Nationwide Survey Reveals Differing Physician and Patient Perceptions
Regarding Impact of Ulcerative Colitis on Patients' Lives
Authors Conclude Communication and Compliance Important for Addressing
Challenges Uncovered in Survey
AVENTURA, Fla., Dec. 7 /PRNewswire/ -- Nearly three out of four patients
with ulcerative colitis (UC) consider feeling unwell to be a normal part of
life, while gastroenterologists estimate this to be true for only 37 percent
of their UC patients, according to results from a nationwide series of surveys
presented today at the 2007 Crohn's & Colitis Foundation's 6th Annual Advances
in the Inflammatory Bowel Diseases conference.
The series of surveys, titled "UC: NORMAL (New Observations on Remission
Management and Lifestyle)," were sponsored by Shire Pharmaceuticals, a
specialty biopharmaceutical company, which markets once-daily LIALDA(TM) and
PENTASA(R) (mesalamines) for UC.
"Before these surveys, patient and physician views on UC's impact had not
been compared and the 'real-life' impact of UC had not been explored to this
extent," says lead author David Rubin, MD, a gastroenterologist and associate
professor of medicine at the University of Chicago Medical Center who helped
design the surveys. "This series of surveys brings to light some challenges
for the UC community: patients accept a high level of disruption from UC on
their lives; physician and patient views regarding the impact of UC are not in
alignment; and compliance with medications requiring multiple daily dosing is
a challenge."
The UC: NORMAL surveys were fielded online between February and March
2007. For the physician survey, doctors were recruited by fax from a complete
list of US board-certified gastroenterologists. Gastroenterologists who spent
less than half their time in direct patient care were excluded from the study.
At the time the surveys were fielded (prior to the availability of a
once-daily mesalamine), patients reported they found it difficult to adhere to
medication dosing schedules. Forty-six percent of patients (n=451) reported
they had not taken all of their medication in the past week and 41 percent of
gastroenterologists (n=300) believed their patients were not adhering to their
medications.
Interestingly, 83 percent of patients report they would be willing to
change to a new medication if their physician advised that they do so, and 89
percent of patients report that they would be interested in trying a
once-daily 5-ASA medication.
According to survey results, some gastroenterologists may underestimate
the level of disruption UC can have on patient lives. For example, 42 percent
of patients surveyed report symptoms of UC cause some disruption to their
everyday activities, while physicians estimate that this is true for just 17
percent of patients.
These physicians and patients also differ in their beliefs on flare
frequency. UC patients surveyed report experiencing an average of eight
disease flares per year (self-defined: five flares for mild patients, eight
flares for moderate patients, and 11 flares for severe patients).
Additionally, the frequency of disease flares was underestimated by
physicians: 58 percent of gastroenterologists estimate that patients with mild
UC will experience only one flare-up per year; 40 percent of
gastroenterologists estimate patients with moderate UC will experience two
flare-ups per year and 30 percent of gastroenterologists estimate three
flare-ups; while 22 percent of gastroenterologists estimate patients with
severe UC will experience six or more flare-ups per year.
The authors conclude that many patients find it difficult to adhere to
multi-dose medication schedules and have accepted frequent flares, symptoms,
and disruptions as normal rather than re-examining their disease management
strategies and helping to improve compliance. "Improved physician-patient
communication and more convenient medication dosing regimens, such as
once-daily formulations, could result in better disease control and we
believe, improved quality of life for those who suffer from UC," says Dr.
Rubin.
Ulcerative Colitis: Patients' Perception Compared with Other Chronic
Diseases
A second presentation of the surveys' findings analyzed UC patients'
responses to quality of life questions as compared to the responses of
patients with three other chronic diseases (rheumatoid arthritis [RA], asthma,
and migraine) and found that UC takes a relatively high psychological toll.
Patients were recruited through an actively managed panel of approximately
900,000 US adults that includes people from all US demographic and geographic
groups.
More UC patients indicate that they think their disease is controlling
their lives (53 percent; n=451) than RA patients (44 percent; n=309), asthma
patients (19 percent; n=305) or migraine patients (37 percent; n=305)
(p<0.05). UC patients also report feelings of stress (82 percent), depression
(62 percent), and embarrassment (70 percent) at higher rates than patients
with any of the other chronic conditions surveyed (p<0.05).
The majority (62 percent) of patients with UC feel that the disease makes
it difficult to lead a normal life, which is significantly higher than the
proportion of patients with asthma (33 percent) or migraine (59 percent) who
feel this way (p<0.05).
"We conclude that patients with UC experience a significantly higher
psychological burden, and their symptoms are frequently more disruptive to
their lives, than patients with the other diseases in the survey. As such, we
as physicians should initiate communication with UC patients on quality of
life issues in order to better understand the effects this disease is having
on them and aggressively treat the disease and its concomitant psychological
effects to lessen the burden," said Dr. Rubin.
About LIALDA
LIALDA is part of a drug class called aminosalicylates, which contain
5-aminosalicyclic acid (5-ASA). 5-ASA is a well-established drug of choice and
often a first-line treatment for UC. LIALDA is indicated for the induction of
remission in patients with active, mild to moderate UC. The safety and
efficacy of LIALDA have been established for up to eight weeks. LIALDA is the
first new formulation in this class to be approved since 2000. LIALDA is the
only ulcerative colitis treatment that utilizes MMX(R) Technology. LIALDA
with MMX Technology combines a pH dependent gastro-resistant coating, which
delays the release of the medication to the colon (the site of the
inflammation in ulcerative colitis), with a tablet core containing mesalamine
with hydrophilic and lipophilic excipients.
Shire has licensed from Giuliani SpA the exclusive rights to develop and
commercialize LIALDA in the US, Canada, Europe -- known as MEZAVANT(TM) --
(excluding Italy) and the Pacific Rim. Giuliani SpA retains the development
and commercialization rights in Italy. Cosmo Pharmaceuticals SpA, Milan,
developed the MMX technology.
Important Safety Information for LIALDA
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 2.4g/day, 4.8g/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.
Important Safety Information for PENTASA
PENTASA is indicated for the induction of remission and for the treatment
of patients with mildly to moderately active ulcerative colitis.
PENTASA is generally well tolerated. In worldwide clinical trials
(n>2100), the most common adverse events were diarrhea (3.4 percent), headache
(2.0 percent), nausea (1.8 percent), abdominal pain (1.7 percent), dyspepsia
(1.6 percent), vomiting (1.5 percent), and rash (1.0 percent). As with other
mesalamine products, serious adverse events may occur. PENTASA is
contraindicated in patients with a hypersensitivity to salicylates. Caution
should be used in patients with impaired hepatic or renal function. Patients
with pre-existing renal disease, increased BUN or serum creatinine, or
proteinuria should be monitored during PENTASA therapy.
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 and hyperactivity
disorder (ADHD), human genetic therapies (HGT), gastrointestinal (GI) and
renal diseases. The structure is sufficiently flexible to allow Shire to
target new therapeutic areas to the extent opportunities arise through
acquisitions. Shire believes that a carefully selected portfolio of products
with a strategically aligned and relatively small-scale sales force will
deliver strong results.
Shire's focused strategy is to develop and market products for specialty
physicians. Shire's in-licensing, merger and acquisition efforts are focused
on products in niche markets with strong intellectual property protection
either in the US or Europe.
For further information on Shire, please visit the Company's website:
http://www.shire.com.
For further information please contact:
Media Blythe Bertolo (GolinHarris) +1 312 729 4463
Matthew Cabrey (Shire) +1 484 595 8248
GIULIANI SpA
Giuliani SpA, founded in 1889, is a privately owned specialty
pharmaceutical company strategically focused in gastroenterology and
dermatology. It is currently marketing proprietary products for the treatment
and management of ulcerative colitis, Crohn's disease, food intolerances and
dermatological disorders. Giuliani's R&D pipeline includes new chemical
entities and biotechnological products targeted to treat inflammatory and
autoimmune diseases.
COSMO Pharmaceuticals SpA
Cosmo is a specialty pharmaceutical company that aims to become a global
leader in optimized therapies for certain gastrointestinal diseases. The
company's proprietary clinical development pipeline specifically addresses
innovative treatments for IBD, such as ulcerative colitis and Crohn's disease,
and colon infections. Cosmo's most advanced development product is LIALDA(TM)/
MEZAVANT(TM) a treatment for ulcerative colitis that is licensed globally to
Giuliani and Shire Pharmaceuticals. Cosmo's proprietary MMX technology is at
the core of the company's product pipeline and was developed from its
expertise in formulating and manufacturing gastrointestinal drugs for
international clients at its GMP (Good Manufacturing Practice) facilities in
Lainate, Italy. For further information on Cosmo, please visit the Company's
Web site: http://www.cosmopharmaceuticals.com.
THE "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, Shire's results could be materially
affected. The risks and uncertainties include, but are not limited to, risks
associated with: the inherent uncertainty of pharmaceutical research; product
development including, but not limited to, the successful development of
JUVISTA(R) (Human TGF.3) and GA-GCB (velaglucerase alfa); manufacturing and
commercialization including, but not limited to, the launch and establishment
in the market of VYVANSE(TM) (lisdexamfetamine dimesylate) (Attention Deficit
and Hyperactivity Disorder ("ADHD")); the impact of competitive products
including, but not limited to, the impact of those on Shire's ADHD franchise;
patents including, but not limited to, legal challenges relating to Shire's
ADHD franchise; government regulation and approval including, but not limited
to, the expected product approval date of INTUNIV(TM) (guanfacine extended
release) (ADHD); Shire's ability to secure new products for commercialization
and/or development; and other risks and uncertainties detailed from time to
time in Shire plc's filings with the Securities and Exchange Commission,
particularly Shire plc's Annual Report on Form 10-K for the year ended
December 31, 2006.
LIALDA(TM) is a trademark of Shire LLC.
PENTASA(R) is a registered trademark of Ferring A/S.
MMX(R) is a trademark owned by Cosmo Technologies Ltd, Ireland, a
wholly-owned subsidiary of Cosmo Pharmaceuticals SpA.
SOURCE Shire PLC
Blythe Bertolo of GolinHarris, +1-312-729-4463, for Shire PLC; or Matthew
Cabrey of Shire PLC, +1-484-595-8248
