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Impact of fingolimod therapy on magnetic resonance imaging outcomes in patients with multiple sclerosis.
Arch Neurol. 2012 Oct; 69(10):1259-69.AN

Abstract

OBJECTIVE

To assess the impact of fingolimod (FTY720) therapy on magnetic resonance imaging measures of inflammatory activity and tissue damage in patients participating in a 2-year, placebo-controlled, phase 3 study.

DESIGN

Patients with active relapsing-remitting multiple sclerosis were randomized to receive fingolimod, 0.5 mg; fingolimod, 1.25 mg; or placebo for 2 years. Standardized magnetic resonance imaging scans were obtained at months 0, 6, 12, and 24 and centrally evaluated for number and volume of T1 gadolinium-enhancing, T2 hyperintense, and T1 hypointense lesions and for percentage of brain volume change. Findings were compared across subgroups by treatment and baseline characteristics.

SETTING

Worldwide, multicenter clinical trial.

PATIENTS

Patients were part of the fingolimod FTY720 Research Evaluating Effects of Daily Oral Therapy in Multiple Sclerosis (FREEDOMS) clinical trial for relapsing-remitting multiple sclerosis (N=1272).

MAIN OUTCOME MEASURES

We measured the effect of therapy on acute inflammatory activity, burden of disease, and irreversible loss of brain volume.

RESULTS

Fingolimod therapy resulted in rapid and sustained reductions in inflammatory lesion activity as assessed by gadolinium-enhancing and new/newly enlarged T2 lesions after 6, 12, and 24 months of therapy (P.001, all comparisons vs placebo). Changes in T2 hyperintense and T1 hypointense lesion volume also significantly favored fingolimod (P.05, all comparisons). Fingolimod, 0.5 mg (licensed dose), significantly reduced brain volume loss during months 0 to 6, 0 to 12, 12 to 24, and 0 to 24 (P.05, all comparisons) vs placebo, and subgroup analyses confirmed these effects over 2 years irrespective of the presence/absence of gadolinium-enhancing lesions, T2 lesion load, previous treatment status, or level of disability.

CONCLUSION

These results, coupled with the significant reductions in relapse rates and disability progression reported previously, support the positive impact on long-term disease evolution.

TRIAL REGISTRATION

clinicaltrials.gov Identifier: NCT00289978

Authors+Show Affiliations

Medical Image Analysis Center, University Hospital, Basel, Switzerland. eradue@uhbs.chNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial, Phase III
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

22751847

Citation

Radue, Ernst-Wilhelm, et al. "Impact of Fingolimod Therapy On Magnetic Resonance Imaging Outcomes in Patients With Multiple Sclerosis." Archives of Neurology, vol. 69, no. 10, 2012, pp. 1259-69.
Radue EW, O'Connor P, Polman CH, et al. Impact of fingolimod therapy on magnetic resonance imaging outcomes in patients with multiple sclerosis. Arch Neurol. 2012;69(10):1259-69.
Radue, E. W., O'Connor, P., Polman, C. H., Hohlfeld, R., Calabresi, P., Selmaj, K., Mueller-Lenke, N., Agoropoulou, C., Holdbrook, F., de Vera, A., Zhang-Auberson, L., Francis, G., Burtin, P., & Kappos, L. (2012). Impact of fingolimod therapy on magnetic resonance imaging outcomes in patients with multiple sclerosis. Archives of Neurology, 69(10), 1259-69.
Radue EW, et al. Impact of Fingolimod Therapy On Magnetic Resonance Imaging Outcomes in Patients With Multiple Sclerosis. Arch Neurol. 2012;69(10):1259-69. PubMed PMID: 22751847.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Impact of fingolimod therapy on magnetic resonance imaging outcomes in patients with multiple sclerosis. AU - Radue,Ernst-Wilhelm, AU - O'Connor,Paul, AU - Polman,Chris H, AU - Hohlfeld,Reinhard, AU - Calabresi,Peter, AU - Selmaj,Krystof, AU - Mueller-Lenke,Nicole, AU - Agoropoulou,Catherine, AU - Holdbrook,Frederick, AU - de Vera,Ana, AU - Zhang-Auberson,Lixin, AU - Francis,Gordon, AU - Burtin,Pascale, AU - Kappos,Ludwig, AU - ,, PY - 2012/7/4/entrez PY - 2012/7/4/pubmed PY - 2013/3/12/medline SP - 1259 EP - 69 JF - Archives of neurology JO - Arch. Neurol. VL - 69 IS - 10 N2 - OBJECTIVE: To assess the impact of fingolimod (FTY720) therapy on magnetic resonance imaging measures of inflammatory activity and tissue damage in patients participating in a 2-year, placebo-controlled, phase 3 study. DESIGN: Patients with active relapsing-remitting multiple sclerosis were randomized to receive fingolimod, 0.5 mg; fingolimod, 1.25 mg; or placebo for 2 years. Standardized magnetic resonance imaging scans were obtained at months 0, 6, 12, and 24 and centrally evaluated for number and volume of T1 gadolinium-enhancing, T2 hyperintense, and T1 hypointense lesions and for percentage of brain volume change. Findings were compared across subgroups by treatment and baseline characteristics. SETTING: Worldwide, multicenter clinical trial. PATIENTS: Patients were part of the fingolimod FTY720 Research Evaluating Effects of Daily Oral Therapy in Multiple Sclerosis (FREEDOMS) clinical trial for relapsing-remitting multiple sclerosis (N=1272). MAIN OUTCOME MEASURES: We measured the effect of therapy on acute inflammatory activity, burden of disease, and irreversible loss of brain volume. RESULTS: Fingolimod therapy resulted in rapid and sustained reductions in inflammatory lesion activity as assessed by gadolinium-enhancing and new/newly enlarged T2 lesions after 6, 12, and 24 months of therapy (P.001, all comparisons vs placebo). Changes in T2 hyperintense and T1 hypointense lesion volume also significantly favored fingolimod (P.05, all comparisons). Fingolimod, 0.5 mg (licensed dose), significantly reduced brain volume loss during months 0 to 6, 0 to 12, 12 to 24, and 0 to 24 (P.05, all comparisons) vs placebo, and subgroup analyses confirmed these effects over 2 years irrespective of the presence/absence of gadolinium-enhancing lesions, T2 lesion load, previous treatment status, or level of disability. CONCLUSION: These results, coupled with the significant reductions in relapse rates and disability progression reported previously, support the positive impact on long-term disease evolution. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00289978 SN - 1538-3687 UR - https://www.unboundmedicine.com/medline/citation/22751847/Impact_of_fingolimod_therapy_on_magnetic_resonance_imaging_outcomes_in_patients_with_multiple_sclerosis_ L2 - https://jamanetwork.com/journals/jamaneurology/fullarticle/10.1001/archneurol.2012.1051 DB - PRIME DP - Unbound Medicine ER -