Author Topic: (CMSC) Can some MS patients stop disease-modifying drugs?  (Read 15 times)

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Offline agate

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(CMSC) Can some MS patients stop disease-modifying drugs?
« on: June 01, 2017, 02:12:21 pm »
This sounds as if insurance companies will be prompted to exclude some categories of MS patients from coverage for disease-modifying drugs, especially those patients with SPMS, those over 55-65, and those with long-established MS.

From MedPage Today, May 31, 2017:

Quote
Can Some MS Patients Stop Disease-Modifying Drugs?

Evidence says "no," but select patients may fit the bill for quitting

 by Kristina Fiore, Deputy Managing Editor, MedPage Today

NEW ORLEANS -- There's scarce evidence about whether to stop disease-modifying therapy (DMT) in multiple sclerosis (MS) patients, but it may be reasonable to start the conversation with certain patients, researchers said here.

In a review of the literature, there were no randomized controlled trials and six observational studies of varying quality that addressed the question, reported Devyn Parsons, of the University of British Columbia, and colleagues at the Consortium of Multiple Sclerosis Centers (CMSC) meeting.

Generally, the data suggested that certain patients may be candidates for stopping therapy, but further investigation is needed, Parsons cautioned. Potential candidates are those with secondary progressive MS (SPMS) who haven't had disease activity in at least a year, and those with relapsing-remitting disease (RRMS), ages 65 and up, whose disease hasn't been active in that time.

"This is not meant to be used as a guideline; it's a review of the existing literature, which certainly...is of poor quality. It's just a sense of what's out there," Parsons said. "It would be a mistake at this point to tell a patient, 'You can come off your DMT and you'll be fine.' There's no evidence to support that. This gives a sense of what patient populations would be reasonable to consider discontinuation in."

A CMSC attendee called stopping DMTs "dangerous. When we treat with a DMT, we do it because we know 20% of those patients are destined to get worse. You're saying we should stop the drug, and let those people who are going to progress do it, and we'll treat them again," adding that "this is giving license to payers to deny people therapy that physicians think they need. This is a very dangerous thing to put in the MS literature. It will only be used for harm to MS patients."

Parsons reiterated that the findings were not meant to be a guideline, given the lackluster body of evidence.

However, she noted that there was sufficient evidence to do a trial in a low-risk population. John Corboy, MD, of the University of Colorado in Denver, is leading a trial that will evaluate the discontinuation of DMTs in MS patients, ages 55 and older, who have had no relapses or brain MRI scan changes for at least 5 years, while continuously taking MS DMTs. The study is funded by the Patient-Centered Outcomes Resource Institute and will involve dozens of MS centers around the U.S.

It's not well known if DMTs offer any benefits to patients late in the course of disease after many years of treatment, or after conversion to SPMS. It's especially a tough question because it was rare for trials of DMTs to enroll patients ages 55 and up.
Parsons' group conducted a literature review of studies through June 2016, and then updated their work to include three more recent trials done through 2017.
Parsons said there was a "paucity of information in the existing literature. There are no published randomized controlled trials and relatively few observational studies."

Ultimately, they found three observational studies. In the one study, which assessed patients, ages 40 and up, who discontinued DMTs after a minimum of 5 years with no disease activity, they found that 90% were free of attacks and 85% had stable MRI 46 months later.

The next observational study included 303 patients, ages 40 and up, who'd been on a DMT for a minimum of 3 years and had no relapses in the past 5 years. They found that most patients resumed DMT use due to increased disease activity after discontinuation. However, there was a 25% reduction in the rate of restarting DMT for every 10-year increase in age.

Finally, the third observational study looked at 485 MS patients who stopped therapy and 854 propensity-matched controls who continued on drug. They found relapse rates were similar, but survival time to confirmed disability progression was shorter in the group that stopped the drug, and there was a 25% reduction in risk of relapse for every 10-year increase in age.

The updated studies included one that concluded that predictors of remaining relapse-free after stopping DMT included being ages 45 and up, having no relapses in the prior 4 years, and no contrast-enhancing lesions.

Another study showed fewer relapses after stopping DMT for older SPMS patients, while another that found two-thirds of those who discontinue natalizumab (Tysabri) therapy had disease activity compared with 35% of those who stopped first-line DMTs.

Additional risks to consider when thinking about stopping treatment include assessing the risk of rebound syndrome and side effects, she added.

Parsons said she consulted with experts at her institution, including co-author Anthony Traboulsee, MD, to determine "a few situations where it may be reasonable to open up a conversation about discontinuation of DMTs. These are not meant to be guidelines. They are just a jumping-off point."

Those categories included:

~Patients with SPMS who have ongoing progression and no new brain or spinal cord MRI lesions in the last 12 to 24 months.

~Stable RRMS patients, ages 65 or older, with no brain or spinal cord MRI lesions in the last 12 to 24 months.

~Stable RRMS patients, ages 55 to 65, with no new brain or spinal cord lesions during the prior 5 years.

_____________________
Parsons disclosed no relevant relationships with industry.
Reviewed by F. Perry Wilson, MD, MSCE Assistant Professor, Section of Nephrology, Yale School of Medicine and Dorothy Caputo, MA, BSN, RN, Nurse Planner

http://www.medpagetoday.com/MeetingCoverage/CMSC/65641?xid=nl_mpt_special_reports_2017-05-31%20&uun=g345846d0r5339616u







SPMS, diagnosed 1980. Avonex 2001-2004. Copaxone 2007-2010.

 

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