The majority of people newly diagnosed with MS go through periods of relative health followed by episodes of new or worsening symptoms, referred to as relapses. Since 1993, disease-modifying therapies have been available that can lessen the frequency and severity of relapses and prevent new MRI lesions. The Food and Drug Administration has approved 14 drugs to treat the symptoms and slow the course of this relapsing-remitting form of MS.
A PCORI-funded study is now testing whether some patients, after years of successful treatment, could safely stop taking those drugs.
Why is this an important issue? The average annual wholesale cost of the drugs is $90,000. Some of the treatments are taken orally, but others require injections. Most have side effects, some of which can be serious. “I give myself a shot three times a week. I don’t want to do that for the rest of my life,” says Robin Beland, MBA, a vice president of sales at a technology company, who was diagnosed with MS around 20 years ago.
Answering a Common Question from Patients
Her neurologist, John Corboy, MD, of the University of Colorado, Denver, says patients constantly ask, “‘Hey doc, how long do I need to take this?’ We really have very little data to answer a very common question,” Corboy says.
John Corboy, MD, of the University of Colorado, Denver, talks about patients' roles in his PCORI-funded study.
So, he and a team of both researchers and other members of the healthcare community have launched a project to begin to answer that question. The study will recruit 300 patients with MS at 15 centers across the country. The patients in the study have been continuously taking MS medications for at least five years with no relapses or new lesions. Half of the participants will be randomly assigned to stop taking their medicines, and the other half will continue.
The research team will closely monitor the patients for two years, performing MRI scans and tracking symptoms, to see how the patients who continue taking the disease-modifying therapies compare to those who halt their medicines.
Although it is important for patients to continue in their assigned group at least until they have a new relapse or MRI lesion, all participants will retain the right to stop, restart, or change their medicine should they feel that is appropriate for them.
I give myself a shot three times a week. I don’t want to do that for the rest of my life.
The study is enrolling people age 55 and older. “As patients age, relapses generally happen less often, and there’s a reduction in new lesions,” Corboy says. “And most importantly, studies have shown that as people age, the medicines tend to be less effective.”
It’s possible, Corboy says, that Beland, who is 55, and others are getting little or no benefit from their medications, while still experiencing side effects.
Weighing the Risks of Stopping Medication
Beland plans to sign up for the study. “I do MRIs yearly, and I don’t have any new lesions. I don’t know if that’s because of the drug or not,” she says. She’s willing to risk having a relapse if the study randomly assigns her to the group of the patients who stop taking medicines. “If I go off the medicine and something happens, then I’ll go back on,” she says.
PCORI has funded seven patient-centered comparative clinical effectiveness research studies, totaling $26 million, about multiple sclerosis (MS).
Two of those studies compare the pros and cons of drugs to reduce MS attacks or slow the disease’s progression. Another assesses whether patients with MS in rural and low-income areas benefit as much from rehabilitation therapies provided via telehealth as they do from clinic-delivered treatments.
For more information, see our fact sheet and a list of projects related to MS. You can also learn more about other PCORI-funded projects on MS in previous blog posts, When a Clinician Becomes a Patient and A Multifaceted Disease Requires a Patient-Centered Response. Learn more about the former post’s guest author, Stephanie Buxhoeveden, here.
Corboy’s team is getting ready to enroll patients at 15 study sites, three of which are supported by funding from the National Multiple Sclerosis Society. To gauge the likelihood of success in recruiting participants, the team did a preliminary survey asking patients whether they’d consider joining such a study.
“Some people are scared about going off medication,” Corboy says. “They say, ‘If it ain’t broke, don’t fix it.’ They won’t want to join our study, and we understand their concerns. But everybody is interested in the study’s results.”
If the research finds no downside to stopping medication, Corboy thinks a larger study should take place, perhaps homing in on the best age to stop taking the medications. If, however, going off disease-modifying drugs carries significant risks, Corboy says, “that would reassure physicians and patients that it’s worthwhile to continue to use these medications in spite of the costs and hassle and side effects.”
There could, of course, be a gray area in the results, where patients face a slight risk of relapse or lesion if they stop treatments. Each patient and doctor would then need to weigh the options together.
Patients and other stakeholders have been involved from the beginning of the study through two stakeholder advisory committees based at the University of Colorado and the Cleveland Clinic, one of the study sites. The advisory committees worked intensively on the language in questionnaires to ask patients about how satisfied they are with their treatment or lack thereof.
“Ultimately, patient satisfaction is the bottom line,” Corboy says.
Editor's note: At the time that this blog post was published, Diane E. Bild, MD, MPH served as associate director in the Clinical Effectiveness and Decision Science program.
Comments
Very interested in this study
Very interested in this study. Was diagnosed at age 65, many lesions & symptoms- started on Rituxan. Since starting meds, on MRI no new activity, nor obvious symptoms. Meds stopped 2 yrs ago - so far OK
Dear Angela, thank you very
Dear Angela, thank you very much for your comment.
I would love to know more
I would love to know more about this study. I was told I had ms in 2007 but had Lyme in 2004. I chose not to take meds but in 2017 started having more trouble and after meeting a new neurologist, I chose ocrevus infusion. I don’t do meds well and having side effects. But going to try for awhile. I’m really not wanting to take this long periods of time. I’m 51 now and in good health otherwise. I’ve alwsys taken vitaminD and believe other herbs have helped me a long the way. I would love more information.
Hi, Beth, thanks for reading.
Hi, Beth, thanks for reading. We encourage you to find out more about this study by visiting the project page and clicking the green box in the upper right corner to receive email updates.
hi beth I am 57yrs and
hi beth I am 57yrs and recently diagnose w/ MS 2018 was a very stressful yr DR wants me start Ocrevus I am scared to star Ocrevus trade off does not look good as women ended up with breast cancer; respiratory infections migraines etc.. with Ocrevus Did it help?
I haven’t had a new lesion in
I haven’t had a new lesion in 10 years! I’ve been on betaseron , avonex and now Tecfidera. I’m 61 and my lymphocytes systematically dropping . My doc seems concerned about taking me off the meds. At this age, I’m afraid of the meds Messing with my white blood cells
how are you now? I started
how are you now? I started taking Copaxone but I feel like crap and have been thinking of getting off.
I am going to forward this to
I am going to forward this to others with MS
DONT! A doctor recommended
DONT! A doctor recommended that my grandmother (who had been treated for MS 30 + years via infusions) stop taking getting her infusions and she died a month later. This is a women who was still shooting hoops in the backyard with Her grandchildren days before she died. There is no evidence that suggests it’s safer to stop being treated. This “theory” lead to fatal advice.
Was your grandmother getting
Was your grandmother getting the infusion for the all of the 30 years she was diagnosed?
I am planning to come off MS
I am planning to come off MS drugs for pregnancy. I have had one neurologist say I could have 6 months off drugs before being sent to a fertility specialist. I have another neurologist that told me I couldn’t have cushion time and had to start trying immediately. Is there any reason to think that 6-8 months off drugs to allow for pregnancy would be a concern? I haven’t had new lesions in years. I had 1 relapse 3 months after having my first child and there is no sign of that relapse on my MRI’s.
Hi Angela, thank you very
Hi Angela, thank you very much for your comment.
After discussion with my
After discussion with my neurologist, I plan to stop my plegridy when my supply runs out in 6 weeks. I was diagnosed in 1990. I haven't had any lesions or new problems in 5 years. I am now 61. He is going to repeat MRI 6 months after last dose. I am interested in what this study finds.
Hi Jane. Thank you so much
Hi Jane. Thank you so much for your comment.
Diagnosed TM 15 years ago
Diagnosed TM 15 years ago then MS 10 months later. Stopped interferon 8 months ago. No attacks in many years. I do not like the interferon side effects . I am interested in the study. Thank you.
Hello. Thank you so much for
Hello. Thank you so much for your comment. If you'd like to find out more on this study, you may do so here.
Hi I was diagnosed with MS
Hi I was diagnosed with MS six years ago. Tried three different medications. They made me feel worse. Now I'm having problems with sciatica very bad and back hurts really bad. My husband is get very fusrated do you have any advice for me.
Hi, Gloria. Thanks for your
Hi, Gloria. Thanks for your comment. We recommend talking to your physician about what treatment option might be right for you.
Stopped medication over a
Stopped medication over a year diagnosed at 50 stopped after 20 yrs interested on stidy
I was diagnosed with Ms at 45
I was diagnosed with Ms at 45, I am now 54 soon to be 55 in July. I started with Copaxone on about 3 years, then gilenya on about 7 years, Ms is progressing, medicines never stopped the lesions from forming on my brain. I haven't had an MRI in about 4 years and in between neurologists, but I'm in no rush. There's nothing they can do for me. My initial diagnosis was six nerve palsy in my right eye. I've never had any problems with my vision since. Secondary progressive MS. I only had one relapse when I was first diagnosed. I'm now using a scooter full-time. I went from normal to cane to scooter Within a year and that was after I had been on the medication for 5 ears. I stopped gilenya in September because I didn't think it was doing anything. I'm also a breast cancer survivor and did a round of chemo 2007 before starting the MS medicines . Good luck with your study. I wish I was in Denver.
interesting about the age -
interesting about the age - and that the meds work less as you get older.
I am not currently on meds, I am in the process of changing doctors.
I want my doctor to discuss these types of things rather than be a statistic of how many patients he has on this medication and % of no new lesions or symptoms.
It is confusing to me how a medication that drastically reduces your white blood cells can be good for someone - especially as we get older?
I have had RR MS and am now
I have had RR MS and am now 66! I have been on Avonex for 20 yrs. and I do not like loosing 24 hrs every week, due to the side effects and the increasing cost of the medication, is becoming of great concern. I live in Oregon and I am applying for the study that stops the meds and watches, closely, your personal response!
I am 67 years old and was
I am 67 years old and was diagnosed with MS October 19. 2010. I take interferon medication, which I inject three times per week. When I receive MRI'S, there are no new lesions. I want to be medication free. I was being treated by infusions for two years. This was not good for me.
I would love to be included
I would love to be included in this study. Am 61 y.o., was diagnosed in 2008. Have been on Rebif ever since. Since my very first diagnosing MRI, I’ve never had an exacerbation or any changes in my MRIs. Whether that is due to Rebif or not, I have no idea.
Hello, Kaye. Thank you for
Hello, Kaye. Thank you for your comment. If you'd like to find out more on this study, you may do so here.
Started taking Avonex in 2000
Started taking Avonex in 2000 when first diagnosed with MS. I have taken Plegridy the last four years. Now at age of 71, side effects was the reason my doctor stopped the medicine. Apprehensive about being on my own, but will try.
I was diagnosed 14 March 1997
I was diagnosed 14 March 1997 , 27 year old. Now I am 48 , stopped my meds 3 years ago. I work 50 hours a week, haven't a MRI in 3 years. I got tired of 3 shots a week or day.
I am interested in this study
Hi, Aron, thanks for your
Hi, Aron, thanks for your comment. We encourage you to find out more about this study by visiting the project page and clicking the green box in the upper right corner to receive email updates.
I was Dx in 2012 and have
I was Dx in 2012 and have been on Copaxone, tecfidera and now Gileniya. Gileniya has helped my MRIs stay stable but my blood counts are too low to continue. I have decided to go medicine free until my I see a specilist in November. I know I am rolling the dice but hoping for the best! If there were a trial I would be very interested.
Hi, Beth, thanks for reading.
Hi, Beth, thanks for reading. We encourage you to find out more about this study by visiting the project page and clicking the green box in the upper right corner to receive email updates.
Do you know of any similar
Do you know of any similar studies being conducted in other areas of the country? I live in Nashville, TN and we have an MS clinic here through Vanderbilt Neurology. I only had one episode which led to diagnosis. After 5 years with no episodes and no new activity shown on MRIs for that period, I came off of Avonex. I would like to know more about long-term risks for being off meds. I would participate in a study, if it were in Nashville, TN.
Hi Charlotte. We don’t have a
Hi Charlotte. We don’t have a related funded project in your area at this time, but we encourage you to stay up to date on this study by visiting the project page and signing up for updates in the upper right corner. Our topic page can provide you more information on PCORI’s multiple sclerosis research portfolio.
I was dx 11/2013 with RRMS
I was dx 11/2013 with RRMS and was on Copaxone since. I stopped taken the medication about one year ago and have no new lessions signs or symptoms.
I was diagnosed with MS in
I was diagnosed with MS in 2001 by Dr, Barbara Guisser in Tucson AZ. I started on Copaxone right away and took it faithfully until last September. when I switched to Aubagio. I have NEVER had a relapse nor a change in my MRI’s.
I will be 75 yo this year and have decided to stop taking all medications for MS.
Hello, Judith. Thank you so
Hello, Judith. Thank you so much for your comment.
Hello Judith, I was glad to
Hello Judith, I was glad to see someone who is in my age bracket that was on Copaxone for many years. I was DX with Gillian Barre syndrome in 2002, then DX with MS in 2003 after sixth nerve palsy in my eye causing severe double vision (which went away in about 8 weeks). After going in Copaxone that year, there were no more exacerbations -- they just stopped. I deal mostly with fatigue and poor balance. Yearly MRI's had only occasional new lesions with no symptoms. I keep asking my Dr if i can stop the injections, I will be 70 next year. I took myself off and my Dr is not happy. I wonder if I did the right thing? But you know the hassle of injections -- and I do not want a drug that makes me feel bad. So I just stopped.
What was the outcome of the
What was the outcome of the study about those who stopped taking their MS drug? Thank you!
Hi, Nancy, thanks for your
Hi, Nancy, thanks for your comment. This project is ongoing, so there aren't results yet, but we suggest signing up for updates in the upper right hand corner of the project page to stay informed on the latest.
I was diagnosed with RRMS in
I was diagnosed with RRMS in 1996. I started on Copaxone injections on April 15, 1997 and have been on it ever since. I will be 65 next month. I would love to stop the injections and have some fear of stopping since I have been very very stable for nearly 15 years. But to not have the cost and the trouble is very appealing.
Thanks for reading, Maureen.
Thanks for reading, Maureen.
Your study is of critical
Your study is of critical importance to so many of we Baby Boomers who may have been diagnosed early but are aging without a roadmap on our MS. I was diagnosed with RRMS in 2002 and have remained on Copaxone/Glatopa ever since. My neurologist recommends that I end injections at age 65, in just a few months as studies were showing medication might not be effective. A recent brain MRI showed no new activity. I would like to stop but relapse or a shift to Progressive is frightening. Some studies seem to indicate the odds of this shift are relatively high. Thank you for this study. Are you still accepting participant applications?
I am 59 and have had MS for
I am 59 and have had MS for 31 years-now in Secondary progressive- I would love to discontinue Avonex as I’m losing a day a week from side effects- have discussed this with my neuro and she was okay with it for a year with a before and after MRI
I too am 59 and suspected by
I too am 59 and suspected by neurologist to have MS in late 80s, but since he said he couldn’t do anything I didn’t have spinal tap to confirm. Symptoms went away and I forgot about it till it was found in 2005. Started with Copaxone but had problems. Told I was benign ms and I stopped treatment. Started on Avonex a few years later. Got worse and had to retire. Couldn’t afford the medication so got off it 2012. Got better for a few years. DNA test shows I don’t metabolism neuro meds right. Now balance worse, but DR can’t address DNA results, just try and see. Still not on anything and trying to judge what gives me the best quality of life.
Thanks, everyone, for your
Thanks, everyone, for your comments. We suggest signing up for email updates for news on this project by clicking the green button in the upper right corner on the project page.
This is a good idea. Perhaps
This is a good idea. Perhaps a long trial of treatment followed by observation would be best. Especially since the prices of the medicines are so high these days. Perhaps insurance companies would support doing the research.
http://medntel.com/index.php/2019/01/25/ms-drug-prices-2019/
Very interesting article.
Very interesting article. This is the first I've learned that the MS drugs lose there effectiveness as you age. I will be 70 next year and had been on Copaxone for 16 years. Little change in my MRI's, but they do show a lot of lesions, but no new physical issues except for balance and fatigue. I wonder why my Dr insists on staying on a DMD forever? I have decided to go off of it for a while to see if I notice a difference, but my Dr is really unhappy. Is he getting a kik back or something?? I didn't know about a study, I'm on the East coast, but really want to know about this. Thank you for the article!
I was diagnosed in with MS,
I was diagnosed in with MS, at 51, in 2012 and have been treated with Copaxone, Tysarbri, back to Copaxone, Ocreveus and now waiting for Siponimod. I had relapses while on Copaxone. Ocreveus did not help me and I experienced many side effects. My MS was downgraded to either primary/secondary PP. After going through all the screening tests for Siponimod/Mayzent, I am seriously considering going off medication.
I was dx in 1998 and was on
I was dx in 1998 and was on copaxon until last year, I was switched over To Aubagio and have been on it for almost a year. I stopp d taking it this week and have made an appointment with my neurologist. I am having peripheral neuropathy. At this point, the other medications carry too much risk of cancer, breast, thyroid, skin so I am planning on going back to Copaxon. I’m 57, I work out 4 times a week, 3 at Pure Barre and one yoga, I ride my horses at least three times a week and work. I would honestly love to get off all these medications. This study is fascinating to me, I will be following your data.
Diagnosed in 2000 am now
Diagnosed in 2000 am now turning 73. No relapses and on Avonex. Been wanting to stop for couple of years now. Have no neurologist presently. Will be consulting primary care to see about stopping meds.
The results?
The results?
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