Results from IMPROVE Study Show MRI Benefits of Rebif Seen Early in Relapsing-Remitting Multiple Sclerosis Treatment and Sustained Over Time
Results from IMPROVE Study Show MRI Benefits of Rebif Seen Early in Relapsing-Remitting Multiple Sclerosis Treatment and Sustained Over Time
• Data presented at the 25th Congress of the European
Committee for the Treatment and Research in Multiple Sclerosis
(ECTRIMS) held in Duesseldorf, Germany, from September 9-12,
2009.
•
Darmstadt, September 11, 2009 - Merck KGaA announced today the
results of the complete 40-week IMPROVE (Investigating MRI
Parameters with Rebif® imprOVEd formulation) study. These data
show a significant 69% reduction in the number of combined unique
brain MRI lesions in patients with relapsing-remitting multiple
sclerosis (RRMS) at 16 weeks after initiation of treatment with
Rebif (44 micrograms three times a week) compared to placebo (3.0
versus 0.9 in the placebo and Rebif groups respectively, p <
0.001), (primary endpoint). A post-hoc analysis showed that this
positive effect can be detected as early as 4 weeks after treatment
initiation. The decreased number of brain lesions was sustained
over the 40-week trial period in patients treated with Rebif. The
16-week results also show a 58% reduction in relapse rate versus
placebo (p = 0.0104).
“The IMPROVE study confirms the consistency of the safety
profile of Rebif, while showing further evidence of the early onset
of action of Rebif on MRI outcomes in patients suffering from
multiple sclerosis,” said Dr. Nicola De Stefano, Professor of
Neurology, Department of Neurological and Behavioural Sciences,
University of Siena, Italy, and the Principal Investigator of the
IMPROVE trial.
The 40-week analysis shows that patients originally randomized to
placebo and switched to Rebif at week 16 had a statistically
significant decrease in combined unique active (CUA) lesions (mean
number of CUA lesions/patient/scan decreased from 2.31 while on
placebo (up to week 16) to 0.65 while on Rebif (weeks 17-40), p
< 0.001) (secondary endpoint).
The safety profile of Rebif reported in this study is consistent with the known safety profile of Rebif. No unexpected safety concerns were identified in this study.
About the IMPROVE Study
The IMPROVE study was a two-arm, randomized, double-blind,
controlled, multicenter, international Phase IIIb study to evaluate
the efficacy, safety and tolerability of a reformulated version of
Rebif in patients with relapsing-remitting MS (according to the
revised McDonald criteria) and evidence of active disease. A total
of 180 patients were randomized in a 2:1 ratio to receive either 44
micrograms of Rebif three times a week, subcutaneously, or placebo
for an initial period of 16 weeks. At the end of the initial
16-week treatment period, patients from the placebo group were
switched in a single-blinded fashion to treatment with Rebif 44
micrograms three times a week subcutaneously for a further period
of 24 weeks (the physician assessing treatment response and side
effects was blinded). Patients who were initially assigned to the
Rebif group continued to receive active treatment for an additional
period of 24 weeks. The duration of the whole treatment period was
40 weeks.
The primary endpoint was the number of combined unique active (CUA) MRI brain lesions at Week 16 in the Rebif group compared with the placebo group, using the baseline MRI scan as a reference. The secondary endpoint was the number of CUA lesions/patient/scan during the double-blind phase (Weeks 1–16) versus the rater-blind phase (Weeks 17–40) in patients originally randomized to placebo.
About Rebif®
Rebif (interferon beta-1a) is a disease-modifying drug used to
treat relapsing forms of multiple sclerosis (MS) and is similar to
the interferon beta protein produced by the human body. The
efficacy of Rebif in chronic progressive MS has not been
established. Interferons are thought to help modulate the
body’s immune system and reduce inflammation. The exact
mechanism is unknown.
Rebif, which was approved in Europe in 1998 and in the US in 2002, is registered in more than 80 countries worldwide. Rebif has been proven to delay the progression of disability, reduce the frequency of relapses and reduce MRI lesion activity and area*. Rebif is available in a 22 micrograms and 44 micrograms ready-to-use pre-filled syringe and a titration pack (8.8 micrograms). Rebif is now available in UK, Germany and Denmark, as well as in Canada, in two multidose cartridges [132 micrograms (three doses of 44 micrograms) and 66 micrograms (three doses of 22 micrograms)] for the use with the RebiSmart device.
Rebif should be used with caution in patients with a history of depression, liver disease and seizures. Most commonly reported side effects are flu-like symptoms, injection site disorders, elevation of liver enzymes and blood cell abnormalities. Patients, especially those with depression, seizure disorders, or liver problems, should discuss treatment with Rebif with their doctors.
The reformulated version of Rebif has been approved in the European Union, Switzerland, Australia and Canada. It is under regulatory review in other countries including the United States.
* The exact correlation between MRI findings and the current or future clinical status of patients, including disability progression, is unknown.
About Merck Serono and multiple sclerosis
Merck Serono is a leader in multiple sclerosis (MS) with
Rebif®(interferon beta-1a), a disease-modifying drug used to
treat relapsing forms of MS, which is registered in more than 80
countries worldwide. Full prescribing information for this product
can be obtained by contacting the Company or visiting its website.
Additional therapeutic options are currently under development at
Merck Serono, including ‘Cladribine Tablets’, currently
undergoing registration review in Europe, as well as several
products in early stage development. Merck Serono also is taking a
leading role in developing an understanding of the role of genetics
in MS.
About multiple sclerosis
Multiple sclerosis (MS) is a chronic, inflammatory condition of the
central nervous system and is the most common, non-traumatic,
disabling neurological disease in young adults. It is estimated
that more than two million people have MS worldwide. While symptoms
can vary, the most common symptoms of MS include blurred vision,
numbness or tingling in the limbs and problems with strength and
coordination. The relapsing forms of MS are the most common
Posted: September 2009
