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Saturday, March 24, 2018

Phase III data in The Lancet show Novartis siponimod significantly improves outcomes in patients with Secondary Progressive MS (SPMS)

Mar 23, 2018

EXPAND shows oral siponimod (BAF312) is the first potential therapy to meaningfully delay disability progression in typical secondary progressive MS (SPMS) patients

Results demonstrate siponimod also had beneficial effects on clinical relapses and MRI disease activity, including brain volume loss (brain shrinkage)

Novartis plans to file siponimod for US approval in SPMS in early 2018. Filing for EU approval planned for later in 2018, pending scientific consultation with EMA

Basel, March 23, 2018 - Novartis today announced that the full results from the Phase III EXPAND study of oral, once-daily siponimod (BAF312) in secondary progressive multiple sclerosis (SPMS) were published in the peer-reviewed journal The Lancet. These pivotal results show significant reductions in the risk of three- (primary endpoint) and six-month confirmed disability progression with siponimod versus placebo[1] and favorable outcomes in other relevant measures of MS disease activity[1]. If approved, siponimod would be the first disease-modifying therapy to delay disability progression in typical SPMS patients, including many who had reached a non-relapsing stage and high level of disability.

SPMS is a form of MS that leads to progressive, irreversible disability, largely independent of relapses[2]. Patients transition to SPMS after an initial phase of relapsing-remitting MS (RRMS), the most commonly diagnosed type of MS[3],[4]. There is a high unmet medical need for new treatments that are safe and effective for patients with SPMS[5].

"Today's published, full EXPAND results show that Siponimod can delay disability progression in typical established SPMS patients, where other approaches tested so far have been unsuccessful," said Professor Ludwig Kappos, University Hospital Basel and Principal Investigator of EXPAND. "These data are all the more impressive when considering that the majority of patients already had advanced disability when starting treatment in EXPAND."

  • Siponimod is an oral selective modulator of sphingosine-1-phosphate (S1P) receptor subtypes one and five (S1P1 and S1P5)[6],[7]. Full data from EXPAND show that Siponimod reduced the risk of three-month confirmed disability progression by a statistically significant 21% versus placebo (p=0.013; primary endpoint); efficacy was consistent across many pre-defined sub groups[1]. Other clinically relevant endpoint data show that Siponimod, when compared to placebo:
  • Reduced the risk of six-month confirmed disability progression by 26% (p=0.0058)[1]
  • Slowed the rate of brain volume loss by 23% (relative difference; mean across 12 and 24 months, p=0.0002)[1],[8]
  • Limited the increase of T2 lesion volume by approximately 80% (mean over 12 and 24 months, p<0.0001)[1],[8]
  • Reduced annualized relapse rate (ARR) by 55% (p<0.0001)[1]
  • Did not show a significant difference in the Timed 25-Foot Walk test and MS Walking Scale[1]
  • Demonstrated a safety profile that was overall consistent with the known effects of S1P receptor modulation[1]

"Novartis is dedicated to advancing MS research and pioneering solutions for people living with SPMS - a complex, debilitating disease," said Danny Bar-Zohar, Global Head, Neuroscience Development for Novartis. "The pivotal EXPAND data provides patients, and the medical community alike, with hope that a much needed, safe and effective treatment option is on the horizon for SPMS, for which treatment options are scarce. We look forward to continuing to work with regulatory agencies to make Siponimod available for these patients as fast as possible."


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Friday, March 23, 2018

Lesion accumulation is predictive of long-term cognitive decline in multiple sclerosis


To investigate the long-term progression of cognitive dysfunction and its neuroanatomical correlates and predictors in multiple sclerosis (MS).

To prevent MS-related cognitive decline and possible dementia this study concludes that you have to prevent MS lesion accumulation.

MS lesions are highly predictive of long-term cognitive decline in pwMS.

Read details:


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Sunday, March 18, 2018

VIDEO: Multiple Sclerosis Treatment Algorithm: Avoiding Sins of Our Fathers!

Why do we insist on using an "escalation model" in treating MS? By escalation model, I'm referring to the common practice of starting a person with MS on a low efficacy drug (that is generally considered quite safe) and only "escalating" or "upgrading" to a more effective drug if "things don't work out". Well, what do you think "things don't work out means?" It MEANS BRAIN DAMAGE that can not be given back. This makes no sense to me. I think part of the reason that we use an escalation model is because of the "SINS OF OUR FATHERS." The men and women that were of the generation who trained me recall when there were NO therapies to treat this disease. When the 1st drug came out it was a revolution!! To go from NOTHING to SOMETHING (even if it's interferon beta- low efficacy and pretty darn safe) is a big deal. Over the subsequent 10-15 years more similar low efficacy drugs came to market and those men and women back very comfortable using these low efficacy drugs. As newer, more effective (yes, they work better guys) but more complex drugs came to market, it's my opinion that many of these men and women, who are not towards the later half of their careers, were reluctant to embrace these high efficacy drugs. It's easier for them to use what they always have used, and maybe "escalate" if things don't work out... These same men and women are of the generation who trained me. They taught me their sins and I carried them forward. Until I realized what I was taught didn't make sense and resulted in my patient's accruing brain damage. MY FELLOWS and TRAINEES do not suffer from the sins of my fathers. They will suffer from my sins, and hopefully carry forward an era of rational application of the most effective therapy a given person with MS is comfortable with, started as early as possible! I risk upsetting many people with this video. My intention is NOT to throw stones but rather to spark discussion and debate. Yes I'm very aware that many MS Neurologists HAVE embraced the use of high efficacy drugs. Yes I know I can't generalize to every person at the same time. No I'm not picking on older doctors. I'm trying to share my personal philosophy and why I disagree with what's been done in the past. Agree with me? Disagree? Sound off below and please share your comments and questions. I want to know what you think about the "sins of our fathers" and escalation therapy in treating MS!

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