialty Pharmaceutical and Human Genetic Therapies products, as
well as the ability to secure and integrate new products for
commercialization and/or development; government regulation of the
Company's products; the Company's ability to manufacture its
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Lialda® is a registered trademark of Shire LLC.
MMX® is a registered trademark owned by Cosmo Technologies
Ltd, Ireland, a wholly owned subsidiary of Cosmo Pharmaceuticals
SpA.
Pentasa® is a registered trademark of Ferring A/S. Asacol® is a registered trademark of Medeva Pharma Schweiz AG. Dipentum® is a registered trademark of UCB Pharma Limited. Colazal® is a registered trademark of Salix Pharmaceuticals, Inc.
Source: Shire plc
CONTACT: Blythe Bertolo of GolinHarris, +1-312-729-4463, for
Shire; or
Matthew Cabrey of Shire, +1-484-595-8248
Web Site: http://www.shire.com/
