Gilenya Seen to Particularly Benefit Young Adults with Higher Relapse Rates, Trial Data Show

Young adults with multiple sclerosis (MS) have higher relapse rates and respond better to Gilenya treatment compared to the overall MS population, data from a post hoc analysis of three separate trials show.

The study, “Relapse Rate and MRI Activity in Young Adult Patients With Multiple Sclerosis: A Post Hoc Analysis of Phase 3 Fingolimod Trials,” was published in the Multiple Sclerosis Journal – Experimental, Translational and Clinical.

Gilenya (fingolimod, marketed by Novartis) is an approved disease-modifying therapy for relapsing forms of MS.

Data from separate Phase 3 clinical trials, two comparing the efficacy of Gilenya to placebo — FREEDOMS (NCT00289978), and FREEDOMS II (NCT00355134) — and one to Avonex (interferon β-1a) — TRANSFORMS (NCT00340834) — were re-analyzed to determine the effectiveness of Gilenya 0.5 mg. This analysis focused on disease activity and response to treatment in a two subgroups — very young and young adult patients.

FREEDOMS and FREEDOMS II were two-year studies, which recruited 1,272 and 1,083 relapsing-remitting MS (RRMS) patients, respectively. TRANSFORMS was a one-year study involving 1,292 RRMS patients. All three trials included patients from 18 to 55 years of age.

Early-onset MS patients are known to have a higher rate of relapse and disease activity, increasing their chances to develop progressive MS at a younger age. Researchers, for this reason, focused on data from patients up to age 20 (youngest group) and those up to age 30 (young group) in the three trials, and compared results in these patients — at ages 20 and 30 — with the trials’ overall MS population.

Results showed that the annual relapse rate (ARR) was higher in the youngest and young study populations compared to patients overall, as measured using the three trials’ control groups. In FREEDOMS, the ARR for patients at age 20, 30, and the overall population were 0.73, 0.57, and 0.40, respectively; the corresponding values for FREEDOMS II were 0.67, 0.51, and 0.40, respectively; and for TRANSFORMS were 0.60, 0.48, and 0.33, respectively.

ARR was significantly lower in patients of all ages treated with Gilenya at 0.5 mg compared to placebo or Avonex. The reduction in ARR, however, was also found to be inversely proportional to a person’s age, with the youngest adult patients (age 20) given Gilenya showing the strongest reductions in ARR — 79% and 59% in FREEDOMS and FREEDOMS II, respectively, compared to placebo; and 77% in TRANSFORMS compared to Avonex.

Disease activity, indicated by the number of new or newly enlarging lesions on MRI (magnetic resonance imaging) scans, was higher in young adults in all three trials, the study reported. But again, Gilenya treatment was significantly associated with a lower number of lesions, compared to placebo and Avonex, in these patients.

The youngest MS population treated with Gilenya also significantly increased their chances of attaining NEDA (No Evidence of Disease Activity) status.

Results also showed Gilenya’s safety profile in young adults to be very similar to that of the control groups.

Based on the findings, the team concluded: “young adults show higher levels of MS disease activity, and may particularly benefit from fingolimod [Gilenya] treatment compared with the overall study population.”

“By efficiently suppressing the higher inflammatory response observed in younger patients, fingolimod may help restore brain plasticity, thereby facilitating recovery mechanisms,” the researchers added.

Gilenya recently became the first disease-modifying therapy approved by the U.S. Food and Drug Administration (FDA) to treat children and adolescents with relapsing MS, starting at age 10. The FDA decision was supported by data from the ongoing Phase 3 PARADIGMS study (NCT01892722) comparing the safety and effectiveness of Gilenya to Avonex in these young patients.