Effectiveness of Gilenya and Tecfidera Compared in Real-World Study in Italy

Effectiveness of Gilenya and Tecfidera Compared in Real-World Study in Italy

Gilenya (fingolimod) and Tecfidera (dimethyl fumarate) are equally effective as first-line treatments in people with relapsing-remitting multiple sclerosis (RRMS), but Gilenya may be of slightly more benefit to those who switch from a previous injectable therapy, according to a real-world study of patients in Italy.

The study, “Fingolimod vs. dimethyl fumarate in multiple sclerosis, A real-world propensity score-matched study,” was published in the journal Neurology.

Gilenya (marketed by Novartis) and Tecfidera (marketed by Biogen) are two disease-modifying therapies approved to treat RRMS.

Researchers retrospectively analyzed data from RRMS patients collected between 2011 and 2017 at seven MS outpatient clinics across central Italy.

In total, data from 275 patients treated with Gilenya and 275 patients treated with Tecfidera were analyzed.

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Patients were divided into two groups: those who received Gilenya or Tecfidera as a first MS therapy (treatment-naive group; 170 patients), and those who switched to either Gilenya or Tecfidera after using self-injectable MS therapies (switchers group; 380 patients).

Researchers appraised treatment efficacy based primarily on indications of “no evidence of disease activity status 3,” or NEDA-3; this is a combined measure that takes into account evidence of relapses, disability worsening, and new lesions seen on imaging scans.

Results showed that, at a median follow-up of 18 months, the number of patients achieving NEDA-3 was statistically similar in both Gilenya and Tecfidera treated groups — 73% and 70%, respectively.

Subgroup analysis showed the two medications to be of comparable effectiveness in treatment-naive patients.

Among switchers, however, a higher number of patients in the Gilenya group achieved NEDA-3 status (72%) compared with the Tecfidera group (68%). The researchers hypothesized that the study’s short follow-up duration (18 months) may have influenced this outcome.

“FNG [Gilenya]-treated patients had a 43% increased likelihood of achieving NEDA-3 status in the short-term period. This result was driven more by the greater effectiveness of FNG on relapses and disability worsening than by the effect on MRI activity,” the researchers wrote.

Three percent of all patients being treated with Gilenya, and  6 percent of those taking Tecfidera dropped out of the study due to treatment-associated adverse events. Their data were not included in the study.

The team highlighted that the study has certain limitations imposed by the small number of patients and lack of randomization. Also, Gilenya was approved in 2011 in Europe, four years before Tecfidera (2015), resulting in patients being treated with each drug at a different time during the study period.

Nonetheless, the team concluded: “We found no significant difference between FNG [Gilenya] and DMF [Tecfidera] on NEDA-3 status, while subgroup analyses suggest the superiority of [Gilenya] over [Tecfidera] in patients switching from self-injectable drugs.”

While their work “should be considered only hypothesis generating,” the researchers added, “our findings may provide additional information to help neurologists in selecting the most appropriate treatment according to different stages of disease.”

3 comments

  1. Heidi says:

    What about brain shrinkage? Which one is better for reducing that. I’d like to be on the drug that reduces brain atrophy rate by the greatest amount but studies don’t seem to assess that. Why not?

  2. Kim Camisa says:

    Possibly because “brain shrinkage,” is also a common finding in aging, and other chronic diseases, they did not use this as a dependent variable in the study. Not something that can be studied in other words. I was diagnosed in 2005, and have been on copaxone, avonex, and then back to copaxone. When Techfidera came on the market, my “new” neurologist decided I should try it as I had a relapse w/in last 24 mo. My relapses have become less debilitating, and no change at regular MRI intervals. I did, however develop a schwannoma, which, I suppose can be debated on whether it would “count,” as a relapse, or just a side effect of living with a neurologic disease that has other comorbid conditions with it. Yes, multiple types of brain tumors associated with the chronicity of this disease. Techfidera made a major difference for my relapse rate and my symptoms are much less with each “exacerbation,” not truly relapse-worthy by definition. The other injectable avonex, copaxone and the like had such severe side effects and were physically disfiguring as well I was eager to change. It worked for me, but the worst possible side effect would be PML and changing over from injectable to oral was really scarry as this was a possible risk factor at the time in 2012-13. Still, here, still alive, still working..

  3. Mark says:

    I used Gilenya for 2.5 years. I did not experience a relapse or new MRI activity in that time. However, my disability score increased significantly. I went from walking unassisted to using walking frame and wheelchair. I am now 7 months post round 1 of lemtrada. Disability continues to worsen, unfortunatley.

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