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Betaferon Causes Less Injection Site Pain and Injection Site Reactions Than Rebif in Patients With Multiple Sclerosis: Presented at ECTRIMS: "MADRID, SPAIN -- October 4, 2006 -- Interferon beta-1b (Betaferon or Betaseron) 250 mcg treatment causes less injection site pain and fewer injection site reactions than interferon beta-1a (Rebif) 44 mcg, report researchers from the (Betaferon versus Rebif InvestigatinG Higher Tolerability (BRIGHT study). for multiple sclerosis

'This was the first large-scale comparison of these 2 agents for these 2 endpoints,' said lead investigator Karl Baum, MD, university lecturer, Free University of Berlin, Berlin, Germany. 'We saw highly significant differences for pain and skin reactions between these 2 agents.'

The subjects self-injected the agents and self-assessed injection site pain for 15 consecutive injections of the same agent. After each injection, patients completed entries in a 0-100 mm visual analogue scale (VAS) diary immediately after, at 30 minutes and at 60 minutes.

Study nurses checked for reported injection site reactions, and they were then confirmed by physicians.

The researchers questioned each subject about treatment satisfaction relative to pain at the injection site.

Investigators analysed evaluable data on 303 patients on Betaferon and 142 on Rebif. Baseline characteristics of both groups of subjects were comparable.

Significantly more patients were free from pain in the Betaferon arm compared with the Rebif arm at 30 minutes (42.6% vs 19.7%; P < .0001).

The mean proportion of pain-free injections at 30 minutes was greater with Betaferon than with Rebif (79.0% vs 53.3%; P < .0001).....

"

Betaferon Causes Less Injection Site Pain and Injection Site Reactions Than Rebif in Patients With Multiple Sclerosis: Presented at ECTRIMS: "MADRID, SPAIN -- October 4, 2006 -- Interferon beta-1b (Betaferon or Betaseron) 250 mcg treatment causes less injection site pain and fewer injection site reactions than interferon beta-1a (Rebif) 44 mcg, report researchers from the (Betaferon versus Rebif InvestigatinG Higher Tolerability (BRIGHT study). for multiple sclerosis

'This was the first large-scale comparison of these 2 agents for these 2 endpoints,' said lead investigator Karl Baum, MD, university lecturer, Free University of Berlin, Berlin, Germany. 'We saw highly significant differences for pain and skin reactions between these 2 agents.'

The subjects self-injected the agents and self-assessed injection site pain for 15 consecutive injections of the same agent. After each injection, patients completed entries in a 0-100 mm visual analogue scale (VAS) diary immediately after, at 30 minutes and at 60 minutes.

Study nurses checked for reported injection site reactions, and they were then confirmed by physicians.

The researchers questioned each subject about treatment satisfaction relative to pain at the injection site.

Investigators analysed evaluable data on 303 patients on Betaferon and 142 on Rebif. Baseline characteristics of both groups of subjects were comparable.

Significantly more patients were free from pain in the Betaferon arm compared with the Rebif arm at 30 minutes (42.6% vs 19.7%; P < .0001).

The mean proportion of pain-free injections at 30 minutes was greater with Betaferon than with Rebif (79.0% vs 53.3%; P < .0001).....

"

New Autoinjection Device Designed to Work With Betaseron(R) Now Available For Patients With MS

" Berlex, Inc. today announced the
availability of Betaject(R) 3, a new autoinjection device specifically
designed to work with Betaseron(R) (interferon beta-1b) as an optional
injection method for patients with relapsing forms of multiple sclerosis
(MS). The Betaject 3 autoinjection device is an easy-to-use, mechanical
device that automatically delivers subcutaneous injections and may help
make it easier for patients to inject their medication.
"With Betaject 3, we've simplified the process for patients by
eliminating an entire set-up step prior to each injection," said Dr. Ludger
Heeck, Vice President and General Manager of Specialized Therapeutics at
Berlex. "It complements the convenient, refrigeration free-formulation
Betaseron offers, and provides patients with an optional tool to help make
using Betaseron therapy quick and easy."
Ease of Use, Convenience and Support
The Betaject 3 autoinjection device is the latest innovation designed
to assist patients on Betaseron treatment. Eliminating a calibration step
prior to each injection, this optional injection device automatically
delivers subcutaneous injections of Betaseron at a standard preset needle
depth, allowing patients to more easily self-inject their medication than
with devices that require calibration.
Betaseron is the only available refrigeration-free MS therapy that can
be stored at room temperature for longer than 30 days(1). This unique
product attribute simplifies the injection process by eliminating waiting
time and allows patients more options for traveling with and storing their
medication in a discrete, safe manner.
Along with the availability of products designed to help simplify the
treatment process, Berlex offers personal support programs for people using
Betaseron through its MS Pathways and B.E.T.A. Nurse programs. The B.E.T.A.
Nurses assist people with MS beginning therapy with Betaseron by providing
in- person injection training. B.E.T.A. Nurses maintain ongoing
communication throughout the course of therapy to help them and their
caregivers adjust to treatment and ease some of the challenges often
associated with the disease. Research has shown that Betaseron patients who
participated in the B.E.T.A. Nurse program were more likely to maintain
their course of therapy with nearly 90 percent of people in the program
remaining on treatment after one year.
For more information about the optional Betaject 3 autoinjection
device, Betaseron or the B.E.T.A. Nurse program is available by calling MS
Pathways at 1.800.788.7467...."

New Autoinjection Device Designed to Work With Betaseron(R) Now Available For Patients With MS

" Berlex, Inc. today announced the
availability of Betaject(R) 3, a new autoinjection device specifically
designed to work with Betaseron(R) (interferon beta-1b) as an optional
injection method for patients with relapsing forms of multiple sclerosis
(MS). The Betaject 3 autoinjection device is an easy-to-use, mechanical
device that automatically delivers subcutaneous injections and may help
make it easier for patients to inject their medication.
"With Betaject 3, we've simplified the process for patients by
eliminating an entire set-up step prior to each injection," said Dr. Ludger
Heeck, Vice President and General Manager of Specialized Therapeutics at
Berlex. "It complements the convenient, refrigeration free-formulation
Betaseron offers, and provides patients with an optional tool to help make
using Betaseron therapy quick and easy."
Ease of Use, Convenience and Support
The Betaject 3 autoinjection device is the latest innovation designed
to assist patients on Betaseron treatment. Eliminating a calibration step
prior to each injection, this optional injection device automatically
delivers subcutaneous injections of Betaseron at a standard preset needle
depth, allowing patients to more easily self-inject their medication than
with devices that require calibration.
Betaseron is the only available refrigeration-free MS therapy that can
be stored at room temperature for longer than 30 days(1). This unique
product attribute simplifies the injection process by eliminating waiting
time and allows patients more options for traveling with and storing their
medication in a discrete, safe manner.
Along with the availability of products designed to help simplify the
treatment process, Berlex offers personal support programs for people using
Betaseron through its MS Pathways and B.E.T.A. Nurse programs. The B.E.T.A.
Nurses assist people with MS beginning therapy with Betaseron by providing
in- person injection training. B.E.T.A. Nurses maintain ongoing
communication throughout the course of therapy to help them and their
caregivers adjust to treatment and ease some of the challenges often
associated with the disease. Research has shown that Betaseron patients who
participated in the B.E.T.A. Nurse program were more likely to maintain
their course of therapy with nearly 90 percent of people in the program
remaining on treatment after one year.
For more information about the optional Betaject 3 autoinjection
device, Betaseron or the B.E.T.A. Nurse program is available by calling MS
Pathways at 1.800.788.7467...."

Bayer Starts EU1.2 Billion Share Sale for Schering
: "July 6 (Bloomberg) -- Bayer AG is selling 1.2 billion euros
($1.53 billion) in new shares to help fund its takeover of rival
drugmaker Schering AG.

The sale of 34 million new shares to institutional
investors will probably be completed today, the company said in
a statement distributed by DGAP. At yesterday's closing price of
35.68 euros, the sale is worth 1.2 billion euros. Buyers will
get the full-year dividend, Bayer said.

Bayer wants to add Berlin-based Schering's best-selling
multiple sclerosis treatment and Yasmin contraceptive pills to
bolster its healthcare unit. The share sale is one of the final
steps in financing the 17 billion-euro purchase after Bayer sold
its medical diagnostics unit to Siemens AG and issued bonds
worth 2.3 billion euros over the past month.
``
Bayer is moving ahead with the financing,'' Silke
Stegemann, an analyst at Landesbank Rheinland-Pfalz in Mainz,
said in an interview today. ``Bayer is on the right path. A
capital increase always puts pressure on the stock.''

Bayer shares fell 63 cents, or 1.8 percent, to 35.05 euros
at 11:34 a.m. in Frankfurt. They've shed 1.2 percent this year.

The developer of aspirin said last week it expects net
proceeds of 3.6 billion euros from the sale of the diagnostics
division to Siemens. Bayer is also planning to sell its Wolff
Walsrode and HC Starck units.

Job Cuts

Schering will help bolster Bayer's health-care unit with
Betaseron and the world's biggest stable of birth-control pills.
Growth at the enlarged company will be led by new products and
demand for cancer drugs such as Bayer's Nexavar, Chief Executive
Officer Werner Wenning said last month. The drug was approved in
the U.S. last December to treat kidney cancer.

Bayer HealthCare suffered from the recall of the
cholesterol-lowering Baycol in August 2001 and the introduction
of generic rivals to its Cipro antibiotic two years later. While
first-quarter operating profit at Bayer's health care and
pharmaceutical units more than doubled, their operating margins
lag behind U.S. industry peers including Johnson & Johnson and
Pfizer Inc.

Leverkusen, Germany-based Bayer last month had to raise its
bid for Schering by 3 euros a share to 89 euros to persuade
rival Merck KGaA to tender its 21.8 percent stake. As many as
6,000 jobs may be cut in the integration, the company has said...."

CLICK HERE FOR VIDEO: Bayer AG won a 17 billion euro ($21.5 billion) contest for Schering AG, the world's largest maker of birth-control pills, after German rival Merck KGaA accepted a sweetened offer for its stake.

"
Schering investors will get 89 euros a share, or 3 euros more than Bayer's original bid in March, after Darmstadt-based Merck agreed to sell its 21.8 percent holding. Investors who have tendered their shares or commit to doing so today will get that price, Leverkusen, Germany-based Bayer said in a statement.

Bayer shares had their biggest gain in three years. Merck's holding, built up since Bayer's March offer, threatened to derail Bayer's plan to become Germany's largest drugmaker. Bayer wants to add Berlin-based Schering's best-selling multiple sclerosis treatment and Yasmin birth control pills to help its lagging health unit. Merck and Bayer may cooperate on other projects.

``This is very good news,'' Boris Schakowski, a fund manager with Union Investment in Frankfurt said in a telephone interview. ``This is value enhancing for Bayer and this is the best fit in our eyes for Schering. It's a financial gain for Merck, and since they have shown themselves to be cooperative, they have laid a foundation for further cooperation.''

Bayer shares rose 2.28 euros, or 7.5 percent, to 32.84 euros at 4:49 p.m. in Frankfurt after gaining as much as 9.8 percent, the most since March 2003. Shares of Darmstadt, Germany-based Merck climbed 4.05 euros, or 5.9 percent, to 72.50 euros. Shares of Bayer had declined 12 percent between June 8, when Merck said it had a 6 percent stake in Schering, and yesterday.

The spread on Bayer bonds narrowed. The extra yield investors demand to hold Bayer's 6 percent euro-denominated bond due in 2012 instead of government bond narrowed to 71.5 basis points, according to RBC Capital. This is more than the 68 basis points the spread hit when Standard & Poor's put the company on credit watch for downgrade on March 24 of this year.

Earlier Bids

Bayer's bid of 86 euros a share was accepted by Schering's board in March, beating a 77 euro offer from Merck. Today's offer is 3.5 percent more than Bayer's first bid. Merck will have a one-time gain of 400 million euros in the second quarter.

``We're very pleased about Merck's decision, because a lengthy competitive bidding process would have greatly affected Schering's future,'' Bayer Chief Executive Officer Werner Wenning said in the statement.

Schering sells drugs, such as Betaseron for multiple sclerosis, as well as substances that help make organs visible on imaging such as X-rays. The company lost its U.S. operations around World War II, and the American unit grew into Kenilworth, New Jersey-based Schering-Plough Corp. The companies aren't now affiliated.

Deutsche Bank is advising Merck, while Morgan Stanley and Dresdner Kleinwort Wasserstein are advising Schering. Bayer is being advised by Credit Suisse and Greenhill.

Merck bought 2.1 million Schering shares yesterday, the company said in a regulatory filing. Bayer filed a lawsuit in New York yesterday alleging that Merck violated U.S. law by failing to publicly disclose that it was acquiring shares of Schering. Bayer said today it will drop the lawsuit".

Bayer wins Schering with sweetened bid
: "Bayer AG won a 17 billion euro ($21.5 billion) contest for Schering AG, the world's largest maker of birth-control pills, after German rival Merck KGaA accepted a sweetened offer for its stake.Schering investors will get 89 euros a share, or 3 euros more than Bayer's original bid in March, after Darmstadt-based Merck agreed to sell its 21.8 percent holding.Bayer wants to add Berlin-based Schering's best-selling multiple sclerosis treatment and Yasmin contraceptive pills to help its lagging health unit.

o derail Bayer's plan to become Germany's largest drugmaker.

Bayer's bid of 86 euros a share was accepted by Schering's board in March, beating a 77 euro offer from Merck. Yesterday's offer is 3.5 percent more than Bayer's first bid. Merck will have a one-time gain of 400 million euros in the second quarter. Bayer and Merck said yesterday they will look at other ways to cooperate.

"We're very pleased about Merck's decision, because a lengthy competitive bidding process would have greatly affected Schering's future," Bayer Chief Executive Officer Werner Wenning said in a statement.

Schering sells drugs, such as Betaseron for multiple sclerosis, as well as substances that help make organs visible on imaging such as X-rays. The company lost its U.S. operations around World War II, and the American unit grew into Kenilworth, N.J.-based Schering-Plough Corp. The companies aren't now affiliated.

Betaferon sales rose 11 percent last year to 867 million euros, while sales of Yasmin rose 36 percent to 586 million euros..... "

"Schering's Betaseron drug has received approval in Europe as a first-line treatment for the earliest stages of MS:

Schering, which rival drugmaker Bayer (BAYG.DE: Quote, Profile, Research) is trying to acquire, said that results of a trial using Betaseron showed that the drug taken in the early phase of the disease could cut risk of MS by 50 percent.

Betaseron is Schering's top drug and brought in 232 million euros ($299 million) in sales in the first quarter, an increase of 23 percent from a year earlier. It is currently used to treat relapsing remitting MS and secondary progressive MS....."

Betaseron: Bayer Extends Schering Offer to Win More Investors
"Chief Executive Officer Werner Wenning wants to buy Schering to help rebuild the company's drug division and gain products such as the Betaseron multiple sclerosis medicine....Bayer held 18.49 percent of Schering yesterday.....that still leaves it short of the 75 percent it set as a threshold...."

Betaseron: EU says approves Bayer bid for Schering

MORE:
"Being part of a successful experimental medical treatment is something to celebrate.Carol Gross of Morris, who was part of a successful experiment for the treatment of multiple sclerosis, was able to celebrate recently with other participants and the doctors from the University of Chicago.On April 22, at the Embassy Suites in Chicago, she attended a reunion of those involved in the study. Those invited were part of the group who participated in the experimental Betaseron treatment for MS between 1988 and 1993.While Betaseron is not a cure for MS, it is effective in slowing, and in some people, stopping the progression of the disease.For Carol Gross, it has allowed her to continue to live independently, 20 years after she was diagnosed with relapsing-remission MS.%u201CIt is not a cure and it is not a miracle,%u201D she said, %u201Cbut it does work.%u201D She added it is important to go into it with proper expectations.%u201CI think it is remarkable that I am able to tutor and do a little work with the school (Immaculate Conception). I can go out with help,%u201D she said.In 1988, Dr. Barry Arnason of the University of Chicago included her in the experiment to see if Betaseron would be successful in treating MS.Of 48 people included in the study, 16 were given a placebo, 16 were given a partial dose of Betaseron and 16, including Gross, received the full dose."

Arch Neurol -- MORE-September 12, 2005, Bagnato et al. 0 (2005): 62.11.noc40499

MORE - MedPage TodayAlthough treatment with Betaseron (interferon β-1b) appears to reduce the frequency of so-called black hole lesions, as seen by MRI scans of patients with multiple sclerosis, the drug does not contain the damage if one forms.


That's the conclusion of researchers at the National Institute of Neurological Diseases and Stroke here, who studied whether treatment with Betaseron could truncate the duration of black holes over a three-year period in six patients with MS.


"We demonstrate that new black holes may significantly accumulate over time even when interferon β-1b is administered," wrote Francesca Bagnato, M.D., and colleagues in an early online edition of the November Archives of Neurology. "However, repeated administration of the drug did significantly decrease the rate of black hole formation, thus protecting the brain tissue from accumulating degenerative lesions."


As the name implies, black holes appear as areas of darkness on MRI scans of patients with multiple sclerosis. Although Betaseron has been shown to reduce formation of both black holes and contrast-enhanced MS lesions on MRI, it had been unclear whether the drug had any effect on the duration of lesions once they've formed, wrote Dr. Bagnato and colleagues.


"This is clinically relevant because black holes of shorter duration are believed to be associated with the presence of transient edema, and chronic, persisting black holes reflect areas of irreversible axonal loss and permanent damage," the investigators wrote. "Hence, by shortening the duration of black holes, the formation of permanent detriment lesions may be prevented, ultimately exerting a neuroprotective effect."


To test this hypothesis, they clinically assessed and then imaged six MS patients monthly for a total of 72 months. The study covered a 36-month natural history phase and 36-month treatment phase. All scans were performed on a 1.5 Tesla MRI with standard precontrast and postcontrast imaging. Gadopentate dimeglumine 0.1 mmoL/kg was used for contrast.


The investigators counted the lesions present at baseline, but included in the statistical analysis only black holes newly arising from contrast-enhanced lesions during the course of the study. They counted lesions separately during the natural-history phase and treatment phase, and did not include lesions present at the end of the natural-history phase in the count for the next phase.


During the treatment phase, patients received Betaseron 8 MIU every other day.


One of the six patients did not have any contrast-enhanced lesions or new black holes during the treatment phase; this patient was excluded from the statistical analysis.


In each of the remaining five patients, there were increases in the number of new black holes during both the natural history phase and treatment phase, although the rate of accumulation was significantly lower while the patients were receiving Betaseron.


In all, 156 new black holes arose during the natural history period, compared with 31 during the treatment period. Half (49.7%) of the new black holes seen in the natural history phase and 38.9% of those seen in the treatment phase persisted until the end of the respective study phases, and were therefore censored from the analysis.


On Kaplan-Meier analysis, the investigators found that the duration of new black holes that cropped up during treatment were no shorter than those that first arose during the natural history phase.


In all but one of the five patients in the analysis, there were "dramatic" decreases in the number of contrast-enhanced lesions, suggesting an effect of treatment with Betaseron. The patient who did not have a decrease in lesion formation had neutralizing antibody titters that appeared during the third month of therapy, peaked at 1:695 at 16 months, and then declined -- but did not disappear -- to below 1:100 at the beginning of the third treatment year.


"One can postulate that although IFNβ may reduce the frequency of black holes, after the lesion occurs, the drug is not changing the pathological process," the investigators wrote. "However, the significance levels at which differences were detected are not straightforward. Heterogeneity in the number of new black holes for each patient as well as large proportions of censored observations during the study phases may potentially bias these results. Consequently, we cannot distinguish between the possible ability of IFNβ-1b to promote either the formation of less aggressive new black holes or faster recovery from them."

The follow-up to a pivotal clinical trial of a currently available multiple sclerosis (MS) therapy is about to wind to a close at nearly a dozen trial sites around the country. It's the longest follow-up of a clinical trial involving Betaseron (interferon beta-1b), spanning nearly two decades. The latest results from the follow-up trial were released in late September at a meeting of neurologists in San DiegMS Neighborhood : MORE

MORE-Entrez PubMed
The reproductive effects of beta interferon therapy in pregnancy

MORE..Entrez PubMed

Multiple Sclerosis Patient-Turned-Marathoner Sends Message
of Health and Hope to Millions

Fifty-one year-old Ramon Sepulveda accomplished his
inspirational goal of running 12 marathons in 12 months when he crossed the finish line
at the LaSalle Bank Chicago Marathon® this weekend. Sepulveda, who was diagnosed
with multiple sclerosis (MS) seven years ago, initially took up running in order to
maintain his active lifestyle and fight the effects of the unpredictable disease. He
embarked on his year-long marathon challenge in order to inspire other MS patients to
lead active, fulfilling lives despite the disease.

With the support of his family and sponsorship from Berlex, Inc. and the Betaseron®
Champions of CourageSM program, Sepulveda began his marathon endeavor last
November, when he ran in the New York City Marathon. Since then he has run one
marathon each month, including the Boston Marathon in April. The Chicago Marathon
on Sunday was Ramon’s final marathon for the year and marked the completion of his
goal.

“I’m really thrilled that I was able to run in the Chicago Marathon, my 12th race in the
last year,” said Sepulveda. “Many MS patients face difficulty walking, let alone running.
But through determination and maintaining my treatment with Betaseron, I have been
able to stay active, allowing me to live a full, productive life despite my disease.”
MORE

CLICK TO READ

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Effects of dose titrationMultiple sclerosis (MS) treatment with interferon beta is associated with well-known, easily managed adverse events, including influenza-like symptoms and injection-site reactions that decline over time. Initial dose titration has been shown to be one way of limiting these adverse events. Hence, a placebo-controlled, multicentre study of 98 patients was set up to explore whether a slower, four-stage, 4-week titration to a final dose of 250 microg subcutaneous interferon beta-1b might improve tolerability over a more rapid two-stage, 2-week titration in patients with relapsing-remitting MS. Frequency of adverse events was found to be similar between the two regimens: notably, no difference in the incidence of injection-site reactions, with a trend towards fewer influenza-like symptoms in the slow-titration group. Relative to placebo, significantly fewer patients receiving interferon beta-1b relapsed. This was more pronounced in the rapid-titration group than in the slow-titration group, showing that rapid and significant improvements in relapse rates were achieved within 90 days of starting interferon beta-1b. Although a rapid-titration regimen results in a quicker onset of clinical benefit, slow titration showed a non-significant trend towards reduced influenza-like symptoms.

CLICK HERE TO GO DIRECTLY TO THE "BETASERON" HOME PAGE

Neutralizing Antibodies can significantly decrease the effectiveness of IFN-b in the treatment of MS

Three studies published in Neurology which included more than 1200 patients, confirm that the three interferon preparations used to treat relapsing-remitting multiple sclerosis (MS) vary in their rate of production of neutralizing antibodies (NAbs).

Further, there is agreement that NAbs reduce or eliminate the biologic activity and clinical efficacy of the interferon-beta (IFN-b) therapies.

Once-weekly Avonex® (interferon beta-1a IM) was shown to be significantly less likely to induce the development of NAbs than the other two available interferon therapies (Rebif® and Betaseron®). Since NAbs reduce or eliminate the clinical benefits of the interferons, these studies highlight a concern for MS patients, neurologists and those who pay for these medications.

For the many Canadians living with MS, and currently being treated with IFN-b therapy, this is important data.

"MS is a chronic disease, and patients need to have the confidence that their therapy will retain its efficacy throughout the course of treatment, which is often for many years," commented Dr. Stanley Hashimoto, neurologist and former medical director of the University of British Columbia MS Clinic, Vancouver, Clinical Director of the UBC MS Clinic, Vancouver, British Columbia. "These studies confirm that in MS, high titre and persistent NAbs are very important in eliminating the efficacy of the therapeutic agent. It is important that we have available a less immunogenic option such as Avonex®."

While each of the studies showed slightly different rates of NAbs, Avonex® (interferon beta-1a IM) consistently demonstrated the lowest rates as compared to the other IFNb therapies. For example, in the first study the Danish Multiple Sclerosis Study group (Neurology 2005;65:33-39) concluded, "Unlike previous findings reported in the literature we did not find any difference in the proportion of patients treated with [Betaseron®] and [Rebif®] who became NAb-positive, but could confirm that Avonex® is much less immunogenic."

In the second study, Kappos and associates (Neurology 2005;65:40-47) analyzed 395 patients over four years in a controlled trial, and clearly demonstrated the loss of efficacy in terms of relapse rate reduction and disability progression over a significant number of years. It can be assumed from this research, that persisting NAbs beyond the four years will continue to suppress the therapeutic activity of the interferons. This was also echoed by Drs. Giovannoni and Goodman in their Editorial (Neurology 2005;65:6-8).

The third study, authored by Dr. Gordon Francis et al. (Neurology 2005;65:48-55), concluded that, "Neutralizing antibody development in IFN-b-treated patients is correlated with reduced efficacy and is a potential cause for renewed (MS) disease activity."

"Many patients being treated for MS are not getting the efficacy they deserve because of the neutralizing effect of NAbs," said Dr. Hashimoto "This is not to mention the fact that our healthcare system is paying for these drugs without realizing the potential negative effects of neutralizing antibodies."

The Danish Multiple Sclerosis study group agreed that the presence of NAbs decrease or eliminate efficacy of the interferons. They recommended that to avoid these negative consequences, all patients on the therapies should be tested at six-month intervals for two years when it becomes less likely the new positivity will develop. Routine testing will assure patients that they are self-injecting their medication and getting benefit from it.

With recent concerns about existing and future MS treatments, patients and physicians are reassessing currently available therapies, like the interferons. As a result, it is more important than ever to re-evaluate which therapy will provide efficacy over the long-term, including minimizing the formation of NAbs


docguide.com

Interferon beta-1b 250 mcg(1) treatment delayed the onset of clinically definite multiple sclerosis (CDMS) by one year (363 days) in patients with first clinical signs of multiple sclerosis (MS) compared to placebo, according to new findings from the BENEFIT (Betaferon/Betaseron in Newly Emerging MS For Initial Treatment) study presented at today's joint 21st Congress of the European Committee for the Treatment and Research in Multiple Sclerosis/10th Annual Meeting of the Americas Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS/ACTRIMS), Thessaloniki, Greece, by Professor Ludwig Kappos, Professor of Neurology and Clinical Neuroimmunology at the University of Basel, Switzerland.

Results from the study showed that treatment may significantly delay the development of CDMS. Patients in the treatment group experienced an additional 363 days delay in development of CDMS compared to the placebo group. At day 255 of the study, one-quarter of patients in the placebo group had developed CDMS, while it took 618 days for a comparable number of patients to develop CDMS in the treatment group. At the end of the two-year period, 45 percent of the placebo group compared with 28 percent in the interferon beta-1b group (p< 0.0001) had developed CDMS, a relative risk reduction of 50 percent in the group treated with interferon beta-1b. {CLICK FOR MORE}

Betaseron Champions of Courage
Funded by a grant from Berlex Inc., co-developer of Betaseron and a leader
in the field of multiple sclerosis therapy, the Betaseron Champions of Courage
program recognizes the accomplishments of people with MS and provides grants
to support programs that will empower the MS community and provide tools to
help better manage the disease. Since its introduction in 1999, the Betaseron
Champions of Courage program has awarded more than 40 grants to individuals
with MS for initiatives ranging from awareness efforts and artistic endeavors
to cross-country journeys. For more information...CLICK

Interferon beta-1b 250 mcg(1) treatment delayed the onset of clinically definite multiple sclerosis (CDMS) by one year (363 days) in patients with first clinical signs of multiple sclerosis (MS) compared to placebo, according to new findings from the BENEFIT (Betaferon/Betaseron in Newly Emerging MS For Initial Treatment) study presented at today's joint 21st Congress of the European Committee for the Treatment and Research in Multiple Sclerosis/10th Annual Meeting of the Americas Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS/ACTRIMS), Thessaloniki, Greece, by Professor Ludwig Kappos, Professor of Neurology and Clinical Neuroimmunology at the University of Basel, Switzerland.

The multi-centre, double-blind, randomized, phase III BENEFIT study was conducted in 98 centres in 20 countries and included a total of 487 patients presenting with a single clinical episode suggestive of MS, for a period of up to 24 months. Two primary endpoints were evaluated:

- Time to CDMS based on a relapse or EDSS progression 1.5 points

- Time to MS according to the criteria by McDonald et al. (2001)

Results from the study showed that treatment may significantly delay the development of CDMS. Patients in the treatment group experienced an additional 363 days delay in development of CDMS compared to the placebo group. At day 255 of the study, one-quarter of patients in the placebo group had developed CDMS, while it took 618 days for a comparable number of patients to develop CDMS in the treatment group. At the end of the two-year period, 45 percent of the placebo group compared with 28 percent in the interferon beta-1b group (p< 0.0001) had developed CDMS, a relative risk reduction of 50 percent in the group treated with interferon beta-1b.

"Treatment with interferon beta-1b appears to delay patient progression to CDMS when they have been identified as being at risk of developing the disease," said Ludwig Kappos, Professor of Neurology and Clinical Neuroimmunology at the University of Basel, Switzerland and lead investigator of the BENEFIT study. "The BENEFIT study was rigorously controlled and will lend support to making early treatment decisions in patients with the first clinical signs of MS."

In assessing MS progression against the McDonald criteria, patients in the interferon beta-1b group were two times less likely to develop MS: fifty-one percent of the placebo group had already progressed to MS after six months, and 85 percent within two years compared with 28 percent and 69 percent of the interferon beta-1b treated group, respectively (p<0.00001).

The study also demonstrated that people who have symptoms suggestive of MS are willing to accept and comply with this treatment regimen that asks for every other day subcutaneous (s.c.) injections. Ninety-four percent and 93 percent of the placebo and interferon beta-1b patients, respectively, completed the two-year study period. Additionally, 95 percent of all eligible patients chose to enter the BENEFIT follow-up study taking open-label interferon beta-1b every other day treatment. The high patient acceptance to therapy in the study was facilitated through the implementation of a series of steps designed to improve a patient's tolerability to therapy, including a dose titration regimen at the initiation of therapy, the use of auto-injectors and co-medication with an analgesic.

About BENEFIT

The BENEFIT study is the first randomized multi-centre study designed to explore the impact of a high-dose, high-frequency beta interferon therapy on the progression of disease in patients with first clinical signs of MS.

A randomised, double blind, placebo controlled, parallel-group, multi-centre clinical trial, the BENEFIT study was carried out among 487 patients presenting with the first clinical event suggestive of MS within the last 60 days. These patients presented with either "monofocal" (clinical symptoms explained by one single CNS lesion) or "multifocal" (clinical symptoms explained by at least two underlying CNS lesions) symptoms and with a magnetic resonance imaging (MRI) screening scan suggestive of MS. Patients were randomized to one of two groups receiving interferon beta-1b 250 mcg or placebo s.c. every other day for up to 24 months continuously. All study participants completing the double blind study were then invited to participate in a separate open-label follow-up study with interferon beta-1b. The open label study will prospectively assess the impact of early treatment as compared to delayed treatment with interferon beta-1b on the long-term course of the disease for a total observation time of five years, as well as on the formation of new brain lesions as measured by MRI.

(1) Interferon beta-1b is marketed by Schering AG as Betaferon in Europe and by Berlex Laboratories as Betaseron in the U.S. and Canada. In the US, Europe and Japan, interferon beta-1b has been approved for all relapsing forms of MS. It is given on alternate days as a subcutaneous injection of 250 mcg.

The BENEFIT (Betaferon/Betaseron in Newly Emerging MS For Initial Treatment) study is sponsored by Schering AG Germany. {CLICK FOR MORE}

OBJECTIVES: The aim of this study was to identify clinical, magnetic resonance imaging (MRI) and biological markers predictive of long-term clinical response to interferon beta (IFN beta) therapy in patients with relapsing-remitting multiple sclerosis (RRMS).METHODS: Sixty-eight patients treated with IFN beta were followed over a 6-year period. Relapse rate and disability progression were evaluated throughout the study. We considered suboptimal clinical response to be either the presence of sustained disability progression, or more than two relapses. Baseline and 12-month demographic, clinical and MRI findings, as well as the development of neutralizing antibodies (NAbs) against IFN beta during the first year of therapy were analyzed as predictors of long-term clinical outcome..CONCLUSIONS: Variables assessable within the first year of treatment significantly influence relapse rate and disability progression in patients with RRMS treated with IFN beta. These findings may help clinicians to make decisions regarding therapy regimen over time, and highlight the need for a prognostic algorithm.Entrez PubMed

Click to read... The study, which is still ongoing, is labeled Quality Assessment in MS Therapy, or QUASIMS. "The goal of this study was to compare the efficacy of interferon-beta products in relapsing MS in different clinical settings throughout the world," Limmoth and his fellow investigators wrote. Patients were included in the study if they had been taking one of four interferon betas uninterrupted for at least two years. That included 30 micrograms (mcg) of Avonex (interferon beta-1a) once per week, 250 mcg of Betaseron (interferon beta-1b) once every other day, or two different doses of Rebif (interferon beta-1a): 22 mcg or 44 mcg three times per week.

"Efficacy was similar among patients treated with the four different interferon-beta preparations in different countries," the researchers wrote. "Switching between different interferon preparations did not appear to provide additional benefits."

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LINKBetaseron (Interferon beta-1b) is a purified, sterile, lyophilized protein product produced by recombinant DNA techniques and formulated for use by injection.

Interferon beta-1b is manufactured by bacterial fermentation of a strain of Escherichia coli that contains the gene for human interferon betaser17.


Betaseron is indicated for use in patients with relapsing-remitting multiple sclerosis to reduce the frequency of clinical exacerbations.

Relapsing-remitting MS is characterized by recurrent attacks of neurologic dysfunction followed by complete or incomplete recovery.

The safety and efficacy of Betaseron in chronic-progressive MS has not been evaluated.

Betaseron is contraindicated in patients with a history of hypersensitivity to natural or recombinant interferon beta, Albumin Human USP, or any other component of the formulation.

Injection site reactions are common.

They include redness, pain and swelling, and discoloration. Less frequently, injection site necrosis (skin breakdown and tissue destruction) has been observed.

To minimize chances for a reaction, you should rotate injection sites as recommended by your physician.

Do not make an injection into skin that is tender, red, or hard.

If you experience a break in the skin or drainage of fluid from the injection site, you should promptly contact your physician before continuing injections with Betaseron.

Flu-like symptoms are also common. They include fever, chills, sweating, fatigue, and muscle aches.

Taking Betaseron at night may help lessen the impact of flu-like symptoms.

Depression, including suicide attempts, has been reported by patients. If you experience such symptoms, contact your physician promptly.

Multiple Sclerosis Society of London Website - linkMitoxantrone is a potent immunosuppressant used in the treatment of some forms of cancer. It is licensed in the US for the treatment of worsening relapsing remitting MS and relapsing progressive MS. This study investigated the effectiveness of mitoxantrone as a "rescue therapy" for people taking beta interferon who continued to experience disabling relapses or significant disability progression.

Ten people who experienced more than three relapses a month and had rapid disability progression took part in the study. Neurological assessments, MRI scans and blood tests, both to monitor ongoing inflammation, were completed initially, every three months and within three days of a relapse. After six months receiving just beta interferon participants received three infusions of mitoxantrone into the vein, in combination with steroids, shown to shorten the recovery time after a relapse, once monthly. After an additional six months of just beta interferon therapy people who did not show a benefit from the first combination therapy again received intravenous infusions of mitoxantrone, in addition to beta interferon therapy, at the rate of once every three months. All participants were monitored for the following 15-18 months.

During the first three months of mitoxantrone treatment none of the participants experienced any relapses and disability levels stabilised. The amount of inflammation present also significantly decreased compared to levels present during beta interferon therapy alone. During the following six months of just beta interferon treatment the relapse rate remained significantly reduced and inflammation levels remained low. Disability levels for seven of the 10 participants remained stable after the initial mitoxantrone treatment. The remaining three participants received additional mitoxantrone, as described. During further mitoxantrone treatment these participants experienced no new relapses and their disability stabilised. Overall, mitoxantrone was well tolerated with a low number of adverse events reported.

In conclusion, mitoxantrone administered concurrently with beta interferon was effective in significantly reducing both the relapse rate and levels of inflammation in people with MS. It also effectively stabilised disability progression in people with rapidly progressive disease. Positive effects were still detectable after 15 months. The authors highlight that further studies of agents for rapidly progressing MS are warranted.

LINK PubMed
"These data showed that the combination of CTX plus IFN beta halted the progression of disease in active and deteriorating MS patients suggesting the necessity of RCTs to test the efficacy of this combination therapy in active RRMS patients or in patients who experienced treatment failure in response to disease modifying drugs (DMDs)."

The Lancet Neurology...LINK TO ARTICLEInterferon beta was the first therapy to be approved for the treatment of relapsing-remitting multiple sclerosis (MS) more than 10 years ago. Interferon beta reduces relapse rates and disease burden and activity, and it may have beneficial effects on the progression of long-term disease disability. The occurrence of neutralising interferon-beta antibodies has been postulated as a possible cause of the failure of interferon beta in some patients with MS. Here we discuss the basic mechanisms that may account for the generation of an interferon-beta antibody response and its biological implications. We review the evidence for neutralising antibodies as a consequence of interferon-beta treatment, and discuss the implications for the treatment of MS. Strategies to assess and manage the long-term impact of neutralising antibodies will be outlined.