Mary Jane and the MS Clinic


Dear MS Neurologist,

I know you’ve already been to school and learned about all the things related to treating my MS.  You also spend lots of time – hours and even days – learning about the latest and greatest advances in medicine and ways to treat the symptoms of MS.  But I read in the headlines that medical marijuana is coming to our state soon, and this is one more thing you will need to learn to add to your  armamentarium (medical bag of tricks).  You will need to better understand the different pharmacological benefits of various marijuana strains so I want to point you to this site that will better instruct you on the sixteen strains recommended for MS.

This is a web-based  resource to give you the straight dope because you won’t get this in any medical text book or through Continuing Education courses to earn CEUs. As a pre-study course you may want to consult a horticultural guide to better understand the differences between sativas, hybrids and indicas.


My first important point in the lesson is you should not be influenced by the names. As mom always told us, don’t judge a book by its cover.  Marijuana names are not as smart sounding as Aubagio, Rebif, Tecfidera, and all the other already established drugs except perhaps for Glatopa which could easily cross over to the medical marijuana name list. For example, Yabba Gabba Goo, has a playful name, but it is listed as effective for both MS and Crohn’s disease and depression and muscle spasms; its benefits are euphoria, relaxation and energy.  Sour Mango says it tastes a bit like a sour patch kid crossed with mango and will help with energy as well but it doesn’t list benefits of treating muscle spasms. I’m sure this sugary tasting high is different than the one you get when actually consuming sour patch kids.


One thing different about these names than the usual MS drugs is all of them will be words you already know and won’t have trouble pronouncing, such as Double Diesel, Super Jack and Medicine Man (promoted as a medicinal delight).


This resource will also help you to better understand your patients when they come to you with a request such as ‘I want to talk to you about Flo,’ which has nothing to do with urinary streams or moving with the crowd.  Instead, Flo is recommend for muscle spasms and anxiety, but should only be prescribed for nighttime use since its effects are relaxation and sleepiness.


There’s so much to learn about these new treatments and no one is expected to know it all, so remember there are tutorials available online and most come with photos and can be used as a refresher course.  This could be useful when patients arrive in your examining room and pull out a fresh bud, and want to know if it will help a particular symptoms but they are unable to tell you what it is. After all, you are expected to be the expert of everything, and able to help weed out the things that don’t work well. Here’s a sample of the pictorial guide as a referencefrom, these four strains are recommended for muscle spasms.

muscle spasms


There won’t be an exam after you study this information; we know memory is affected by consuming marijuana and we’re unsure of the contact high you might encounter through these photos and your patients.   You also won’t need to worry yourself about an aptitude test on filling a bowl, rolling a J, or sifting seeds, as those skills fall to other sources.  But it would be nice if you could keep some brownie recipes handy when your patients ask for alternative consumption methods.


Until medical books and training catch up with contemporary practices, I hope you will find this guide useful.


Your best bud,











Zinbryta – newest MS drug in the pharmacy


Add another disease modifying therapy (DMT) to the possible treatments for MS – following is the official FDA announcement of the approval of Zinbryta (daclizumab) by Biogen…  I’m sure there will be more to write about this latest from news at the upcoming Annual Meeting for the Consortium of MS Centers.  In the meantime, here is the FDA release –


May 27, 2016


The U.S. Food and Drug Administration today approved Zinbryta (daclizumab) for the treatment of adults with relapsing forms of multiple sclerosis (MS). Zinbryta is a long-acting injection that is self- administered by the patient monthly.

“Zinbryta provides an additional choice to patients who may require a new option for treatment,” said Billy Dunn, M.D., director of the Division of Neurology Products in the FDA’s Center for Drug Evaluation and Research.

MS is a chronic, inflammatory, autoimmune disease of the central nervous system that disrupts communication between the brain and other parts of the body. It is among the most common causes of neurological disability in young adults and occurs more frequently in women than men. For most people with MS, episodes of worsening function (relapses) are initially followed by recovery periods (remissions). Over time, recovery may be incomplete, leading to progressive decline in function and increased disability. Most people experience their first symptoms of MS between the ages of 20 and 40.

The effectiveness of Zinbryta was shown in two clinical trials. One trial compared Zinbryta and Avonex in 1,841 participants who were studied for 144 weeks. Patients on Zinbryta had fewer clinical relapses than patients taking Avonex. The second trial compared Zinbryta with placebo and included 412 participants who were treated for 52 weeks. In that study, those receiving Zinbryta had fewer relapses compared to those receiving placebo.

Zinbryta should generally be used only in patients who have had an inadequate response to two or more MS drugs because Zinbryta has serious safety risks, including liver injury and immune conditions. Because of the risks, Zinbryta has a boxed warning and is available only through a restricted distribution program under a Risk Evaluation and Mitigation Strategy.

The boxed warning tells prescribers that the drug can cause severe liver injury, including life-threatening and fatal events. Health care professionals should perform blood tests to monitor the patient’s liver function prior to starting Zinbryta, monthly before each dose, and for up to six months after the last dose.

The boxed warning also highlights other important risks of Zinbryta treatment including immune conditions, such as inflammation of the colon (non-infectious colitis), skin reactions, and enlargement of lymph nodes (lymphadenopathy).

Additional highlighted warnings include hypersensitivity reactions (anaphylaxis or angioedema), increased risk of infections, and symptoms of depression and/or suicidal ideation.

The most common adverse reactions reported by patients receiving Zinbryta in the clinical trial that compared it to Avonex include cold symptoms (nasopharyngitis), upper respiratory tract infection, rash, influenza, dermatitis, throat (oropharyngeal) pain, eczema, and enlargement of lymph nodes. The most common adverse reactions reported by patients receiving Zinbryta when compared to placebo are depression, rash, and increased alanine aminotransferase.

Zinbryta is manufactured by Biogen, Inc. of Cambridge, Massachusetts.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.


World MS Day 2016 and OrangeMoji’s


World MS Day is May 25 and the Multiple Sclerosis Foundation (MSF) with support from Novartis is challenging us to bring out our best orange for the day – as in a real orange that we have turned into an OrangeMoji to bring awareness to MS.

ripe orange with leaves on white background

I have to go on record that  even though I love the color orange I still wish our official awareness color was one that could be rhymed.  Songwriters and poets have yet to come up with anything that rhymes with orange so instead we have to settle for the thought that a picture is worth a thousand words.   Keep thinking about it and let me know if you come up with a word or two.IMG_1886Interpreters say the dream of an orange is a symbol of health and the fulfillment of wishes.  Now they don’t say what kind of health that may be but perhaps someday as we all wish for, there will be a cure for MS and we will all have good health.  If this is the case, we might want to dream more about oranges but I think dreams about unicorns and rainbows would be even better since they signify hope and happy endings.


MSF invites everyone to create their own OrangeMoji that will convey the ‘I can do this!’ message of the song with the same name done by David Osmond. Please click on the link and have a listen – you might be surprised at the power of his message.  David also has MS and is a celebrity spokesperson for the Novartis company. People who submit an OrangeMoji will be eligible to win a chance to attend a listening party with David. So it’s simple – take an orange and some markers or other materials and make your own OrangeMoji, take a picture of it, and submit it online.  Your OrangeMoji might even appear in the next music video.


The message could show you’re not going to take what MS is dishing out ….IMG_1878

Or how your everyday attitude of laughing in the face of MS gets you through….IMG_1881

As David Osmond’s lyrics for I Can Do This remind us –

I’ve rehearsed a thousand times

I played it all out in my mind

And now it’s time to go, time to give the world the show

That I – I’ve been dreaming all my life


The day has come – I’m gonna give myself a chance

The fear is gone – This time I’m gettin’ off the fence

I’m moving on – The wait is over

Yeah, it’s my life, This is my life!


Whether you make an OrangeMoji or do something else, please be sure to join me and the 2.2+ million people in the world who have multiple sclerosis,  as we observe World MS Day 2016.  Whatever your OrangeMoji might look like – remember when you peel it open we are all the same and hoping for increased awareness to finding an end to MS for us and future generations.

be well,



IVC Filter? No thanks!!


I was scheduled for corrective surgery to my foot but had to postpone due to my husband’s hip replacement surgery (prioritized by me!), and now find myself back on the orthopedic surgeon’s schedule.

I’m honestly thankful for the delay because it gave me time to consider the surgical options.  Initially the surgeon said I would need to be fitted with an inferior vena cava (IVC) filter to catch any potential blood clots from the surgery and prevent me from having a pulmonary embolism or worse.  The delay gave me time to do research and ponder what I had read and fortify myself for an important conversation with the surgeon about why I would not want to undergo this procedure.

The IVC filter is implanted via a heart catherization procedure.  It is designed to be removable, but in about 80% of the time, the filter is left in or it has been unretrievable.   Now I’ve been through a heart catherization and that part didn’t bother me so much but reading about the problems with placing one of these filters, as well as the documented problems that they sometimes come apart and pieces of it can travel to the heart and cause death made me pause.   I researched further and found very little scientifically rigorous research to support the use of the IVC filter – there was even more written that said it wasn’t the best option for most people.

I did my best to not let all the personal injury attorney ads that are running on television these days about IVC Filters and their causing injury and death influence my decision, but I couldn’t exactly ignore them, either.  IT seems these ads are running all hours of the day and night, and include attention grabbing scare tactics.

In my pre-surgery consultation appointment, my surgeon listened to my concerns and then agreed that we could proceed with the surgery if we took other precautions, so I am now self-injecting Lovenox, a blood thinner, for the next 21 days to ward off any blood clot problems.  I would much rather do this than take an unnecessary and unwarranted risk with the implant of an IVC filter.

Thankfully the doctors I have are open to having conversations, answering my questions and even willing to compromise if I propose alternative routes of treatment.  I wouldn’t want it any other way and I hope everyone has this type of relationship with their physicians.

Be well,




Many People are #MySupportHero


Who qualifies as #MySupportHero extends beyond the people who are with me every day on this journey, to the great people who work behind the scenes to support MS research.  There is so much exciting activity taking place in laboratories, especially the  work through the International MS Federation to look for treatments for Primary Progressive MS. I’m not always a great fan of the pharmaceutical companies and how MS drugs are priced and I am often an outspoken critic,  but I am always thankful for the development of new treatments.

A group of unsung heroes I want to acknowledge are the people who make up the core supporters for iConquerMS™ and the fine folks at the non-profit Accelerated Cure Project. Not one of them had a personal connection to MS before they began their work and yet they are 110% committed to support patient powered research and finding a cure for MS.  They listen attentively and respond respectfully to those of us who have MS and recognize our ability to contribute to meaningful and impactful research.

Another group of  #MySupportHero people  I want to mention are the almost 3,000 people with MS who have joined iConquerMS™,  the patient powered research network.  They didn’t have to take the time to donate their information, but they decided we would all benefit from their contributions. If you haven’t already joined us for this research revolution, it’s not too late…. Sign up at

#MySupportHero can be found in many places – my husband, my family, my medical team and researchers, and all of you who believe in the power of people affected by MS.    Regardless of which category you fall into, please accept my thanks!  You are all heroes and deserve a medal!

Be well,



#MySupportHero is a project of MS World and MS drug manufacturer Biogen.

“To honor the unsung heroes who support and make a difference for people living with multiple sclerosis (MS), MSWorld and Biogen are introducing #MySupportHero. For MS Awareness Month in March, we’re going to celebrate and thank those individuals or groups who help people rise Above MS.”   Learn more at


Holidays, Diets and MS!


That’s quite the combination to even think about at the same time but I want you to consider helping us think about diet and multiple sclerosis.  The patient-led initiative, iConquerMS™ needs your input on diet and how it might affect your life with MS.  We are surveying members for their input on what might be important to look at and I invite you to join us.  To take the survey you will have to register at the site, but I promise that is simple.  The survey will remain open until January 3.

Here’s is the official invitation to participate  and more of an explanation – I hope it will spark your interest and you will help us create this important look at diet.  Wishing you well, Laura


We are writing to share some exciting news about an iConquerMS™ research study that’s being developed. We also want to ask for your input on this study.

Background: Our initial award from PCORI to create iConquerMS™ included funding to work with Dr. Carolyn Schwartz, an expert in the area of patient-reported outcomes research. We decided to use these funds to conduct a research study on a topic that has been directly suggested by iConquerMS™ members.

Looking across all of the research questions that have been submitted to iConquerMS™, one of the most common themes is the use of complementary and alternative medicine (CAM) and dietary strategies in MS. For instance, people with MS have asked about yoga, massage, meditation, the Paleo diet, vitamin D, and medical marijuana, to name a few. They’re curious about how many people have tried these approaches and what their experiences have been like. They’re also interested in sharing their own knowledge with others.

We would therefore like to conduct a study that gives people with MS helpful information about the use of CAM therapies and diet. The results of this study could also be used to design later studies on these topics.

Because this is an iConquerMS™ study and you are an iConquerMS™ member, you can get involved in many ways. For instance, you can help design the study to make sure that the results will be useful to you and others with MS. You can participate in the study once it’s developed. Once the study is complete, you can have access to the data and findings to explore as you like.

As a first step in designing this study, we need some input from you: What information do you want to have when considering a new CAM therapy or diet? Which therapies and diets are you interested in trying and which ones have you used already?

We’ve posted a survey on iConquerMS™ to collect this initial input. To fill it out, follow these three simple steps:

  1. Go to and log in at the top of the page. (If you’ve forgotten your password, click here and fill in your email address.)  NOTE from Me- if you haven’t already joined, you will need to create your account before you can complete the Diet/CAM survey
  2. On your iConquerMS™ dashboard, find the “My Research Surveys” area and locate the survey named “Diet/CAM Study – Initial Input Survey” in the “New” column.
  3. Click on the link for the survey, fill it out, and submit. It’s a short survey which should only take a few minutes to complete.

Please send us your responses on or before January 3. Once we have this input, we’ll work with Dr. Schwartz to develop a research proposal and will share this with you as well. The actual study will take place in early 2016.

If you have any questions or need help logging in, just send us an email

We look forward to working with you to develop and conduct the first iConquerMS™ research study!

Happy Holidays!
The iConquerMS™ Team

Recap and wishes for a happy new year!


In case you missed my recent articles on, here is a recap of the ones published from September up to today.   I hope everyone has a wonderful holiday season and healthy and happy new year.  Be well, Laura


Feasting and MS

By Laura Kolaczkowski – December 20, 2015

The holidays are here and that means for many of us, it is also a season of gluttony – there’s so much to take in, we often are overwhelmed. There are so… READ MORE

Another Medical Mystery

By Laura Kolaczkowski – December 17, 2015

We recognize the cause of multiple sclerosis is one huge mystery waiting to be solved, but there is another medical question that plagues us almost as much…. What will treating my MS… READ MORE

Speaking of Multiple Sclerosis

By Laura Kolaczkowski – December 2, 2015

The other day I was listening to XM Radio and had it on the Doctor Radio Channel – yes, that is my guilty pleasure. I tune in to in and listen and learn,… READ MORE

Changing Seasons for MS

By Laura Kolaczkowski – November 21, 2015

I don’t know about your feelings, but I am pleased that summer is gone and the heat of the dog days of summer have given way to the cool nights of the fall. The… READ MORE

Mary Poppins & MS

By Laura Kolaczkowski – November 14, 2015

We all get them in our online browsing – those small advertisements that promote something about multiple sclerosis in the hope we will take the time to click on it and learn… READ MORE

When Life Has Other Plans

By Laura Kolaczkowski – November 7, 2015

It’s an easy wager that most everyone can identify with the reality that our life plan rarely follows the course we think it will. Sometimes there are minor changes in our plans, but… READ MORE

What Happens When We Stop DMTs?

By Laura Kolaczkowski – October 31, 2015

We’ve talked about this before – the idea that perhaps the disease modifying treatment (DMT) I’m taking is no longer packing a punch and it is not doing much of anything for… READ MORE


Breast Exams & Multiple Sclerosis

By Laura Kolaczkowski – October 29, 2015

October health awareness moments are dominated by pink for breast cancer but as I slowly stepped up to the machine for my annual mammogram, I muttered that it might take a bit longer… READ MORE

MS Truths on the Internet

By Laura Kolaczkowski – October 24, 2015

If it’s on the Internet it has to be true, right? Especially if it shows up on your notices through someplace special like Google alerts, which send me the multiple sclerosis TOP headlines… READ MORE

Siblings & MS

By Laura Kolaczkowski – October 18, 2015

Today is my baby sister’s birthday – ok, none of us are babies anymore so I’ll switch that one to my youngest sister, but it still tells you her birth order in… READ MORE

Creepy MS

By Laura Kolaczkowski – October 15, 2015

We’re heading into the fall season and thoughts turn to the creepy, crawling paranormal things that startle even the strongest and bravest of us at Halloween, especially when they appear from nowhere…. READ MORE

Determination or Stubbornness?

By Laura Kolaczkowski – October 12, 2015

What is it that keeps us going when stopping might be the wiser choice? I was in Washington DC a while back and had some free time and I was excited that my… READ MORE

Interview on the PPMS ORATORIO Study

By Laura Kolaczkowski – October 11, 2015

People with primary progressive multiple sclerosis (PPMS) finally have something to cheer about in a potential disease modifying therapy. Genentech and Roche pharmaceutical companies announced the results of their studies of ocrelizumab in… READ MORE

Knockout Drugs: Ocrelizumab and Biotin

By Laura Kolaczkowski – October 6, 2015

It’s that time again for the MS specialists, researchers, nurses, therapists and journalists to gather for the annual ECTRIMS conference. ECTRIMS, short for the European Committee for the Treatment and Research in Multiple… READ MORE

Got MS? Who Cares?

By Laura Kolaczkowski – October 4, 2015

No, I’m not being rude and flippant with that question. I’ve been thinking about this a lot lately as I read materials on MS caregivers and the articles and responses by people here… READ MORE

Do You Remember?

By Laura Kolaczkowski – October 1, 2015

For me, it’s sometimes yes, and often no. I wish I could find a pattern to what it is that sticks in my memory for longer than a fleeting moment. I know there are… READ MORE



By Laura Kolaczkowski – September 22, 2015

This article is part of an ongoing series about people who are Making A Difference (MAD) about MS. Visit Ashli Hopson’s, Stuart Schlossman’s, and Lydiaemily’s interviews. Perhaps you are one of the… READ MORE


By Laura Kolaczkowski – September 10, 2015

Legalized gambling can be found in 46 states – gambling is legal in all but Hawaii, Tennessee, Utah and Vermont. Each time a person puts money into a casino machine or puts… READ MORE

It’s All About MEE


No, not me, but MEE – Motivating, Educating and Empowerment, which is the teleconferences theme for the Multiple Sclerosis Foundation.  You might already know I am a big fan of all the free programs made available in the MS community to help us to learn more.  You probably also know, I am a big fan of my MS neurologist, Aaron Boster, Ohio Health.  When you put the two together, I expect really great things.

December 8, 8:30-9:30 PM,  the MS Foundation is hosting a teleconference featuring Dr. Boster, who will speak on Technology to Improve the Treatment of MS.  At my last appointment, he hinted at new MRI imaging techniques for all of his MS patients that will not only look for lesions but also measure brain atrophy and I  hope he will speak about those advances.  That alone could take the entire hour, but I’m sure there are other technology advances he will address as well.

The MSF teleconferences are free, and you can join via phone and also view the presentation via the internet via these links:

Call 1-888-550-5602  then dial code 23441168 when prompted

To view the presentation, go to

If you can’t make it Tuesday night live, MSF offers replays on their website  at 

You might want to also check out the other great speakers they have hosted, including MS physical therapist specialist Herb Karpatkin, who did a teleconference last week on Maintaining Independence through Assistive Technology.  Unfortunately there is only the audio and not the slides and he talks about a lot of simple and inexpensive devices that might be useful to us.  A search on the internet will turn up many of these devices he talks about in this teleconference.  Note – it took a while but I finally found the controls for fast forward and pausing these sessions located at the bottom of the page and not at the top where there is a play only button.

As always, I encourage everyone to learn more about MS – the field of multiple sclerosis constantly changes and it’s up to us to educate ourselves.

be well,




Looking for Answers?


We all have questions about multiple sclerosis  – living with it, treating it, finding ways to make it take a back seat in our lives.  We also often lack good resources to hunting down the answers.


That is why I try to attend as many of the live MS programs as possible.  Yes, they are usually sponsored by the drug companies and I have to hear the official program first before satisfying my own curious thoughts.  But at the end the speakers are usually open to taking additional questions and it’s always great to have mine and those of others answered for free by the experts.  They often even toss is a free meal … free everything except for the cost of transportation to get to the venue is a good thing, right?


There’s an education  program out there that skips all the promotional materials and goes straight to the heart of what we want – the MS Views and News, delivered commercial free.  This non-profit organization out of Florida gets its sponsorship money from the pharmaceutical companies but does not endorse any particular brand,  All the money they receive is unconditional use money and MS Views and News, under the direction of their leader Stuart Schlossman, puts that money to great use by providing education programs that cover a wider range of topics.


They have recently expanded their reach beyond Florida and have ventured as far north as Michigan and east into the Carolinas.  A complete listing of upcoming programs can be found on the  MSVN Events Calendar .  They have a program in Indianapolis coming November 18 and I will be there –  stop and introduce yourself if you happen to be a participant in the Hoosier state. Take a look and see if one of their programs is coming close to you soon and plan to attend.


If you can’t make it to a live program , they almost always record their programs and then have them posted on their website.  you can view those from the comfort of your own home.

MS Views and News has its Learning Channel on YouTube 

Live or recorded, please take advantage of this incredible resource – you will learn something and that’s always time well spent.

be well,



Ocrelizumab and Biotin’s Race for PPMS Treatment


ECTRIMS (European Committee for Treatment and Research in Multiple Sclerosis), concluded their 2015 annual meeting with ‘late breaking news’ sessions, which included the results from two separate drugs being looked at for treatment in primary progressive MS (PPMS).  This is significant, because as most of you know, PPMS has no official, authorized disease modifying therapy, although several drugs are used off-label.

One drug for PPMS has gotten most of the attention- that would be Ocrelizumab.  The other one in the shadows is Biotin.  I offer here the abstracts for both of these drugs so you might learn a bit more about them and the trial outcomes, although there are still many details outstanding. Note at the end of each, they give more information about the researchers on the project and their affiliations. Yes, there are many of  us who do like reading these, even if all the information doesn’t make complete sense. 


Be well,




Abstract: 233

Type: Oral LB

Abstract Category: Invited / Oral LB / Poster LB

Introduction: High doses of Biotin, a co-enzyme for acetylCoA carboxylase, a potentially key-enzyme in myelin synthesis, was evaluated over placebo in patients with progressive multiple sclerosis (MS).

Methods: MS-SPI is a randomized, double-blind, placebo-controlled (2:1) trial of oral biotin 300 mg / day in patients with secondary (SPMS) or primary (PPMS) progressive MS. Treatment duration was 48 weeks. The primary endpoint was the proportion of patients who improved at M9 and confirmed at M12, defined as decreased EDSS or improved TW25 of at least 20%. Main secondary endpoints included mean EDSS change, clinical impression of change (CGI and SGI).

Results: 13/103 (12·6%) of MD1003-treated patients achieved the primary endpoint versus none of 51 placebo-treated patients (p=0·0051). The primary endpoint was confirmed by a significant decrease in the mean change EDSS, CGI and SGI in the MD1003 group. The proportion of responders was higher in patients (1) with a baseline EDSS score in the [4.5;5] range compared to patients with a baseline EDSS score in the [6;7], (21.4% versus 9.3%); (2) with no concomitant fampridine administration compared to patients with concomitant fampridine administration (20.7% versus 2.2%) and (3) with SPMS, compared to PPMS (14.8% versus 9.5%). Treatment with MD1003 significantly reduced mean EDSS scores, CGI and SGI in the sub-group of patients with SPMS, and in patients with or without concomitant fampridine administration. Although similar trends were observed in the PPMS subgroup, results were not statistically significant.

Conclusion: Biotin significantly improved MS-related disability and decreased the risk of progression in patients with progressive MS. The effect was more pronounced in patients with SPMS although the relative low number of patients with PPMS in the study precludes robust conclusions. Patients with concomitant treatment with fampridine benefited from biotin in terms of decreased risk of progression and clinical global impression.

Sponsored by Medday Pharmaceuticals


AT is the principal investigator and discloses travel grants from MedDay

FS is CEO and a shareholder at MedDay Pharmaceuticals (the study sponsor)

CL-F ,GE, MC, CP, SV, JD, MD, PC, OG, GD, D-ALTM, PL, BB JP have nothing to disclose in relation with this abstract





Abstract: 228

Type: Oral LB

Abstract Category: Invited / Oral LB / Poster LB

Background: Primary progressive multiple sclerosis (PPMS) accounts for 10-15% of the MS population. There is currently no approved disease-modifying treatment for PPMS. B cells are believed to contribute to the pathogenesis of MS, including PPMS. Ocrelizumab (OCR) is a recombinant humanised monoclonal antibody that selectively targets CD20+ B cells.

Objectives: ORATORIO is a Phase III, multicentre, randomised, double-blind, placebo-controlled study aiming to assess the efficacy and safety of OCR in patients with PPMS (NCT01194570).

Methods: Patients were randomised (2:1) to receive OCR 600 mg (given as two 300 mg intravenous infusions 14 days apart) or matching placebo every 24 weeks for at least 120 weeks or until approximately 253 three-month confirmed disability progression events occurred. Eligibility criteria included an age of 18-55 years, a diagnosis of PPMS (2005 revised McDonald criteria); Expanded Disability Status Scale (EDSS) score of 3.0-6.5 at screening; disease duration (since MS symptoms) of < 15 years in patients with an EDSS score of > 5.0 at screening and < 10 years in patients with an EDSS score of ≤ 5.0 at screening; and documented evidence of elevated immunoglobulin index and/or presence of oligoclonal bands within the CSF. The primary endpoint is time to onset of confirmed disability progression, defined as a ≥ 12-week sustained increase in EDSS score.

Results: Overall, 732 patients were randomised at 183 sites. Mean age at baseline was 44.6 years; 49.3% of patients were female and 94.1% were white. Mean (standard deviation, SD) baseline EDSS score was 4.70 (1.17); mean (SD) duration since MS symptom onset was 6.48 (3.89) years; and mean (SD) duration since PPMS diagnosis was 2.82 (3.22) years. The number of patients untreated with any MS medication in the prior 2 years was 656 (89.6%). At baseline, 26.4% of patients had gadolinium-enhancing (Gd+) T1 lesions; mean (SD) number of Gd+ T1 lesions was 1.0 (4.31); median (min-max) volume of T2 lesions was 6.96 (0-90.3) cm3; and mean (SD) normalised brain volume was 1464.99 (85.96) cm3 on brain magnetic resonance imaging.

Conclusions: The ORATORIO baseline characteristics are consistent with disease characteristics of a PPMS population. As the primary endpoint is an event-driven analysis, the treatment period will be extended until approximately 253 three-month confirmed disability progression events have occurred. The results from this study will be presented after this target is reached.


Research funded by F. Hoffmann-La Roche Ltd., Basel, Switzerland.

Xavier Montalban has received speaking honoraria and travel expenses for scientific meetings, has been a steering committee member of clinical trials or participated in advisory boards of clinical trials in the past years with Bayer Schering Pharma, Biogen Idec, Merck Serono, Genentech Inc., Genzyme, Novartis, Sanofi-Aventis, Teva Pharmaceuticals, GSK, F. Hoffmann-La Roche Ltd., Almirall, NMSS and MSIF; he is also Editor for Clinical Cases for MSJ.

Bernhard Hemmer has served on scientific advisory boards for F. Hoffmann-La Roche Ltd., Novartis, Bayer Schering, Merck Serono, Biogen Idec, GSK, Chugai Pharmaceuticals, Micromet, Genentech Inc. and Genzyme Corporation; serves on the international advisory board of Archives of Neurology and Experimental Neurology; has received speaker honoraria from Bayer Schering, Novartis, Biogen Idec, Merck Serono, F. Hoffmann-La Roche Ltd. and Teva Pharmaceutical Industries Ltd.; has received research support from Biogen Idec, Bayer Schering, Merck Serono, Five Prime Therapeutics Inc., Metanomics, Chugai Pharmaceuticals and Novartis; and has filed a patent for the detection of antibodies and T cells against KIR4.1 in a subpopulation of MS patients and genetic determinants of neutralising antibodies to interferon-beta.

Kottil Rammohan has received honoraria for participating in advisory boards and consulting for Acorda, Biogen Idec, EMD Serono, Genentech/F. Hoffmann-La Roche Ltd., Genzyme and Teva; he has also received grants from Accera, NIH and NMSS.

Gavin Giovannoni has received honoraria from Abbvie, Bayer HealthCare, Biogen, Canbex, FivePrime, Genzyme, GlaxoSmithKline, GW Pharma, Merck Serono, Novartis, Protein Discovery Laboratories, Roche, Synthon, Teva Neuroscience, UCB, and Vertex; research grant support from Biogen, Ironwood, Merck Serono, Merz, and Novartis; and compensation from Elsevier as co−Chief Editor of MS and Related Disorders.

Jerome de Seze has nothing to declare.

Amit Bar-Or has received personal compensation for consulting, serving on scientific advisory boards and/or speaking activities from Bayer, Bayhill Therapeutics, Berlex, Biogen Idec, BioMS, Diogenix, Eli Lilly, Genentech Inc., GSK, Guthy-Jackson/GGF, Merck Serono, Novartis, Ono Pharmacia, F. Hoffmann-La Roche Ltd., Sanofi-Aventis, Teva Neuroscience and Wyeth.

Douglas Arnold reports equity interest in NeuroRx Research, which performed the MRI analysis for the trial, and consultation fees from Acorda, Biogen Idec, Genzyme, F. Hoffmann-La Roche Ltd., Innate Immunotherapeutics, MedImmune, Mitsubishi Pharma, Novartis, Receptos, Sanofi-Aventis and Teva.

Annette Sauter is an employee and/or shareholder of F. Hoffmann-La Roche Ltd.

Algirdas Kakarieka is an employee and/or shareholder of F. Hoffmann-La Roche Ltd.

Donna Masterman is an employee of Genentech Inc., a member of the Roche Group.

Peter Chin is an employee of Genentech Inc., a member of the Roche Group.

Hideki Garren is an employee and/or shareholder of F. Hoffmann-La Roche Ltd.

Jerry Wolinsky has received compensation for service on steering committees or data monitoring boards for Novartis, F. Hoffmann-La Roche Ltd., Genzyme and Teva Pharmaceuticals; consultant fees from AbbVie, Actelion, Alkermes, Athersys Inc., EMD Serono, Forward Pharma, Genentech Inc., Genzyme (Sanofi), Novartis, F. Hoffmann-La Roche Ltd., Teva and XenoPort; and research support from Genzyme, Sanofi, the NIH and the NMSS through the University of Texas Health Science Center at Houston (UTHSCH) and royalties for monoclonal antibodies out-licensed to Chemicon International through UTHSCH.