Canadian RRMS Patients Less Likely to Discontinue Treatment with Oral Gilenya, Compared to Injectable or Infusible Therapies

Multiple sclerosis (MS) patients in Canada are more likely to comply with their treatment plan and less likely to discontinue the use of the oral disease-modifying treatment Gilenya (fingolimod), compared to injectable or infusible treatment options, new research shows.

The research article with that finding, “A retrospective claims analysis: Compliance and discontinuation rates among Canadian patients with multiple sclerosis treated with disease-modifying therapies,” was published in the journal PLOS One.

Disease-modifying therapies are effective in reducing the frequency and severity of relapses, or in delaying disability progression in MS patients.

In Canada, a total of 14 disease-modifying treatments have been approved for the treatment of relapsing-remitting MS (RRMS), with first- and second-line therapies available. However, the real effectiveness of those therapies can vary greatly, being affected by patient compliance rates (the frequency at which patients follow their prescribed medical treatment plan).

Evidence suggests that self-injectable disease-modifying treatments have poor compliance rates and high discontinuation rates. However, oral disease-modifying treatments, such as Gilenya, have shown higher compliance rates and lower discontinuation rates.

But there has not been a direct comparison of compliance and discontinuation rates of these different disease-modifying treatments among RRMS patients.

So, a team led by researchers at Novartis Pharmaceuticals Canada and Notre-Dame Hospital, Université de Montréal, Canada, conducted a retrospective study on the compliance and discontinuation rates of MS disease-modifying treatments available in Canada. (Of note, Novartis is the developer of Gilenya.)

Using highly detailed claims data from insurers, researchers identified RRMS patients who had at least one prescription filled for a disease-modifying treatment. They examined compliance and discontinuation rates at various time points (6, 12, and 24 months) following the initial claim.

In total, researchers identified 26,157 patients to be included in the compliance group, and and 32,795 patients in the discontinuation group.  Compliance was defined as a “medication possession ratio equal or higher than 80%,” while discontinuation was defined as a “gap greater than 30 days from the end of the index prescription.”

Claims data were collected for several disease-modifying treatments, namely:

• Oral: Gilenya, Tecfidera (dimethyl fumarate), and Aubagio (teriflunomide);
• Infusible: Tysabri (natalizumab);
• Injectables: Betaseron (interferon beta-1b), Rebif (interferon beta-1a), Avonex (interferon beta-1a), Copaxone (glatiramer acetate), and Extavia (interferon beta-1b); collectively, these therapies are known as “BRACE.”

Results showed that, after two years of treatment, a higher percentage of RRMS patients treated with Gilenya or Aubagio were more compliant, compared to those treated with other disease-modifying treatments.

A higher proportion of patients treated with Gilenya were deemed compliant at the different time points, compared to Tecfidera or BRACE — compliance at the 6-, 12- and 24-month time points with Gilenya was 75%, 75%, and 70%, respectively, compared to Tecfidera (70%, 68%, and 56%), and BRACE (53%, 47%, and 35%).

Researchers also found that patients treated with Gilenya or Aubagio had the lowest discontinuation rate, compared to either BRACE, Tysabri, or Tecfidera. Specifically, at the 6-, 12- and 24-month time points, patients using Gilenya had a far lower discontinuation rate (26%, 24%, and 29%), compared to BRACE (49%, 44%, and 57%), and Tysabri (33%, 29%, and 45%).

Patients on BRACE therapies had the lowest compliance and highest discontinuation rate at all time points.

In summary, researchers found that RRMS patients in Canada who are treated with oral disease-modifying treatments like Gilenya or Aubagio showed better compliance and lower discontinuation rates, compared to those treated with injectable or infusible treatments.

These findings were consistent with studies performed in the U.S.

“Improved compliance may help achieve therapeutic goals and may be associated with improved clinical benefits,” the researchers wrote. “These findings may help multiple sclerosis management strategies, which may lead to improved clinical and economic outcomes.”

The team emphasized the findings need to be confirmed by further research, because the entire study was done indirectly through claims data.