Long-term Treatment with Gilenya Found to Limit Lesions, Relapses in Japanese MS Patients

Continuous treatment with Gilenya (fingolimod) helps limit relapses and detectable lesions in multiple sclerosis (MS) patients, according to a three-year, follow-up study in Japan. The results confirm the findings of trials conducted in predominantly Caucasian populations.

The findings were reported in the study, “Long-term efficacy and safety of fingolimod in Japanese patients with relapsing multiple sclerosis: 3-year results of the phase 2 extension study,” published in the journal BMC Neurology.

Gilenya has been found to reduce symptoms and magnetic resonance imaging (MRI)-detected lesions in Caucasian MS patients compared to interferon beta-1a, another treatment for MS. Gilenya’s benefits in Japanese patients with relapsing MS were reported in a six-month, Phase 2 study (NCT00537082).

In the follow-up study (NCT00670449), 143 of the initial trial’s 147 patients continued with treatment. Two-thirds were women with a mean age of 35.1 years. They continued the treatment until Gilenya received marketing authorization in Japan in November 2011.

Patients who received a placebo in the initial study switched to Gilenya at doses of 0.5 mg or 1.25 mg. After a benefit-risk analysis, all patients were moved to the 0.5 mg dose.

The extension study confirmed that continuous treatment with Gilenya helps sustain a low level of MRI-detected lesions. In total, 75% to 100% of the patients did not show gadolinium-enhanced T1 lesions, and 88% to 100% remained free of new or newly enlarged T2 lesions.

In addition, 45% to 62% did not have relapses. Patients who were taking a placebo in the first study and switched to Gilenya showed a 79.5% reduction in annualized relapses.

“Continuous fingolimod treatment over 36 months was associated with maintained efficacy and a manageable safety profile with no new safety signals. These results indicate that fingolimod provides long-term treatment benefit for Japanese patients with relapsing MS,” the team concluded.

Adverse effects with continuous treatment were generally mild or moderate. Nasopharyngitis, in which the throat and nasal passages become infected and inflamed, was most common. There were serious adverse effects in 19 patients, including bradycardia, macular edema, and infections. Five patients had to stop the treatment.

Patients with neuromyelitis optica (NMO), an inflammatory demyelinating disorder like MS that affects the optic nerve and spinal cord, should not receive the treatment on a continuous basis, the researchers wrote. For these patients, Gilenya could enhance disease activity through an unknown mechanism.

“NMO exacerbation has been reported in patients treated with MS disease-modifying therapies who were subsequently found to be anti-AQP4 antibody-positive, and in whom the initial diagnosis of MS was changed to NMO,” the researchers wrote.