Drug discontinuation

The U.S. Food and Drug Administration (FDA) has issued a safety alert, warning that people with relapsing multiple sclerosis (MS) who stop using Gilenya (fingolimod) may experience disease worsening beyond that when starting the medicine or while taking it. Reported cases of such increases in MS disability upon stopping treatment are…

Up to half of women with multiple sclerosis (MS) who stop treatment with Gilenya (fingolimod) when planning to become pregnant will experience a relapse during pregnancy, according to a new study. The findings also revealed relapses over the first six months after giving birth in a quarter of…

I’m not taking all the medication I’ve been prescribed. Chances are, you’re not either. Medication nonadherence, or not taking medicine as prescribed, is a thing — a big thing. According to a column in The New York Times,…

Discontinuing Gilenya (fingolimod) treatment and starting on rituximab therapy may be more complicated than originally thought. A new report chronicles the medical journey of a man with multiple sclerosis (MS) treated with these drugs, and proposes a new treatment regimen. Both Gilenya (an approved MS therapy marketed by…

Online Meditation Course Seen to Help MS Patients Manage Symptoms in Clinical Trial Can someone use a website to learn how to meditate, and then do it well enough to have their MS symptoms improve? Well, maybe. This small study reports that patients who completed an online…

A lot of people with multiple sclerosis take disease-modifying therapies to reduce the inflammation associated with the disease — but in many patients, the treatments’ effectiveness wanes at a certain points. When that occurs, the question is whether to stop taking these treatments, known as DMTs. A study reports that patients’…

Biogen and AbbVie Voluntarily Withdraw Marketing Authorizations for MS Therapy Zinbryta You may have heard about this already, so forgive me if it’s not new to you, but it’s important information. A dozen cases of encephalitis or meningoencephalitis have been reported in patients using Zinbryta, and…

Biogen and AbbVie have voluntarily withdrawn global marketing authorizations for their relapsing multiple sclerosis therapy Zinbryta (daclizumab) because of serious side effects that include brain inflammation. The Europe Medicine Agency, which oversees medications across the European Union, also released a statement recommending a “immediate suspension” of Zinbryta’s use by patients and…

Usually, I’ve got a fair idea of where I’m headed in my column. This time, I really don’t. I’m confronting something. Maybe nothing. It’s as clear as the cliché involving wet, clingy earth. For the first time since the last week in November 2017, I’ve stopped taking antibiotics. That’s…

Multiple sclerosis patients with high relapse rates but less physical impairment before starting on  Novartis’ Gilenya (fingolimod) are likely to experience a surge in disease activity if they stop the treatment, researchers in Turkey report. The study, which dealt with patients with relapsing forms of MS, referred to the surge as "severe disease reactivation," or SDR. Researchers published their article, “Factors Predictive of Severe Multiple Sclerosis Disease Reactivation After Fingolimod Cessation,” in the journal The Neurologist. Studies have shown that Gilenya, which the U.S. Food and Drug Administration approved in 2010, can benefit adults with relapsing MS. It reduces annualized relapse rates and prevents more brain lesions from forming, compared with standard interferon treatments. Lesions are damaged nerve cell areas. Despite its benefits, Gilenya is not recommended for patients with heart or liver problems, low levels of white blood cells, severe herpes virus infections or other infections. Also, patients who do not respond to Gilenya and women who are planning to become pregnant are advised to stop the treatment. Discontinuing Gilenya can lead to a return to pretreatment disease activity, or severe disease reactivation, in some patients. It is unclear why this happens and why it affects only some patients. To better understand what risk factors could be associated with reactivation, a team at Istanbul University compared the demographic and disease features of patients who developed SDR after stopping treatment with Gilenya. SDR was defined as including these elements within 6 months of Gilenya discontinuation: more than 5 gadolinium-enhanced lesions or a tumefactive demyelinating lesion detectable by magnetic resonance imaging, the disease progressing to the point that additional treatment with methylprednisolone or plasma exchange was required, and progressive physical disability reflected by a 1-point or more increase in patients' scores on the Expanded Disability Status Scale, or EDSS, Thirty-one patients at the university’s MS clinic who had discontinued Gilenya were included in the study. Eight experienced SDR and 11 relapses. The mean time for SDR patients' reactivation to occur was 2.6 months, researchers said. Patients had significantly higher levels of lymphocytes — white blood cells involved in autoimmunity — than during Gilenya treatment. When the team compared the disease features of SDR and non-SDR patients, they found that SDR patients had significantly higher annualized relapse rates before starting Gilenya and lower EDSS scores. “A higher ARR [annualized relapse rate] is the major contributory factor toward development of SDR,” the researchers wrote. “Patients who had higher ARRs before fingolimod [Gilenya] treatment must be closely followed up both clinically and radiologically in terms of the early signs of severe reactivation,” they wrote. About 38 percent of the SDR patients failed to respond to steroid treatment. They received a plasma exchange, which led to moderate improvement in their condition. Based on this finding, the researchers suggested that “plasmapheresis [plasma exchange] must be considered in patients exhibiting steroid-refractory SDR.” "In conclusion, SDR may be observed within the first 3 months after cessation of fingolimod," the team wrote. "This may be explained by the rapid influx of lymphocytes into the CNS [central nervous system]. Patients with higher annualized relapse rates and lower Expanded Disability Status Scale scores before commencing fingolimod treatment were more likely to exhibit SDR."  

A majority of relapsing-remitting multiple sclerosis (RRMS) patients at a Swedish clinic who initiated treatment with Tecfidera (dimethyl fumarate; DMF) either stopped or switched to another therapy within two years, a study reports. Researchers in the observational study were not able to determine exact reasons for discontinuation. But, they wrote,…

Zinbryta (daclizumab) may not be the best follow-up therapy for relapsing–remitting multiple sclerosis patients who stop taking Tysabri (natalizumab) for safety reasons, a case study suggests. An article on the 25-year-old patient’s case, titled “Disease reactivation after switching from natalizumab to daclizumab,” was published in…

Have you ever thought about stopping whatever MS treatment you’re using? I have. So has John Corboy. Corboy’s not an MS patient. Rather, he’s a researcher at the University of Colorado’s medical school. And he’s studying whether older patients, if they haven’t had a relapse for several…

The European Medicines Agency has restricted the use of Zinbryta (daclizumab) for relapsing multiple sclerosis after reports of patients experiencing severe liver damage and one dying of liver disease. The temporary order restricts Zinbryta to European Union patients with a highly active disease who have failed to respond to…

MS patients who start treatment at a younger age, and whose condition requires hospitalization, are more likely to stop treatment, a Canadian study reports. The research, published in the journal Dovepress, dealt with the main reasons Canadian patients quit first-line injected disease-modifying therapies, or DMTs. It was titled “Persistence to disease-modifying therapies for multiple sclerosis in a Canadian cohort.” DMTs can reduce MS activity, but patients must stick with them in order for them to be effective. “There is currently a paucity of clinical trial data on what happens to individuals when they discontinue DMT," the researchers wrote. "However, recent preliminary evidence from observational studies suggest increased relapses and disability in those who discontinue DMT." Researchers sought to identify MS patients at higher risk of discontinuing treatment. They looked at Manitoba Province's medical database to identify the types of drugs MS patients were taking, and for how long. The analysis covered 721 patients who received injected beta-interferons or Copaxone between 1996 and 2011, and whom doctors followed for at least a year. Teva manufactures Copaxone, whose generic name is glatiramer acetate. The mean age of the patients in the study was 37.6 years, and 74.2 percent were women. Researchers defined a discontinuation of a DMT as a 90-day or longer gap in treatment. A third of the patients were treated with beta-interferon-1b, either Bayer HealthCare's Betaferon/Betaseron or Novartis' Extavia. It was the first such therapy available in Manitoba. Twenty-three percent of patients received beta-interferon-1a, either Biogen's Avonex or Merck's Rebif. And 21 percent received Copaxone. The median time before a patient discontinued a DMT was 4.2 years. Although 62.6 percent of patients discontinued treatment at some point, 57.4 percent either reinitiated it or switched to a different DMT. Patients who were on DMT at least a year were more likely to stay with it than those who stopped in the first year. Importantly, patients who started a DMT at a younger age were more likely to stop taking it than older patients. “Our results are also consistent with previous work examining persistence for other chronic medication classes, including statins, antihypertensives, bisphosphonates, and oral antidiabetic agents, where the risk for discontinuing drugs declined in a linear fashion with age,” the researchers wrote. The team also found that 16 percent of patients had to be hospitalized overnight, with 3 percent of the cases due to MS-related complications. And these hospitalized patients were more likely to stop their DMT treatment earlier, the researchers said. Summing up, the team said: "Subjects who were younger when starting a DMT, had prior MS-related hospitalizations, were more recently diagnosed with MS, or had a greater lag time between their MS diagnosis and DMT initiation were more likely to discontinue therapy." Although "not all of the factors identified with discontinuing DMT" can be modified, "they may help practitioners enhance MS care by identifying individuals who may be at particular risk for DMT discontinuation," the researchers concluded.

In case you missed them, here are some news stories that appeared in MS News Today that caught my eye over the past week. Acne Therapy Reduces Rate of Multiple Sclerosis Progression, Canadian Study Reports At first glance, the headlines about this drug announced what seemed to be…

Older patients with secondary progressive multiple sclerosis (SPMS) as well as older relapsing patients whose MS has been inactive after five years may safely discontinue their treatments, Canadian researchers at Vancouver’s University of British Columbia argue. Their Sanofi Genzyme-sponsored study, “When Should Disease-Modifying Treatments Be Discontinued in Patients with Multiple Sclerosis: An…

Many decisions to stop taking the multiple sclerosis treatment Tysabri (natalizumab) appear to be based largely on subjective factors such as patients’ or physicians’ view of the risk, rather than objective assessments of the risk, a study indicates. Tysabri is an approved immunotherapy for active relapsing-remitting multiple sclerosis (RRMS). Despite its benefits, there…

I was a teenager during the 1980s and cannot say the word “holiday” without Madonna’s song playing briefly in my head. For most holidays the perky music seems okay, but for discussion of a “drug holiday” it feels a bit off. Sort of like, “Yay! You have a chronic…

Multiple sclerosis (MS) patients with more advanced disease, as evidenced by disability, and those more frequent relapses or aversion to needles are among the groups of people at higher risk of discontinuing Betaferon (interferon beta-1b) treatment, researchers report. These findings may help to alert clinicians to those least likely to adhere to…

Rebound symptoms after stopping fingolimod (Gilenya) treatment affect a “clinically relevant” number of multiple sclerosis (MS) patients, a study by University of California, San Francisco, researchers reported. The study called attention to the need for determining the best method of sequencing or stopping MS treatments, and highlighted the need to identify factors…

A team led by researchers at the New York University (NYU) Langone Medical Center recently assessed what happens when clinically stable patients with multiple sclerosis (MS) stop taking their medication and found that almost 40% of them experience to some extent a return in disease activity and related symptoms. The…