Any more positive from Tecfidera

Discuss Tecfidera (BG-12, dimethyl fumarate) as an oral treatment for multiple sclerosis.
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Algis
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Any more positive from Tecfidera

Post by Algis »

Hi Friends;
I am now for 6 months on Tecfidera, and would like to see if now, April 2023; anyone can vouch any improvement due to the med.
I have not much side effects which includes rash, occasional diarrhea (lasting 2 days) and red flush that last 2 hours.

I am EDSS 8+ and honestly don't feel much difference, so I'd like to know if anyone can support the viability of the treatment.

Thanks all; be well,

Algis
Zyklon
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Re: Any more positive from Tecfidera

Post by Zyklon »

Hi Algis,

As I remember you have SPMS. Did you relapse after MSCT? Tecfidera is a somewhat unusual choice. What is the reasoning for it?

Glad to hear you. Take care
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Pain! You break me down, you build me up, believer, believer
Pain! Oh let the bullets fly, oh let them rain
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NHE
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Re: Any more positive from Tecfidera

Post by NHE »

Hi Algis,
Welcome back to ThisIsMS. It’s good to hear from you again.
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Algis
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Re: Any more positive from Tecfidera

Post by Algis »

Thanks for the replies.

@Zyklon : yes, SPMS. No much other option over here (Taiwan). I tried Copaxone injections but they makes me very sick with relapses... I was really down and had to stop it.
The neurologist chose, he knows me since 1998 and follow my case, I trust him.

@NHE thanks :)


The problem now seems more the damaged nerves rather than MS in itself, waiting for nanobots to go there fix the stuff hahahaha

Cheers all
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Re: Any more positive from Tecfidera

Post by Zyklon »

Does your neurologist think there are better options but not available in Taiwan? If so, any chance that you can get your medicine from somewhere else?

Did you try Vitamin B12 and other Bs lately? Any tests?
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Pain! You break me down, you build me up, believer, believer
Pain! Oh let the bullets fly, oh let them rain
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NHE
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Re: Any more positive from Tecfidera

Post by NHE »

Hi Algis,
Algis wrote: Sat Apr 15, 2023 3:45 am I am EDSS 8+ and honestly don't feel much difference, so I'd like to know if anyone can support the viability of the treatment.
Tecfidera is approved for SPMS according to the Prescribing Information. There are two phase III studies discussed. However, both of these were for RRMS. I'm not sure what evidence Biogen has in order to get SPMS approval.

http://www.tecfidera.com/pdfs/full-prescribing-info.pdf

The following is from the Cleveland Clinic's info page for Tecfidera.
Cleveland Clinic wrote:Q: Is DMF effective in progressive MS?

A: The effectiveness and safety of DMF in primary and secondary progressive MS are not known.
https://my.clevelandclinic.org/departme ... -dmf-in-ms

Six months isn't too long for an MS med. You may need to give it more time. Have you had any progression since you've been on it? Is so, has the rate of progression changed?
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Algis
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Re: Any more positive from Tecfidera

Post by Algis »

@NHE : Well; I know 6 months is too short a time, but... I have no progression nor regression since I started Tecfidera.
As I use to say "At lest I don't get worse"

Thanks all; I'll keep working on it and relate if I find changes,
Cheers, be well all :)
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NHE
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Re: Any more positive from Tecfidera

Post by NHE »

Here’s a very small study of Tecfidera in SPMS from 2021. The study ran for 28 weeks. There were only 20 people involved, just 16 pwSPMS and 4 controls. Three of the 16 pwSPMS left the study due to persistent side effects. There was benefit seen in biomarkers of disease activity (neurofilament light chain (NfL) and glial fibrillary acidic protein (GFAP)), but no difference in MRI. There was minor improvement in EDSS. It’s interesting that 5 of the 9 authors were from Biogen.

A pharmacokinetic and biomarker study of delayed-release dimethyl fumarate in subjects with secondary progressive multiple sclerosis: evaluation of cerebrospinal fluid penetration and the effects on exploratory biomarkers
Mult Scler Relat Disord. 2021 Jun;51:102861.

Background: Biomarkers are a useful and reliable measure of disease activity in many fields of medicine. Axonal and glial biomarkers in multiple sclerosis (MS) are being applied more often as technology is improving and becoming increasingly reliable. Nonclinical studies have shown dimethyl fumarate (DMF) to have cytoprotective and anti-inflammatory effects. The purpose of this study is to explore the pharmacokinetics (PK) of DMF (by measuring MMF, the active compound) in serum and cerebrospinal fluid (CSF) as well as relevant biomarker data for patients with secondary progressive MS (pwSPMS) and whether there is objective evidence for neuroprotection in pwSPMS treated with DMF.

Methods: Sixteen pwSPMS had serum and cerebrospinal fluid (CSF) evaluation for PK studies levels of MMF at various time points after ingestion of DMF. The CSF biomarkers neurofilament light chain (NfL), glial fibrillary acidic protein (GFAP), ubiquitin carboxyo-terminal hydrolase isozyme L1 (UCH-L1) and total tau (T-tau) were measured at baseline, week 6 and week 28 after initiating DMF with a starting dose of 120 mg twice daily for 4 weeks, followed by a maintenance dose of 240 mg twice daily. Clinical correlation of these patients with EDSS and MRI at these same time periods were made with the biomarkers. Four normal human volunteers had CSF studies for biomarkers at baseline.

Results: PK data showed CSF MMF concentration 11% of plasma with Tmax of plasma at 5 hr and Tmax of CSF at 7 hr. Biomarker data showed that CS NfL and to a lesser extent, GFAP, but not UCH-L1 nor T-tau showed relevant changes with clinical data. Some pwSPMS receiving DMF showed clinical improvements in Expanded Disability Status Scale (EDSS). Biomarker changes, but not MRI, correlated with clinical measures in this group of pwSPMS over the observation period.

Conclusions: PK data showed that the Tmax of CSF MMF peaked only 2 hours later than that of plasma with 11% measured in the CSF so that MMF readily crossed the blood brain barrier allowing potential direct penetration into the brain. NfL CSF levels, and to a lesser extent, GFAP CSF levels, showed correlation to disease activity in pwSPMS. These data suggest that DMF may have some benefit in reducing disease activity in pwSPMS if studied for a longer duration and larger well-controlled studies are warranted. DMF was reasonably well tolerated but 3 of the 16 patients did discontinue DMF at 6 weeks due to persistent side effects. NfL appeared to be more clinically relevant biomarker than brain MRI in this this group during the 28-week study period.
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Algis
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Re: Any more positive from Tecfidera

Post by Algis »

Thanks :) I will forward that to the neurologist.
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