Long-term Gilenya Use Safe, Effective in Real-world Czech Study

Lindsey Shapiro, PhD avatar

by Lindsey Shapiro, PhD |

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Treatment with Gilenya (fingolimod) for up to four years was found safe and lowered relapse rates among people with multiple sclerosis (MS) in the Czech Republic, according to a real-world study called GOLEMS.

Older age, lower disability level, and fewer relapses prior to the treatment’s start were all associated with a lower risk of relapse during treatment with it.

“GOLEMS study demonstrated the sustained effectiveness and manageable safety profile of fingolimod under real-world conditions over 48 months in patients with MS,” the researchers wrote.

The study, “Real-world effectiveness and safety of fingolimod in patients with multiple sclerosis in the Czech Republic: results from core and extension parts of the GOLEMS study up to 48 months,” was published in BMC Neurology

Gilenya is an immunomodulatory treatment for MS that’s manufactured by Novartis. In Europe, it’s approved for patients over age 10 with relapsing-remitting MS (RRMS) and with active disease despite being treated with at least one other disease-modifying therapy.

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Gilenya’s approval was based on results from three large Phase 3 trials — FREEDOMS (NCT00289978), FREEDOMS II (NCT00355134), and TRANSFORMS (NCT00340834) — which showed it led to a significant reduction in relapse rates, MRI brain lesions, disability progression, and loss of brain volume.

Long-term extension studies from these trials, in addition to the long-term observational study LONGTERMS (NCT01201356), confirmed Gilenya’s sustained safety and effectiveness for long-term use.

The GOLEMS study — which stands for Gilenya (FingOLimod) in prescribing conditions defined by the CzEch regulator of drug reiMburSement — was designed to evaluate the real-world long-term safety and effectiveness of Gilenya in people who were prescribed the treatment at MS centers in the Czech Republic.

GOLEMS enrolled 240 patients in a one-year core study, with 211 entering an extension aimed at monitoring treatment outcomes for up to 48 months (four years). Overall, 155 people completed the four-year study period.

Most participants were female (70.4%) with an average age of 37 at the study’s start. The mean disease duration was 10.35 years before study enrollment. In the year before Gilenya initiation, 19.6% of patients were relapse-free, 22.5% had one relapse, and 57.9% had two or more relapses.

During the study, 65 patients permanently discontinued treatment and 20 stopped treatment temporarily. In patients for whom the information was available, the most common reasons for discontinuation were dissatisfaction with the treatment’s effects and adverse events.

The treatment was generally well tolerated and safe. Among 147 patients, 222 adverse events were reported, 100 of which were deemed to be treatment-related. Of all reported events, 21 were considered serious, with nine associated with Gilenya treatment.

Treatment was permanently discontinued due to side effects in 45 patients.

Among all treated participants, 91.1% were relapse-free after one month of treatment, which steadily declined to 40.1% after 48 months (four years). Of those who experienced relapses, most were considered moderate in severity.

In the year before treatment, the mean number of relapses was 1.6, which declined to 0.36 per year in those who completed the entire four years of treatment, indicating a reduction in relapse rate with Gilenya. Overall, patients with lower disability at the study’s start, as measured with the expanded disability status scale (EDSS), were more likely to be relapse-free than those with greater disability (EDSS score greater than three).

Older age and fewer relapses in the two years before Gilenya initiation were also significantly associated with a greater likelihood of being relapse-free during treatment. The researchers estimated that with “every 10-year increase in the age at baseline [study start], the chance of being free of relapses was almost 1.5 times higher.”

EDSS scores, work productivity, and work capability were relatively stable throughout treatment, illustrating that disability did not get worse for most patients while they were taking Gilenya.

Since the study was a non-interventional, observational trial, a standardized protocol to evaluate brain lesions via MRI was not established, and MRI data were not included in the analysis, the researchers noted.

Cessation of Tysabri (natalizumab), another approved MS treatment marketed by Biogen, is associated with a relatively high risk of relapse among MS patients. Gilenya is often considered a standard of care for preventing relapses after stopping Tysabri treatment.

One year before the study’s start, 59 people had received Tysabri. Among them, 19 were relapse-free after four years of Gilenya. Of those who relapsed, 40% had mild relapses, 45% moderate, and six had severe relapses.

The results demonstrate that “long-term treatment with fingolimod [Gilenya] showed sustained efficacy on disease activity measured by presence and severity of relapses and progression in neurological disability,” the researchers wrote.

They also said the study “confirmed a favorable safety profile by the low incidence of [serious adverse events] under real-world conditions in the Czech Republic.”

The study was supported by Novartis s.r.o., Czech Republic, and two of the four study authors are affiliated with the company.

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