April 29, 2021 | News | MS Research MS Treatments

Congress update: How do treatments perform in the real world?

The annual meeting of the American Academy of Neurology (AAN) has just wrapped up, with researchers presenting a number of new studies about the effectiveness of treatments in people with MS.

Current research efforts have focussed on ‘real-world’ studies rather than clinical trials. While trials are needed to establish a drug’s efficacy and safety, the people enrolled are highly selected – they have to meet a very narrow set of criteria (e.g. being a certain age, meeting certain disease criteria) to be included. In fact, a recent analysis of the German MS registry found that 83% of people would not have met the criteria to be enrolled in a trial for the drug they were taking (Jalusic et al. Mult Scler 2021; epublished January 20, 2021). We have seen a similar situation with COVID vaccines. Children are not eligible for vaccination at the moment because the trials did not enrol anyone younger than 16 years of age.

Clinical trials typically ask a very specific question, such as “Is this treatment safe and effective?’ But there are countless other questions, many of which can only be addressed by real-world studies.

For example, a Danish study looked at people on an injectable medication (an interferon or Copaxone) who had switched to Tecfidera or Aubagio (Buron and colleagues. AAN 2021; now published in J Neurol Neurosurg Psychiatry 2021;92:556-562). The researchers wanted to know if changing treatments would cause MS to get worse. They found that if people were clinically stable, they could safely be switched off the injectable to an oral therapy; their MS did not flare up and their level of disability did not get worse with the change in medication. This was not altogether surprising. A similar study in France previously reported that the risk of having a relapse was lower for people starting on an oral drug compared to one of the injectables (Vermersch and colleagues. Mult Scler Relat Disord 2020;46:102521).

Two studies presented at the AAN annual meeting compared Gilenya with Tecfidera. The first looked at cognitive processing speed. The Tecfidera group was slightly older (average age 47 years compared to 44 years with Gilenya). However, the two treatments had similar effects on mental processing speed over the course of a year (Hersh and colleagues. AAN 2021; P15.050).

The second study looked at the FDA’s adverse events database (called FAERS) to see if there were differences in the side effects that have been reported for the two drugs (Roman and colleagues. AAN 2021; P.15.224). There were more reports of infections with Gilenya compared to Tecfidera – something to consider in these COVID times. Viral infections were three-fold more common and herpesvirus infections were five-fold more common with Gilenya than Tecfidera. Flushing occurred more often with Tecfidera than with Gilenya.

Tecfidera was also compared with Vumerity, which received FDA approval in 2019. The two drugs are very similar and have the same mode of action, but Vumerity was shown to cause fewer gastrointestinal problems in a trial called EVOLVE-2 (Naismith and colleagues. CNS Drugs 2020;34:185-196). EVOLVE-2 also showed that the number of MRI lesions decreased in the first seven weeks of treatment with either Vumerity or Tecfidera; after everyone was switched to Vumerity, their MRIs continued to show improvement over the next year (Singer and colleagues. AAN 2021; P15.098). A separate analysis reported that about 82% of people were relapse-free after taking Vumerity for up to two years (Wray and colleagues. AAN 2021; P15.075). Also noteworthy was the first real-world study of people taking Vumerity in the U.S. Over the 8-month observation period, about 89% remained on therapy and few (3.8%) stopped treatment because of gastrointestinal side effects (Lewin and colleagues. AAN 2021; P15.227).

Share this article

Related Posts

Back