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Aubagio (Teriflunomide) Summary

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    Aubagio (Teriflunomide) Summary

    I am attempting to summarize information on Aubagio. I have not been involved in the Aubagio trials, have no relationship to Sanofi and claim no medical (or any other) expertise.

    What is Aubagio?
    Teriflunomide is an immunomodulatory, disease-modifying oral drug with anti-inflammatory properties, and is under investigation for the treatment of relapsing-remitting multiple sclerosis (RRMS) and clinically isolated syndrome (CIS).

    Aubagio, an oral medication, initially tested as a complimentary medication to Copaxone and interferon patients. This means you would take Aubagio is addition to Copaxone or interferon therapy. The results were encouraging enough to consider the drug as a standalone therapy choice.

    Who makes Aubagio?
    Sanofi manufactures Aubagio. Sanofi is also the manufacturer of Lemtrada (Campath) another MS medication pending FDA approval.

    Is Aubagio new?
    Teriflunomide is the active metabolite of leflunomide (a rheumatoid arthritis drug). Aubagio has approximately 10 years of continuous use for MS patients in clinical trials. Teriflunomide is not an approved medication for other conditions.

    Is the drug approved?
    Aubagio is still under review by the European Union and US Food & Drug Administration. Approval should be expected prior to Q1 of 2013.

    How does the drug work?
    Aubagio has both immunomodulatory and anti-inflammatory properties. Aubagio:
    - blocks the proliferation and functioning of activated T and B lymphocytes by selectively and reversibly inhibiting a critical mitochondrial enzyme.
    - reduces inflammation by preventing immune cells dividing (multiplying)

    How is Aubagio administered?
    Aubagio is a daily oral medication that has been tested in both 7 and 14 mg doses. I will differentiate between the two doses using Au-7 and Au-14.

    What Aubagio MS trial have been conducted?
    TEMSO, TENERE, TOWER and TERACLES trials were conducted.

    What were the trial results?


    -> Compared to placebo
    Relapses were reduced by 31% when compared with placebo. Relapse rates leading to hospitalization were reduced by 36%. Non-hospital, emergency medical visits were reduced by 42% for Au-14 and 31% for the Au-7 dose.

    Overall, the drug reduced areas of active inflammation in the brain, but MRI lesion activity and related brain atrophy rose at both the doses.

    EDSS disability scores rose moderately at the Au-7 dosage, but remained stable for Au-14 patients.

    -> Compared to Rebif
    Overall, the drug has "disappointed" by not proving to be better than Rebif when compared head-to-head. The annual relapse rate was statistically similar for both Rebif and Au-14 and both performed better than Au-7 dose.
    Patients were almost three times more likely to discontinue Rebif with compared with Au-7 and were twice more likely than Au-14.

    What about side effects?
    Teriflunomide has been well tolerated with no major safety concerns.

    Common side effects:
    The most common side effects experienced by patients were nausea, diarrhea, colds, mild hair loss and/or thinning, back pain and elevated levels of liver enzymes. Between 10-20% of patients indicated they "believed" hair changes were noticeable.

    Serious infections were lower for Au-7 than placebo and slightly higher for patients taking Au-14. Three significant kidney infections occurred in the Au-14 patients, but were successfully treated. There were no patient deaths observed in any of the trials

    Note: Many MS drugs carry pregnancy warnings. A woman that is trying to become pregnant, knowns or suspects they are pregnant should ALWAYS consult with their medical team before starting or stopping any medication they are on.

    Pregnant women were intentionally excluded from the trial. Approximately 33 women were identified as pregnant during the trial period. A few pregnancies were “spontaneously aborted” while other babies were born healthy and without any detectable abnormalities. The drug leflunomide carries a warning against the use during pregnancy.

    Doctors were able to successfully reduce Aubagio system levels by treating with cholestyramine or charcoal after a pregnancy determination was made.

    What will Aubagio cost?
    There is currently no cost information available.

    Will there be a financial assistance program?
    At this time, this information is unknown.

    #2
    Aubagio approved by the FDA!!!

    I began Aubagio 14mg approximately 3 weeks ago. I am very excited so far about this switch. Before Au-14, I was on Avonex. The side effects of the Avonex were awful, but I stayed on it for nearly 2 years because it DID slow down the progression, with no significant changes in my MRI for 2 different 6 month intervals, which is why I dealt with te side effects.

    After reading your thread, I am now concerned about being on Aubagio. I am thrilled that it has an anti-inflammatory agent, but concerned that lesion activity in the brain continued. Although taking all of my symptomatic meds are crucial to quality of life, when taking any type of major, supposedly preventing progression meds, I'm nt looking for symptom relief, rather, slowing down of the progression. You see, lesion activity in the brain, has been my biggest thorn in the flesh...kept me in pain, kept me weak, cognition and memory issues, put me in need of a rollator and a power chair and putting me in the place in my life where I'm going to have to apply for disability!

    Avonex was keeping this under control, since switching, I have taken a major downward slide. I have been thinking that we just need to give the Aubagio some time to begin taking effect, but after readng your thread, not so sure. Insight please!!!

    ** Moderator's note - Post broken into paragraphs for easier reading. Many people with MS have visual difficulties that prevent them from reading large blocks of print. **

    Comment


      #3
      azgraves, lesion activity can continue on any of the therapies. Per the MS Society, "Both doses also had a favorable effect on several MRI measures, including a smaller increase in total lesion volume and fewer new and actives lesions compared with placebo."

      http://www.nationalmssociety.org/abo...gio/index.aspx

      So yes, more disease activity occurred while on the med, as it does with other MS meds, but there was a benefit comparing it to the placebo, thankfully.

      I'm starting Aubagio in the near future; I hope it works out for you!

      Comment


        #4
        Thanks!

        Thanks a bunch for the info Alicious! I will keep everyone posted on how this medication has worked for me....I'm only 3weeks into it as of right now.

        Comment


          #5
          Me too

          My doctor has started the testing so that I can start Aubagio. It tested positive for the jcVirus and well since death is not an option in my world I stopped the Tysabri

          Comment


            #6
            personal update on Aubagio therapy

            I have now begun my second pack. Unsure yet as to the progression it has held back, but want to give an update on one of the side effects.

            One of the most well known side effects of Aubagio is hair thinning. I cannot complain! The hair on my head does not seem to be thinning yet, BUT, I have not shaved my legs or under my arms in 2 weeks....now, before you get judgemental, hear me out....the hair in both areas look like I just shaved one day ago! This is definitely a side effect I could live with for the rest of my life...lol! More updates to come at a later time.

            Comment


              #7
              Please please please let me get that effect!

              Comment


                #8
                Aubagio

                In in the process of getting insurance approval for aubagio. I'm concerned about the severe liver problems it could cause.

                I've been allergic to 4 MS
                injections and can't take Tysabri. I have the positive antibody that they test for to see if we can take it.

                Do any of you take Aubagio? if so, have you had liver damage?:confused

                Thank you!

                Comment


                  #9
                  I hope to start this soon.
                  Will I be albe to take after dinner, before bed, and
                  SLEEP IT OFF?
                  Also wondering if they can be cut in half.

                  Thank you for posting these summaries, Marco.
                  My vision has gotten so that if it isn't on the internet,
                  I dont read it!
                  I know that aubagio wont slow this downhill ride,
                  But I hope it will help.
                  Hoping for help, expecting hell.
                  Wondering if I can sleep through most...or half...of
                  These side FX of dizziess, nausea.
                  Thank you to anyone with ideas.
                  Laura

                  Comment


                    #10
                    I hope to start this soon and I't very happy about that.
                    But the SFX...
                    Will I be able to take after dinner, before bed, and
                    SLEEP IT OFF?
                    Also wondering if the pills can be cut in half.

                    Thank you for posting these summaries, Marco.
                    My vision has gotten so that if it isn't on the internet,
                    I dont read it!
                    I know that aubagio wont slow this downhill ride,
                    But I hope it will help.
                    Hoping for help, expecting hell.
                    Wondering if I can sleep through most...or half...of
                    These side FX of dizziess, nausea.
                    Thank you to anyone with ideas.
                    Laura

                    Comment


                      #11
                      Hmmmmmmmmmm

                      Hi all!

                      I was currently told to go off Copaxone as it has not helped. My doctor, who is great, has suggested the Aubagio however I am reluctant that it is so new and no long term information. I have had 6 new leisions since May and do not really worry about that but I just do not feel myself; my memory and engery level is not doing well. Is anyone out there on this new medication and feel safe taking it?! Anything you can share I would very much appreciate it.

                      Comment


                        #12
                        I am so happy to find this thread. my dr has suggested he may switch me to Aubagio. Because I am presently on Gilenya but am unable to take my beta blocker while on the. Gilenya and that has caused me issues. I will be discussing this further with my dr in early feb please keep me posted on how you are feeling on Aubagio thanks

                        Comment


                          #13
                          I'm on Tysabri right now and my neuro will not switch me to Ambagio.....too may side effects he says.

                          To those of you on Ambagio....What have your side effects been? Great risk of infection???

                          Comment


                            #14
                            Starting Aubagio

                            At my Dr. appointment early Dec we discussed drug options, and he suggested Aubagio. After researching I decided to change over to it. I've now been thru the required process (paper work, blood work, insurance etc) and will be receiving my first prescription this week.

                            I've been on Tysabri (just had #39 and last one last week). No issues or side effects, no relapses since I started it, but slow disability progression has continued. I take Ampyra too.

                            Hoping to see a Forum for Aubagio soon since others are moving over to it or are in discussions with their Dr.

                            Comment


                              #15
                              I called Aubagio and asked them about a forum and they know of none. The drug was approved in Oct. It doesnt seem to have very many people willing to discuss theeir experience even those in the trials so i appreciate anyone keeping us updated on your oppinion. How you feel while on it and your progress... Someone wrote they are not a canidate because they are JCV positive.. I thought that was only Tysabri. Good luck to all

                              Comment

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