In patients with aged 10-17 and treated with fingolimod for up to 6 years in the PARADIGMS study, the annualized relapse rate (ARR) and the rate of new/newly enlarging T2 lesions remained low. These rates were significantly reduced in patients who switched from interferon (IFN) β-1a to fingolimod. No new safety signals were observed.
In the 2-year core phase of the PARADIGMS study, fingolimod demonstrated superior efficacy in terms of relapses and MRI outcomes versus IFNβ-1a in patients with pediatric MS aged 10-17. Fingolimod reduced the ARR by 82% and the annual rate of new/newly enlarging T2 lesions by 53%. The safety profile was similar to that seen in adults. Dr. Kumaran Deiva (Paris South University Hospitals, France) presented results of the ongoing, long-term, extension phase, during which patients are treated with open-label fingolimod for up to 5 additional years.
Of 215 patients randomized in the core phase, 170 (79.5%) continued in the extension phase. The extension phase consisted of 2 groups: patients who received fingolimod in the core and extension phase (continuous group; n=95) and patients who switched from IFNβ-1a in the core phase to fingolimod in the extension phase (switch group; n=76). The mean age at the start of the study in the core phase was 15.3 years. The median duration of fingolimod exposure was 2,061 days in the continuous-fingolimod group and 1,493 days in the switch group.
“Patients receiving IFN in the core phase benefited from a significant reduction in ARR after switching to fingolimod in the extension phase,” noted Dr Deiva. “ARR remained low and comparable with that of the core phase throughout the extension phase for patients who were on fingolimod from the start.” Adjusted ARR was 0.34 (95% CI, 0.25–0.47) in the switch group versus 0.11 (95% CI, 0.08–0.016) in the continuous group: a relative reduction of 67% (P<0.0001). A comparison within the switch group showed that the adjusted ARR in the core phase was 0.61 (0.44–0.84) and in the extension phase, after switching to fingolimod, this was 0.22 (0.15–0.34): a reduction of 64% (P<0.0001). The ARR among fingolimod users in the core phase was 0.07 (0.03–0.16) and 0.11 (0.06–0.19) in the extension phase (P=0.1634). Fingolimod had a likewise positive effect on the annualized new/newly enlarging T2 lesions. The between-group comparison showed a 40% reduction (P=0.0007); the within-group comparison showed a reduction of 42% (P<0.0001) during the extension phase, as well as a 27% reduction among patients who used fingolimod in both the core and extension phase.
The most frequently reported adverse events were nasopharyngitis (43.5%), headache (34.1%), leukopenia (25.3%), and upper respiratory tract infection (21.2%). Overall, no qualitative or quantitative changes in reported adverse events were observed with long-term exposure. The same was true for serious adverse events, and most of these were single events. Dr Deiva concluded that these results continue to support the positive benefit-risk profile of fingolimod in pediatric MS patients.
- Deiva K. Long-term efficacy and safety of fingolimod in pediatric multiple sclerosis patients: analysis of PARADIGMS study up to 6 years of treatment. Abstract O020, ECTRIMS 2022, 26–28 October, Amsterdam, the Netherlands.
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