Final Infusion on CHORDS Trial

This is my 5th infusion today if you count the 1st two half doses. I've been on this medication for a year and a half, and will need to go in for some final MRI and blood tests within the next 6 months. I have applied to continue taking Ocrevus with my insurance company, but am skeptical on the results that I have seen so far. I will wait until after those final MRI images come back before making any decisions to change. Here is how my last infusion went.

Weight: 252

Initial Blood Pressure:  120/74

Initial Temp: 98 degrees

Initial Blood Sugar: 85

EDSS Score: 4.5

11:40 Start IV

12:45-12:00pm - Solumedrol

12:03 - Blood Sugar 106

12:04 - Premeds

12:30   Temp 97.9 / BP 126/82 - Pulse 78

12:45   Temp 98.1 / BP 137/78 - Pulse 77

13:00   Temp 98.1 / BP 128/82 - Pulse 81

13:15   Temp 98 / BP 126/84 - Pulse 78

13:30   Temp 97.5 / BP 121/73 - Pulse 85

14:00   Temp 98.3 / BP 125/79 - Pulse 83

14:30   Temp 98.7 / BP 127/84 - Pulse 88

14:45   Naxopren

15:00   Temp 98 / BP 122/71 - Pulse 89

15:30   Temp 98.4 / BP 121/83 -  Pulse 84

16:00   Temp 98.3 / BP 126/82 - Pulse 88

16:30   Temp 98.2 / BP 127/81 - Pulse 84

17:00   Temp 98.2 / BP 137/83 -  Pulse 90

17:30   Temp 98.5 / BP 130/78 - Pulse 85

18:00   Temp 98.4 / BP 139/82 - Pulse 85

Here is a picture of the infusion rates: 

I was able to drive myself to and from the infusion without issue. Although I don't feel like the disease is not progressing, my EDSS score did go down from 6 to 4.5. Not sure how this happened, since I wasn't able to finish the walking porting of the test.  I slept for about an hour total during this infusion, but spend the rest of the time on my ipad either working or surfing the net. No side effects at all during this infusion.

Symptoms Worse, EDSS Better???

I have been tracking my symptoms since I started in the trial. I have made a few adjustments, as what I thought was bad last year, wasn't nearly what I anticipated.  Interestingly enough, even though I added additional issues to my EDSS interview, my score got better from a 4.5 to a 4.0. I know for a fact that my MS symptoms have gotten significantly worse in the last 6 months. The good news is that there are no new findings on the MRI.  However, my good and bad days have been pretty erratic. You can see from my tracking worksheet that I've had some pretty bad days. I'm not sure how long I'll need to wait to see if my situation gets worse, but I'm committed to finishing out the study for now.  Today, the day after the infusion was very challenging. After the 1st infusion, I rebounded pretty well due to the steroids.  Not today.  I really struggled, and even fell hard tripping at the gas station today.  I had my dad in town helping with yard work, and felt helpless that I couldn't do anything.  I love the help, but hate the feeling of helplessness and being a burden on anyone. Don't get me wrong, I love seeing the others who are helped by Ocrelizumab, and hope that I'm just a slow learner.  Now I wait for a few months to see how it progresses. 

EDSS Score: 4.0

2017 WalkMS Milwaukee

Five Months Post Infusion

I went in today to get another MRI, as well as blood and urine tests before my next infusion.  While I was at the office, I also needed to sign a new consent form for the CHORDS study, as they've made some minor changes. My next infusion is January 9th, and I'm excited to continue on the study, but am somewhat skeptical at this point on how effective it is for me personally. I have had a rough month or two, and my conditions seem to be deteriorating. My overall symptoms have gotten worse, but I remain optimistic that this drug will do what it's supposed to do in the long run. I was in South Carolina with family over the holidays, so the change in weather was great. Now, I'm back in Wisconsin and had a challenging MS day today. Good news is that I have a 3 day weekend coming up to relax and watch some football.

So, I found out today that roughly 294 out of the 600 participants in the CHORDS trial have already received the drug. Apparently, there was a high number of people getting declined for the study, so they have loosened the requirements to get into the trial. Nothing changes for me regarding the study and how I get the drug, but new people into the study will not have as much difficulty. From my understanding, they will not do as many blood tests, and/or make some modifications to the ones they do do. They have also changed their stance on reproduction for men, as they were pretty clear that you were not to try for kids while on this drug. This has changed for Men, and they only ask now that if you do try and get pregnant with your partner, that they are notified and have a chance to monitor that.

On a side note, the WalkAide device that I was using stopped working about 2 weeks into testing it. Not sure if going to a different part of the country affected that, but I wasn't able to get a full month of usage, and am not sure if I'll try to buy one. I did see that people are selling used units online, and this may be a more economical way to get one.

Testing out WalkAide: Treatment for Foot Drop

FYI:  This post has nothing to do with Ocrelizumab, but is part of my treatment plan:

I had a prescription from my Neuro to go get a consultation for and AFO (Ankle-Foot Orthosis) or WalkAide, which can help MS patients with foot drop. I finally went into my local orthotics office to test both options. The AFO is basically just a carbon fiber brace that fits into your show and connects to your shin to prevent your toes from bending.  I was more interested in the WalkAide system, which is an electornic device that you wear that sends an electrical impulse to your foot each time you take a step. I have used a TENS unit and EMS for therapy after my back surgeries, and think that it basically works the same way, but localized to ensure that your foot is fully up by contracting the muscles.

The device is mounted using a brace above the calve muscle, and uses sticky pads to deliver the shock to the foot. You can change the level of intensity with a quick turn of the dial  I got a pretty good reaction from the device at about 3.5.  I was able to rent a test unit for the month of December to ensure that it would work for me. Initial results were very positive, and seemed to be walking at a faster pace.  It does NOT help with balance and fatigue.  After wearing the device for a few days, I noticed that I was developing shin splints, and it was almost painful to wear the device, so I'm taking a day off from wearing it. It also has an exercise mode, that will deliver shocks at a regular interval for like 20 minutes, just stimulating the muscles.  I will continue to wear and test the device for the rest of the month, and then report back here.

The biggest detractor is that this device costs about $5,000, and there is no guarantees that insurance will cover it. They even said that my insurance will most likely deny this, making it an out of pocket expense, even though it's a prescription by my neurologist. I decided to pay a $250 fee to rent the unit for a month, and used some FSA dollars that I'd lose at the end of the year anyway.  There are used models online that could save me some money, but not sure if I'll still be interested after using it a month. For more information on the walkaide system, visit www.walkaide.com.

Battling Fatigue - Amantadine

When I went into the office earlier this week to get my 2nd Ocrelizumab infusion, I asked the Neurologist if there was anything that I could do to help with my increasing fatigue. I struggle with getting tired even doing small things, and hoped that there would be something that could help. He explained that there are a number of different options for Multiple Sclerosis patients who experience fatigue, but suggested we try a drug called Amantadine. Apparently, this drug has been on the market so long for use with Parkinson's disease patients, that there is only a generic version of it. I filled the prescription yesterday, and there was no charge from my insurance. I have a couple of business trips coming up, and I dread how tired I get dragging my luggage through the airport.  Hopefully, this will help address the fatigue while I wait to see how Ocrelizumab works for me. I will say that I had a hard time sleeping last night, and was up a number of times. I'll have to ensure that I don't take it too late in the day. There are other options if this doesn't seem to work, so let's hope for the best!

*** Amantadine is used to treat Parkinson's disease and conditions similar to those of Parkinson's disease. It also is used to prevent and treat respiratory infections caused by influenza A virus.  Amantadine is an antiviral medication used to prevent or treat certain influenza infections. It has been demonstrated that this amantadine, through some unknown mechanism, is sometimes effective in relieving fatigue in multiple sclerosis.

http://www.nationalmssociety.org/Treating-MS/Medications/Amantadine
https://medlineplus.gov/druginfo/meds/a682064.html

What EDSS?

Someone asked me yesterday what my EDSS score meant.  My score since being diagnosed 2 years ago has gone from 2.0 to 4.0.  Very hopeful that Ocrelizumab will stop that progression.

Expanded Disability Status Scale (EDSS)

Score	Description
1.0	No disability, minimal signs in one FS
1.5	No disability, minimal signs in more than one FS
2.0	Minimal disability in one FS
2.5	Mild disability in one FS or minimal disability in two FS
3.0	Moderate disability in one FS, or mild disability in three or four FS. No impairment to walking
3.5	Moderate disability in one FS and more than minimal disability in several others. No impairment to walking
4.0	Significant disability but self-sufficient and up and about some 12 hours a day. Able to walk without aid or rest for 500m
4.5	Significant disability but up and about much of the day, able to work a full day, may otherwise have some limitation of full activity or require minimal assistance. Able to walk without aid or rest for 300m
5.0	Disability severe enough to impair full daily activities and ability to work a full day without special provisions. Able to walk without aid or rest for 200m
5.5	Disability severe enough to preclude full daily activities. Able to walk without aid or rest for 100m
6.0	Requires a walking aid - cane, crutch, etc - to walk about 100m with or without resting
6.5	Requires two walking aids - pair of canes, crutches, etc - to walk about 20m without resting
7.0	Unable to walk beyond approximately 5m even with aid. Essentially restricted to wheelchair; though wheels self in standard wheelchair and transfers alone. Up and about in wheelchair some 12 hours a day
7.5	Unable to take more than a few steps. Restricted to wheelchair and may need aid in transfering. Can wheel self but can not carry on in standard wheelchair for a full day and may require a motorised wheelchair
8.0	Essentially restricted to bed or chair or pushed in wheelchair. May be out of bed itself much of the day. Retains many self-care functions. Generally has effective use of arms
8.5	Essentially restricted to bed much of day. Has some effective use of arms retains some self care functions
9.0	Confined to bed. Can still communicate and eat
9.5	Confined to bed and totally dependent. Unable to communicate effectively or eat/swallow
10.0	Death due to MS

My First Ocrelizumab Infusion!

Today is the day!  I started out by having a conversation with the Neurologist and physical exam.  This office currently has 7 people on this drug, but everyone else is part of the original OPERA trials.  I am patient number 1 on the CHORDS study for this office, which is from a company called Genentech with a Protocol number of MN30035.  They have 3 others that are queued up behind me.  My doctor told me that this drug should deplete my B Cells, but has an added effect of stimulating stem cell regeneration.  Those stem cells are thought to then have the positive effect of reducing the lesions that cause MS.  He said that if my condition doesn't get any worse, then this is a success.  If it gets better, then it is a grand slam.  I've waited over 7 months to get this drug, and my optimism is high.  Here is the purpose of the study:

This study will evaluate the efficacy and safety of ocrelizumab in participants with RRMS who have had a suboptimal response to an adequate course of DMT. Participants will receive ocrelizumab as an initial dose of two 300-milligram (mg) intravenous (IV) infusions (600 mg total) separated by 14 days followed by one 600-mg IV infusion every 24 weeks for the study duration. Anticipated time on study treatment is 96 weeks.

Initial Vitals:

• Weight 252.6  
• Initial Blood pressure 124/79
• My EDSS score today is 4.0.

Started out taking 50mg Benadryl and 500mg Tylenol, followed by a 100mg Solu-Medrol (Methylprenisolone) steroid infusion.  I did not  initially get sleepy from the Benedryl, and didn't really notice anything with the steroid drip either.  In the last 30 minutes of the Ocrelizumab infusion, I did doze off for a few minutes and did have some minor spasms in my left leg.

The Ocrelizumab on the first visit is administered over a period of 2.5 hours, for a total of 300mg.
It is sensitive to light, so the drug is covered.  They change the flow rate of the drug 5 times, with the volume increasing with each level until the 300mg is gone.

Volume	Minutes	Rate
16ml	30	32ml/hr
32.5ml	29	65ml/hr
48.5ml	29	97ml/hr
64.5ml	29	129ml/hr
97ml	29	194ml/hr

My body temperature was normal all day, and didn't spike at all.  My blood pressure did drop for the first few readings, but then came up.

• 122/73
• 119/77
• 113/75
• 100/69
• 123/73
• 135/74
• 140/76
• 134/72
• 123/74
• 113/73

I did have them check to see my EDSS scores from the previous Gileyna trial I was on.  In July of 2014, it was 2.0.  In July of 2015, it was 2.5.  So, a 4.0 shows that I am deteriorating.  I'm anxious to see if this number remains stable, or gets better!

During the infusion process, if you have to go to the bathroom, they have you bring the infusion trolley with you.  I brought lunch, and tons of things to do, but spend most of my time online on my iPad writing this post.  After the infusion is complete, they have you sit around for an hour to ensure there are no problems.  I did not have any side effects from the infusion.  My body temp stayed stable, and I didn't get any rashes.  I was able to drive myself home without incident.  I go back in 2 weeks for the 2nd 300mg.  

Final Tasks: MRI, Blood Test, and Pee in Cup...

Getting into the death tube now seems like routine.  I think that this is the 4th MRI I've done in the past 2 years.  I'm not claustrophobic and I enjoy being able to just relax and think when I'm in the MRI machine.  The substance they inject made my hand feel heavy and left a metallic taste in my mouth, but that's pretty much the extent of the downside of an MRI.  I did my final blood and urine test today as well.  Only one week left until my first infusion.  I'm getting excited about the possibility of getting some of my life back.  I do have copies of a couple of my older MRI's.  Since this is part of a drug study, I probably won't personally get to have copies of the MRI from today, so here is a sequence from 2014 when I was diagnosed:

2014 MJM MRI from Michael Mikkelson on Vimeo.

Mobility, Canes, and Falling on my face

I've been hesitant to use a cane, but find myself hugging the walls and struggling with long distances. I tripped and fell at work last week, the first time that has happened at work. I was trying to hurry to a meeting, and my shoe tripped over the carpet when I didn't pick my foot up far enough. I fell hard. I have the rug burn on my elbow, and sprained knee to prove it. I had difficulty getting up. No one saw me, but it was still embarrassing. A week later and my leg still hurts. Having sprained my knee again, I was reminded that I heal much slower these days. I went to a Milwaukee Brewers game yesterday and used my cane to help traverse the distance to the stadium from the parking lot. I tried not to pay attention to the people, but walking down the steps to my seat was slow, and I'm painfully aware that people are impatient behind me. I now keep 2 canes in my car, just in case.

My MS symptoms have degraded very quickly in the past 6 months, and I've now accepted that I need to have some type of mobility assistance when walking long distances. I'm really getting nervous that my condition has deteriorated enough that even trying something like Ocrelizumab will not help. But, I'm am cautiously optimistic that it will be a life-saver for me. I'm back at work today, and really struggling with the fatigue and walking. But, I brought donuts for the staff, as it's tradition to do so for your Birthday. I turned 45 yesterday, and hope to see science create more breakthroughs for MS in the coming years. My first infusion is a few weeks off still.  I'm really looking forward to seeing what it does to me.  :)

My History with MS

Before I get my Ocrelizumab (Ocrevus) infusion in a few weeks, I thought that I would give a little history of my condition.  I realize that not everyone with MS has the same experience or symptoms, but maybe some of the things that I went through will be similar to others who are fighting MS.  From a health standpoint, I've always been pretty healthy.  I was athletic and did a lot of water and snow sports to keep active.  I had a lower back surgery in 2009 to deal with a protruding disc that was causing a ton of discomfort and sciatica.  I had a second surgery in the fall 2013 on the same area, as I was having more back problems.  Around the same time, I notices tingling in my toes and fingers.  Unfortunately, the back surgery did not alleviate any of the tingling in my extremities.  I was sent to my first Neurologist, and he suspected Multiple Sclerosis almost immediately.

He referred me to a specialist in MS after the tests and MRI came back confirming the diagnoses. In 2014, there was a number of different treatments for MS, but no cure.  I made the decision to participate in a clinical trial for the drug Gilenya.  I wasn't too excited about taking any drugs that forced me to take injections daily, and the possibility of taking a pill to slow down or halt the disease.  I was part of the clinical study for a year, and then switched over to my insurance footing the bill for the drug.  I continued to see progression of the disease, so in December of 2015, I talked to my Neurologist about other options.  I had seen some articles praising Ocrelizumab as a breakthrough medication that would be going tor FDA approval.  I wasn't willing to wait that long.  He told me about a potential study that would be available in 2016 using the drug.  I was also told about an alternative called Lemtrada, which worked in many of the same ways as Ocrelizumab, but had higher risks.  I told him that I was willing to wait to see if I could get in the study, versus having my insurance pay for Lemtrada.  Unfortunately, there were delays in getting the drug study for Ocrelizumab going, but we're very close now.

Here are my symptoms as I go into the study:

• Numbness in my toes, with it being far worse on the right side.
• Cannot bend my big toe on the right side without significant effort.  
• Knee pain on left leg, and stiff ligaments.
• Difficulty walking after sitting for a while.  Need to stretch for a few steps.
• Severe difficulty with stairs.  
• Balance is messed up.  Hug the walls when walking inside.
• Numbness and tingling in fingertips.  Dexterity has worsened.
• Cannot lift right leg without significant effort.  Impacts things like driving and getting in and out of a car.
• Cannot bend right foot forward.  Range of motion is limited.
• Walking is getting to be difficult.  Cannot walk extended periods without rest.
• Trouble sleeping
• Spasms in legs at night / Spasticity
• Cramping of legs

The good news is that my vision is still exceptional.  My latest test still showed 20/10 vision without glasses in both eyes.  I am still able to walk, but it is strenuous at times.  I don't really feel back pain, but with less padding between the bones in the spinal cord, I do have soreness at times.  I have been off of Gilenya for a few weeks now to ensure that I start with a clean slate in the study.  I have noticed some degradation in my abilities in the past few weeks, but it also has been incredibly hot outside which can affect people with MS.