Thursday, April 9, 2015

Cognitive Improvements, Yes, That's Happening!

I was asked about cognitive improvements by a fellow MSer on the UK site- I highly recommend this site for general support and a positive MS community. The creaters also make short films about MS which are though provoking and have the signature British Humor. Check out Shift.MS if you have not already.

Anyway, this question of cognitive issues post-Lemtrada made me stop and think about the issue. If you do not have this symptom count yourself among the lucky. The type of cognitive impairment MS causes can be quite debilitating and embarrassing.

Some symptoms:
Forgetting common words in the course of a conversation- so common you feel like the village idiot
Inability to retain numbers in your head
    This was especially hard for me as my job requires manipulation of lots of numbers
    I could not calculate a number in my head, and I had to use a calculator for the most basic tasks
    Then if I did a calculation and came up with a number like 216.32 I could not hold this in my
           brain long enough to enter the # in the appropriate place, so everything must be written down.
I lost the ability to remember a plot in a book from start to finish
I could not remember sub-plots or characters in TV drama shows from one week to the next
I love American football but lost the ability to remember who won what game from one week
            to the next- embarrassing as I watched the entire game...

With these symptoms comes HUGE doubts in yourself and your ability. For me personally this lead to retiring from my job as a Nurse Practitioner (serving adults with HIV) very early on in my diagnosis. I was terrified of missing a possible drug interaction when prescribing complicated drug regimens.

It seemed my ability to store new information was affected the most.

These deficits also put the person at huge risk of being taken advantage of. I felt I needed to tell people that my memory was bad so that I did not offend if I forgot a name or even an entire event. But then if I were to tell a story and someone remembered it differently I felt I always had to defer to their version and trust them. For example, you agree upon a price for a service or 'remember' you prepaid- and someone challenges you- what do you do?

I had learned to live with this and joke about it as a coping mechanism. My memory was a running joke among family and friends and I tried to just go with it. Being so unsure of 'truth' and 'reality' is a very strange way to live.

Good News

Against all odds- this symptom started to improve with time!

Again, this is a symptom I never thought could improve. It struck me early and so had been present and worsening for at least 7 years by the time I was given Lemtrada.

The first thing I noticed was work- I started to retain those numbers between the calculator and the spreadsheet. At first I thought it was just 'a good day' but then this started to feel more permanent.

Then I began to attempt 'math in my head' and as I challenged myself I was able to do this too- although it took me a long time to trust myself (for business purposes I could not afford mistakes). But soon the checking and double checking receded and I gained confidence in my ability with numbers.

For the fall TV & Sports line up- I had a plan. I was going to keep all my 'favorite shows' on my DVR so when a new episode came out I could watch the previous ones to remind myself. When it got around to fall (Lem infusion was April 2014) I found I didn't need my plan! I started to remember details!

I have even contemplated re-training as a Nurse Practitioner although my home job is quite cushy- but the point is- I feel ABLE to do so!

Cognitive improvement really affects your whole life. I feel more confident, happy and 'settled' in social conversations and business life. I am building new memories and now even able to remember more than my husband in many occasions. I think this is due to the many 'tricks' I developed over this period to help me through.

I am unsure if I will regain the memories I was unable to store for those 7 years. I suspect not, but who knows really. If this was a problem of laying down new memories all those years the opportunity to store them may be lost- but the future is so bright! I would say I have to wear shades- but due to Lemtrada my pupils are now constricting for the first time in 15 years :)

I am forever thankful to the German people (Dr. Ziemssen & nurse Teresa in particular, the research scientists and medical funding to bring this amazing treatment to life for MS patients world wide. So far I have not found one area of my life that Lemtrada has not made some significant improvement.

Tuesday, March 17, 2015

Information from Genzyme

I emailed Genzyme the other day to inquire about how the program works for doctor training, facility training and the FDA mandated monitoring- and a few others. My questions are in Blue. Here are the answers:

Do both docs & centers have to go through training?

Yes, before Lemtrada treatment is initiated, healthcare providers, infusion centers, specialty pharmacies and patients must be enrolled in the Lemtrada REMS (Risk Evaluation and Mitigation Strategy) Program.  

This is a restricted distribution program intended to help educate healthcare providers and patients on the serious risks associated with Lemtrada and the appropriate periodic monitoring required to support the detection of these risks for 48 months after a patient’s last infusion.  

The REMS is based on a developmental risk management program that was successfully implemented in the Phase 2 and Phase 3 trials and allowed for early detection and management of some of the serious risks associated with Lemtrada. 

Lemtrada REMS training has begun and continues to be ongoing.  

For more information on the REMS program, people living with MS as well as healthcare providers can call 1-855-676-6326 or visit

Is there a list of approved docs & infusion centers?

Individuals can call the LEMTRADA REMS Program (number above) to see if a specific infusion center or prescriber is REMS enrolled.  

We are also in the process of preparing an update to the Lemtrada REMS website mentioned above, which will include a site locator that will provide information about prescribers and infusion centers enrolled in the REMS program.

Announcement that the first U.S. patients had been treated with Lemtrada: 

News Article About First US Lemtrada Patient

How does the monitoring program work- is this One to One?

MS One to One is separate from the Lemtrada monitoring program. MS One to One is a support resource that Genzyme offers to people living with MS and their care partners 24 hours a day, 7 days a week.  

Financial assistance is available to MS patients through the One to One program. Please call and inquire if you have a large copay or Lemtrada is denied coverage by your insurance program.

For more information about these support services, we encourage people to call the MS One to One line at 1-855-MSOne2One (1-855-676-6326) or visit this site

When the first Patient Live Education forums will start?

Genzyme is not allowed to begin direct-to-patient outreach until six months after the approval of Lemtrada.  So stay tuned – we expect to have information about these types of events in the June timeframe, and information will be posted on as it becomes  available.  

The six month wait is now standard, it is based on the code set by PhRMA.

I recommend going to the site and providing your email and/or address 
so you will be notified when these events start. 

Sunday, March 8, 2015

GoodPastures Question answered

Today I received this comment to the blog:

Hi Emma, i've just had the first set of Lemtrada infusions and now in second month of recovering immune cells....i've just started reading your blog (thank you!) and was confused about Goodpastures.

You mention that it needs to be detected and treated within 3 days of onset, and that we are obviously tested for bloods and urine only once a your suggestion to test urine at home makes sense.

However i can't find online where it says this about Goodpastures, only that it may occur over weeks or months. Can you post your reference for this, i'm keen to send it to my neurologist so that i can request details for how to test my urine and what to look for. Many thanks!

Here is the reply:
I am traveling but will get you a good link when I return. My internet is slow today and web surfing difficult.

In the meantime this is a good overview of Goodpastures:

Are you in the US? You can buy urine testing strips to test yourself- look for a test that tells you the protein and glucose in your urine. Usually this is on a 10 test strip. I can get 100 tests for about $10-15 USD.

Note that Goodpastures is extremely rare but also the most serious of the possible adverse effects (AE). Also science is currently working on several ways to de-risk this AE. One is a med that you take at the time of Lem administration (too late for you and me) another is low dose Rituximab which I did for another issue. Bring this possibility up to your neuro. Most are not doing it but some are more adventurous than others.

Also note that the earliest onset of GP is at least 4 months after your second dose, but more like 1-2 years after your second dose. So you are not in the risk zone for GP now.

Testing urine twice a week is a cheap and easy habit to get into. You can do it from home and might provide peace of mind. If you do go ahead with it you should make a chart for yourself and log your testing so if something does go awry (testing strip is also useful in detecting a bladder or urinary tract infection, common in MS) you have a chart to show your doc.

Most docs will be aware of the testing time frame for GP. So you probably don't need to have a reference for them. If you want to test yourself it should be something they would support.

If you cannot get testing strips in your country they are available in the US as over the counter products- if you can ship them from an online source. I know a patient in Russia that was able to acquire them locally.

Sunday, March 1, 2015

Lemtrada Clinical Trial Data Overview

I am working on vacation here because I think this information will be of interest to everyone who has just received Lemtrada or will in the near future.

Short personal update. This time last year I could not drive and did not have the energy to even go to the grocery store. This morning I swam along a reef in rip tide conditions and found a sea turtle and swam along with him for 20 minutes- after about 1 hour of swimming along the reef. No flotation device, just fins and some snorkeling gear- moments only made possible by Lemtrada!

I must thank Beth (Lem patient infused in London May 2014). She sent me this article.

This is a fairly technical article but I did try to par it down and add explanations. What I find most interesting is the info on the AE (adverse events aka side effects) but I really think you should try to understand all these points, take notes, and follow your own labs and symptoms.

I truly believe a well informed patient makes the best medical decisions for themselves. This is the real purpose of this blog- so you can understand this treatment and make the informed decision if it is right for you.

Article from Medscape on Lemtrada

Here is the direct link:

 Here is the Text with My Summary Points


It was granted licensing approval by the European Medicines Agency (EMA) in September 2013.

In November 2014, alemtuzumab was approved by the FDA for relapsing forms of MS

How Lemtrada Works

Alemtuzumab (Lemtrada) targets CD52, an antigen of unknown function that is expressed on lymphocytes, monocytes, some dendritic cell populations and, to a lesser degree, on natural killer (NK) cells and other leukocytes

Alemtuzamab primarily depletes circulating T and B lymphocytes via antibody-dependent cytolysis and complement-dependent cytolysis (ie- Lem lyses- breaks apart- T & B cells) see other posts on immune system in general).

Depletion is followed by lymphocyte repopulation, which begins within weeks.

B-lymphocyte counts typically return to baseline by 6 months post-treatment. This is when sensory symptoms returned for me. I was treated with Ritux which depletes B cells. And it worked :)

CD4+ T-cell repopulation is particularly delayed. In a long-term follow-up of 37 patients who had received alemtuzumab treatment in the 1990s for MS, median recovery time to normal levels was 8.4 months for B cells, 20 months for CD8+ T cells and 12 years for CD4.

The therapeutic effect of alemtuzumab is likely not solely a consequence of lymphocyte depletion, but also of repopulation features. This is what is meant when lay people say "the immune system resets.

Early studies on when to retreat after the initial 2 doses:
CAMMS223 phase II study design. Alemtuzumab was infused intravenously (IV) on 5 consecutive days at baseline and on 3 consecutive days at year 1. The third treatment course at year 2 was given at the discretion of the investigator if CD4+ T-cell counts were ≥100 × 106 cells/l.

Long-term safety data for alemtuzumab are not yet available. However, safety data up to 4 years (CARE-MS extension), 7 years (CAMMS223 extension) or up to 12 years (Cambridge cohort) have thus far been consistent with what was observed in the core clinical trials. Whether any new safety signals emerge beyond this point remains to be seen.

Infusion-associated Reactions- IARs

IARs were the most common AEs in all three studies and those associated with alemtuzumab are thought to be mainly attributable to cytokine-release syndrome.

Cytokine release occurs as a result of target cell lysis and recruitment of inflammatory cells. (ie, Lem lyses cells, they fall open, release their contents- cytokines).

The incidence of IARs was ≥90% across studies.

Serious IARs were reported in up to 1–3% of patients in each alemtuzumab treatment group.

Most common were as follows:
headache (43–56%);
rash (39–89%);
pyrexia- fever (16–36%);
nausea (14–20%);
urticaria- rash (11–26%);
pruritus- itch (10–28%);
flushing (8–11%);
insomnia (10–19%);
fatigue (7–24%);
chills (7–18%);
chest discomfort (6–14%); and
dyspnea (6–13%).

There were no cases of anaphylaxis and no IARs resulted in death in the core studies.

The IARs were most frequent during the first treatment course (85%), and decreased during course 2 (69%) and course 3 (63%) [Mayer et al. 2014]. Few patients (2–6.6% per infusion day) required infusion interruption or infusion rate adjustment.

Infusion-associated reactions are common with alemtuzumab, but rarely serious.


Most were mild or moderate in severity.

Serious infections were rare, but slightly elevated with alemtuzumab versus injectable interferons.

The most common infections were those of the respiratory tract and urinary tract.
Herpetic infections (herpes viruses- fever blisters, chicken pox- so you need vaccination if you did not have the disease, also shingles). These infections declined after the introduction of acyclovir prophylaxis- now standard practice.

Follow-up for up to 7 years shows Infection incidence did not increase with each course of alemtuzumab. Most infections (96%) were mild or moderate over the follow-up period and upper respiratory tract infections were most common.

Is PML a problem?
Alemtuzumab has not been associated with any cases of progressive multifocal leukoencephalopathy (PML) in studies of patients with MS. There have been several cases of PML in patients treated with alemtuzumab for transplant rejection or for CLL. In these cases, however, patients had been heavily treated with immunosuppressive therapies before receiving alemtuzumab.

Cancer Risks?

Of 1486 alemtuzumab-treated patients in the clinical development program, 29 have been diagnosed with a cancer of any kind.

Six were thyroid cancers caught due to the routine monitoring.
     Five were in patients with known thyroid disease.
     One patient who developed thyroid cancer did not have thyroid disease prior to cancer diagnosis.

Other cancers included:
basal cell carcinoma (n = 6),
breast (n = 5) and
malignant melanoma (n = 4).

Autoimmune AEs

Autoimmune AEs represent the most important risk associated with alemtuzumab treatment. Autoimmune sequelae are thought to arise from the way in which lymphocyte repopulation proceeds.

Stay with me while I try to break this down.

 If T lymphocytes repopulate from mature T cells that are not killed, lyses, etc patients who go on to develop autoimmune AEs.

In contrast, patients without autoimmune AEs tend to generate relatively more new T lymphocytes in the thymus- the new baby T cells created from scratch are associated with fewer autoimmune problems.


In 5-year follow-up Thyroid problems occurred in:

39% of patients treated with alemtuzumab 12 mg and
29% of those who received the 24-mg dose.

In total, 102 episodes were reported in 73 alemtuzumab patients.

Graves' hyperthyroidism (65.8%), hypothyroidism (20.5%) and subacute thyroiditis (12.3%) were most common.

Onset ranged from 6 to 61 months after the first treatment course.

Incidence peaked at year 3 and declined in subsequent years.

Thyroid disorders responded to conventional therapy with antithyroid drugs, radioactive iodine, thyroid hormone or surgery.

Overall, thyroid AEs were reported in 36% of patients
Serious thyroid AEs in 3.8% of patients over 4 years of follow-up
Hyperthyroidism, hypothyroidism, goiter and thyroiditis were most common. These are also the easiest to treat.


Alemtuzumab is associated with a unique form of ITP characterized by delayed onset, responsiveness to conventional ITP therapies, and prolonged remission. So in English- comes on late, responds to treatment & goes into a long term remission that does not require ongoing treatment.

The first case of ITP occurred when a patient presented with intracranial hemorrhage (brain bleed) and died.

This prompted the implementation of a risk-management plan that comprised patient and physician education, monthly complete blood count (CBC) and monthly symptom surveys offset from the CBC by 2 weeks.

How ITP was defined in the studies:
Either a confirmed platelet count between 50 and 100 × 109/l on ≥2 consecutive occasions over a period of at least 1 month, or
A confirmed platelet count <50 × 109/l without clumping documented on two or more consecutive occasions over any period of time

This gets into the weeds but if you are watching your own labs you can make a note of these numbers and know where you stand. I personally treated HIV patients with low platelet counts. We would closely monitor at a level of 30, and treat at 10- for reference.

The incidence of ITP was 2.0% (n = 30/1486).

A further 21 patients did not meet the protocol definition but had platelet counts below normal limits.

ITP onset occurred a mean of 16 months (range: 1–34) after the last dose of alemtuzumab.

Most patients responded to first-line therapy with corticosteroids, intravenous immunoglobulin or platelet transfusion. Other therapies were rituximab (n = 4) and splenectomy (n = 1), and several events (n = 2) resolved spontaneously.

Nephropathy. ie- Kidney Disease

In pilot studies, two patients developed antiglomerular basement membrane (anti-GBM) disease that ultimately required renal transplant.

Incidence 4 cases out of 1486 treated patients occurred:
Including 1 case of anti-GBM disease,
1 case of glomerulonephritis with positive anti-GBM antibody, and
2 cases of membranous glomerulonephritis

Onset ranged from 4 to 39 months after the last dose of alemtuzumab. Each case responded to medical treatment.

Pregnancy and Fertility
Women of childbearing potential are advised to use contraception during a course of alemtuzumab and for 4 months afterwards.

Males: CD52 is expressed in the male reproductive system, including the epididymis and seminal vesicle, sperm and seminal fluid, posing a theoretical risk of alemtuzumab for male fertility.

However, developing sperm are negative for CD52 expression, and although mature sperm express CD52, an abundance of CD52 antigen in seminal plasma effectively competes with sperm for alemtuzumab binding, making an adverse impact on male fertility unlikely. A limited data set (n = 13) showed that at baseline, and 1, 3 and 6 months post alemtuzumab treatment, there was no evidence of defects in sperm motility or morphology, and no patient had a consistently depressed sperm count.

Choosing the Right Patient for Alemtuzumab

Alemtuzumab is not for every patient with MS and the decision to use it should be carefully considered.

Study data suggest that alemtuzumab may be ineffective in patients with secondary progression.

Although the safety profile is generally manageable for the right patient, risks probably outweigh benefits in patients with mild disease or clinically isolated syndrome, and there are no available data on these populations.

Alemtuzumab should be reserved for patients with active inflammatory disease (early in disease) Active disease was defined as:
 ≥1 relapse in the past year and
≥2 relapses in the past 2 years,
plus the presence of MRI lesions;

Patients with active disease despite treatment (relapses on other therapies) benefited from alemtuzumab and are clearly candidates for more powerful therapy.

For patients who meet criteria for active disease but are early in their disease course and treatment-naive benefits from alemtuzumab.

Although some clinicians may be hesitant to use alemtuzumab as first-line therapy, the current lack of established neuroprotective or neuroregenerative therapies leaves only the option of preserving existing neural tissue before extensive pathology occurs. USE LEMTRADA EARLY!!!

In patients with early MS who are clearly on a path of rapidly advancing disease, high-efficacy antiinflammatory therapy must be considered. USE LEMTRADA EARLY!!!

The Decision to Re-treat With Alemtuzumab

The issue of retreatment with alemtuzumab beyond the initial two courses of therapy will become important as the second anniversary of its approval in Europe approaches.

Labeling guidelines do not currently address whether or how retreatment with alemtuzumab should be undertaken. In phase III studies, alemtuzumab treatment beyond the initial two courses was offered if a relapse occurred or if a patient accumulated ≥2 unique MRI lesions (either Gd-enhancing lesions and/or new or enlarging T2 lesions).

Lymphocyte reconstitution rate does not appear to predict breakthrough disease activity, and use of lymphocyte counts as a biomarker to indicate retreatment has been discouraged [Kousin-Ezewu et al. 2014]. ie no particular lab can tell you when to retreat at this time.

In clinical practice, it may be appropriate to monitor alemtuzumab efficacy by MRI. MRI scans were performed annually in clinical trials and helped to guide the decision to re-treat during the extension study.

The maximal number of alemtuzumab courses that may be safely given is unknown. Some have suggested the use of a platform therapy (I believe they are referring to another DMT after you finish 2 Lem courses) after alemtuzumab but there are currently no data addressing this approach.

Alemtuzumab is a highly effective therapy for patients with active RRMS who are either treatment-naive (never been treated) or who have had breakthrough disease on DMT.

The available safety data from the phase II and III clinical studies span about 5 years and are consistent with the 12-year data from the Cambridge cohort.

The safety profile is manageable with continued monitoring. Further experience with alemtuzumab in the clinic will provide the needed long-term data.

A comprehensive monitoring program lasting at least 4 years after the last alemtuzumab dose allows early detection and effective management of autoimmune adverse events. Further experience with alemtuzumab in the clinic will provide needed long-term data.

Wednesday, February 25, 2015

Absence from the Blog

I will be on vacation starting 2/25/15 until 3/10/15. I will not have much access to the internet during this period (the best type of get away) so any comments left here will be answered on my return.

Good news- it seems the first round of US doc training to prescribe Lemtrada has just been completed. Call your neurologist to see if Lemtrada is not available in your area!

Good luck to everyone staring in March- I know there are many of you!

Keep Hydrated- the best way to make it through Lem Week :)

Take care,

Friday, February 20, 2015

Sites Currently Infusing Lemtrada in the US as of 2/20/15

Here is an updated list of the currently approved infusion centers as provided by members of the closed Facebook Group "Lemtrada for MS Treatment"

If you are not a member of this group I would encourage you to join. Members are from many countries. This is the primary group for English Speakers. There are other closed groups for other primary languages.

Advantage of a closed group: after you are accepted (it is almost automatic, im not aware they exclude anyone), the comments you post there are NOT a part of your common page. So if an employer or other person whom you do not share your diagnosis with looks you up on facebook they will not see any posts you make to the closed group page.

I have found people in this group to be helpful and optimistic. :)

Thursday, February 19, 2015

"You are taking Lemtrada and Rituximab concurrently. Should I?"

"You are taking Lemtrada and Rituximab concurrently. Should I?"

I am now getting this question from quite a few potential Lemtrada patients. I answered one woman's question via email but thought I would repost my answer- since this question seems to be coming up all the time these days.

The writer is a 31 year old Australian woman diagnosed in 2014 but with symptoms going back to 2010. Her EDSS  (expanded disability status score) 1.0-2.0- so low and she is considered 'newly diagnosed' in the Lemtrada World.

Australia is going to start infusing in April and she wanted to use Rituxan with Lemtrada. Here is my response to her: 

You sound like a great candidate for Lemtrada- young, relatively newly diagnosed  (counting back to 2010) and a low EDSS score (we don’t really use those in the states but I know what they mean).

For your case- based on the details above, Lemtrada is likely all you need. I know Australia is going to start infusing in April so I would recommend claiming your spot on the infusion list. Right now would be the time to do the screening procedures and possible vaccinations- depending on your vaccination history (or exposure to chicken pox)  this might delay your Lemtrada start date. If you don’t understand why- ask I can answer.

I need the Ritux because my MS is much older than yours (diagnosed 11.5 years as of Feb 2015) and I have established lesions you have not accumulated yet (basing this again on the details above). Ritux is generally its own treatment and used in cases that don’t respond to other therapies (prior to lem being approved- I am unsure if docs will still use Ritux as much because Lemtrada would be better).

Let me see if I can explain why- and if you don’t understand please ask- I tend to be long winded, so I apologize in advance for that.

OK, here goes:

A bit about the immune system- your White Blood Cells (aka leukocytes) are divided into 5 subclasses- but we are only going to talk about Lymphocytes here- it is the only one you need to worry about for this discussion.

Lymphocytes have different types- the main being T and B cells. More specifically all lymphocytes are further divided into CD types based on the protein expressed on the outside of the lymphocyte cell. You may have heard of CD4- important in HIV. The HIV disease attacks the lymphocyte that expresses the CD4 protein on its cell wall. Does that make sense?

Think of these cells as circles with bumps on the side that say “I am a CD4 cell or I am a CD19 cell” There are over 300 CD types CD1-CD326 have been identified. See the little sucker looking thing- those are the proteins telling the other cells "I am this type":

Image result for cd4 cell picture

Now here is the difference between what Lemtrada does and what Ritux does.

Lemtrada enters your blood stream and destroys all Lymphoctes- every one in the blood stream (some are hanging out in organs or the lymph system and Lemtrada doesn’t reach those areas, but this is a very small %). So CD1 to CD326+ are destroyed (we believe).

The immediate effect is to stop all Lymphocyte activity. This includes the ability for the WBCs to attach your central nervous system CNS(brain and spinal cord). All inflammatory activity stops everywhere in your body. You are unable to produce a fever (an immune system function) and may be more susceptible to disease because your ‘disease fighters’ are damaged.

When we run blood tests you will see the CD3-CD20 (common ones measured) are all 0 one month out. The hope is that when the immune system grows back (Lemtrada does not affect bone marrow, where the new cells are made) it will ‘forget’ to keep attacking the CNS. The thinking is this that this break from inflammation is immediately good for the CNS but these effects keep happening years after your Lemtrada doses- improvements still being seen 3+ years out from your first dose.

If you want to look at my CD counts I have attached them belowl. It might make more sense by looking at real #s. So you are not confused, look only at the T&B Subset section and follow the trend.

That is what Lemtrada does in a nutshell.

What Ritux does:

Ritux is selective- targeting only the area of the CD subsets around CD19 and CD20. These are primary B cells (Lymphocytes are subdivided into T&B cells- Lemtrada kills both, Ritux just one specific B cell area of the CD cells).

Ritux does not have an indication for MS but doctors (in the states mostly) have been using this drug for 5+ years in cases where no conventional MS medication worked. It worked ok in those hard-to-treat patients.

Ritux is selective. Lemtrada kills them all- basic difference.

Dosing schedule for Ritux
First dose 1gm given at the same time after 1gm of IV steroids are given (basically the same pre-treatment protocol as Lemtrada)

Some docs will repeat this IV Steroid and Ritux 2 weeks later. This is the standard protocol for Rheumatoid Arthitis (RA) treatment, one of the approved indications for Ritux use. Some docs will not. There is some variability because it is not approved for MS so doesn’t have the govt required dosing schedule for MS- so we use the doing we know is safe in RA.

When is the next dose?
(you will need to reference the lab chart here and find the lines that say %CD19 and Absolute CD19)
When the CD19% (or if your lab can do a CD20%, this is newly available in the last 6 mo here in the states) increases over 0 (so when it pops up anything other than zero), time to re-treat.

Docs check the CD counts in Ritux patients every 3 months or sooner if the pt is symptomatic.

Treatment is generally needed every 4-6 months and then only with one treatment (not one 2 weeks later).

Why you only need Lem and not Ritux

If you follow the lab chart again you will see on Aug 23 labs my CD19% jumped from 1% on July 24 to 45% in just 28 days. That coincided with a return of some sensory symptoms for me. I informed my doc  and he is proactive with Ritux and suggested we try Ritux because it targets the CD19/20 and this was what was elevated- so maybe that was a problem (we are all lab rats in this).

It worked beautifully.

So it is definitely an option for you if this happens to you- but it probably wont- and research of 15+ years says it is unlikely in a case like yours.

This was also an experiment by my doc- so really no one else is doing this. There is thinking (no research, just based on what we know about the immune system) that a tiny dose of Ritux- like 50mg instead of 1gm- MIGHT be beneficial in reducing the likelihood you experience on of the 3 long term problems with Ritux- thyroid, ITP and GoodPastures. There is no evidence of this- but it will likely be studied one day.

I hope most of that makes sense and I also hope you get Lemtrada April 1, 2015! 

Sunday, February 15, 2015

Centers in the US Certified to Infuse Lemtrada

Below is a list of Centers and Doctors infusing Lemtrada in the US.

This list was compiled from information provided on a the "Lemtrada for Multiple Sclerosis" facebook group.

I will keep updating this document as more data comes in. Both the doctor and the center have to go through training before they can infuse. So many centers/doctors are going through this training right now.

If you know of a group that is infusing please post a comment below and I will get the list updated with that information.

On note on the Cullman, Alabama center: Dr. Chris Laganke is VERY dedicated to agressively treating MS. His mother was diagnosed  when he was just a boy. It has been his life mission to find effective treatment for MS.

Here is a great story about this wonderful doctor:

Friday, February 6, 2015

Amazing- Things are Still Improving!

I honestly did not think I would be posting any longer on NEW improvements in my disease or symptoms. I really thought all improvements had happened and I was looking forward to being stable.

The improvements that happen now are more subtle and under the umbrella of incremental positive changes- vs Hit You Over the Head things that have already happened- like improvement in eye sight or regaining the energy to do everyday things or the return of the ability to drive and also have energy to go and do what I drove to! :)

I will elaborate more after the weekend, but just a tidbit.

Stamina, stamina and more stamina- I have returned to the gym 4-5 days a week- am doing cardio interval training and weight training.

I can tell things are even easier to do now compared with 6 months ago- when I thought I was doing well- combining multiple activities into a single day with no fatigue

Complete resolution of numbness or tingling in any area of my body- save for a quarter-size spot on my left foot- which I actually appreciate is there, more on why later

Improvement in swallowing- a common problem in MS- but connected to a cranial nerve- so like the eye improvement this is very much tied to specific brain pathways so I thought this would never improve.

I will continue to think of small things that are improving- there are many- and return on Sunday to finish this post after weekend house guests are gone.

The main thing I want to say- is that 9 months out things are still improving- 

and MS patients just dont do that- 

they NEVER improve- 

and 9 months after 5 days of 1 medicine

 I am still seeing improvement- WOW- what does the future hold?

Off to clean house- because I can do that now! :)

Monday, January 19, 2015

Considering your Lemtrada Protocol

What will the Week of Lemtrada Infusion be Like?

I hope to answer a few questions with this post but I know there will be more. Here are a few 'givens' with the week of infusion:

1) The Days are LONG
     Prepare to be at your infusion center at least 6 hours on the first day. Plan for your own creature comforts and meals.

2) Steroids will be first
    So if you need a hard candy for the metallic taste bring some. If you have any odd reaction to IV steroids just plan what you will do- bring a blanket, etc

3) You will be given oral medications- Don't refuse them
    I will go through them more in detail below but you will need Tylenol, Motrin, Benadryl, Zantac and possibly others. You need this for the potential side effects during infusion so go with it.

4) Lemtrada will be started slowly
    If you have no reaction after an hour they may speed up your drip. If you do have a reaction they will stop it, intervene, and restart at a lower drip rate. They may keep increasing your drip rate every hour if you are doing well.

5) On subsequent days they may speed up your Lemtrada infusion
    Days 4 & 5 might be significantly shorter if you dont get steroids (I recommend you do, more later) and if it is deemed safe to speed up your infusion

Potential Complications and Why

Rash & Allergic Reaction

Why this Happens:
During Lem treatment the medicine will lyse (break apart) all your circulating WBCs (not the ones hiding out in organs or in your lymph system). When this happens they will release Histamine which can cause an allergic reaction. 

Histamine is the culprit in most Asthma cases and skin rashes. It is part of the body's immune system response. Lem will lyse WBC, they will release the histamine inside of them and you may experience rash or an allergic reaction

Take a Class 1 Antihistamine: Benadryl is for allergies and is an anti-histamine
Take a Class 2 Antihistamine: Zantac is for a histamine receptor in the stomach, used here as a back up to Benadryl
IV Steroids: This is also why we give steroids- to suppress the body's natural response to lysed WBCs
On Hand: Albuterol Inhaler your infusion center will have this ready to use in case you need it. A bad histamine reaction can lead to asthma symptoms. 

So it is important to take Benadryl prior to Lem and every day of treatment. You can start up to a week ahead if you are concerned. I started the night before and I was fine. Zantac (for stomach) is also a histamine blocker. This just means they both work against the histamine response in different ways.

You will likely be given both. Talk with your doctor about taking both a class 1 and class 2 histamine blocker. Claritin might be substituted for Benadryl because it is less drowsy than Benadryl. This was what was recommended to me but I opted for Benadryl because I believe it is stronger and I didn’t mind being drowsy.

I never needed the Inhaler- and neither did any of the approx 10 people whose stories have contributed to this blog

Headache and Body Aches

Why this Happens:
When these cells lyse you may feel achy or have a headache. Again think about the immune system fighting something like flu. The immune system sends in WBC, when they ‘die in battle’ they cause the achyness & sometimes fever you get with the flu- you get the same effect with Lem because both are caused by cell death either by Lem or in fighting a virus. 

Take a NSAID- Motrin is an example
Take Tylenol- the clinic will likely give you an oral dose when you have finished the IV Steroids

I experienced a headache on the first day but I believe this to be due to lots of travel the day before. No one else I have talked with has had a fever, headache body ache. They all took Motrin and Tylenol pre-medication.

A Bit About Steroids

I hate them. 

Ok that is not really what is important here but I just needed to get that out. 

Your doctor will give you IV Steroids for the first 3 days- which I am sure you have had before. The standard protocol is 1gm for the first 3 days then nothing on days 4 & 5 but each center might vary this dosing. I asked to ‘step down’ on days 4 and 5 with 500mg and 250mg respectively. I do better when I taper down. You likely know how this medication affects you and what is best for you. Some people stay with 1gm x 5 days then do an oral taper. I hate the orals so I stepped down during the week.

If you do get a rash or allergic reaction they will likely continue the 1gm for all 5 days, providing the reaction was mild enough to continue with the treatment. I was most worried about the rash and allergic reaction. I got neither. I also did not get any body aches, fever or malaise. It is uncommon. But once you know why this is happening (WBC are dying and releasing their contents) I think it makes it easier to decide which pre-meds are right for you.

One Other Medication

Valcyclovir tablet twice daily

You will also be placed on an antiviral to prevent Herpetic infections- herpes virus- responsible for a slew of infections but most commonly fever blisters and vaginal herpes. You will continue this for 4-8 weeks as a preventive. The dose is low and has few side effects. 

To Sum Up

With the proper pre-medications and precautions are you unlikely to experience any of these side effects or have a very mild response. If you are prone to 'react' to medications or have a pre-existing asthma or allergic problem with a rash discuss this with your doctor in advance. You can tailor the protocol to your specific needs.

If you are very concerned about these reactions ask your doctor about starting Benadryl, Zantac, and motrin a few days to 1 week ahead. As long as you can handle the drowsiness that comes with Benadryl and are not allergic to any of these you should be fine to start early.

Take the full course of your Valcyclovir. You dont want to get a raging fever blister just because you are immune supressed. You will have to take this for several weeks- dont skip or be lazy about this step- this is an easily avoidable side effect.

Infusion Protocol

Your clinic or infusion center will have their own protocol. This is just a sample protocol that sums everything up. Please follow your doctor's guidelines. This guide is provided as a reference and a 'talking point' to begin the discussion with your provider. Please keep in mind there will be several opinions about how to proceed with infusion and your doctor should lead this care.

Saturday, January 10, 2015

Lemtrada, the Pregnancy Friendly Choice

None of the currently available therapies are approved during pregnancy. Some are abortifacient (can cause a spontaneous abortion) like Avonex and some are known to be teratogenic (cause birth defects) like Gilenya, among others.

The rate of the latter is very high so women on therapy are encouraged if not required to take a method of birth control, sometimes in addition to condom use. Men with MS are also encouraged to wear condoms to prevent impregnating their partner.

So how is a woman (or man) to both treat her MS and start a family?

This is a real concern in the MS world and one reason I chose to not have children. The other main reason was concerns with being able to keep up with said children. Although the 3rd trimester is thought to be 'MS' protectant- those 3 months could not offset the years of MS damage that had both happened and was yet to come.

Even if you stopped therapy you need to wait several months for the drug to clear your system, then attempt pregnancy but after 6-8 months of no therapy symptoms would return and you are best advised to return to therapy and plan for another 'attempt'.

My husband and I went through this twice- with a neurologist and obstetrician on board and 'ready' for kids to work for us. It never happened and the years passed. My MS inevitably worsened (as it will on all therapies prior to Lemtrada) and I didnt feel I could manage a future with kids when the time came around for a third try.

But now Lemtrada is changing this reality of MS- no only is it safer to contemplate pregnancy (more below) but you will have the energy to chase those kids around to boot!

This is one of the many BIG things Lemtrada is providing to the MS community. Lemtrada is in your system for less than 30 days but its effects on your disease last for years longer. So you can in fact treat your disease and become pregnant at the same time!


Well you need to get through at least one course of Lemtrada (5 days) and wait until your White Blood Cells rebound- about 4-6 months and then you can attempt pregnancy. Men only need to wait the 30 days.

If you are young enough to have many reproductive years left, I would recommend going through both basic cycles of Lemtrada. This will benefit you and your family in the long run- you will have more energy for family life and also be 'done' with MS therapy for a while to concentrate on your growing family.

If you are nearing 35-36 (and a woman, not important for males) you may want to get one course only and wait for the second course until after your pregnancy. Of course your doctor should be in the loop for these decisions.

I hope this provides young women out there with more Lemtrada hope!

As for me, nearing 41, I think my window has passed and I am accustomed to life without little ones but I am so happy for those of you who have CHOICES that us old people never really had :)