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PostPosted: Sat Mar 02, 2013 2:40 pm    Post subject: MS TREATMENTS: AUBAGIO/TERIFLUNOMIDE Reply with quote

Aubagio or teriflunomide is a daily oral medication, in 7 or 14mg doses and does not need refrigeration.
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PostPosted: Sat Mar 02, 2013 2:46 pm    Post subject: US FDA approves Aubagio (teriflunomide) for MS [9/14/12] Reply with quote

From the Rocky Mountain MS Center eNews, September 14, 2012:


Quote:
The U.S. Food and Drug Administration has approved a new, once-daily, medication for the treatment of relapsing forms of multiple sclerosis. Aubagio (teriflunomide), made by Genzyme, a Sanofi company, is expected to be available for prescription in the US by October 1, 2012. This will be the second oral treatment available for MS. Aubagio has been investigated in three large clinical trials, and there are several more still underway.

In a phase III study named TEMSO, Aubagio reduced the average number of MS relapses and disease activity on MRI scans by as much as 31.5% over placebo. This study involved 796 people with relapsing forms of MS.

In a phase III TOWER study, 1,169 people with relapsing-remitting MS were randomly assigned to receive Aubagio 7 mg or 14 mg, once daily by mouth, or placebo for 48 weeks. The 14 mg dose reduced relapses by 36.3% versus placebo and a 7 mg dose reduced relapses by 22.3% versus placebo. In the 14 mg dose group, the time to disability progression was reduced by 31.5% and there was no significant reduction in the lower dose group.

In another study, called TENERE, Aubagio was compared with Rebif® (interferon beta-1a, EMD Serono and Pfizer) in relapsing MS, and did not reach its primary endpoint (the main question posed by the study) -- the “risk of failure,” meaning the first occurrence of a relapse, or permanent discontinuation of the study treatment, whichever came first. There was no significant difference in the numbers of participants who experienced events defined as treatment failure among the Aubagio and Rebif groups. This suggests Aubagio and Rebif are similar in their effectiveness.

A range of 22-36 percent reduction in relapse rates is modest, but Aubagio has a good safety profile and with up to 10 years of continuous use in a Phase II extension, it has the longest clinical experience of any investigational oral MS therapy.

The most common side effects of Aubagio experienced by patients in clinical trials included diarrhea, abnormal liver tests, nausea, and hair loss, according to the FDA. Before people begin taking Aubagio, they should have their liver enzymes tested. This testing should continue monthly for the first six months and after the first six months, patients should be monitored for signs of liver damage.

“The true potential of this drug rests in its possible use as a combination therapy,” advises Dr. Timothy Vollmer, Medical Director of the Rocky Mountain MS Center and Professor at the University of Colorado School of Medicine. “Combination therapies ideally combine two moderately effective but safe therapies such that they can be highly effective while maintaining a good safety profile. The result is a more effective and safe treatment option for people with MS.”

Currently there is a study (The TERACLES trial) evaluating the effect of Aubagio taken in combination with interferons. This phase III study aims to recruit 1455 participants worldwide. The study will compare relapse rates while taking one of two doses of teriflunomide or placebo added on to existing beta interferon treatment over a treatment period of between 48 to 152 weeks.

The estimated completion date of this study is April 2014.


Last edited by agate on Sat Mar 02, 2013 3:03 pm; edited 2 times in total
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PostPosted: Sat Mar 02, 2013 2:50 pm    Post subject: Reply with quote

[posted 9/16/12]

More on this from Medical News Today, September 15, 2012:

Aubagio (teriflunomide) Approved For Multiple Sclerosis Treatment, FDA

Quote:
Aubagio (teriflunomide), a once-daily tablet for adults with relapsing forms of MS (multiple sclerosis), has been approved by the US Food and Drug Administration (FDA).

According to experts, the multiple sclerosis prescribing market is worth $12 billion annually. If Aubagio becomes popular, it has the potential to become a major earner for its makers, Sanofi-Aventis. However, it is entering a highly competitive market with very effective existing medications. Novartis' Gilenya and Tysabri from Elan Corp are said to be more effective than teriflunomide.

Director of the Division of Neurology Products in the FDA's Center for Drug Evaluation and Research, Russell Katz, M.D., director of the Division of Neurology Products in the FDA's Center for Drug Evaluation and Research, said:


"In a clinical trial, the relapse rate for patients using Aubagio was about 30 percent lower than the rate for those taking a placebo. Multiple sclerosis can impair movement, sensation, and thinking, so it is important to have a variety of treatment options available to patients."


Multiple sclerosis is a long-term autoimmune, inflammatory disease of the central nervous system. Communication between the brain and other parts of the body are disrupted. Multiple sclerosis is one of the most common causes of neurological disability in young adults. Twice as many females live with MS than males.

People with MS have episodes of relapses (worsening function), followed by remissions (recovery). Eventually, remission periods may be incomplete as the disease progresses. Aubagio has been approved for the initial phases of the disease.

According to clinical trial results, the following side effects among people taking Aubagio were reported: hair loss, nausea, abnormal liver test results, and diarrhea.

Aubagio contains a Boxed Warning explaining to doctors and their patients that there is a risk of liver problems, which may sometimes be fatal, as well as birth defects. Doctors should carry out blood tests beforehand to make sure liver function is normal. During treatment with Aubagio, liver functions tests should be performed periodically.

The boxed Warning also alerts prescribers and their patients about some animal studies which linked the drug with a higher risk of fetal harm. That is why Aubagio is labeled as a Pregnancy Category X drug, meaning that female patients of childbearing age should have negative pregnancy test results (and use effective birth control therapy) before being considered for Aubagio treatment.

When Aubagio is dispensed, it will be accompanied with a patient Medication Guide that provides important instructions on its use and drug safety information. Aubagio is manufactured and marketed by Sanofi Aventis.

Written by Christian Nordqvist




The entire article, which includes a map showing "Multiple Sclerosis Presence Worldwide," can be seen here.
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PostPosted: Tue Mar 05, 2013 11:09 am    Post subject: (summary) MRI outcomes from phase 3 teriflunomide trial Reply with quote

From the MS International Federation Research News, March 5, 2013:


Quote:
Magnetic resonance imaging outcomes from a phase III trial of teriflunomide

Summary:

In this randomised controlled trial, the researchers looked at the effects of oral teriflunomide on MS pathology by MRI. 1088 RRMS patients were randomised to teriflunomide 7mg or 24mg once daily or placebo for 108 weeks.

The primary endpoint was annualised relapse rate and secondary outcomes included confirmed progression of disability. The main MRI outcome was change in total lesion volume. Total lesion volume was 67.4% and 39.4% lower in the 14mg and 7mg dose groups versus placebo.

Overall, teriflunomide showed favourable outcomes on brain MRI activity on several measures, with a dose effect evident on several markers. These results complement the clinical data showing significant teriflunomide-related reductions in relapse rate and disease progression.


authors: Wolinsky JS, Narayana PA, Nelson F

source: Mult Scler. 2013 Feb 27.


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PostPosted: Wed Mar 06, 2013 7:18 pm    Post subject: Earlier posts about teriflunomide/Aubagio: Reply with quote

Earlier threads about teriflunomide that I'm transferring here, with the most recent posted first:

POSTED 10/23/11:

Quote:
From Medscape Medical News, October 21, 2011:

Extension Phase Data on Oral Teriflunomide for MS Released

Megan Brooks


October 21, 2011 (Amsterdam, the Netherlands) — The benefits of oral teriflunomide on clinical and magnetic resonance imaging endpoints in the pivotal phase 3 Teriflunomide MS Oral (TEMSO) study were maintained in the extension study, 5 years after randomization.

"Numerically greater improvements were observed in patients who received teriflunomide throughout the core study and extension compared with those initially assigned to placebo," the study team reported here at the 5th Joint Triennial Congress of the European and Americas Committees for Treatment and Research in Multiple Sclerosis (ECTRIMS/ACTRIMS).

Teriflunomide is a novel oral disease modifier in development for the treatment of relapsing-remitting multiple sclerosis (MS) being developed by Sanofi-Aventis, which also supported the TEMSO trial.

The company announced October 20 that the US Food and Drug Administration has accepted for review the new drug application for oral teriflunomide as a potential therapy for people with relapsing forms of MS. The company plans to file for European regulatory approval in the first quarter of 2012.

"Teriflunomide is a story that is still unfolding, and I think it's very exciting," TEMSO investigator Paul O'Connor, MD, from St. Michael's Hospital, Toronto, Canada, said during a press briefing.

"Long-term studies, so far, show that the drug remains effective in reducing disease activity and, as importantly, the drug is well-tolerated with no new safety signals with prolonged exposure," he added.

Earlier this month, Timothy Coetzee, PhD, chief research officer for the National MS Society, told Medscape Medical News that if teriflunomide is approved by the US Food and Drug Administration, "we see it as a good addition to the physician's toolbox."

TEMSO Extension Study

The phase 3 TEMSO study enrolled 1088 adults with relapsing-remitting MS with an Expanded Disability Status Scale score of 5.5 or higher and either at least 1 relapse in the previous year or at least 2 relapses in the previous 2 years. They were randomly assigned to receive either placebo or teriflunomide (7 or 14 mg/day) and were followed-up for 108 weeks.

In the extension phase, actively treated patients continued on their original dose, whereas those originally randomly assigned to receive placebo were reallocated to receive teriflunomide (7 or 14 mg/day). A total of 742 patients entered the extension phase.

In the original study, published October 6 in the New England Journal of Medicine and reported by Medscape Medical News at the time, both doses of teriflunomide reduced annualized relapse rates by more 31%, with no evidence of dose effect.

In the extension study, the relapse rate "was quite low," Dr. O'Connor reported. "As is common in extension studies, the relapse rate was actually lower than in the pivotal trial. The range of relapse rates over the 5 years was from 0.18 to 0.25, so quite low," he said.

In the extension study, changes from baseline in total magnetic resonance imaging scan lesion volume were numerically lower in patients who received teriflunomide first in the core study and then in the extension phase compared with those initially assigned to placebo, the authors say.

Consistent with observations in the core TEMSO study, both doses of teriflunomide were well-tolerated and had favorable safety profiles in the extension phase. "If we look at adverse events over the long-term in the extension study, there were no surprises," Dr. O'Connor said.

"There was 1 death in each of the treatment groups, and each was cardiac in nature and not drug-related," he reported.

There was a "low and similar" incidence of infections between the groups, and no reports of serious opportunistic infections. In addition, there was "no signal" for increased risk for malignancy or fetal risk. There were no structural or functional deficits reported in 8 healthy newborns with prenatal teriflunomide exposure.

Less Resource Use, Preserved Cognition

In separate analyses presented here in a poster session on October 20, researchers showed that patients receiving teriflunomide used fewer healthcare resources and had preserved cognition vs placebo.

During the briefing, Professor Fred Lublin, MD, neurologist at Mount Sinai Medical Center, New York City, reported data showing that teriflunomide 14 mg "could result in reduced healthcare costs."

The data suggest that the drug reduces annualized relapse rates leading to hospitalization by 36% (P = .015) at the 7-mg dose and by 59% (P < .0001) at the 14-mg dose compared with placebo.

The risk for hospitalization per relapse was also significantly reduced by 43% (P < .001) for the 14-mg dose, and numerically reduced by 6% for the 7-mg dose, although this reduction was not statistically significant.

The benefits on hospitalization for relapse "may suggest an effect on relapse severity," Dr. Lublin said. The drug was also associated with fewer emergency medical facility visits not resulting in hospital admission.

Another tertiary objective of TEMSO was to look at the effects of teriflunomide treatment on cognitive function, measured as a change from baseline scores on the Paced Auditory Serial Addition Test, 1 of 3 components of the Multiple Sclerosis Functional Composite assessment. That assessment was done at baseline and then at weeks 24, 48, 72, and 96.

The least squares mean changes from baseline at week 96 in the Z-score for cognitive function were −0.022 for placebo compared with 0.075 for the 7-mg and 0.073 for the 14-mg teriflunomide groups, with positive scores indicating improvement.

The TEMSO trial was supported by Sanofi-Aventis. Dr. O'Connor has disclosed financial relationships with various commercial entities including Actelion, Bayer, Biogen Idec, BioMS, Cognosci, Daiichi Sankyo, EMD Serono, Genentech, Genmab, Novartis, Roche, Sanofi-Aventis, Teva, and Warburg Pincus. Dr. Lublin has disclosed relationships with several companies including Acorda Therapeutics, Biogen Idec, Novartis, Teva Neuroscience, Genzyme, and Sanofi-Aventis. Dr. Coetzee has disclosed no relevant financial relationships.

5th Joint Triennial Congress of the European and Americas Committees for Treatment and Research in Multiple Sclerosis (ECTRIMS/ACTRIMS): Abstracts P250, P438, P924. Presented October 20 and 21, 2011.

N Engl J Med. 2011;365:1293-1303. Abstract




________________________________________________
POSTED 10/7/10:

From PeerViewInstitute, NTK Watch, October 7, 2010:

Quote:

Acta Neurol Scand. 2010 Sep 29.

Pathophysiology of multiple sclerosis and the place of teriflunomide

Gold R, Wolinsky JS.

Department of Neurology, St. Josef-Hospital, University of Bochum, Bochum, Germany Department of Neurology, The University of Texas Health Science Center at Houston, Houston, TX, USA.


Significant progress in multiple sclerosis (MS) treatment has been made over the last two decades, including the emergence of disease-modifying therapy (DMT). However, substantial unmet medical need persists and has stimulated the search for new therapeutics.

Teriflunomide, one of the several oral DMTs under investigation, is a selective inhibitor of de novo pyrimidine synthesis which exerts a cytostatic effect on proliferating T- and B lymphocytes in the periphery and thus has both antiproliferative and anti-inflammatory properties. Anti-inflammatory effects have been demonstrated in rodent MS models, with reductions in macrophage and B- and T-cell infiltration in the central nervous system and preservation of myelin and oligodendrocytes. Delays in disease onset, reductions in disease relapses and improvements in clinical symptoms were also observed.

A proof-of-concept clinical trial in patients with relapsing MS demonstrated that teriflunomide significantly reduced magnetic resonance imaging (MRI) activity and improved clinical endpoints, with both effects maintained with longer-term treatment. Additional studies have shown that teriflunomide can be safely added to beta interferon or glatiramer acetate therapy, with some evidence of additional improvements in MRI disease burden and clinical signs.

Teriflunomide has an acceptable and manageable safety and tolerability profile. A large clinical programme is underway to further elucidate the role of teriflunomide in the treatment of MS.

PMID: 20880295


__________________________________________________
POSTED 5/28/09:

From the Rocky Mountain MS Center eMS News, May 28, 2009:

Quote:
:
MS Therapies in the Pipeline:
Teriflunomide


In this week’s eMS News, we continue with our series, MS Therapies in the Pipeline.


Teriflunomide, a pill taken once daily, demonstrated beneficial effects in patients with MS in a Phase II clinical trial. The therapy, now in Phase III, continues to show an encouraging safety profile, and investigation is ongoing in a number of Phase II and Phase III studies.

Teriflunomide is chemically and functionally related to leflunomide, an FDA-approved treatment for rheumatoid arthritis. An immunomodulatory drug, teriflunomide is technically an inhibitor of an enzyme known as dihydroorotate dehydrogenase. This means that teriflunomide inhibits rapidly dividing cells, including activated T cells, which are thought to drive the disease process in MS. It is thought that teriflunomide, unlike other similar drugs, does not affect other immune functions, possibly providing patients with a decreased risk of infections and other complications linked to chemotherapy-like drugs.

Results from one Phase II trial were released in 2006. The study involved 179 people: 157 people with relapsing-remitting MS and 22 people with secondary-progressive MS who still experienced relapses. Once a day for the duration of the study – 36 weeks – study participants took an oral placebo, a 7 mg dose of teriflunomide, or a 14 mg dose of teriflunomide. MRI scans were conducted every six weeks in order to measure the primary objective of the study: to determine the effect of treatment on the average number of active lesions of disease activity. Secondary objectives included the frequency of relapses, as well as the progression of disability as measured by the EDSS, a standardized scale.

Among those participants who took teriflunomide, a significant reduction in disease activity was seen. Specifically, teriflunomide-treated patients had significantly fewer active and new lesions per scan. Participants who received 14 mg of teriflunomide demonstrated trends toward a lower annualized relapse rate, a disability progression rate lower than those on placebo, and fewer patients ever having a relapse versus placebo. Because this was a small study, it was not expected to reach statistical significance for relapse rate or disability.

The safety profile of teriflunomide is still being investigated. During the course of the above-mentioned Phase II study, the therapy was well tolerated. Side effects, seen more among study participants taking the higher 14 mg dose of teriflunomide, included upper respiratory tract infections, nausea, headaches, diarrhea, and limb pain. There was also some concern regarding liver function, which will need to be looked into further.

The effectiveness and safety profile of teriflunomide is now being further explored in other studies, including a Phase III study called TEMSO. The number of study participants was expected to reach 1,030, and recruitment concluded in 2008. The principal objective is to study if teriflunomide is able to reduce the frequency of relapses and the progression of disability. The study is likely to conclude this year, and published results are expected in 2010.
There are two other ongoing Phase II studies. One is a two-year study that began in November 2007, which will evaluate the long-term safety and tolerability of teriflunomide as an add-on treatment to interferon-beta or glatiramer acetate in relapsing remitting MS patients. The other study will investigate the effect of teriflunomide on people at high risk for MS: those who have experienced a single neurological event suggestive of demyelination (clinically isolated syndrome, CIS), and MRI findings suggestive of MS. Recruitment for this latter study began earlier this year.

In regards to FDA approval, there are rumors that the sponsor could submit a NDA (New Drug Application) to the FDA within the next year seeking approval of teriflunomide as a new oral treatment for MS.




**************************

Dr. Timothy Vollmer, medical director of the Rocky Mountain MS Center. Dr. Vollmer, widely recognized as one of the world's leading experts on MS, has been working with MS patients for more than 20 years. He joined the Rocky Mountain MS Center in August.
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PostPosted: Wed Jul 17, 2013 1:31 pm    Post subject: (Abst.) Effect on immune response to flu vaccine Reply with quote

From PubMed, July 17, 2013:

Quote:
Neurology. 2013 Jul 12.

Teriflunomide effect on immune response to influenza vaccine in patients with multiple sclerosis


Bar-Or A, Freedman MS, Kremenchutzky M, Menguy-Vacheron F, Bauer D, Jodl S, Truffinet P, Benamor M, Chambers S, O'Connor PW.

From McGill University (A.B.-O.), Montreal, Quebec, Canada; University of Ottawa and the Ottawa Hospital Research Institute (M.S.F.), Ottawa, Ontario, Canada; Western University (M.K.), London, Ontario, Canada; Genzyme, a Sanofi company (F.M.-V., P.T.), Chilly Mazarin, France; Sanofi (D.B.), Bridgewater, NJ; Kleinmachnow (S.J.), Germany; Sanofi (M.B.), Chilly Mazarin, France; Fishawack Communications Ltd. (S.C.), Abingdon, UK; and University of Toronto (P.W.O.), Toronto, Ontario, Canada.

OBJECTIVE:

To investigate the effect of teriflunomide on the efficacy and safety of seasonal influenza vaccine.

METHODS:

The 2011/2012 seasonal influenza vaccine (containing H1N1, H3N2, and B strains) was administered to patients with relapsing forms of multiple sclerosis (RMS) treated for ≥6 months with teriflunomide 7 mg (n = 41) or 14 mg (n = 41), or interferon-β-1 (IFN-β-1; n = 46). The primary endpoint was the proportion of patients with influenza strain-specific antibody titers ≥40, 28 days postvaccination.

RESULTS:

More than 90% of patients achieved postvaccination antibody titers ≥40 for H1N1 and B in all groups. For H3N2, titers ≥40 were achieved in ≥90% of patients in the 7 mg and IFN-β-1 groups, and in 77% of the 14-mg group, respectively. A high proportion of patients already had detectable antibodies for each influenza strain at baseline. Geometric mean titer ratios (post/prevaccination) were ≥2.5 for all groups and strains, except for H1N1 in the 14-mg group (2.3). The proportion of patients with a prevaccination titer <40 achieving seroprotection was ≥61% across the 3 treatment groups and 3 influenza strains. However, fewer patients in the 14-mg than the 7-mg or IFN-β-1 groups exhibited seroprotection to H3N2 (61% vs 78% and 82%, respectively).

CONCLUSION:

Teriflunomide-treated patients generally mounted effective immune responses to seasonal influenza vaccination, consistent with preservation of protective immune responses.

CLASSIFICATION OF EVIDENCE:

This study provides Class II evidence that teriflunomide generally does not adversely impact the ability of patients with RMS to mount immune responses to influenza vaccination.

PMID: 23851964


The abstract can be seen here.
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PostPosted: Sun Oct 06, 2013 3:33 pm    Post subject: (ECTRIMS) Once-daily teriflunomide in CIS patients (TOPIC) Reply with quote

Presented at the annual ECTRIMS conference in Copenhagen, October 2-5, 2013:

Quote:
Window of opportunity in MS treatment

Thursday, October 03, 2013, 12:01 - 12:13

TOPIC main outcomes: efficacy and safety of once-daily oral teriflunomide in patients with clinically isolated syndrome

A. Miller, J. Wolinsky, L. Kappos, G. Comi, M.S. Freedman, T. Olsson, A. Rugina, D. Bauer, J. Delhay, B. Wamil, P. Truffinet, P. O’Connor (New York, Houston, US; Basel, CH; Milan, IT; Ottawa, CA; Stockholm, SE; Chilly-Mazarin, FR; Bridgewater, US; Toronto, CA)

Introduction:

Teriflunomide is a novel, once-daily, oral immunomodulator approved in the USA, Argentina and Australia for treatment of relapsing MS (RMS). Clinical studies of teriflunomide in patients with RMS (TEMSO NCT00134563; TOWER NCT00751881) showed consistent efficacy across key clinical measures and a well-characterised safety profile. TOPIC (NCT00622700) is a phase 3 clinical trial conducted to assess the efficacy and safety of teriflunomide in patients with a first clinical episode suggestive of MS (clinically isolated syndrome, CIS).

Methods:

In TOPIC, a double-blind, placebo-controlled, parallel-group study, 618 patients with CIS were enrolled from Feb 2008 to Sep 2012 (planned end Dec 2012) and randomized to placebo, teriflunomide 7 mg or teriflunomide 14 mg. TOPIC ended early as revised diagnostic criteria enabled earlier diagnosis of MS. The primary and key secondary endpoints were conversion to clinically definite MS (CDMS) and occurrence of a new clinical relapse or MRI lesion. Other efficacy endpoints and safety/tolerability were also assessed.

Results:

Baseline characteristics were generally well balanced among treatment groups. Of the randomized population (n=618), 59.1% had monofocal and 40.9% had multifocal lesion presentation, and 31.4% had >=1 Gd-enhancing lesion. Median time since first neurological event was 2 months.

Compared with placebo, teriflunomide 14 mg reduced the risk of conversion to CDMS by 42.6% (p=0.0087), with a probability of conversion to CDMS at 108 weeks of 24.0% (probability for placebo group 35.9%). Teriflunomide 14 mg also reduced the risk of occurrence of new relapse or new MRI lesion by 34.9% (p=0.0003). Teriflunomide 7 mg reduced the risk of conversion to CDMS by 37.2% (p=0.0271; 108-week probability 27.6%), and the risk of occurrence of new relapse or new MRI lesion by 31.4% (p=0.0020).

The proportion of patients experiencing adverse events (AEs) was similar across treatment groups. The most common AEs reported more frequently in the teriflunomide arms included alanine aminotransferase elevation, headache, hair thinning (14 mg only), diarrhoea and paraesthesia.

Conclusions:

Results from the TOPIC study demonstrate the efficacy of teriflunomide 14 mg and 7 mg in the treatment of patients with CIS, highlighting the ability of early intervention with teriflunomide to delay onset of MS symptoms. To date, all teriflunomide phase 3 studies have shown consistent safety and efficacy, and greater efficacy for a 14 mg dose.
__________________________

Study supported by Genzyme, a Sanofi company.

Aaron E Miller has received research support from Acorda Therapeutics, Biogen Idec, Genentech, Genzyme Corporation, sanofi-aventis, Novartis, Osmotica, Roche and Teva. He has received consulting fees from Acorda Therapeutics, , Biogen Idec, , EMD Serono, GlaxoSmithKline, Merck Serono, Novartis, Nuron Biotech, ONO and sanofi-aventis.

Jerry S Wolinsky has received consulting/speaker fees from Celgene, Consortium of MS Clinics, Genzyme, Janssen RND, Hoffman LaRoche, Medscape CME, Novartis, PRIME, sanofi-aventis, Serono Symposia International Foundation, Teva, Teva Neurosciences; royalties from Millipore (Chemicon International) Corporation; research / contractual support from: Genzyme, National MS Society, National Institutes of Health, and sanofi

Ludwig Kappos has received research support from Actelion, Advancell, Allozyne, BaroFold, Bayer Health Care Pharmaceuticals, Bayer Schering Pharma, Bayhill, Biogen Idec, BioMarin, CSL Behring, Elan, Genmab, Genmark, GeNeuro SA, GlaxoSmithKline, Lilly, Merck Serono, MediciNova, Novartis, Novonordisk, Peptimmune, sanofi-aventis, Santhera, Roche, Teva, UCB, and Wyeth, and from the Swiss MS Society, the Swiss National Research Foundation, the European Union, and the Gianni Rubatto, Novartis, and Roche Research Foundations.

Giancarlo Comi has received consulting fees from Novartis, Teva Pharmaceutical Ind. Ltd, sanofi-aventis, Merck Serono, Actelion and Bayer Scherin; lecture fees: Novartis, Teva Pharmaceutical Ind. Ltd, sanofi-aventis, Merck Serono, Biogen Dompè, Bayer Schering, and Serono Symposia International Foundation.

Mark S Freedman has received research and educational grant support from Bayer Healthcare and Genzyme; honoraria/consultation fees from Bayer Healthcare, Biogen Idec, EMD Canada, Novartis, sanofi-aventis, Teva Canada Innovation and is a member of Company Advisory Board/Board of Directors/or other similar group for Bayer Healthcare, Biogen Idec, Merck Serono, Novartis, sanofi-aventis, and Celgene.

Tomas P Olsson has received consulting fees and/or research support from Biogen Idec, Merck Serono, and sanofi-aventis; participation in scientific advisory boards and/or speaking activities: Merck Serono, Biogen Idec and sanofi-aventis.

Anca Rugina, Deborah Bauer, Jean-Luc Delhay, Barbara D. Wamil, and Philippe Truffinet are employees of Sanofi

Paul O’Connor has received consulting fees and/or research support from Actelion, Bayer, Biogen Idec, BioMS, Cognosci, Daiichi Sankyo, EMD Serono, Genentech, Genmab, Novartis, Roche, sanofi-aventis, and Teva.
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PostPosted: Wed Oct 16, 2013 11:30 am    Post subject: (Abst.) Aubagio vs. subq IFN beta-1a in RRMS... Reply with quote

From PubMed, October 16, 2013:

Quote:
Mult Scler. 2013 Oct 14.

Teriflunomide versus subcutaneous interferon beta-1a in patients with relapsing multiple sclerosis: a randomised, controlled phase 3 trial

Vermersch P, Czlonkowska A, Grimaldi LM, Confavreux C, Comi G, Kappos L, Olsson TP, Benamor M, Bauer D, Truffinet P, Church M, Miller AE, Wolinsky JS, Freedman MS, O'Connor P; for the TENERE Trial Group.

Neurology, University of Lille Nord de France, Lille, France.

BACKGROUND:

In previous studies, teriflunomide significantly reduced the annualised relapse rate (ARR) and disability progression.

OBJECTIVE:

This phase 3, rater-blinded study (NCT00883337) compared teriflunomide with interferon-beta-1a (IFNβ-1a).

METHODS:

Patients with relapsing multiple sclerosis were randomised (1:1:1) to oral teriflunomide 7-or 14mg, or subcutaneous IFNβ-1a 44µg. The primary composite endpoint was time to failure, defined as first occurrence of confirmed relapse or permanent treatment discontinuation for any cause.

Secondary endpoints included ARR, Fatigue Impact Scale (FIS) and Treatment Satisfaction Questionnaire for Medication (TSQM). The study was completed 48 weeks after the last patient was randomised.

RESULTS:

Some 324 patients were randomised (IFNβ-1a: 104; teriflunomide 7 mg: 109; teriflunomide 14 mg: 111). No difference in time to failure was observed. There was no difference in ARR between teriflunomide 14 mg and IFNβ-1a, but ARR was significantly higher with teriflunomide 7 mg. FIS scores indicated more frequent fatigue with IFNβ-1a, though differences were only significant with teriflunomide 7 mg. TSQM scores were significantly higher with teriflunomide. There were no unexpected safety findings.

CONCLUSION:

Effects on time to failure were comparable between teriflunomide and IFNβ-1a. There was no difference between teriflunomide 14 mg and IFNβ-1a on ARR, though ARR was higher with teriflunomide 7 mg. The teriflunomide safety profile was consistent with previous studies.


PMID: 24126064


The abstract can be seen here.
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