Serono Study Provides 'most convincing evidence
yet that patients with relapsing-remitting MS treated with interferon beta
will develop less permanent disability'(1)
http://finance.individual.com/display_news.asp?doc_id=PR20010628HSTH020&page=news
Thursday June 28 6:16am
GENEVA, June 28 /PRNewswire/ -- Serono
S.A. (SWX Swiss Exchange: SEO and NYSE: SRA) An article published in this
week's issue of Neurology(2) reports the results of PRISMS(3), a comprehensive
four-year study of interferon beta-1a (Rebif(R), Serono) in the treatment
of relapsing remitting multiple sclerosis (RRMS). The conclusions of the
four-year study, involving 560 patients, give further support to the use
of Rebif(R) at high dose (44mcg) three times per week. Moreover, the study
provides evidence that early treatment of MS results in significant benefits
over later treatment.
An accompanying editorial(1) describes
the PRISMS study as providing "the most convincing evidence yet that patients
with relapsing-remitting MS treated with interferon beta will develop less
permanent disability." According to the study results, patients receiving
high dose interferon beta-1a treatment for the full four years of the study
had less impairment and disability than the low dose interferon beta-1a
and placebo groups, and patients who received placebo for the first two
years of the study never regained losses caused by delaying treatment.
Two-year data from the PRISMS study
was published in The Lancet(4) in 1998. Adverse events during years three
and four of PRISMS were similar to those observed in the first two years
of the study with injection site inflammation and flu-like symptoms being
the most common.
The PRISMS data has formed the basis
for approval of Rebif(R) in 67 countries worldwide. Rebif(R) is currently
not approved in the USA because a competitor product holds Orphan Drug
status.
Earlier this year, Serono announced
that, on the basis of the 4-year PRISMS data, the European Commission's
CPMP(5) recommended the highest available dose of Rebif(R) (44mcg 3 times
weekly) as first line therapy (compared to 22mcg 3 times weekly) for those
RRMS patients using Rebif(R).
Background
Multiple Sclerosis (MS) is the most
common disease of the central nervous system in young adults and it is
estimated that up to two million people are affected worldwide, 450,000
of whom are in Europe alone.
Rebif(R) is currently the most frequently
selected treatment for newly diagnosed MS patients in the world outside
the USA. In 2000, Rebif(R) recorded worldwide sales of $254m.
Please see attached further details
on the 4-Year Results of the PRISMS Study.
About Serono
Serono, headquartered in Geneva,
Switzerland, is a global biotechnology leader. The Company has six recombinant
products on the market, Gonal-F(R), Luveris(R), Ovidrel(R), Rebif(R), Serostim(R)
and Saizen(R), (Rebif(R) and Luveris(R) are not approved in the USA). In
addition to being the world leader in reproductive health, Serono has strong
market positions in neurology, metabolism and growth. The Company's research
programs are focused on growing these businesses and on establishing new
therapeutic areas. Currently, there are eleven molecules in development.
In 2000, Serono achieved worldwide
revenues of US$1.240 billion, and a net income of US$301 million, making
it the third largest biotech company in the world based on revenues. The
Company operates in 45 countries, and its products are sold in over 100
countries. Bearer shares of Serono S.A., the holding company, are traded
on the SWX Swiss Exchange (SEO) and its American Depositary Shares are
traded on the New York Stock Exchange (SRA).
4-YEAR RESULTS OF THE PRISMS STUDY
Summary of results
The 4-year data from this study indicate
that:
Five hundred and sixty patients (389
females, 171 males) with RRMS and an EDSS score of 0-5 were initially randomized
to receive IFN-(beta)1a, 3x22 mcg/week (189 patients), 3x44 mcg/week (184
patients) or placebo (187 patients) subcutaneously. After the first 2 years,
placebo patients were re-randomized in a blinded way to receive one of
the two active doses for an additional 2 years, while patients already
on active treatment continued with the same dose in a blinded fashion.
After 2 years, a total of 506 patients
(90%) remained in the trial and continued into the additional 2-year extension
phase. Four hundred and forty-five out of 560 patients (79%) finished the
4 years of the study, demonstrating an excellent adherence to treatment
and study protocol by patients and physicians over 4 years. All patients
underwent clinical and neurological assessments every 3 months during the
first 3 years and every 6 months during year 4, while MRI scans were performed
at least every 6 months during the first 2 years and yearly thereafter.
Persistence of efficacy over 4
years
Even though biased against treatment,
the Intention To Treat (ITT) analysis demonstrated highly significant treatment
advantages of both doses of IFN-(beta)1a versus placebo on number of relapses,
time to first and second relapse, and proportion of patients who were relapse-free
during the full 4 years of therapy. Time to first confirmed progression
was delayed by almost 12 and 18 months for patients on IFN-(beta)1a, 3x22
mcg/week and 3x44 mcg/week, compared with the placebo group. In addition,
the total number of confirmed progressions was reduced.
Burden of disease was defined as
the total area of lesions (abnormal plaques) in the brain, assessed using
MRI scans. These were expressed as a percentage change from baseline. Natural-history
studies indicate that untreated patients with RRMS show an increase in
MRI burden of disease of 5-10% annually. Over years 1-4, patients who received
placebo for 2 years and who were re-randomized to receive IFN-(beta)1a,
3x22 mcg/week and 3x44 mcg/week, for the last 2 years, demonstrated a median
increase in burden of disease of 9.7% and 7.2%, respectively. Patients
receiving IFN-(beta)1a, 3x22 mcg/week throughout, demonstrated a median
increase in burden of disease of 3.4%, while those receiving 3x44 mcg/week
showed a median reduction of 6.2%. There was also a sustained decrease
in MRI activity over 4 years.
Dose-effect
The following outcomes showed a clear
dose-response in this 4-year trial, with IFN-(beta)1a, 3x44 mcg/week, giving
significantly (p<0.05) better results than IFN-(beta)1a, 3x22 mcg/week:
The total exposure to IFN-(beta)1a
during this trial was 1624 patient-years, and the total length of observation
of all patients was 2015 patient-years. IFN-(beta)1a treatment at both
doses was also well tolerated long term, and most of the adverse events
reported were mild in severity. Only 7.5% of patients who received active
treatment during the 4 years of study discontinued treatment due to adverse
events. Side effects observed in the trial were generally those expected
with interferon beta treatment. As expected, the effects most commonly
attributable to active therapy were injection site reactions and flu-like
symptoms. The great majority of side effects were not dose-related, with
the exception of injection site reactions, asymptomatic decreases in white
blood cells and platelet counts and asymptomatic increases in liver enzymes
which were more common in the high dose group. The development of persistent
neutralizing antibodies is associated with reduced efficacy.
Serono International
S.A.
For more information,
please contact:
Serono, Inc.,
Norwell, MA
Source: Serono S.A.
Source: PR Newswire
Some of the statements in this press
release are forward looking. Such statements are inherently subject to
known and unknown risks, uncertainties and other factors that may cause
actual results, performance or achievements of Serono S.A. and affiliates
to be materially different from those expected or anticipated in the forward-looking
statements. Forward-looking statements are based on Serono's current expectations
and assumptions, which may be affected by a number of factors, including
those discussed in this press release and more fully described in Serono's
Annual Report on Form 20-F filed with the U.S. Securities and Exchange
Commission on April 23, 2001. These factors include any failure or delay
in Serono's ability to develop new products, any failure to receive anticipated
regulatory approvals, any problems in commercializing current products
as a result of competition or other factors, our ability to obtain reimbursement
coverage for our products, and government regulations limiting our ability
to sell our products. Serono has no responsibility to update the forward-looking
statements contained in this press release to reflect events or circumstances
occurring after the date of this press release.
Study objectives
Study design
Safety
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