Did I Jinx Myself?

A week ago, I had a few GI problems: three or four days with mild diarea, gas, and feeling a bit nauseous. Did I jinx myself? Or is it unrelated with taking Tecfidera. If it is related it would be weird having the first symptoms a month and a half after starting.

Last week-end, things were much better for me. Unfortunately, my wife had sever nausea, vomitting, etc. Most likely, this was some kind of virus.

As my neurologist told me, one thing that we tend to do when we have MS is attribute a bunch of things to the disease that are not necessarily a symptom. I guess, the same goes for attributing things to the treatment.

All is back to normal now!

Update - a week later

It's been about a week since my last update.

Tecfidera: thumbs up
No symptoms so far, nothing. I take the pills in the morning with breakfast and at night with supper. I have not been punctual, i.e. exactly 12 hours in between because of my schedule, but I try to keep doses between 10 and 14 hours apart.

There has been no issues. Also, I don't make sure, as I did at first, that I have a good portion of protein with the medication. I just eat normally.

I also went to the pharmacy to fill the next month long prescription for Tecfidera. I was kind of pissed because, I had called ahead to make sure the 240mg pills were ordered (they don't keep it at the local pharmacy). When I picked them up, two days later, they had ordered 120mg pills, just twice as many.

It's no big deal, but it shows that they are not extremely reliable and I need to order the updates at least a week before in case they make another error.

MRI
Had an MRI done a few days ago. It's the six months follow-up MRI. It shows that it's been six months since I had my first and last episode. I'll get the results at my next appointment with the neurologist in October.

MS symptoms
They are still there, that is I have a bit of blurry vision or slow vision. When my body heats up, as on a long run last Sunday, the blurry vision gets worse.
But the good news is that, I seem better at work. I'm not feeling as tired as the day progresses.

Running on MS - Blurry vision

As I said in a previous blog article, my MS symptoms are visual: blurry vision and double vision were my main symptoms during my last flare. These last three weeks have been up and down in terms of MS symptoms. I have had some blurry vision, on and off. It is not as acute as during my last flare, but definitely present.

The Biogen nurse told me, the symptoms could be happening because of the temperature going up and down lately. I don't seem to find an obvious correlation between outside temperature and my MS symptoms and I do seem more sensitive to exercise intensity. Thursday, my running training involved a 2km warm-up and an easy pace, followed by a tempo run consisting of: 2km on a slight uphill, then up long stairs (260 steps), running two by two, and a slight uphill of about 1km. After the first kilometer of the tempo (tempo means speed I can say two short words in, no more and no less), I started having blurred vision. That was even before I hit the stairs. When running up the stairs, intensity went up and blurred vision accentuated. All that to say, it's not the first time I run tempo runs, I do so almost every week. But it seemed that it's getting worse.

This could be related to the fact that my blurred vision increased overall. When I started Tecfidera, I thought it was improving. And although, the Tecfidera literature did not mention any improvement in symptoms, I thought it might help some. But now, I'm back to the same or worse. We're in August, one month left until temperatures start going down. We'll see if this blurriness tapers off.

Regular dose (240 mg) - Started

Yesterday, I upped my dose of Tecfidera and started taking the regular dose (240mg). Since the starter pack contains 56 pills of 120mg, I’m simply taking two pills instead of one until I go through them. The pharmacist told me that the following packs will have 240mg pills.

So far so good! No side effects after three. Still not claiming victory as I don’t want to jinx it and side effects are not ruled out in a few days. But, things are looking good so far.

Looking at the Tecfidera prescription information, the table below describes the incidence of each side effect. It shows that things are not as bad as it seems, especially when reading forums. It's normal that people that are having side effects tend to go on the forums much more often than people that don't.

Unfortunately, if you read the data above, you can't draw conclusions at the number of people that had no side effects as the types are independent. What I mean, is that you can’t add the numbers together. 

The most obvious example is that a person experiencing vomiting is likely to also experience nausea. Here 12% of patients in the study experienced nausea, and 9% experienced vomiting. I would be that almost all patients that vomited also had nausea. The same goes, maybe to a lesser extent, with other GI issues. Now, how independent are GI issues from flushing, the most frequent side effect? Now, if both side effects, GI issues and flusing, were completely independent, i.e. having one doesn’t up the chances of having the other, to find how many unlucky patients had both GI issues and flushing, you need to multiply the percentages. Here, I’ll assume GI issues are pretty dependent and guess 20% of patients had some GI issue. 

So the percentage of patients having both is 20% x 40% = 8%. This means that 32% only had flushing, 12% only had GI issues. Which brings the proportion of patients that had none of the two side effects to 48%. As for the other side effects registered, they’re mostly skin issues that I would guess affect the people that experienced flushing. 48% had no side effects, see it as you wish, the glass is half full or half empty.

Furthermore, with the same kind of estimates and statistical evaluation, 17% of patients taking the placebo have experienced some of the side effects listed! These are unrelated to the Tecfidera administration, obviously. So the glass is even fuller! You're 35% more likely to experience some side effect if you're on Tecfidera than if you're not. This added to the fact that most side effect, while on Tecfidera, seem to reduce over time and sometimes disappear, no wonder it's been judged by an external review as the drug with the least side effects.

First week summary

Today, the Biogen nurse called me to ask me how my first week went. Yes, today is my 7th day on Tecfidera and the last day on the half dose.

So far, I've been very lucky in that the side effects that are often reported with the drug have not showed up.
I had one case where I had a mild stomach burn, but that could also have to do with the pasta and tomato sauce I had that night. Other than that, nothing: no flushing, no nausea, nothing.

Let's see of I'm as lucky starting tomorrow, as I double the dose. The Biogen nurse, which is replacing my regular nurse on vacation, told me that if I didn't have side effects the first week, it's very likely I don't get any next week. But I'm still a bit anxious because I read cases of people getting them only when doubling the dose or even a few days later.

I also discussed the aspirin taken 30 minutes before. The nurse told me that I could discontinue it if I want, since I didn't get any side effects, but I'll continue taking the low dose aspirin this week just in case. I will discontinue it the following week if I don't experience any flushing.

Tecfidera - day 6 and exercise

Today I started day 6 of my Tecfidera treatment. Tomorrow will be my last half dose and, even though I consider myself very lucky not having any side effects yet, I'm a bit nervous about doubling the dose since I read that this is when a number of people start having their side effects.

In any case, the good thing about Tecfidera, as confirmed by my neurologist, is that it has a very short half life. This means that it gets out of your system very fast when stopped, if ever the side effects become unbearable.

Physical Activity

I started, in my last blog article to talk about multiple sclerosis, Tecfidera and physical activity. In my case, this involves running, cycling and swimming, since I train for triathlons.

First, let me say that I consider myself very lucky that my MS symptoms did not touch my motor abilities, at least directly. The symptoms I had during my last flare related to my vision, more specifically blurred and double vision. If it had incapacitated my legs or arms, this would have had a much bigger impact on my life, since triathlon training is what keeps me busy outside of work and family. Even my social life revolves around my training buddies.

After my last flare up got treated, it took a week or two to get all the blurriness gone, but even after a week or so, I felt relatively safe to ride my bicycle. The first couple of weeks, I also had the blurriness reappear during effort. On a run, I felt a bit of a blurry vision, starting 20 minutes in the run and had to concentrate a bit more if I had to run up a curb, for example. My neurologist said it was normal since MS symptoms usually reappear when the body temperature rises. But, everything should go back to normal once it cools down again. A couple of weeks later, the blurriness started going away completely, even when running.

Trail running

So my training buddies convinced me to register for a long distance trail run in September. It’s a 28k run through woods and mountains. Although not planned, it also happens to be a fundraiser for the Canadian MS Society: another incentive for registering. So I started training on trails, especially for my long runs, and I find my MS symptoms are making it hard. Let me explain.

Trail running means you need to constantly focus on the terrain: roots, rocks and such. Also, there’s a lot of ups and downs. When going up, it’s easier as you’re going slower and have time to evaluate and handle the obstacles. On flat or down, it’s another story as you’re going faster. Roots and rocks come at you much faster and it seems my vision is slow, not fast enough to get a good picture of what’s coming. It’s like if I was watching a cartoon drawn in a notebook and your were flipping through the pictures a bit slowly.

As a result, I fell a few times. Initially, I thought it was my lack of attention. But, running with friends, given it was happening to me much more often than all others combined and on the same terrain, I started suspecting the MS, and I’m pretty sure it’s an effect. That basically corroborates a test my neurologist had me do a couple of months ago. It’s called the “Visual Evoked Potential Test”. Basically, they put some electrodes on your scalp behind your head and flash an alternating checkerboard on a screen in front of you. They measure how long the visual signal takes to get through your eyes, brain, to the electrodes. That test was positive, in that it was slower than normal, confirming the MS.

If this is the case, the fact that, at my first trail race, I had a similar difficulty descending, fell and twisted my ankle a few times, probably confirms that I had MS in 2012.

I also find it particularly hard when I run marathons or longer triathlons. You might say: “dah, a marathon, that’s expected”. But, if I compare my marathon times and half marathon times, there is no comparison: my personal best marathon is twice my personal best half plus 35 minutes! That’s huge! If I remember the end of my last marathon, I remember a blurry vision and weakness and right after I finished the last 3 or 4 marathons and two half Ironman triathlons, I vomited.

With regards to trail running, I’ll have to take special precautions, go a bit slower and hope I’m lucky. And if I’m really lucky, I’m hoping the Tecfidera treatments help in reducing the vision problems. As for longer races, I’ll pay more attention to how my vision is, and other symptoms, to see if MS is the source for my problems.

A final note about the vision problems: I find that when there is a lot happening in my peripheral vision, I find it hard. Walking in a department store, or at Ikea is hard because there are so many things placed around you to grab your attention.

Tecfidera – Day 5

Today is my fifth day taking Tecfidera, the half dose. It has all been very good so far – knock on wood – as I haven’t had any side effects, except for that mild burning stomach on the first night, which might have been something else. Even better yet, and maybe an unrelated event, is that the light-headedness I was experiencing the two weeks prior to starting Tecfidera is almost gone! From what I read, DMDs are not supposed to work on the multiple sclerosis symptoms, just delay the remission occurrences and progression of disability. But, maybe, it has an undocumented benefit. It might have been undocumented just because, unlike flares, brain lesions, even disability progression, which all have their tests and measures, it is hard to quantify symptom reduction. First of all, symptoms vary a lot from one person to the next. Also, they do come a go: it’s not the first time since my flare that I’ve had the light-headedness and it went away. So, if you’re reading this, and you have some MS symptoms, I don’t want to get your hopes up. But if the symptoms are tapering off because of Tecfidera, I’ll take it.

Oh, and this morning, I was a bit stupid. I took my aspirin bottle, the Tecfidera tablets and the vitamin D. I always take the aspirin 30 minutes before. This time, I wasn't thinking and took the Tecfidera before eating or taking my aspirin. I still took the aspirin right after thinking it might help with flushing.

Exercise

For those that are or were physically active, here’s a first summary of my experience so far. First of all, I’m quite physically active. I’ve been running for 12 years and doing triathlons for 6 years, from the sprint distance to half Ironman distances. This summer, I’ve been taking it relatively easy in regards to exercise. Not that I’m not training! I’m still running three times a week with intensity and a long run every Sunday. I also try to cycle regularly with long rides on Saturday, usually between 80 km and 200 km. As for swimming, I haven’t been very good at going to the swim workouts, mostly because of lack of time and motivation.

As for actual races, that’s were I’ve taken it easy. There is a big end-of-project rush going on at work this summer, that’s why I didn’t commit to any race. I didn’t know for sure, how busy I was going to be: not extremely busy, after all.  I’ve only had to work, so far, two week-end days and two holidays. But, again, it’s hard committing to races as you usually need to register ahead. Also, MS is new to me, and managing it and starting on a long term treatment also has its share of uncertainty.

But although I haven’t done any triathlons, so far, this year. I did do a few running races:

-          Half marathon in February (called the Hypothermic half J)

I raced this half a couple of weeks before my first MS episode.

It was the second year I do this race, it occurs in cold weather (around -15 degrees Celcius), and on snowy ground, although packed snow most of the time, but loose snow at some points. I did pretty well and was very happy of my results! I almost beat my PR which was set in spring on bare ground and arrived in the top 3% of finishers with a 1h 36m finish.

Half marathon in April

This was my first race after my first flare up. I was already registered a while ago, and I felt better after the Solumedrol treatments and some rest.

I beat my PR by about 5 minutes, finishing in 1h 31m. Conditions were perfect and I didn’t notice anything particular related to MS symptoms.

-          A 10k run in June. I registered the morning of the race. I haven’t done a 10k outside of a triathlon for a very very long time, probably since my first years running. I did very well in finishing just over 41 minutes especially considering there was a hill to climb at each of the two loops. I also placed 12^th, but it was a small race with 230 participants. Again, I didn’t feel any of the MS symptoms during or after the race.

Those were the only three races I registered for. I did register and do a long organised bike ride: a 200 km ride that was more like 210 km. It went very well, tired at the end, as I would expect.

What else? I’ve been convinced by friends to register for a trail run in the mountains this September, a 28k with 1000 meters positive elevation.  I’ve been doing trail runs for my long runs, lately, in preparation. More about trail running in the next post since, it has it’s challenges with regards to MS.

Tecfidera – Day 2

Today is my second day on Tecfidera. Since last post, I took one pill last night at around 8:30 pm and one pill this morning at 8:30 am, each preceded by an aspirin 30 minutes before. Last night was a bit of a race against the clock as I had a training run I coach at 6 pm, followed by meeting at 8 pm. I bought a pasta dish with tomato sauce and vegetables at a store that prepares such meals and brought it over to my meeting. Around 10 pm, I started feeling my stomach burning; a burning stomach is not something I think I ever got. I sometimes, but rarely, get heartburn, but further up in my digestive tract. My first guess is that having pasta with tomato sauce was definitely not helping the cause, but I was a bit stuck with an unplanned meal. I ate some more at 10 pm, some cheese, almonds, Greek yogurt and bread and took two Gaviscon tablets not to be bothered by my stomach during the night. The Gaviscon helped almost immediately.

Last night I had a little insomnia in the middle of the night. But insomnia is common for me. Had the same cereal and soy milk with blueberries, this morning. Except that instead of also having Greek yogurt as yesterday morning, I had a hardboiled egg. Took the Tecfidera at 8:30 am. It’s now noon and everything has been good so far, fingers crossed.

Note that I’m a bit less stressed today. Yesterday, every itch or feeling in my stomach made me think I had some side effect. Today, I’m a bit less worried which probably helps. Other than that, I called my Biogen nurse yesterday afternoon, to tell her, as asked, that I started the treatment. She said she'll take note in my file and let my neurologist know as well. She's going on vacation for a week but there's another nurse to cover for her in case I need help.

Tecfidera - first pill

I’m starting this blog to track my experience taking Tecfidera as a long term MS disease modifying drug. My expectations are far from a cure as there are none to this date, I’m just trying to put the odds on my side to delay the progression of the sickness. Maybe delay enough, until something better comes up.

If you’re reading this, I don’t expect you to use it to determine what’s going to happen in your case. It’s a very small sample, i.e. one person, much too small to draw from it any conclusions. I've read many official information online, either the MS societies of Canada, UK and US, and also the information from Biogen. I also have read some of the many forum discussions, but knowing that can lead me to wrong impressions. Not only is what you read on the forums single experiences (a bigger sampling that just one, but still not very big), but also the data is strongly biased. I assume that you are much more likely to post on a forum if you have problems than if your issues are nonexistent or benign.

At least, this blog even though it’s a very small sample, thus not anything to base yourself on, I’m hoping it is not bias as I’m starting it before any symptom occur.

Here we go: day 1

Today I took my first Tecfidera pill. This is also my first DMD, disease modifying drug, for MS. My neurologist prescribed the suggested dosage, that is 120 mg, twice a day for the first week. The subsequent weeks, I double the dose.

So it’s been just over four hours since I took the first pill, a bit nervous because of the side effects. My Biogen nurse told me that she never had a patient that did not have side effects. However, they are often manageable and taper with time. Also, she advised me, to take it with a meal. Although this is not “required”, taking it with a meal, or at worst, snack, can help alleviate some GI problems some people have. It doesn’t hurt, anyways.

So it’s been four hours, it’s obviously much too early to claim victory, but I have no side effects so far. Reading some forums and blogs of people having side effects, some experience the first ones a few days after they start or when they double the dose, or a few days after that, on a regular basis or randomly. So, at least, one piece of information these forums give me is that, just like the disease itself, the reaction to the drug varies a lot from person to person.

So I took my first dose with my regular breakfast, cereal, soy milk and blueberries. But I had some Greek yogurt as well. Some say that a bit of protein helps. I’m thinking of starting to take some yogurt with active cultures to help prevent any GI issues. Oh and I almost forgot, as suggested by my nurse, I took a low dose aspirin 30 minutes before breakfast and the Tecfidera. This is supposed to help with the flushing. I'm wondering about the benefits of the aspirin. It could help with the flushing, but from what I remember, aspirin is not great to the digestive system. Maybe it's alright because the pills are coated and low dose, I'll have to check.

I’ll try to take the evening dose, around 8 pm, after my running workout, which is 12 hours later.

A couple of notes on actually getting the medication and insurance approval

Things have been quite surprisingly very straightforward and fast. Two Fridays ago, my neurologist faxed the insurance approval form to my insurance company (Tecfidera is marked as requiring special approval). He also faxed a form to Biogen, to start the process. Monday, I received a call from the nurse at Biogen who took her time explaining the medication. Tuesday, I received the approval from the insurance company. I call the nurse to tell her, and she informs me that the next step is to do an initial blood and urine test before starting the medication. She contacts the neurologist so that the exams are ordered. The neurologist was waiting for approval before ordering them, which he did. Thursday, I get my tests done. The nurse gets the OK from the doctor on Tuesday, the doctor was busy with ER and other stuff. I order the medication at the drugstore, Tuesday noon and pick it up Wednesday evening.

The first pack contains 56 pills of 120 mg. The pharmacist tells me that I can start taking two a day the first week and they move to four a day afterwards. I can’t move, the second week, to big 240 mg pills because the pills come in packs of 56. I just have to take two 120 mg pills instead of one.

The 56 pills of 120 mg were about 960$ Canadian. Luckily, insurance pays for 90% and when I reach 750$ out of my pocket they’re covered 100%. Even better, the Biogen nurse told me that Biogen can help patients financially to cover some of the costs that are not covered. After sending my family income statements, she tells me that they’ll chip in 50% of what I pay. That means, the whole treatment will cost me 375$ a year. This is not bad considering that one 240 mg pill costs around 35$. Yikes, that’s 70$ a day, 7 days a week! What’s sad is that this is probably more than the full time cashier at the drugstore makes.

Good thing for public health care and the insurance coverage: MS will have cost me only 375$ a year, for drugs, scans, MRI, doctors, etc. Even if I didn't have private insurance, it would be around that through public health care. I never thought I would be on the receiving end that early, but it helps in that it confirms that the taxes we pay are a pretty good safety net when we're not at the lucky end.

Why Tecfidera?

As I said earlier, this is my first long term drug for MS. My neurologist, which I like a lot, told me to go to the Canadian MS Society and read about the different available treatments and choose one. From reading the side effects of each treatment and their effectiveness, Tecfidera seemed like my best option. The side effects are usually manageable, the administration was oral which is practical, there are no scary risks such as PML, etc. Regarding effectiveness, two studies say Tecfidera reduces the number of episodes to about 50% of placebo and reduces brain lesion and disability progression significantly. Statistically, this brings my next episode to four years from now. But there is a very big variance between each person. Now let's see how this plays for me. And if I can't handle the side effects, I'm in a lucky position, there are other options.