Tags

Type your tag names separated by a space and hit enter

Oral fingolimod for the treatment of patients with relapsing forms of multiple sclerosis.
Int J Clin Pract. 2011 Aug; 65(8):887-95.IJ

Abstract

Fingolimod, a sphingosine 1-phosphate receptor modulator, is the first oral treatment approved by the US Food and Drug Administration for the treatment of relapsing forms of multiple sclerosis (MS). The aim of this review was to provide a concise, comprehensive overview of the clinically relevant mechanism of action, efficacy and safety information available for fingolimod. Key data were derived from two international, Phase III, double-blind, randomised trials (TRANSFORMS and FREEDOMS) performed over 12 and 24 months, respectively, which evaluated fingolimod 0.5 and 1.25 mg daily in 1703 patients with relapsing forms of MS. In TRANSFORMS, there was a 52% reduction in the annualised relapse rate (ARR) with fingolimod 0.5 mg vs. 30 μg intramuscular interferon beta-1a (0.16 vs. 0.33; p < 0.001) at 1 year. In FREEDOMS, there was a 55% decrease in ARR at 2 years with fingolimod 0.5 mg vs. placebo (0.18 vs. 0.40; p < 0.001). Risk of disability progression, confirmed at 3 months, was also reduced by 30% over the 2-year study period with fingolimod vs. placebo (p = 0.02). Significantly fewer new or enlarged lesions on T(2) -weighted images were seen in both studies (TRANSFORMS, p = 0.002 vs. interferon beta-1a at 1 year; FREEDOMS, p < 0.001 vs. placebo at 2 years). Overall, fingolimod 0.5 mg was well tolerated by patients. Transient, generally asymptomatic bradycardia and infrequent atrioventricular block were seen with the administration of the first dose. Macular oedema and serious infections occurred infrequently. Reversible, asymptomatic elevations of liver enzymes could also occur. As the first approved oral disease-modifying treatment, fingolimod offers patients a convenient alternative to regular self-injection for the treatment of relapsing forms of MS. In addition to high efficacy with a relatively acceptable safety profile, fingolimod provides a therapy with a new mechanism of action.

Authors+Show Affiliations

MS Center for Innovations in Care, Missouri Baptist Medical Center, St Louis, MO 63131, USA. hg@schmerzklinik.deNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Meta-Analysis
Research Support, Non-U.S. Gov't
Review

Language

eng

PubMed ID

21679286

Citation

Singer, B, et al. "Oral Fingolimod for the Treatment of Patients With Relapsing Forms of Multiple Sclerosis." International Journal of Clinical Practice, vol. 65, no. 8, 2011, pp. 887-95.
Singer B, Ross AP, Tobias K. Oral fingolimod for the treatment of patients with relapsing forms of multiple sclerosis. Int J Clin Pract. 2011;65(8):887-95.
Singer, B., Ross, A. P., & Tobias, K. (2011). Oral fingolimod for the treatment of patients with relapsing forms of multiple sclerosis. International Journal of Clinical Practice, 65(8), 887-95. https://doi.org/10.1111/j.1742-1241.2011.02721.x
Singer B, Ross AP, Tobias K. Oral Fingolimod for the Treatment of Patients With Relapsing Forms of Multiple Sclerosis. Int J Clin Pract. 2011;65(8):887-95. PubMed PMID: 21679286.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Oral fingolimod for the treatment of patients with relapsing forms of multiple sclerosis. AU - Singer,B, AU - Ross,A P, AU - Tobias,K, Y1 - 2011/06/16/ PY - 2011/6/18/entrez PY - 2011/6/18/pubmed PY - 2011/12/24/medline SP - 887 EP - 95 JF - International journal of clinical practice JO - Int. J. Clin. Pract. VL - 65 IS - 8 N2 - Fingolimod, a sphingosine 1-phosphate receptor modulator, is the first oral treatment approved by the US Food and Drug Administration for the treatment of relapsing forms of multiple sclerosis (MS). The aim of this review was to provide a concise, comprehensive overview of the clinically relevant mechanism of action, efficacy and safety information available for fingolimod. Key data were derived from two international, Phase III, double-blind, randomised trials (TRANSFORMS and FREEDOMS) performed over 12 and 24 months, respectively, which evaluated fingolimod 0.5 and 1.25 mg daily in 1703 patients with relapsing forms of MS. In TRANSFORMS, there was a 52% reduction in the annualised relapse rate (ARR) with fingolimod 0.5 mg vs. 30 μg intramuscular interferon beta-1a (0.16 vs. 0.33; p < 0.001) at 1 year. In FREEDOMS, there was a 55% decrease in ARR at 2 years with fingolimod 0.5 mg vs. placebo (0.18 vs. 0.40; p < 0.001). Risk of disability progression, confirmed at 3 months, was also reduced by 30% over the 2-year study period with fingolimod vs. placebo (p = 0.02). Significantly fewer new or enlarged lesions on T(2) -weighted images were seen in both studies (TRANSFORMS, p = 0.002 vs. interferon beta-1a at 1 year; FREEDOMS, p < 0.001 vs. placebo at 2 years). Overall, fingolimod 0.5 mg was well tolerated by patients. Transient, generally asymptomatic bradycardia and infrequent atrioventricular block were seen with the administration of the first dose. Macular oedema and serious infections occurred infrequently. Reversible, asymptomatic elevations of liver enzymes could also occur. As the first approved oral disease-modifying treatment, fingolimod offers patients a convenient alternative to regular self-injection for the treatment of relapsing forms of MS. In addition to high efficacy with a relatively acceptable safety profile, fingolimod provides a therapy with a new mechanism of action. SN - 1742-1241 UR - https://www.unboundmedicine.com/medline/citation/21679286/Oral_fingolimod_for_the_treatment_of_patients_with_relapsing_forms_of_multiple_sclerosis_ L2 - https://doi.org/10.1111/j.1742-1241.2011.02721.x DB - PRIME DP - Unbound Medicine ER -