A paper from our group.
There are an immune cells in the brain and spinal cord called the microglia that are important in MS.
It is believed that activation of microglia, as part of the inflammation in MS, contributes to the processes that lead to progressive MS.
In the laboratory Fingolimod (Gilenya), a new drug for treating relapsing MS, reduces the activity of these cells and increases marker of remyelination.
This knowledge supports the testing of Fingolimod (Gilenya) in MS’ers with progressive disease.
For those of you with PPMS there is trial, called the INFORMS study, that is almost fully recruited doing just this.
“Good news? This will be the next trial to report a DMT in PPMS.”
Acknowledgments: This work was done as part of the Promise 2010 programme and was generously funded by the NMSS and the MS Society of GB and NI.
CoI: Multiple and part of this work was supported by Novartis, the makers of Fingolimod (Gilenya)
Epub ahead of print: Jackson SJ, Giovannoni G, Baker D. Fingolimod modulates microglial activation to augment markers of remyelination. J Neuroinflammation. 2011 Jul 5;8(1):76.
Additional reading: microglia, Fingolimod
Previous posts: Please use search engine above to see previous posts on Fingolimod
03 Jun 2011
What exactly are you planning on doing to change that Prof G? Having seen the Fingolimod corporate advert extolling its excellence I have to ask that if it is so effective why it is only approved for RRMS patients? …
30 Apr 2011
In addition to its immune effects Fingolimod readily penetrates the CNS and may have direct effects on neural cells. This central mechanism of action distinguishes Fingolimod from other immunosuppressive drugs and may …
02 May 2011
Fingolimod: brain volume data. As a follow-up to my comment on a previous posting; I predict that if the PPMS trial is positive Fingolimod will be the first drug to be licensed as a neuroprotective therapy in MS. …
21 Mar 2011
(1) Fingolimod is approved in the EU for people with highly active relapsing-remitting multiple sclerosis (RRMS) despite treatment with beta interferon, or in patients with rapidly evolving severe RRMS. …
When will this trial actually report? Also, I was put on Mitoxantrone 2 years ago but it seems I will not be allowed to participate in this study: WHY IS THIS?Furthermore, in RRMS, Fingolimod increases oligodendrocytes in the CNS. Do the scientists think something similar will happen for those with PPMS?
Re "When will this trial actually report?" The trial is a three study. Headline results will be available in late 2014 or early 2015.
Re: "Fingolimod increases oligodendrocytes in the CNS. Do the scientists think something similar will happen for those with PPMS?"Yes, we think that it make work directly on the oligodendrocytes to promote remyelination and recovery.
Prof G, Do you think Fingolimod will have any affect on SPMS
Re "Yes, we think that it make work directly on the oligodendrocytes to promote remyelination and recovery."That's good. I so hope you're righton that. It kind of annoys me I can't have the drug to treat my PPMS right now when it's already on the market for RRMS. I'll be much worse by 2015. Seems unethical not to give it to me.
Re: "Do you think Fingolimod will have any affect on SPMS?"Yes, I don't think there are major differences between PPMS and SPMS. If it works in PPMS it will work in SPMS.
Re: "Seems unethical not to give it to me."The problem is the costs. In the UK it costs £19,000/year and more when you include the costs of starting the drug and monitoring its effects. This figure may be too high for NICE. Until NICE give it a green light we can't even prescribe it for RRMS. The chances that funders or commissioners will allow us to prescribe it off license for PPMS without data is very low. This is the new era we live in; it is run by health economists that want value for money.
£19,000 a year. UnbelievableI remember reading that Fingolimod is derived from something that Traditional Chines Medicine has used for ages.What if one took the herb (or whatever) from a traditional Chinese physician? Would it be any use?
Re “The problem is the costs. In the UK [Fingolimod] costs £19,000/year and more when you include the costs of starting the drug and monitoring its effects.”Come on Prof G, you can’t put a price on good/ improved health, can you?It’s this quagmire of N.I.C.E bureaucracy that does me more in than the actual progressive MS disease (I know I’m overstating there).By the way, who and what is a “health economist”? Sounds like some overpaid executive civil servant who’d rather siphon public coffers to maintain their own inflated salary/ pension rather than doing the right thing and giving me drugs that may improve the quality of my life, exponentially.As far as this “new era” of substandard NHS care is concerned, I thought this newish coalition party is to invest greater sums into public health? It’s not right that £170 billion went on bailing the greedy banking sector and yet you’re all (not you personally Prof G) tearing your hair out over prescribing me £19,000 of drugs that could keep me in work and save me from requesting DLA. Surely that’s “more value for money” than what currently exists.Sometimes I think that one has to take an illiteracy test to become a British health policy maker. It’s so myopic, it benumbs me.On one hand the Government is saying Britain should not legislate for patients with chronic illnesses to opt for assisted dying, which I happen to agree with. On the other hand they simply want those very patients to wallow in their incurable suffering. It’s an illogical stance on Parliament’s part.This is the state of modern Britain. These are the inequities of a first world nation that ostensibly prides itself on duty of care and fairness. Humbug.Shame on this country.
Let’s do the math for giving Fingolimod to PwPPMS:• 100,000 MS sufferers in the UK.• 15% are PPMS, makes 1,500 UK sufferers.• 1500x£19,000= £2,850,000 per year.Add consultancy care – well, can’t be more than the drug, and if it is then consultants need a pay cut.So, now let’s take a moral high ground on drug addiction (The Guardian):• Last year there were an estimated 330,000 people in England alone who are addicted to heroin, crack cocaine, or both.• They cost the country an estimated £15bn a year, and commit an estimated £13.9bn of crime annually. A record 200,000 of those 330,000 are in treatment, which usually involves methadone.• Drug treatment has expanded in recent years, with around 11,000 drugs workers in England and at least 1,000 drug projects across the UK, variously funded by the NHS, councils, the police, charities or combinations of some of them.• Some £800m a year is spent on drug treatment, half of it by the NHS's National Treatment Agency for Substance Misuse.I would rate my PPMS above drug addiction. I did nothing to get the disease and yet no one has given me any treatment to improve my condition.It seems that this country prioritises the wrong people when it comes to health care.
Re "It seems that this country prioritises the wrong people when it comes to health care." I agree; however, we need to the data to support using Fingolimod in PPMS before we make comparisons. We need to show that it is effective!! The drug is not a panacea for MS and comes with risks that are both defined and undefined.The downside is that it will take another 3+ years to get this data. The upside is that Novartis is making a large investment to obtain this data; I would estimate that the PPMS trial is costing them ~$75,000,000-$100,000,000 to perform. Is this a small or large investment? I suspect it depends on your worldview. I think it is an essential investment; an investment of hope. Well done and thank you Novartis; people with PPMS are very grateful that you haven't forgotten, or worse ignored, them.
"I would rate my PPMS above drug addiction. I did nothing to get the disease and yet no one has given me any treatment to improve my condition."I have to agree with you fully on this. If I had a smoking related illness, got a sexually transmitted disease, needed a gastric band op, got an infection in my peircing, the NHS will rush to my aid. You pay you taxes and get a disease which is no fault of your home and the money isn't there.
"I would estimate that the PPMS trial is costing them ~$75,000,000-$100,000,000 to perform. Is this a small or large investment?"It's an investment – they will expect a return on that investment. The company made $10 billion of profit (net income) in 2010.If there are 2 million with MS in the world and 15% are PPMS, there are 300,000 with PPMS.If half take Fingolimod (if it becomes available):150,000 x £19,000 = £2.85 billion (year) = $4.56 billion.We mustn't delude ourselves that they do this for charity!