Evaluating the long-term benefits of treatment
A recent MSology survey found that most people start a disease-modifying therapy (DMT) for their multiple sclerosis with the hope of slowing the development of neurological disability (see Drug effectiveness is the most important factor, MSology, March 30, 2020). This benefit won’t be immediately evident – it requires years of follow-up – so it’s important to look at treatments over the longer term to see how well people do.
A number of long-term studies have recently been presented at three neurology congresses: the American Academy of Neurology (AAN) annual meeting; the European Academy of Neurology (EAN) annual meeting; and the Consortium of MS Clinics (CMSC) annual meeting. All were held online this year due to the COVID-19 pandemic. Here’s a summary of what was found.
Copaxone (glatiramer acetate): The GALA trial now has data for people treated with Copaxone (the three times per week formulation) for up to seven years (Rieckmann and colleagues. EAN 2020; EPR1146). Over the longer term, most people on continuous treatment (52%) continued to have relapses, which contributed to a somewhat high annualized relapse rate (0.26). However, only 18% have had a worsening of their disability thus far.
Aubagio (teriflunomide): A similar relapse rate (ranging from 0.19 to 0.26) was seen with Aubagio in a pooled analysis of people treated for up to 13 years (Cohan and colleagues. CMSC 2020; abstract DXT71). The proportion of people with worsening disability ranged from 37% up to 53% at 13 years.
Tecfidera (dimethyl fumarate): A study looked at people in clinical trials treated with Tecfidera for at least 10 years (Gold and colleagues. AAN 2020; abstract P6.012). Most people (51%) had no relapses over a 10-year period; 73% had no more than one relapse so the overall relapse rate was very low (0.107). Two-thirds of people experienced no worsening of their disability after a decade on treatment.
The North American Research Committee on Multiple Sclerosis (NARCOMS) maintains a database of people with MS in the U.S. and Canada. The group looked at over 1,100 people treated with Tecfidera for up to five years (Salter and colleagues. AAN 2020; abstract P15.002). This was an older group – the average age of people starting Tecfidera was 52 years. Changes in disability were reported by people themselves rather than being based on a doctor’s exam. Overall, 22% of people reported some worsening of their disability in the first few years of treatment, suggesting that disability can be slowed even in older individuals with MS.
NARCOMS also looked at employment and work productivity in people treated with Tecfidera for up to five years (Salter and colleagues. CMSC 2020; abstract DXT01). At the start of the study, people were 48 years of age on average and had been living with MS for 12 years. Most were able to maintain their job and their level of productivity. About 12% of people went from employed to not employed, 4% switched from working full-time to working part-time, and 7% went from unemployed to employed. About 11% said they had reduced the number of hours they now worked. People most commonly reported missing three work days per year, suggesting that people are generally able to maintain their wellness and functioning during treatment.
Tysabri (natalizumab): The Tysabri Observational Program (TOP) has been keeping track of over 6,000 people treated with Tysabri for over a decade and a new study reported on how people did in France in the period 2007-2016 (Kwiatkowski and colleagues. EAN 2020; abstract EPR2133). At the start of the study, most people had been living with MS for about eight years and had moderate disability (which is why they were put on Tysabri). After starting treatment, the relapse rate decreased to 0.19 and remained low over the next six years. Disability levels were stabilized but results were very individualized: about 26% had worsening disability, but 42% showed improvement in their level of disability.
Ocrevus (ocrelizumab): People with relapsing-remitting MS in the clinical trials of ocrelizumab have now been followed for six years and continue to do well (Giovannoni and colleagues. AAN 2020; abstract S5.010). The annualized relapse rate has remained low (0.05), although 1 in 5 people have experienced a worsening of their disability during six years of Ocrevus.
Also noteworthy this year was a database analysis of about 25,000 people with MS, which underscored the importance of treating MS early (Kalincik and colleagues. AAN 2020; abstract P5.008). Overall, treatment reduced relapses by about one-half and the risk of disability by about 26%. But there was a note of caution. The benefits of treatment declined with age (about 1% less per year). Therapies were less effective as a person’s level of disability increased and entered the secondary-progressive phase of the disease. People who started treated were more likely to show improvements in their disability – but the amount of benefit decreased about 2% for every year that they delayed starting a medication.
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