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Phase II study of oral fingolimod (FTY720) in multiple sclerosis: 3-year results.
Mult Scler. 2010 Feb; 16(2):197-207.MS

Abstract

In a 6-month, placebo-controlled trial, oral fingolimod (FTY720) 1.25 or 5.0 mg, once daily, significantly reduced MRI inflammatory activity and annualized relapse rate compared with placebo in patients with relapsing multiple sclerosis (MS). The objectives were to monitor the 36-month, interim efficacy and safety results of the ongoing extension of this study. In the extension (months 7-36), placebo-treated patients were re-randomized to either dose of fingolimod; fingolimod-treated patients continued at the same dose. During months 15-24, all patients receiving fingolimod 5.0 mg switched to 1.25 mg. Of the 250 patients who entered the extension study, 173 (69%) continued to month 36. Most patients were free from gadolinium-enhanced lesions (88-89%) or new T2 lesions (70-78%) at month 36. Patients receiving continuous fingolimod treatment had sustained low annualized relapse rates of 0.20-0.21, and 68-73% remained relapse-free at month 36. Over 36 months, nasopharyngitis (34%), headache (30%), fatigue (19%) and influenza (18%) were the most commonly reported adverse events. Pulmonary function remained stable and blood pressure was stable after an initial increase (3-5 mmHg) during the first 6 months of fingolimod treatment; serious adverse events included infections and skin cancer. The low MRI and clinical disease activity at 6 months were maintained at 36 months with fingolimod, which was generally well tolerated by most patients. The efficacy and safety of oral fingolimod are being further evaluated in a large phase III MS study programme.

Authors+Show Affiliations

Department of Neurology, Università Vita-Salute San Raffaele, Milan, Italy. g.comi@hsr.itNo 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 II
Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

20028707

Citation

Comi, G, et al. "Phase II Study of Oral Fingolimod (FTY720) in Multiple Sclerosis: 3-year Results." Multiple Sclerosis (Houndmills, Basingstoke, England), vol. 16, no. 2, 2010, pp. 197-207.
Comi G, O'Connor P, Montalban X, et al. Phase II study of oral fingolimod (FTY720) in multiple sclerosis: 3-year results. Mult Scler. 2010;16(2):197-207.
Comi, G., O'Connor, P., Montalban, X., Antel, J., Radue, E. W., Karlsson, G., Pohlmann, H., Aradhye, S., & Kappos, L. (2010). Phase II study of oral fingolimod (FTY720) in multiple sclerosis: 3-year results. Multiple Sclerosis (Houndmills, Basingstoke, England), 16(2), 197-207. https://doi.org/10.1177/1352458509357065
Comi G, et al. Phase II Study of Oral Fingolimod (FTY720) in Multiple Sclerosis: 3-year Results. Mult Scler. 2010;16(2):197-207. PubMed PMID: 20028707.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Phase II study of oral fingolimod (FTY720) in multiple sclerosis: 3-year results. AU - Comi,G, AU - O'Connor,P, AU - Montalban,X, AU - Antel,J, AU - Radue,E-W, AU - Karlsson,G, AU - Pohlmann,H, AU - Aradhye,S, AU - Kappos,L, AU - ,, Y1 - 2009/12/22/ PY - 2009/12/24/entrez PY - 2009/12/24/pubmed PY - 2010/4/23/medline SP - 197 EP - 207 JF - Multiple sclerosis (Houndmills, Basingstoke, England) JO - Mult. Scler. VL - 16 IS - 2 N2 - In a 6-month, placebo-controlled trial, oral fingolimod (FTY720) 1.25 or 5.0 mg, once daily, significantly reduced MRI inflammatory activity and annualized relapse rate compared with placebo in patients with relapsing multiple sclerosis (MS). The objectives were to monitor the 36-month, interim efficacy and safety results of the ongoing extension of this study. In the extension (months 7-36), placebo-treated patients were re-randomized to either dose of fingolimod; fingolimod-treated patients continued at the same dose. During months 15-24, all patients receiving fingolimod 5.0 mg switched to 1.25 mg. Of the 250 patients who entered the extension study, 173 (69%) continued to month 36. Most patients were free from gadolinium-enhanced lesions (88-89%) or new T2 lesions (70-78%) at month 36. Patients receiving continuous fingolimod treatment had sustained low annualized relapse rates of 0.20-0.21, and 68-73% remained relapse-free at month 36. Over 36 months, nasopharyngitis (34%), headache (30%), fatigue (19%) and influenza (18%) were the most commonly reported adverse events. Pulmonary function remained stable and blood pressure was stable after an initial increase (3-5 mmHg) during the first 6 months of fingolimod treatment; serious adverse events included infections and skin cancer. The low MRI and clinical disease activity at 6 months were maintained at 36 months with fingolimod, which was generally well tolerated by most patients. The efficacy and safety of oral fingolimod are being further evaluated in a large phase III MS study programme. SN - 1477-0970 UR - https://www.unboundmedicine.com/medline/citation/20028707/Phase_II_study_of_oral_fingolimod__FTY720__in_multiple_sclerosis:_3_year_results_ L2 - http://journals.sagepub.com/doi/full/10.1177/1352458509357065?url_ver=Z39.88-2003&rfr_id=ori:rid:crossref.org&rfr_dat=cr_pub=pubmed DB - PRIME DP - Unbound Medicine ER -