Can Some MS Patients Safely Stop Taking Medicines?
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Multiple sclerosis is an often disabling neurological condition that affects about 400,000 people in the United States. People with MS can develop a wide variety of symptoms, including vision problems, fatigue, pain, and loss of coordination. The disease is diagnosed by a thorough examination that may use magnetic resonance imaging (MRI) to detect damage, or lesions, in the brain and spinal cord.
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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.
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.
I give myself a shot three times a week. I don’t want to do that for the rest of my life.
Robin Beland, MBA
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.
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.
PCORI's Multiple Sclerosis Focus
As of March 2017, 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 topic page, fact sheet, and a listing of current funded projects related to MS. You can also learn more about other PCORI-funded projects on MS in these 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.
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.
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.
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Comments
September 25, 2018, 8:46 PM
Comment by Beth,
September 18, 2018, 11:10 PM
Comment by Gloria R Gilliam,
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.
September 16, 2018, 5:43 AM
Comment by Aron Chambers,
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
August 18, 2018, 7:51 PM
Comment by Ruth Seloover,
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.
August 10, 2018, 11:20 PM
Comment by Kay Roche,
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.
August 4, 2018, 4:07 PM
Comment by Gwendolyn Patterson,
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.
May 23, 2018, 12:33 AM
Comment by Bradley Macklin,
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!
May 3, 2018, 4:46 PM
Comment by Lori,
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?
April 24, 2018, 6:17 AM
Comment by Kelly Farrell,
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.
April 14, 2018, 4:23 PM
Comment by karl knaebel,
Stopped medication over a year diagnosed at 50 stopped after 20 yrs interested on stidy
April 12, 2018, 9:24 PM
Comment by PCORI,
Hello. Thank you so much for your comment. If you'd like to find out more on this study, you may do so here.
March 30, 2018, 1:16 AM
Comment by Beth Papaioannou,
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.
March 6, 2018, 8:23 PM
Comment by PCORI,
Hi Jane. Thank you so much for your comment.
March 1, 2018, 11:50 PM
Comment by Jane Showalter,
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.
February 5, 2018, 6:43 PM
Comment by PCORI,
Hi Angela, thank you very much for your comment.
February 2, 2018, 2:44 AM
Comment by Angela,
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.
January 6, 2018, 9:46 PM
Comment by Sandra Finestone,
I am going to forward this to others with MS
March 19, 2017, 6:43 PM
Comment by PCORI,
Dear Angela, thank you very much for your comment.
March 15, 2017, 7:29 PM
Comment by angela c gomez,
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
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.